Transcatheter valve leaflet replacement devices, delivery, guidance and fixation systems and methods

Abstract

A transcatheter heart valve leaflet replacement system includes a valve prosthesis and a multi-stage multi-lumen (MSML) heart valve delivery and implantation system for guiding and implanting the prosthesis into a native valve annulus. The prosthesis includes a stent frame including an upper atrial flared portion and a lower ventricular portion, a plurality of prosthesis leaflets, and at least one skirt portion. The prosthesis is configurable or otherwise dimensionable to fit within the MSML delivery and implantation system and subsequently selectively expanded to an operational size and position after being deployed within the annulus. Portions of the prosthesis can be configured to couple with a dual guide and fixation (DGF) member to guide and secure the prosthesis to the annulus. In one aspect, the MSML delivery and implantation system includes a main docking system, a DGF member delivery system, and a valve containment, positioning, and locking system.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of co-pending U.S. Provisional Application Serial No. 62 / 988,253, filed March 11, 2020, and is a partial continuation of co-pending Application Serial No. 15 / 453,518, filed March 8, 2017, which claims the benefits of U.S. Provisional Application Serial Nos. 62 / 305,204, filed March 8, 2016; 62 / 413,693, filed October 27, 2016; and 62 / 305,204, filed November 29, 2016. The benefit of application 427,551, and a partial continuation of co-pending application serial number 17 / 121,615 filed on December 14, 2020, which is a continuation of international application PCT / US2019 / 037476 filed on June 17, 2019, which claims the benefit of U.S. provisional application 62 / 685,378 filed on June 15, 2018, the disclosure of which (including the description and drawings) is incorporated herein by reference in its entirety. Technical Field

[0003] This application generally relates to heart valve replacement systems and transcatheter implantation of prosthetic heart valves, for example, for replacing diseased mitral and / or tricuspid valves in humans or animals. More specifically, embodiments of this subject matter relate to tissue-based leaflet replacement systems and methods for operatively delivering and securing leaflet replacement valves to their target locations. Background Technology

[0004] The mitral valve (MV) is located between the left atrium (LA) and left ventricle (LV) of the human heart and is typically composed of the mitral annulus (MA), two leaflets, chordae tendineae (“chordaes”), two papillary muscles, and left ventricular myocardium. The mitral annulus is further divided into anterior and posterior portions.

[0005] When the mitral valve closes, the corresponding anterior and posterior leaflets come into close contact to form a single, juxtaposed region. As those skilled in the art will understand, normal MV function involves proper force balance, with each component working in concert during the cardiac cycle. Pathological changes affecting any component of the MV, such as cord rupture, annular dilation, papillary muscle displacement, leaflet calcification, and myxoma disease, can lead to altered MV function and cause mitral regurgitation (MR).

[0006] Mitral regurgitation is a dysfunction of the mitral valve that causes an abnormal leakage of blood from the LV back into the left atrium during cardiac systole (i.e., the cardiac cycle phase in which blood moves from the LV to the aorta).

[0007] Current treatments for MV disease include surgical repair and MV replacement, with more recent advancements including transcatheter repair and replacement of the MV.

[0008] The challenges associated with effective MV replacement devices generally include operational delivery challenges; positioning and fixation challenges; sealing and paravalvular leakage challenges; and hemodynamic functional challenges, such as left ventricular outflow tract (LVOT) obstruction.

[0009] Regarding the reported operational delivery challenges, it is more difficult to fold and compress the larger mitral valve prosthesis into the catheter for deployment and to retrieve it via conventional transapical or transfemoral delivery techniques because the standard mitral valve prosthesis is larger than the standard aortic prosthesis.

[0010] Turning to the challenges of positioning and implantation, given that the mitral valve is subjected to high and repetitive loads under the conditions of high transvalvular pressure gradients and the dynamic motion of the beating heart during the cardiac cycle, instability and migration are the most significant obstacles.

[0011] Regarding sealing and paravalvular leakage, due to the large mitral annulus, a good fit between the natural annulus and the prosthesis is desirable, minimizing paravalvular leakage. Generally, prosthetic mitral valves may have a large, overhanging atrial portion or flare to prevent leakage; however, the problem is that a large valve size is also required at the ventricular level so that the prosthesis can fit snugly into the natural mitral valve. Conventionally, the prosthetic mitral valve is smaller than the diseased natural valve, and additional material is added around the prosthetic valve to compensate for the large natural mitral annulus. Undesirably, adding more material to the prosthetic valve increases the size of the delivery system and may cause valvular thrombosis.

[0012] Some current transcatheter delivery systems utilize the folded structure of the replacement valve stent to capture and grip the natural leaflets and annulus, thereby anchoring the replacement valve. Such methods are often subject to device displacement—instability and / or migration of the implant due to insufficient interaction forces between the implant and the natural tissue, or excessive interaction forces that cause damage (e.g., tearing) and / or remodeling (e.g., elongation, reshaping) of the natural tissue.

[0013] Finally, regarding the preservation of hemodynamic function, as described above, the operative positioning of a conventional large prosthetic mitral valve device should not obstruct the LVOT at the anterior mitral annulus and should not interfere with the natural aorta and / or related structures of the mitral valve.

[0014] Therefore, it would be beneficial to have a heart valve leaflet replacement device and delivery and implantation system that does not suffer from the shortcomings and defects of current systems. It is desirable to fix the prosthetic mitral valve replacement system to the natural mitral valve annulus. It is also desirable to improve the positioning of the mitral valve prosthesis, avoid LVOT obstruction, and prevent blood leakage between the mitral valve prosthesis and the natural mitral valve. Furthermore, other desired features and characteristics will become apparent from the following detailed description and appended claims, in conjunction with the accompanying drawings and the foregoing technical and background information. Summary of the Invention

[0015] This document describes a heart valve leaflet replacement system, including a heart valve leaflet replacement device (e.g., a prosthetic mitral valve replacement device) and a multi-stage, multi-lumen (MSML) heart valve delivery and implantation system for guiding and securing the heart valve leaflet replacement device to one or more natural mitral annulus. On one hand, the MSML heart valve delivery and implantation system can be configured to guide and secure a mitral valve replacement device to a natural mitral annulus. On the other hand, the MSML heart valve delivery and implantation system can be configured to guide and secure a prosthetic tricuspid valve replacement device to a natural tricuspid annulus. For clarity, it will be understood that this disclosure focuses on the delivery and implantation of a valve leaflet replacement device for treating functional and degenerative mitral regurgitation; however, it is understood that the valve leaflet replacement device, MSML delivery and implantation system, and related methods can also be used or otherwise configured for treating other valvular disease conditions and replacing other valves in the human heart, or can be used or otherwise configured for use in other mammals or animals with valvular defects.

[0016] On one hand, a heart valve leaflet replacement system may include a heart valve leaflet replacement device, or prosthesis, which is configurable or otherwise sizing-adaptable to fit within an MSML delivery and implantation system and subsequently selectively expanded to an operative size and position after removal from the MSML delivery and implantation system within the heart. In other aspects, at least a portion of the prosthesis may include a stent having an upper atrial flaring portion and a lower ventricular portion. On one hand, the atrial flaring portion may be configured to couple with multiple dual guide and fixation (DGF) members to guide and fix the stent onto the valve annulus, which may help prevent post-implantation paravalvular leakage and prosthesis displacement. The lower ventricular portion of the prosthesis may displace a portion of the natural leaflet into the blood flow channel and receive at least one prosthetic leaflet. On the other hand, the heart valve leaflet replacement device may include a lining skirt that may be coupled to at least a portion of the inner and / or outer surfaces of the stent. Optionally, the outer surface of the stent may be configured with additional skirt material to prevent paravalvular leakage. In one exemplary aspect, at least one prosthetic leaflet may be mounted on the inner lumen of the stent and / or at least a portion of the outer side of the stent, which may replace at least one natural leaflet to restore normal valve function, such as preventing mitral regurgitation.

[0017] In an exemplary embodiment, the MSML delivery system can be configured to implant a heart valve leaflet replacement system in a two-step procedure. In step 1, multiple DGF components are implanted into the natural annulus of the diseased valve. In step 2, a prosthetic heart valve leaflet replacement device is implanted and secured in place at the appropriate location on the implanted DGF components.

[0018] It will be apparent to those skilled in the art that various other prosthetic valve replacement devices, whether hemivalve or total valve, circular or non-circular in shape, can be delivered and implanted using the MSML delivery method described in this disclosure.

[0019] On the one hand, several desired delivery access routes can be employed for the delivery of the prosthesis, such as, but not limited to, minimally invasive surgery, transseptal, or transatrial approaches. In one exemplary aspect, the transseptal approach may include creating an opening in the internal jugular or femoral vein to allow subsequent minimally invasive delivery of portions of the heart valve leaflet replacement device or prosthesis through the superior or inferior vena cava flowing into the right atrium of the heart. In this exemplary aspect, the access path of the transseptal approach traverses the interatrial septum of the heart, and once completed, components of the heart valve leaflet replacement device can be operatively positioned in the left atrium, the natural mitral valve, and the left ventricle.

[0020] On the one hand, MSML delivery and implantation systems may include a master docking / guidance system, a DGF component delivery system, and a valve receiving, positioning, and locking system (VHPL).

