Loading System and Method for a Collapsible Artificial Heart Valve Device

Abstract

A loading system for an artificial heart valve device is disclosed. A loading funnel is disposed within a watertight interior space that is at least partially filled with or fillable with a biocompatible fluid. The funnel may have a cylindrical end to which a delivery catheter is connected, the delivery catheter having a lumen that will receive a collapsed artificial heart valve device. The expanded artificial heart valve device may be placed within the funnel and pushed or pulled into the funnel, the funnel providing a predictable, reliable, and repeatable surface for collapsing the artificial heart valve device. Ultimately, the artificial heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

Description

[0001] Inventors

[0002] Jason S. Diedering, a citizen of the United States, residing in Minneapolis, Minnesota.

[0003] Saravana B. Kumar, a citizen of the United States, residing in Minnetonka, Minnesota.

[0004] Cross - Reference to Related Applications

[0005] This application claims the benefit of priority to U.S. Non - Provisional Patent Application No. 16 / 848,328, filed on April 14, 2020, entitled "LOADING SYSTEMS FOR COLLAPSIBLE PROSTHETIC HEART VALVE DEVICES AND METHODS THEREOF", and also claims the benefit of priority to U.S. Provisional Application Serial No. 62 / 833,862, filed on April 15, 2019, entitled "LOADING SYSTEMS FOR COLLAPSIBLE PROSTHETIC HEART VALVE DEVICES AND METHODS THEREOF", the entire contents of which are incorporated herein by reference.

[0006] Statement Regarding Federally Sponsored Research or Development

[0007] Not applicable Technical Field

[0008] The present invention relates to devices, systems, and features for loading stents (including but not limited to prosthetic heart valve devices) into delivery catheters. Background Art

[0009] The human heart includes four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium, and right ventricle. The four heart valves include the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. See generally Figure 1 .

[0010] The mitral valve is located between the left atrium and the left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve, thus preventing backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in the arteries that carry blood away from the heart. All of these valves are one-way valves, where the leaflets open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by the reverse blood flow to prevent blood from flowing back (retrograde) into the chamber from which it has just exited. For example, when functioning properly, the mitral valve provides a one-way valve between the left atrium and the left ventricle, opening to allow antegrade flow from the left atrium to the left ventricle and closing to prevent retrograde flow from the left ventricle to the left atrium. This retrograde flow (when present) is called mitral regurgitation or mitral valve regurgitation.

[0011] Figure 2 The relationship of the left atrium, annulus, chordae tendineae, and left ventricle with respect to the mitral valve leaflets is shown. As shown, the upper surface of the annulus forms at least a part of the bottom or lower surface of the left atrioventricular, and thus for the purposes described herein, the upper surface of the annulus is defined as marking the lower boundary of the left atrial chamber.

[0012] Due to various reasons and / or circumstances (including but not limited to disease, trauma, congenital malformations, and aging), natural heart valves may become or become dysfunctional. In the case of mitral valve failure, these types of conditions may cause the valve structure to not close properly, resulting in retrograde blood flow from the left ventricle to the left atrium. Figure 3 The blood flow of the regurgitation of an example dysfunctional mitral valve is shown.

[0013] Mitral valve regurgitation is a particular problem caused by a dysfunctional mitral valve that allows at least some retrograde blood to flow from the left atrium back into the left atrium. In some cases, the dysfunction is due to the mitral valve leaflets prolapsing into the left atrial chamber, i.e., above the upper surface of the annulus, rather than being connected or engaged to prevent retrograde flow. This backflow of blood places a volume load on the left ventricle, which may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, which vary considerably during the long-term clinical course of mitral regurgitation.

[0014] Generally, regurgitation can be a problem with natural heart valves, including the tricuspid valve, aortic valve, pulmonary valve, and mitral valve.

[0015] Accordingly, native heart valves (e.g., mitral valves) may often require functional repair and / or assistance, including partial or complete replacement. Such interventions can take several forms, including open-heart implantation of replacement heart valves and open-heart surgery. See, e.g., U.S. Patent No. 4,106,129 (Carpentier), for a highly invasive, patient-risky process that not only requires extended hospitalization but also a highly painful recovery period.

