JP6541971B2 - Cardiac support device - Google Patents

Cardiac support device Download PDF

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JP6541971B2
JP6541971B2 JP2014266294A JP2014266294A JP6541971B2 JP 6541971 B2 JP6541971 B2 JP 6541971B2 JP 2014266294 A JP2014266294 A JP 2014266294A JP 2014266294 A JP2014266294 A JP 2014266294A JP 6541971 B2 JP6541971 B2 JP 6541971B2
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heart
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permanent magnet
electromagnet
auxiliary membrane
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JP2016123593A (en
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喜郎 松居
喜郎 松居
林　秀朗
秀朗 林
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Japan Medical Creative LLC
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Description

本発明は、心臓支援補助装置に関する。   The present invention relates to a cardiac support device.

拡張型心筋症のように心臓のポンプ機能が低下した心疾患患者に対しては、左心室形成術や、患者の心臓を人工心臓で補助する手術が行われる。また、特許文献１のような補助人工心臓装置を心臓に直接取り付ける手術も提供提案されている。   For patients with heart disease, such as dilated cardiomyopathy, in which the heart's pumping function is reduced, left ventricular angioplasty and surgery are performed to assist the patient's heart with an artificial heart. In addition, a surgery in which an auxiliary artificial heart device as in Patent Document 1 is directly attached to the heart is also proposed and proposed.

特許文献１の補助人工心臓装置は心臓を包み込む袋形状で、内側に被覆部材、外側に固定成形部材を有し、被覆部材に永久磁石、固定成形部材に極性を切り替え可能な電磁石が設置されている。電磁石の極性の切り替えによる永久磁石の反発、引き合いにより、被覆部材が心臓の心筋壁を押したり離したりすることで、心臓のポンプ機能を補助する。   The auxiliary artificial heart device of Patent Document 1 has a bag shape that wraps the heart, has a covering member on the inside and a fixed molding member on the outside, and a permanent magnet on the covering member and an electromagnet capable of switching polarity to the fixed molding member is installed There is. The repulsion and attraction of the permanent magnet by switching the polarity of the electromagnet causes the covering member to push and release the myocardial wall of the heart, thereby assisting the pump function of the heart.

特許第６９７３３１号公報Patent No. 697331

特許文献１の補助人工心臓装置は、心臓をそのまま包み込むように取り付けられるものである。心臓は完全には胸腔内に固定されていないため、均等に収縮させるのはやや困難であり、特許文献１のように袋形状で包み込んでも、有効に収縮させるには複雑な調整が必要となる可能性がある。   The auxiliary artificial heart device of Patent Document 1 is attached so as to wrap the heart as it is. Since the heart is not completely fixed in the thoracic cavity, it is somewhat difficult to uniformly contract, and even if wrapped in a bag shape as in Patent Document 1, complex adjustments are required to effectively contract. there is a possibility.

本発明は、上記事項に鑑みてなされたものであり、その目的とするところは、手技が簡便で複雑な調整を必要とせずに、心臓のポンプ機能を補助可能な心臓支援補助装置を提供することにある。   The present invention has been made in view of the above-described matters, and an object thereof is to provide a cardiac support assisting device capable of assisting the pump function of the heart without requiring a simple procedure and complicated adjustment. It is.

本発明の第１の観点に係る心臓支援補助装置は、
心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記心臓補助膜の前記心臓に縫い付けられる部位に環状の規制部材が設置され、
前記規制部材を境に前記心臓補助膜が移動する、
ことを特徴とする。 The cardiac support system according to the first aspect of the present invention is
A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
An annular regulating member is installed at a portion of the heart auxiliary membrane to be sewn to the heart,
The cardiac auxiliary membrane moves across the restriction member,
It is characterized by

本発明の第２の観点に係る心臓支援補助装置は、A cardiac support system according to a second aspect of the present invention is
心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
前記心臓補助膜には、前記心臓補助膜の移動を促進する移動促進部材が設置されている、The cardiac auxiliary membrane is provided with a movement promoting member for promoting movement of the cardiac auxiliary membrane,
ことを特徴とする。It is characterized by

また、前記心臓補助膜の前記心臓に縫い付けられる部位に環状の規制部材が設置され、
前記規制部材を境に前記心臓補助膜が移動するよう構成されていてもよい。 Further , an annular restricting member is installed at a portion of the heart auxiliary membrane to be sewn to the heart,
The cardiac auxiliary membrane may be configured to move across the restriction member .