[0021] In one exemplary aspect, the VHPL may include a guide sheath, multiple locking catheters, a stent retainer sheath, and a valve chamber sheath.

[0022] On the one hand, it takes into account that the main docking sheath can be placed within the access path to allow the desired components of the heart valve leaflet replacement system to be operatively positioned within the left atrium without complications.

[0023] In one aspect, a component of a heart valve leaflet replacement device may include a DGF member, which can be operatively positioned and implanted in the desired location within the natural mitral annulus prior to prosthesis delivery. In this aspect, the DGF member guides subsequent precise positioning and fixation of the prosthesis. In other aspects, multiple DGF members help prevent blood leakage between the operatively positioned prosthesis and the natural mitral annulus. In another aspect, the DGF member may be configured with a removable component and a permanent component, wherein the removable component helps guide the heart valve leaflet replacement device to an operative position and is then removed from the patient's body after the prosthesis has been fixed, while the permanent component remains in the patient's body to maintain the heart valve leaflet replacement device fixed to the natural annulus.

[0024] In one exemplary aspect, the DGF member may include multiple segments, such as a head member, a body member, and a tail member. On one hand, the DGF head member is operatively insertable and embedded in the valve annulus tissue. On another hand, the DGF body member may be configured with a DGF locking member to secure the heart valve leaflet replacement device to the natural mitral valve annulus. On yet another hand, the DGF body member may be configured to engage with a catheter, drill the DGF head member into the tissue, and disengage from the catheter to leave the entire DGF member permanently implanted in the valve annulus. The DGF member is designed to be removable and repositionable. On one hand, the DGF tail member may be configured as a flexible component extending from a proximal portion of the DGF body to the proximal end of the MSML system. Optionally, the DGF tail may be configured to be selectively removable, allowing it to be removed from the body upon completion of the heart valve leaflet replacement system implantation procedure.

[0025] Those skilled in the art will understand that during the procedure, the patient's heart is beating and the valve annulus tissue is moving, making it difficult to: 1) engage the valve annulus tissue; and 2) maintain the correct positioning of the DGF delivery system throughout the implantation of the DGF member. Under such conditions, having a stabilizing component can be considered necessary. In this respect, the DGF head member may be configured with a stabilizer component, such as a concentric needle within the DGF head member, for stabilizing the DGF member and the DGF member delivery mechanism during implantation. On the other hand, the stabilizer component may be configured with other mechanisms for engaging and / or disengaging from the tissue, such as vacuum aspiration, clamping and release mechanisms, or other mechanisms attributable to changes caused by electromagnetic or thermal fields.

[0026] On one hand, the DGF main component can be configured with a prosthetic valve fixation mechanism including multiple DGF locking components. On the other hand, the DGF locking components can be configured to engage the prosthetic valve to fix it in the operating position.

[0027] In an exemplary aspect, the DGF locking member can be configured to be attached to the DGF body member via a flexible member.

[0028] The DGF locking member can be configured to engage the DGF tail member.

[0029] On one hand, the prosthesis can be configured to engage the DGF locking member via multiple through-holes in the atrial diaphragm portion of the stent frame. In this aspect, the DGF tail member can be a tether, configured such that one end of the tether is attached to the DGF body member, while the other end is detached from the body. The tether can then be inserted through a hole in the atrial diaphragm portion of the stent, allowing the prosthesis to be delivered onto the DGF tail member and the atrial diaphragm portion of the stent to be precisely delivered to the DGF body member embedded in the valve annulus.

[0030] On the one hand, the positioning of such DGF components is not random. The spacing of the DGF components on the valve annulus should closely match the spacing of the through holes on the prosthesis stent to ensure accurate positioning and placement of the prosthesis within the posterior valve annulus.

[0031] On the other hand, the two sets of DGF components can be deployed separately. In this aspect, the initial set of DGF components can be implanted near the commissure of the natural valve and in the middle of the posterior annulus. This set of DGF components will guide the precise positioning and deployment of the prosthesis. After valve deployment, the second set of DGF components can be implanted directly on top of the deployed prosthesis. Alternatively, the second set of DGF components can be deployed on top of the flared segment of the prosthesis stent. The technician will understand that with the additional DGF component implanted in the posterior annulus, the gap between the prosthesis and the natural annulus is smaller, thereby preventing paravalvular leakage and eventual prosthesis valve rupture.

[0032] On one hand, the DGF locking member can be configured such that it can be selectively compressed to a diameter smaller than the diameter of the hole in the atrial flare portion of the stent, allowing it to pass through the hole, and then selectively re-expanded to its original size to a diameter larger than the diameter of the hole in the flare portion of the stent, to prevent the DGF locking member from moving in the opposite direction through the hole.

[0033] In one exemplary aspect, the DGF locking member may be configured with a plurality of radially compressible legs, for example, formed in a tapered shape, wherein the proximal tip (terminus) of the tapered shape has a diameter smaller than the hole in the atrial diaphragm of the stent, and the distal base of the tapered shape has a diameter larger than the hole in the atrial diaphragm of the stent. In operation, the DGF tail can be tensioned to pull the proximal tip of the DGF locking member into the hole in the atrial diaphragm of the stent, and radially compressed as the locking member leg contacts the edge of the hole to allow the DGF locking member to be fully pulled through the hole. After the locking member has fully passed through the stent, the DGF locking member leg can be re-expanded to its full size to prevent the DGF locking member from reversing through the hole in the atrial stent diaphragm.

[0034] On one hand, the VHPL system may include a guide sheath that fits within the lumen of the docking sheath and can accommodate all other VHPL system components. In one exemplary aspect, the guide sheath may be configured with a separator at its distal tip that organizes all the inner tubing and prevents the DGF tail and locking catheter from becoming entangled or overlapping.

[0035] On the other hand, the entire guide sheath can be configured with multiple lumens to organize the inner tube. In one exemplary aspect, the separator may have four lumens: a central lumen surrounded by three outer lumens. A stent retainer sheath may pass through the central lumen of the separator, and a locking catheter may pass through each of the three outer lumens.

[0036] On one hand, a VHPL may include a valve chamber. In this aspect, the heart valve leaflet replacement device may be folded down to fit within a valve chamber distal to the VHPL system, and subsequently selectively expanded to an operational size and positioned after removal from the valve chamber of the VHPL system.

[0037] On one hand, the stent retainer can be configured to fit within the valve chamber and facilitate the release of the prosthetic valve. In this aspect, the stent retainer can be configured to attach to the distal tip of a stent retainer sheath extending proximally to the VHPL system, such that the position of the stent retainer within the valve chamber can be controlled by manipulating the stent retainer sheath proximally to the VHPL system.

[0038] On the one hand, the valvular chamber sheath can be configured to be either maneuverable or non-maneuverable to fit within the lumen of a stent retainer sheath. The valvular chamber sheath can optionally be configured as a tube or a solid rod.

[0039] In one exemplary aspect, the stent can be folded onto a stent retainer sheath proximal to the stent retainer and loaded into the valve chamber. The prosthesis can then be released from the valve chamber by distally advancing the valve chamber sheath while maintaining the stent retainer in position. The stent retainer prevents distal movement of the prosthesis, and as the valve chamber moves distally, the prosthetic valve is released from the valve chamber—initiating proximally to the prosthetic valve and terminating distally.

[0040] In one exemplary aspect, three DGF head members may first be implanted in the valve annulus: one at the medial commissure, one at the lateral commissure, and one in the center of the posterior valve annulus. A slit in the valve chamber is aligned with the holes on the medial, lateral, and central edges of the atrial flare portion of the folded prosthetic valve, respectively, allowing the trailing DGF tail to be easily fed through the corresponding atrial flare hole and then through the corresponding locking catheter in the valve receiving, positioning, and locking system.

[0041] On one hand, the VHPL system can be inserted into the patient's body, and the DGF tail can be tensioned to guide the valve chamber, and thus the prosthetic valve, to the operating position at the previously implanted DGF head member. Once in the appropriate position at the mitral annulus, the valve chamber sheath can be advanced to begin releasing the prosthetic valve at the atrial dilatation and continue until the entire ventricular portion of the prosthetic valve has been released.

[0042] On one hand, to achieve better positioning of the heart valve leaflet replacement system, one or more sheaths within the MSML delivery system can be configured to be deflectable and / or maneuverable. Further in this aspect, it is conceivable that the heart valve leaflet replacement system can be implanted into the mitral annulus via a transfemoral, transseptal procedure. In this way, the docking sheath can be inserted into the femoral vein, advanced into the inferior vena cava, and then engaged to bend the distal tip from the inferior vena cava through the transseptal puncture site at the fossa ovalis to obtain access to the left atrium. The VHPL system can be inserted through the docking sheath and advanced into the left atrium. The stent retainer and valve chamber sheath can be advanced, and the stent retainer sheath can be engaged to bend the stent retainer sheath tip toward the left ventricle and position the valve chamber at the center of the mitral annulus orifice.

[0043] On the one hand, before the folded prosthesis is fully released from the valve chamber, the prosthesis can be fixed in place at one or more implanted DGF head components by tensioning the corresponding DGF tail and engaging the corresponding DGF locking device with the prosthesis.