[0016] Less invasive methods and devices for replacing dysfunctional heart valves are also known and involve percutaneous access and catheter-assisted delivery of replacement valves. Most of these solutions involve replacement heart valves attached to a structural support (such as a stent known in the art or other forms of wire mesh designed to expand upon release from a delivery catheter). See, e.g., U.S. Patent No. 3,657,744 (Ersek); U.S. Patent No. 5,411,552 (Andersen). Self-expanding variants of the support stent assist in positioning the valve and maintaining the expanded device in place within a patient's heart chamber or blood vessel. This self-expanding form also presents problems when the device is not correctly positioned on the first positioning attempt and must therefore be recaptured and repositioned (which is often the case). In the case of a fully or even partially expanded device, this recapture process requires the device to be recontracted to a point that allows the operator to withdraw the contracted device back into the delivery sheath or catheter, adjust the entry position of the device, and then re-expand to the correct position by deploying the repositioned device distally out of the delivery sheath or catheter. Contracting an already expanded device is difficult because the expanded stent or wire mesh is typically designed to achieve an expanded state that also resists contractive or shrinking forces.

[0017] In addition to the open-heart surgical approaches discussed above, access to the valve of interest is achieved percutaneously via at least one of the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques.

[0018] Typically, the art has focused on systems and methods that use one of the above-known access routes, which allow for the partial delivery of a collapsible valve device, where one end of the device is released from a delivery sheath or catheter and expanded for initial positioning, and then fully released and expanded upon achieving correct positioning. See, for example, U.S. Patent Nos. 8,852,271 (Murray, III); 8,747,459 (Nguyen); 8,814,931 (Wang); 9,402,720 (Richter); 8,986,372 (Murray, III); and 9,277,991 (Salahieh); as well as U.S. Patent Publication Nos. 2015 / 0272731 (Racchini); and 2016 / 0235531 (Ciobanu).

[0019] In addition, all known artificial heart valves are designed to fully replace a native heart valve. Thus, in the case of the mitral valve, these replacement heart valves and / or anchoring or tethering structures physically extend out of the left atrial chamber and engage the annulus and / or valve leaflets. In many cases, the native leaflets are sutured against the wall of the annulus, thereby permanently eliminating all remaining function of the native valve and leaving the patient completely dependent on the replacement valve. In other cases, the anchoring structure extends into the left ventricle and can be anchored to the left ventricular wall tissue and / or the subannular surface at the top of the left ventricle. Others can include being present in or engaging the pulmonary artery.

[0020] Obviously, there will be cases where the native valve has actually lost all of its function prior to an interventional implantation procedure. In such cases, a preferred solution would include an implant that does not extend outside of, for example, the left atrium, and that is used to fully replace the native valve function. However, in many other cases, the native valve remains functional to some extent and may or may not continue to lose function after the implantation procedure. In such cases, a preferred solution includes delivering and implanting a valve device that will act both as a supplement or enhancement to the valve without damaging the native leaflets so as to maintain their function as long as the native valve leaflets are present, while also being fully capable of replacing the native function of the valve that slowly loses most or all of its function after the artificial valve implantation. SUMMARY OF THE INVENTION

[0021] During loading an artificial heart valve device into a delivery catheter for transport through a patient's vasculature in a collapsed state through the lumen of the delivery catheter to a patient's heart chamber (e.g., atrium or ventricle), the known delivery systems for artificial heart valve devices can be improved by at least reducing the loading force and minimizing the air introduced into the system. Once the collapsed artificial heart valve device is translated distally out of the lumen of the delivery catheter, it can expand from the collapsed transport configuration to an expanded working configuration.

[0022] Various embodiments of several inventions disclosed herein particularly address these problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Certain features of the heart are shown in cross-section.

[0024] Figure 2 A cross-sectional perspective view of the left side of the heart is shown.

[0025] Figure 3 A cross-sectional view of the heart is shown, which shows retrograde blood flow caused by mitral valve regurgitation compared to normal blood flow.

[0026] Figure 4 A perspective view of an embodiment of the present invention is shown.

[0027] Figure 5 A side view of an embodiment of the present invention is shown.

[0028] Figure 6A Exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention are shown.

[0029] Figure 6B Exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention are shown.

[0030] Figure 6C Exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention are shown.

[0031] Figure 6D Exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention are shown.

[0032] Figure 6E Exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention are shown.

[0033] Figure 7A A perspective view of an embodiment of the present invention is shown.

[0034] Figure 7B A cross-sectional view of an embodiment of the present invention is shown.

[0035] Figure 8 An exploded view of an embodiment of the present invention is shown.

