JPWO2021087276A5 - - Google Patents

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JPWO2021087276A5
JPWO2021087276A5 JP2022525622A JP2022525622A JPWO2021087276A5 JP WO2021087276 A5 JPWO2021087276 A5 JP WO2021087276A5 JP 2022525622 A JP2022525622 A JP 2022525622A JP 2022525622 A JP2022525622 A JP 2022525622A JP WO2021087276 A5 JPWO2021087276 A5 JP WO2021087276A5
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tubular body
distal end
outer tubular
inner tubular
engaging member
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JP2022553808A (en
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Priority claimed from US16/672,217 external-priority patent/US10980523B1/en
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臓器に薬剤および／またはモダリティを送達するための医療デバイスであって、
第１の近位端、第１の遠位端、前記第１の近位端と前記第１の遠位端との間に延在する第１の管腔、および前記第１の近位端から前記第１の遠位端まで延在する第１の長手方向軸を備える、外側管状体と、
第２の近位端、第２の遠位端、前記第２の近位端と前記第２の遠位端との間に延在する第２の管腔、および前記第２の近位端から前記第２の遠位端まで延在する第２の長手方向軸を備える、内側管状体であって、
前記内側管状体は、前記外側管状体の前記第１の管腔内に移動可能に配置されており、
前記内側管状体の前記第２の近位端は、前記外側管状体の前記第１の近位端に動作可能に結合されており、
前記内側管状体は、前記外側管状体の前記第１の長手方向軸に沿って、第１の位置から第２の位置まで変位可能である、内側管状体と、
第３の近位端、第３の遠位端、および前記第３の近位端から前記第３の遠位端まで延在する第３の長手方向軸を備える、組織係合部材であって、
前記組織係合部材は、前記内側管状体の前記第２の遠位端に取り付けられており、
前記組織係合部材は、らせん形に成形されており、前記内側管状体を前記第２の長手方向軸を中心に回転させたときにコルク栓抜き様の移動で移動するように構成されており、
前記組織係合部材は、前記組織係合部材を前記第２の長手方向軸を中心に回転させたとき、前記コルク栓抜き様の移動によって、標的組織に貫入するように、かつ前記標的組織に前記医療デバイスを固定するように構成されており、
前記組織係合部材は、前記外側管状体の前記第１の管腔内にあり、前記組織係合部材の前記第３の遠位端は、前記内側管状体が前記第１の位置にあるときには前記外側管状体の前記第１の遠位端に対して陥凹しており、前記組織係合部材の前記第３の遠位端は、前記内側管状体が前記第２の位置にあるときには前記外側管状体の前記第１の遠位端の外に延在しており、
前記組織係合部材の前記第３の長手方向軸は、前記内側管状体が前記第１の位置、前記第２の位置、および前記第１の位置と前記第２の位置との間の位置にあるときには、前記外側管状体の前記第１の長手方向軸および前記内側管状体の前記第２の長手方向軸に実質的に平行である、組織係合部材と、
第４の近位端および第４の遠位端を有する、少なくとも１つの送達機構であって、
前記少なくとも１つの送達機構は、前記外側管状体の前記第１の管腔内に位置しており、
前記少なくとも１つの送達機構は、前記外側管状体に動作可能に結合されており、
前記少なくとも１つの送達機構は、前記外側管状体の前記第１の長手方向軸に沿って、第３の位置から第４の位置まで変位可能であり、
前記少なくとも１つの送達機構の前記第４の遠位端は、前記少なくとも１つの送達機構が前記第３の位置にあるときには前記外側管状体の前記第１の遠位端に対して陥凹しており、
前記少なくとも１つの送達機構の前記第４の遠位端は、前記少なくとも１つの送達機構が前記第４の位置にあるときには前記外側管状体の前記第１の遠位端の外に延在するように構成されている、少なくとも１つの送達機構と、を備える、医療デバイス。 A medical device for delivering agents and/or modalities to an organ, comprising:
an outer tubular body including a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end;
an inner tubular body comprising a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end;
the inner tubular body is movably disposed within the first lumen of the outer tubular body;
the second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body;
an inner tubular body displaceable from a first position to a second position along the first longitudinal axis of the outer tubular body;
a tissue engaging member comprising a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end,
the tissue engaging member is attached to the second distal end of the inner tubular body;
the tissue engaging member is helically shaped and configured to move in a corkscrew-like motion when the inner tubular body is rotated about the second longitudinal axis;
the tissue engaging member is configured to penetrate and secure the medical device to a target tissue by the corkscrew-like movement when the tissue engaging member is rotated about the second longitudinal axis;
the tissue engaging member is within the first lumen of the outer tubular body, the third distal end of the tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position, and the third distal end of the tissue engaging member extends outside the first distal end of the outer tubular body when the inner tubular body is in the second position;