[0044] On the one hand, the VHPL system can be configured with a suture tensioning mechanism that can be operated to tension the DGF tail individually or optionally to tension multiple DGF tails simultaneously to guide the positioning and locking of the heart valve replacement system.

[0045] On the one hand, after valve deployment, multiple locking catheters can be advanced distally to the atrial dilatation portion against the stent, while simultaneously tensioning the DGF tail to engage the DGF locking mechanism with the prosthesis.

[0046] On one hand, the locking catheter is configured to be flexible and can bend along with other steerable sheaths during prosthesis locking. On the other hand, the inner diameter of the distal tip of the locking catheter is larger than that of the DGF locking member, allowing it to pass over the DGF locking member. In this aspect, the locking catheter is pushed against the atrial dilatation portion of the prosthesis until the DGF locking member is pulled through the atrial dilatation opening.

[0047] On one hand, the lower ventricular portion of the stent can be configured to selectively engage the VHPL system, enabling the prosthesis to be guided, positioned, and secured in a highly controlled manner. In one exemplary aspect, the stent retainer can be configured with a recess having a shape complementary to a protrusion on the lower ventricular portion of the stent frame, such that the protrusion adapts to the recess of the stent retainer, and the recess serves to hold the protrusion of the stent frame against the inner wall of the valve chamber until the valve chamber is advanced distally to expose the protruding recess.

[0048] On one hand, the lower ventricular portion of the stent frame may be configured with a protrusion at the tip of an extension member that is longer than the rest of the stent, such that the protrusion is the lowest point of the stent during operation. In one exemplary aspect, the stent frame may be configured to resemble a stingray in shape, wherein the extension member resembles a stingray tail that can extend longer than the body of the stent frame, and the tip of the extension member may be configured to engage with a stent retainer. On the other hand, the lower ventricular portion of the stent frame may be configured with multiple protrusions or holes, or other engaging members, at the tips of multiple extension members that are longer than the rest of the stent. The engaging members are operable to engage with complementary engaging members such as recesses or protrusions on a stent retainer or stent retainer sheath.

[0049] In an optional aspect, the prosthesis can be released from the valve chamber, with only the extension member protruding and engaging in the stent retainer, allowing the prosthesis to fully expand within the mitral annulus. A locking catheter can be advanced and the DGF tail can be tensioned to lock the prosthesis in place at the implanted DGF member while maintaining the stent protrusion engaged in the stent retainer. Those skilled in the art will understand that once the prosthesis is released, without a mechanism to hold it in place, blood pressure in the left ventricle may cause undesirable migration of the prosthesis. The safety of the delivery and implantation process is significantly improved by including a mechanism that restrains the prosthesis within the valve chamber until it is secured by the DGF locking member. This mechanism can be implemented using a variety of engagement members that allow for partial engagement and disengagement of the prosthesis valve device from the VHPL system during prosthesis valve deployment.

[0050] On one hand, considering that if any paravalvular leak or instability exists in the operating position after the deployment of the prosthetic valve and DGF locking member, multiple additional DGF members can be deployed on top of the prosthetic leaflet assembly using a DGF delivery system. Each of these additional DGF members' DGF head members is driven through the skirt material on the atrial diaphragm portion of the prosthesis and embedded in the muscular annulus tissue until the main body of the DGF body member is flush with the atrial diaphragm portion of the prosthesis. In this aspect, no additional fixation mechanism, i.e., a locking member, is required on the DGF body member.

[0051] Considering that after the implantation of the heart valve leaflet replacement system, all components of the MSML delivery system can be removed, and the septal closure device can be inserted through the docking sheath to close the hole in the atrial septum, the entire MSML delivery system can then be removed from the body.

[0052] The various embodiments described in this disclosure may include additional systems, methods, features, and advantages that are not necessarily explicitly disclosed herein but will be apparent to those skilled in the art upon review of the following detailed description and accompanying drawings. All such systems, methods, features, and advantages are intended to be included within this disclosure and protected by the appended claims. Attached Figure Description

[0053] A better understanding of the features and advantages of this subject matter will be obtained by referring to the following detailed description of exemplary embodiments and the accompanying drawings. Features and components are illustrated in the following drawings to emphasize the general principles of this disclosure. For consistency and clarity, corresponding features and components throughout the drawings can be specified by matching reference characters.

[0054] Figures 1A-1D Schematic diagrams of different prosthetic valves. Figure 1AA front view of a stent frame for a prosthetic valve is shown, illustrating an atrial flare portion characterized by multiple through-holes and a lower ventricular portion characterized by an elongated member with protrusions. Figure 1B A side view of the stent frame for a prosthetic valve is shown. Figure 1C An example of a frontal view of a prosthetic valve is shown, displaying its three leaflets. Figure 1D A side view of the leaflet attached to the prosthetic valve stent is shown, illustrating the forked structure of the middle leaflet attached to the surface of the internal stent.

[0055] Figures 2A-2C An exemplary aspect of the DGF component is shown. Figure 2A Examples of the components of a DGF component are provided. Figure 2B A top view of the DGF head component is shown as an example. Figure 2C The DGF locking member and its components are illustrated.

[0056] Figure 3A and Figure 3B This is a schematic diagram of a bracket that is fixed in place by multiple DGF components. Figure 3A It is a side view showing the atrial flare portion of the stent sandwiched between the DGF head and the DGF locking member. Figure 3B The locations of three DGF components along the flared portion of the prosthetic valve stent are illustrated.

[0057] Figure 4 This is a schematic diagram depicting one aspect of the implantation of an additional DGF component, without the DGF locking component, in the atrial dilatation portion of the stent.

[0058] Figure 5 It is a schematic diagram of the docking system and the valve receiving, positioning and locking system installed on the angled base.

[0059] Figure 6 This is a schematic diagram of a valve receiving, positioning, and locking system catheter, in which the valve chamber is attached to the distal segment, followed by a stent retainer mounted on a maneuverable stent retainer sheath, and multiple locking catheters; all are housed within a guide sheath and separated by a separator.

[0060] Figure 7 It is a three-dimensional view of the valve chamber attached to the distal end of the valve chamber sheath.

[0061] Figures 8A-8D The paper illustrates a heart valve leaflet replacement system and the steps for loading, releasing, and locking the prosthetic valve. Figure 8A The image shows a prosthetic valve (only the stent is shown for visual clarity) being loaded into the valve chamber. Figure 8B It shows how to release a prosthetic valve by advancing the valve chamber distally. Figure 8CThe image shows the prosthetic valve being stabilized in the valve chamber during the mechanism locking process, with the locking catheter being guided from the tail of the DGF component (not shown) to the DGF component (not shown) on the flank segment of the prosthetic valve and locking the prosthetic valve in place. Figure 8D The prosthesis was shown to be secured at the first three DGF components, and the entire valve receiving, positioning, and locking system could be removed. Detailed Implementation

[0062] The invention can be more readily understood by referring to the following detailed description, examples, drawings, and claims, as well as their preceding and following description. However, before disclosing and describing the apparatus, system, and / or method, it should be understood that, unless otherwise specified, the invention is not limited to the specific apparatus, system, and / or method disclosed, and therefore, variations are naturally possible. It should also be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0063] The following description is provided as an example to teach about apparatus, systems, and methods. Therefore, those skilled in the art will recognize and understand that various changes can be made to the various aspects described herein while still obtaining the beneficial results of the invention. It will also be apparent that certain desired benefits of the inventive embodiments herein can be obtained by selecting some of the features without utilizing others.

[0064] Therefore, those skilled in the art will recognize that various modifications and adaptations are possible, and in some cases even desirable and part of this invention. Thus, the following description is provided as an illustration of the principles of the invention, and not as a limitation thereof.

[0065] For clarity, it will be understood that this disclosure will focus on the treatment of functional mitral regurgitation; however, it is taken into consideration that heart valve leaflet replacement systems and related methods may also be used or otherwise configured to treat other types of mitral regurgitation or to replace other diseased valves of the human heart, such as the tricuspid valve, or may also be used or otherwise configured for other mammals that also have valvular defects.

[0066] As used throughout the text, the singular forms “a,” “one,” and “the / that” include plural references unless the context explicitly indicates otherwise. Thus, for example, unless the context explicitly indicates otherwise, a reference to “one leaf” may include two or more such leaves.

[0067] A range in this text may be expressed as from “about” one particular value and / or to “about” another particular value. When such a range is expressed, the other side includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation using the antecedent “about,” it will be understood that the particular value forms the other side. It will also be further understood that the endpoints of each range are significant both relative to and independent of the other endpoint.

[0068] As used herein, the terms “optional” or “optionally” mean that an event or situation described below may or may not occur, and the description includes both cases in which the event or situation occurs and cases in which it does not occur.

[0069] As used herein, the word “or” refers to any single member of a particular list, and also includes any combination of members of that list. Furthermore, it should be noted that conditional language, such as “can,” “may,” “possibly,” or “may,” unless explicitly stated otherwise or understood differently in the context, is generally intended to convey that certain aspects include certain functions, elements, and / or steps, while others do not. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are necessary in any way for one or more particular aspects, or that one or more particular aspects necessarily include logic for determining (with or without author input or prompting) whether such features, elements, and / or steps are included or will be performed in any particular implementation.