[0036] Figure 9A Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0037] Figure 9B Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0038] Figure 9C Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0039] Figure 9D Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0040] Figure 9E Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0041] Figure 9F Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0042] Figure 10 Illustrates a perspective view of an embodiment of the present invention.

[0043] Figure 11 Illustrates an exploded view of an embodiment of the present invention.

[0044] Figure 12A Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0045] Figure 12B Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0046] Figure 12C Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0047] Figure 12D Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0048] Figure 12E Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention.

[0049] Figure 12F Illustrates exemplary method steps for loading a collapsible artificial heart valve device into the lumen of a delivery catheter according to an embodiment of the present invention. Detailed Description

[0050] Generally, various embodiments of the present invention relate to devices and methods for optimizing the loading of an artificial heart valve device, the artificial heart valve device including a collapsible and expandable frame, such as a stent or other device that can be collapsed and expanded into the lumen of a delivery catheter. The embodiments described herein optimize the delivery of the artificial heart valve device by (1) reducing the loading force during collapse and translation through the lumen of the delivery catheter; and / or (2) by reducing, minimizing, or eliminating air being introduced into the system including the artificial heart valve device and / or the lumen of the delivery catheter.

[0051] Figure 4 and Figure 5 Illustrates an embodiment of the present invention that includes a container, such as a sealable bag, that is at least partially filled with a biocompatible fluid (such as saline or other fluid). Figure 4 Illustrates an embodiment of the basic structure, while Figure 5 provides method 200, which has method steps shown in combination with Figure 4 the structure shown.

[0052] Thus, turning to Figure 4 and Figure 5 , illustrates an embodiment of a loading system 100. The loading system 100 includes a resealable container 102, such as a bag, that is adapted to contain a biocompatible fluid 104, such as saline, within it, in an interior defined by the container 102. The container may include a resealable opening 103 and a valved line or flush tube 105 to allow fluid to enter the container 102, in particular. A funnel 106 is disposed within the interior of the container (such as a bag) 102 and is submerged in the biocompatible fluid 104 contained within the container. As is known in the art, the funnel 106 includes an upper opening 110 that tapers downwardly through a conical portion 112 and terminates at a cylindrical portion 114 that is opposite the upper opening 114. Wherein, the upper opening 110 includes a radius that is larger than that of the cylindrical portion 114.

[0053] Container 102 also includes an access opening 108 into the interior of container 102. This access opening 108 may be engaged by the distal cylindrical portion and / or the conical tube portions 110, 112 of the funnel 106. The interconnection between the funnel 106 and the container 102 is generally sealed or at least partially watertight to prevent fluid from flowing out therefrom. Further alternatively, the proximal end of the delivery conduit 120 may be disposed inside the container 102, engaging the cylindrical portion 114 of the funnel and being immersed in the biocompatible fluid. The interconnection between the proximal end of the delivery conduit 120 and the container 102 and / or the funnel 106 is adapted to prevent substantial loss of the fluid 104 in the presence of the fluid 104.

[0054] Alternatively, the access opening 108 into the interior of the container may include a self-sealing material that may be pierced by the cylindrical portion 114 or the conical portion 112 of the funnel 106 or by the proximal end of the conduit 120, but self-seals to prevent fluid loss after the piercing is achieved. A valve as shown in Figure 7B may also be used.

[0055] Thus, the cylindrical portion 114 or the conical portion 112 of the funnel 106 may extend outwardly from the container 102 through the access opening 108, or the proximal end of the delivery conduit 120 may extend into the interior of the container 102 to connect with the cylindrical portion 114 of the funnel 106. In either case, a fluid connection between the cylindrical portion 112 or the conical portion 112 of the funnel 106 and the proximal end of the delivery conduit is required.

[0056] As shown, the expandable and contractible artificial heart valve device 150 is placed into the container 102 through the resealable opening 103, placed in the fluid-filled interior of the container 102, positioned in the upper opening 110 of the funnel 106, and pressed down into the conical portion 112 of the funnel, thereby contracting the heart valve device 150 in a repeatable and predictable manner and evenly distributing the loading force around the contractible frame 152 (e.g., a stent or equivalent as shown) of the device 150. This prevents highly undesirable stress on certain regions or elements of the frame 152 of the artificial heart valve device 150, including in the case of a stent, multiple individual units, and / or struts (including the outer contractible frame 152).

