Systems, devices, and methods for anchoring and / or sealing heart valve prosthesis

Abstract

A method, device and system for anchoring and / or sealing a heart valve prosthesis, and in particular a mitral valve prosthesis (202). The expandable elements (204, 206) are used to seal and anchor a mitral valve prosthesis (202) and / or other elements associated with repairing a native mitral valve.

Description

[0001] This application is a divisional application of the patent application for invention titled "Systems, Devices, and Methods for Anchoring and / or Sealing Heart Valve Prostheses" with application number 201780025645.2, filed on February 28, 2017.

[0002] Cross - reference to related applications

[0003] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 301,924, filed on March 1, 2016 (pending), and U.S. Provisional Patent Application Serial No. 62 / 349,830, filed on June 14, 2016 (pending), the disclosures of which are hereby incorporated herein by reference. Background Art

[0004] Despite considerable efforts, repairing and replacing the mitral valve via catheter remains a challenge. The replacement of the aortic valve via catheter has advanced very rapidly. The aortic valve has an annulus that can be used as an anchor for a prosthetic valve positioned inside the native valve. The mitral valve does not have a natural anchor available to support the valve. Thus, devices for replacing the mitral valve require an anchoring or fastening system to hold the prosthesis in place. This process requires the delivery of the valve prosthesis and the anchoring system. Not surprisingly, given the high pressure within the heart, the stability of the implanted mitral valve is a problem. Uncommonly, there are anatomical variations in the mitral valve. Thus, leakage may occur around the implanted valve. And sometimes the anchoring is fragile. Also, some anchoring systems are bulky to accommodate a variety of anatomical variations. Other methods of anchoring and / or sealing valve prostheses would be useful, which may be smaller, more secure and also reduce leakage.

[0005] Surgical experience can be useful. Surgery allows for a fair amount of flexibility - each patient can be treated taking into account the variations observed during the surgery. The degree of mitral valve variation among patients is large. The diameter of the annulus has a wide range. The amount of leaflet tissue is also very variable - some patients have abundant leaflet tissue while others have very little. The chordae tendineae can be long or short. The ventricles can be small or very large.

[0006] Many patients have large valve diameters and a large amount of valve tissue. Surgeons have found it very useful to leave the leaflet tissue (i.e., not excise all the redundant leaflet tissue), or even fold the leaflet tissue. The folded leaflet tissue reduces the size of the annulus and fills the space, so a smaller valve can be used. This forms a circle of leaflet pledgets that reduces the diameter of the annulus. The retained leaflets also make the connection more secure. The retained leaflets act as shock absorbers by distributing the load around the anchors of the valve.

[0007] Folding and tensioning the leaflet tissue and thereby folding and tensioning the chordae tendineae also aids mitral valve replacement. The mass of the folded tissue creates a very strong anchor for the valve. In addition, the tensioned leaflet-chordae system reduces the movement of the valve. If the leaflets and chordae are not tensioned, the prosthetic valve may move with the beating of the heart. Valve movement after valve replacement is very dangerous. The movement applies a rhythmic load on the attachment, and with approximately 100,000 heartbeats per day, the risk of valve rupture, tissue tearing, and leakage is amplified.

[0008] Tensioning the chordae tendineae after mitral valve replacement also aids the function of the left ventricle after valve replacement. The tensioned chordae tendineae help maintain the correct shape of the left ventricle to optimize the filling and emptying of the myocardium and its function.

[0009] It would be useful to address leakage or eliminate the possibility of leakage in a flexible manner and also provide other options for anchoring the valve in the mitral position.

[0010] Expandable devices have been used in various locations. They have been used in abdominal procedures to move the viscera and allow the surgeon to perform the operation without the risk of harming adjacent abdominal contents. Direct Flow Medical has also developed an aortic valve that has an "expandable" component to help anchor the valve. Summary of the Invention

[0011] An anchor for sealing and / or stabilizing a mitral valve prosthesis in a native mitral valve position, comprising an elongate expandable element and a wire, the elongate expandable element configured to be guided beneath at least a portion of the native mitral valve, the wire operably coupled to the elongate expandable element and configured to guide the elongate expandable element beneath at least a portion of the native mitral valve. The wire may be fixed to the elongate expandable element to prevent any sliding movement between the elongate expandable element and the wire. The elongate expandable element is configured for delivery through the mitral commissure and / or at least partial implantation between the left ventricular wall and the chordae tendineae. The wire may be connected to the elongate expandable element in a manner that allows sliding movement between the elongate expandable element and the wire.

[0012] A method for implanting an anchor for sealing and / or stabilizing a mitral valve prosthesis in a native mitral valve position, comprising guiding an elongate expandable element beneath at least a portion of the native mitral valve and using a wire operably coupled to the elongate expandable element to guide the elongate expandable element beneath a portion of the native mitral valve. The wire may be fixed to the elongate expandable element, and using the wire also includes guiding the elongate expandable element without any sliding movement between the elongate expandable element and the wire. Guiding the elongate expandable element also includes implanting the elongate expandable element at least partially between the left ventricular wall and at least one of the chordae tendineae and / or native mitral valve leaflets. The wire may be coupled to the elongate expandable element in a manner that permits sliding movement between the elongate expandable element and the wire, and using the wire also includes guiding the elongate expandable element while sliding the elongate expandable element along the wire. Guiding the elongate expandable element also includes implanting the elongate expandable element at least partially between the left ventricular wall and at least one of the chordae tendineae and / or native mitral valve leaflets.

[0013] A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising an expandable mitral valve prosthesis configured to be delivered to the position of the patient's native mitral valve via a catheter. The expandable mitral valve prosthesis includes anchoring arms located at its lower portion, which are configured to bend upwardly upon deployment from the catheter to capture the native mitral valve leaflets; and an expandable structure capable of expanding when delivered to the position of the native mitral valve and engaging the native mitral valve leaflets and / or the anchoring arms of the mitral valve prosthesis for stabilizing the implantation of the mitral valve prosthesis in the native mitral valve position. The expandable structure also includes a discontinuous balloon structure that at least partially surrounds the mitral valve prosthesis. The expandable structure also includes discrete and individually expandable balloons.

[0014] A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising an expandable mitral valve prosthesis configured to be delivered via a catheter to the location of the patient's native mitral valve, the expandable mitral valve prosthesis including an expandable stent portion configured to be delivered to the location of the native mitral valve and then expanded; and an inflatable structure that can be carried on the expandable stent portion and is capable of inflating when delivered to the location of the native mitral valve and providing a seal and / or stabilization between the expandable mitral valve prosthesis and the patient's native mitral valve. The inflatable structure further includes first and second sealing balloons adapted to be positioned generally on opposite (diameter) sides of the mitral valve prosthesis. The inflatable structure further includes at least one pair of sealing balloons positioned adjacent to each other and configured to provide a seal at one commissure of the native mitral valve. The inflatable structure further includes a continuous annular balloon adapted to be positioned around the mitral valve prosthesis. The inflatable structure further includes a discontinuous balloon structure configured to be positioned above and / or below the annulus of the native mitral valve. The inflatable structure further includes a discontinuous balloon structure configured to be positioned generally around the mitral valve prosthesis. The system further includes a reinforcement structure coupled to the discontinuous balloon structure. The reinforcement structure further includes wires and / or inflatable reinforcement balloons. First and second inflatable leaflet capture members are coupled to the inflatable structure and configured to inflate to capture and stabilize the native mitral valve leaflets. The system further includes a mitral valve prosthesis and a plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage at least one of the inflatable structure and / or the native mitral valve leaflets. The anchoring arms further include hook-like members that may include fabric or other materials to form a "paddle" shape.

[0015] A method of implanting an expandable mitral valve prosthesis into a patient's heart, comprising delivering an inflatable structure beneath at least one leaflet of the native mitral valve, delivering the expandable mitral valve prosthesis to the native mitral valve, inflating the inflatable structure, and at least partially anchoring the mitral valve prosthesis in place by using the inflatable structure. Delivering the inflatable structure beneath at least one leaflet further includes guiding the inflatable structure with a wire. Guiding the inflatable structure with a wire may further include guiding the inflatable structure with a wire fixed to the inflatable structure such that there is no relative sliding movement between the wire and the inflatable structure. Guiding the inflatable structure with a wire may alternatively further include guiding the inflatable structure by sliding the inflatable structure along the wire. Delivering the inflatable structure beneath at least one leaflet further includes guiding the inflatable structure between the chordae tendineae and the left ventricular wall.

[0016] A method of implanting an expandable mitral valve prosthesis into a patient's heart, wherein the mitral valve prosthesis includes a plurality of anchoring arms coupled to its lower portion, and the method includes delivering an inflatable structure beneath at least one leaflet of the native mitral valve, delivering the expandable mitral valve prosthesis to the native mitral valve, and engaging the anchoring arms with the inflatable structure and / or at least one leaflet to anchor the expandable mitral valve prosthesis. The anchoring arms further include hooked members, and the method further includes engaging the hooked members with the inflatable structure and / or at least one leaflet of the native mitral valve.

[0017] A system for replacing a patient's native mitral valve with a mitral valve prosthesis, the system comprising an expandable mitral valve prosthesis configured to be delivered via a catheter to the location of the patient's native mitral valve, the expandable mitral valve prosthesis including an expandable stent portion configured to be delivered to the location of the native mitral valve and then expanded; an inflatable structure capable of being delivered beneath at least one leaflet of the native mitral valve and anchoring the expandable mitral valve prosthesis to the patient's native mitral valve; and a plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage the inflatable structure and / or at least one native mitral valve leaflet. The anchoring arms further include hooked members.

[0018] A system for anchoring a mitral valve prosthesis, the system comprising a delivery catheter including a lumen and a distal opening in communication with the lumen; and an inflatable structure received in the lumen of the delivery catheter in a collapsed form and adapted for delivery from the distal opening. The inflatable structure is capable of expanding when delivered from the distal opening and forming an inflated anchoring element positioned between the mitral valve prosthesis and the patient's native mitral valve, wherein the inflatable structure is capable of being delivered separately from the distal opening to the location of the patient's native mitral valve. The mitral valve prosthesis is capable of being delivered to the location of the patient's mitral valve and radially expanded and engaged with the inflatable element. The inflatable structure further includes first and second sealing balloons adapted to be positioned on opposite sides of the mitral valve prosthesis, and at least one pair of sealing balloons positioned adjacent to each other and configured to provide a seal at one commissure of the native mitral valve. The inflatable structure further includes a continuous annular balloon adapted to be positioned around the mitral valve prosthesis. The inflatable structure further includes a discontinuous balloon structure including first and second portions adapted to be positioned generally on opposite sides of the mitral valve prosthesis, wherein the continuous annular balloon is configured to be positioned above the native mitral valve annulus and the discontinuous balloon structure is configured to be positioned below the native mitral valve annulus. A reinforcing structure is coupled to the discontinuous balloon structure and includes wires and / or inflatable reinforcing balloons. First and second inflatable leaflet capture members are configured to be inflated to capture and stabilize the native mitral valve leaflets. The system further includes a mitral valve prosthesis and a plurality of anchoring arms, the plurality of anchoring arms being coupled to the mitral valve prosthesis and configured to engage at least one of the inflatable structure and / or the native mitral valve leaflets. The anchoring arms further include hooked members.

[0019] A method of implanting an expandable mitral valve prosthesis into a patient's heart, which includes delivering an inflatable structure to the native mitral valve, delivering the expandable mitral valve prosthesis separately from the inflatable structure to the native mitral valve, and anchoring the mitral valve prosthesis in place to replace the patient's native mitral valve by inflating the inflatable structure and positioning the inflatable element generally between the expandable mitral valve prosthesis and the native mitral valve. The method also includes delivering the inflatable structure and the expandable mitral valve prosthesis percutaneously through the patient's venous system to the native mitral valve. Delivering the inflatable structure also includes delivering a first balloon of the inflatable structure into the left ventricle of the heart below the mitral valve and delivering a second balloon of the inflatable structure into the left atrium of the heart above the mitral valve. The inflatable structure also includes first and second sealing balloons and delivering the inflatable structure also includes positioning the first sealing balloon on one side of the native mitral valve and positioning the second sealing balloon on the opposite (diameter) side of the native mitral valve and sealing the first and second commissures of the native mitral valve using at least the first and second balloons respectively. The inflatable structure also includes third and fourth sealing balloons, and delivering the inflatable structure also includes positioning a pair of sealing balloons to provide a seal at one commissure of the native mitral valve and positioning another pair of sealing balloons to provide a seal at the other commissure of the native mitral valve. The inflatable structure also includes a continuous annular balloon, and delivering the inflatable element also includes positioning the continuous annular balloon around the mitral valve prosthesis. The inflatable structure also includes a discontinuous balloon structure connected to the continuous annular balloon, and delivering the inflatable structure also includes positioning the continuous annular balloon above the annulus of the native mitral valve and positioning the discontinuous balloon structure below the annulus of the native mitral valve. The inflatable structure also includes a discontinuous balloon structure and delivering the inflatable structure also includes positioning the discontinuous balloon structure above or below the annulus of the native mitral valve. The method also includes reinforcing the discontinuous balloon structure with wires and using the wires to assist in the delivery of the discontinuous balloon structure. Delivering the inflatable structure also includes delivering first and second inflatable leaflet capture members and inflating the first and second inflatable leaflet capture members to capture and stabilize the native mitral valve leaflets. The expandable mitral valve prosthesis also includes a plurality of anchoring arms coupled to its lower portion, and the method also includes engaging the anchoring arms with the inflatable structure and / or at least one native mitral valve leaflet to assist in stabilizing the expandable mitral valve prosthesis. The anchoring arms also include hook members and the method also includes engaging the hook members under the leaflets of the native mitral valve.

[0020] A system for replacing a patient's native mitral valve, comprising a mitral valve prosthesis including a generally tubular portion and a flange portion extending radially outwardly from the tubular portion, the flange portion configured to provide an anchor above the annulus of the native mitral valve in the patient's left atrium; an expandable structure configured to be positioned beneath at least a portion of the native mitral valve leaflets; and a plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage at least one of the expandable structure and / or the native mitral valve leaflets to assist in securing the mitral valve prosthesis in place. The anchoring arms further include hook-like members. The expandable structure has a generally semi-circular elongated shape for positioning between the left ventricular wall and the chordae tendineae and / or the native mitral valve leaflets and generally following the curvature of the annulus of the native mitral valve. The system further includes a wire operatively coupled to the expandable element and configured to guide the expandable element to a position between the left ventricular wall and the chordae tendineae and / or the native mitral valve leaflets and generally following the curvature of the annulus of the native mitral valve. The wire may be fixed to the expandable element to prevent any sliding movement between the expandable element and the wire. Alternatively, the wire may be coupled to the expandable element in a manner that permits sliding movement between the expandable element and the wire.

[0021] A mitral valve prosthesis comprising a generally tubular portion; a plurality of anchoring arms coupled to a lower section of the tubular portion and configured to be positioned beneath the native mitral valve leaflets and to bend upwardly upon deployment; and an expandable structure coupled to the anchoring arms and configured to engage and capture the native mitral valve leaflets upon deployment of the anchoring arms. The mitral valve prosthesis further includes a flange portion extending radially outwardly from the tubular portion, the flange portion configured to provide an anchor above the annulus of the native mitral valve in the patient's left atrium.

[0022] A mitral valve commissure seal comprising an expandable structure including a first portion extending in a first direction for passing through the commissure of the native mitral valve and expandable to prevent blood leakage through the commissure; and a second portion extending generally transverse to the first portion and configured to be positioned above or below the native mitral valve annulus and expandable to serve as an anchor for the mitral valve prosthesis.

