Device for expanding an implant within a heart chamber

Abstract

Various embodiments of the present invention include a single-chamber collapsible and expandable artificial valve implantation device, which includes the following performances: (1) maintaining the function of the native valve; (2) initially maintaining the function of the native valve and subsequently completely replacing the function of the native valve; (3) completely replacing the function of the native valve gate; and / or (4) reducing the prolapse distance of the dysfunctional leaflets by preventing the prolapsed leaflets from shifting anteriorly above the upper annular surface and into the left atrial chamber so as to maintain the function of the native leaflets for as long as possible. The expanded and implanted device does not extend beyond the boundaries of the patient's heart chamber, such as the left atrium, thereby being able to maintain any remaining native valve function and subsequently completely replace the function of the native valve when needed. A device for expanding an implanted device within a heart chamber is disclosed, which includes a base segment having a lower surface, an atrial dome, an intermediate segment attached to the base segment and the atrial dome, and a central cylindrical valve support.

Description

[0001] This application is a divisional application of a Chinese patent application with an application date of August 11, 2017, a national application number of 201780055881.9 (PCT application number of PCT / US2017 / 046434), and a title of "Single Chamber Anchored Heart Chamber Artificial Valve Implant with Base, Spring and Dome Sections for Maintaining, Supplementing and / or Replacing Autologous Valve Function".

[0002] Cross - Reference to Related Applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 373541, filed on August 11, 2016, and titled "HEART CHAMBER PROSTHETIC VALVE IMPLANT WITH STENT, SPRING AND DOME SECTIONS", U.S. Provisional Application No. 62 / 373560, filed on August 11, 2016, and titled "HEART CHAMBER PROSTHETIC VALVE IMPLANT WITH STENT, MESH AND DOME SECTIONS", and U.S. Provisional Application No. 62 / 373551, filed on August 11, 2016, and titled "HEART CHAMBER PROSTHETIC VALVE IMPLANT WITH ELEVATED VALVE SECTION", each of which is incorporated herein by reference in its entirety.

[0004] Statement Regarding Federally Sponsored Research or Development

[0005] Not applicable

[0006] Background of the Invention Technical Field

[0007] The present invention relates to devices and methods for implanting devices within a heart chamber. More particularly, the present invention relates to a single - chamber anchoring frame that includes an anchoring structure fully positioned within a single chamber and an artificial valve positioned to maintain and / or replace the function of an autologous valve. Background Art

[0008] The human heart includes four chambers and four heart valves that assist blood in flowing forward (antegrade) through the heart. The chambers include the left atrium, left ventricle, right atrium, and left ventricle. The four heart valves include the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. Generally refer to Figure 1 .

[0009] The mitral valve is positioned between the left atrium and the left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is positioned between the right atrium and the right ventricle, while the aortic valve and pulmonary valve are semilunar valves positioned in the arteries that carry blood away from the heart. The valves are all one-way valves with leaflets that open to allow forward (antegrade) blood flow. Normally functioning valve leaflets close under the pressure exerted by reverse blood flow to prevent blood from flowing back (retrograde) into the chamber from which it has just exited. For example, the mitral valve provides a one-way valve between the left atrium and the left ventricle when functioning normally, opening to allow antegrade flow from the left atrium to the left ventricle and closing to prevent retrograde flow from the left ventricle into the left atrium. This retrograde flow (when present) is referred to as mitral regurgitation or mitral insufficiency.

[0010] Figure 2 The relationship between the left atrium, annulus, chordae tendineae, and left ventricle relative to the mitral valve leaflets is shown. As shown, the upper surface of the annulus forms at least a part of the bottom or lower surface of the left atrial chamber such that for the purposes of the description herein, the upper surface of the annulus is defined as marking the lower boundary of the left atrial chamber and is generally represented by at least one point A that indicates the general location of an implant target placed or mounted on the designated upper annular surface, which is specified in detail below. In practice, more than one point A may be used to specify the upper annular surface in order to position the anchoring structure and prosthetic valve within a single cardiac chamber and not interfere with the native valve leaflets.

[0011] The region through which blood in the annulus flows in a generally downward antegrade direction between the left atrium and the left ventricle - but above the bend points of the native leaflets - is referred to herein as the intra-annulus. Refer Figure 7 to the cross-sectional side view of the annulus, native leaflets, designated upper annular surface, and intra-annulus. Note that the above-described designated upper annular surface defines the lower boundary of at least a part of the left atrium. Thus, the designated upper annular surface may also extend across the annulus itself, for example, covering the annular plane as is well known to those skilled in the art. However, as described further below, the designated upper annular surface may also extend downward (antegrade) into the annulus a distance, but may not extend downward (antegrade) beyond the point where any structure placed at the designated upper annular surface may adversely affect the function of the native valve leaflets within the intra-annulus, for example, at the bend points of the native valve leaflets.

[0012] Due to a variety of reasons and / or circumstances (including but not limited to disease, trauma, congenital malformations, and aging), native heart valves may malfunction or become dysfunctional. These types of circumstances may cause the valve structure to fail to close properly, resulting in retrograde blood flow from the left ventricle into the left atrium in the case of mitral valve failure.Figure 3 and Figure 4 shows regurgitant blood flow in the case of mitral valve dysfunction. Figure 4 shows a prolapsed native valve in the case of loss of junction between the leaflets and thus regurgitant blood flow from the left ventricle to the left atrium.