a tissue engaging member, the third longitudinal axis of the tissue engaging member being substantially parallel to the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body when the inner tubular body is in the first position, the second position, and positions between the first and second positions;
at least one delivery mechanism having a fourth proximal end and a fourth distal end,
the at least one delivery mechanism is located within the first lumen of the outer tubular body;
the at least one delivery mechanism is operably coupled to the outer tubular body;
the at least one delivery mechanism is displaceable from a third position to a fourth position along the first longitudinal axis of the outer tubular body;
the fourth distal end of the at least one delivery mechanism is recessed relative to the first distal end of the outer tubular body when the at least one delivery mechanism is in the third position;
at least one delivery mechanism, wherein the fourth distal end of the at least one delivery mechanism is configured to extend out of the first distal end of the outer tubular body when the at least one delivery mechanism is in the fourth position. 前記外側管状体は、ステンレス鋼で作製されており、
前記外側管状体の外径は、前記第１の遠位端から前記第１の近位端に向かって増加し、
前記外側管状体の前記第１の遠位端は、面取りされている、請求項１に記載の医療デバイス。 the outer tubular body is made of stainless steel;
an outer diameter of the outer tubular body increases from the first distal end to the first proximal end;
The medical device of claim 1 , wherein the first distal end of the outer tubular body is beveled. 前記組織係合部材の前記第３の遠位端に取り付けられた先端部をさらに備え、
前記先端部の自由端は、鈍端である、請求項１に記載の医療デバイス。 a tip attached to the third distal end of the tissue engaging member;
The medical device of claim 1 , wherein the free end of the tip is blunt. 歯車をさらに備え、
前記歯車は、前記内側管状体の前記移動を制御するように構成されており、
前記外側管状体に対する前記歯車の回転可能範囲は、第１の所定の角度に制限されている、請求項１に記載の医療デバイス。 Further comprising gears;
the gear is configured to control the movement of the inner tubular body;
The medical device of claim 1 , wherein the range of rotation of the gear relative to the outer tubular body is limited to a first predetermined angle. 前記内側管状体を前記第２の長手方向軸を中心に第１の方向に回転させたとき、前記内側管状体および前記組織係合部材は、前記外側管状体の前記第１の遠位端に向かって移動し、
前記内側管状体を前記第２の長手方向軸を中心に第２の方向に回転させたとき、前記内側管状体および前記組織係合部材は、前記外側管状体の前記第１の近位端に向かって移動する、請求項４に記載の医療デバイス。 when the inner tubular body is rotated in a first direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first distal end of the outer tubular body;
5. The medical device of claim 4, wherein when the inner tubular body is rotated in a second direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first proximal end of the outer tubular body. ばねと、
親指押しボタンと、をさらに備え、
前記ばねは、前記内側管状体の移動を制御するように構成されており、
前記親指押しボタンは、前記ばねの移動を制御するように構成されている、請求項５に記載の医療デバイス。 A spring,
a thumb push button;
the spring is configured to control movement of the inner tubular body;
The medical device of claim 5 , wherein the thumb button is configured to control the movement of the spring. 前記外側管状体に対する前記内側管状体の回転可能範囲は、第１の所定の角度に制限されており、
前記親指押しボタンの操作は、前記外側管状体に対する前記内側管状体の回転を漸増的に可能にする、請求項６に記載の医療デバイス。 a range of rotation of the inner tubular body relative to the outer tubular body is limited to a first predetermined angle;
The medical device of claim 6 , wherein operation of the thumb push button incrementally enables rotation of the inner tubular body relative to the outer tubular body. 前記少なくとも１つの送達機構は、ニードル、カテーテル、チューブ、ガイドワイヤ、マッピング電極、リード、およびカメラからなる群から選択される少なくとも１つを含む、請求項１に記載の医療デバイス。 The medical device of claim 1, wherein the at least one delivery mechanism comprises at least one selected from the group consisting of a needle, a catheter, a tube, a guidewire, a mapping electrode, a lead, and a camera. 前記外側管状体に動作可能に結合された側面ポートをさらに備え、