[0023] A system for replacing a patient's native mitral valve, comprising a mitral valve prosthesis including a generally tubular portion and a flange portion extending radially outwardly from the tubular portion, the flange portion configured to provide an anchor above the native mitral valve annulus in the patient's left atrium; and an expandable structure configured to be positioned at at least one commissure of the native mitral valve and expand to at least assist in sealing the commissure to prevent blood leakage.

[0024] An expandable structure is formed to generally follow the native mitral annulus and permit implantation of a mitral valve prosthesis, where the diameter of the mitral valve prosthesis is smaller than the native mitral annulus. An expandable anchor is formed to generally be a semi-circular elongated shape so as to be configured to be positioned beneath at least one native mitral leaflet and in a plane generally parallel to the native mitral annulus and assist in anchoring the mitral valve prosthesis. The expandable anchor is delivered via at least one anchoring arm of the mitral valve prosthesis and is capable of being delivered to a proper position through the commissure of the native mitral valve. The expandable anchor further includes a portion configured to seal a part of the gap formed by the commissure of the native mitral valve. This portion extends generally transversely to another portion of the expandable anchor and is configured to be implanted in a proper position to extend through the commissure.

[0025] An expandable anchoring system for a mitral valve prosthesis includes at least one expandable anchor formed to generally be a circular or semi-circular shape so as to be configured to be positioned above and / or below the native mitral annulus to assist in anchoring the mitral valve prosthesis, and where the expandable anchor includes a portion capable of expanding at the location of the mitral annulus to seal the commissure to prevent blood leakage.

[0026] A strategy for improving the quality of mitral valve replacement, reducing the size of the prosthesis used, and using leaflet tissue to cushion the implant and tension the leaflet-chordae system is useful for catheter-based mitral valve replacement. An expandable system can be used to achieve these goals. Additionally, the expandable system can be adjusted to account for patients of different sizes and different mitral valve and mitral annulus compositions. The amount of expansion or the actual number of expansions filled (some of which can be optionally filled) can provide considerable flexibility.

[0027] The following figures illustrate how expandable anchoring components can be used for, for example:

[0028] Reducing the annulus diameter and reducing the need for a large valve prosthesis;

[0029] Providing native leaflet filling around the prosthetic valve;

[0030] Tensioning the leaflet-chordae apparatus to reduce prosthesis movement and lower the risk of rupture and failure;

[0031] Improving left ventricular (LV) function by tensioning the leaflets and chordae

[0032] Improving the seal of the prosthetic valve to prevent leakage;

[0033] Adjusting the filling of the expandable anchor to accommodate different valve diameters, leaflets, and chordae; folding the leaflets and tensioning the chordae tissue; and / or

[0034] Capturing the leaflet and chordae tissue.

[0035] In another embodiment, the present invention provides a system for replacing a patient's native mitral valve with a mitral valve prosthesis, which includes an inflatable mitral valve prosthesis and an inflatable stabilization structure. The inflatable mitral valve prosthesis is configured to be delivered to the location of the patient's native mitral valve via a catheter. The inflatable stabilization structure is capable of inflating and engaging with native tissue when delivered to the location of the native mitral valve to stabilize the implantation of the mitral valve prosthesis at the location of the native mitral valve.

[0036] In another embodiment, the present invention provides a system for replacing a patient's native mitral valve with a mitral valve prosthesis, the mitral valve prosthesis including an inflatable mitral valve prosthesis and an inflatable stabilization structure. The inflatable mitral valve prosthesis is configured to be delivered to the location of the patient's native mitral valve via a catheter. The inflatable mitral valve prosthesis includes an inflatable portion configured to be delivered to the location of the native mitral valve and then expanded. The inflatable stabilization structure is carried on the inflatable portion and is capable of inflating when delivered to the location of the native mitral valve and providing a seal and / or stabilization between the inflatable mitral valve prosthesis and the patient's native mitral valve. The inflatable stabilization structure may further include first and second sealing balloons adapted to be positioned generally on opposite sides of the inflatable mitral valve prosthesis. The inflatable stabilization structure may further include a continuous annular balloon adapted to be positioned around the expandable mitral valve prosthesis. The inflatable stabilization structure may further include a discontinuous balloon structure configured to be positioned above and / or below the annulus of the native mitral valve.

[0037] The inflatable stabilization structure may further include a discontinuous balloon structure configured to be positioned generally around the expandable mitral valve prosthesis. The system may further include a reinforcement structure coupled to the discontinuous balloon structure. The reinforcement structure may further include wire. The system may further include first and second inflatable leaflet capture members coupled to the inflatable mitral valve prosthesis and / or the inflatable stabilization structure and configured to inflate to capture and stabilize the native mitral valve leaflets.

[0038] In another aspect, the present invention also provides a method of implanting an inflatable mitral valve prosthesis into a patient's heart. The method includes delivering the inflatable stabilization structure beneath at least one leaflet of the native mitral valve. The inflatable mitral valve prosthesis is delivered to the native mitral valve. The inflatable stabilization structure is inflated and the inflatable mitral valve prosthesis is at least partially anchored in place by using the inflatable stabilization structure. Delivering the inflatable stabilization structure beneath at least one leaflet may further include guiding the inflatable structure with wire.

[0039] In another embodiment, the present invention provides a system for repairing a patient's native mitral valve using a mitral valve prosthesis, the mitral valve prosthesis including a mitral valve clamp and an inflatable sealing structure. The mitral valve clamp is configured to be delivered to the location of the patient's native mitral valve via a catheter. The mitral valve clamp is configured to capture the native leaflets of the mitral valve and hold the native leaflets of the mitral valve together. The inflatable sealing structure is capable of inflating when delivered to the location of the native mitral valve and engaging with native tissue to seal leaks through the native mitral valve. The inflatable sealing structure may be independent of or physically coupled to the mitral valve clamp. The inflatable sealing structure may be physically coupled to the mitral valve clamp via an inflatable connection structure.

[0040] In another aspect, the present invention provides a method of applying a mitral valve clamp to a patient's native mitral valve. The method includes delivering the mitral valve clamp beneath the leaflets of the native mitral valve and capturing the leaflets using the mitral valve clamp. The inflatable sealing structure is delivered to the native mitral valve. The inflatable sealing structure inflates to engage with native tissue to seal one or more leaks through the native mitral valve. As with any method herein, the steps or portions of each method may be performed in any order depending on the application and / or desire of the person performing the method.

[0041] After reading the following detailed description of the illustrative embodiments in conjunction with the accompanying drawings, various additional advantages and features will become more apparent to those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 FIG. 1 is a schematic diagram showing a cross-section of a patient's heart and an exemplary method of delivering a device according to various embodiments of the present invention.

[0043] Figure 2A FIG. 2 is an enlarged cross-sectional view of the heart showing the introduction of a catheter assembly into the left atrial chamber or atrium of the heart and through the mitral valve into the left ventricle.

[0044] Figure 3 FIG. 3 is a cross-sectional view showing an expandable mitral valve prosthesis including a stent and a pair of inflatable sealing balloons.

[0045] Figure 4A FIG. 4 is a top view of the native mitral valve, with the mitral valve prosthesis shown in dashed lines.

[0046] Figure 4B FIG. 5 is a top view of the native mitral valve, with the mitral valve prosthesis in place.

[0047] Figure 4C FIG. 6 is similar to Figure 4B FIG. 5, but shows the two sealing balloons in their inflated state.

[0048] Figure 5A is a cross-sectional view of a native mitral valve taken along line 5A-5A generally Figure 4C as shown, but showing an expandable stent valve in an unexpanded state.

[0049] Figure 5B is similar to Figure 5A a cross-sectional view, but showing an expandable stent valve in an expanded state and a balloon seal element shown in dashed lines.

[0050] Figure 5C is similar to Figure 5B a cross-sectional view, but showing an inflatable balloon in an inflated and sealed state.

[0051] Fig. 6A is a perspective view showing an alternative embodiment of an inflatable seal balloon on an expandable stent valve.

[0052] Figure 6B is Fig. 6A a side view.

[0053] Figure 6C is a cross-sectional view showing an expandable stent valve and a balloon seal element implanted in the position of the native mitral valve.

[0054] Fig.6D is a perspective view of an expandable stent valve having an alternative inflatable element in the form of a continuous annular balloon surrounding the expandable stent valve.

[0055] Figure 7 is a perspective view of another alternative expandable stent valve for mitral valve replacement, including an inflatable balloon for sealing at the commissure position of the native mitral valve.

[0056] Fig. 8A is Figure 7 a top view of the expandable stent valve and shown in the position of the native mitral valve.

[0057] Figure 8B is showing the implantation Figure 7 and 8A of an expandable stent valve, for capturing the native mitral valve leaflets before the pair of arms are fully deployed.

[0058] Figure 8C is similar to Figure 8B a cross-sectional view, but showing the fully deployed arms.

[0059] Fig.8D is similar to Figure 8C a cross-sectional view, but showing the inflation of one of a pair of seal balloons located at the commissure position of the native mitral valve.

[0060] Fig. 8E is similar to Fig.8D in cross-sectional view, but shows another embodiment using an additional inflatable balloon.

[0061] Fig.8F and Figure 8G is similar to Fig. 8E in cross-sectional view, but shows an embodiment using an alternative inflatable balloon.

[0062] Fig. 9A Shows a cross-sectional view of another embodiment, showing a mitral valve prosthesis including an inflatable element for stabilizing and anchoring the position of the mitral valve prosthesis at the native mitral valve position.

[0063] Fig. 9B is similar to Fig. 9A in cross-sectional view of the native mitral valve position, but shows the inflatable element in its inflated state.

[0064] Figures 10A-10D is a perspective view showing various additional embodiments of an inflatable element that can be used in connection with a mitral valve prosthesis.

[0065] Fig.11A is a cross-sectional view of the native mitral valve position and a perspective view of a delivery catheter, generally showing the method from below the native mitral valve.

[0066] Fig. 11B is similar to Fig.11A in cross-sectional view, but shows the delivery of an inflatable anchoring and / or sealing element to the position of the native mitral valve.

[0067] Fig. 11C is similar to Fig. 11B in cross-sectional view, but shows an alternative embodiment of an inflatable element for anchoring and / or sealing a mitral valve prosthesis.

[0068] Fig.11D is similar to Fig. 11B and Fig. 11C in cross-sectional view, but shows another embodiment of an inflatable element for anchoring and / or sealing a mitral valve prosthesis relative to the native mitral valve.

[0069] Fig.11E is similar to Fig.11D in cross-sectional view, but shows another step in the delivery method for inflating the inflatable element, including the portion delivered below the native mitral valve.

[0070] Fig.11F and Fig.11G is Fig.11D and Fig.11E A corresponding side view of the expandable element shown in, and separately showing the expansion and deployment process of the lower discontinuous portion of the expandable element, which is configured to be deployed beneath the native mitral valve leaflets.

[0071] Fig. 12A Is a perspective view showing a deployable stent valve used in combination with an expandable element as shown in FIG. 11D to FIG. 11G As a mitral valve prosthesis.

[0072] Fig. 12B Is a perspective view showing separately Fig. 12A The expandable element.

[0073] Fig. 12C Is a perspective view showing another embodiment of the expandable element, which includes a reinforcing structure for supporting the lower discontinuous portion of the expandable or balloon element.

[0074] Fig.12D Is Fig. 12A And Fig. 12B A partial cross-sectional side view of the balloon-expandable element, which shows the expansion input and fluid in the form of a material that can be cured.

[0075] Fig.12E Is similar to Fig.12D A partial cross-sectional side view, but shows another embodiment of the expandable element including a reinforcing structure in the form of a wire frame.

[0076] Fig.12F Is a top view showing the placement and orientation of the lower discontinuous portion of the expandable element relative to the native mitral valve.

[0077] Figure 12G Is a lateral cross-sectional view of an expandable element constructed according to another embodiment.

[0078] Fig.12H Is similar to Fig. 12C An enlarged cross-sectional view of the expandable element, but shows the use of an additional sealing balloon.

[0079] Figure 13A-13E Is a perspective view showing an alternative embodiment of the expandable element for sealing and / or anchoring a mitral valve prosthesis according to the present invention.

[0080] Fig.14A Is a perspective view showing another alternative embodiment of the expandable element for anchoring and / or sealing a mitral valve prosthesis.

[0081] Fig. 14B Is a perspective view showing the native mitral valve indicated by a dashed line and Fig.14ACross-sectional view of the initial delivery and deployment of the inflatable element taken generally along line 14B-14B as shown.

[0082] Fig. 14C is similar to Fig. 14B a cross-sectional view, but shows the deployment of the inflatable lobe capture element or extension.

[0083] Fig.14D is similar to Fig. 14C a cross-sectional view, but shows an alternative embodiment of the lobe capture element or arm.

[0084] Fig.14E is Fig. 14C and Fig.14D a top view.

[0085] Fig.15A is a perspective view showing another alternative embodiment for the lower discontinuous inflatable element portion including a guide wire coupled thereto and showing the inflatable element in an unexpanded state.

[0086] Fig. 15B Similar to Fig.15A but shows the inflatable element in its expanded state.

[0087] Fig.16A is a cross-sectional view showing a tip of an inflatable element similar to that shown in Fig.15A and 15B but shows the end of the wire encapsulated within the balloon element and the balloon element in an unexpanded state.

[0088] Fig. 16B is similar to Fig.16A a cross-sectional view, but shows the inflatable element in its expanded state.

[0089] Fig. 16C is a cross-sectional view showing an enlarged portion of an inflatable element and a guide wire similar to that shown in Fig.15A and Fig. 15B and the inflatable element is in an unexpanded state.

[0090] Fig.16D is similar to Fig. 16C an enlarged cross-sectional view, but shows the inflatable element in an expanded state and the retraction of the guide wire.

[0091] Fig.16E is a cross-sectional view taken generally along Fig. 16C line 16E-16E.

[0092] Fig.17A and Fig. 17Bis a corresponding cross-sectional view of a native mitral valve, showing the deployment of an expandable anchoring and / or sealing element beneath the leaflets of the native mitral valve.

[0093] Figures 18A-18C is a cross-sectional view of a native mitral valve, showing an alternative method for deploying one or more expandable elements beneath the native mitral valve, including an initial introduction of a guide wire.

[0094] Fig.18D shows Fig. 18C the deployment steps in a top view.

[0095] Fig.18E is a cross-sectional view showing another step in the deployment process.

[0096] Fig.18F is a perspective view showing a mitral valve prosthesis and an expandable element in a collapsed state within a delivery catheter.

[0097] Figure 18G shows another step in the deployment or delivery process, where the expandable mitral valve prosthesis is deployed and expanded, and the expandable element is also expanded or inflated, but before retracting the guide wire.

[0098] Fig.18H is similar to Figure 18G the perspective view, but shows the retraction of the delivery catheter and the guide wire.

[0099] Fig.19A is a perspective view showing another alternative embodiment of a mitral valve prosthesis having anchoring arms combined with an expandable balloon anchor.

[0100] Fig.19B is Fig.19A a side view of the system shown in

[0101] Fig.19C is Fig.19B a side view of the system shown in

[0102] Fig.19D is Fig.19C a side view of the implant system shown in

[0103] Fig.19E is a side view of another alternative embodiment, where the expandable element or balloon is fixed to the anchoring arms of the mitral valve prosthesis.

[0104] Fig.19F is Fig.19F a side view of the system shown in

[0105] Fig. 20A is a perspective view showing another alternative embodiment of a mitral valve prosthesis having an anchoring arm, which is similar to Fig.19A the embodiment of

[0106] Fig. 20B but includes an inflatable element on the anchoring arm. Fig. 20A is a side view of the mitral valve prosthesis shown in

[0107] Fig. 20C which is being delivered within the patient's native mitral valve. Fig. 20B is a side view similar to

[0108] Fig.21A but shows the deployment of the anchoring arm to capture the native mitral valve leaflets and the inflation of the associated inflatable balloon element to assist in capturing the native valve leaflets.