[0013] Mitral regurgitation is a specific problem caused by a dysfunctional mitral valve that allows at least some retrograde blood to flow back from the left atrium. In some cases, the dysfunction is caused by the upward prolapse of the mitral valve leaflets into the left atrial chamber - i.e., above the upper surface of the annulus as defined by line or plane A - rather than being joined or engaged to prevent retrograde flow. This blood backflow places a volume load on the left ventricle that can lead to a series of left ventricular compensatory adaptations and adjustments (including remodeling of the ventricular chamber size and shape), which vary widely over the long-term clinical course of mitral regurgitation.

[0014] Accordingly, native heart valves (e.g., the mitral valve) often may require functional repair and / or assistance (including partial or complete replacement). Such interventions can take several forms, including open heart surgery and open heart implantation of a replacement heart valve. See, e.g., U.S. Patent No. 4,106,129 (Carpentier), for highly invasive, patient-risky surgery that not only requires extended hospitalization but also a very painful recovery period.

[0015] Less invasive methods and devices for replacing a dysfunctional heart valve are also known and involve percutaneous access and catheter-assisted delivery of a replacement valve. Most of these solutions involve a replacement heart valve attached to a structural support (such as a stent well known in the art), or other forms of wire mesh designed to expand when released from a delivery catheter. See, for example, U.S. Patent No. 3,657,744 (Ersek); U.S. Patent No. 5,411,552 (Andersen). Self-expanding variants of the support stent assist in positioning the valve and maintaining the expanded device in the proper position within a patient's heart chamber or blood vessel. When (as is often the case) the device is not properly positioned on the first placement attempt and thus must be recaptured and repositioned, this self-expanding form also presents problems. In the case where the device is fully or even partially expanded, this recapture process requires collapsing the device back to the point where the operator can retract the collapsed device into the delivery sheath or catheter, adjusting the entry position for the device, and then redeploying the repositioned device distally from the delivery sheath or catheter and re-expanding it to the proper position. Collapsing an already expanded device is difficult because the expanded stent or wire mesh is typically designed to achieve an expanded state that also resists compressive or collapsing forces.

[0016] In addition to the open-heart surgical methods discussed above, percutaneous access to the valve of interest is achieved via at least one of the following known access routes: transapical delivery techniques; transfemoral delivery techniques; transatrial delivery techniques; and transseptal delivery techniques.

[0017] Generally, the art is concerned with systems and methods that use one of the above-known access routes to permit partial delivery of a collapsed valve device, where one end of the device is released from the delivery sheath or catheter and expanded for initial placement and then fully released and expanded when proper placement is completed. See, for example, U.S. Patent No. 8,852,271 (Murray, III); 8,747,459 (Nguyen); 8,814,931 (Wang); 9,402,720 (Richter); 8,986,372 (Murray, III); and 9,277,991 (Salahieh); and U.S. Patent Publication No. 2015 / 0272731 (Racchini); and 2016 / 0235531 (Ciobanu).

[0018] In addition, all known artificial heart valves are designed to completely replace the native heart valve. Thus, in the case of the mitral valve, these replacement heart valves and / or anchoring or tethering structures physically extend out of the left atrial chamber and engage the annulus and / or valve leaflets, in many cases stapling the native leaflets against the wall of the annulus, thereby permanently eliminating all remaining function of the native valve and leaving the patient completely dependent on the replacement valve. In other cases, the anchoring structure extends into the left ventricle and may be anchored into the left ventricular wall tissue and / or the subannular surface at the top of the left ventricle.

[0019] Each artificial valve implantation solution that requires extending, purchasing, anchoring, operating, and / or fluidly connecting, operatively connecting, and / or engaging tissue, valves, and / or conduits and / or chambers outside the left atrium while simultaneously reducing or eliminating the associated native valve function needs improvement. For convenience, we will collectively refer to these solutions as biventricular solutions. Generally speaking, when the native valve leaflets retain some function, the preferred solution is a solution that maintains and / or preserves the native function of the heart valve, and thus it is preferred to supplement or enhance the native valve and its function rather than completely replace it.

[0020] Obviously, prior to an interventional implantation procedure, there will be cases where the native valve has almost completely lost its function. In such cases, the preferred solution will include an implant that does not extend outside, for example, the left atrium and is used to completely replace the native valve function. However, in many other cases, the native valve retains some function to some extent and may or may not continue to lose function after the implantation procedure. In such cases, the preferred solution includes delivering and implanting a valve device that will be used to supplement or enhance the valve without damaging the native leaflets so as to retain the native valve leaflet function as long as the native valve leaflet function exists, while also being fully capable of replacing the native function of the valve that slowly loses most or all of its function after the artificial valve implantation.

[0021] Biventricular solutions have other problems. From a strictly structural perspective, they are all unnecessarily bulky and long, making delivery and placement / recapture / repositioning more difficult. In addition, biventricular solutions have difficulty in making ventricular anchoring and / or tethering connections required to maintain position. Moreover, as described above, these solutions interfere with native valve function because the portion of the device disposed within the left ventricle must be guided through the annulus and transmitted through at least a portion of the annulus and the native mitral valve, thereby necessarily permanently disrupting and in some cases eliminating any remaining engagement ability and function of the native leaflets. Additionally, many biventricular solutions typically require some degree of invasive anchoring of native tissue, resulting in unnecessary trauma and potential complications.