また、前記移動促進部材が環状部材であり、前記環状部材が前記永久磁石を中心とする同軸上に複数設置されていてもよい。   In addition, the movement promoting member may be an annular member, and a plurality of the annular members may be coaxially disposed around the permanent magnet.

また、前記移動促進部材が前記永久磁石を中心として放射状に配置され補強されていてもよい。   In addition, the movement promoting member may be radially disposed and reinforced around the permanent magnet.

本発明の第３の観点に係る心臓支援補助装置は、
心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記心臓補助膜がシート状の前記永久磁石から構成される、
ことを特徴とする。 A cardiac support system according to a third aspect of the present invention is
A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
Before Symbol heart assist film Ru consists sheet of the permanent magnet,
It is characterized by

本発明の第４の観点に係る心臓支援補助装置は、
心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記電磁石取付部材は、前記心臓補助膜の一部の縫い付け部から前記心臓補助膜の中心部を通り対岸の他の一部の縫い付け部へと架橋して設置されている、
ことを特徴とする。 A cardiac support system according to a fourth aspect of the present invention is
A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
Before SL electromagnet mounting member that is disposed cross-linked with a part of the sewn part to the sewing portion of the central portion as the other side of the other part of the heart assist layer of the cardiac assist film,
It is characterized by

また、前記電磁石は心臓ペースメーカーによる刺激の指令に基づいて極性が切り替えられてもよい。   Also, the electromagnet may be switched in polarity based on the instruction of stimulation by the cardiac pacemaker.

本発明に係る心臓支援補助装置では、左心室の内腔に取り付けることができるため、心臓補助膜が自己心筋を補助して直接血液を拍動的に送る。このため、心臓支援補助装置を駆動させるために、大きな電力を必要とせずに有効的に左心室を収縮させることができ、複雑な調整等が不要である。   In the cardiac support system according to the present invention, since it can be attached to the lumen of the left ventricle, the cardiac auxiliary membrane assists the autologous myocardium and sends blood directly. Therefore, the left ventricle can be effectively contracted without requiring a large amount of power in order to drive the cardiac support device, and complicated adjustment and the like are not necessary.

心臓支援補助装置の斜視図である。It is a perspective view of a heart support auxiliary device. 図２（Ａ）、（Ｂ）は、心臓支援補助装置の動作状況を示す側面図である。FIGS. 2A and 2B are side views showing the operating state of the cardiac support device. 心臓支援補助装置を心臓の左心室内腔に取り付ける状況を示す図であり、図３（Ａ）は手術前の心臓の状態を示す外観図、図３（Ｂ）は心臓の断面図である。FIG. 3A is an external view showing a state of the heart before surgery, and FIG. 3B is a cross-sectional view of the heart. 心臓支援補助装置を心臓の左心室内腔に取り付ける状況を示す図であり、心臓の病変部が切開された状態を示す外観図（図４（Ａ））、及び断面図（図４（Ｂ））である。It is a figure which shows the condition which attaches a heart assistance auxiliary device to the left ventricular lumen of a heart, and is an external view (FIG. 4 (A)) which shows the state from which the lesion part of the heart was incised, and sectional drawing (FIG. 4 (B). ). 心臓支援補助装置を心臓の左心室内腔に取り付ける状況を示す心臓の断面図である。FIG. 5 is a cross-sectional view of the heart showing the attachment of a cardiac assistance device to the left ventricular lumen of the heart. 心臓支援補助装置を心臓の左心室内腔に取り付けられた状態を示す心臓の断面図である。FIG. 2 is a cross-sectional view of the heart showing the cardiac support device attached to the left ventricular lumen of the heart. 心臓支援補助装置が心臓の左心室内腔に取り付けられた状態を示す心臓の外観図である。FIG. 1 is an external view of a heart showing a state in which a heart support assist device is attached to the left ventricular lumen of the heart. 図８（Ａ）、（Ｂ）は心臓の左心室内腔に取り付けられた心臓支援補助装置の動作状況を示す断面図である。8 (A) and 8 (B) are cross-sectional views showing the operating condition of the cardiac support device attached to the left ventricular lumen of the heart. 図９（Ａ）、（Ｂ）は心臓の右心室の外側に取り付けられた心臓支援補助装置の動作状況を示す断面図である。FIGS. 9A and 9B are cross-sectional views showing the operating condition of the cardiac support device attached to the outside of the right ventricle of the heart. 他の形態に係る心臓補助膜の平面図である。It is a top view of the cardiac auxiliary membrane which concerns on another form. 他の形態に係る心臓補助膜の平面図である。It is a top view of the cardiac auxiliary membrane which concerns on another form. 他の形態に係る心臓補助膜の平面図である。It is a top view of the cardiac auxiliary membrane which concerns on another form. 他の形態に係る心臓支援補助装置の平面図である。It is a top view of the heart assistance auxiliary device which concerns on another form. 他の形態に係る心臓支援補助装置の斜視図である。It is a perspective view of the heart assistance auxiliary device which concerns on another form. 図１５（Ａ）、（Ｂ）は他の形態に係る心臓支援補助装置の動作状況を示す断面図である。FIGS. 15 (A) and 15 (B) are cross-sectional views showing the operating condition of the cardiac support device according to another embodiment.