[0109] Fig.21B is a side view similar to Fig.21A but shows a partial inflation of the balloon inflatable element for positioning the prosthetic valve.

[0110] Fig. 21C is a side view similar to Fig.21B but shows a further inflation of the balloon element to provide further positioning assistance.

[0111] Fig.22A is a perspective view showing another alternative embodiment of an inflatable mitral valve prosthesis.

[0112] Fig. 22B is Fig.22A a side view of the mitral valve prosthesis shown in

[0113] Fig. 22C is Fig.22A and Fig. 22B a top view of the mitral valve prosthesis shown in

[0114] Fig.23A is a side view that partially transects and shows the Figure 22A-22C mitral valve prosthesis implanted at the location of the native mitral valve.

[0115] Fig. 23B is a side view similar to Fig.23A but is shown from a perspective rotated 90 degrees relative to Fig.23A

[0116] Fig.24 is a side view of another alternative embodiment of an inflatable mitral valve prosthesis.

[0117] ​ Fig.24A is a side view of another alternative embodiment showing a collapsible mitral valve prosthesis similar to Fig.24 but having a further stabilizing structure.

[0118] Fig. 24B is Fig.24A a top view of the collapsible mitral valve prosthesis shown in

[0119] Fig.25A is a perspective view showing another alternative embodiment of a mitral valve prosthesis including a structure for joining adjacent ends of a collapsible element together.

[0120] Fig.25B is similar to Fig.25A in perspective view but shows a subsequent time during the process of joining the ends together.

[0121] Fig.25C is similar to Fig.25B in perspective view but shows the completion of the process of joining the ends together.

[0122] Figure 26A-26C is a cross-sectional view showing an end portion of a collapsible element for locking adjacent ends of a collapsible element together.

[0123] Fig.27A and Fig.27B show cross-sectional views of alternative locking elements that can be used to lock the ends of a collapsible element together.

[0124] Fig.28A and Fig.28B show another alternative structure for locking the ends of a collapsible element together.

[0125] Fig.29A is a perspective view of another embodiment showing a collapsible mitral valve prosthesis having anchoring arms combined with a collapsible balloon.

[0126] Fig.29B is a side view showing Fig.29A the mitral valve prosthesis positioned at the location of the native mitral valve.

[0127] Fig.29C is a side view showing a mitral valve prosthesis similar to Fig.29B but showing the deployment of the anchoring arms.

[0128] Fig.29D is similar to Fig.29C in side view but further shows the inflation of the balloon element associated with the anchoring arms.

[0129] Fig. 30Ais a perspective view of another alternative embodiment showing an expandable mitral valve prosthesis having anchoring arms combined with an expandable balloon element.

[0130] Fig. 30B is after delivery within the native mitral valve Fig. 30A side view of the mitral valve prosthesis.

[0131] Fig. 30C is similar to Fig. 30B side view, but shows the inflation of the balloon element associated with the anchoring arms.

[0132] Fig.31A is a perspective view of another alternative embodiment showing an expandable mitral valve prosthesis having expandable anchoring arms.

[0133] Fig.31B shows Fig.31A side view of the mitral valve prosthesis within the native mitral valve but before the expandable anchoring arms are fully deployed.

[0134] Fig.31C is similar to Fig.31B side view, but shows the full deployment and inflation of the anchoring arms associated with the mitral valve prosthesis.

[0135] Fig.32A is an alternative embodiment showing an expandable seal and / or anchoring structure combined with a mitral valve clip for securing the native mitral valve leaflets together.

[0136] Fig.32B is similar to Fig.32A side view, but shows further deployment of the balloon expandable element and introduction of the mitral valve clip via a catheter.

[0137] Fig.32C is similar to Fig.32B side view, but shows further deployment of the mitral valve clip beneath the native mitral valve leaflets.

[0138] Fig.32D is similar to Fig.32C side view, but shows the full deployment and implantation of the balloon expandable structure together with the mitral valve clip that captures the native mitral valve leaflets.

[0139] Fig.33A and Fig.33B is similar to Fig.32C and Fig.32D side view, but shows an alternative embodiment having an expandable connector that extends from the mitral valve clip and couples the mitral valve clip to the expandable seal structure. Detailed Description

[0140] In all of the various embodiments shown and described herein, the same reference numerals will be used in the drawings to represent the same structures. Accordingly, no corresponding description of these same elements is required and is generally not included in this written description.

[0141] Figure 1 A method of mitral valve surgery is shown that can be associated with the various devices, systems, and methods disclosed herein. A catheter 10 having a lumen and a distal opening is advanced through a peripheral vein, such as the femoral vein. Here, the catheter 10 is advanced upward along the inferior vena cava and through the atrial septum into the left atrium 12 of the heart 14. The distal tip of the catheter 10 passes through the native mitral valve 16. The heart 14 also includes a left ventricle 17 having chordae tendineae 18 that couple the mitral valve leaflets 16a, 16b to the papillary muscles 19. The leaflets 16a, 16b extend from the mitral valve annulus 16c. Inside the catheter 10, which can be considered a delivery catheter, is a mitral valve prosthesis 20 that can be coupled to, for example, an anchor and / or a seal or used and implanted independently of the anchor and / or the seal for mitral valve replacement as further described herein.

[0142] FIG. 2 shows an enlarged view of the distal delivery catheter 10 within the heart. A guide wire 22 having a U-turn has advanced beneath the mitral valve leaflets 16a, 16b of the native mitral valve 16. Other approaches can also be taken to reach the native mitral valve 16. For example, the native mitral valve 16 can be accessed directly surgically and can be accessed via the apex. This figure focuses on the transseptal approach, but it should be understood that various embodiments of the present invention can use a catheter or catheter assembly to reach the native mitral valve 16 by other methods.

[0143] Figure 3An embodiment of the present invention is shown, which shows a prosthetic heart valve 30 commonly used in aortic valve surgery. The prosthetic valve is a stent valve and attached to the stent valve is an inflatable sealing balloon 34. If there are extreme calcification conditions of the native mitral valve 16, such a stent valve 30 can be directly implanted. Alternatively, the stent valve 30 can be implanted in a docking station or unit fixed to the native mitral valve and holding the stent valve 30 in place. More commonly, mitral valve prostheses for transcatheter implantation have an integrated anchoring mechanism. The sealing balloon 34 can be made of, for example, a polymer and is shrunk or collapsed for delivery. The sealing balloon 34 can have any shape or size useful for the surgery. Attached to the balloon is a catheter or tube 38, which allows the delivery of gas or fluid to fill the balloon. The catheter 38 can be detachable, leaving a seal on the balloon 34 so that gas or fluid does not escape. Threading mechanisms for attaching these catheters or fluid / gas delivery tubes 38 are known in the art, and this also allows the detachment of the fluid or gas delivery tube 38. Initially, these fluid or gas delivery tubes or catheters 38 are used to deliver a contrast material visible to X-rays. Once it is confirmed that the mitral valve prosthesis 30 is in place, the contrast material is replaced with a curable fluid material such as a suitable known polymer permanently held inside the sealing balloon 34. The inflatable sealing balloon 34 can be used not only for sealing at the commissure position (with another sealing balloon at another commissure position), but also for helping to hold the mitral valve prosthesis 30 in place for implantation purposes. An inflatable element such as the sealing balloon 34 can have limited uses, such as dealing with local leakage. The most common leakage site after mitral valve replacement is at the commissure. But leakage can occur anywhere, and these inflatable elements can be used elsewhere at least for that reason. It can be guided Figure 3 the shown sealing balloon 34 such that it is at the commissure site. The sealing balloon 34 can be directly fixed to the mitral valve prosthesis 30, or used together with an attached anchoring system (not shown). Such a balloon or inflatable element 34 can even be used in aortic valve surgery. The position of the sealing balloon 34 can vary, and depending on the desired use, there can be different numbers of balloons. The shape can also vary.

[0144] Figure 4A The mitral valve prosthesis 30 is shown having been delivered to the position of the native mitral valve annulus and viewed from above, i.e., viewed in the left atrium. As shown, gaps 40 can be formed between the leaflets 16a, 16b at the commissure, and these gaps can represent locations where blood leakage may occur, i.e., locations where blood flows past the mitral valve prosthesis 30. As Figure 4B and Figure 4CAs further shown, two sealing balloons 34 are positioned so that they will be located at the corresponding commissures. The sealing balloons 34 can be expanded conventionally or during surgery in response to evidence of leakage around the valve. Inflating the balloon 34 at the commissure will close or seal the gap 40 between the leaflets 16a, 16b, thereby preventing or at least reducing the leakage of blood through the mitral valve prosthesis 30. The sealing balloon 34 shown has a hemispherical shape. However, the sealing balloon 34 does not necessarily have this shape, and any convenient or desired shape can be used instead. There can be multiple balloons 34 on the valve prosthesis 30, and the operator can decide which or which balloons to expand according to the situation. Because the prosthesis can be inserted in any orientation relative to the commissure and then the most suitable balloon 34 can be expanded for sealing and / or anchoring purposes, providing multiple sealing balloons 34 can make it easier to implant the prosthesis 30. It is also possible to have a balloon or expandable element that extends around the periphery of the valve 30 to prevent blood leakage. The balloon 34 may also be located or positioned higher or lower on the prosthesis 30 than shown by way of illustration.

[0145] Figure 4B The expanded state of the sealing balloon 34 is shown. The sealing balloon in its expanded state expands to the native mitral valve annulus to completely close the gap 40 so that there is no possible significant blood leakage. For clarity, the mitral valve prosthesis 30 is shown without a docking station or mechanism and without an anchoring mechanism. However, it should be understood that various types of docking stations or mechanisms may be provided for anchoring the mitral valve prosthesis 30, such as those described below.

[0146] Figure 5A , Figure 5B and Figure 5C A mitral valve prosthesis 50 in the form of a stent-valve is shown being delivered within a native mitral valve. Figure 5A As shown, the delivery catheter carries an expandable stent-valve prosthesis 50 that can expand to its operating size. Some stent-valves are self-expanding, and this concept of adding expandable elements can also be used with such prostheses. The arrow indicates that the stent holding the valve is being expanded with a large balloon 56. An expandable sealing balloon 34 is shown on the generally opposite side of the mitral valve prosthesis 50 that is in a contracted or collapsed state for delivery purposes. Attached to the sealing balloon 34 is a gas or fluid delivery conduit 38 that will be used to expand the sealing balloon. Figure 5B The mitral valve prosthesis 50 is shown now expanded to its operational size. Again, for clarity, a docking station or other anchoring mechanism is not shown, but it should be understood that such a system or mechanism may be used in addition to the sealing balloon 34. The arrows indicate that fluid or gas is introduced into the sealing balloon, and the balloon 34 will expand to the size shown in dashed-dotted lines. Figure 5CThe balloon 34 is shown having been inflated to fill the gaps at the commissures and seal any blood leaks around the mitral valve prosthesis 50. The balloon 34 on the right is shown in cross-section to show that it is filled with a hardenable material such as a known polymer that will permanently retain the balloon shape.

[0147] FIG. 6A to FIG. 6D Alternative shapes for sealing balloon 60 are shown. Fig. 6A , Figure 6B and Figure 6C A sealing balloon 60 having a generally semi-cylindrical shape is shown. The sealing balloon 60 can be attached to any location on the mitral valve prosthesis 62, or to a valve prosthesis anchoring system (not shown) to prevent blood leakage. Figure 6B and Figure 6C As best shown, the sealing balloon 60 can extend along the entire height of the stent-valve or other mitral valve prosthesis 62, or they can be shorter than the entire height of the valve 62, or even extend beyond one or both of the upper edge and / or lower edge of the valve prosthesis 62. The sealing balloon 60 can be attached to the valve prosthesis 62, or can simply be located between the valve prosthesis 62 and the native tissue. Any attachment can be located at discrete points on the valve prosthesis 62 or along the entire extent of the sealing balloon 60. The sealing balloon 60 or other expandable element can be integrated with any portion of the docking or anchoring mechanism for the valve prosthesis 62 or integrated into the valve retaining mechanism attached to the valve prosthesis 62. In other words, the expandable element or sealing balloon 60 as described may or may not be physically coupled to the valve prosthesis, and may or may not be physically coupled to a separate docking system or anchoring mechanism associated with the valve prosthesis for retaining the prosthesis within the native mitral valve. Figure 6C A cross-sectional view at the location of the native mitral valve is shown. As shown, a longer sealing balloon 60 can more securely stop or seal any leakage at the commissure. Sometimes, leakage may occur in other locations, such as cracks in the native mitral valve or calcified portions of the valve, or locations where the valve anchoring mechanism is prone to leakage. These expandable elements, such as the sealing balloon shown, can be used in different locations to solve any overflow leakage problems. Fig.6D Another alternative expandable member 70 is shown in the form of a circular or annular expandable member that generally surrounds a prosthetic valve. Such a structure may be used for sealing and / or anchoring purposes.

[0148] Figure 7Another embodiment of a type of valve prosthesis clinically used for mitral valve replacement is shown. In this case, the prosthetic valve 80 is contained within an anchoring structure 82. A large skirt or flange 84 is configured to be located within the left atrium and create a sealing and anchoring structure. Anchoring arms 88 are provided at the other end of the valve prosthesis 80 and flip or bend upward as shown by the arrows during deployment and surround the native anterior leaflet 16a and posterior leaflet 16b of the mitral valve 16 to hold the prosthetic valve 80 in place. These arms 88 are straight during delivery through a catheter and then rotate or bend around the leaflets 16a, 16b to perform the anchoring function. Figure 7 A pair of side-by-side sealing balloons 90, 92 are also shown. This is further shown in FIG. 8A to FIG. 8D that described below.

[0149] Fig. 8A Two pairs of sealing balloons 90, 92, 94, 96 are shown positioned on opposite sides of the mitral valve prosthesis 80. In the previous figures, a single sealing balloon has been shown to block or close the gap between the anterior leaflet 16a and the posterior leaflet 16b at the commissure. In this figure, the respective pairs 90, 92, 94, 96 of sealing balloons are inflated below each of the anterior leaflet 16a and the posterior leaflet 16b to push the leaflets together and seal the gap to prevent blood leakage through the valve prosthesis 80. The sealing balloons will be delivered through the commissure (when performing surgery from the left atrium) such that these sealing balloons are located below the level of the native mitral valve. An inflation conduit 38 is also shown. The arms 88 are shown before they surround the leaflets 16a, 16b, and the arrows show the arms 88 when around the anterior and posterior leaflets near the midpoint of the leaflets. The leaflets are shown in dashed lines. Figure 8B It is shown that the sealing balloons 90, 92, 94, 96 are inflated through a fluid or gas delivery conduit 38. For clarity, the anchoring arms 88 on the valve prosthesis 80 have engaged the anterior leaflet 16a and the posterior leaflet 16b in a deeper plane than shown in this figure around the central portions of the anterior leaflet 16a and the posterior leaflet 16b. At this time Figure 8B the pair of sealing balloons 94, 96 shown are located below the native leaflets 16a, 16b of the native mitral valve 16. One is located below the anterior leaflet and the other is located below the posterior leaflet. There is a gap between the two leaflets at the commissure as indicated by the comment "leakage at the commissure". Figure 8C It is shown that two sealing balloons 94, 96 are inflated below the leaflets 16a, 16b and the two leaflets 16a, 16b are pushed together to block or stop the leakage. Using a pair of sealing balloons in this way can also make the valve prosthesis 80 more secure and less prone to displacement when the heart is beating and the valve is subjected to high pressure loads and millions of cardiac cycles. Fig.8DShows the fully inflated state of the sealing balloons 94, 96 and the sealing of the gap between the native leaflets at the commissure. The same procedure and result are used at the opposite commissure as needed or desired to prevent blood leakage in a similar manner.

