JPWO2021113670A5 - - Google Patents
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- 238000004146 energy storage Methods 0.000 claims description 65
- 210000005246 left atrium Anatomy 0.000 claims description 29
- 210000005245 right atrium Anatomy 0.000 claims description 25
- 230000001746 atrial effect Effects 0.000 claims description 12
- 239000008280 blood Substances 0.000 claims description 6
- 210000004369 blood Anatomy 0.000 claims description 6
- 210000002837 heart atrium Anatomy 0.000 claims description 6
- 230000005684 electric field Effects 0.000 claims description 4
- 239000012528 membrane Substances 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- 230000007704 transition Effects 0.000 claims description 4
- 230000036772 blood pressure Effects 0.000 claims description 2
- 239000003990 capacitor Substances 0.000 claims description 2
- 230000000747 cardiac effect Effects 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims description 2
- 230000002107 myocardial effect Effects 0.000 claims description 2
- 230000000977 initiatory effect Effects 0.000 claims 1
- 238000000034 method Methods 0.000 description 6
- 230000017531 blood circulation Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 1
Description
例えば、いくつかの実施形態では、本技術は心房間シャントシステムを提供する。それらのようなシステムは、中隔壁で、またはそれに隣接して患者に植込み可能なシャント要素を含む。シャント要素は、患者のＬＡ及びＲＡを流体連結し、それらの間の血流を促進することができる。例えば、シャント要素は、ＬＡに配置可能な第１のオリフィスとＲＡに配置可能な第２のオリフィスとの間に、貫通して伸びる管腔を有することができる。システムは、（ｉ）管腔、第１のオリフィス、及び／または第２のオリフィスの形状を選択的に調整するように構成された作動機構、（ｉｉ）患者の外部に配置されたエネルギー源からエネルギーを受取るように構成された植込み式エネルギー受取構成要素、及び（ｉｉｉ）植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵するように構成された植込み式エネルギー貯蔵構成要素をさらに含むことができる。植込み式エネルギー貯蔵構成要素は、蓄積されたエネルギーを選択的に放出して、作動機構及び／または１つまたは複数のセンサなどのシステムの１つまたは複数の能動構成要素に電力を供給することができる。
本発明は、例えば、以下を提供する。
（項目１）
患者の左心房と右心房との間で血液をシャントするためのシステムであって、
前記左心房に配置可能な第１のオリフィスと前記右心房に配置可能な第２のオリフィスとの間を貫通して伸びる管腔を有するシャント要素であって、前記管腔は、前記シャント要素が前記患者に植込まれるときに、前記左心房と前記右心房とを流体連結するように構成されている、シャント要素、
エネルギーを受取るように構成された植込み式エネルギー受取構成要素、及び
前記エネルギー受取構成要素と電気的に通信するように構成された植込み式エネルギー貯蔵構成要素、を含み、
前記エネルギー貯蔵構成要素内に貯蔵された前記エネルギーを使用して、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの形状を選択的に調整することができる、システム。
（項目２）
前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調整するように構成された作動機構をさらに備え、
前記エネルギー受取構成要素は、前記患者の外部に配置されたエネルギー源からエネルギーを受取るように構成され、
前記エネルギー貯蔵構成要素は、（ａ）前記エネルギー受取構成要素によって受取られたエネルギーを貯蔵し、（ｂ）前記貯蔵されたエネルギーを選択的に放出して前記作動機構に電力を供給するようにさらに構成される、項目１に記載のシステム。
（項目３）
前記作動機構が１つまたは複数の形状記憶要素を含み、
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを放出して前記１つまたは複数の形状記憶要素を加熱するように構成される、項目２に記載のシステム。
（項目４）
前記エネルギー受取構成要素が、（ｉ）前記患者の外部に配置された前記エネルギー源からエネルギーを受取り、及び／または（ｉｉ）前記患者の外部に配置された前記エネルギー源によって生成される磁場または電場に曝されたときにエネルギーを生成するように構成された金属ワイヤである、項目２に記載のシステム。
（項目５）
前記エネルギー受取構成要素が、前記エネルギー貯蔵構成要素から放出されたエネルギーを受取るように構成され、
前記エネルギー受取構成要素で受取られた前記エネルギーが、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調節するために使用される、項目１に記載のシステム。
（項目６）
前記エネルギー受取構成要素が、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調整するように構成された形状記憶作動要素を含む、項目５に記載のシステム。
（項目７）
前記エネルギー受取構成要素で受取られた前記エネルギーが、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調整するために前記形状記憶作動要素を加熱する、項目６に記載のシステム。
（項目８）
患者の左心房と右心房との間で血液をシャントするためのシステムであって、
前記左心房に配置可能な第１のオリフィスと前記右心房に配置可能な第２のオリフィスとの間を貫通して伸びる管腔を有するシャント要素であって、前記管腔は、前記シャント要素が前記患者に植込まれるときに、前記左心房と前記右心房とを流体連結するように構成されている、シャント要素、