[0022] Unless otherwise stated, the specific innovative embodiments described herein can be easily applied to single-chamber or double-chamber solutions. Additionally, the specific embodiments discussed herein can be generally applied to maintaining and / or replacing the function of the native valve and are thus not limited to the mitral valve.

[0023] Various embodiments of several inventions disclosed herein particularly address these problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Certain features of the heart are shown in cross-section.

[0025] Figure 2 A cross-sectional perspective view of the left side of the heart is shown.

[0026] Figure 3 A cross-sectional view of the heart is shown, which shows retrograde blood flow caused by mitral regurgitation compared to normal blood flow.

[0027] Figure 4 A cross-sectional view of a part of the heart is shown, which shows a prolapsed mitral valve leaflet and regurgitant blood flow.

[0028] Figure 5A A top view of the annulus and an embodiment of the present invention are shown.

[0029] Figure 5B A cross-sectional side view of the annulus and the native leaflets and an embodiment of the present invention are shown.

[0030] Figure 5C A cross-sectional side view of the annulus and the native leaflets and an embodiment of the present invention are shown.

[0031] Figure 5D A cross-sectional side view of the annulus and the native leaflets and an embodiment of the present invention are shown.

[0032] Figure 5E A cross-sectional side view of the annulus and the native leaflets and an embodiment of the present invention are shown.

[0033] Figure 6 A perspective view of an embodiment of the present invention is shown.

[0034] Figure 7 A perspective view of an embodiment of the present invention is shown.

[0035] Figure 8 A bottom view of an embodiment of the present invention is shown.

[0036] Figure 9 A cutaway perspective view of an embodiment of the present invention is shown.

[0037] Figure 9AA perspective view of an embodiment of the present invention is shown.

[0038] Figure 10 A sectional perspective view of an embodiment of the present invention is shown.

[0039] Figure 11 A perspective view of an embodiment of the present invention is shown. Detailed Description

[0040] Each embodiment of the present invention includes a single-chamber anchoring solution that includes (1) maintaining the native valve function; (2) initially maintaining the native valve function and subsequently fully replacing the native valve function; (3) fully replacing the native valve function; and (4) reducing the prolapse distance of dysfunctional leaflets by preventing the prolapsed leaflets from shifting anteriorly above the upper annulus surface and into the left atrial chamber so as to maintain the function of the native leaflets for as long as possible.

[0041] As discussed, all known artificial heart valves are designed for full replacement of native heart valves. Thus, these replacement heart valves physically engage the inner annulus and / or valve leaflets, in many cases stapling the native leaflets against the wall of the inner annulus, thereby eliminating all remaining function of the native valve and making the patient fully dependent on the replacement valve. Generally, when the native valve leaflets retain some function, the preferred solution is a solution that maintains and / or preserves the native function of the heart valve, and thus it is preferred to supplement or enhance the native valve and its function rather than fully replace it.

[0042] In some cases, prior to an interventional implantation procedure, the native valve will have lost nearly all of its function. In such cases, the preferred solution provides a complete functional replacement for the native valve.

[0043] In other cases, after implantation of an artificial valve, the native valve will retain some function but will lose its native function over time. Thus, in these cases, the preferred solution includes delivery and implantation of a valve device that will initially serve as a supplemental functional valve to maintain and preserve the function of the native valve leaflets (for as long as there is function of the native valve leaflets), and over time will gradually be used to replace the native function of the valve as the valve slowly loses its native function. Thus, in these cases, the preferred solution may be to initially maintain the native valve function when only a lower level of supplemental or enhanced support is needed, and to provide an increasing level of supplemental or enhanced support as the native leaflet function slowly deteriorates to accommodate the increasing replacement needs. Finally, the preferred solution can provide a full replacement function.

[0044] In this regard, the various embodiments of the present invention are characterized by preventing the prolapsed valve leaflets from rising above the upper annular surface and entering the left atrium, so as to provide additional support for the function of the native leaflets and maintain the function of the native leaflets for as long as possible.

[0045] In addition, the single-chamber dilation and implant device structure includes certain embodiments as shown in the figures. Thus, these embodiments of the dilation and implant device structure may not include structures that extend below a boundary (e.g., the annular plane as shown in the figures and referred to in the art). Alternatively, as further discussed, within the annular throat, no structure may extend below the defined boundary. Yet alternatively, certain embodiments may not include structures of the dilation and implant device structure that extend from a heart chamber (e.g., the left atrium) to a blood vessel (e.g., the pulmonary artery as shown in the figures) that is in fluid communication therewith.

[0046] Thus, in certain embodiments, the dilation and implant structure in the left atrium may include one or more of those not present in or not engaging with the patient's mitral valve including native leaflets, left ventricle, and pulmonary artery.

[0047] In addition, embodiments of the present invention may include delivering a collapsed artificial heart valve structure to a heart chamber (e.g., the left atrium) that includes one or more of those not present in or not engaging with the patient's mitral valve including native leaflets, left ventricle, and pulmonary artery.