[0150] As Fig. 8E shown, an inflatable element can also be provided to seal the leakage, and this sealing involves using one or more balloons on the atrial and ventricular sides of the annulus. For example, the figure shows a third balloon 100 which is located at a higher plane compared to the first two sealing balloons 94, 96 which are located below the leaflets at one of the commissures. This increases the capture of the leaflets 16a, 16b and further ensures the safety of leak prevention. The third balloon 100 can be larger or smaller, or have a different shape, but the key feature is that it can help capture the leaflets on each side of the native mitral valve 16. This arrangement with sealing balloons 94, 96, 100 above and below the leaflets 16a, 16b also helps to anchor the valve 80. This arrangement makes it difficult for the valve prosthesis 80 to slip out of the proper position, and in fact it can be envisioned that the valve prosthesis 80 can be anchored only by fixation at the commissure as shown. Ideally, the sealing balloons will be larger for anchoring purposes to ensure that the valve 80 does not slide. Fig. 8E Shows three balloons 94, 96, 100 attached to the valve prosthesis 80, however it should be understood that one or more of these balloons can be used separately or independently of the valve prosthesis 80. For example, after the valve prosthesis 80 is implanted, leakage may occur, and these three balloons can be implanted at the commissure and inflated to seal the leakage. In this case, the balloons may have to be connected together. Fig. 8E Further shows inflatable elements or balloons 102, 104 attached to the anchoring arms 88 for additional fixation and anchoring capabilities.

[0151] Fig.8F and Figure 8G Shows an alternative embodiment having larger sealing and / or anchoring balloons 110, 112 attached to the arm 88 for the purpose of better stabilizing the valve prosthesis 80.

[0152] Fig. 9A and 9B Shows a mitral valve prosthesis 120 having an anchoring and / or sealing balloon 122 attached to the mitral valve prosthesis 120 and, when inflated, these balloons or inflatable elements 122 extend beyond the valve prosthesis 120. For example, the balloon 122 can initially be in a collapsed state, such as a rolled-up state as shown. This will allow for delivery through a catheter. As Fig. 9A shown, the balloon 122 is deployed or extended by injecting fluid or gas into the fluid delivery conduit 38 to form the inflatable element 122 into Fig. 9BThe expanded and inflated states shown. In these expanded states, the inflatable element 122 can be used for sealing and / or anchoring purposes. As needed, the deployment or expansion of the inflatable element 122 moves the balloon to its sealing and / or anchoring position. There can be any number of inflatable elements, and the inflatable elements can be used at any location along the valve prosthesis 120. In the example shown, there are four separate balloons 122 or inflatable elements, two of which are located above the native mitral annulus 16c and two of which are located below the native mitral annulus 16c. A circumferential balloon or inflatable element can also be created. For example, the two balloons 122 shown above the native mitral annulus can be replaced by a balloon that extends circumferentially around the prosthetic valve 120. By extending beyond the edge of the prosthetic valve 120, the inflatable element 122 is able to play a greater role in anchoring. The balloon 122 below the native annulus 16c can extend from the commissure and surround the prosthetic valve 120 below the native valve annulus to hold the prosthesis 120 in place.

[0153] Fig. 10A and 10B An inflatable element 130 is shown, which is rolled up in the deflated position ( Fig. 10A ) as described above and then deployed to the operative position by inflation. In this embodiment, the superelastic wire 132 is embedded or otherwise fixed to the inflatable element 130 to initially hold the inflatable element 130 in Fig. 10A the deflated state shown. Fig. 10C Another of many possible inflatable element shapes is shown, namely, a sealing element and / or anchor 140 that extends longitudinally in a substantially linear orientation after inflation. Fig. 10D Another possible shape that is more complex is shown. Here, there is an inflatable element 150 that has an enlarged balloon portion 152 linearly at the distal end.

[0154] Fig.11A Another method of implanting a mitral valve prosthesis 160 using catheter technology is shown. Here, the valve prosthesis 160 is guided to the position of the native mitral valve 16 through the apex of the heart via the delivery catheter 162. Previous embodiments have shown valve prostheses implanted via the left atrium. The procedure in the figure below can also be performed from the left atrium. The valve prosthesis 160 and its implantation or delivery catheter 162 have passed through the native mitral valve 16 from the left ventricle, and the tip of the system is located in the left atrium. In this embodiment, an inflatable anchoring and / or sealing system 170 is shown, which includes an upper portion 172 for being located above the native mitral valve 16 and a portion 174 ( Fig. 11B ) for being located below the native mitral valve 16. As Fig. 11BAs shown, after deployment, the upper portion 172 includes a circular or continuous annular expandable element, while the lower portion 174 includes a discontinuous expandable structure. In other words, the lower portion includes discontinuous expandable elements 174a that are separated from each other, for example, by gaps. It will be understood that the upper portion 172 may also include discontinuous expandable elements and may thus be a discontinuous expandable structure as opposed to, for example, the continuous expandable element shown. Also, Fig. 11B An expandable structure coupled to an inflation conduit or catheter 38 is shown and the valve prosthesis 160 is not shown for clarity. It will be understood that the expandable structure 170 may be connected to the valve prosthesis 160 during delivery, or the expandable structure 170 may be delivered first and then the valve prosthesis 160 may be subsequently delivered to a position within the expandable structure 170 and expanded using the expandable structure 170 as described above for anchoring and / or sealing. The expandable elements 174a located below the native mitral valve 16 are introduced at each of the commissures and have extensions located below the anterior leaflet 16a and the posterior leaflet 16b. The upper portion 172 and the lower portion 174a are connected together at and through the commissure location 176. The previous series of illustrations show how an anchor and / or sealing balloon is delivered in a closed or collapsed configuration and then expanded outwardly to achieve the configuration shown as Fig. 11B shown.

[0155] Fig. 11C The valve prosthesis 160 is shown in dashed lines but has been disposed inside the expandable docking / anchoring system 170. Since the valve prosthesis 160 is supported by upper and lower expandable anchoring portions 172, 174 that include circular / annular and / or semi-circular shaped elements located on each side of the native mitral valve 16, the valve prosthesis 160 will be implanted very securely. The leaflets 16a, 16b are captured or engaged between the expandable elements 174a and this results in a very secure attachment. In this example, the upper annulus 172 is continuous and closed, while the lower expandable elements 174a consist of substantially two semi-circular expandable elements that are not directly attached to each other. It is important to note that the expandable elements may be pre-attached to the valve prosthesis. This will allow for a one-step procedure for delivering the valve prosthesis 160 and its anchoring and / or sealing components 172, 174. It is worth noting that this may require less material than is currently used with solid anchoring systems (such as solid anchoring systems formed from metallic materials). Expandable elements that more fully surround the valve prosthesis may provide better anchoring than the discontinuous balloons shown on opposite sides of the valve prosthesis in the previous embodiments. It should also be understood that the valve prosthesis may use a sealing balloon as described above at the junction location and one or more additional expandable elements (such as Fig. 11B or Fig. 11Cbe properly anchored and sealed (such as those shown). Fig. 11C shows Fig. 11B the fully expanded structure shown in and shows the dilated valve prosthesis 160 within the expandable seal / anchoring system 170 in phantom lines.

[0156] FIG. 11D to FIG. 11G shows another alternative embodiment for deploying one or more balloon elements. In this regard, balloon elements 182, 184 are shown in the lower portion of the expandable structure 180 for the purpose of implanting below the native mitral valve 16. At the implantation site where the lower portion of the expandable structure 180 has been inserted through the native mitral valve 16 at the commissure location 176 as shown in Fig.11D the lower expandable elements 182, 184 expand from their respective collapsed states ( Fig.11D ) to an expanded position that guides them below the respective anterior native mitral valve leaflet 16a and posterior native mitral valve leaflet 16b. As described below, these expandable portions 182, 184 may have a tapered distal end shape and even include an integrated guide wire system to assist in guiding the expandable elements past the chordae tendineae 18 and beneath the native leaflets 16a, 16b. The deployment process is shown in Fig.11E and Fig.11F and the fully expanded is shown in Fig.11G As further shown in Fig.11E the dilatable mitral valve prosthesis 190 is then deployed within the annular space of the expandable anchoring / sealing system 180 and the valve prosthesis 190 is firmly anchored in place. As another alternative, the expandable anchoring / sealing system 180 may be pre-attached to the valve prosthesis 190 and the entire assembly may be implanted via a single delivery catheter system.

[0157] Fig. 12A shows an expandable prosthetic valve anchoring / sealing system 200 that has a mitral valve prosthesis 202 therein. The native mitral valve leaflets are not shown. The upper expandable ring 204 is closed and continuous while the lower expandable ring 206 has two gaps, one below the anterior leaflet and one below the posterior leaflet. The upper and lower expandable elements or rings 204, 206 capture the native mitral valve leaflets and provide very firm anchoring for the prosthesis 202. If the expandable system 200 is pre-attached to the valve prosthesis 202, it is not necessary to configure the upper expandable element 204 and the lower expandable element 206 to be fully or nearly fully circumferential. Alternatively, the expandable elements may be attached around the perimeter of the valve prosthesis in discontinuous expandable segments and not form a complete or even nearly complete circle around the prosthesis. Fig. 12B shows in a more complete form Fig. 12A the expandable structure of Fig. 12BThe connecting portion shown as a dashed line in the middle passes through the commissure and connects the upper and lower expandable elements of the structure. It will also be understood that one or more expandable elements can be used in combination with a mechanical anchoring structure instead of other expandable structures.

[0158] Fig. 12C Another alternative embodiment is shown, in which a reinforcing structure 210 is added to the lower expandable element. This reinforcing structure 210 includes additional expandable elements for providing additional strength to anchor the expandable element below the mitral annulus. The portion of the expandable element 206 closest to the connector portion 208 and the upper expandable element 204 will be relatively stable. However, the portion extending from this part, and especially the free end 206a, will be less stable. Therefore, in order to enhance the stability of the lower anchoring / sealing portion 206, a suitable reinforcing structure is desirable or may be desirable below the native mitral leaflets. The two ends of each of the lower expandable elements 206 are arranged in a triangular shape and extend downward into the left ventricle, which enhances their stability and the ability to press against the upper expandable element. Other reinforcing structures can also be used to replace or supplement this structure.

[0159] Fig.12D is shown Fig. 12B A partial cross-sectional view of the structure shown in is shown to illustrate the outer shell of the expandable element, as previously described, which can be composed of a suitable polymer for implantation purposes and is internally filled with a curable fluid. The figure also shows a catheter or fluid delivery conduit 38 that allows fluid to enter and be removed. These catheters 38 can vary in their attachment position and number to the expandable element. As previously described, these fluid delivery catheters or conduits 38 can be attached with a threaded mechanism. The valve can be placed within a balloon to hold the fluid or polymer resin in place when the catheter is removed. When the fluid delivery conduit 38 is in place, the fluid delivery conduit 38 can block the valve. Other systems have described removing the catheter or fluid delivery conduit and heat-sealing with a polymer to seal the outlet or exit position.

[0160] Fig.12E It is shown that the expandable structure can have additional supports or reinforcements in the form of a frame or wire 220 as shown. The wire can be superelastic, such as a nitinol wire or other shape memory material, and the wire can be added within the structure or as part of the expandable element. For those lower portions that need to be guided in a more precise manner, the wire or other reinforcing structure can extend beyond the end of the balloon, as further described below. Fig.12F is from Fig.12D and Fig.12E the view seen from below the expandable structure shown in.

[0161] Figure 12G is shown similar to Fig.12D Another alternative embodiment, however, has an upper inflatable portion that includes an additional outer balloon element 230 for a snug fit and / or increased anchoring ability, especially for accommodating different sized anatomical structures and / or valve prostheses. In a similar manner, an outer balloon or inflatable element 232 can be added to the lower inflatable portion as shown. It will be appreciated that intermittent balloons or inflatable elements can be added at different locations circumferentially around the structure. This may be a desirable alternative for allowing a smaller sized valve prosthesis to be used in a larger sized native or natural mitral annulus. To accommodate a smaller valve, an additional inflatable ring can be inflated, or the annulus can be inflated with an additional hardenable fluid.

[0162] Fig.12H shows Figure 12G Another alternative embodiment of the structure shown in. In this embodiment, additional inflatable elements or balloons 240 can be placed at the location of the struts or connecting portions for the purpose of sealing at the commissure locations. These inflatable elements can be separate elements as shown, or integral and inflatable with one or more of the other balloons.

[0163] FIG. 13A to FIG. 13E shows additional alternative embodiments of inflatable elements for sealing and / or anchoring purposes, especially at locations beneath the native mitral valve. As previously described, the inflatable elements can be delivered in a collapsed state, and the collapsed state can be a rolled-up state as shown by element 250 in Fig.13A or any other suitable collapsed state. FIG. 13B to FIG. 13E shows various semi-circular shapes 252, 254, 256 that can be used for the lower inflatable elements beneath the native anterior and posterior mitral valve leaflets. Fig.13D and Fig.13E The embodiments shown in are preferred because the distal end 256a is tapered to allow the balloon element to pass through the chordae tendineae (see for example FIG. 11A to FIG. 11E ) and provide better and more accurate guidance beneath the native leaflets.

[0164] FIG. 14A to FIG. 14E shows another embodiment of an inflatable element. In this embodiment, the upper inflatable element 260 is also a complete continuous annular element, but includes two inflatable extension elements 262 that are initially in a collapsed state, such as the wound-up state shown in Figure 14A and Figure 14B . When inflated, these inflatable extensions 262 surround the native anterior mitral valve leaflet 16a and the native posterior mitral valve leaflet 16b as shown in Figure 14C . Figure 14DAnother alternative embodiment is shown, in which the distal ends 262a of these inflatable extension elements 262 have bulbous portions for the purpose of enhancing leaflet retention. Figure 14E The inflated state is shown as viewed from above. A mitral valve prosthesis (not shown) is guided and deployed within a continuous annular inflatable element, and then the inflated extension elements are also radially expanded outwardly together with the native mitral valve leaflets in the manner previously shown and discussed herein.

[0165] Figure 15A and Figure 15B is shown similar to Figure 13D and Figure 13E However, a guide wire is used to more accurately guide the inflatable element 270 during delivery. In this regard, the wire 272 can be a superelastic or other shape memory material, such as nitinol. The balloon 270 preferably covers the entire wire or frame. However, a portion 272a of the wire 272 preferably extends from the distal end of the inflatable element 270 to help guide the distal end of the inflatable element 270 to an appropriate position below the native mitral valve leaflets (not shown). The guide wire 272 can be fixed to the inflatable element 270 such that there is no sliding movement possible between the wire and the inflatable element, or the wire can be used as a guide within a channel as discussed below.

[0166] Figure 16A and Figure 16B is shown similar to Figure 15A and Figure 15B However, one or more distal ends 272a of the wire 272 are encapsulated within the housing of the inflatable element 270. Again, the inflatable element 270 is filled with a curable fluid, such as a suitable resin material known in the art.

[0167] Figures 16C to 16E Another embodiment is shown in which the guide wire 272 is contained within a channel 278 to allow sliding movement between the guide wire 272 and the inflatable element 270 when the inflatable element is guided to an appropriate position below mitral valve leaflets, such as the native mitral valve (not shown).

[0168] Figure 17A and Figure 17B An example of using a guide wire 272 to guide the inflatable element 270 below the native mitral valve leaflets 16a, 16b is shown, where the guide wire 272 is rigidly fixed to the inflatable element 270 or can slide relative to the inflatable element 270. These figures also show the aortic valve 276.