前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの形状を選択的に調整するように構成された作動機構、
エネルギー源からエネルギーを受取るように構成された植込み式エネルギー受取構成要素、及び
前記植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵するように構成された植込み式エネルギー貯蔵構成要素であって、前記貯蔵されたエネルギーを選択的に放出して、前記作動機構及び／または前記システムの１つまたは複数の能動構成要素に電力を供給するようにさらに構成される、植込み式エネルギー貯蔵構成要素、
を含む、システム。
（項目９）
植込まれると、前記エネルギー受取構成要素及び前記エネルギー貯蔵構成要素が、前記患者の中隔壁の反対側に存在するように構成される、項目８に記載のシステム。
（項目１０）
前記エネルギー貯蔵構成要素が、前記エネルギー貯蔵構成要素の内皮化を促進するように構成された１つまたは複数の組織内部成長特徴を含む、項目８に記載のシステム。
（項目１１）
前記１つまたは複数の組織内部成長特徴が、外部コーティング、格子構造、粗面化された表面、及び／またはメッシュ構造を含む、項目１０に記載のシステム。
（項目１２）
前記エネルギー貯蔵構成要素が、電池またはコンデンサを含む、項目８に記載のシステム。
（項目１３）
前記エネルギー貯蔵構成要素は、第１のエネルギー貯蔵構成要素であり、前記システムは、第２のエネルギー貯蔵構成要素をさらに含む、項目８に記載のシステム。
（項目１４）
前記第１のエネルギー貯蔵構成要素が電池を含み、前記第２のエネルギー貯蔵構成要素がスーパーキャパシタを含む、項目１３に記載のシステム。
（項目１５）
前記エネルギー受取構成要素が、（ｉ）前記エネルギー源からエネルギーを受取り、及び／または（ｉｉ）前記エネルギー源によって生成された磁場または電場に曝されたときにエネルギーを生成するように構成された金属ワイヤを含む、項目８に記載のシステム。
（項目１６）
前記エネルギー受取構成要素が、前記患者の外部に配置されたエネルギー源からエネルギーを受取るように構成される、項目８に記載のシステム。
（項目１７）
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを選択的に放出して前記作動機構を作動させるように構成される、項目８に記載のシステム。
（項目１８）
前記作動機構が１つまたは複数の形状記憶要素を含み、
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを放出して前記１つまたは複数の形状記憶要素を加熱するように構成される、項目１７のいずれかに記載のシステム。
（項目１９）
前記形状記憶要素が転移温度を有し、
前記エネルギー貯蔵構成要素が、前記１つまたは複数の形状記憶要素を、前記転移温度を超える温度に加熱するのに十分なエネルギーを放出するように構成される、項目１８に記載のシステム。
（項目２０）
前記シャント要素が外径を有し、前記管腔が管腔直径を有し、
前記作動機構が、前記外径を実質的に変更することなく前記管腔直径を選択的に調整するように構成される、項目８に記載のシステム。
（項目２１）
前記作動機構がモータを含み、
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを選択的に放出して前記モータに電力を供給するように構成される、項目８に記載のシステム。
（項目２２）
前記１つまたは複数の能動構成要素は、前記患者の１つまたは複数の生理学的パラメータを測定するように構成された１つまたは複数のセンサを含み、
前記エネルギー貯蔵要素は、前記貯蔵されたエネルギーを選択的に放出して前記１つまたは複数のセンサに電力を供給するように構成される、項目８に記載のシステム。
（項目２３）
前記１つまたは複数のセンサは、前記左心房の第１の生理学的パラメータを測定するために前記患者の体内に植込まれ得る第１のセンサと、前記右心房の第２の生理学的パラメータを測定するために前記患者に植込まれ得る第２のセンサとを含む、項目２２に記載のシステム。
（項目２４）
前記中隔壁を横断するように構成された植込み式ハウジングをさらに備え、前記ハウジングが、
前記左心房内に延びるように構成される第１の端部であって、前記第１のセンサを収容する、第１の端部、及び
前記右心房内に延びるように構成される第２の端部であって、前記第２のセンサを収容する、第２の端部、
を備える、項目２３に記載のシステム。
（項目２５）
前記第１の生理学的パラメータは左心房圧であり、前記第２の生理学的パラメータは右心房圧である、項目２３に記載のシステム。
（項目２６）
前記測定された第１の生理学的パラメータ及び前記測定された第２の生理学的パラメータに少なくとも部分的に基づいて、前記左心房と前記右心房との間の圧力差を計算するように構成されたプロセッサをさらに備える、項目２５に記載のシステム。
（項目２７）
前記第１及び／または第２の生理学的パラメータ及び／または前記左心房と前記右心房との間の前記圧力差に少なくとも部分的に基づいて、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調整するために前記作動機構を方向付けるように構成されたコントローラをさらに備える、項目２６に記載のシステム。
（項目２８）
前記コントローラは、前記圧力差が所定の閾値上限を超える、及び／または所定の閾値下限を下回る場合に、前記作動機構を調整するように構成される、項目２７に記載のシステム。
（項目２９）
前記コントローラは、前記圧力差の変化率が所定の閾値を超えた場合に前記作動機構を調整するように構成される、項目２７に記載のシステム。
（項目３０）
前記シャント要素、前記作動機構、前記エネルギー受取構成要素、または前記エネルギー貯蔵構成要素のうちの少なくとも１つに無線で接続されるコントローラをさらに備え、
前記コントローラは、前記作動機構の作動を開始させるユーザインターフェースを提供する、項目８に記載のシステム。
（項目３１）
植込み式ハウジングであって、前記ハウジングの外部の環境から流体を隔離するように構成されたチャンバを含み、前記チャンバは、前記システムの１つまたは複数の構成要素を含む、植込み式ハウジングをさらに備える、項目８に記載のシステム。
（項目３２）
前記ハウジングが、前記左心房内に配置されるように構成された第１の端部と、前記右心房内に配置されるように構成された第２の端部とを有する、項目３１に記載のシステム。
（項目３３）
前記シャント要素に結合された膜をさらに含み、
前記シャント要素が前記患者に植込まれるとき、前記膜は前記中隔壁を備えたチャンバを画定し、
前記チャンバは前記左心房と前記右心房とから流体的に隔離され、
前記エネルギー受取構成要素、前記エネルギー貯蔵構成要素、前記作動機構、及び／または前記ハウジングは、前記チャンバ内に配置されている、項目８に記載のシステム。
（項目３４）
患者の左心房と右心房との間で血液をシャントするためのシステムであって、
前記患者の中隔壁を横切って植込まれ得るシャント要素であって、前記患者に植込まれたときに前記患者の前記左心房と前記右心房とを流体的に接続するように構成される、シャント要素、