本実施の形態に係る心臓支援補助装置１は、図１に示すように、心臓補助膜１０、永久磁石２０、電磁石取付部材３０、電磁石４０、制御部５０とを備える。   As shown in FIG. 1, the heart support auxiliary device 1 according to the present embodiment includes a heart auxiliary film 10, a permanent magnet 20, an electromagnet mounting member 30, an electromagnet 40, and a control unit 50.

心臓補助膜１０は、心筋に代わって心室を拡張、収縮させる部材である。心臓補助膜１０は、例えば、シリコーン樹脂、ポリウレタン樹脂、ポリテトラフルオロエチレン樹脂等、柔軟性を有する生体適合性の素材から形成されており、抗血栓性を得るため内膜造成を促す人工繊維で裏打ちされる。或いは牛心膜が用いられていてもよい。また、心臓補助膜１０は、凸状に湾曲したものが用いられる。また、心臓補助膜１０は、可変性を有していてもよい。   The cardiac auxiliary membrane 10 is a member that expands and contracts the ventricle in place of the myocardium. The heart auxiliary film 10 is made of a flexible biocompatible material such as silicone resin, polyurethane resin, polytetrafluoroethylene resin, etc., and is an artificial fiber that promotes intimal formation in order to obtain antithrombogenicity. Backed. Alternatively, bovine pericardium may be used. In addition, as the cardiac auxiliary film 10, one which is curved in a convex shape is used. In addition, the cardiac auxiliary membrane 10 may have variability.

心臓補助膜１０には、環状の規制部材１１が設置されており、心臓補助膜１０は、規制部材１１を境に移動する。心臓補助膜１０における規制部材１１の周辺に位置する部位が心臓へ縫い付けられる縫い付け部となる。縫い付け部は、縫合糸による負荷を抑えるべく、生体適合性の膜が二重、三重に重ねられて補強されていてもよい。また、規制部材１１は、ステンレスやチタン等の金属線やプラスチック樹脂などから構成される。規制部材１１は、永久磁石２０及び電磁石４０の磁気に干渉することがないよう、非磁性体から構成されることが好ましい。また、規制部材１１には、ねじれ等の応力が加わるため、このような応力に耐えられるよう構成される。たとえば、規制部材１１が金属線の場合、ワイヤーのように複数本の線条が捻られた形態やガイドワイヤ−のように金属線が螺旋状に成形された形態などが挙げられる。また、規制部材１１は一繋がりでなくてもよく、破線状に断続して設置されていてもよい。これら使用材料表面は抗血栓処理がなされ、電磁石４０は発熱防止剤が封入された防水加工がなされている。   An annular regulating member 11 is provided on the cardiac auxiliary membrane 10, and the cardiac auxiliary membrane 10 moves across the regulating member 11. A portion of the cardiac auxiliary membrane 10 located around the regulating member 11 is a sewing portion to be sewn to the heart. The stitching may be reinforced with double, triple overlapping, biocompatible membranes to reduce suture loading. Further, the restriction member 11 is made of metal wire such as stainless steel or titanium or plastic resin. The restricting member 11 is preferably made of a nonmagnetic material so as not to interfere with the magnetism of the permanent magnet 20 and the electromagnet 40. Further, since a stress such as a twist is applied to the regulating member 11, the regulating member 11 is configured to withstand such a stress. For example, when the restriction member 11 is a metal wire, a form in which a plurality of filaments are twisted like a wire, a form in which a metal wire is formed in a spiral like a guide wire, etc. may be mentioned. Moreover, the regulation member 11 may not be in one line, and may be intermittently installed in a broken line shape. The surface of the material used is subjected to antithrombotic treatment, and the electromagnet 40 is waterproofed in which an antipyretic agent is enclosed.

