Mitral Prosthesis and Methods for Implantation
First Claim
1. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
- an inner support structure having a downstream section and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into a left ventricle by applying an axial force directed toward the left ventricle;
a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure; and
an outer support structure having two or more engagement arms, downstream ends of the engagement arms being coupled to the inner support structure,the prosthesis being configured such that, upon implantation thereof;
downstream ends of native valve leaflets of the native mitral valve complex,the downstream ends of the engagement arms, anddownstream ends of the prosthetic leaflets,are disposed at a longitudinal distance from one another of less than 3 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis.
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Accused Products
Abstract
Apparatus and methods are provided including a mitral valve prosthesis. The prosthesis includes an inner support structure having downstream and upstream sections, the upstream section having a cross-sectional area greater than the downstream section. The inner support structure is configured to be positioned on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into the left ventricle. A prosthetic valve having prosthetic valve leaflets is coupled to the inner support structure. An outer support structure has engagement arms, downstream ends of the engagement arms being coupled to the inner support structure. The prosthesis is configured such that, upon implantation thereof:
- downstream ends of the native valve leaflets,
- downstream ends of the engagement arms, and
- downstream ends of the prosthetic leaflets,
- are disposed at a longitudinal distance from one another of less than 3 mm. Other embodiments are also described.
321 Citations
40 Claims
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1. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into a left ventricle by applying an axial force directed toward the left ventricle; a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure; and an outer support structure having two or more engagement arms, downstream ends of the engagement arms being coupled to the inner support structure, the prosthesis being configured such that, upon implantation thereof; downstream ends of native valve leaflets of the native mitral valve complex, the downstream ends of the engagement arms, and downstream ends of the prosthetic leaflets, are disposed at a longitudinal distance from one another of less than 3 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section, and an upstream section, wherein the upstream section has a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to apply an axial force directed toward a left ventricle; and an outer support structure having posterior and anterior engagement arms configured to be placed over, respectively, posterior and anterior leaflets of the native mitral valve complex, wherein the engagement arms are coupled to the inner support structure, wherein a ratio of a length of the anterior engagement arm to a length of the posterior arm is between 1.1;
1 and 15;
1. - View Dependent Claims (21, 22, 23, 24, 25)
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26. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section, and an upstream section, wherein the upstream section has a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to apply an axial force directed toward a left ventricle; and an outer support structure having posterior and anterior engagement arms configured to be placed over native leaflets of the native mitral valve complex, wherein the engagement arms are coupled to the inner support structure, the engagement arms being configured to define first configurations thereof during implantation of the prosthesis, and to change shape so as to define second configurations thereof, subsequent to being placed over the native leaflets of the native mitral valve complex, each of the engagement arms spanning a width of less than 12 mm in the first configuration thereof, and spanning a width of more than 15 mm when in the second configuration thereof. - View Dependent Claims (27, 28, 29)
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30. The apparatus according to claim 26, wherein, in the first configuration thereof, the engagement arms are configured to fit between papillary muscles of the native valve complex.
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30-1. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into a left ventricle by applying an axial force directed toward the left ventricle; an outer support structure having two or more engagement arms, the engagement arms being coupled to the inner support structure, and a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure such that downstream ends of the prosthetic valve leaflets are at least 4 mm upstream of the downstream ends of the engagement arms.
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31. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into a left ventricle by applying an axial force directed toward the left ventricle; an outer support structure having two or more engagement arms, downstream ends of the engagement arms being coupled to the inner support structure, and a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure such that downstream ends of the prosthetic valve leaflets are within 3 mm of the downstream ends of the engagement arms; a longitudinal distance from a downstream end to an upstream end of each of the engagement arms being less than 18 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis. - View Dependent Claims (32, 33, 34, 35, 36)
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37. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:
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an inner support structure having a downstream section and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into a left ventricle by applying an axial force directed toward the left ventricle; a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure; and an outer support structure having two or more engagement arms, the engagement arms being coupled to the inner support structure, the prosthesis being configured such that, upon implantation thereof; downstream ends of native valve leaflets of the native mitral valve complex, and downstream ends of the engagement arms are disposed at a longitudinal distance from one another of less than 3 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis, and a downstream end of the inner support structure and downstream ends of the prosthetic valve leaflets are at a longitudinal distance of at least 4 mm upstream of the downstream ends of the native valve leaflets, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis. - View Dependent Claims (38)
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40. The apparatus according to claim 39, wherein the prosthetic valve leaflets are coupled to the inner support structure such that the downstream ends of the prosthetic valve leaflets are at least 10 mm upstream of the downstream ends of the engagement arms.
Specification