JPWO2020255105A5 - - Google Patents

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JPWO2020255105A5
JPWO2020255105A5 JP2022523737A JP2022523737A JPWO2020255105A5 JP WO2020255105 A5 JPWO2020255105 A5 JP WO2020255105A5 JP 2022523737 A JP2022523737 A JP 2022523737A JP 2022523737 A JP2022523737 A JP 2022523737A JP WO2020255105 A5 JPWO2020255105 A5 JP WO2020255105A5
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Japan
Prior art keywords
needle
subassembly
living body
injection
skin
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Pending
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JP2022523737A
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Japanese (ja)
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JP2023510677A (en
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Priority claimed from PCT/IB2020/055874 external-priority patent/WO2020255105A1/en
Publication of JP2023510677A publication Critical patent/JP2023510677A/en
Publication of JPWO2020255105A5 publication Critical patent/JPWO2020255105A5/ja
Pending legal-status Critical Current

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Claims (11)

生体への筋肉内および/または皮下注射に適した流体注入装置(1)であって、
前記装置はトリガ以外、一切の前記使用者のアクションなしに操作サイクルを完了させる必要なエネルギーを収容しており、ハウジング(2)に内蔵されるエネルギー貯蔵機構を有し、前記エネルギー貯蔵機構は少なくとも2つのバーストでエネルギーを提供する2つの予圧ばね(352、552)を含み、第1のバーストは、少なくとも1つの針(454)を十分な距離まで伸ばすのに適した第1のエネルギー量を第1の予圧ばねから提供し、前記生体の皮膚を貫通し、前記皮膚のさらなる距離まで挿入して注射部位に到達するようにし、第2のバーストは、所定の粘度の流体を注入し、前記流体を、少なくとも1つのリザーバ(602)から前記生体に押し出し、前記少なくとも1つの針を前記生体から退避するのに適した第2のエネルギー量を第2の予圧ばねから提供する装置。
A fluid injection device (1) suitable for intramuscular and/or subcutaneous injection into a living body,
Said device contains the necessary energy to complete an operating cycle without any action of said user other than a trigger, and has an energy storage mechanism incorporated in housing (2), said energy storage mechanism comprising at least It includes two preload springs (352, 552) that provide energy in two bursts, the first burst providing a first amount of energy suitable to extend at least one needle (454) a sufficient distance. provided from one preloaded spring to pierce the skin of the living body and insert a further distance through the skin to reach the injection site, a second burst injecting a fluid of predetermined viscosity, the fluid from at least one reservoir (602) into said living body and providing a second amount of energy from a second preload spring suitable for retracting said at least one needle from said living body.
前記少なくとも1つの針(452)は第1の端と第2の端とを有し、該第1の端と第2の端は、使用の際に、前記少なくとも1つの針の前記第1の端が動く方向は患者の皮膚に平行な方向に、前記少なくとも1つの針の前記第2の端が動く方向は前記患者の皮膚にほぼ非直交な方向になるように、一緒に並進しながらそれぞれの表面を指すように適合された請求項に記載の装置。 Said at least one needle (452) has a first end and a second end, said first end and said second end connecting said first end of said at least one needle in use. while translating together such that the direction of movement of the ends is parallel to the patient's skin and the direction of movement of the second end of the at least one needle is substantially non-perpendicular to the skin of the patient, respectively. 2. The device of claim 1 adapted to point to the surface of the . 前記少なくとも1つの針は、前記少なくとも1つの針の並進方向を、患者の皮膚に対して典型的には平行な1つの向きから、患者の皮膚に対して非直交な角度に変化させるマンドレルを通過する請求項1または2に記載の装置。 