[0057] As shown, in some embodiments, the internal valve support 154 that supports the artificial valve leaflets therein (the leaflets are not shown but are well known to those skilled in the art) is also a structure that is contractible and expandable and can extend radially within the outer frame 152 of the artificial heart valve device. As shown, translating the device 150 into the funnel also functions to contract the internal valve support in a manner of predictable, repeatable, and evenly distributed loading forces. Eventually, the device 150 is predictably and repeatably contracted in a controlled manner until the device 150 is loaded into the lumen of the delivery catheter 120 connected to the container 102.

[0058] In addition to the above-described reduced and / or evenly distributed and predictably distributed loading forces, this embodiment eliminates the introduction of air into the system (such as the artificial heart valve device 150) and the lumen of the delivery catheter by immersion in the biocompatible fluid 104. Once immersed in the fluid 104, there is no air at the funnel 106, and only the fluid 104 and the contracting device 150 can enter the lumen of the delivery catheter.

[0059] As shown, certain embodiments of the container 102 may include a bag that includes a sealed or resealable opening 103 in the middle along its length to provide a region that is completely filled with the fluid 104, and the expanded device 150 is completely immersed within this region. The container 102 or the bag is held upright and tilted such that the access opening 108 is located on the bottom side, causing any air to rise to the top of the bag or the container 102, and the fluid 104 and the artificial heart valve device 150 are completely immersed. Thus, the immersed heart valve device 150 is controllably contracted into the cylindrical portion 114 of the funnel 106 as described above, and then the fully contracted device 150 can be translated distally towards the patient's heart chamber into the lumen of the delivery catheter 120.

[0060] During the translation of the contracted device 150, the connection of the container 102 and / or the funnel 106 to the delivery catheter 120 can be maintained in place, or after the device 150 is contracted and translated into the lumen of the delivery catheter 120, the delivery catheter 120 can be disconnected from the container 102 and / or the funnel 106.

[0061] Figures 6A - 6E A diagram of an exemplary method using the above embodiments is provided. Thus, as Figure 6AAs shown at step 202, the container (in this case a bag) 102 is set in an upright position with the access opening 108 at the bottom of the container 102. A flushing tube or line 105 that is fluidly connected to an external fluid reservoir (not shown) is connected and this allows a controlled fluid 104 to flow into the interior of the container from it through, for example, the stopcock valve shown. Alternatively, the container 102 can simply be filled through the sealable opening 103.

[0062] At Figure 6B step 204, the expanded artificial stent 150 and any associated delivery tools (such as push and / or pull wires) are introduced into the biocompatible fluid 104, for example through the sealable opening 103. The bag or container 102 can be pre-filled with the biocompatible fluid 104 (such as saline) before the expanded device 150 is introduced into the container 102, or the biocompatible fluid 104 can be filled after the device 150 is introduced into the container 102. Figure 6C Step 206 shows the introduction of the device 150 into the container, followed by filling with the biocompatible fluid.

[0063] Then, Figure 6D at step 208, the device 150 is contracted into the catheter lumen via controlled contraction through the funnel 106 structure as described above. The device 150 can be pulled out from the distal end of the catheter lumen using a detachable wire (pull wire) connected to the artificial heart valve device 150, or it can be pushed into the proximal end of the lumen of the catheter 120. If a detachable pull wire is used, it can be detached and removed from the lumen of the catheter 120 when the contracted artificial device 150 is loaded in the lumen of the delivery catheter, or the pull wire can remain in place.

[0064] Figure 6E Step 210 is shown where, after the contracted device 150 is loaded into the delivery catheter 120, the container 120 and the funnel 106 are removed from the delivery catheter 120.

[0065] Now turning to Figures 7A - 9F , another embodiment of a loading system for a collapsible artificial heart valve device is provided. The basic function behind the device is similar to the function discussed above, where a funnel-shaped device is used to provide a uniformly distributed loading force to the collapsible artificial heart valve device with great predictability, and where the contraction is done while the artificial heart valve device is immersed in the biocompatible fluid, and where the contracted device is loaded into the lumen of the delivery catheter.

[0066] Here, as shown, the expanded artificial heart valve device 150 is placed in the funnel 106', and can be connected to a pull wire that extends through the lumen of the delivery catheter 120 and extends from the proximal and distal ends of the delivery catheter 120 to allow the pull wire and the device 150 to engage at the proximal end of the delivery catheter, and such that the engagement of the pull at the distal end of the delivery catheter 120 can push the device 150 into and through the lumen of the delivery catheter 120. As seen in Figure 7B a valve can be provided in the cylindrical portion 114' or the conical portion 112' of the funnel 106' to help ensure a fluid seal before and during the loading process.

