WO2018029622A1

WO2018029622A1 - Personalized mitral valve assembly

Info

Publication number: WO2018029622A1
Application number: PCT/IB2017/054875
Authority: WO
Inventors: Moshe Flugelman
Original assignee: Mor Research Applications Ltd.
Priority date: 2016-08-12
Filing date: 2017-08-10
Publication date: 2018-02-15
Also published as: GB201620390D0; GB2557238A

Abstract

A prosthetic mitral valve assembly comprises an annular body configured to fit a patient specific size of a mitral annulus. The prosthetic mitral valve assembly comprises one or more clips are configured to attach the annular body to a patient specific position of at least one meeting point of posterior and anterior mitral leaflets. The prosthetic mitral valve assembly comprises at least one rod configured to attach the annular body to a patient's left atrium, wherein the at least one rod is attached to and extending away from the annular body, and wherein the at least one rods comprises a patient specific size and shape.

Description

PERSONALIZED MITRAL VALVE ASSEMBLY

CROSS REFERENCE TO RELATED APPLICATIONS

[001] This application claims priority to U.S. Provisional Patent Application No. 62/374,091, filed August 12^th, 2016, and entitled "Personalized Mitral Valve Assembly"; and to U.K. Patent Application No. 1620390.3, filed December 1^st, 2016, and entitled "Personalized Mitral Valve Assembly", which are incorporated herein by reference in their entirety.

TECHNICAL FIELD [002] The invention relates to the field of prosthetic valves.

BACKGROUN D

[003] The heart of vertebrate animals is divided into four chambers, and is equipped with four valves (the mitral, aortic, pulmonary and tricuspid valves). The valves ensure that blood pumped by the heart flows in a forward direction through the cardiovascular system. The mitral valve is located between the left atrium and the left ventricle. The mitral valve of a healthy heart prevents the backflow of blood from the left ventricle into the left atrium of the heart, and comprises two flexible leaflets (anterior and posterior) that close when the left ventricle contracts. The leaflets are attached to a fibrous annulus, and their free edges are tethered by subvalvular chordae tendineae to papillary muscles in the left ventricle to prevent them from prolapsing into the left atrium during the contraction of the left ventricle.

[004] Various cardiac diseases or degenerative changes may cause dysfunction in any of these portions of the mitral valve apparatus, causing the mitral valve to become abnormally narrowed or dilated, or to allow blood to leak (i.e. regurgitate) from the left ventricle back into the left atrium. Any such impairments compromise cardiac sufficiency, and can be debilitating or life threatening.

[005] Numerous surgical methods and devices have accordingly been developed to treat mitral valve dysfunction. Mitral valve replacement is a cardiac surgical procedure in which the mitral valve is replaced by a prosthetic valve.

[006] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY

[007] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. [008] One embodiment provides a prosthetic mitral valve assembly comprising: an annular body configured to fit a patient specific size of a mitral annulus; a first clip configured to attach the annular body to a patient specific position of a first meeting point of posterior and anterior mitral leaflets; a second clip configured to attach the annular body to a patient specific position of a second meeting point of posterior and anterior mitral leaflets; and rods configured to attach the annular body to a patient's left atrium, wherein the rods are attached to and extending away from the annular body, and wherein each one of the rods comprises a patient specific size shape and orientation.

[009] Optionally, the prosthetic mitral valve assembly may presume a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart. Optionally, the prosthetic mitral valve assembly can be introduced via the apex, the back of the left atrium, or the intra-atrial septum. [010] Another embodiment provides a method for generating a prosthetic mitral valve assembly, the method comprises: providing an annular body configured to fit a patient specific size of a mitral annulus; attaching a first clip to the annular body according to a patient specific position of a first meeting point of posterior and anterior mitral leaflets; attaching a second clip to the annular body according to a patient specific position of a second meeting point of posterior and anterior mitral leaflets; wherein the first and second clips are configured to capture mitral tissue; and attaching rods to the annular body, wherein the rods are configured to extend away from the annular body and wherein each one of the rods comprises a patient specific size shape and orientation.

[011] Optionally, the patient specific parameters are provided by a computer software.