The at least one needle passes through a mandrel that changes the direction of translation of the at least one needle from one orientation, typically parallel to the patient's skin, to a non-orthogonal angle to the patient's skin. 3. Apparatus according to claim 1 or 2 . 前記マンドレル(702)は、前記針(452)が通過する際に前記針(452)を変形するように適合されている請求項に記載の装置。 4. The apparatus of claim 3 , wherein the mandrel (702) is adapted to deform the needle (452) as it passes through. 前記マンドレル(702)は、前記針の弾性限界を超えて前記針を変形させるように適合されており、それによって前記装置の再利用を防ぐ請求項に記載の装置。 4. The device of claim 3 , wherein the mandrel (702) is adapted to deform the needle beyond the elastic limit of the needle, thereby preventing reuse of the device. 注射のための作動時に前記少なくとも1つの針が貫通し延在する前記装置内の少なくとも1つの開口(706)を被覆し封止するように、前記ハウジング(2)に少なくとも1つの不浸透性薄膜(704)が貼り付けられている請求項1~のいずれか1項に記載の装置。 At least one impermeable membrane on said housing (2) to cover and seal at least one opening (706) in said device through which said at least one needle extends when actuated for injection. 6. Apparatus according to any one of claims 1 to 5 , wherein (704) is affixed. 請求項1に記載の装置(1)を作動する方法であって、以下のステップ:
前記装置(1)を第2の装置(1)に対として取り付けられている場合、前記装置(1)を取り外して一度に1つの装置を使用するステップと、
前記少なくとも1つの針(454)が貫通できる薄膜(704)が前記装置を封止するために使用されない限り、カバー(4)を取り外し、カバーを不要とするステップと、
装置本体(2)を前記生体の皮膚に押圧するステップと、
次のステップで手動トリガを可能にする押しボタン(14)を任意の検出器(12)が解除するのに十分になるまで、または、代替的に、前記検出器(12)がトリガ機構(200)を自動的に作動させるのに十分になるまで、前記生体の皮膚に加わる圧力を任意的に大きくするステップであり、後者の場合はステップfに移るステップと、
前記押しボタン(14)を押下し、それによって、代わりに少なくとも1つの挿入サブアセンブリ(300)を解除する前記トリガ機構(200)を作動させるステップと、
針注入端(454)が注入深さで前記生体に挿入されるまで、前記挿入サブアセンブリ(300)を使用して少なくとも1つの針サブアセンブリ(400)を押下し、針抽出端(456)が少なくとも1つのリザーバ(602)の、少なくとも1つの隔壁(604)を貫通するステップと、
一定の位置に到達すると、前記挿入サブアセンブリ(300)を主構造(102)にロックするステップと、
前記少なくとも1つの挿入サブアセンブリ(300)に取り付けられている、前記少なくとも1つの針サブアセンブリ(400)をロックするのと同時に、注入アセンブリ(500)を解除し、流体リザーバサブアセンブリ(600)を前記針サブアセンブリ(400)に押し出すステップと、
前記少なくとも1つの隔壁(604)を前記少なくとも1つのリザーバ(602)の底面方向に変位させ、ピストンとして作用して、前記流体(606)を、前記針抽出端(456)、前記少なくとも1つの針(452)、前記少なくとも1つの針注入端(454)を介して前記生体に注入するステップと、
前記装置を前記生体から取り外すステップと、
を含む方法。
A method of operating a device (1) according to claim 1, comprising the steps of:
a ) when said device (1) is attached to a second device (1) in pairs, removing said device (1) and using one device at a time;
b ) removing the cover (4) and making it unnecessary unless a membrane (704) through which said at least one needle (454) can penetrate is used to seal said device;
c ) pressing the device body (2) against the skin of the living body;
d ) until it is sufficient for any detector (12) to release the push button (14) allowing manual triggering in the next step, or alternatively, said detector (12) is optionally increasing the pressure applied to the skin of said living body until it is sufficient to automatically actuate (200), in which case proceeding to step f;
e ) depressing said push button (14), thereby actuating said trigger mechanism (200) which in turn releases at least one insertion subassembly (300);
f ) using the insertion subassembly (300) to depress at least one needle subassembly (400) until the needle injection end (454) is inserted into the living body at the injection depth; ) through at least one septum (604) of at least one reservoir (602);
h ) locking said insertion subassembly (300) to the main structure (102) once a certain position is reached;