[0048] The various embodiments of the present invention include preferred solutions for each of the above conditions.

[0049] Now referring to Figure 5A - Figure 5E , a specified site or location on the upper surface or upper annular surface of the annulus can be achieved by specifying at least two points A, each of which must be located on the now-specified site of the upper annular surface. Plane B, best seen in Figure 5A and Figure 5B , represents a plane that is generally flat and collinear with the at least two specified points A located on the specified upper surface of the annulus in the left atrium. The critical and required feature of the at least two specified points A is that they are positioned above the flexion point FP of the native valve leaflets. This arrangement in turn helps to locate the lowest part of the structure that extends across the annulus or, in some cases, into the inner annulus. Thus, a structure having its lowest part located at or above the at least two specified points will not unduly interfere with the remaining normal native valve function. Those skilled in the art will as Figure 5BThe plane B shown is recognized as being generally on or collinear with what is commonly referred to as the annulus plane, but as described below, other portions can be designated for the upper annulus surface, each of which is within the scope of the present invention.

[0050] In addition, the left atrium and / or left atrial chamber are defined herein relative to the lowest point or bottom of the annulus (including the inner annulus in some embodiments) as being positioned by at least one line (straight or curved) connecting at least two of the designated points A. Thus, in the case of a curve or a series of lines that can be curves, the generally flat plane shown as plane B can form a curvilinear sheet C as Figure 5B shown, and can include curvilinear variations across the segment C.

[0051] A structure having a lower portion positioned at or above the upper annulus surface defined and designated by at least two designated points A, the flat plane B or curvilinear segment C connecting the at least two points is defined herein as being within the left atrium or left atrial chamber.

[0052] A structure positioned below the upper surface of the annulus defined by at least two designated points A and the plane B or curvilinear segment C connecting the at least two points is defined herein as being positioned outside the left atrium or left atrial chamber.

[0053] The definition of the lower boundary of the left atrium relative to the annulus, and the corresponding definitions inside and outside the lower boundary of the left atrium have, in addition to designating at least two points, a requirement that the positions of the at least two designated points A and the corresponding plane B or curvilinear segment C can never interfere unfavorably with the function of the native valve leaflets. As will be readily appreciated by those skilled in the art, the remaining boundaries of the left atrium or left atrial chamber include the chamber walls and the upper surface or top. This definition of the boundaries of the left atrium or left atrial chamber now forms the basis for positioning and anchoring structures only within the left atrium or left atrial chamber, with no anchoring or other structure extending beyond the defined boundaries of the left atrium or left atrial chamber.

[0054] We note here that the lowest portion of the various embodiments of the artificial heart valve device described herein can, in some embodiments, provide a barrier to a prolapsed mitral valve, thereby preventing prolapse to varying degrees depending on the depth within the inner annulus of the designated upper annulus surface as described above. This is one of the inventive objectives of the embodiments of the present invention. However, the lowest structure that can extend down into the inner annulus of the various embodiments must be positioned on or above the designed upper annulus surface as defined herein.

[0055] It should be understood that, as shown in the figure, the at least two specified points A and the plane B or the curved segment C connecting the at least two specified points are always positioned above the flexion point FP of the native leaflet. This is one of the features that allows to prevent the prolapse of the native leaflet to varying degrees in certain cases and at the same time enables no adverse interference with the native leaflet function. Note that in Figure 5C the extension of the curved segment C across part of the annulus can be curved or tilted downward below what is commonly referred to as the annular plane, such that the specified upper annular surface can include a downward extension or offset into the inner annulus. This configuration is within the scope of the present invention as long as the curved segment C remains compliant with the above requirements for the specified upper annular surface (e.g., positioned above the flexion point PF of the native leaflet) at all points so as not to impede the native function.

[0056] Alternatively, at least a portion of the lower surface 106 of the base segment 100 can also be placed on the lower surface of the left atrium surrounding at least a portion of the annulus.

[0057] In more alternative embodiments, a portion of the designed upper annular surface can extend below the flexion point FP of the native leaflet while still maintaining the native function of the native leaflet, as long as at least partial engagement of the leaflets can be achieved. Additionally, in cases where the function of the native leaflets is evaluated as very poor, the valve structure can extend downward through the inner annulus to effectively nail the native leaflets against the wall tissue. This is only a possible solution in very few cases, but it is within the scope of the presently described invention. In this embodiment, the upper annular surface is also defined and specified at a position below the flexion point of the native leaflet.

[0058] In Figure 5D and Figure 5E the relationship and definition of the upper surface of the annulus and the at least two specified points A and the plane B are further shown. There, the annulus is shown in a side cross-section, where the inner annulus is represented as an internal passage with a height H of the annulus. Figure 5D The upper surface of the annulus is shown, where the corresponding plane B is substantially aligned with the annular plane. Figure 5E An alternative is shown, where the upper surface of the annulus is specified to be slightly lower than the position in Figure 5D and is the specified plane B'. However, in each case, the position specification as shown by the plane B and / or the curved segment C and the upper surface of the annulus position must be above the flexion point FP of the native leaflet such that the implanted lower surface 106 of the base segment 100 to be placed on at least the upper surface of the annulus does not interfere with the native leaflet function. This alternative embodiment further illustrates the existence of multiple specified points A and the associated plane B or curved segment C for positioning and locating the upper surface of the annulus and thus for positioning the lower surface 106 of the base segment 100 during implantation.