前記中隔壁の第１の側に配置されるように構成された植込み式エネルギー受取構成要素であって、エネルギーを受取るようにさらに構成された、エネルギー受取構成要素、及び
前記第１の側とは反対側の前記中隔壁の第２の側に配置されるように構成された植込み式エネルギー貯蔵構成要素であって、（ｉ）前記植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵し、及び／または（ｉｉ）前記貯蔵されたエネルギーを選択的に放出して前記システムの１つまたは複数の能動構成要素に電力を供給するようにさらに構成される、エネルギー貯蔵構成要素、
を備える、システム。
（項目３５）
前記エネルギー貯蔵構成要素が、前記植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵するように構成される、項目３４に記載のシステム。
（項目３６）
前記エネルギー貯蔵構成要素は、前記貯蔵されたエネルギーを選択的に放出して、前記システムの前記１つまたは複数の能動構成要素に電力を供給するように構成される、項目３４に記載のシステム。
（項目３７）
前記エネルギー貯蔵構成要素は、（ｉ）前記植込まれたエネルギー受取構成要素によって受取られたエネルギーを貯蔵し、（ｉｉ）前記貯蔵されたエネルギーを選択的に放出して、前記システムの前記１つまたは複数の能動構成要素に電力を供給するように構成される、項目３４に記載のシステム。
（項目３８）
前記中隔壁の前記第１の側が前記左心房側であり、前記中隔壁の前記第２の側が前記右心房側である、項目３４に記載のシステム。
（項目３９）
前記中隔壁の前記第１の側が前記右心房側であり、前記中隔壁の前記第２の側が前記左心房側である、項目３４に記載のシステム。
（項目４０）
前記システムの前記１つまたは複数の能動構成要素が、前記患者の生理学的パラメータを測定するように構成された１つまたは複数のセンサを含む、項目３４に記載のシステム。
（項目４１）
前記１つまたは複数のセンサが、血圧、流速、ｐＨ、ＳｐＯ２、ＳｐＣ、ＳｐＭｅｔ、心拍数、心拍出量、及び／または心筋ストレインを測定するように構成される、項目４０に記載のシステム。
（項目４２）
前記１つまたは複数の能動構成要素が、前記シャント要素の形状を選択的に調整するように構成された作動機構を含む、項目３４に記載のシステム。
（項目４３）
前記１つまたは複数の能動構成要素は、前記エネルギー受取構成要素を含み、
前記エネルギー受取構成要素は、前記エネルギー貯蔵構成要素からエネルギーを受取るように構成される、項目３４に記載のシステム。
（項目４４）
前記エネルギー受取構成要素が、前記シャント要素の形状を選択的に調整するように構成された作動要素を含む、項目４３に記載のシステム。
（項目４５）
前記エネルギー受取構成要素が、前記患者の外部に配置されたエネルギー源からエネルギーを受取るように構成される、項目３４に記載のシステム。
（項目４６）
左心房と右心房を流体的に接続する管腔を有する調整可能な心房間シャントシステムを使用して、患者の前記左心房と前記右心房との間の血流を選択的に制御する方法であって、
植込まれたエネルギー受取構成要素を介して、前記患者の外部に配置されたエネルギー源からエネルギーを受取ること、
前記植込まれたエネルギー受取構成要素で受取られた前記エネルギーを、植込まれたエネルギー貯蔵構成要素に転送することであって、前記エネルギー貯蔵構成要素は、前記エネルギーを貯蔵する、こと、
前記植込まれたエネルギー貯蔵構成要素からの前記貯蔵されたエネルギーを選択的に放出して、前記管腔の形状を調整し、前記管腔を通る流れを選択的に変更すること、
を備える、方法。
（項目４７）
前記エネルギーを受取ることは、高周波エネルギー及び／または磁気エネルギーを受取ることを含む、項目４６に記載の方法。
（項目４８）
１つまたは複数のセンサを介して、１つまたは複数の生理学的パラメータを測定することをさらに含む、項目４６に記載の方法。
（項目４９）
少なくとも部分的に前記１つまたは複数の測定された生理学的パラメータに基づいて、前記左心房と前記右心房との間の圧力差を判定することをさらに含む、項目４８に記載の方法。
（項目５０）
前記管腔の前記直径を調整することは、少なくとも部分的に、所定の範囲以外にある前記判定された圧力差に基づく、項目４９に記載の方法。
For example, in some embodiments, the present technology provides an interatrial shunt system. Systems such as these include a shunt element implantable in the patient at or adjacent to the septal wall. The shunt element can fluidly connect the patient's LA and RA and facilitate blood flow therebetween. For example, the shunt element can have a lumen extending therethrough between a first orifice positionable at the LA and a second orifice positionable at the RA. The system includes: (i) an actuation mechanism configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice; (ii) an energy source located external to the patient; The implantable energy receiving component may further include an implantable energy receiving component configured to receive energy, and (iii) an implantable energy storage component configured to store energy received by the implantable energy receiving component. . The implantable energy storage component can selectively release stored energy to power one or more active components of the system, such as an actuation mechanism and/or one or more sensors. can.
The present invention provides, for example, the following.
(Item 1)
A system for shunting blood between the left and right atria of a patient, the system comprising:
A shunt element having a lumen extending between a first orifice positionable in the left atrium and a second orifice positionable in the right atrium, the lumen comprising: a first orifice positionable in the left atrium; a shunt element configured to fluidly connect the left atrium and the right atrium when implanted in the patient;
an implantable energy receiving component configured to receive energy; and
an implantable energy storage component configured to electrically communicate with the energy receiving component;
A system wherein the energy stored in the energy storage component can be used to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice.
(Item 2)
further comprising an actuation mechanism configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice;
the energy receiving component is configured to receive energy from an energy source located external to the patient;
The energy storage component is further configured to (a) store energy received by the energy receiving component and (b) selectively release the stored energy to power the actuation mechanism. The system according to item 1, comprising:
(Item 3)
the actuation mechanism includes one or more shape memory elements;
3. The system of item 2, wherein the energy storage component is configured to release the stored energy to heat the one or more shape memory elements.
(Item 4)
The energy receiving component (i) receives energy from the energy source located external to the patient, and/or (ii) magnetic or electric field generated by the energy source located external to the patient. 3. The system of item 2, wherein the metal wire is configured to generate energy when exposed to.
(Item 5)
the energy receiving component is configured to receive energy emitted from the energy storage component;
Item 1, wherein the energy received at the energy receiving component is used to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice. system.
(Item 6)
Item 5, wherein the energy receiving component includes a shape memory actuation element configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice. system.
(Item 7)
The energy received at the energy receiving component heats the shape memory actuating element to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice. , the system described in item 6.
(Item 8)
A system for shunting blood between the left and right atria of a patient, the system comprising:
A shunt element having a lumen extending between a first orifice positionable in the left atrium and a second orifice positionable in the right atrium, the lumen comprising: a first orifice positionable in the left atrium; a shunt element configured to fluidly connect the left atrium and the right atrium when implanted in the patient;
an actuation mechanism configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice;
an implantable energy receiving component configured to receive energy from an energy source; and
an implantable energy storage component configured to store energy received by the implantable energy receiving component, the implantable energy storage component configured to selectively release the stored energy to activate the actuation mechanism and/or the an implantable energy storage component further configured to power one or more active components of the system;
system, including.