また、心臓補助膜１０は略楕円形状であり、例えば、長辺（図１に示すｈ）が８〜１０ｃｍ、短辺（図１に示すｗ）が３〜５ｃｍに設定される。また、心臓補助膜１０の湾曲部から縁部まで（図２（Ａ）に示すｄ）は、例えば、２ｃｍ程度に設定される。また、心臓補助膜１０は、規制部材１１の外側に張り出す周縁部１２を有しており、不要な箇所はカットして用いられる。   In addition, the heart auxiliary film 10 has a substantially elliptical shape, and for example, the long side (h shown in FIG. 1) is set to 8 to 10 cm and the short side (w shown in FIG. 1) to 3 to 5 cm. In addition, from the curved portion of the cardiac auxiliary membrane 10 to the edge (d shown in FIG. 2A) is set to, for example, about 2 cm. In addition, the cardiac auxiliary membrane 10 has a peripheral edge portion 12 projecting to the outside of the regulating member 11, and unnecessary portions are cut and used.

永久磁石２０は、心臓補助膜１０の中心付近に固定されている。永久磁石１０の固定は、例えば、心臓補助膜１０の中心付近が二重構造となっており、二重構造の間に固定されている。また、永久磁石は、Ｎ極又はＳ極のいずれかの面が電磁石４０に対向するよう固定されている。   The permanent magnet 20 is fixed near the center of the heart auxiliary film 10. The permanent magnet 10 is fixed, for example, in the vicinity of the center of the cardiac auxiliary membrane 10 in a double structure and fixed between the double structures. Also, the permanent magnet is fixed so that either the N pole or the S pole faces the electromagnet 40.

電磁石取付部材３０に、電磁石４０が設置されているとともに、心筋による負荷で心臓補助膜１０が引っ張られることがないよう規制している。このため、電磁石取付部材３０は、心筋による負荷で変形することがないよう、心筋よりも硬い素材から構成されている。電磁石取付部材３０は、凸状に湾曲し、心臓補助膜１０の一部の縫い付け部から永久磁石２０が設置されている中心部を通り対岸の他の一部の縫い付け部へと架橋して設置されている。   The electromagnet mounting member 30 is provided with the electromagnet 40 and is regulated so as to prevent the cardiac auxiliary membrane 10 from being pulled by a load due to the myocardium. For this reason, the electromagnet mounting member 30 is made of a material harder than the myocardium so as not to be deformed by the load by the myocardium. The electromagnet attachment member 30 is curved in a convex shape, and is bridged from a part of the sewn part of the heart auxiliary film 10 through the central part where the permanent magnet 20 is installed to another part of the sewn part on the opposite side. Is installed.