[0059] Now turning to Figure 6 and Figure 7 which shows an embodiment of the present invention, which includes a collapsible and expandable anchoring structure 10, the anchoring structure 10 includes a base support 100 having a mesh or unit that can be expanded and collapsed as known in the art, an intermediate spring-like section 200, and an atrial dome 300, wherein the intermediate spring-like section 200 is operatively connected to the base support 100 and the atrial dome 300. Figure 6 Shows the anchoring structure 10 within the left atrium without intervening, engaging, or disturbing the structures outside the left atrium.

[0060] The base section 100 includes an inner surface 102, an outer surface 104, a lower surface 106 having a diameter D1, an upper surface 108 having a diameter D2, and a height H1 that is generally defined as the vertical length between the lower surface 106 and the upper surface 108. As is well known, the base section 100 may include a stent or other structure that can collapse and expand. The base section 100 is preferably biased to expand, so as to reach the expanded state from the collapsed state, but other collapsed-to-expanded mechanisms may also be employed. In addition, the base section 100 can achieve multiple expanded states, so as to expand and contract with the natural movement of the heart chamber wall and bottom. The base section 100 may include a shape memory material (e.g., nitinol or a similar wire mesh structure or sliding element structure), which is biased to achieve the expanded state, as known in the art. Similarly, a shape memory polymer can be used for at least a part of the base section 100.

[0061] Preferably, when implanted in the left atrium, the outer surface 104 of the base section is at least covered with a material M, which is at least consistent with and seals the atrial wall in at least the circumferential region of the wall surrounding the left atrial appendage (LAA) within the left atrium, so as to seal the LAA.

[0062] Figure 6 and Figure 7 Shows that the lower surface 106 of the base section occupies the exemplary plane B representing the designated upper annular surface discussed above, but as described herein, other designations and positions are also possible. The artificial one-way valve 400 is generally aligned with the annulus to allow one-way fluid communication therethrough, and is positioned within the base section 100 and shown to be generally located on the exemplary plane B, as discussed above, which plane B represents the designated position of the upper surface of the annulus. The artificial valve 400 includes at least one leaflet, preferably two leaflets 402, and defines a one-way opening 404 through the lower surface 106 of the base support, as Figure 8As shown in [FIGURE], to facilitate fluid flow therethrough and then into the annulus while preventing backflow. The artificial one-way valve 400 may include a valve support device (e.g., the central cylinder 406), which is open to fluid flow and is in fluid communication with atrial blood and the annulus when the one-way artificial valve is open. The central cylinder 406 is configured to provide support and attachment for the valve leaflets 402, is open to the fluid flow received within the left atrium, and in some embodiments, is configured to collect or concentrate the received fluid flow toward the valve leaflets 402.

[0063] As Figure 9 shown in [FIGURE], the central cylinder 406 may include the valve leaflets 402 disposed at or near the lower surface 408 of the central cylinder 406. Alternatively, the valve leaflets 402 may be disposed and operatively connected at a point above the lower surface 408 within the central cylinder 406, as shown by the dashed line and 402' in the exemplary embodiment.

[0064] Alternatively, an orifice (e.g., Figure 8 the opening 404) may be generally aligned with the annulus and disposed along the curved segment C or along the at least two designated points A within the plane B, and artificial leaflets attached thereto may be provided to contribute to the one-way valve function. The valve support device (e.g., the central cylinder 406), when present, includes a height H2 and a lower surface 408, and the height H2 may be less than, greater than, or equal to the height of the basal segment 100. The central cylinder 406 will also include a diameter D3 that is less than the diameters of the lower surface 106 and the upper surface 104 of the basal segment 100.

[0065] Since the artificial one-way valve 400 (especially its lower surface 408) is not allowed to extend below the designated upper surface of the annulus as defined herein, it is preferred not to eliminate or otherwise reduce the function of the native valve, unless in the very few cases described herein.

[0066] It should be appreciated that in certain embodiments, the central cylinder 406 and the valve leaflets 402 supported therein may be constructed and positioned such that the lower surface 408 of the central cylinder 406 may extend below the lower surface 106 of the basal segment at the time of implantation. See Figure 9AExemplary embodiments shown. Again, with this arrangement, the valve leaflets 402 can be positioned at any point along or within the central cylinder 406. However, in these embodiments, the central cylinder 406 (including the lower surface 408 thereon) is not positioned at a point that in any way infringes upon, impinges upon, or encroaches upon the function of the native leaflets, in order to meet one of the purposes of the present invention: namely, to maintain the function of the native leaflets for as long as possible. In other words, in this embodiment, the lower surface 408 of the central cylinder 406 can be positioned along a specified upper annular surface defined by at least the two specified points and / or the corresponding plane B or curve segment C as defined herein, while the lower surface 106 of the base segment 100 can be positioned at a point slightly above the specified upper annular surface, or the lower surface 106 of the base segment 100 and the lower surface 408 of the central cylinder 406 can both be positioned on or above the specified upper annular surface.