[012] Another embodiment provides a method of anchoring a prosthetic mitral valve assembly in a patient's heart, the method comprises: providing a prosthetic valve, wherein the prosthetic mitral valve assembly comprises an annular body, a first clip, a second clip and rods, and wherein the prosthetic mitral valve assembly has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart; positioning the prosthetic mitral valve assembly in a patient's heart; expanding the annular body radially outward so as to lie over a mitral annulus, and anchoring the annular body against a portion of a patient's atrium; clipping the first clip against a first meeting point of posterior and anterior mitral leaflets, such that a mitral tissue comprised of posterior and anterior mitral leaflets is captured; clipping the second clip against a second meeting point of posterior and anterior mitral leaflets, such that mitral tissue comprised of posterior and anterior mitral leaflets is captured; anchoring the rods to a patient's left atrium.

[013] Optionally, positioning the prosthetic mitral valve assembly is done by using diagnostic imaging technique selected from a group consisting of: X-Ray, Echocardiography, transesophageal echocardiogram (TEE) or a combination thereof.

[014] Further embodiments may concern a prosthetic mitral valve assembly comprising an annular body configured to fit a patient specific size of a mitral annulus; at least one clip configured to attach the annular body to a patient specific position of at least one meeting point of a posterior and an anterior mitral leaflet; at least one rod configured to attach the annular body to a patient's left atrium, wherein the rods are attached to and extending away from the annular body, and wherein the at least one rod comprises a patient specific size and shape. [015] Optionally, the prosthetic mitral valve assembly has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart.

[016] Optionally, the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet.

[017] Optionally, the annular body is manufactured to a specific anatomy of a patient based on an analysis of a three-dimensional (3D) image of the mitral valve annulus of the patient.

[018] Optionally, the at least one rod comprises a central rod. [019] Optionally, the at least one clip comprises an attached configuration and a detached configuration, and the at least one clip is further configured to be detachable from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

[020] Optionally, the at least one rod comprises an attached configuration and a detached configuration, and the at least one rod is further configured to be detachable from at least one of the annular body and the left atrium. [021] Optionally, a method for generating a prosthetic mitral valve assembly comprises: providing an annular body configured to fit a patient specific size and shape of a mitral annulus; attaching at least one clip to the annular body according to a patient specific position of at least one meeting point of a posterior and an anterior mitral leaflet, wherein the at least one clip is configured to capture mitral tissue; and attaching at least one rod to the annular body, wherein the at least one rod is configured to extend away from the annular body and wherein the at least one rod comprises a patient specific size and shape.

[022] Optionally, the prosthetic mitral valve assembly has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart; [023] Optionally, the patient specific size and shape are provided by a computer software.

[024] Optionally, the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet. [025] Optionally, the method further comprises an action of manufacturing the annular body to a specific anatomy of a patient based on an analysis of a 3D image of the mitral valve annulus of the patient.

[026] Optionally, the at least one rod comprise a central rod.

[027] Optionally, the at least one clip comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one clip from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

[028] Optionally, the at least one rod comprises an attached configuration and a detached configuration, and wherein the method further comprises detaching the at least one rod from at least one of the annular body and the left atrium. [029] Optionally, a method of anchoring a prosthetic mitral valve assembly in a patient's heart comprises: providing a prosthetic mitral valve assembly, wherein the prosthetic mitral valve assembly comprises (i) an annular body, (ii) at least one clip, and (iii) at least one rod, and wherein the prosthetic mitral valve assembly has (a) a collapsed configuration for delivery to the heart via a catheter, and (b) an expanded configuration for anchoring in a patient's heart; positioning the prosthetic mitral valve assembly in the patient's heart via a catheter; extracting the prosthetic mitral valve assembly from the catheter, thereby allowing the annular body to expand radially into a mitral annulus, and anchoring the annular body against a portion of a patient's atrium; anchoring the at least one clip against a at least one meeting point of a posterior and an anterior mitral leaflet; anchoring the at least one rod to a patient's left atrium.

[030] Optionally, the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet.

[031] Optionally, the method comprises an action of manufacturing the annular body to a specific anatomy of a patient based on an analysis of a 3D image of the mitral valve annulus of the patient.