電磁石４０には、外部からの指令に基づいて電磁石４０の極性を切り替える制御部５０が接続されている。制御部５０は、例えば、生体内に取り付けられた心臓ペースメーカー６０の指令に基づいて、電磁石４０の極性を切り替える。一般的に、心臓ペースメーカー６０は、元々の心臓自体の自脈の電気的リズムを検知する機能と、通常拍動がある時間の間に自脈を検知しなければ、リードを通じて心室を定電圧で刺激する機能とを有している。心臓ペースメーカー６０のリードが制御部に接続され、上記の刺激を行うべきタイミングで制御部５０は、電磁石４０の極性を切り替えるよう構成されていてもよい（心電図同期）。なお、制御部５０は電磁石４０とともに、ユニットとして一体的に構成され設置されていてもよい。また、心臓ペースメーカー６０が制御部５０としての機能を兼ねることができれば、制御部５０が別途設置されなくてもよく、更には、心臓ペースメーカー６０から電源供給により電磁石４０が駆動するよう構成されていてもよい。   A control unit 50 that switches the polarity of the electromagnet 40 based on an external command is connected to the electromagnet 40. The control unit 50 switches the polarity of the electromagnet 40 based on, for example, a command from the cardiac pacemaker 60 attached in the living body. In general, if the cardiac pacemaker 60 has a function to detect the electrical rhythm of the original heart itself's own pulse, and if it normally does not detect the own pulse during a certain period of time, the ventricle is at a constant voltage through the lead. It has a stimulating function. The lead of the cardiac pacemaker 60 may be connected to the control unit, and the control unit 50 may be configured to switch the polarity of the electromagnet 40 at the timing to perform the above-described stimulation (electrocardiogram synchronization). The control unit 50 may be integrally configured and installed as a unit together with the electromagnet 40. Further, if the cardiac pacemaker 60 can also function as the control unit 50, the control unit 50 may not be separately installed, and furthermore, the electromagnet 40 is configured to be driven by the power supply from the cardiac pacemaker 60. It is also good.

なお、心臓支援補助装置１は、体内に入れられるものであるため、心臓支援補助装置１の全ての部材について、抗血栓処理が行われる。抗血栓処理として、例えば、ヘパリンやビタミンＣ等の抗血栓剤が心臓支援補助装置１の全ての部材にコーティングされることが挙げられる。なお、心臓補助膜１０については、内膜造成を促す人工繊維で裏打ちされている場合、抗血栓処理は必ずしも必要としない。   In addition, since the heart support assist device 1 is put into the body, antithrombotic treatment is performed on all the members of the heart support assist device 1. As an antithrombotic treatment, for example, antithrombotic agents such as heparin and vitamin C may be coated on all members of the heart support / assistance device 1. In the case where the cardiac auxiliary membrane 10 is lined with an artificial fiber that promotes intimal formation, antithrombotic treatment is not necessarily required.

上記の構成により、心臓支援補助装置１は、電磁石４０と永久磁石２０とが引き合っている場合、図２（Ａ）に示すように、心臓補助膜１０が電磁石４０の方へ凸状に変位する。また、電磁石４０と永久磁石２０とが反発している場合、図２（Ｂ）に示すように、心臓補助膜１０が電磁石４０の逆方向へ凸状に変位する。   With the above configuration, when the electromagnet 40 and the permanent magnet 20 are attracted to each other, the cardiac assistance auxiliary device 1 displaces the cardiac auxiliary film 10 in a convex shape toward the electromagnet 40 as shown in FIG. . Further, when the electromagnet 40 and the permanent magnet 20 repel each other, the cardiac auxiliary film 10 is displaced in a convex shape in the opposite direction of the electromagnet 40 as shown in FIG. 2 (B).

続いて、上述した心臓支援補助装置１を用いた手術方法について説明する。ここでは、左心室が拡張した拡張型心筋症の手術を例にとり説明する。   Subsequently, a surgical method using the above-described cardiac support assist device 1 will be described. Here, an operation of dilated cardiomyopathy in which the left ventricle is expanded will be described as an example.

まず、図３（Ａ）、（Ｂ）に示される心臓１００の心筋の病変部１１０を切開する。病変部１１０は、収縮機能が衰え心筋として機能しなくなった部位である。病変部１１０の切開により、図４（Ａ）、（Ｂ）に示すように、心臓１００にパッチ縫合部が形成される。   First, the lesion 110 of the myocardium of the heart 100 shown in FIGS. 3 (A) and 3 (B) is incised. The lesioned part 110 is a part where the contractile function is impaired and does not function as a myocardium. As shown in FIGS. 4A and 4B, patch sutures are formed in the heart 100 by the incision of the lesion 110.