前記少なくとも１つの送達機構は、前記側面ポートまたは前記親指押しボタンを操作することによって、前記第３の位置と前記第４の位置との間を移動するように構成されており、
前記側面ポートは、前記側面ポートを通して供給され、かつ前記少なくとも１つの送達機構の前記第４の遠位端から分配される、前記薬剤および／または前記モダリティを送達するための導管となるように構成されている、請求項６に記載の医療デバイス。 a side port operably coupled to the outer tubular body;
the at least one delivery mechanism is configured to be moved between the third position and the fourth position by operating the side port or the thumb button;
7. The medical device of claim 6, wherein the side port is configured to be a conduit for delivery of the agent and/or the modality fed through the side port and dispensed from the fourth distal end of the at least one delivery mechanism. 前記側面ポートに取り付けられた活栓をさらに備え、
前記活栓は、空気漏れを防止するように構成されており、
前記活栓は、注射器を接続するように構成されている、請求項９に記載の医療デバイス。 a stopcock attached to the side port;
The stopcock is configured to prevent air leakage;
The medical device of claim 9 , wherein the stopcock is configured to connect a syringe. 前記薬剤および／または前記モダリティは、医薬、ゲル、成長因子、細胞、電流、電圧、または電気信号を含む、請求項１に記載の医療デバイス。 The medical device of claim 1, wherein the agent and/or modality comprises a medicine, a gel, a growth factor, a cell, an electric current, a voltage, or an electrical signal. 医療デバイスの挿入深度を制御する方法であって、
請求項７に記載の医療デバイスの親指押しボタンの選択的操作によって、医療デバイスを所定の深度まで挿入することを含む、方法。 1. A method for controlling an insertion depth of a medical device , comprising:
10. A method comprising inserting a medical device to a predetermined depth by selective actuation of a thumb button of the medical device of claim 7 . １つ以上の薬剤および／またはモダリティを前記所定の深度まで直接送達することをさらに含み、
前記１つ以上の薬剤および／または前記モダリティは、第１の薬剤または前記モダリティと、１つ以上のさらなる薬剤および／または前記モダリティと、を含み、
前記第１の薬剤または前記モダリティ、および前記１つ以上のさらなる薬剤および／または前記モダリティは、同時または順次に送達され、
前記第１の薬剤または前記モダリティを受容する領域、および前記１つ以上のさらなる薬剤および／または前記モダリティを受容する領域は、実質的に重複する、請求項１２に記載の方法。 further comprising delivering one or more agents and/or modalities directly to said predetermined depth;
the one or more agents and/or modalities include a first agent or modality and one or more further agents and/or modalities;
the first agent or modality and the one or more additional agents and/or modalities are delivered simultaneously or sequentially;
The method of claim 12 , wherein the region receiving the first agent or modality and the region receiving the one or more further agents and/or modalities substantially overlap. 前記１つ以上の薬剤および／またはモダリティは、医薬、ゲル、成長因子、細胞、電流、電圧、または電気信号を含む、請求項１３に記載の方法。 The method of claim 13 , wherein the one or more agents and/or modalities include a medicine, a gel, a growth factor, a cell, an electrical current, a voltage, or an electrical signal. 前記内側管状体が前記第１の位置にある状態の前記医療デバイスの前記第１の遠位端を患者の体腔に挿入することと、
前記医療デバイスの前記第１の遠位端が前記患者の心膜と接触しているように前記医療デバイスを操作することと、
前記組織係合部材の前記先端部を使用して、前記心膜を貫通することと、
前記内側管状体を第１の方向に回転させて、前記組織係合部材を患者の心臓と係合させることと、
前記内側管状体を前記第２の位置に位置させることと、
前記１つ以上の薬剤および／またはモダリティを前記心筋に送達することと、
前記組織係合部材を第２の方向に回動させることにより、前記医療デバイスを前記患者から解放することと、
前記医療デバイスを前記患者から取り出すことと、を含む、請求項１３に記載の方法。 inserting the first distal end of the medical device with the inner tubular body in the first position into a body cavity of a patient;
manipulating the medical device such that the first distal end of the medical device is in contact with the patient's pericardium;
penetrating the pericardium using the tip of the tissue engaging member;
rotating the inner tubular body in a first direction to engage the tissue engaging member with the patient's heart;
positioning the inner tubular body in the second position;
delivering the one or more agents and/or modalities to the myocardium;
releasing the medical device from the patient by rotating the tissue engaging member in a second direction; and