[0070] Components that can be used to perform the disclosed methods and systems are disclosed herein. These and other components are disclosed herein, and it should be understood that while specific references to every various individual and group combination and arrangement of these components cannot be explicitly disclosed, each is specifically considered and described herein for all methods and systems. This applies to all aspects of this application, including but not limited to the steps in the disclosed methods. Therefore, if multiple additional steps are possible to be performed, it should be understood that each of these additional steps can be performed using any specific implementation or combination of implementations of the disclosed methods.

[0071] The method and system can be more easily understood by referring to the following detailed description of preferred embodiments.

[0072] Throughout the description, the terms “prosthetic valve” and “prosthesis” and “valve stent” and “heart valve leaflet replacement device” and “valve device” are used interchangeably and are considered as heart valve replacement devices described herein.

[0073] Throughout the description, the terms "far side" and "proximal side" are used in relation to the operator during the use of the delivery system. "Far side" indicates that the part of the equipment is far from the operator, or in a direction away from the operator, while "proximal side" indicates that the part of the equipment is close to the operator, or in a direction towards the operator.

[0074] Those skilled in the art will understand the complexity of transcatheter methods and systems for successfully deploying prosthetic valves into the heart. Such methods involve multiple components and multiple steps. Although these components and steps are described in different sections of the description, it should be understood that these components and steps do not necessarily need to be used and performed in the order described herein.

[0075] The heart valve replacement system described herein can be used in conjunction with any heart valve replacement device or prosthesis. It is understood that the heart valve replacement system described herein includes a range of systems capable of simultaneously delivering a prosthetic valve 2 into the heart of a patient.

[0076] On one hand, heart valve replacement systems include multi-level multi-chamber (MSML) delivery systems configured to deliver a heart valve replacement device or prosthesis 2 to the implantation site or natural mitral annulus. Such systems may include dual-guided and fixed (DGF) delivery systems and valve containment, positioning, and locking (VHPL) systems. On the other hand, the DGF delivery system described herein is configured to implant multiple DGF components within the natural annulus and facilitates the guidance and fixation of the prosthesis valve to the targeted implantation site. On the other hand, a novel VHPL system can be configured to contain and organize multiple DGF component tails, folded prosthesis valves, and can be designed to progressively release the folded prosthesis valves and fix the prosthesis valve at the implanted DGF components via a DGF body fixation mechanism.

[0077] On one hand, the MSML delivery system can access the mitral valve: via the inferior vena cava, into the right atrium, across the interatrial septum to the left atrium, and then downwards to engage the natural mitral valve annulus. The MSML delivery system can also be navigated to the implantation site via the superior vena cava, following the same previously described path as toward the natural mitral valve annulus.

[0078] refer to Figures 1A-1DOn one hand, the crescent-shaped stent 3 of the MSML delivery system may include an atrial dilatation portion 4, a ventricular portion 5, and a neck portion 6. On the other hand, the atrial dilatation portion 4, the ventricular portion 5, and the neck portion 6 are continuously attached to form a single body. At least a portion of the atrial dilatation portion 4 and / or a portion of the ventricular portion 5 may be configured to be self-expandable or balloon-expandable to a desired operating position. In this aspect, it is considered that the stent 3 can be conventionally laser-cut or braided into a desired shape, which may be radially collapsible and expandable. Therefore, it is further considered that the stent 3 may include a plurality of operatively connected components to form an expandable mesh or non-mesh body, which may be made of: metallic or polymeric materials or biologically derived materials, including but not limited to cobalt-chromium alloys, stainless steel; or metals with inherent shape memory properties, including but not limited to nitinol. Optionally, it is considered that the stent 3 may include a plurality of vertical rigid structures connected by compliant materials such as biological tissue, synthetic materials such as polymers, and the like. The stent 3 can be configured to allow natural dynamic movement of any remaining natural leaflets (one or more) to align with the prosthetic leaflets (one or more) 10.

[0079] On one hand, when implanted, the atrial dilatation portion 4 of the stent 3 is configured to be positioned on and / or above the natural valve annulus. In this aspect, the atrial dilatation portion 4 of the stent 3 can be configured to facilitate fixation and sealing of the prosthesis 2, which helps prevent paravalvular leakage and post-implantation displacement. The mitral valve annulus is asymmetrical. The atrial dilatation portion 4 of the prosthesis 2 can be configured to cover or drape over the posterior portion of the mitral valve annulus, which is divided into three leaflets, namely P1, P2, and P3. On one hand, the atrial dilatation portion 41 can span two commissures, namely the anterior AC commissure and the posterior PC commissure. On the other hand, the atrial dilatation portion 4 can include an anterior atrial dilatation portion and a posterior atrial dilatation portion, such that when operatively positioned, it covers the entire circumference of the mitral valve.

[0080] On the one hand, such as Figure 1A-Figure 1B As depicted, at least a portion of the atrial dilatation portion 4 has a bend 14. In this aspect, the bend may be an upward curve away from the heart chamber wall to prevent excessive expansion of the heart chamber, which could lead to deep penetration of heart tissue. In other aspects, the orientation of the upward curve is between approximately 90 and 120 degrees (90-120°) from the atrial dilatation portion 4. In still other aspects, the bend 14 is only at the unit struts of the atrial dilatation portion 4, thus not interfering with or distorting the circular shape of the through-hole 9 in the atrial dilatation portion 4.

[0081] On the other hand, at least a portion of the atrial dilatation portion 4 is configured to have a plurality of through holes 9 for selectively engaging the DGF member 101. On one hand, the through holes 9 may be designed in a circular shape to connect unit supports and form bridge connections with adjacent units. The through holes 9 may be designed at each bridge connection of the atrial dilatation portion 4. On the other hand, the through holes 9 may be designed at fewer locations than the total number of bridge connections in the atrial dilatation portion 4.

[0082] On the one hand, the entire circumference of the ventricular portion 5 of the stent can bend towards the left ventricular wall. (Reference) Figure 1B The bending angle 15 relative to the atrial dilatation portion 4 of the stent 3 can be between 60 and 120 degrees (60-120°).

[0083] refer to Figure 1A and Figure 1B On one hand, the support 3 is provided with an extension member 7. On the other hand, the extension member 7 can be configured as a straight section. On the other hand, the extension member 7 can be configured with a short extension length and a protrusion 8 that is continuously connected to the straight section at the distal end.

[0084] On the one hand, the protrusion 8 can be configured to have a wider width than the rest of the extension member 7.

[0085] In one exemplary aspect, at least one extension member 7 may be designed at the center of the distal portion of the ventricular portion 5 of the stent. In this aspect, in the operating position, the extension member 7 is the longest segment of the stent 3, extending furthest into the left ventricle. In this aspect, the extension member 7 is approximately 2 to 7 millimeters (2 to 7 mm) longer than the other portions of the stent 3.

[0086] In an exemplary aspect, and as such Figure 1B As depicted, the extension member 7 can be configured to bend radially inward to avoid interfering with the posterior wall of the ventricle during operation.

[0087] In an optional aspect, the extension member 7 may be located in other sections along the circumference of the ventricular portion 5 of the stent. In an exemplary aspect, reference is made to... Figure 1A The extension member 7 may extend from one or more lower units of the ventricular portion 5 of the stent 3.

[0088] refer to Figure 1A On one hand, the protrusion 8 of the extension member 7 is configured to retain the prosthesis during release from the VHPL system to prevent accidental migration before the DGF fixation mechanism can be engaged. In this aspect, the (VHPL) system 1 is selectively designed to attach to the protrusion 8 of the extension member 7 until the prosthesis is secured to the targeted implantation site. After the prosthesis 2 is fully secured in the implantation site, the protrusion 8 can be selectively released from the (VHPL) system 1 to disengage the prosthesis 2 from the (VHPL) system 1.

[0089] On one hand, the protrusion 8 is configured with a dome, circle, square, rectangle, triangle or irregular shape. On the other hand, the protrusion 8 is configured with at least one through hole.

[0090] On the one hand, such as Figure 1C and Figure 1D As depicted, at least one prosthetic leaflet 10 is mounted on the inner surface of the ventricular portion 5 of the stent 3. In other aspects, at least one of the prosthetic leaflets 10 has a different shape. Furthermore, at least one fork structure 11 of the at least one prosthetic leaflet 10 includes a plurality of fork structures 11. It is considered that at least one fork structure 11 is coupled to the free edge of the leaflet.

[0091] In one aspect of the MSML delivery system, the prosthetic leaflet 10 can be configured in shape to resemble the natural mitral valve leaflet.

[0092] Considering that at least one prosthetic leaflet 10 and at least one forked structure 11 can be configured using a single, flat, flexible material such as biological tissue, polymer material, or fabric, and can be attached to the stent 3 in such a way that it creates a 3D dome-shaped structure bulging radially inward from the stent attachment point. The prosthetic leaflet 10 can be configured to be movable during the cardiac cycle, wherein the prosthetic leaflet 10 moves closer to the inner surface of the stent during diastole and further away from the inner surface of the stent during systole.