[032] Optionally, the at least one rod comprise a central rod. [033] Optionally, the at least one clip comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one clip from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

[034] Optionally, the at least one rod comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one rod from at least one of the annular body and the left atrium. [035] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[036] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below. [037] FIG. 1A is a schematic view of an exemplary embodiment of a prosthetic mitral valve assembly, having a shape of a funnel that may be inserted into the native mitral annulus, and anchored to mitral valve tissue;

[038] FIG. IB is a schematic view that illustrates, according to an exemplary embodiment, a collapsed configuration of the prosthetic mitral valve; [039] FIG. 2 is a schematic view of an exemplary implementation of the prosthetic mitral valve assembly of Fig. 1A;

[040] FIG. 3A is an flow chart according to an exemplary embodiment of a method for generating/ manufacturing the prosthetic mitral valve of Figs 1A-B; and

[041] FIG. 3B is a flow chart according to an exemplary embodiment of a method for anchoring a prosthetic mitral valve assembly of Figs 1A-B in a patient's heart.

DETAILED DESCRIPTION

[042] A prosthetic valve assembly is disclosed herein, which is designed to replace a diseased native cardiac valve in a patient in need thereof. The prosthetic valve assembly is designed and manufactured according to patient specific parameters. These parameters may be provided by computer software that analyzes a three- dimensional (3D) structure of the patient's heart and/or the valve site (e.g., the sites of the native mitral, aortic, pulmonary and/or tricuspid valves). Also disclosed are methods for generating the prosthetic valve as well as methods for using the valve to replace a native valve in a patient's heart. The prosthetic valve comprises: · an annular opening which may match the shape and/or size of a patient's heart valve annulus,

• clips and/or rods for retaining the annular opening at the annulus (or other location), and

• valve mechanical elements, such as one or more tubes, sails, flaps, and/or the like, which allow blood flow in a single direction through the annular opening.

[043] Optionally, the prosthetic valve is pre-manufactured, at least in part, to different patient sizes and shapes. For example, the annulus body is manufactured for patient specific mitral valve geometry, and the funnel is pre-manufactured in different sizes and attached to the annulus prior to surgery.

[044] Optionally, the 3D structure is analyzed from images taken of the patient's mitral valve. For example, 3D images are captured of patients, mitral valve, such as ultrasound images, computed tomography images, magnetic resonance images, visual images, infrared images, and/or the like. [045] Reference is now made to Fig. 1A which shows a prosthetic mitral valve assembly ("assembly") 100 that may be used as a mitral valve replacement. Assembly 100 may extend from a proximal end having an inlet and terminate in a distal end having an outlet. Assembly 100 may comprise a funnel ending with a short (e.g., at least 20 mm, at least 30 mm, at least 40 mm or no more than 50 mm) cylindrical tube 114. Other shapes may be used as well to perform the fluid flow functions. Assembly 100 may include an annular body 102 that fits a patient specific size of a mitral annulus; a first clip 104 that attaches annular body 102 to a patient specific position of a first meeting point of the patient's posterior and anterior mitral leaflets (not shown); a second clip 106 that attaches annular body 102 to a patient specific position of a second meeting point of posterior and anterior mitral leaflets; and rods 108 that attach annular body 102 to a patient's left atrium, wherein the rods are attached to and extend away from annular body 102, and wherein each one of the rods has a patient specific size shape and orientation. Rods 108 may include at least two rods, at least three rods or more. Optionally, assembly 100 may further include a central rod 110 that connects the first clip to the second clip.

[046] Optionally, assembly 100 may include a first rod 104a and a second rod 106a to control clips 104 and 106 from outside a body. Rods 104a and 106a may be attached (e.g., by snapping, threading, etc.) to clips 104 and 106, respectively. Optionally, rods 104a and 106a extend proximally from clips 104 and 106 on a vertical axis. For example, a rod and/or clip may comprise a hook at one end for anchoring into the tissue surrounding the mitral valve. Optionally, the attachments of rods 104a and 106a to clips 104 and 106 respectively, are detachable, such by having a first mechanical configuration in an open position and a second mechanical configuration in a closed position. In a non-limiting example, rods 104a and 106a may each terminate at its distal end in a threaded portion (not shown), and clips 104 and 106 may each include internal threads (not shown) to engage the threaded portions of rods 104a and 106a, respectively.