(Item 9)
9. The system of item 8, wherein when implanted, the energy receiving component and the energy storage component are configured to reside on opposite sides of the patient's septal wall.
(Item 10)
9. The system of item 8, wherein the energy storage component includes one or more tissue ingrowth features configured to promote endothelialization of the energy storage component.
(Item 11)
11. The system of item 10, wherein the one or more tissue ingrowth features include an external coating, a lattice structure, a roughened surface, and/or a mesh structure.
(Item 12)
9. The system of item 8, wherein the energy storage component includes a battery or a capacitor.
(Item 13)
9. The system of item 8, wherein the energy storage component is a first energy storage component, and the system further includes a second energy storage component.
(Item 14)
14. The system of item 13, wherein the first energy storage component includes a battery and the second energy storage component includes a supercapacitor.
(Item 15)
The energy receiving component is a metal configured to (i) receive energy from the energy source and/or (ii) generate energy when exposed to a magnetic or electric field generated by the energy source. 9. The system of item 8, comprising a wire.
(Item 16)
9. The system of item 8, wherein the energy receiving component is configured to receive energy from an energy source located external to the patient.
(Item 17)
9. The system of item 8, wherein the energy storage component is configured to selectively release the stored energy to actuate the actuation mechanism.
(Item 18)
the actuation mechanism includes one or more shape memory elements;
18. The system of any of item 17, wherein the energy storage component is configured to release the stored energy to heat the one or more shape memory elements.
(Item 19)
the shape memory element has a transition temperature;
19. The system of item 18, wherein the energy storage component is configured to release sufficient energy to heat the one or more shape memory elements above the transition temperature.
(Item 20)
the shunt element has an outer diameter, the lumen has a luminal diameter,
9. The system of item 8, wherein the actuation mechanism is configured to selectively adjust the lumen diameter without substantially changing the outer diameter.
(Item 21)
the actuation mechanism includes a motor;
9. The system of item 8, wherein the energy storage component is configured to selectively release the stored energy to power the motor.
(Item 22)
the one or more active components include one or more sensors configured to measure one or more physiological parameters of the patient;
9. The system of item 8, wherein the energy storage element is configured to selectively release the stored energy to power the one or more sensors.
(Item 23)
The one or more sensors may include a first sensor implantable within the patient to measure a first physiological parameter of the left atrium and a second physiological parameter of the right atrium. and a second sensor implantable in the patient for measuring.
(Item 24)
further comprising an implantable housing configured to cross the septal wall, the housing comprising:
a first end configured to extend into the left atrium and housing the first sensor; and
a second end configured to extend into the right atrium and housing the second sensor;
The system according to item 23, comprising:
(Item 25)
24. The system of item 23, wherein the first physiological parameter is left atrial pressure and the second physiological parameter is right atrial pressure.
(Item 26)
configured to calculate a pressure difference between the left atrium and the right atrium based at least in part on the measured first physiological parameter and the measured second physiological parameter. 26. The system of item 25, further comprising a processor.
(Item 27)
based at least in part on the first and/or second physiological parameters and/or the pressure difference between the left atrium and the right atrium, the lumen, the first orifice, and/or 27. The system of item 26, further comprising a controller configured to direct the actuation mechanism to selectively adjust the shape of the second orifice.
(Item 28)
28. The system of item 27, wherein the controller is configured to adjust the actuation mechanism if the pressure difference exceeds an upper predetermined threshold and/or falls below a lower predetermined threshold.
(Item 29)
28. The system of item 27, wherein the controller is configured to adjust the actuation mechanism if the rate of change of the pressure difference exceeds a predetermined threshold.
(Item 30)
further comprising a controller wirelessly connected to at least one of the shunt element, the actuation mechanism, the energy receiving component, or the energy storage component;
9. The system of item 8, wherein the controller provides a user interface to initiate actuation of the actuation mechanism.
(Item 31)
further comprising an implantable housing including a chamber configured to isolate fluid from an environment external to the housing, the chamber containing one or more components of the system. , the system described in item 8.
(Item 32)
Item 31, wherein the housing has a first end configured to be placed in the left atrium and a second end configured to be placed in the right atrium. system.
(Item 33)
further comprising a membrane coupled to the shunt element;
when the shunt element is implanted in the patient, the membrane defines a chamber with the septal wall;
the chamber is fluidly isolated from the left atrium and the right atrium;
9. The system of item 8, wherein the energy receiving component, the energy storage component, the actuation mechanism, and/or the housing are located within the chamber.