[0093] refer to Figure 1C In one aspect, at least one prosthetic leaflet 10 may include three leaflets: two smaller lateral leaflets and a large central leaflet, forming three distinct dome-shaped structures extending radially from the inner surface of the ventricular portion 5 of the stent 3. In this aspect, the three leaflets may be configured to span the circumference of the lower ventricular portion of the stent. The prosthetic leaflets 10 may be tightly fitted together on the inner surface of the stent 3 to prevent transvalvular leakage during operation. Furthermore, in this aspect, the leaflets may be configured to bulge radially inward from the stent 3 such that they are positioned in a blood flow path during operation and can close the mitral valve orifice under systolic blood pressure.

[0094] In one exemplary aspect, such as Figures 1C-1DAs shown, the smaller lateral leaflets can be asymmetrical, with shorter lengths on the lateral edges corresponding to the shape of the lower ventricular portion 5 of the stent 3. On the other hand, the larger central leaflet can have a symmetrical shape and two forked structures 11 extending from the free edge of the leaflet. Furthermore, in this aspect, the free ends of the forks 11 can be attached to portions of the stent 3, for example, by sewing the ends of the forks 11 to the stent via through-holes 12 in the lower ventricular portion 5 of the stent 3. In this aspect, the forked structures 11 prevent excessive bulging and prolapse of the large central leaflet and also help to distribute stress evenly within the prosthetic leaflet 10, which is important for durability. Optionally, one or more forked structures 11 can be added to the lateral leaflets.

[0095] refer to Figure 5 The MSML delivery and implantation system may include a docking system 326, a DGF component delivery system, and a VHPL system 1, which may be mounted on a handle platform 301 to facilitate the delivery process. The handle platform 301 is mounted on a base 324.

[0096] On the one hand, the base 324 is characterized by a mechanism that allows for angle adjustment of the MSML system to optimally access the body's access site. The base 324 can be made of, but is not limited to, rigid materials such as metals, plastics, and other similar materials.

[0097] On one hand, the docking system 326 includes a docking sheath 327 and a docking handle. The docking sheath 327 can first be inserted into the body through the guide sheath. In one exemplary aspect, the docking sheath 327 can be configured to be deflectable to access the implantation site. In this aspect, the distal end of the docking sheath 327 can be configured to bend up to 180 degrees relative to the proximal end of the sheath.

[0098] After docking system 326 is in place, the DGF system can be guided. In this respect, multiple DGF components 101 (e.g., as shown in FIG. 2) can be delivered and implanted sequentially or simultaneously at the desired location on the valve annulus.

[0099] In other respects, it is considered that the method of implanting the DGF component 101 can be performed before the delivery of the prosthesis 2.

[0100] refer to Figure 2A On the one hand, the DGF component 101 may include a DGF head component 102, a DGF body component 103, a DGF locking component 105, and a tether 114, which is intended to be permanently implanted in the mitral valve annulus.

[0101] On the other hand, after delivery and fixation of the prosthesis 2, an additional DGF component 101A can be implanted. In this aspect, the DGF component 101A may be configured with a DGF head component 102, a DGF body component 103, and a DGF tether 114 forming a loop.

[0102] On the one hand, such as Figure 2B As shown, the DGF component 101 is configured with: a head portion 102 that engages tissue on or around the valve annulus; and a body portion 103 having an adapter 109 that engages the DGF delivery catheter.

[0103] It is also considered that the DGF head member 102 can be configured to be implanted into the natural valve annulus tissue and resist separation after implantation. In an exemplary aspect, the DGF head member 102 may have, but is not limited to, a helical shape, a coil shape, a fork shape, a screw shape, and a barbed hook shape, which engages the valve annulus tissue. The DGF head member 102 may be formed of, but is not limited to, nitinol, stainless steel, cobalt-chromium alloys, polymers, etc.

[0104] In one exemplary aspect, the DGF head member 102 is configured with a coil 108 having a length between about four and ten millimeters (4-10 mm) and a diameter between about two and five millimeters (2-5 mm), formed of wire with a diameter between 0.25 and one millimeter (0.25-1.0 mm).

[0105] On one hand, the DGF head member 102 may be configured with a stabilizing member 111 to facilitate controlled implantation of the DGF head member 102 into the valve annulus tissue during operation via the DGF delivery system. In one exemplary aspect, the stabilizing member 111 is configured as a straight wire with a diameter between about 0.25 and 1 mm (0.25-1.0 mm) extending axially through the center of the helix, the straight wire having a sharp tip extending about 1 to 3 mm (1-3 mm) beyond the end of the helix. In other aspects, the stabilizing member 111 may be configured as a needle with a sharp distal tip 112 extending axially beyond the DGF head member coil 108 by about 1 to 5 mm (1-5 mm). During operation, the stabilizing member 111 can be used to engage the valve annulus tissue before screwing the DGF head member 102 into the tissue, which helps prevent unintended movement of the DGF delivery system, thus allowing the DGF head member 102 to be easily implanted along the valve annulus at the desired location. Understandably, such a stabilizing member 111 can be used to engage tissue with the DGF member at a preferred implantation site and to prevent the DGF member from moving from the target location during implantation.

[0106] In other aspects, the tip 119 of the coil 108 of the DGF head member 102, such as Figure 2AFor example, it can be shaped and configured to facilitate easy penetration into the annular tissue. In one exemplary aspect, the tip 119 of the coil 108 is sharp and bent to the same pitch as the rest of the coil 108. In another exemplary aspect, the tip 119 may be straight. In yet another optional aspect, the tip 119 may have an arc length between about one and three millimeters (1-3 mm).

[0107] On the other hand, such as Figure 2B As shown, the DGF body component 103 includes a base and an extruded section 109 configured for engaging the DGF delivery catheter. In this aspect, the base and the extruded section may be a single piece. In other aspects, the extruded section 109 has a smaller outer diameter than the base, allowing engagement of the DGF delivery catheter with it.

[0108] On one hand, the extrusion section 109 includes three through holes, two of which are configured for attaching the DGF locking member 105 via a tether 114. In this aspect, the distal section of the tether 114 is secured to the DGF body via the two attachment holes 110, the middle portion of the tether 114 is configured to loop through the DGF locking member 105 in a manner that constrains the movement of the DGF locking member 105 along the tether 114, and the proximal section of the tether 114 near the DGF locking member 105 is configured with a loop.

[0109] On one hand, the DGF main body member 103, including the DGF locking member, is configured to be attached to the DGF tail member 104 via a loop near the tether 114.

[0110] On the one hand, the tether 114 can be straight, curved, a single line, a double line, or multiple lines.

[0111] On one hand, the distance between the DGF main member 103 and the DGF locking member 105 can be between about 0.4 and 1 mm (0.4-1.0 mm), such that the atrial dilatation portion 4 of the stent 3 can be tightly fitted between the DGF main member 103 and the DGF locking member 105 in the operating position. Optionally, each DGF main member 103 may include a plurality of DGF locking members 105, wherein the spacing between adjacent DGF locking members 105 can be between about 0.4 and 2 mm (0.4-2.0 mm). The DGF main member 103 and the DGF locking member 105 can be separated on the tether 114 by, for example, by tying multiple knots on the tether 114. In other aspects, if the tether 114 is made of metal or plastic, or the like, small protrusions may be welded, molded, or attached to flexible components to maintain the spacing.

[0112] On the one hand, it is considered that the tether 114 containing the DGF locking member 105 can be formed from a tether made of sewing thread, rope, thread or polymer material.

[0113] refer to Figure 2A The DGF head component 103 and the DGF body component 103 can be formed as a single part, or optionally formed by connecting different parts through one or more of welding, bonding, adhesives, or similar methods that are resistant to separation during in vivo loading. Furthermore, in this aspect, the DGF head component 103 and the DGF body component 103 can be formed of robust and biocompatible materials, enabling them to be permanently implanted in the human body and resistant to damage, such as, but not limited to, stainless steel, cobalt-chromium alloys, nitinol, non-absorbable polymers, biomaterials, and the like.

[0114] In one exemplary aspect, it is considered that the DGF locking member 105 may be configured to allow a portion of the atrial dilatation portion 4 of the stent 3, guided by the DGF tail member 104, to pass through in only one direction, and the atrial dilatation portion 4 of the stent 3 to subsequently move in the opposite direction.

[0115] On one hand, the DGF locking member 105 can be configured such that it can be selectively compressed to a diameter smaller than the diameter of the through hole 9 on the atrial dilatation portion 4 of the stent 3, allowing it to pass through the hole, and then selectively re-expanded to its original size to a diameter larger than the through hole 9 to prevent the DGF locking member 105 from moving in the opposite direction through the hole.

[0116] In one exemplary aspect, reference Figure 2C The DGF locking member 105 may be configured with a proximal portion 107 and a distal portion 106. On one hand, the locking member 105 may have an overall length between approximately 1.5 and 3.5 mm. The length of the proximal portion 107 may be between approximately 0.5 and 1.5 mm. The length of the distal portion 106 may be between approximately one and two millimeters (1.0-2.0 mm).