[0169] Figures 18A to 18G A possible method for implanting an inflatable anchoring and / or sealing structure according to an embodiment of the present invention is shown. In this regard, asFigure 18A As shown, the delivery catheter system 280 is used from above and has two catheter extensions 282, 284 for accessing the commissural position and deploying beneath the native mitral valve 16. Figure 18B Four guide wires 286 are inserted and deployed through the catheter extensions 282, 284 and naturally follow a predetermined path. Figure 18C A view from above is shown in Figure 18D wherein the guide wires 286 partially surround the native mitral valve 16 beneath the anterior native leaflet 16a and the posterior native leaflet 16a. Figure 18E As shown, the catheter extensions 282, 284 are removed leaving the guide wires 286 in place. As shown ( Figure 18F ), the expandable structure 290 is initially contained in the delivery catheter in a collapsed state with or without the mitral valve prosthesis 292. Figure 18G Then, as shown, the expandable structure 290 is inserted and deployed through the guide wires 286 and, simultaneously or in a subsequent step, as shown in Figure 18G , the mitral valve prosthesis 292 is deployed within the expandable anchoring / sealing system 290. The expandable element is inflated with the curable fluid as described above and as shown in Figure 18H , and the guide wires 286 are removed along with the catheter extensions 282, 284. The corresponding fluid retention valve is sealed to retain the curable fluid within the expandable element.

[0170] Figures 19A to 19D A view is shown using the valve 80 shown in Figure 7 above, wherein one or more expandable elements 300 are provided beneath the native mitral valve leaflets 16a, 16b for additional sealing and / or anchoring fixation. In this regard, when the anchoring arm 88 is flipped or bent upward, as shown in Figure 19A and Figure 19BAs shown by the arrows in [description], the anchoring structure including the arm 88 will capture the expandable element 300 against the native mitral valve leaflets 16a, 16b and / or against the flange 84 to achieve a high level of stability and anchoring. However, any number of anchoring arms 88 can be used, which can generally be used at the midpoints of the native mitral valve leaflets 16a, 16b for additional fixation and sealing purposes, and if needed, also at positions 90 degrees spaced therefrom or at commissure positions. It will be understood that the valve mounted on the expandable frame can replace the mechanical prosthetic valve structure 80 shown in these figures. The large flange 84 located at the upper or inflow end of the prosthetic valve 80 in the left atrium improves the sealing of the native mitral valve inflow region. This type of device is commonly used in mitral valve implants for catheter procedures. The upper flange 84 can be composed of a nitinol (i.e., shape memory material) frame, an elastomeric component, and a fabric covering or any other suitable structure. Alternatively, it can be composed of an expandable material that expands in the native mitral valve inflow region and covers the lower part of the left atrium. As shown, the prosthetic valve includes leaflets 80a, 80b.

[0171] In Figures 19A to 19D the expandable element or member 300 is shown on the left ventricular side or the underside of the native mitral valve leaflets. These expandable elements 300 can be inserted through the commissures of the native mitral valve 16 (see, for example, Figures 11A to 11E)。As shown previously, the expandable elements 300 can be narrow before expansion such that they slide under the chordae tendineae 18 at the commissures of the native mitral valve 16. The "bull horn" or conical expandable members 300 can have various lengths depending on the needs or desires of the application. Ideally, these expandable elements 300 will engage the mitral valve prosthesis 80 by positioning the natural mitral valve leaflets 16a, 16b between the flange 84 at the upper end and one or more expandable elements 300 below. The expandable elements 300 taper towards their ends to a reduced width or diameter. It may be useful for the expandable elements 300 to be larger at the ends. Particularly with reference to the expandable element 300 or anchoring member located below the posterior native mitral valve leaflet 16b, a large end on this type of anchor can fill the space below the native posterior leaflet 16b and result in very stable prosthetic valve fixation. Filling the space below the native leaflet 16b and at the left ventricular base in the attachment region of the native posterior leaflet 16b can allow for the insertion of a smaller prosthetic valve 80. This will also result in greater stability of the implant or valve 80. When a surgeon replaces the mitral valve, the posterior leaflet 16b is often folded with sutures to create a filler that reduces the diameter of the native mitral annulus and supports the valve prosthesis or implant 80. An expandable implant or prosthesis (not shown in this embodiment) can serve the same function. The expandable elements can also distribute the load over a larger area to reduce the risk of valve cracking and tissue tearing. In an alternative (not shown), the discontinuous expandable elements 300 can alternatively be formed as a continuous annular shape or ring. These designs are shown, for example, in other embodiments herein. These designs can also be used in combination with the discontinuous "bull horn" elements 300 shown in this embodiment, or in place of the discontinuous expandable structure shown. The annular expandable element or ring can follow the course of the native leaflets 16a, 16b, for example generally along Figure 19A and 19B the same path or course as the expandable element 300 shown in

[0172] In any of the embodiments shown and described herein, including as Figures 19A to 19DIn the illustrated embodiment, the amount of inflation or filling of the expandable element (e.g., element 300) can be adjusted to achieve a desired size, fit, force application, or other effect. Also, as shown in the above embodiments, there can be multiple chambers or multiple expandable elements that can be filled or inflated. Additionally or alternatively, some expandable chambers or elements can be filled, and some expandable chambers or elements can be left unfilled or partially filled to achieve the desired size and shape for the expandable anchoring and / or sealing element. The anchoring arms 88 can surround the anterior native mitral valve leaflet 16a and the posterior native mitral valve leaflet 16b. These arms 88 are typically made of nitinol or other superelastic materials such that they can be straightened to be inserted into a catheter and then spontaneously or automatically bend around the native mitral valve leaflets 16a, 16b to anchor the valve prosthesis 80.

[0173] As Figure 19D best shown therein, the inflation path of the expandable element 300 passes through the native mitral valve commissure 176. The expandable element 300 is designed to inflate from the commissure location 176 and travel towards the middle scallop of both the anterior native mitral valve leaflet 16a and the posterior native mitral valve leaflet 16a. Although, for example, Figure 19B shown therein are expandable elements 300 whose ends touch, these expandable elements 300 can be shorter and thus may not engage. Alternatively, the expandable elements 300 can be longer and thus overlap.

[0174] Figure 19CShows the position of the mitral valve prosthesis 80 after delivery across the native mitral valve leaflets 16a, 16b. The anchoring arms 88 and the native mitral valve leaflets 16a, 16b can engage against the expandable structure 300. The engagement between the anchoring arms 88 and the expandable structure 300 is desirable. First, this results in a more robust and stable implant. Second, the ends of the "ox horn" expandable element 300 are not attached to each other, such that pressing the native mitral valve 16 and the anchoring arms 88 against the expandable element 300 will reduce the movement of the ends of the two expandable elements 300. The large expandable end (not shown) of the expandable element 300 can facilitate the interaction of the components. It can also have the advantage of reducing the native mitral annulus size and stabilizing the entire implant attachment below the posterior native mitral valve leaflet 16b as previously described. This will produce an effect similar to that of a surgeon, leaving the native posterior leaflet 16b and passing sutures from the native mitral annulus 16c through the fan-shaped posterior mitral valve leaflet 16b into the valve prosthesis 80. Filling the space below the native posterior leaflet 16b can be particularly useful. The left ventricular wall lies behind the native posterior leaflet 16b. The expandable structure 300 will contact the leaflet 16b as well as the annulus 16c and the left ventricular posterior wall, thus providing a large surface to absorb the vibrations that occur with each contraction of the heart. Moreover, the expandable element 300 filling the space at this location will not obstruct the outflow of blood from the heart. An expandable element located near the native anterior leaflet and too large may cause obstruction of blood outflow.

[0175] Figure 19D Shows a view substantially from native mitral commissure to native mitral commissure, i.e., from Figure 19C rotated approximately 90 degrees. A portion of the expandable structure 300 passes through the commissure 176. This also couples an expandable anchoring and / or sealing element (not shown) that may be located above the native mitral valve leaflets 16a, 16b on the atrial side with an expandable portion 300 generally located below the native mitral valve leaflets 16a, 16b on the ventricular side. The inflation path is shown as a narrow short tubular structure 302. The component 302 of the expandable element 300 passing through the commissure 176 can be much larger. It can also be more spherical or have a suitable portion that helps to close or seal the commissure 176 by acting as a "cork" or sealing structure or by forcing the native leaflet edges 16a, 16b together at the commissure 176. The expandable element 300 is shown surrounding the native mitral valve leaflets 16a, 16b. The engagement of the expandable element 300 with the native leaflets 16a, 16b and the anchoring arms 88 can be improved by increasing the size of the expandable element 300. For example, the expandable element 300 can extend further and deeper into the left ventricle below the native mitral valve leaflets 16a, 16b. In many cases, it is not possible to have the chordae tendineae 18 (see Figure 19E and 19F)Tightened enough to achieve this contact. More generally, the stability of the entire implant can be improved by having two anchoring components. One anchoring component can be positioned at the level of the native mitral valve leaflets 16a, 16b and the native mitral valve annulus 16c, and the second component can surround the native mitral valve leaflet edges. The stability of the entire implant can be further improved by engaging or connecting these two anchoring components to each other.

[0176] Figure 19E and Figure 19F Another alternative embodiment of the mitral valve prosthesis 320 is shown, which includes a flange portion 322 and the anchoring arm 324 as described above. However, in this embodiment, the anchoring arm 324 (which may also include a fabric or other covering to form a more "paddle" configuration) includes a balloon anchoring element 326 fixed thereto. In this way, as Figure 19F best shown in, when the arm 324 is flipped upward, the inflatable element 326 also flips upward and captures the native mitral valve leaflets 16a, 16b against the mitral valve prosthesis 320. The balloon element 326 can be in a deflated state during delivery and when the arm 324 is flipped upward, and then the balloon 326 can be inflated by an appropriate amount to further fix the implantation of the prosthesis 320. As Figure 19E and Figure 19F shown, these balloon elements 326 substantially extend beyond the perimeter of the anchoring arm 324 such that they abut against a sufficient portion of the mitral valve leaflets 16a, 16b and / or a portion of the mitral valve prosthesis 320 for anchoring purposes. These arms 324 can extend all the way to the commissure 176 and can have various shapes. For example, an inflatable element in the shape of an extended paddle can be fixed to the mechanical anchoring arm 324 to provide more surface area contact between the inflatable arm and the mitral valve leaflets 16a, 16b and / or the mitral valve prosthesis 320. The balloon element 326 can be fixed to the mechanical anchoring arm 324 by any suitable means (such as an adhesive). This embodiment is particularly applicable in cases where the native mitral valve leaflets are very small. In such cases, the anchoring arm 324 contacts the inflatable element 326 positioned below the native mitral valve leaflets 16a, 16b.

[0177] Figure 20A is shown to be similar to that combined with Figure 19AThe mitral valve prosthesis 330 of the described embodiment. The inflatable elements 332 are fixed to each of the anchoring arms 88. The attachment of each inflatable element 332 is shown to be located on the inner side and at the hinged or bent position of each anchoring arm 88. That is, the inflatable elements 332 are generally located at the position where the anchoring arms 88 are bent to surround the natural mitral valve leaflets 16a, 16b. Of course, the specific attachment may be different from that shown in the figures. Many examples of inflatable elements attached to the anchoring arms 88 are possible. The inflatable elements 332 may be fully attached to the anchoring arms 88, or the inflatable elements 332 may be attached to the anchoring arms 88 at one portion and other portions of the inflatable elements 332 may extend beyond the anchoring arms 88. The attachment may be achieved in various ways, such as by adhering the inflatable elements 332 to the anchoring arms 88 along their outer surfaces, or by other methods, such as passing the anchoring arms 88 through the inflatable elements 332.

[0178] Figure 20B The thermal valve prosthesis 330 implanted inside the natural mitral valve 16 is shown. The anchoring arms 88 have been guided through the natural mitral valve leaflets 16a, 16b, but have not been hinged or rotated radially outward and upward. An arrow 336 is provided to indicate the expected deployment direction when the anchoring arms 88 are bent upward. When the mitral valve prosthesis 330 is deployed from a catheter (not shown) to the appropriate position, this bending action will preferably be spontaneous or automatic, and the arms 88 will surround the natural mitral valve leaflets 16a, 16b, generally surrounding the central portions of the anterior natural mitral valve leaflet 16a and the posterior natural mitral valve leaflet 16b. The inflatable elements 332 are shown to be located inside the folding or bending positions of each anchoring arm 88.

[0179] Figure 20CThe anchoring arm 88 is shown deployed and bent into the anchoring position and the balloon element 332 is inflated. The balloon element 332 helps to compress and capture the native mitral valve leaflets 16a, 16b. The inflatable element 332 may extend beyond the anchoring arm 88 to which it is attached so as to surround more of the native leaflets 16a, 16b beyond the ends of the anchoring arm 88. The balloon (i.e., inflatable) element 332 may extend to the sides of the anchoring arm 88 to increase the engagement of the native mitral valve leaflets 16a, 16b to the prosthetic valve 330. The balloon element 332 may extend upward to abut the underside of the native mitral valve leaflets 16a, 16b and the native annulus 16c. The inflatable element 332 may be larger particularly below the posterior native leaflet 16b and extend all the way to the plane of the native annulus 16c and around more of the circumference of the native annulus 16c. The inflatable element 332 may be a flatter structure in the region of the anterior mitral valve leaflet 16a. This will help to prevent obstruction of blood flow out of the left ventricle of the heart. In this figure, there are no anchors at the level of the native leaflets 16a, 16b, such as the previously described "ox horn" element 300 located below the native annulus 16c. When or if combined with one or more of the other features discussed herein, the inflatable element 332 on the anchoring arm 88 may also engage a "ox horn" (not shown), such as element 300( Figure 19A ). As previously described, the amount of inflation fluid filling the inflatable element 332 may be adjusted, or there may be multiple chambers or elements for inflation purposes that may be filled or not filled or partially filled to achieve the desired result.

[0180] Figures 21A to 21C Illustrated is how the inflatable element 340 may be used to move the prosthetic valve 342 relative to the associated native tissue of the mitral valve 16 or how it may be used to move components of the prosthetic valve 342 relative to each other. The inflatable element 340 may perform a "motor" type function. As Figure 21AAs shown, the prosthetic valve 342 having one or more anchoring arms 344 can be moved upward relative to the native mitral valve 16. The anchoring arms 344 are shown in a straight wire configuration prior to delivery. Arrow 346 shows the path that the anchoring arms 344 will take as they loop around the free edges of the anterior native mitral leaflet 16a and the posterior native mitral leaflet 16b. The figure shows an upper arm portion 344a generally located at the top of the valve 342. The entire prosthetic 342 and the anchoring arms 344 can slide freely upward relative to the native mitral leaflets 16a, 16b. As shown, the anchoring arms 344 continue to the atrial side of the prosthetic 342. The upper arm portion 344a is located above the expandable element 340. The expandable element 340 can be formed into any desired and suitable shape. The expandable element 340 can even be a circumferential structure around the entire inflow end or portion of the prosthetic valve 342. The expandable element 340 can act on more than one of the anchoring arms 344. The expandable element 340 is located on a support portion A 348 similar to the aforementioned flange 84. The support portion A 348 provides a abutment base for the expandable element 340 such that the expandable element 340 can provide a force to move the anchoring arms 344. The entire prosthetic valve 342 can be covered with a tissue ingrowth fabric.

[0181] As Figure 21B As shown, the prosthetic valve 342 has been delivered and the anchoring arms 344 have looped around the native mitral leaflets 16a, 16b. The anchoring arms 344 loop around the leaflets 16a, 16b, but it is difficult for the anchoring arms 344 to apply a tension or force on the native leaflets 16a, 16b that will lift upward on the leaflets 16a, 16b to tension the chordae tendineae 18. Anchoring arms that only loop around the leaflets 16a, 16b but do not provide tension to the leaflets 16a, 16b and the chordae tendineae 18 result in suboptimal anchoring. Due to inadequate anchoring, the leaflets 16a, 16b and the chordae tendineae 18 can still move up and down with each heartbeat.