(Item 34)
A system for shunting blood between the left and right atria of a patient, the system comprising:
a shunt element implantable across the patient's septal wall and configured to fluidly connect the left atrium and the right atrium of the patient when implanted in the patient; shunt element,
an implantable energy receiving component configured to be disposed on a first side of the septal wall, the energy receiving component further configured to receive energy;
an implantable energy storage component configured to be disposed on a second side of the septal wall opposite the first side, the implantable energy storage component being configured to: (i) be received by the implantable energy receiving component; and/or (ii) further configured to selectively release the stored energy to power one or more active components of the system. element,
A system equipped with.
(Item 35)
35. The system of item 34, wherein the energy storage component is configured to store energy received by the implantable energy receiving component.
(Item 36)
35. The system of item 34, wherein the energy storage component is configured to selectively release the stored energy to power the one or more active components of the system.
(Item 37)
The energy storage component (i) stores energy received by the implanted energy receiving component, and (ii) selectively releases the stored energy to improve the performance of the one of the systems. or the system of item 34, configured to power a plurality of active components.
(Item 38)
35. The system of item 34, wherein the first side of the septal wall is the left atrial side and the second side of the septal wall is the right atrial side.
(Item 39)
35. The system of item 34, wherein the first side of the septal wall is the right atrial side and the second side of the septal wall is the left atrial side.
(Item 40)
35. The system of item 34, wherein the one or more active components of the system include one or more sensors configured to measure physiological parameters of the patient.
(Item 41)
41. The system of item 40, wherein the one or more sensors are configured to measure blood pressure, flow rate, pH, SpO2, SpC, SpMet, heart rate, cardiac output, and/or myocardial strain.
(Item 42)
35. The system of item 34, wherein the one or more active components include an actuation mechanism configured to selectively adjust the shape of the shunt element.
(Item 43)
the one or more active components include the energy receiving component;
35. The system of item 34, wherein the energy receiving component is configured to receive energy from the energy storage component.
(Item 44)
44. The system of item 43, wherein the energy receiving component includes an actuation element configured to selectively adjust the shape of the shunt element.
(Item 45)
35. The system of item 34, wherein the energy receiving component is configured to receive energy from an energy source located external to the patient.
(Item 46)
A method of selectively controlling blood flow between the left atrium and the right atrium of a patient using an adjustable interatrial shunt system having a lumen fluidly connecting the left atrium and the right atrium. There it is,
receiving energy from an energy source located external to the patient via an implanted energy receiving component;
transferring the energy received at the implanted energy receiving component to an implanted energy storage component, the energy storage component storing the energy;
selectively releasing the stored energy from the implanted energy storage component to adjust the shape of the lumen and selectively alter flow through the lumen;
A method of providing.
(Item 47)
47. The method of item 46, wherein receiving energy includes receiving radio frequency energy and/or magnetic energy.
(Item 48)
47. The method of item 46, further comprising measuring one or more physiological parameters via one or more sensors.
(Item 49)
49. The method of item 48, further comprising determining a pressure difference between the left atrium and the right atrium based at least in part on the one or more measured physiological parameters.
(Item 50)
50. The method of item 49, wherein adjusting the diameter of the lumen is based, at least in part, on the determined pressure difference being outside a predetermined range.
Claims (44)
前記左心房に配置可能な第１のオリフィスと前記右心房に配置可能な第２のオリフィスとの間を貫通して伸びる管腔を有するシャント要素であって、前記管腔は、前記シャント要素が前記患者に植込まれるときに、前記左心房と前記右心房とを流体連結するように構成されている、シャント要素、
エネルギーを受取るように構成された植込み式エネルギー受取構成要素、及び
前記エネルギー受取構成要素と電気的に通信するように構成された植込み式エネルギー貯蔵構成要素、を含み、
前記エネルギー貯蔵構成要素内に貯蔵された前記エネルギーを使用して、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの形状を選択的に調整することができる、システム。 A system for shunting blood between the left and right atria of a patient, the system comprising:
A shunt element having a lumen extending between a first orifice positionable in the left atrium and a second orifice positionable in the right atrium, the lumen comprising: a first orifice positionable in the left atrium; a shunt element configured to fluidly connect the left atrium and the right atrium when implanted in the patient;
an implantable energy receiving component configured to receive energy; and an implantable energy storage component configured to be in electrical communication with the energy receiving component;
A system wherein the energy stored in the energy storage component can be used to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice.
前記エネルギー受取構成要素は、前記患者の外部に配置されたエネルギー源からエネルギーを受取るように構成され、
前記エネルギー貯蔵構成要素は、（ａ）前記エネルギー受取構成要素によって受取られたエネルギーを貯蔵し、（ｂ）前記貯蔵されたエネルギーを選択的に放出して前記作動機構に電力を供給するようにさらに構成される、請求項１に記載のシステム。 further comprising an actuation mechanism configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice;
the energy receiving component is configured to receive energy from an energy source located external to the patient;
The energy storage component is further configured to (a) store energy received by the energy receiving component and (b) selectively release the stored energy to power the actuation mechanism. The system of claim 1, configured.