[0067] Additionally, in addition to the simple cylindrical profile, the central cylinder 406 can alternatively include a variety of different alternative leaflet connection structures and shapes, for example, while maintaining the above functions, rectangular, oval, polygonal, conical profiles, and other profiles can be used. Each of these alternatives is within the scope of the present invention.

[0068] Now turning to the intermediate class spring section 200, Figure 6 and Figure 7The embodiments shown include a plurality of spring elements 202, such as but of course not limited to springs. The spring elements 202 used within section 200 are defined herein to include any structure or device that can be inelastically compressed and is used to store mechanical energy that generates a biasing force when the device is compressed. Thus, when the spring element 202 of the present embodiment is elastically compressed or stretched from its rest position, it exerts a reaction force that is generally proportional to the change in its length. Generally speaking, the spring elements 202 of section 200 include a first end 204 and a second end 206, wherein the first end 204 of each spring element 200 is operatively connected to the base section 200, and the second end 204 of each spring element 202 is operatively connected to the atrial dome 300. When implanted, each spring element 200 is preferably inelastically compressed, so that the spring elements 200 each exert a force tending to separate the atrial dome 300 from the base section 200, thereby seeking to increase the distance D3 therebetween to ultimately return the spring to its uncompressed and unstretched equilibrium position. Thus, the distance D3 between the atrial dome 300 and the base section 200 when implanted is less than the distance D3 between the atrial dome 300 and the base section 200 when not implanted and expanded (and in some embodiments, when not implanted and deflated). These forces are then transmitted between the atrial dome 300 and the upper surface of the atrial chamber and between the base section 200 and the upper surface of the annulus and / or the bottom of the atrial chamber and, in some embodiments, against the wall tissue of the atrial chamber.

[0069] The spring elements 202 are further preferably implanted in a compressed state that maintains a certain degree of compression of the spring elements 202, such that the natural mounting and expansion state within the atrial chamber includes a generally upward and downward (axial) biasing force set based on the plurality of spring elements 200.

[0070] The spring element 202 can be an elastic or superelastic material such as shape memory, e.g., nitinol, polymers, etc. Alternatively, the spring element 202 can include a shock absorber configuration (mechanical or gas compressed) or any structure that allows inelastic compression to store energy in order to provide a constant biasing force tending to separate the atrial dome 300 and the base section 200, and to press the atrial dome 300 and the base section 200 into the tissue of the atrial chamber when implanted with the spring element 202 in an inelastically compressed state.

[0071] The biasing force generated by the spring element in combination with the general complementary structural configuration between various aspects of the device 10 (e.g., the outer surface 104 and the lower surface 106 of the base segment and / or the atrial dome 300), as well as the contour of the atrial chamber (e.g., the upper annular surface of the atrial chamber, the atrial chamber bottom, and / or the wall) allows the anchoring structure to remain in place within the left atrium, and at least the base segment 100 does not rotate or translate. Additionally, in various embodiments, the spring element 202 can in particular become at least partially endothelialized within the atrial wall tissue over time to provide additional anchoring support. This arrangement also allows for a bendable, generally axial translation of the atrial dome 300 relative to the base segment 100, and the spring element 202 will allow a degree of compliant bending of the intermediate spring-like segment 200 in multiple radial directions, such that the implanted artificial valve can move with or conform to the natural movement of the heart.

[0072] Alternatively, as Figure 7 shown, multiple spring elements 200 can be provided in combination (possibly alternately) with a rigid wire 208 having little or no expansion or contraction characteristics, and can be disposed between the base segment 100 (in some embodiments, on the upper surface 108 of the base segment 100) and the outer surface 302 of the atrial dome 300 (e.g., wire boundary). This configuration can provide an upward expansion force bias to the structure while also tending to prevent a generally downward deflection or compression of the atrial dome 300 relative to the base segment 100. Alternatively, multiple only rigid wires 208 can be connected between the base segment 100 (in some embodiments, on the upper surface 108 of the base segment 100) and the outer surface 302 of the atrial dome 300 (e.g., wire boundary). These rigid wires 208 can also become endothelialized over time, with the atrial chamber tissue providing additional anchoring support.

[0073] Compared to embodiments having only spring members, this arrangement can also allow for firm anchoring within the left atrium while allowing a degree of axial bending of the atrial dome 300 relative to the base segment 100 as well as the bending compliance of the intermediate spring-like segment 200, although to a lesser extent or more controlled degree.

[0074] As shown, the second end of the spring element is operatively connected to the outer surface of the dome structure. The dome (e.g., atrial dome) can be formed by a wire boundary having a diameter and connected to the second element of the spring element, and can include any closed geometric shape, such as circular, elliptical, triangular, polygonal. The dome can include a diameter or maximum distance D4 across the dome structure, which is preferably less than the diameter of the upper surface of the base.