i ) locking said at least one needle subassembly (400) attached to said at least one insertion subassembly (300), simultaneously releasing an injection assembly (500) and a fluid reservoir subassembly (600); ) into said needle subassembly (400);
j ) displacing said at least one septum (604) towards the bottom surface of said at least one reservoir (602) and acting as a piston to force said fluid (606) through said needle extraction tip (456), said at least one injecting into the living body via one needle (452), the at least one needle injection tip (454);
k ) removing the device from the living body;
method including.
請求項に記載の方法であって、ステップkでの除去に先んじて、前記注入サブアセンブリ(500)が前記少なくとも1つのリザーバを空にする際に、前記少なくとも1つの針サブアセンブリ(400)を前記少なくとも1つの挿入サブアセンブリ(300)から解除し、その後開始位置に押し戻し、それによって前記針注入端(454)が完全に前記主構造(102)内に退避するまで前記少なくとも1つの針(452)を退避させて、露出した針が引き起こしうる害を防ぐ追加ステップを含む方法。 8. The method of claim 7 , wherein the at least one needle subassembly (400) is emptied of the at least one reservoir prior to removal in step k when the injection subassembly (500) empties the at least one reservoir. is released from said at least one insertion subassembly (300) and then pushed back to its starting position, thereby pushing said at least one needle ( 452) to prevent harm that an exposed needle may cause. ステップhでのロックがラッチシステム(334)を利用して達成される請求項に記載の作動の方法。 8. The method of operation of claim 7 , wherein locking in step h is accomplished utilizing a latch system (334). 前記流体を導く前記針(452)の内部流路の少なくとも一部(754)が、前記針の前記内部流路の別の一部(756)の直径と異なる直径を有する請求項1~のいずれか1項に記載の装置。 7. The method of claims 1-6 , wherein at least a portion (754) of the internal channel of the needle (452) for conducting the fluid has a diameter different from a diameter of another portion (756) of the internal channel of the needle. A device according to any one of claims 1 to 3. 少なくとも2つの針が1つのハウジング内で同時に使用されて前記流体を前記生体へ導入する請求項1~10のいずれか1項に記載の装置。 11. The device of any one of claims 1-6 , 10 , wherein at least two needles are used simultaneously within one housing to introduce said fluid into said living body.
JP2022523737A 2019-06-21 2020-06-22 Medical injection system and method Pending JP2023510677A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962864572P 2019-06-21 2019-06-21
US62/864,572 2019-06-21
PCT/IB2020/055874 WO2020255105A1 (en) 2019-06-21 2020-06-22 Medical injection system and method

Publications (2)

Publication Number Publication Date
JP2023510677A JP2023510677A (en) 2023-03-15
JPWO2020255105A5 true JPWO2020255105A5 (en) 2023-05-08

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US (1) US20220355033A1 (en)
EP (1) EP3986507A1 (en)
JP (1) JP2023510677A (en)
CN (1) CN114080250A (en)
WO (1) WO2020255105A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023138800A1 (en) * 2022-01-19 2023-07-27 Subcuject Aps Auto injector with a separate distribution system

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US4227528A (en) * 1978-12-26 1980-10-14 Wardlaw Stephen C Automatic disposable hypodermic syringe
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DK2609946T3 (en) * 2003-08-12 2018-08-27 Becton Dickinson Co PLASTER-LIKE INFUSION DEVICE WITH PROTECTIVE ELEMENT
WO2008064092A2 (en) * 2006-11-21 2008-05-29 Intelliject, Inc. Devices, systems and methods for medicament delivery
JP5968326B2 (en) * 2010-11-03 2016-08-10 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Medicinal module for administering fixed doses
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