The method of claim 13 , further comprising: removing the medical device from the patient. 前記医療デバイスは、前記第１の薬剤またはモダリティの送達中、ならびに前記１つ以上のさらなる薬剤および／またはモダリティの送達中に、前記組織係合部材を介して前記心筋に取り付けられており、
前記医療デバイスは、前記第１の薬剤またはモダリティの前記送達と、前記１つ以上のさらなる薬剤および／またはモダリティの前記送達との間に、前記心筋から解放されない、請求項１３に記載の方法。 the medical device is attached to the myocardium via the tissue engaging member during delivery of the first agent or modality and during delivery of the one or more additional agents and/or modalities;
The method of claim 13 , wherein the medical device is not released from the myocardium between the delivery of the first agent or modality and the delivery of the one or more additional agents and/or modalities. 臓器に薬剤および／またはモダリティを送達するための医療デバイスであって、
第１の近位端、第１の遠位端、前記第１の近位端と前記第１の遠位端との間に延在する第１の管腔、および前記第１の近位端から前記第１の遠位端まで延在する第１の長手方向軸を備える、外側管状体であって、
前記外側管状体の外径は、前記第１の遠位端から前記第１の近位端に向かって増加し、
前記外側管状体の前記第１の遠位端は、面取りされている、外側管状体と、
第２の近位端、第２の遠位端、前記第２の近位端と前記第２の遠位端との間に延在する第２の管腔、および前記第２の近位端から前記第２の遠位端まで延在する第２の長手方向軸を備える、内側管状体であって、
前記内側管状体は、前記外側管状体の前記第１の管腔内に移動可能に配置されており、
前記内側管状体の前記第２の近位端は、前記外側管状体の前記第１の近位端に動作可能に結合されており、
前記内側管状体は、前記外側管状体の前記第１の長手方向軸に沿って、第１の位置から第２の位置まで変位可能である、内側管状体と、
第３の近位端、第３の遠位端、および前記第３の近位端から前記第３の遠位端まで延在する第３の長手方向軸を備える、組織係合部材であって、
前記組織係合部材は、前記内側管状体の前記第２の遠位端に取り付けられており、
前記組織係合部材は、らせん形に成形されており、前記内側管状体を前記第２の長手方向軸を中心に回転させたときにコルク栓抜き様の移動で移動するように構成されており、
前記組織係合部材は、前記組織係合部材を前記第２の長手方向軸を中心に回転させたとき、前記コルク栓抜き様の移動によって、標的組織に貫入するように、かつ前記標的組織に前記医療デバイスを固定するように構成されており、
前記組織係合部材は、前記外側管状体の前記第１の管腔内にあり、前記組織係合部材の前記第３の遠位端は、前記内側管状体が前記第１の位置にあるときには前記外側管状体の前記第１の遠位端に対して陥凹しており、前記組織係合部材の前記第３の遠位端は、前記内側管状体が前記第２の位置にあるときには前記外側管状体の前記第１の遠位端の外に延在しており、
前記組織係合部材の前記第３の長手方向軸は、前記内側管状体が前記第１の位置、前記第２の位置、および前記第１の位置と前記第２の位置との間の位置にあるときには、前記外側管状体の前記第１の長手方向軸および前記内側管状体の前記第２の長手方向軸に実質的に平行である、組織係合部材と、
歯車であって、
前記歯車は、前記内側管状体の前記動きを制御するように構成されており、
前記外側管状体に対する前記歯車の回転可能範囲は、第１の所定の角度に制限されており、
前記内側管状体を前記第２の長手方向軸を中心に第１の方向に回転させたとき、前記内側管状体および前記組織係合部材は、前記外側管状体の前記第１の遠位端に向かって移動し、
前記内側管状体を前記第２の長手方向軸を中心に第２の方向に回転させたとき、前記内側管状体および前記組織係合部材は、前記外側管状体の前記第１の近位端に向かって移動し、
前記外側管状体に対する前記内側管状体の回転可能範囲は、第１の所定の角度に制限されている、歯車と、
ばねであって、
前記ばねは、前記内側管状体の動きを制御するように構成されている、ばねと、
親指押しボタンであって、
前記親指押しボタンは、前記ばねの移動を制御するように構成されており、
前記親指押しボタンの操作は、前記外側管状体に対する前記内側管状体の回転を漸増的に可能にする、親指押しボタンと、
第４の近位端および第４の遠位端を有する少なくとも１つの送達機構であって、
前記少なくとも１つの送達機構は、前記外側管状体の前記第１の管腔内に位置しており、
前記少なくとも１つの送達機構は、前記外側管状体に動作可能に結合されており、
前記少なくとも１つの送達機構は、前記外側管状体の前記第１の長手方向軸に沿って、第３の位置から第４の位置まで変位可能であり、
前記少なくとも１つの送達機構の前記第４の遠位端は、前記少なくとも１つの送達機構が前記第３の位置にあるときには前記外側管状体の前記第１の遠位端に対して陥凹しており、
前記少なくとも１つの送達機構の前記第４の遠位端は、前記少なくとも１つの送達機構が前記第４の位置にあるときには前記外側管状体の前記第１の遠位端の外に延在するように構成されている、少なくとも１つの送達機構と、を備える、医療デバイス。 A medical device for delivering agents and/or modalities to an organ, comprising:
an outer tubular body comprising a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end;
an outer diameter of the outer tubular body increases from the first distal end to the first proximal end;
an outer tubular body, the first distal end of the outer tubular body being chamfered;
an inner tubular body comprising a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end;
the inner tubular body is movably disposed within the first lumen of the outer tubular body;
the second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body;
an inner tubular body displaceable from a first position to a second position along the first longitudinal axis of the outer tubular body;
a tissue engaging member comprising a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end,
the tissue engaging member is attached to the second distal end of the inner tubular body;
the tissue engaging member is helically shaped and configured to move in a corkscrew-like motion when the inner tubular body is rotated about the second longitudinal axis;