[0182] Figure 21CShows an expandable element 340 that has been filled with fluid and lifted upward on the anchoring arm 344. This is shown by arrow 350 below the leaflets 16a, 16b and arrow 352 adjacent to the expandable element 340. The platform of the exemplary stent portion 348 shown with fabric in the left atrium provides a support base to ensure that expansion causes the prosthetic valve 342 to move upward. This upward movement tensions the anchoring arm 344 against the leaflets 16a, 16b and loads or tensions the chordae tendineae 18. The likelihood of movement of the prosthesis 342 is reduced and the valve replacement is more secure. Expansion of the expandable element or "lifting balloon" 340 can be completed at the end of the procedure. The amount of expansion can be adjusted to ensure there is sufficient tension on the native leaflets 16a, 16b and chordae tendineae 18. This can be observed, for example, by echocardiography through imaging. The operator can fill or expand the expandable element 340 until slack and movement are reduced or eliminated. The adjusted, i.e., elevated or lifted, valve 342 has another important advantage. A valve prosthesis that is too low in the left ventricle can impede the function of the heart and block blood ejection. To prevent this problem, it is desirable to be able to allow the valve prosthesis to be positioned or located at a higher position in the heart, where more of the prosthesis is in the left atrium. The anchoring arm 344 on the prosthesis 342 is movable relative to the cylindrical body 354 of the prosthesis 342. Using one or more expandable members 340 to adjust the relative position of the prosthetic valve 342 with respect to native tissue or with respect to other parts of the valve prosthesis can vary and be used in a variety of ways to improve valve function and safety. The relative positions of the components of the prosthetic valve can be adjusted appropriately.

[0183] Figure 22A and Figure 22B shows a prosthetic valve 360 that can be retracted within a catheter delivery system (not shown) and then expanded within the patient's heart (see Figure 1 ). A circular expandable support 362 at the top and another circular expandable support 364 at the bottom of the prosthesis 360 are coupled by a vertical expandable connecting element 366. The prosthetic leaflets 368 are fixed within a generally circular structure and are shown in dashed lines in Figure 22B . The direction of blood flow is shown by arrow 370. The prosthetic leaflets 368 are typically made of processed animal material or other biologic material, but can be synthetic or even human-derived material. The expandable members 362, 364, 366 are filled with fluid to shape them. Typically, a hardened or polymerized material is used in place of the fluid to maintain the final shape. This can be achieved with any of the expandable elements disclosed herein. Tubes 374 are shown filling the expandable elements 362, 364, 366, and these tubes 374 are removable after use. Figure 22BIt is shown that the tube 374 can be temporarily attached to the prosthetic valve 360 to fill the expandable elements 362, 364, 366 with fluid and material to harden the implant 360. The prosthetic valve structure 360 shown here includes adding two "horn" expandable elements 380. Although the expandable elements 380 can be located below the lower annulus 364, these are shown as being located between the two annuli 362, 364. The "horn" expandable elements 380 are designed to be delivered through the natural commissure 176( Figure 19D ) and then expanded below the level of the natural leaflets 16a, 16b( Figure 19D ). This will cause the expandable elements 380 to be placed or positioned on the ventricular side of the natural leaflets 16a, 16b, and the lowermost circular expandable element 364 to remain on the atrial side of the leaflets 16a, 16b. This will capture the natural leaflets 16a, 16b between the two "horn" expandable elements 380 and the lower continuous expandable annulus 364. The supports at the two levels (i.e., the "horn" expandable elements 380 and the circular expandable element 364) can have the same diameter or different diameters. Other possibilities for the configuration are, for example, that the expandable elements 364, 380 can have similar or different cross-sectional diameters and / or can be interlocked or otherwise fixed to each other. When the ventricle contracts, the lower support annulus 364 will be forced upward into the "horn" expandable elements 380. The natural leaflets 16a, 16b will pass between the two expandable elements 364, 380 in a sandwich configuration, which will help keep the prosthetic valve 360 in place.

[0184] Figure 22C A top view of the implant 360 is shown. This includes the complete continuous circular expandable elements 362, 364 for the upper and lower parts of the expandable prosthetic valve 360 and the also expandable vertical support element 366. This figure shows the "horn" expandable elements 380 with a slightly larger curvature diameter. The unexpanded "horn" expandable elements 380 are introduced through the commissure 176 and then expanded so that they expand and travel around the perimeter of the natural valve 16.

[0185] Figure 23A and Figure 23BShown is an expandable prosthetic valve 360 associated with native mitral valve leaflets 16a, 16b. For clarity, only two of the vertical expandable connectors 366 are shown. As shown, the "ox horn" expandable element 380 is positioned on the ventricular side of the native mitral valve leaflet 16a. The lower continuous circular expandable element 364 is located on the atrial side of the native leaflets 16a, 16b, even though the lower continuous circular expandable element 364 is at or located at a lower level than the "ox horn" expandable support element 380. The native mitral valve leaflets 16a, 16b pass between the two elements 364, 380. These expandable elements 364, 380 can be configured such that after expansion, the two expandable adjacent elements 364, 380 overlap and help capture the native leaflets 16a, 16b therebetween to effect a secure prosthetic valve attachment. This is most effective in the region of the commissure 176, where the continuous circular expandable element 364 and the "ox horn" element 380 will be most able to provide force to one another. If the diameter of the "ox horn" support 380 is larger and fills more space below the native leaflets 16a, 16b, the "ox horn" support 380 may be more effective. Both of the adjacent support elements 364, 380 are shown as having a circular cross-section; however, they can be configured to have any suitable cross-sectional shape and can be designed to interact or engage with one another in various ways. For example, there may be a groove (not shown) on one element that engages a portion of the other element, such as a depression (not shown). To mitigate any tendency for the implant 360 to rock back and forth during the heartbeat, any other stabilizing features shown herein or otherwise described can be used for lateral support. Other features that may not be shown or described herein can also be used for support and stabilization purposes. For example, support elements can extend from the "ox horn" element 380, particularly at the commissure 176, or from the continuous circular upper ring 362 and / or the lower ring 364, or from the vertical connecting element 366. Figure 23B The mitral valve prosthesis 360 is shown in a commissure-to-commissure view. The lowermost continuous circular expandable element 364 is located on the atrial side of the native leaflets 16a, 16b, while the "ox horn" shaped expandable support element 380 is positioned below the native leaflets 16a, 16b, i.e., on the left ventricular side of the native leaflets 16a, 16b. As described, these "ox horn" shaped expandable support elements 380 are expanded via connections located at the commissure 176.

[0186] Figure 24A view showing a variant of the mitral valve prosthesis 390 is presented, where the "ox horn" inflatable element 392 is positioned below the lower circular inflatable element 394, and the "ox horn" support element 392 positions itself below each of the native leaflets 16a, 16b on the ventricular side of the leaflets 16a, 16b. The lower continuous circular inflatable element 394 is positioned above the native mitral valve leaflets 16a, 16b on the atrial side of the native valve 16.

[0187] Figure 24A and Figure 24B Another alternative mitral valve prosthesis 400 with a stable support element 402 is shown. Similar to the prosthesis described above, the prosthesis 400 can be composed of inflatable elements 404, 406, 408 that are connected together and include prosthesis leaflets 410. Although not shown, one option for providing additional stability, such as preventing back-and-forth swaying, is to make the upper circular ring 404 large enough to cover the lower part of the left atrium. Such a circular ring 404 can be less like a circular ring than a structure similar to the flange shown in the previous figures (e.g., Figure 19A ). This type of circular ring or inflatable flange 404 will be present along the bottom of the left atrium. Another option is to add additional supports. These supports can take various shapes and configurations. Figure 24A and Figure 24B An inflatable support member 402 extending from the lower circular inflatable ring 406 to form an arch is shown. These arches 402 will abut against the lower part of the left atrium to prevent the back-and-forth swaying motion of the prosthesis valve 400. The surface contour of the left atrium is irregular. The atrial part adjacent to or closest to the native aortic valve 16 has a steep angle. These individual arches 402 or even more linear support members can adapt to the contour of the atrium and stabilize the valve prosthesis 400 to prevent swaying. The inflatable support members 402 are shown extending from the lower ring 406; however, they can also extend from the vertical struts 408 or the connecting elements that connect the upper ring 404 to the lower ring 406. These support arches 402 or other support elements can be used, for example, in various numbers and configurations, and there can be a "arch-on-arch" design or other configurations, and the same type of elements can be used on any part of the prosthesis 400.

[0188] Figure 25A 、 Figure 25B and Figure 25C An alternative for improving stability is shown. In particular, the ends of two inflatable support elements 410 can be stabilized by joining them together to produce a more complete circular structure. This can be achieved in various ways, which will be exemplified below. Figure 25Ashows a large loop element 412 passing through an expandable support element 410 and then a straight linear element 414 passing through the ends of adjacent support elements 410. The loop element 412 is large enough such that the straight linear element 414 will easily guide through the loop element 412 and then inflate a balloon 416 as shown at the end of the straight linear element 414. In Figure 25B the loop element 412 and the linear element 414 have been pulled back and then the ends of adjacent "horn" expandable elements 410 are pulled or drawn together. The delivery path for accomplishing these operations is shown in the upper portion of the prosthetic valve 400 in Figure 25C . Figure 25C

[0189] Figure 26A , Figure 26B and Figure 26C show the progression of diagrams showing the ends of expandable anchoring elements 420 such as any of the horn elements described herein. The ends of the element 420 include portions 422 that can expand to create a bulge or can be part of a "lock" or other structure. Locking the ends of the expandable anchoring elements 420 (only one is shown) together will create a stronger and more durable attachment of an associated valve prosthesis (not shown) to a native mitral valve (not shown). For this purpose, any expandable anchoring elements (commonly used for implantation purposes) that include unjoined adjacent ends can be joined together. For example, expandable anchoring elements located beneath native leaflets (such as "horn" type) can be joined to an expandable element that is delivered to an anchoring arm that encircles the native leaflet as described above. Tying such anchoring components together will improve the stability of the prosthesis. As Figure 26A , Figure 26B and Figure 26C show, the expandable balloon element 420 can surround a nitinol wire 424. There is a channel 428 for inflation that allows the balloon 420 to inflate. The balloon 420 can be permanently filled by filling it with a hardened resin. The nitinol wire 424 can be located inside or outside of the expandable element 420, even though the latter design is not shown. Once inflated, as Figure 26C shows, the bulge portion 422 can be used to interconnect with another expandable device (not shown) such that for example another portion includes a doughnut-shaped ring to separate an opening. The ring will be expandable and the Figure 26A shown un-inflated element 420 will pass through the expandable ring. As Figure 26B and Figure 26C show, the expandable element 420 will be inflated to fill the ring with the bulge portion 422 and prevent the expandable element 420 from passing back through the inflated ring. To further tension the system, the expandable anchoring element 420 can be tensioned by pulling on the end opposite the end that carries the expandable portion 422. Figure 26CAn expandable portion 422 filled with a hardened resin or other material is shown to keep the system stable after deployment.

[0190] Figure 27A and Figure 27B Another alternative embodiment is shown for connecting and locking together the ends of two adjacent expandable anchoring elements 430, 432. In this case, an expandable sphere 434 can engage inside the ends of adjacent expandable structures 436. The two expandable structures 434, 436 can be guided together by traveling via a common guide wire 438. The second structure 438 can then be expanded to close the "mouth" of the joint and capture the two separate expandable elements 434, 436 together. There are many other options. For example, a serrated device (not shown) can be used instead of a ball.

[0191] Figure 28A and Figure 28B A locking structure 440, 442 is shown that is very similar to the locking structure shown and described with respect to Figure 27A and Figure 27B However, in this embodiment, the spherical or other locking element 440 is not expandable, but is solid or other rigid or non-expandable structure. As Figure 28B shown, the receiver portion 442 is expandable and locks with the solid spherical structure 440. These components 440, 442 can be reversed, i.e., the non-expandable structure can be the receiver and the expandable receiver can be the inserted locking element.

[0192] Figure 29A Another alternative expandable valve prosthesis 450 is shown. Similar to other embodiments described herein, the valve prosthesis 450 includes anchoring arms 452 configured to surround the native mitral valve leaflets 16a, 16b during deployment. These anchoring arms 452 also carry expandable elements 454 that can be filled and expanded. The size and configuration of the expandable elements 454 can vary. The expandable elements 454 can be attached to the anchoring arms 452, or the anchoring arms 452 can pass through the expandable elements 454. The expandable elements 454 can be attached to the anchoring arms 452 completely or only partially. If the expandable elements 454 are attached to the anchoring arms 452 partially, then when the expandable elements 454 are filled and expanded, other portions of the expandable elements 454 can extend beyond the anchoring arms 452.

[0193] Figure 29BShows a prosthetic valve 450 positioned at the location of the native mitral valve 16, and the expandable element extends beyond the associated anchoring arm 452. The annuloplasty ring 456 has been placed and fixed in a manner that can be conventional. It is well known to insert the prosthetic valve 450 inside the annuloplasty ring 456 using catheter surgery. However, according to the inventive aspect, the expandable valve prosthesis 450 includes an anchoring arm 452, and the anchoring arm includes an expandable anchoring element 454. During deployment, the arm 452 folds upwards as shown by arrow 458. This deployment is as Figure 29C shown.

[0194] Figure 29D Further shows that the expandable element 454 has expanded on each anchoring arm 452. There is one or more expandable anchoring elements 454 on each side of the native mitral valve 16, and thus the leaflet tissues 16a, 16b are captured between the corresponding expandable elements or anchors 454. The expandable anchors 454 also cover the lower portion of the anchoring arm 452. Thus, when the expandable element 454 expands, the leaflets 16a, 16b are forced upwards and the chordae tendineae 18 and the chordal attachments in the papillary muscles 19 are tensioned. As shown by the arrows 460 on the papillary muscles 19 and the chordae tendineae 18, this tensions the leaflets 16a, 16b and the chordae tendineae 18 attached to the edges of the leaflets 16a, 16b. This has many beneficial effects. First, better anchorage to the native mitral valve leaflets 16a, 16b. Second, the anchoring system has no "slack". That is, the leaflets 16a, 16b and the chordae tendineae 18 are under tension, so the prosthesis 450 is less likely to sway or move back and forth during the heartbeat. This improves the fixation of the valve prosthesis 450 and reduces the risk of late failure. Also note that in the figure, the balloon anchor 454 can extend beyond the anchoring arm 452. The balloon anchor 454 sweeps under the mitral valve leaflets 16a, 16b, thus allowing the use of a smaller prosthesis. The balloon or expandable anchor 454 pushed under the annulus 16c provides rigidity to the anchoring area. The balloon or expandable anchor 454 can be larger than Figure 29D shown, such that for example they fill the space under the native leaflets 16a, 16b and adjacent to the left ventricular wall. On one side of the native mitral valve 16, blood leaves the left ventricle through the aortic valve (not shown). The anchoring balloon 454 is likely to be smaller in this position to prevent obstruction of blood outflow. The tensioned chordae tendineae 18 and leaflets 16a, 16b are also thought to improve left ventricular function. When in a diseased state, the shape of the left ventricle becomes more spherical. Tensioning the chordae tendineae 18 can help prevent this distortion of the heart shape and produce a better functioning, more conical left ventricle.