[047] The components of prosthetic mitral valve assembly 100 may be made of any biocompatible material. As used herein, a material is biocompatible if the material and any degradation products of the material are generally nontoxic to the patient and also possess no significant deleterious or untoward effects on the patient's body, such as a significant immunological reaction. Prosthetic mitral valve assembly 100 may be made from one or more synthetic materials, such as a polyester material. One example of a polyester material is polyethylene terephthalate (PET). One or more alternative materials may be used. For example, prosthetic mitral valve assembly 100 may be made from expanded polytetrafluoroethylene (ePTFE). In yet another example, prosthetic mitral valve assembly 100 may be made from biological matter, such as pericardial tissue (e.g., bovine, porcine or equine pericardium). One or more other materials may prove suitable, as will be appreciated by one skilled in the art. [048] Annular body 102 may be self-expandable and formed from a shape memory material, such as, for example, Nitinol. Alternatively, annular body 102 may be made of metal, stainless still and/or any other suitable material. The size of annular body 102 correlates to a radial size of a mitral annulus as obtained from a specific patient. For example, the patient specific geometry is analyzed from one or more images, a mold is manufactured for the patient specific geometry, and a Nitinol annulus body is formed from the mold, such as by pressing.

[049] As used herein, the mitral annulus constitutes the anatomical junction between a ventricle and a left atrium, and serves an insertion site for the prosthetic mitral valve assembly. [050] Prosthetic mitral valve assembly 100 may include a valve (not shown), which is optionally a mitral valve known in the art. The valve may have a leafed-valve configuration, such as a bicuspid valve or tricuspid valve configuration. Alternatively, the valve may be a mechanical type valve, rather than a leafed type valve. Optionally, the valve may be a flap that allows flow of fluid in one direction. The valve may be connected to the mitral valve assembly 100 using, for example, sutures (not shown) or other suitable connection techniques known in the art. Blood flow through the valve proceeds in a direction from the upper portion to the lower portion.

[051] Prosthetic mitral valve assembly 100 may assume a collapsed state (also "configuration") for minimally-invasive delivery to a site of a native valve, such as by percutaneous or transluminal delivery using one or more catheters. Optionally, a direct delivery to the left atrium is performed via a chest wall. Alternatively, prosthetic mitral valve assembly 100 may be delivered via a left ventricle apex. The prosthetic valve assembly is expanded upon exiting the catheter and delivery to the native valve. Reference is now made to Fig. IB, which shows a collapsed state (configuration) of prosthetic mitral valve assembly 100. As illustrated, prosthetic mitral valve assembly 100 may be collapsed and inserted to a site of valve replacement via catheter 112. Optionally, central rod 110 may be anchored to catheter 112.

[052] Reference is now made to Fig. 2 which shows a prosthetic mitral valve assembly ("assembly") 200, in accordance with another embodiment. Assembly 200 is substantially similar to assembly 100 described in Fig. 1A with the notable difference that assembly 200 is shaped as a sail having two leaflets 214a and 214b, rather than as a funnel ending with cylindrical tube as shown in Fig.lA. Assembly 200, similarly to assembly 100 of Fig. 1A may extend from a proximal end having an inlet and terminate in a distal end having an outlet. Leaflets 214 and 216 extend from annular body 202 that corresponds to annular body 102 of Fig. 1A to a distal end, defining the outlet of assembly 200. Assembly 200 may further include a first clip 204, corresponding to first clip 104 of Fig. 1A, that attaches annular body 202 to a patient specific position of a first meeting point of the patient's posterior and anterior mitral leaflets (not shown); a second clip 206, corresponding to second clip 106 of Fig. 1A, that attaches annular body 202 to a patient specific position of a second meeting point of posterior and anterior mitral leaflets; and rods 108, corresponding to rods 108 of Fig. 1A, that attach annular body 202 to a patient's left atrium, wherein the rods are attached to and extend away from annular body 202, and wherein each one of the rods has a patient specific size shape and orientation. Rods 208 may include at least two rods, at least three rods or more. Optionally, assembly 200 may further include a central rod 210, corresponding to central rod 110 of Fig. 1A, that connects the first clip to the second clip. Optionally, assembly 200 may further include a first rod 204a, corresponding to first rod 104a of Fig. 1A, and a second rod 206a, corresponding to first rod 104a of Fig. 1A, to control clips 204 and 206 from o utside a body. Rods 204a and 206a may be detachably connected to clips 204 and 206 respectively.