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを放出して前記１つまたは複数の形状記憶要素を加熱するように構成される、請求項２に記載のシステム。 the actuation mechanism includes one or more shape memory elements;
3. The system of claim 2, wherein the energy storage component is configured to release the stored energy to heat the one or more shape memory elements.
前記エネルギー受取構成要素で受取られた前記エネルギーが、前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの前記形状を選択的に調節するために使用される、請求項１に記載のシステム。 the energy receiving component is configured to receive energy emitted from the energy storage component;
2. The energy receiving component according to claim 1, wherein the energy received at the energy receiving component is used to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice. System described.
前記左心房に配置可能な第１のオリフィスと前記右心房に配置可能な第２のオリフィスとの間を貫通して伸びる管腔を有するシャント要素であって、前記管腔は、前記シャント要素が前記患者に植込まれるときに、前記左心房と前記右心房とを流体連結するように構成されている、シャント要素、
前記管腔、前記第１のオリフィス、及び／または前記第２のオリフィスの形状を選択的に調整するように構成された作動機構、
エネルギー源からエネルギーを受取るように構成された植込み式エネルギー受取構成要素、及び
前記植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵するように構成された植込み式エネルギー貯蔵構成要素であって、前記貯蔵されたエネルギーを選択的に放出して、前記作動機構及び／または前記システムの１つまたは複数の能動構成要素に電力を供給するようにさらに構成される、植込み式エネルギー貯蔵構成要素、
を含む、システム。 A system for shunting blood between the left and right atria of a patient, the system comprising:
A shunt element having a lumen extending between a first orifice positionable in the left atrium and a second orifice positionable in the right atrium, the lumen comprising: a first orifice positionable in the left atrium; a shunt element configured to fluidly connect the left atrium and the right atrium when implanted in the patient;
an actuation mechanism configured to selectively adjust the shape of the lumen, the first orifice, and/or the second orifice;
an implantable energy receiving component configured to receive energy from an energy source; and an implantable energy storage component configured to store energy received by the implantable energy receiving component, the implantable energy storage component configured to store energy received by the implantable energy receiving component, an implantable energy storage component further configured to selectively release stored energy to power the actuation mechanism and/or one or more active components of the system;
system, including.
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを放出して前記１つまたは複数の形状記憶要素を加熱するように構成される、請求項１７のいずれかに記載のシステム。 the actuation mechanism includes one or more shape memory elements;
18. The system of any of claims 17, wherein the energy storage component is configured to release the stored energy to heat the one or more shape memory elements.
前記エネルギー貯蔵構成要素が、前記１つまたは複数の形状記憶要素を、前記転移温度を超える温度に加熱するのに十分なエネルギーを放出するように構成される、請求項１８に記載のシステム。 the shape memory element has a transition temperature;
19. The system of claim 18, wherein the energy storage component is configured to release sufficient energy to heat the one or more shape memory elements above the transition temperature.
前記作動機構が、前記外径を実質的に変更することなく前記管腔直径を選択的に調整するように構成される、請求項８に記載のシステム。 the shunt element has an outer diameter, the lumen has a luminal diameter,
9. The system of claim 8, wherein the actuation mechanism is configured to selectively adjust the lumen diameter without substantially changing the outer diameter.
前記エネルギー貯蔵構成要素が、前記貯蔵されたエネルギーを選択的に放出して前記モータに電力を供給するように構成される、請求項８に記載のシステム。 the actuation mechanism includes a motor;
9. The system of claim 8, wherein the energy storage component is configured to selectively release the stored energy to power the motor.
前記エネルギー貯蔵構成要素は、前記貯蔵されたエネルギーを選択的に放出して前記１つまたは複数のセンサに電力を供給するように構成される、請求項８に記載のシステム。 the one or more active components include one or more sensors configured to measure one or more physiological parameters of the patient;
9. The system of claim 8, wherein the energy storage component is configured to selectively release the stored energy to power the one or more sensors.
前記左心房内に延びるように構成される第１の端部であって、前記第１のセンサを収容する、第１の端部、及び
前記右心房内に延びるように構成される第２の端部であって、前記第２のセンサを収容する、第２の端部、
を備える、請求項２３に記載のシステム。 further comprising an implantable housing configured to cross the septal wall, the housing comprising:
a first end configured to extend into the left atrium and housing the first sensor; and a second end configured to extend into the right atrium. a second end, the second end accommodating the second sensor;
24. The system of claim 23, comprising:
前記コントローラは、前記作動機構の作動を開始させるユーザインターフェースを提供する、請求項８に記載のシステム。 further comprising a controller wirelessly connected to at least one of the shunt element, the actuation mechanism, the energy receiving component, or the energy storage component;
9. The system of claim 8, wherein the controller provides a user interface for initiating actuation of the actuation mechanism.