[0195] Figure 30A 、 Figure 30B and Figure 30CAnother embodiment of an expandable mitral valve prosthesis 470 is shown, which includes collapsible anchoring arms 472 and associated expandable anchoring elements or anchors 474. The valve 470 also has the previously described "ox horn" anchoring element 476 to help generally anchor the prosthetic valve 470 at the level of the native mitral annulus 16c, or in other words, generally at the level of the leaflet attachments attached to the native mitral annulus 16c. Generally as described above, the anchoring arms 472 surround the native mitral leaflets 16a, 16b and can be made of nitinol or other shape memory materials such that they are in a straightened state during delivery through a catheter (not shown) and spontaneously or automatically deploy into their folded state during delivery from the catheter( Figure 30B ). This is schematically depicted by arrow 478 in Figure 30A . Figure 30B The valve prosthesis 470 after delivery inside the native mitral valve 16 is shown Figure 30A . In this setting, the "ox horn" expandable anchoring element 476 is located on the left ventricular side of the native mitral leaflets 16a, 16b. The lower circular expandable element 480 of the prosthesis 470 is located on the atrial side of the native leaflets 16a, 16b and at a lower level inside the heart. This stabilizes and seals the prosthesis 470 at the level of the native leaflets 16a, 16b. It is also evident that the anchoring arms 472 have surrounded the native leaflets 16a, 16b and provide additional anchoring. As Figure 30B shown, the expandable element 474 associated with the anchoring arms 472 has not been activated Figure 30C . The expandable anchoring element 474 associated with the anchoring arms 472 is shown in an expanded state. The expandable anchoring element 474 associated with the anchoring arms 472 is partially attached to the anchoring arms 472 but also extends upward with a portion that does not contact the anchoring arms 472. Ideally, these expandable anchors 474 will press against the underside of the native mitral valve 16 and the base of the heart. The expandable anchors 474 shown here are annular to provide higher mechanical strength to press against the underside of the native mitral valve 16. The expandable anchoring element 474 forms a continuous ring, however the ring can alternatively be discontinuous and / or there can be additional rings or struts connecting different sections. The shape of the expandable anchors 474 can vary and can consist of separate sections for example

[0196] Figure 31A 、 Figure 31B and Figure 31C show another alternative embodiment of an expandable mitral valve prosthesis 480, which further includes expandable anchoring elements or arms 482 Figure 31A The valve prosthesis 480 is shown, where the anchoring arms 482 are in an expanded state. Like the rest of the valve prosthesis 480, the anchoring arms 482 can ultimately be inflated or filled with a hardening material for stability purposesFigure 31B The wire or other rigid support member 484 used for support purposes within the expandable anchoring element 482 or otherwise fixedly attached to the expandable anchoring element 482 is shown in dashed lines. Shape memory materials such as nitinol can perform this function well. The support element 484 can be positioned within the fluid cavity of the expandable anchoring arm 482 or otherwise fixed internally or externally on the expandable anchoring arm or element 482. The nitinol or other shape memory support 484 will force the expandable anchoring element 482 into the desired configuration. Such a metal or rigid support element 484 can have any desired configuration and any desired number. The supports 484 can be overlapped to increase the reliability and strength of the anchoring produced by these elements, and multiple rigid or hardened supports 484 can be present to produce multiple configurations. Figure 31B The arrow 488 in shows the expected travel of the expandable anchoring element 482 around the natural mitral valve leaflets 16a, 16b. Figure 31C The expandable anchoring element 482 is shown in its final position, where the natural leaflets 16a, 16b are folded, lifted, and tensioned, and the chordae tendineae 18 are tensioned. As previously mentioned, the length of the chordae tendineae 18 and the amount of leaflet tissue and the diameter of the annulus 16c are highly variable from patient to patient. The expansion of the anchoring element 482 around the mitral valve leaflets 16a, 16b can achieve the tensioning of the natural mitral valve organ (i.e., the valve 16 and the chordae tendineae 18) by adjusting the tension. In addition, effective annulus reduction can be achieved by an anchor produced or extended from the anchoring arm around the natural leaflets 16a, 16b or from any structure located at or near the level of the natural leaflets 16a, 16b and / or the natural annulus 16c. For example, expandable or non-expandable anchors can extend from the previously described "ox horn" anchoring element. The various combinations of the previously shown anchoring and attachment to the anchoring arm can also be used with this embodiment. For example, the expandable element can be shaped to produce a combination Figure 29C and 29D the natural leaflet capture and natural leaflet folding described. The wire support or other rigid (i.e., hardened) support for the expandable anchoring element can also be applied to other embodiments, such as Figure 14C and Figure 14D the devices shown in, which can help facilitate implantation.

[0197] Figure 32A , Figure 32B , Figure 32C and Figure 32D show another alternative embodiment of using an expandable sealing structure in combination with a known mitral valve clip device 490. The expandable sealing structure can be of any suitable type as described and shown herein, where Figures 32A - 32D only one example is shown. The mitral valve clip device 490 is shown inFigures 32B - 32D is shown as being applied in a known manner to the native mitral valve leaflets 16a, 16b so as to Figure 32D clamp and permanently fix together the native mitral valve leaflet edges generally near the midpoint as shown. Clamping the native mitral valve leaflets 16a, 16b together in this way effectively forms two openings through the mitral valve 16 on either side of the generally central clamping position. When the heart beats, this can cause the valve 16 to leak during operation. For example, the inflatable structure 200 utilizing the upper inflatable element 204 and the lower inflatable element 206 can be physically connected to the clamp structure 490 as shown by the dashed lines in Figure 32D or can be used separately from the clamp structure in a completely independent manner. The inflatable seal structure 200 chosen to illustrate this concept is shown and described more fully in conjunction with Figure 12A and Figure 12B . It will be understood that other inflatable seal structures can be substituted, such as many of those shown and described herein.

[0198] Figure 33A and Figure 33B show another alternative embodiment of an inflatable seal structure for use in conjunction with a known mitral valve clamp device 490. This embodiment is similar to the embodiment described above in conjunction with Figures 32A - 32D . The inflatable seal structure can be of any suitable type as described and shown herein, with Figures 32A - 32D only one example being shown. As described and shown in conjunction with Figures 32B - 32D , the mitral valve clamp device 490 is applied to the native mitral valve leaflets 16a, 16b in a generally known manner so as to Figure 32D clamp and permanently fix together the native mitral valve leaflet edges generally near the midpoint as shown. As previously described, when the heart beats, this can cause the valve 16 to leak during operation. For example, the inflatable structure 200 utilizing the upper inflatable element 204 and the lower inflatable element 206 is physically connected to the clamp structure 490 by a portion 500 of the inflatable structure 200. The inflatable connection portion 500 can be inflated with fluid delivered by a conduit 502. It will be understood that a separate conduit 38 ( Figure 32A ) can be used for the inflatable seal structure 200, or the same supply can be used for the entire inflatable structure 200, 500. The inflatable seal structure 200 chosen to illustrate this concept is shown and described more fully in conjunction with Figure 12A and Figure 12B . It will be understood that other inflatable seal structures can be substituted, such as many of those shown and described herein.

[0199] Although the present invention has been illustrated by the description of specific embodiments thereof, and although the embodiments have been described in considerable detail, it is not intended to limit the scope of the appended claims or in any way to be restricted to these details. The various features discussed herein may be used singly or in any combination. Other advantages and modifications will be readily apparent to those skilled in the art. Accordingly, the invention in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept.

[0200] Example clause

[0201] Item 1. An anchor for sealing and / or stabilizing a mitral valve prosthesis at the native mitral valve location, comprising:

[0202] An elongate expandable element configured to be guided beneath at least a portion of the native mitral valve, and

[0203] A wire operably coupled to the elongate expandable element and configured to guide the elongate expandable element beneath at least a portion of the native mitral valve.

[0204] Item 2. The anchor according to Item 1, wherein the wire is fixed to the elongate expandable element to prevent any sliding movement between the elongate expandable element and the wire.

[0205] Item 3. The anchor according to Item 2, wherein the elongate expandable element is configured for delivery through the mitral commissure and at least partially implanted between the left ventricular wall and the chordae tendineae.

[0206] Item 4. The anchor according to Item 1, wherein the wire is connected to the elongate expandable element in a manner that permits sliding movement between the elongate expandable element and the wire.

[0207] Item 5. The anchor according to Item 4, wherein the elongate expandable element is configured to be at least partially implanted between the left ventricular wall and the chordae tendineae.

[0208] Item 6. A method for implanting an anchor for sealing and / or stabilizing a mitral valve prosthesis at the native mitral valve location, comprising:

[0209] Guiding an elongate expandable element beneath at least a portion of the native mitral valve, and

[0210] Using a wire operably coupled to the elongate expandable element to guide the elongate expandable element beneath the portion of the native mitral valve.

[0211] Item 7. The method according to item 6, wherein the wire is fixed to the elongate expandable element, and using the wire further comprises:

[0212] Guiding the elongate expandable element without any sliding movement between the elongate expandable element and the wire.

[0213] Item 8. The method according to item 7, wherein guiding the elongate expandable element further comprises:

[0214] At least partially implanting the elongate expandable element between the left ventricular wall and at least one of the chordae tendineae and / or the native mitral valve leaflets.

[0215] Item 9. The method according to item 6, wherein the wire is connected to the elongate expandable element in a manner that permits sliding movement between the elongate expandable element and the wire, and using the wire further comprises:

[0216] Guiding the elongate expandable element while sliding the elongate expandable element along the wire.

[0217] Item 10. The method according to item 9, wherein guiding the elongate expandable element further comprises:

[0218] At least partially implanting the elongate expandable element between the left ventricular wall and at least one of the chordae tendineae and / or the native mitral valve leaflets.

[0219] Item 11. A system for replacing a patient's native mitral valve with a mitral prosthesis, comprising:

[0220] An expandable mitral prosthesis configured to be delivered to the location of the patient's native mitral valve via a catheter, the expandable mitral prosthesis including anchoring arms on its lower portion, the anchoring arms configured to bend upwardly upon deployment from the catheter to capture the native mitral valve leaflets, and

[0221] An expandable structure capable of expanding upon delivery to the location of the native mitral valve and engaging the native mitral valve leaflets and / or the anchoring arms of the mitral prosthesis to stabilize implantation of the mitral prosthesis at the location of the native mitral valve.

[0222] Item 12. The system according to item 11, wherein the expandable structure further comprises a discontinuous balloon structure that at least partially surrounds the mitral prosthesis.

[0223] Item 13. The system according to item 11, wherein the expandable structure further comprises intermittently and individually expandable balloons.

[0224] Item 14. A system for replacing a patient's native mitral valve with a mitral prosthesis, comprising:

[0225] An expandable mitral prosthesis configured to be delivered via a catheter to the location of the native mitral valve of the patient. The expandable mitral prosthesis includes an expandable stent portion configured to be delivered to the location of the native mitral valve and then expanded, and

[0226] An inflatable structure carried on the expandable stent portion and capable of inflating when delivered to the location of the native mitral valve and providing a seal and / or stability between the expandable mitral prosthesis and the native mitral valve of the patient.

[0227] Item 15. The system according to Item 14, wherein the inflatable structure further includes a first sealing balloon and a second sealing balloon, and the first sealing balloon and the second sealing balloon are adapted to be positioned substantially on opposite sides of the mitral prosthesis.

[0228] Item 16. The system according to Item 14, wherein the inflatable structure further includes at least a pair of sealing balloons positioned adjacent to each other and configured to provide a seal at one commissure of the native mitral valve.

[0229] Item 17. The system according to Item 14, wherein the inflatable structure further includes a continuous annular balloon adapted to be positioned around the mitral prosthesis.

[0230] Item 18. The system according to Item 14, wherein the inflatable structure further includes a discontinuous balloon structure configured to be positioned above and / or below the annulus of the native mitral valve.

[0231] Item 19. The system according to Item 14, wherein the inflatable structure further includes a discontinuous balloon structure configured to be positioned substantially around the mitral prosthesis.

[0232] Item 20. The system according to Item 19, further comprising a reinforcement structure coupled to the discontinuous balloon structure.

[0233] Item 21. The system according to Item 20, wherein the reinforcement structure further includes wires.

[0234] Item 22. The system according to Item 20, wherein the reinforcement structure further includes an inflatable reinforcement balloon.

[0235] Item 23. The system according to Item 14, further comprising:

[0236] A first inflatable leaflet capture member and a second inflatable leaflet capture member, the first inflatable leaflet capture member and the second inflatable leaflet capture member being coupled to the inflatable structure and configured to inflate to capture and stabilize the native mitral valve leaflets.

[0237] Item 24. The system according to item 14, further comprising:

[0238] A mitral valve prosthesis, and

[0239] A plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage at least one of the inflatable structure and / or the native mitral valve leaflets.

[0240] Item 25. The system according to item 24, wherein the anchoring arms further comprise hook members.

[0241] Item 26. A method of implanting an expandable mitral valve prosthesis into a patient's heart, comprising:

[0242] Delivering an inflatable structure beneath at least one leaflet of the native mitral valve,

[0243] Delivering the expandable mitral valve prosthesis to the native mitral valve,

[0244] Inflating the inflatable structure,

[0245] Anchoring the mitral valve prosthesis in place at least in part by using the inflatable structure.

[0246] Item 27. The method according to item 26, wherein delivering the inflatable structure beneath at least one leaflet further comprises:

[0247] Guiding the inflatable structure with a wire.

[0248] Item 28. The method according to item 27, wherein guiding the inflatable structure with a wire further comprises:

[0249] Using a wire fixed to the inflatable structure to guide the inflatable structure such that there is no relative sliding movement between the wire and the inflatable structure.

[0250] Item 29. The method according to item 27, wherein guiding the inflatable structure with a wire further comprises:

[0251] Guiding the inflatable structure by sliding the inflatable structure along the wire.

[0252] Item 30. The method according to item 26, wherein delivering the inflatable structure beneath at least one leaflet further comprises:

[0253] Guide the expandable structure between the chordae tendineae and the left ventricular wall.

[0254] Item 31. A method of implanting an expandable mitral valve prosthesis into a patient's heart, the mitral valve prosthesis including a plurality of anchoring arms coupled to its lower portion, and the method including:

[0255] Deliver an expandable structure beneath at least one leaflet of the native mitral valve,

[0256] Deliver the expandable mitral valve prosthesis to the native mitral valve, and

[0257] Cause the anchoring arms to engage the expandable structure and / or the at least one leaflet to anchor the expandable mitral valve prosthesis.

[0258] Item 32. The method according to item 31, wherein the anchoring arms further include hook members, and the method further includes:

[0259] Cause the hook members to engage the expandable structure and / or the at least one leaflet of the native mitral valve.

[0260] Item 33. A system for replacing a patient's native mitral valve with a mitral valve prosthesis, including:

[0261] An expandable mitral valve prosthesis configured to be delivered via a catheter to the location of the native mitral valve of the patient, the expandable mitral valve prosthesis including an expandable stent portion configured to be delivered to the location of the native mitral valve and then expanded,

[0262] An expandable structure capable of being delivered beneath at least one leaflet of the native mitral valve and anchoring the expandable mitral valve prosthesis to the native mitral valve of the patient, and

[0263] A plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage the expandable structure and / or at least one native mitral valve leaflet.

[0264] Item 34. The system according to item 33, wherein the anchoring arms further include hook members.

[0265] Item 35. A system for anchoring a mitral valve prosthesis, including:

[0266] A delivery catheter including a lumen and a distal opening in communication with the lumen, and

[0267] An inflatable structure that is received in the lumen of the delivery catheter in a collapsed form and is adapted for delivery from the distal opening, the inflatable structure being capable of inflating when delivered from the distal opening and forming an inflated anchoring element located between the mitral valve prosthesis and the patient's native mitral valve, wherein the inflatable structure is capable of being delivered from the distal opening to the native mitral valve position of the patient independently of the mitral valve prosthesis.

[0268] Item 36. The system according to item 35, further comprising:

[0269] A mitral valve prosthesis that can be delivered to the mitral valve position of the patient, expand radially outwardly, and engage with the inflatable element.

[0270] Item 37. The system according to item 35, wherein the inflatable structure further comprises a first sealing balloon and a second sealing balloon, the first sealing balloon and the second sealing balloon being adapted to be positioned on opposite sides of the mitral valve prosthesis.

[0271] Item 38. The system according to item 35, wherein the inflatable structure further comprises at least a pair of sealing balloons, the at least a pair of sealing balloons being positioned adjacent to each other and configured to provide a seal at one commissure of the native mitral valve.