[053] Reference is now made to Figure 3A, which is a flow chart of a method for manufacturing the prosthetic mitral valve of Figs. 1A-B. [054] Measurements of dimensions of a patient's heart and/or defective valve site are obtained (step 300). Optionally, a computer program that provides a three dimensional (3D) structure of a patient's heart (also referred to as cardiac tissue) and/or defective valve site is used. Patient specific parameters for manufacturing assembly 100 (Figs. 1A-B) are provided (step 302). For this purpose a computer program that provides the desired 3D complementary structure for the prosthetic mitral valve assembly, may be used. Annular body 102 (Figs. 1A-B) that fits a patient specific size of a mitral annulus is provided (step 304). First clip 104 (Figs. 1A-B) is attached to the annular body according to a patient specific position of a first meeting point of posterior and anterior mitral leaflets (step 306). Second clip 106 (Figs. 1A-B) is attached to the annular body according to a patient specific position of a second meeting point of posterior and anterior mitral leaflets (step 308). Optionally, a first side of central rod 110 (Figs. 1A-B) is attached to first clip 104 (Figs. 1A-B) and a second side of central rod 110 (Figs. 1A-B) is attached to second clip 106 (Figs. 1A-B) according to a patient specific position of first clip 104 (Figs. 1A- B) and second clip 106 (Figs. 1A-B) (step 310). Optionally, a first rod 104a (Figs. 1A- B) is attached to (e.g., affixed by screws) first clip 104 (Figs. 1A-B) (step 312). Optionally, a second rod 106a (Figs. 1A-B) is attached to (e.g., affixed by screws) second clip 106 (Figs. 1A-B) (step 314). Rods 108 (Figs. 1A-B), having a patient specific size shape and orientation, are attached to and extend outward from annular body 102 (Figs. 1A-B) (step 316).

[055] Reference is now made to Figure 3B, which is a flow chart of a method for anchoring assembly 100 of Figs 1A-B in a patient's heart. Assembly 100 (Figs. 1A-B) is provided in its collapsed configuration in catheter 112 (Fig. IB) (step 320). Assembly 100 (Figs. 1A-B) is positioned in a patient's heart via catheter 112 (Fig. IB) (step 322). Assembly 100 (Figs. 1A-B) is extracted from the catheter, and annular body 102 (Figs. 1A-B) is expanded radially outward so as to overlay a mitral annulus (step 324). Optionally, central rod 110 (Figs. 1A-B) is rotated to position first clip 104 (Figs. 1A-B) at a first meeting point of posterior and anterior mitral leaflets and second clip 106 (Figs. 1A-B) at a second meeting point of posterior and anterior mitral leaflets (step 326). Optionally, central rod 110 may be controlled (e.g., rotated) by catheters 112. Alternatively, additional element is provided to control central rod 110 from outside a body. Optionally, a first rod 104a (Figs. 1A-B) is rotated to position first clip 104 (Figs. 1A-B) at a first meeting point of posterior and anterior mitral leaflets and further rotated to open first clip 104 (Figs. 1A-B) (step 326). Optionally, a second rod 106a (Figs. 1A-B) is rotated to position first clip 106 (Figs. 1A-B) at a second meeting point of posterior and anterior mitral leaflets and further rotated to open second clip 106 (Figs. 1A-B) (step 328). First clip 104 (Figs. 1A-B) is clipped against a first meeting point of posterior and anterior mitral leaflets, such that a mitral tissue comprised of posterior and anterior mitral leaflets is captured (step 330). Second clip 106 (Figs. 1A-B) is clipped against a second meeting point of posterior and anterior mitral leaflets, such that mitral tissue comprised of posterior and anterior mitral leaflets is captured (step 332). Rods 108 (Figs. 1A-B) are anchored to a patient's left atrium to provide support for the prosthetic mitral valve assembly in the left atrium (step 334).

[056] Optionally, following deployment of mitral valve assembly 100, central rod 110 is set in an operable position so that blood flow through mitral valve assembly 100 remains substantially unaffected. [057] Optionally, following deployment of mitral valve assembly 100, rods 104a and 106a are detached from clips 104 and 106 respectively and withdrawn outside the body. [058] Any of steps 322-336 may be done by using a diagnostic imaging technique such as: X-Ray, echocardiography, transesophageal echocardiogram (TEE) or a combination thereof.

[059] Steps 300 and/or 302 for example may utilize, as briefly discussed above, a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.

[060] The present invention may be a system, a method, and/or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.

[061] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc readonly memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiberoptic cable), or electrical signals transmitted through a wire. Rather, the computer readable storage medium is non-transient (also "non-volatile").

[062] Computer readable program instructions described herein can be downloaded to respective computing/processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and/or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. A network adapter card or network interface in each computing/processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing/processing device. [063] Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like, and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present invention.

[064] Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

[065] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that cfan direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks. [066] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.