前記シャント要素が前記患者に植込まれるとき、前記膜は前記中隔壁を備えたチャンバを画定し、
前記チャンバは前記左心房と前記右心房とから流体的に隔離され、
前記エネルギー受取構成要素、前記エネルギー貯蔵構成要素、前記作動機構、及び／または前記ハウジングは、前記チャンバ内に配置されている、請求項８に記載のシステム。 further comprising a membrane coupled to the shunt element;
when the shunt element is implanted in the patient, the membrane defines a chamber with the septal wall;
the chamber is fluidly isolated from the left atrium and the right atrium;
9. The system of claim 8, wherein the energy receiving component, the energy storage component, the actuation mechanism, and/or the housing are located within the chamber.
前記患者の中隔壁を横切って植込まれ得るシャント要素であって、前記患者に植込まれたときに前記患者の前記左心房と前記右心房とを流体的に接続するように構成される、シャント要素、
前記中隔壁の第１の側に配置されるように構成された植込み式エネルギー受取構成要素であって、前記エネルギー受取構成要素は、エネルギーを受取るようにさらに構成され、前記エネルギー受取構成要素は、前記シャント要素の形状を選択的に調整するように構成された作動要素を含む、エネルギー受取構成要素、及び
前記第１の側とは反対側の前記中隔壁の第２の側に配置されるように構成された植込み式エネルギー貯蔵構成要素であって、（ｉ）前記植込み式エネルギー受取構成要素によって受取られたエネルギーを貯蔵し、及び／または（ｉｉ）前記貯蔵されたエネルギーを選択的に放出して前記システムの１つまたは複数の能動構成要素に電力を供給するようにさらに構成される、エネルギー貯蔵構成要素、
を備える、システム。 A system for shunting blood between the left and right atria of a patient, the system comprising:
a shunt element implantable across the patient's septal wall and configured to fluidly connect the left atrium and the right atrium of the patient when implanted in the patient; shunt element,
an implantable energy receiving component configured to be disposed on a first side of the septal wall, the energy receiving component further configured to receive energy , the energy receiving component comprising: an energy receiving component configured to selectively adjust the shape of the shunt element; and an energy receiving component disposed on a second side of the septal wall opposite the first side. an implantable energy storage component configured to (i) store energy received by the implantable energy receiving component; and/or (ii) selectively release the stored energy. an energy storage component further configured to power one or more active components of the system;
A system equipped with.
前記エネルギー受取構成要素は、前記エネルギー貯蔵構成要素からエネルギーを受取るように構成される、請求項３４に記載のシステム。 the one or more active components include the energy receiving component;
35. The system of claim 34, wherein the energy receiving component is configured to receive energy from the energy storage component.
35. The system of claim 34, wherein the energy receiving component is configured to receive energy from an energy source located external to the patient.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962944193P | 2019-12-05 | 2019-12-05 | |
| US62/944,193 | 2019-12-05 | ||
| US201962952894P | 2019-12-23 | 2019-12-23 | |
| US201962952903P | 2019-12-23 | 2019-12-23 | |
| US62/952,903 | 2019-12-23 | ||
| US62/952,894 | 2019-12-23 | ||
| PCT/US2020/063360 WO2021113670A1 (en) | 2019-12-05 | 2020-12-04 | Implantable shunt systems and methods |
Publications (2)
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| WO2021217055A1 (en) * | 2020-04-23 | 2021-10-28 | Shifamed Holdings, Llc | Intracardiac sensors with switchable configurations and associated systems and methods |
| EP4203847A4 (en) * | 2020-08-25 | 2024-02-28 | Shifamed Holdings Llc | Adjustable interatrial shunts and associated systems and methods |
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2020
- 2020-12-04 WO PCT/US2020/063360 patent/WO2021113670A1/en unknown
- 2020-12-04 JP JP2022533472A patent/JP2023504548A/en active Pending
- 2020-12-04 US US17/298,396 patent/US11253685B2/en active Active
- 2020-12-04 EP EP20896031.0A patent/EP4069345A4/en active Pending
- 2020-12-04 AU AU2020398239A patent/AU2020398239A1/en active Pending
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2022
- 2022-01-11 US US17/573,544 patent/US20220218964A1/en active Pending
- 2022-11-22 US US17/992,655 patent/US20230084193A1/en active Pending
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2023
- 2023-02-14 US US18/168,758 patent/US20230201546A1/en active Pending
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