そして、切開された部位から、左心室１０１の内腔へ心臓支援補助装置１を挿入する。そして、図５、図６に示すように、心臓支援補助装置１の電磁石４０を外側に向け、心臓補助膜１０の縫い付け部を、縫合糸等の縫合部材７０にて心臓１００に縫い付ける。   Then, the cardiac support assist device 1 is inserted into the lumen of the left ventricle 101 from the incision site. Then, as shown in FIG. 5 and FIG. 6, the electromagnet 40 of the cardiac support auxiliary device 1 is directed outward, and the sewn portion of the cardiac auxiliary membrane 10 is sewn to the heart 100 by a suture member 70 such as a suture.

その後、図６に示すように、切開された心筋の端部を縫合部材７０で縫合する。例えば、縫い付け部、すなわち、規制部材１１が重度病変部と軽度病変部の境界にくるようにして縫合する。このようにして、心臓支援補助装置１を左心室１０１の内腔に取り付けられる。そして、制御部５０を生体内に取り付けられている心臓ペースメーカー６０のリード等に接続する。   Thereafter, as shown in FIG. 6, the end of the dissected myocardium is sutured with a suture member 70. For example, the sewn part, that is, the regulation member 11 is sutured in such a way as to come to the boundary between the severe lesion and the mild lesion. In this manner, the cardiac support device 1 is attached to the lumen of the left ventricle 101. Then, the control unit 50 is connected to a lead or the like of the cardiac pacemaker 60 attached in the living body.

心臓支援補助装置１は、制御部５０による電磁石４０の極性の切り替えにより、図８（Ａ）、（Ｂ）に示すように稼働する。図８（Ａ）に示したように、永久磁石２０と電磁石４０が引き合っている状態では、左心室が拡張し、左心房から左心室へと血液が吸引される補助が可能となる。また、図８（Ｂ）に示したように、永久磁石２０と電磁石４０が反発している状態では、左心室が収縮し、左心室から大動脈へと血液が送られ収縮補助が可能となる。   The cardiac support assisting device 1 operates as shown in FIGS. 8A and 8B by switching the polarity of the electromagnet 40 by the control unit 50. As shown in FIG. 8A, in the state where the permanent magnet 20 and the electromagnet 40 are attracted to each other, the left ventricle is expanded, and it is possible to assist the suction of blood from the left atrium to the left ventricle. Further, as shown in FIG. 8B, in a state where the permanent magnet 20 and the electromagnet 40 repel each other, the left ventricle contracts, and blood is sent from the left ventricle to the aorta, which makes it possible to assist the contraction.

心臓支援補助装置１は、このように左心室の内腔に取り付けることができるため、心臓補助膜１０が自己心筋を補助して直接血液を送ったり吸引したりするよう作用する。このため、心臓支援補助装置１を駆動させるために、大きな電力を必要とせずに、有効に左心室を収縮させることができ、複雑な調整等が不要である。   Since the cardiac support device 1 can be attached to the lumen of the left ventricle in this way, the cardiac support film 10 acts to assist the autologous myocardium to directly send or aspirate blood. For this reason, in order to drive the cardiac assistance device 1, the left ventricle can be effectively contracted without requiring a large amount of power, and complicated adjustment and the like are unnecessary.

なお、右心室のポンプ機能を補助する場合、右心室の心筋はさほど厚くないため、図９（Ａ）、（Ｂ）に示すように、心臓支援補助装置１を直接右心室の外側から取り付けて、心臓補助膜１０が右心室の心筋を押すように駆動させてもよい。   When assisting the right ventricular pumping function, the heart muscle of the right ventricle is not so thick. Therefore, as shown in FIGS. 9A and 9B, the cardiac assist device 1 is attached directly from the outside of the right ventricle. Alternatively, the cardiac auxiliary membrane 10 may be driven to push the myocardium of the right ventricle.

また、心臓補助膜１０には、その移動がスムーズに行われるよう、具体的には、永久磁石２０が電磁石４０と心臓補助膜１０の中心部（規制部材１１の中心部）を結ぶ直線上を往復動しやすくするよう、移動促進部材が設置されていてもよい。これにより、永久磁石２０が斜め方向（電磁石４０と心臓補助膜１０の中心部を結ぶ直線に対して斜め方向）への移動が規制されるので、設定された血液量を送り出すことができる。   Further, in order to facilitate the movement of the heart auxiliary film 10, specifically, the permanent magnet 20 is on a straight line connecting the center of the electromagnet 40 and the heart auxiliary film 10 (the center of the regulating member 11). A movement facilitating member may be installed to facilitate reciprocation. As a result, the movement of the permanent magnet 20 in the oblique direction (the oblique direction with respect to the straight line connecting the center of the electromagnet 40 and the heart auxiliary film 10) is restricted, so that the set blood volume can be delivered.