[067] The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[068] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

CLAIMS What is claimed is:

1. A prosthetic mitral valve assembly comprising: an annular body configured to fit a patient specific size of a mitral annulus; at least one clip configured to attach the annular body to a patient specific position of at least one meeting point of a posterior and an anterior mitral leaflet; at least one rod configured to attach the annular body to a patient's left atrium, wherein the rods are attached to and extending away from the annular body, and wherein the at least one rod comprises a patient specific size and shape.

2. The prosthetic mitral valve assembly of claim 1, wherein the prosthetic mitral valve assembly has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart.

3. The prosthetic mitral valve assembly of claim 1 or claim 2, wherein the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet.

4. The prosthetic mitral valve assembly of any one of the preceding claims, wherein the annular body is manufactured to a specific anatomy of a patient based on an analysis of a three-dimensional (3D) image of the mitral valve annulus of the patient.

5. The prosthetic mitral valve assembly of any one of the preceding claims, wherein the at least one rod comprises a central rod.

6. The prosthetic mitral valve assembly of any one of the preceding claims, wherein the at least one clip comprises an attached configuration and a detached configuration, and the at least one clip is further configured to be detachable from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

7. The prosthetic mitral valve assembly of any one of the preceding claims, wherein the at least one rod comprises an attached configuration and a detached configuration, and the at least one rod is further configured to be detachable from at least one of the annular body and the left atrium.

8. A method for generating a prosthetic mitral valve assembly, the method comprising: providing an annular body configured to fit a patient specific size and shape of a mitral annulus; attaching at least one clip to the annular body according to a patient specific position of at least one meeting point of a posterior and an anterior mitral leaflet, wherein the at least one clip is configured to capture mitral tissue; and attaching at least one rod to the annular body, wherein the at least one rod is configured to extend away from the annular body and wherein the at least one rod comprises a patient specific size and shape.

9. The method of claim 8, wherein the prosthetic mitral valve assembly has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring in the heart.

10. The method of claim 8 or claim 9, wherein the patient specific size and shape are provided by a computer software.

11. The method of any one of claims 8 to 10, wherein the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet.

12. The method of any one of the claims 8 to 11, wherein the method further comprises an action of manufacturing the annular body to a specific anatomy of a patient based on an analysis of a 3D image of the mitral valve annulus of the patient.

13. The method of any one of the claims 8 to 12, wherein the at least one rod comprise a central rod.

14. The method of any one of the claims 8 to 13, wherein the at least one clip comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one clip from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

15. The method of any one of claims 8 to 14, wherein the at least one rod comprises an attached configuration and a detached configuration, and wherein the method further comprises detaching the at least one rod from at least one of the annular body and the left atrium.

16. A method of anchoring a prosthetic mitral valve assembly in a patient's heart, the method comprising: providing a prosthetic mitral valve assembly, wherein the prosthetic mitral valve assembly comprises (i) an annular body, (ii) at least one clip, and (iii) at least one rod, and wherein the prosthetic mitral valve assembly has (a) a collapsed configuration for delivery to the heart via a catheter, and (b) an expanded configuration for anchoring in a patient's heart; positioning the prosthetic mitral valve assembly in the patient's heart via a catheter; extracting the prosthetic mitral valve assembly from the catheter, thereby allowing the annular body to expand radially into a mitral annulus, and anchoring the annular body against a portion of a patient's atrium; anchoring the at least one clip against a at least one meeting point of a posterior and an anterior mitral leaflet; anchoring the at least one rod to a patient's left atrium.

17. The method of claim 16, wherein the at least one clip comprises at least two opposing clips, each of the at least two opposing clips attached at an opposing side of the annular body and each configured to attach the annular body to a patient specific position of at least two meeting points of a posterior and an anterior mitral leaflet.

18. The method of claim 16 or claim 17, wherein the method comprises an action of manufacturing the annular body to a specific anatomy of a patient based on an analysis of a 3D image of the mitral valve annulus of the patient.

19. The method of any one of claims 16 to 18, wherein the at least one rod comprise a central rod.

20. The method of any one of claims 16 to 19, wherein the at least one clip comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one clip from at least one of the annular body and the at least one meeting point of a posterior and an anterior mitral leaflet.

21. The method of any one of claim 16 to 20, wherein the at least one rod comprises an attached configuration and a detached configuration, and wherein the method further comprises an action of detaching the at least one rod from at least one of the annular body and the left atrium.