the tissue engaging member is configured to penetrate and secure the medical device to a target tissue by the corkscrew-like movement when the tissue engaging member is rotated about the second longitudinal axis;
the tissue engaging member is within the first lumen of the outer tubular body, the third distal end of the tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position, and the third distal end of the tissue engaging member extends outside the first distal end of the outer tubular body when the inner tubular body is in the second position;
a tissue engaging member, the third longitudinal axis of the tissue engaging member being substantially parallel to the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body when the inner tubular body is in the first position, the second position, and positions between the first and second positions;
A gear,
the gear is configured to control the movement of the inner tubular body;
a rotatable range of the gear relative to the outer tubular body is limited to a first predetermined angle;
when the inner tubular body is rotated in a first direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first distal end of the outer tubular body;
when the inner tubular body is rotated in a second direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first proximal end of the outer tubular body;
a gear, the range of rotation of the inner tubular body relative to the outer tubular body being limited to a first predetermined angle;
A spring,
a spring configured to control movement of the inner tubular body; and
A thumb push button,
the thumb push button is configured to control the movement of the spring;
a thumb push button, operation of which incrementally enables rotation of the inner tubular body relative to the outer tubular body;
at least one delivery mechanism having a fourth proximal end and a fourth distal end,
the at least one delivery mechanism is located within the first lumen of the outer tubular body;
the at least one delivery mechanism is operably coupled to the outer tubular body;
the at least one delivery mechanism is displaceable from a third position to a fourth position along the first longitudinal axis of the outer tubular body;
the fourth distal end of the at least one delivery mechanism is recessed relative to the first distal end of the outer tubular body when the at least one delivery mechanism is in the third position;
at least one delivery mechanism, wherein the fourth distal end of the at least one delivery mechanism is configured to extend out of the first distal end of the outer tubular body when the at least one delivery mechanism is in the fourth position. 中央ルアーロックをさらに備え、
前記中央ルアーロックの管腔は、前記内側管状体の前記第２の管腔と、または前記少なくとも１つの送達機構の管腔と連続しており、
前記中央ルアーロックは、前記中央ルアーロックを通して供給され、かつ前記内側管状体の前記第２の遠位端または前記少なくとも１つの送達機構の前記第４の遠位端から分配される、前記薬剤および／または前記モダリティを送達するための導管となるように構成されており、
前記中央ルアーロックは、活栓を受容するように構成されている、請求項１７に記載の医療デバイス。 It also has a central luer lock.
a lumen of the central luer lock is continuous with the second lumen of the inner tubular body or with a lumen of the at least one delivery mechanism;
the central luer lock is configured to be a conduit for delivery of the agent and/or the modality fed through the central luer lock and dispensed from the second distal end of the inner tubular body or the fourth distal end of the at least one delivery mechanism;
The medical device of claim 17 , wherein the central luer lock is configured to receive a stopcock.
JP2022525622A 2019-11-01 2020-10-30 Medical device for controlled access to the pericardial space Pending JP2022553808A (en)

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