例えば、図１０に示すように、永久磁石２０を中心として、同軸上に環状の移動促進部材１３が心臓補助膜１０に複数設置されていてもよい。移動促進部材１３は、非磁性の金属や樹脂等から構成される。このような構成により、永久磁石２０が電磁石４０と心臓補助膜１０の中心部（規制部材１１の中心部）を結ぶ直線上を往復動するよう規制することができる。   For example, as shown in FIG. 10, a plurality of annular movement promoting members 13 may be coaxially disposed on the heart auxiliary film 10 with the permanent magnet 20 as the center. The movement promoting member 13 is made of nonmagnetic metal, resin or the like. With such a configuration, the permanent magnet 20 can be regulated to reciprocate on the straight line connecting the electromagnet 40 and the central portion of the cardiac auxiliary film 10 (the central portion of the regulating member 11).

また、図１１に示すように、永久磁石２０を中心として、放射状に伸びる移動促進部材１３が設置されていてもよい。   Further, as shown in FIG. 11, a movement promoting member 13 extending radially around the permanent magnet 20 may be installed.

また、心臓補助膜１０が楕円形状である場合について説明したが、心臓補助膜１０の形状は制限されず、例えば、図１２に示すような形状であってもよい。   Further, although the case where the heart auxiliary film 10 has an elliptical shape has been described, the shape of the heart auxiliary film 10 is not limited, and may be, for example, a shape as shown in FIG. 12.

また、電磁石取付部材３０が縫い付け部を図１における左右方向へ架橋する１本の架橋構造である形態について説明したが、上述した電磁石取付部材３０の機能を果たし得る限り、どのような形状でもよく、例えば、縫い付け部を図１における上下方向に架橋する構造、電磁石４０が設置される部位から３本以上放射状に延びる構造や椀型の構造などでもよい。   Also, although the embodiment has been described in which the electromagnet mounting member 30 is a single bridging structure that bridges the sewn portion in the left and right direction in FIG. 1, any shape may be used as long as the above-described electromagnet mounting member 30 can perform its function. For example, a structure in which the sewn portion is bridged in the vertical direction in FIG. 1, a structure in which three or more pieces radially extend from a site where the electromagnet 40 is installed, or a hook-like structure may be used.

また、上記では、心臓補助膜１０に永久磁石２０が一つ設置された形態について説明したが、図１３に示すように、２つ以上の永久磁石２０が設置され、それぞれの永久磁石２０に対応する電磁石４０が設置された形態であってもよい。   Further, although the embodiment has been described above in which one permanent magnet 20 is installed on the heart auxiliary film 10, as shown in FIG. 13, two or more permanent magnets 20 are installed and correspond to each permanent magnet 20. The electromagnet 40 may be installed.

また、図１４、図１５（Ａ）、（Ｂ）に示すような、電磁石取付部材３０が椀型形状の磁性材料から構成され、心臓補助膜１０がシート状の永久磁石が椀型形状に加工されたもので構成されていてもよい。   Also, as shown in FIG. 14 and FIGS. 15A and 15B, the electromagnet attachment member 30 is formed of a wedge-shaped magnetic material, and the cardiac auxiliary film 10 is processed into a wedge-shaped permanent magnet sheet. It may be composed of

１ 心臓支援補助装置
１０ 心臓補助膜
１１ 規制部材
１２ 周縁部
１３ 移動促進部材
２０ 永久磁石
３０ 電磁石取付部材
４０ 電磁石
４１ 配線
５０ 制御部
５１ 配線
６０ 心臓ペースメーカー
７０ 縫合部材
１００ 心臓
１０１ 左心室
１０２ 右心室
１１０ 病変部 DESCRIPTION OF SYMBOLS 1 heart support auxiliary device 10 heart auxiliary film 11 regulating member 12 peripheral part 13 movement promoting member 20 permanent magnet 30 electromagnet mounting member 40 electromagnet 41 wiring 50 control unit 51 wiring 60 cardiac pacemaker 70 suture member 100 heart 101 left ventricle 102 right ventricle 110 Lesion area