[0117] On one hand, the proximal portion 106 includes a tubular shape with an outer diameter ranging from about 0.5 to 1.5 mm and an inner diameter ranging from about 0.4 to 1.2 mm. On the other hand, the distal portion 106 of the DGF member 101 includes a plurality of radially compressible legs that are tapered in their original state. On the other hand, the outer diameter of the proximal portion of the locking member is smaller than the inner diameter of the through-hole 9 on the atrial flare 4 of the stent 3. Furthermore, in this aspect, the distal tip 107 of the DGF locking member 105 may be configured with a maximum fully expanded outer diameter larger than the inner diameter of the through-hole 9 on the atrial flare 4 of the stent 3, such that it cannot pass through the through-hole 9. The proximal portion 107 and the distal portion 106 of the DGF locking member 105 may be connected and continuous.

[0118] During operation, the tail 104 of the DGF member can be tensioned to pull the proximal portion 107 of the DGF locking member 105 into the through hole 9, and when the distal portion 106 of the DGF locking member contacts the edge of the through hole 9, it will radially contract, making its outer diameter smaller than the inner diameter of the through hole 9, which will allow the DGF locking member 105 to pass through the through hole 9. After the DGF locking member 105 has completely passed through the through hole 9, the distal portion 106 of the DGF can be re-expanded to its original size to prevent the DGF locking member 105 from moving backward through the through hole 9.

[0119] The DGF locking member 105 can be manufactured, for example, by laser-cutting multiple slits from a tube and then deforming these legs by bending them radially outward. In an exemplary embodiment, the width of the slits may be between about 0.3 and 0.6 mm, and the length may be between about 0.6 and 1.5 mm. A heat treatment process can be performed to form the final flared tapered geometry. The legs are designed such that they can be selectively compressed to pass through the through-hole 9, and then re-expanded and returned to their original shape after fully passing through the through-hole 9.

[0120] On the one hand, it is considered that one or more DGF locking members 105 may be formed of, but not limited to, polymers, polytetrafluoroethylene (PTFE), stainless steel, nickel-titanium and metalloid materials or combinations thereof.

[0121] On one hand, the extruded section 109 of the DGF body member 103 can be configured as a protrusion, which is shaped to fit snugly into a complementary recess within the distal tip of the DGF delivery catheter, such that when the protrusion engages with the distal DGF delivery catheter, rotation of the DGF delivery catheter in one direction will cause the DGF head member 102 to engage with the tissue, while rotation of the DGF delivery catheter in another direction will cause the DGF head member 102 to disengage from the tissue.

[0122] In an exemplary aspect, the extruded section 109 of the DGF main component 103, such as Figure 2B As shown, it can have a rounded rectangular shape, which rises about 0.5 to 2 millimeters (0.5-2mm) from the base of the DGF main body member 103.

[0123] On the one hand, such as Figure 2A As shown, the loop on the tether 114 can be configured to engage the DGF tail member 104. In one exemplary aspect, one end of the DGF member tail 104 can be inserted through the loop on the tether 114, while the two free ends of the DGF member tail 104 can extend through and out of the proximal side of the MSML delivery system.

[0124] On one hand, the tail portion 104 of the DGF component connects the DGF delivery system and the VHPL system 1. In this aspect, the tail portion 104 of the DGF component acts as a bridging element to guide the VHPL system 1 from the access site to the implantation site.

[0125] On the one hand, it is considered that after the DGF component 101 is deployed, the two free ends of the tail 104 of the DGF component can be inserted through the atrial dilatation orifice 9 of the prosthesis 2. Thus, the two free ends of the tail 104 of the DGF component can also be inserted into the VHPL system 1, allowing the tail 104 of the DGF component to be tensioned and guided towards the DGF component 101 implanted in the valve annulus when the operator pulls the free ends of the tail 104 away from the body. Further tensioning of the tail 104 of the DGF component will help secure the prosthesis to the valve annulus via the DGF locking member 105 on the DGF component 101. After device implantation, the tail 104 of the DGF component can be removed from the VHPL system and the main body by pulling one of the free ends of the tail 104 of the DGF component.

[0126] On the other hand, one end of the DGF tail component 104 can be attached to the ring, while the other end can extend from the body to the proximal side of the MSML delivery system. In this aspect, after the heart valve leaflet replacement device is implanted and fixed in place, the trailing DGF tail can be cut by conventional cutting methods or by a catheter suture cutting device.

[0127] It is considered that the DGF tail member 104 can be configured to fit within the inner conduit of the MSML delivery system and is long enough to extend from the DGF body member 103 and exit the MSML delivery system. In this respect, the DGF tail member 104 may have a diameter of about 0.1 to 0.5 mm and a length of at least about 2.5 meters.

[0128] Reference Figure 3A On the one hand, after the implantation of prosthesis 2, the atrial dilatation portion 4 of prosthesis 2 will be sandwiched between the DGF locking member 105 and the DGF main body member 103. Understandably, the spacing between the DGF locking member 105 and the DGF main body member 103 is optimized to allow for limited movement of prosthesis 2 after implantation.

[0129] Reference Figure 3B On the one hand, at least three DGF components 101 were implanted, two of which were implanted in the lateral portion of the atrial flare portion 4 of the stent 3, and one was implanted in the center of the atrial flare portion 4 of the stent 3.

[0130] In one aspect of the method using the MSML delivery system, at least three DGF members 101 are implanted in the valve annulus before the prosthesis 2 is implanted via the VHPL system 1. After implantation of the prosthesis 2, at least one additional DGF member 101A—excluding the DGF locking member 105—is implanted above the atrial dilatation portion 4 of the prosthesis 2. The DGF member 101A can penetrate the skirt material of the prosthesis and be anchored into the tissue. Alternatively, the DGF member 101A can be configured to pass through the through-hole 9 of the atrial dilatation portion 4. (Reference) Figure 4 As shown in the figure, three DGF components 101 can be implanted at the lateral sides (P1 and P3) of the atrial dilatation portion 4, and one DGF component 101 can be implanted at the center (P2) of the atrial dilatation portion 4. Additional DGF components 101A can be implanted between the DGF components 101 at positions P1 and P2, and between positions P2 and P3. By implanting additional DGF components 101A, as those skilled in the art will understand, paravalvular leakage between the prosthesis 2 and the valve annulus can be eliminated, and displacement of the prosthesis 2 can be prevented, thereby allowing normal occlusion between the prosthesis leaflet and the natural leaflet.

[0131] For clarity, the following description outlines an exemplary VHPL system 1 design for the successful delivery and fixation of a prosthesis. The shape and design of the external compartments, construction, and assemblies controlled by the VHPL system 1 can vary, as long as they perform the same general functions, such as translational or restricted movement of the sheath, tensioning of the wires or tethers, etc. Therefore, the examples shown herein are for better description and illustration, but are not limited to the specific design of any component.

[0132] refer to Figure 6 On the one hand, the VHPL system 1 may include an outer sheath 306, which contains multiple catheters and tubes that serve to deliver the prosthesis.

[0133] In one aspect, the outer sheath 306 can be a guiding sheath. In this aspect, the guiding sheath 306 can accommodate a stent retainer sheath 206 attached to the valve chamber 201, which contains the prosthetic valve in its folded stage. In this aspect, the stent retainer sheath 206 can deflect to guide and position the valve chamber 201 from the access site to the left ventricle. In this aspect, the valve chamber 201 is connected to a valve chamber sheath 203, which can slide along the lumen of the stent retainer sheath 206. In this aspect, the sliding of the valve chamber sheath 203 is the mechanism for releasing the prosthetic valve.

[0134] On one hand, the outer sheath 306 can accommodate multiple locking catheters 317. In this aspect, the locking catheters 317 and the stent retainer sheath 206 can be organized using a multi-lumen guiding sheath 306, all of which can be inserted into the body through a larger diameter docking sheath 327. During operation, the prosthetic valve 2 is guided to multiple previously implanted DGF components 101 by tracing along the DGF tail 104, the DGF tail 104 being loaded through the atrial flare orifice 9 of the folded prosthetic valve 2 and through the corresponding locking catheter 317 to reach the proximal end of the VHPL system 1.

[0135] In this respect, the valve chamber sheath 203, stent retainer sheath 206, locking catheter 317, and guide sheath 306 are configured to move independently of the docking sheath 327 to achieve proper positioning. Furthermore, the valve chamber sheath 203 and stent retainer sheath 206 are configured to move together and independently of the locking catheter 317 and guide sheath 306. For valve 2 deployment, the valve chamber sheath 203 can be advanced relative to the stent retainer sheath 206. For securing the prosthesis 2 in place, the tail 104 of the DGF component must be individually tensioned while each locking catheter 317 is individually advanced. After the prosthesis 2 is fully released and secured in place, all sheaths can be retracted together outside the patient's body.

[0136] Those skilled in the art will recognize the need for a precise and stable valve release mechanism. Therefore, the VHPL system can be mounted on the handpiece platform 301, for example, as... Figure 5 As shown. In the example shown, the handle platform 301 is located on the base 324, proximal to the docking system 326. The outermost guide sheath 306 and the associated inner sheath on the handle platform 301 are inserted into the docking sheath 327. The handle platform 301 is configured such that it allows the guide sheath 306, the stent retainer sheath 206, and the valve chamber sheath 203 to slide simultaneously a specified distance along the base 324. In other respects, the handle platform 301 is designed to prevent the guide sheath 306 from rotating throughout the valve delivery process. The handle platform 301 can be made of any rigid and durable material such as metal, plastic, and the like.