[0272] Item 39. The system according to item 35, wherein the inflatable structure further comprises a continuous annular balloon, which is adapted to be positioned around the mitral valve prosthesis.

[0273] Item 40. The system according to item 39, wherein the inflatable structure further comprises a discontinuous balloon structure, the discontinuous balloon structure being connected to the continuous annular balloon and comprising a first part and a second part adapted to be positioned generally on opposite sides of the mitral valve prosthesis, wherein the continuous annular balloon is configured to be positioned above the native mitral valve annulus and the discontinuous balloon structure is configured to be positioned below the native mitral valve annulus.

[0274] Item 41. The system according to item 35, wherein the inflatable structure further comprises a discontinuous balloon structure, which is configured to be positioned generally around the mitral valve prosthesis.

[0275] Item 42. The system according to item 41, further comprising a reinforcing structure connected to the discontinuous balloon structure.

[0276] Item 43. The system according to item 42, wherein the reinforcing structure further comprises wires.

[0277] Item 44. The system according to item 42, wherein the reinforcing structure further comprises an inflatable reinforcing balloon.

[0278] Item 45. The system according to item 35, further comprising:

[0279] A first inflatable leaflet capture member and a second inflatable leaflet capture member, the first inflatable leaflet capture member and the second inflatable leaflet capture member being coupled to the inflatable structure and configured to inflate to capture and stabilize the native mitral valve leaflets.

[0280] Item 46. The system according to item 35, further comprising:

[0281] A mitral valve prosthesis, and

[0282] A plurality of anchoring arms, the plurality of anchoring arms being coupled to the mitral valve prosthesis and configured to engage at least one of the inflatable structure and / or the native mitral valve leaflets.

[0283] Item 47. The system according to item 46, wherein the anchoring arm further comprises a hook member.

[0284] Item 48. A method of implanting an expandable mitral valve prosthesis into a patient's heart, comprising:

[0285] Delivering an inflatable structure to the native mitral valve,

[0286] Delivering the expandable mitral valve prosthesis separately from the inflatable structure to the native mitral valve, and

[0287] Anchoring the mitral valve prosthesis in place to replace the native mitral valve of the patient by inflating the inflatable structure and positioning the inflatable element generally between the expandable mitral valve prosthesis and the native mitral valve.

[0288] Item 49. The method according to item 48, further comprising:

[0289] Delivering the inflatable structure and the expandable mitral valve prosthesis percutaneously through the patient's venous system to the native mitral valve.

[0290] Item 50. The method according to item 48, wherein delivering the inflatable structure further comprises:

[0291] Delivering a first balloon of the inflatable structure into the left ventricle of the heart below the mitral valve.

[0292] Item 51. The method according to item 50, wherein delivering the inflatable structure further comprises:

[0293] Delivering a second balloon of the inflatable structure into the left atrium of the heart above the mitral valve.

[0294] Item 52. The method according to item 48, wherein the expandable structure further comprises a first sealing balloon and a second sealing balloon, and delivering the expandable structure further comprises:

[0295] Positioning the first sealing balloon on one side of the native mitral valve and positioning the second sealing balloon on the opposite side of the native mitral valve, and

[0296] Sealing at least the first commissure and the second commissure of the native mitral valve using the first sealing balloon and the second balloon, respectively.

[0297] Item 53. The method according to item 52, wherein the expandable structure further comprises a third sealing balloon and a fourth sealing balloon, and delivering the expandable structure further comprises:

[0298] Positioning a pair of sealing balloons to provide a seal at one commissure of the native mitral valve, and positioning another pair of sealing balloons to provide a seal at another commissure of the native mitral valve.

[0299] Item 54. The method according to item 48, wherein the expandable structure further comprises a continuous annular balloon, and delivering the expandable element further comprises:

[0300] Positioning the continuous annular balloon around the mitral prosthesis.

[0301] Item 55. The method according to item 54, wherein the expandable structure further comprises a discontinuous balloon structure connected to the continuous annular balloon, and delivering the expandable structure further comprises:

[0302] Positioning the continuous annular balloon above the annulus of the native mitral valve and positioning the discontinuous balloon structure below the annulus of the native mitral valve.

[0303] Item 56. The method according to item 48, wherein the expandable structure further comprises a discontinuous balloon structure, and delivering the expandable structure further comprises:

[0304] Positioning the discontinuous balloon structure above or below the annulus of the native mitral valve.

[0305] Item 57. The method according to item 56, further comprising:

[0306] Reinforcing the discontinuous balloon structure with the wire.

[0307] Item 58. The method according to item 56, further comprising:

[0308] Use the wire to assist in delivering the discontinuous balloon structure.

[0309] Item 59. The method according to item 48, wherein delivering the expandable structure further comprises:

[0310] delivering a first expandable leaflet capture member and a second expandable leaflet capture member, and

[0311] expanding the first expandable leaflet capture member and the second expandable leaflet capture member to capture and stabilize the native mitral valve leaflets.

[0312] Item 60. The method according to item 48, wherein the expandable mitral valve prosthesis further comprises a plurality of anchoring arms connected to its lower portion, and the method further comprises:

[0313] engaging the anchoring arms with the expandable structure and / or at least one native mitral valve leaflet to assist in stabilizing the expandable mitral valve prosthesis.

[0314] Item 61. The method according to item 60, wherein the anchoring arms further comprise hook members, and the method further comprises:

[0315] engaging the hook members under the leaflets of the native mitral valve.

[0316] Item 62. A system for replacing a patient's native mitral valve, comprising:

[0317] a mitral valve prosthesis comprising a generally tubular portion and a flange portion extending radially outward from the tubular portion, the flange portion configured to provide an anchor above the native mitral valve annulus in the patient's left atrium,

[0318] an expandable structure configured to be positioned beneath at least a portion of the native mitral valve leaflets, and

[0319] a plurality of anchoring arms coupled to the mitral valve prosthesis and configured to engage at least one of the expandable structure and the native mitral valve leaflets to assist in anchoring the mitral valve prosthesis in place.

[0320] Item 63. The system according to item 62, wherein the anchoring arms further comprise hook members.

[0321] Item 64. The system according to item 62, wherein the expandable structure has a generally semi-circular elongated shape for positioning between the left ventricular wall and the chordae tendineae and / or the native mitral valve leaflets and generally following the curvature of the native mitral valve annulus.

[0322] Item 65. The system according to item 64, further comprising:

[0323] A wire, operably coupled to the expandable element and configured to guide the expandable element to a position between the left ventricular wall and the chordae tendineae and / or the native mitral valve leaflets and generally follow the curvature of the native mitral annulus.

[0324] Item 66. The system according to item 65, wherein the wire is fixed to the expandable element to prevent any sliding movement between the expandable element and the wire.

[0325] Item 67. The system according to item 65, wherein the wire is coupled to the expandable element in a manner that allows sliding movement between the expandable element and the wire.

[0326] Item 68. A mitral valve prosthesis, comprising:

[0327] A generally tubular portion,

[0328] A plurality of anchoring arms, coupled to a lower section of the tubular portion and configured to be positioned below the native mitral valve leaflets and bend upwardly upon deployment, and

[0329] An expandable structure, coupled to the anchoring arms and configured to engage and capture the native mitral valve leaflets upon deployment of the anchoring arms.

[0330] Item 69. The mitral valve prosthesis according to item 68, further comprising:

[0331] A flange portion, extending radially outward from the tubular portion, the flange portion configured to provide an anchor in the patient's left atrium above the native mitral annulus.

[0332] Item 70. A mitral valve commissure seal, comprising:

[0333] An expandable structure having a first portion and a second portion, the first portion extending in a first direction for passing through the commissure of the native mitral valve and expandable to prevent blood leakage through the commissure; and the second portion extending generally transverse to the first portion and configured to be positioned above or below the native mitral annulus and expandable to serve as an anchor for a mitral valve prosthesis.

[0334] Item 71. A system for replacing a patient's native mitral valve, comprising:

[0335] A mitral valve prosthesis, comprising a generally tubular portion and a flange portion extending radially outward from the tubular portion, the flange portion configured to provide an anchor in the patient's left atrium above the native mitral annulus, and

[0336] An expandable structure configured to be positioned at the location of at least one commissure of the native mitral valve and expand to at least assist in sealing the commissure to prevent blood leakage.

[0337] Item 72. An expandable structure shaped to generally follow the native mitral annulus and allow implantation of a mitral valve prosthesis, wherein the diameter of the mitral valve prosthesis is smaller than the native mitral annulus.

[0338] Item 73. An expandable anchor shaped to be generally semi - circular and elongated so as to be configured to be positioned beneath at least one native mitral valve leaflet and positioned in a plane generally parallel to the native mitral annulus and assist in anchoring a mitral valve prosthesis.

[0339] Item 74. The expandable anchor according to item 73, wherein the expandable anchor is delivered via at least one anchoring arm of the mitral valve prosthesis.

[0340] Item 75. The expandable anchor according to item 73, wherein the expandable anchor can be delivered to the appropriate position through the commissure of the native mitral valve.

[0341] Item 76. The expandable anchor according to item 73, further comprising a portion configured to seal a gap formed by the commissure of the native mitral valve.

[0342] Item 77. The expandable anchor according to item 76, wherein the portion extends generally transversely to another portion of the expandable anchor and is configured to be implanted in place to extend through the commissure.

[0343] Item 78. An expandable anchoring system for a mitral valve prosthesis, comprising:

[0344] At least one expandable anchor shaped to be generally circular or semi - circular so as to be configured to be positioned above and / or below the native mitral annulus to assist in anchoring the mitral valve prosthesis, and wherein the expandable anchor includes a portion capable of expanding at the location of the mitral annulus to seal the commissure to prevent blood leakage.

[0345] Item 79. A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising:

[0346] An expandable mitral valve prosthesis configured to be delivered to the location of the patient's native mitral valve via a catheter, and

[0347] An expandable stabilizing structure capable of expanding when delivered to the location of the native mitral valve and engaging native tissue to stabilize the implantation of the mitral valve prosthesis at the location of the native mitral valve.

[0348] Item 80. A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising:

[0349] An inflatable mitral valve prosthesis configured to be delivered to the location of the native mitral valve of the patient through a catheter, the inflatable mitral valve prosthesis including an inflatable portion configured to be delivered to the location of the native mitral valve and then inflated, and

[0350] An inflatable stabilizing structure carried on the inflatable portion and capable of inflating when delivered to the location of the native mitral valve and providing a seal and / or stability between the inflatable mitral valve prosthesis and the native mitral valve of the patient.

[0351] Item 81. The system according to Item 80, wherein the inflatable stabilizing structure further includes a first sealing balloon and a second sealing balloon, the first sealing balloon and the second sealing balloon being adapted to be generally positioned on opposite sides of the inflatable mitral valve prosthesis.

[0352] Item 82. The system according to Item 80, wherein the inflatable stabilizing structure further includes a continuous annular balloon adapted to be positioned around the inflatable mitral valve prosthesis.

[0353] Item 83. The system according to Item 80, wherein the inflatable stabilizing structure further includes a discontinuous balloon structure configured to be positioned above and / or below the annulus of the native mitral valve.

[0354] Item 84. The system according to Item 80, wherein the inflatable stabilizing structure further includes a discontinuous balloon structure configured to be generally positioned around the inflatable mitral valve prosthesis.

[0355] Item 85. The system according to Item 84, further comprising a reinforcing structure connected to the discontinuous balloon structure.

[0356] Item 86. The system according to Item 85, wherein the reinforcing structure further includes wires.

[0357] Item 87. The system according to Item 80, further comprising:

[0358] A first inflatable leaflet capture member and a second inflatable leaflet capture member, the first inflatable leaflet capture member and the second inflatable leaflet capture member being coupled to the inflatable mitral valve prosthesis and / or the inflatable stabilizing structure and configured to inflate to capture and stabilize the native mitral valve leaflets.

[0359] Item 88. A method of implanting an expandable mitral valve prosthesis into a patient's heart, comprising:

[0360] delivering an expandable stabilizing structure beneath at least one leaflet of the native mitral valve,

[0361] delivering the expandable mitral valve prosthesis to the native mitral valve,

[0362] expanding the expandable stabilizing structure,

[0363] anchoring the expandable mitral valve prosthesis in place at least in part by using the expandable stabilizing structure.

[0364] Item 89. The method according to Item 88, wherein delivering the expandable stabilizing structure beneath at least one leaflet further comprises:

[0365] guiding the expandable structure with a wire.

[0366] Item 90. A system for repairing a patient's native mitral valve, comprising:

[0367] a mitral valve clip configured to be delivered to the location of the native mitral valve of the patient through a catheter, the mitral valve clip configured to capture and hold the native leaflets of the mitral valve together, and

[0368] an expandable sealing structure capable of expanding and engaging with native tissue when delivered to the location of the native mitral valve to seal leaks through the native mitral valve.

[0369] Item 91. The system according to Item 90, wherein the expandable sealing structure is physically coupled to the mitral valve clip.

[0370] Item 92. The system according to Item 91, wherein the expandable sealing structure is physically coupled to the mitral valve clip by an expandable connection structure.

[0371] Item 93. A method of applying a mitral valve clip to a patient's native mitral valve, comprising:

[0372] delivering the mitral valve clip beneath the leaflets of the native mitral valve,

[0373] capturing the leaflets with the mitral valve clip,

[0374] delivering an expandable sealing structure to the native mitral valve, and

[0375] expanding the expandable sealing structure to engage with native tissue to seal one or more leaks through the native mitral valve.

Claims

1. A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising: an expandable mitral valve prosthesis configured to be delivered via a catheter to the location of the native mitral valve of the patient, the expandable mitral valve prosthesis including anchoring arms on its lower portion, the anchoring arms configured to bend upwardly upon deployment from the catheter to capture the native mitral valve leaflets, and an inflatable structure capable of inflating upon delivery to the location of the native mitral valve and engaging the native mitral valve leaflets and / or the anchoring arms of the mitral valve prosthesis to stabilize implantation of the mitral valve prosthesis at the location of the native mitral valve.

2. The system according to claim 1, wherein, The inflatable structure further includes a discontinuous balloon structure that at least partially surrounds the mitral valve prosthesis.

3. The system according to claim 1, wherein, The inflatable structure further includes discrete and individually inflatable balloons.

4. A system for replacing a patient's native mitral valve with a mitral valve prosthesis, comprising: an expandable mitral valve prosthesis configured to be delivered via a catheter to the location of the native mitral valve of the patient, the expandable mitral valve prosthesis including an expandable stent portion configured to be delivered to the location of the native mitral valve and then expanded, and an inflatable structure carried on the expandable stent portion and capable of inflating upon delivery to the location of the native mitral valve and providing a seal and / or stability between the expandable mitral valve prosthesis and the native mitral valve of the patient.

5. The system according to claim 4, wherein The inflatable structure further includes a first sealing balloon and a second sealing balloon, the first sealing balloon and the second sealing balloon being adapted to be positioned generally on opposite sides of the mitral valve prosthesis.

6. The system according to claim 4, wherein The inflatable structure further includes at least one pair of sealing balloons positioned adjacent to each other and configured to provide a seal at one commissure of the native mitral valve.

7. The system according to claim 4, wherein The inflatable structure further includes a continuous annular balloon adapted to be positioned around the mitral valve prosthesis.

8. The system according to claim 4, wherein, The inflatable structure further includes a discontinuous balloon structure configured to be positioned above and / or below the annulus of the native mitral valve.

9. The system according to claim 4, wherein, The inflatable structure further includes a discontinuous balloon structure configured to be positioned generally around the mitral valve prosthesis.

10. An inflatable structure that is shaped to generally follow the natural mitral annulus and permit implantation of a mitral valve prosthesis, wherein, The diameter of the mitral valve prosthesis is smaller than the native mitral valve annulus.

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