Claims (8)

心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記心臓補助膜の前記心臓に縫い付けられる部位に環状の規制部材が設置され、
前記規制部材を境に前記心臓補助膜が移動する、
ことを特徴とする心臓支援補助装置。 A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
An annular regulating member is installed at a portion of the heart auxiliary membrane to be sewn to the heart,
The cardiac auxiliary membrane moves across the restriction member,
Heart assist device characterized by. 心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記心臓補助膜には、前記心臓補助膜の移動を促進する移動促進部材が設置されている、
ことを特徴とする心臓支援補助装置。 A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
The cardiac auxiliary membrane is provided with a movement promoting member for promoting movement of the cardiac auxiliary membrane,
Heart support auxiliary equipment shall be the characterized in that. 前記心臓補助膜の前記心臓に縫い付けられる部位に環状の規制部材が設置され、An annular regulating member is installed at a portion of the heart auxiliary membrane to be sewn to the heart,
前記規制部材を境に前記心臓補助膜が移動する、The cardiac auxiliary membrane moves across the restriction member,
ことを特徴とする請求項２に記載の心臓支援補助装置。The cardiac support system according to claim 2, characterized in that: 前記移動促進部材が環状部材であり、前記環状部材が前記永久磁石を中心とする同軸上に複数設置されている、
ことを特徴とする請求項２又は３に記載の心臓支援補助装置。 The movement promoting member is an annular member, and a plurality of the annular members are coaxially disposed around the permanent magnet.
The cardiac support system according to claim 2 or 3 , characterized in that: 前記移動促進部材が前記永久磁石を中心として放射状に配置され補強されている、
ことを特徴とする請求項２又は３に記載の心臓支援補助装置。 The movement promoting member is radially disposed and reinforced about the permanent magnet,
The cardiac support system according to claim 2 or 3 , characterized in that: 心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記心臓補助膜がシート状の前記永久磁石から構成される、
ことを特徴とする心臓支援補助装置。 A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
The cardiac auxiliary membrane is composed of the sheet-like permanent magnet,
Heart support auxiliary equipment shall be the characterized in that. 心臓の右心室の心筋に外側から直接又は心臓の拡大した左心室の心筋前壁で心内腔に取り付けられ、永久磁石を有する心臓補助膜と、
前記永久磁石に対向して配置される電磁石が取り付けられ、心筋より硬い材料から構成される電磁石取付部材と、を備え、
心電図同期下に前記電磁石と前記永久磁石との反発により、前記心臓補助膜が移動して心室内を収縮させ、
前記電磁石と前記永久磁石の引き付けにより、前記心臓補助膜が移動して心室内を拡張させ、
前記電磁石取付部材は、前記心臓補助膜の一部の縫い付け部から前記心臓補助膜の中心部を通り対岸の他の一部の縫い付け部へと架橋して設置されている、
ことを特徴とする心臓支援補助装置。 A cardiac auxiliary membrane attached to the myocardium of the right ventricle of the heart directly from the outside or at the myocardial anterior wall of the enlarged left ventricle of the heart and having a permanent magnet,
An electromagnet attachment member attached to the permanent magnet, the electromagnet attachment member being made of a material harder than the myocardium;
Under synchronization of the electrocardiogram, repulsion between the electromagnet and the permanent magnet moves the cardiac auxiliary membrane to contract in the ventricle,
The attraction of the electromagnet and the permanent magnet causes the cardiac auxiliary membrane to move and expand in the ventricle,
The electromagnet attachment member is installed by being bridged from a part of sewn part of the heart auxiliary membrane through a center part of the heart auxiliary membrane to another part of sewn part on the opposite side.
Heart support auxiliary equipment shall be the characterized in that. 前記電磁石は心臓ペースメーカーによる刺激の指令に基づいて極性が切り替えられる、
ことを特徴とする請求項１乃至７のいずれか一項に記載の心臓支援補助装置。 The electromagnets are switched in polarity based on the instruction of stimulation by a cardiac pacemaker,
The cardiac support system according to any one of claims 1 to 7, characterized in that:
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