[0075] One scenario can include across the diameter or maximum distance of the dome structure, which is equal to the diameter of the central cylinder disposed within the base support. In this case, multiple support lines or struts (rigid or spring-like, or a combination thereof arranged in an alternating manner perhaps) can be operatively connected to the central cylinder and the line boundaries that define the dome structure in a generally vertically aligned manner to provide further axial force and / or support, thereby concentrating the axial expansion force in a relatively small area on the top surface of the chamber, but where the force is not concentrated at a single point. Instead, in the case of an open structure, the axial expansion force is distributed around the outer surface of the dome structure. Additionally, in some closed structure configurations (e.g., where the material inside the dome is not non-compliant or rigid like in a molded dome), the axial expansion force is also distributed throughout the internal material itself, which in turn presses against the top of the chamber in contact. In the case of a molded dome, line boundaries may or may not be required. When not required, the necessary connections are made directly to the molded material.

[0076] The atrial dome 300 can further include an open structure, i.e., there is no internal material on the inner portion of the line boundary, or as shown, can be closed, i.e., the internal material covers the inner portion of the line boundary, e.g., tissue, fabric, etc. The atrial dome 300 can include a flexible compliant line boundary, or can be rigid. In the case of a closed structure, the atrial dome 300 can further include a flexible compliant line boundary that incorporates a flexible internal material. Alternatively, the dome can include a rigid compliant line boundary that incorporates a flexible internal material or a rigid internal material in a closed structure. Alternatively, the closed structure embodiments of the dome can include a molded piece of the shape shown, or can include a circumferential lip surface that extends downward from the surface of the dome. The molded embodiments provide additional axial deflection / compression protection for the device.

[0077] The spring element is shown in Figure 6 and Figure 7 to generally conform to the shape of the wall of the chamber, the spring element having a generally arched concave profile with a slightly inward angle α, and a rigid line member (when present) with a slightly inward angle α', where angle α' can be equal to or different from angle α. Alternatively, as Figure 10 shown, the spring element 202 and the rigid line (when a rigid line is present) can be provided with a shorter length to achieve an inward angled orientation of angle α between the upper surface of the base section 100 and the outer surface of the atrial dome 300 (e.g., the line boundary), so as to further maximize the atrial force transfer from the biased spring element 202 and the pressure and friction fit of the device within the chamber. When a rigid line is present, they can also be angled at angle α', where angle α' can be equal to angle α, or can be different from angle α. Generally, the angles α, α' in the Figure 10 structure will be greater than inFigure 6 and Figure 7 the angles α, α' of the structures in Figure 7 are sharper.

[0078] Additionally, the basal segment 100 contacts or may extend to the upper annular surface and provides a radially expanding force to achieve additional pressure and a friction fit against the chamber surface.

[0079] Figure 11 Another alternative embodiment is shown, where the spring element 202 and the rigid wire (when present) employ a concentration of axial force in a relatively small area to maximize the pressure and friction fit achieved upon expansion. Thus, the spring element 202 and the rigid wire (when present) are approximately 90 degrees relative to the basal segment 100, which also includes a valve segment 400 as in other embodiments. Accordingly, the axial force concentration is directly transmitted to the atrial dome 300 and is distributed around it when the dome 300 is in an open configuration, and also through the atrial dome 300 when the atrial dome 300 is covered or tethered with transverse members such as struts and especially when the covering is a molded material. This axial force concentration is maximized when the support struts are angled in a substantially straight connection from the basal stent to the circumference of the atrial dome.

[0080] Each embodiment discussed and shown herein may further include an expanded and implanted structure that does not extend into the lumen of the pulmonary artery or otherwise engage the pulmonary artery. Additionally, each embodiment may include a delivery device and a collapsed structure for delivery to a patient's heart chamber (e.g., the left atrium) that, during delivery, is not included in or does not engage at least one of the mitral valve, left ventricle, and / or pulmonary artery that includes native leaflets.

[0081] The description of the invention and its applications set forth herein is illustrative and is not intended to limit the scope of the invention. The features of the various embodiments may be combined with other embodiments within the inventive concept. Variations and modifications of the embodiments disclosed herein are possible, and those skilled in the art will appreciate the actual alternatives and equivalents of the various elements of the embodiments upon studying this patent document. These and other variations and modifications may be made to the embodiments disclosed herein without departing from the scope and spirit of the invention.

Claims

1. An apparatus for implant expansion within a cardiac chamber, the cardiac chamber being in fluid communication with an annulus including an upper annular surface and functioning native leaflets located within the annulus, the apparatus comprising: A basal segment, the basal segment including a lower surface; An atrial dome; An intermediate segment operatively attached to the basal segment and the atrial dome, and A central cylindrical valve support including a lower surface, the central cylindrical valve support being at least partially disposed within the basal segment and including at least one artificial valve leaflet operatively attached therein; Wherein, The intermediate segment includes a plurality of springs or dampers adapted to cause the intermediate segment to bend in a plurality of radial directions when the device is expanded and implanted within a heart chamber, and Wherein each of the plurality of springs or dampers defines a first end and an opposing second end, wherein the first end is operatively connected to the atrial dome and the second end is operatively connected to the basal segment, and each of the directly adjacent springs or dampers among the plurality of springs or dampers is separated from each other and not directly interconnected, Wherein the lower surface of the central cylindrical valve support extends below the lower surface of the basal segment.

2. The apparatus according to claim 1, wherein, The at least one artificial valve leaflet is attached at the lower surface of the central cylindrical valve support.