[0137] On the one hand, the guiding sheath 306 is composed of a distal portion and a proximal portion.

[0138] On the one hand, the distal portion of the guide sheath 306 may be made of a composition of materials that are flexible and conform to the curvature of the deployment path in the natural heart chamber, one of which includes a path from the inferior vena cava to the septum; while the proximal portion of the guide sheath 306 may be made of a composition of materials that are more rigid than the distal portion, with the aim of preventing buckling during delivery.

[0139] On one hand, the distal end of the guide sheath 306 may be configured with a separator 307. In this aspect, the separator 307 of the guide sheath 306 acts as an organizer to separate the inner sheath within the guide sheath 306, thereby preventing entanglement during the entire delivery of the prosthetic valve.

[0140] On one hand, the separator 307 of the guide sheath 306 is a separate component fixed to the distal portion of the guide sheath 306. On another hand, the separator 307 can be a cylindrical component with multiple lumens. On yet another hand, the separator 307 can have multiple lumens, such as four lumens, including a central lumen and three peripheral lumens surrounding the central lumen. In this aspect, the central lumen accommodates the deflectable stent retainer sheath 206, and the three peripheral lumens accommodate the locking catheter 317. As those skilled in the art can recognize, the separator 307 organizes the inner sheath within the guide sheath 306 to prevent tangling throughout the delivery of the prosthetic valve 2.

[0141] In another alternative aspect, the guide sheath 306 may be configured as a multi-cavity tube extending its entire length without additional separators 307. In this aspect, the multi-cavity guide sheath may have four cavities, one in the center and three in the periphery, and all cavities are separated by walls.

[0142] In one aspect, the bracket retainer sheath 206 is deflectable and translatable along the handle platform. In this aspect, the bracket retainer sheath 206 can be mounted on handle systems 309, 301, which allow the operator to deflect the distal portion of the bracket retainer sheath 206. In other aspects, the bracket retainer sheath 206 can be mounted on a sliding handle system.

[0143] refer to Figure 6 On one hand, the deflectable support retainer sheath 206 can be located in the central cavity of the guide sheath separator 307. On the other hand, the deflectable support retainer sheath 206 can be configured as a composite sheath comprising portions having other notable properties—such as maneuverability and kink resistance—with varying stiffness and flexibility. These properties allow the support retainer sheath 206 to deflect from 0° to 180° while maintaining its integrity and the ability to deflect the sheath contained within.

[0144] On one hand, the deflectable stent retainer sheath 206 may include three segments: a distal segment, a middle segment, and a proximal segment. In this aspect, the distal segment is a rigid, straight segment on which the prosthetic valve 2 is folded. The middle segment of the deflectable stent retainer sheath 206 is a flexible, coiled segment with the inherent ability to bend at a tight radius without kinking or damaging any sheath residing within it. The proximal portion of the deflectable stent retainer sheath 206 is a long, rigid segment that provides stability and stiffness across the entire VHPL 1. At least one traction wire is embedded within the wall of the deflectable stent retainer sheath 206. By selectively tensioning at least one traction wire, the deflection of the flexible middle segment can be controlled.

[0145] In this respect, the stent retainer 207 acts as a safety feature within the delivery system to maintain control and repositioning of the prosthetic valve before it is fully deployed and locked onto the natural mitral annulus. As the valve chamber 201 is translated distally past the stent retainer 207, the protrusion 8 on the extension member 7 of the stent 3 is released from the stent retainer 207, thereby completely releasing the prosthetic valve from the valve chamber 201.

[0146] On one hand, the distal segment of the VHPL system 1 may include a valve chamber 201 to accommodate the prosthetic valve 2 within the VHPL system 1. In this aspect, the prosthetic valve 2 may be folded down to fit within the valve chamber 201 at the distal end of the VHPL 1, and then selectively dilated to the operating size and positioned once released from the valve chamber 201.

[0147] On the one hand, refer to Figure 7 The valve chamber 201 may comprise a cylindrical or conical shape, which is closed at the distal end, and has an inner diameter of approximately six to eight millimeters (6 to 8 mm), or large enough to accommodate the folded prosthetic valve 2, and an outer diameter of approximately seven to nine millimeters (7 to 9 mm), or small enough to fit within the mating sheath. The length of the valve chamber may be configured to be greater than the length of the folded prosthetic valve 2, such that it can accommodate the entire folded prosthetic valve 2. The length of the valve chamber may be approximately twenty to fifty millimeters (20 to 50 mm).

[0148] In other respects, a smaller diameter valve chamber sheath 203 may be configured to attach a closed end to the distal end of the valve chamber 201, extending proximally to the VHPL system 1, so that the valve chamber 201 can be controlled by manipulating the valve chamber sheath 203 proximally to the VHPL system 1—that is, on the operator's side—and thus the position of the prosthetic valve 3 within the heart.

[0149] Considering that the distal end 204 of the valve chamber and the cylindrical portion of the valve chamber 201 can be made of a single solid material, or optionally of separate pieces of similar or different materials attached together in other ways, [reference needed]. Figure 6 In an optional aspect, the distal end of the valve chamber 201 may be configured with: a central lumen to facilitate attachment to the valve chamber sheath 203; and rounded edges to prevent damage to surrounding tissues during operation.

[0150] The valve chamber sheath 203 can optionally be configured as a tube or a solid rod. On one hand, the valve chamber sheath 203 can be configured with multiple segments of varying stiffness along its length. Ideally, the valve chamber sheath 203 can be configured with: a stiff distal segment within the valve chamber 201; followed by a compliant intermediate segment to allow bending and facilitate manipulation of the VHPL system 1 within the patient; and then another stiff segment proximal to provide maneuverability.

[0151] On one hand, the stent retainer 207 can be configured to fit within the valve chamber 201 with the same outer diameter as the folded prosthesis 2. The stent retainer 207 can be configured to attach to the distal tip of a smaller diameter stent retainer sheath 206 extending proximally to the VHPL system 1, such that the position of the stent retainer 207 within the valve chamber 201 can be controlled by manipulating the stent retainer sheath 206 proximally to the VHPL system 1.

[0152] On the one hand, during operation, the stent retainer 207 can be positioned distal to the folded prosthesis 2 within the valve chamber 201. Therefore, the valve chamber can be configured to have a length longer than the combined length of the stent retainer 207 and the folded prosthesis 2.

[0153] The prosthetic valve 2 is designed to be folded around the stent retainer sheath 206 proximal to the stent retainer 207 and loaded into the valve chamber 201. The valve stent 2 can then be released from the valve chamber 201 by advancing the valve chamber sheath 203 distally relative to the stent retainer 207. The stent retainer 207 will prevent distal movement of the prosthetic 2, and as the valve chamber 201 moves distally, the prosthetic 2 will be released from the valve chamber 201—initiating proximally to the valve stent 2 and terminating distally.

[0154] On the one hand, refer to Figure 6The stent retainer 207 may include a recess 208 configured to receive a protrusion 8 on the extension member 7 of the prosthetic valve stent frame 3. In operation, the protrusion 8 on the extension member 7 of the stent 3 is inserted into the recess 208 on the stent retainer 207, and the stent retainer 207 is advanced into the valve chamber 201 to clamp the protrusion 8 between the recess 208 and the inner wall of the valve chamber 201. The prosthesis 2 is folded around the stent retainer sheath 206, and the stent retainer 207 is advanced to the distal end of the valve chamber 201 to load the folded prosthesis 2 into the valve chamber 201. To release the prosthesis 2, the valve chamber sheath 203 is advanced distally while maintaining the stent retainer 207 in position. In this respect, the protrusion 8 engages with the stent retainer 207 until the valve chamber 201 is advanced sufficiently to expose the recess 208 in the stent retainer 207. Those skilled in the art will understand that the recess 208 thus acts as a safety mechanism for securing the prosthesis 2 to the VHPL system 1, allowing its positioning and manipulation within the heart to be controlled using the VHPL system 1 until it is selectively released.

[0155] On one hand, the valve chamber 201 may have a plurality of slits 205 extending axially from the proximal end of the valve chamber 201, each slit approximately one to five millimeters (1-5 mm) long. The slits 205 may be positioned on the valve chamber 201 to align with the holes 9 on the flared portion of the folded stent 3, such that after the DGF member 101 is implanted, the tail of the trailing DGF member 104 can be inserted through the slits 205 of the valve chamber 201. The slits 205 may be designed to correspond to the number and position of the implanted DGF members 101.

[0156] In one exemplary aspect, three DGF head members 102 may first be implanted in the valve annulus: one at the medial commissure representing position P3, one at the lateral commissure representing position P1, and one at the center of the posterior valve annulus representing position P2. The slit 205 is positioned circumferentially along the valve chamber 201 to align with the holes 9 on the medial, lateral, and central edges of the flared portion of the folded prosthesis 2, respectively, when the folded prosthesis 2 is loaded into the valve chamber 201, allowing easy access for the tailed DGF tail 104 through the slit 205 and into the corresponding flared portion hole 9, and then through the corresponding locking catheter 317 in the VHPL system 1.

