초록 ▼

Methods, delivery systems and engaging apparatuses for the placement and treatment of an insufficient or stenotic cardiac valve, such as the mitral valve are disclosed. One such method is based on a two step procedure, where during the first step the engaging apparatus is brought to the valve annulu

Methods, delivery systems and engaging apparatuses for the placement and treatment of an insufficient or stenotic cardiac valve, such as the mitral valve are disclosed. One such method is based on a two step procedure, where during the first step the engaging apparatus is brought to the valve annulus using a delivery system which permits continued normal blood flow. In some preferred embodiments, this is implemented with a balloon and other preferred embodiments it is implemented using a multi-pronged structure that is collapsible like an umbrella frame. The second step is performed after the engaging apparatus has been integrated into the annular wall by natural processes of tissue healing and remodeling. In the second step the engaging apparatus is tightened leading to tightening of the valve annulus and correction of existing valvular insufficiency. Optionally, an artificial valve may be anchored to the engaging apparatus during the same or subsequent procedure to correct either valvular insufficiency or stenosis.

대표청구항 ▼

1. A method of tightening an annulus of a heart comprising the steps of: pressing an engaging apparatus with a contractible diameter up against an inner surface of the annulus, wherein the engaging apparatus is configured to attach to the inner surface with an initial anchoring strength when pressed

1. A method of tightening an annulus of a heart comprising the steps of: pressing an engaging apparatus with a contractible diameter up against an inner surface of the annulus, wherein the engaging apparatus is configured to attach to the inner surface with an initial anchoring strength when pressed against the inner surface, wherein the initial anchoring strength is less than that necessary to withstand tightening;waiting for a bond to develop between the engaging apparatus and the annulus based on tissue healing and remodeling into and around the engaging apparatus that is strong enough to withstand tightening; andcontracting the engaging apparatus after development of the bond based on tissue healing and remodeling. 2. The method of claim 1, wherein the pressing step comprises the step of inflating a balloon-like object to press the engaging apparatus against the inner surface of the annulus, and wherein the balloon-like object has a channel that permits blood to flow therethrough during the pressing step. 3. The method of claim 1, wherein the pressing step comprises the step of opening a truncated wire-whisk shaped structure configured to press the engaging apparatus against the inner surface of the annulus, and wherein blood is free to flow past the truncated wire-whisk shaped structure during the pressing step. 4. The method of claim 1, wherein the step of waiting for a bond to develop between the engaging apparatus and the annulus comprises waiting for at least one week. 5. The method of claim 1, wherein the engaging apparatus has an annulus contact portion that is shaped like a helical spring that has been formed to be substantially arc-shaped, with an arc that subtends at least 270°. 6. An apparatus for repairing an annulus comprising: an annulus contact portion having an outer boundary that is configured for pressing outwards against the annulus, wherein the annulus contact portion is substantially arc-shaped and has an inner core, and wherein the annulus contact portion is configured to attach to the annulus with an initial anchoring strength when pressed against the annulus, the initial anchoring strength being less than that necessary to withstand tightening, and wherein the annulus contact portion is also configured to permit tissue healing and remodeling into and around the annulus contact portion that increases the anchoring strength over time;a truncated wire-whisk shaped structure configured to press the annulus contact portion against the inner surface of the annulus while permitting blood to flow freely past the truncated wire-whisk shaped structure; anda wire that runs through the inner core and is arranged with respect to the annulus contact portion so that pulling on the wire causes the outer boundary to contract. 7. The apparatus of claim 6, wherein the annulus contact portion has a plurality of barbs configured to promote initial anchoring of the annulus contact portion to the annulus. 8. The apparatus of claim 6, wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 180°. 9. The apparatus of claim 6, wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 270°. 10. The apparatus of claim 6, wherein annulus contact portion comprises a helical spring that has been formed into an arc. 11. The apparatus of claim 10, wherein the helical spring has an outer diameter between about 25 and about 60 mm, a helix diameter between about 1 and about 3 mm, and a helix pitch between about 1 and about 3 mm. 12. The apparatus of claim 10, wherein the annulus contact portion has a plurality of barbs configured to promote attachment of the annulus contact portion to the annulus. 13. The apparatus of claim 10, wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 180°. 14. The apparatus of claim 10, wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 270°. 15. The method of claim 3, wherein the step of waiting for a bond to develop between the engaging apparatus and the annulus comprises waiting at least one week. 16. The method of claim 3, wherein the engaging apparatus has an annulus contact portion that is shaped like a helical spring that has been formed to be substantially arc-shaped, with an arc that subtends at least 270°.