3. The apparatus according to claim 1, wherein, The at least one artificial valve leaflet is attached at a point above the lower surface of the central cylindrical valve support.

4. The apparatus according to claim 1, wherein, The heart chamber is the left atrium and the native leaflets are mitral valve leaflets.

5. The apparatus according to claim 1, wherein, The expanded and implanted device does not include a structural junction that is present within or engages the native leaflets.

6. The apparatus according to claim 4, wherein, The expanded and implanted device does not include a structure that is present within or engages one or more of the group consisting of: mitral valve leaflets, left ventricle, and pulmonary artery.

7. The apparatus according to claim 1, wherein, The atrial dome includes a wire boundary.

8. The apparatus according to claim 7, wherein, The atrial dome includes an open structure defined by the wire boundary.

9. The apparatus according to claim 1, wherein, The atrial dome includes a covering structure defined by the wire boundary.

10. The apparatus according to claim 1, wherein, The intermediate segment includes one or more wires operatively connected between the basal segment and the atrial dome.

11. An apparatus for implant expansion within a cardiac chamber, the cardiac chamber being in fluid communication with an annulus including an upper annular surface and functioning native leaflets located within the annulus, the apparatus comprising: A basal segment, the basal segment including a lower surface; An atrial dome; An intermediate segment operatively attached to the basal segment and the atrial dome, and A central cylindrical valve support including a lower surface, the central cylindrical valve support being at least partially disposed within the basal segment and including at least one artificial valve leaflet operatively attached therein; Wherein, The intermediate segment includes a plurality of springs or dampers adapted to cause the intermediate segment to bend in a plurality of radial directions when the device is expanded and implanted within a heart chamber, and Wherein each of the plurality of springs or dampers defines a first end and an opposing second end, wherein the first end is operatively connected to the atrial dome and the second end is operatively connected to the basal segment, and each of the directly adjacent springs or dampers among the plurality of springs or dampers is separated from each other and not directly interconnected, Wherein the lower surface of the central cylindrical valve support does not extend beyond the lower surface of the basal segment.

12. The apparatus according to claim 11, wherein,The at least one artificial valve leaflet is attached at the lower surface of the central cylindrical valve support.

13. The device according to claim 11, wherein, The at least one artificial valve leaflet is attached at a point above the lower surface of the central cylindrical valve support.

14. The device according to claim 11, wherein, The heart chamber is the left atrium, and the native leaflet is the mitral valve leaflet.

15. The device according to claim 11, wherein, The device, when expanded and implanted, does not include a structural junction that is present within or engages with the native leaflet.

16. The device according to claim 14, wherein, The device, when expanded and implanted, does not include a structure that is present in or engages with one or more of the group consisting of: mitral valve leaflets, left ventricle, and pulmonary artery.

17. The device according to claim 11, wherein, The atrial dome includes a line boundary.

18. The device according to claim 17, wherein, The atrial dome includes an open structure defined by the line boundary.

19. The device according to claim 11, wherein, The atrial dome includes a covering structure defined by the line boundary.

20. The device according to claim 11, wherein, The intermediate section includes one or more lines operatively connected between the basal section and the atrial dome.

21. A device for dilating an implant within a cardiac chamber, the cardiac chamber being in fluid communication with an annulus including an upper annular surface and an autologous leaflet located within the annulus and having a function, the device comprising: A basal section, the basal section including a lower surface; An atrial dome; An intermediate section, which is operatively attached to the basal section and the atrial dome, and A central cylindrical valve support including a lower surface, the central cylindrical valve support being at least partially disposed within the basal section and including at least one artificial valve leaflet operatively attached therein; wherein, the intermediate section includes a plurality of springs or dampers, and when the device is expanded and implanted within the heart chamber, the plurality of springs or dampers are adapted to cause the intermediate section to bend in a plurality of radial directions, and wherein each of the plurality of springs or dampers defines a first end and an opposite second end, wherein the first end is operatively connected to the atrial dome and the second end is operatively connected to the basal section, and each of the directly adjacent springs or dampers among the plurality of springs or dampers is separated from each other and not directly interconnected, wherein the lower surface of the central cylindrical valve support is disposed above the lower surface of the basal section.

22. The device according to claim 21, wherein, The at least one artificial valve leaflet is attached at the lower surface of the central cylindrical valve support.

23. The device according to claim 21, wherein, The at least one artificial valve leaflet is attached at a point above the lower surface of the central cylindrical valve support.

24. The device according to claim 21, wherein, The heart chamber is the left atrium, and the native leaflet is the mitral valve leaflet.

25. The device according to claim 21, wherein, The device, when expanded and implanted, does not include a structural junction that is present within or engages with the native leaflet.

26. The device according to claim 24, wherein, The device, when expanded and implanted, does not include a structure that is present in or engages with one or more of the group consisting of: mitral valve leaflets, left ventricle, and pulmonary artery.

27. The device according to claim 21, wherein, The atrial dome includes a line boundary.

28. The device according to claim 27, wherein, The atrial dome includes an open structure defined by the line boundary.

29. The device according to claim 21, wherein, The atrial dome includes a covering structure defined by the line boundary.

30. The device according to claim 21, wherein, The intermediate section includes one or more lines operatively connected between the basal section and the atrial dome.

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