[0157] On one hand, the VHPL system 1 can be inserted into the patient's body, and the tail 104 of the DGF component can be tensioned to guide the valve chamber 201 and thus the valve stent to the operating position at the previously implanted DGF component 101. After being in the appropriate position at the mitral valve annulus, the valve chamber sheath 203 can be advanced to release the prosthesis from the atrial dilatation portion 4 and continue until the entire ventricular portion 5 of the prosthesis 2 has been released.

[0158] On one hand, when the tails 104 of the multiple DGF components are tensioned, multiple locking catheters 317 are used to prevent the prosthesis 2 from moving proximally, thereby pulling the locking member 105 on the DGF component 101 through the atrial diaphragm orifice 9 of the prosthesis 2, thus locking the prosthesis 2 into place on the natural mitral valve annulus. The locking catheters 317 are composite sheaths, which in one exemplary aspect consist of three distinct segments that facilitate fixation of the prosthesis 2. The proximal segment of the locking catheter 318 may include, but is not limited to, a long, rigid metal tube. The metal tube 318 may span a large portion of the delivery system and may function to control the translation of the locking catheter 317 through the valve receiving, positioning, and locking system handle 1. The intermediate portion of the locking catheter 319 may include a flexible material conforming to the curvature of the deployment path. The flexible portion 319 of the locking catheter 317 is capable of bending at a small radius of curvature equal to or greater than about 90 degrees (90°) to ensure locking can be achieved along all portions of the valve annulus. The flexible portion 319 may be made of, but is not limited to, metal, polymer, or rubber materials and the like, and optionally may feature a coiled structure that allows for low bending stiffness and prevents luminal wrinkling. The distal segment of the locking catheter 320 may include a metal locking insert that engages with the locking member 105 and the atrial flare portion 4 of the prosthetic valve 2 to help secure the prosthetic valve 2 to the DGF body member 103.

[0159] In one exemplary aspect, the locking conduit 317 may be attached to a handle to enable the operator to grip and facilitate the locking process.

[0160] On one hand, the suture tensioning mechanism can be configured to allow each of the DGF locking members 105 to be independently locked in place on top of the atrial dilatation portion of the valve 4. In this aspect, the tail 104 of each individual DGF member is controlled within the suture tensioning mechanism.

[0161] On one hand, the DGF tail tensioning mechanism comprises a combination of a ratchet gear and a knob. The ratchet gear includes a sprocket with pivotable teeth. A spring-loaded finger component engages the teeth of the gear. The gear teeth are uniform, and the two bevels on the teeth are symmetrical, thus allowing the teeth to move in both forward and reverse directions. The stiffness of the spring-loaded finger and the bevels on the gear teeth allow the gear to rotate in a controlled, progressive manner, and therefore allow the tail 104 of the DGF component to be tensioned in a controlled, progressive manner.

[0162] On the other hand, the gear can be configured with an asymmetrical ramp to allow rotation in one direction, thereby preventing the DGF tail member 104 from loosening during the process.

[0163] Furthermore, in describing representative embodiments, the specification may have presented methods and / or processes as specific sequences of steps. However, methods or processes should not be limited to the specific sequence of steps described herein, to the extent that they do not depend on the specific order of steps set forth herein. Other sequences of steps are also possible, as will be understood by those skilled in the art. Therefore, the specific order of steps set forth in the specification should not be construed as limiting the claims.

[0164] While the invention is susceptible to various modifications and alternative forms, specific examples have been shown in the accompanying drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather encompasses all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. A heart valve leaflet replacement delivery system for implanting a prosthetic heart valve to treat a diseased heart valve, the system comprising: A prosthetic valve comprising a stent and at least one prosthetic leaflet, the stent comprising a plurality of through-holes; A multi-stage multi-chamber (MSML) delivery system comprising a dual-guided and fixed (DGF) delivery system, a plurality of elongated DGF components, and a valve receiving, positioning, and locking (VHPL) system, wherein the dual-guided and fixed (DGF) delivery system, the plurality of elongated DGF components, and the valve receiving, positioning, and locking (VHPL) system are cooperatively configured for advancing to an operating position and for delivering and implanting the plurality of DGF components into the operating position, and for guiding, delivering, and fixing a prosthetic valve into the operating position; A DGF delivery system is configured to implant the plurality of DGF components in the natural valve annulus to help guide and fix the prosthetic valve; Each DGF component includes: a head portion configured to embed in tissue; a body portion including a fixation mechanism; and a tail portion extending from the body portion proximally to the DGF delivery system to guide prosthetic valve delivery via the plurality of vias; and A VHPL system configured to track the tail portions of multiple DGF components to a desired implantation location at a previously implanted DGF component, progressively release the prosthetic valve from a folded state, starting with the proximal portion of the prosthetic valve and moving to the distal portion of the prosthetic valve, and secure the prosthetic valve to the DGF component via the fixation mechanism, wherein the VHPL system includes: Stent retainer sheath, which carries the prosthetic valve; and A valve chamber sheath, surrounding the stent retainer sheath and including a valve chamber, wherein the entire prosthetic valve is provided in a folded delivery state within the valve chamber, the valve chamber sheath being distally advanceable relative to the stent retainer sheath to deploy the prosthetic valve, and The stent of the prosthetic valve engages with the stent retainer sheath, such that the prosthetic valve can be guided, dilated, and secured in place before selectively disengaging from the stent retainer sheath.

2. The system of claim 1, wherein each head portion is configured with a helix of length between 4 and 10 mm and diameter between 2 and 5 mm, the helix being formed of wire with a diameter between 0.25 and 1.0 mm, and wherein each DGF component further comprises a stabilizing member configured as a straight wire with a diameter between 0.25 and 1.0 mm extending axially through the center of the helix, the straight wire having a sharp tip extending 1 to 3 mm beyond the end of the helix.

3. The system of claim 2, wherein each body portion is configured to attach to a corresponding head portion and resist separation, and each body portion is configured with a plurality of engagement structures designed to engage with the DGF delivery system, and includes a plurality of channels, wherein at least one channel is configured to secure a fixing mechanism to the body portion, and at least one channel is configured to attach the stabilizing member.

4. The system of claim 1, wherein the fixation mechanism comprises at least one locking member and at least one tether; wherein the tether is configured to attach the at least one locking member to the body portion, and the at least one locking member is configured to pass through a through-hole in the prosthetic valve in only one direction.

5. The system of claim 4, wherein the at least one locking member is configured with a plurality of radially compressible legs that open outward to form a conical or dome shape.

6. The system of claim 1, wherein the VHPL system further comprises: A stent retainer, carried by the stent retainer sheath, adapted to the valve chamber and engaging the stent of the prosthetic valve, to prevent migration of the prosthetic valve during deployment and expansion within the natural valve annulus after advancement of the valve chamber sheath; Multiple locking catheters are positioned proximal to the stent retainer and extend to the proximal side of the VHPL system; and A multi-lumen guide sheath for accommodating the stent retainer sheath and locking catheter.

7. The system of claim 6, wherein the VHPL system is configured to receive a trailing tail portion of the DGF member implanted prior to valve delivery, wherein a plurality of locking catheters are positioned proximal to the folded prosthetic valve in the VHPL system.

8. The system according to any one of claims 1-7, wherein the proximal end of the VHPL system is configured with a suture tensioning mechanism to individually and selectively tension the tail portion to guide the delivery and fixation of the prosthetic valve.

9. The system of claim 6, wherein the lower flared portion of the stent of the prosthetic valve includes at least one feature configured to selectively engage the stent retainer, such that the prosthetic valve can be guided, expanded, and secured in place at the appropriate location at a plurality of DGF members before selectively disengaging the prosthetic valve from the stent retainer.

10. The system according to any one of claims 1-7, wherein each head portion is configured to be implanted through the upper flare portion of the prosthetic valve, such that after the prosthetic valve has been secured in place by a plurality of previously implanted DGF members with DGF locking members, a plurality of additional DGF members can be implanted on top of the prosthetic valve in the operating position.

11. The system of claim 1, wherein the prosthetic valve stent includes a lower flare portion configured to selectively engage the stent retainer sheath such that the prosthetic valve can be guided, dilated, and secured in place at a plurality of DGF members before selectively disengaging the prosthetic valve from the VHPL system.

12. The system of claim 11, wherein the prosthetic valve stent includes at least one elongated member extending from the lower flare portion and a protrusion at a distal tip of the elongated member, the protrusion being configured to adapt to at least one recess in a stent retainer positioned distal to the prosthetic valve in the valve chamber when the prosthetic valve is folded in the valve chamber, such that the prosthetic valve can be selectively attached to the VHPL system by placing the at least one protrusion in the at least one recess in the stent retainer and inserting the stent retainer into the valve chamber such that the protrusion is clamped between the inner wall of the valve chamber and the at least one recess in the stent retainer, and the prosthetic valve can be selectively disengaged from the VHPL system by further distally advancing the valve chamber relative to the stent retainer to expose the at least one recess in the stent retainer and releasing the protrusion.

13. The system of claim 6 or 9, wherein the prosthetic valve is folded onto the stent retainer sheath proximal to the stent retainer and loaded into the valve chamber, such that by then advancing the valve chamber sheath distally relative to the stent retainer, the stent of the prosthetic valve can subsequently be released from the valve chamber to allow the stent to expand within the natural valve annulus without being released from the stent retainer sheath.

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