[0067] Also as shown, the proximal end of the delivery catheter 120 can be attached or engaged with the cylindrical portion 114' or the conical portion 112' of the funnel 106' to form a fluid communication between the funnel 106' and the lumen of the delivery catheter 120. These steps are shown in Figure 9A (step 302) and Figure 9B (step 304).

[0068] As Figure 9C and step 306 show, once the expanded artificial heart valve device 150 is placed in the funnel 106' as shown, the connection top 160 is connected to and covers the upper opening 110' of the funnel 106 to create a substantially watertight interior. As shown, the fluid injection line 105 can be in fluid communication with the substantially watertight interior for injecting a biocompatible fluid 104 (such as saline) into the interior so as to immerse the device 150 therein once the connection top 160 is fixed to the funnel 106'. The fixing of the connection top 160 to the upper opening 110' of the funnel 106' can be accomplished by several known methods and structures, including but not limited to threading.

[0069] As Figure 9D and step 308 show, once the substantially watertight interior is defined and formed and is at least partially filled with the biocompatible fluid 104 via the fluid supply line 105, a fluid communication is formed between the watertight interior and the lumen of the delivery catheter 120.

[0070] Now, as Figure 9E and step 310 show, the contraction of the immersed artificial heart valve device 150 can be initiated by pulling the pull wire distally. Next, as Figure 9F and step 312 show, when the contracted device 150 has reached a predetermined position in the lumen of the delivery catheter 120, the funnel 106' and the catheter 120 can be disengaged or disconnected. Additionally, at this time, the pull wire can be disconnected from and removed from the lumen of the delivery catheter 120, or the pull wire can remain attached.

[0071] Now turning to asFigures 10 - 12F An alternative embodiment of the loading system shown. The funnel 106" is arranged to be detachably engaged or connected to the delivery catheter 120. Therein, a fluid connection is formed between the inner cavities of the funnel 106" and the delivery catheter 120. As in all the foregoing embodiments, when the artificial heart device 150 is loaded therein, the inner cavity of the cylindrical or conical portion of the funnel 106" is substantially axially aligned with the inner cavity of the delivery catheter 120.

[0072] In this embodiment, as in the foregoing embodiments, the delivery catheter 120 and the funnel 106" are connected or engaged as Figure 12A shown in and step 402, and as Figure 12B shown in and step 404, the artificial heart valve device 150 is attached using, for example, a pull wire that passes through the inner cavity of the delivery catheter 120 and is adapted to hold the expanded artificial heart valve device 150 in place within the funnel 106", and to provide a distal force that forces the artificial heart valve device 150 to contract into the inner cavity of the cylindrical or conical portion of the funnel and ultimately into the inner cavity of the delivery catheter 120.

[0073] As Figure 12C shown in and step 406, once the expanded artificial heart valve device 150 is positioned within the funnel 106", the funnel can be magnetically attached to the base or cap 180. The base or cap includes an interior that is sized, shaped, and adapted to receive at least a portion of the expanded artificial device 150 therein. Also as Figure 10 shown, the top portion of the expanded device 150 is disposed within the base or cap 180. Additionally, a series of ribs or supports 182 may be provided within the base or cap 180 to support the expanded device. Therein, the ribs or supports 182 are at least partially submerged in a biocompatible fluid. In other embodiments, the ribs may be omitted. As in all the previous embodiments discussed herein, the cylindrical or conical portion of the funnel may include a valve to prevent air and / or fluid from moving into the inner cavity of the delivery catheter 120.

[0074] Moving on to Figure 12D and step 408, once the funnel 106" and the base or cap 180 are magnetically coupled together, thereby defining and creating an interior that is substantially watertight. A fluid injection line may be in fluid communication with the base or cap 180, or with the funnel, to provide a controlled injection of biocompatible fluid into the watertight interior and to fully or at least partially submerge the expanded device 150, or the base or cap 180 may simply be manually filled with fluid 104. At this point, as Figure 12EAs shown in step 410, the contraction of the artificial heart valve device 150 can be initiated by pulling the pull wire distally, thereby contracting the device 150 (and in some cases including the internal valve support) as described above into the funnel lumen and ultimately into the lumen of the delivery catheter 120 (entering after passing through the valve in the funnel lumen when there is a valve in the funnel lumen).

[0075] When the contracted artificial heart valve device 150 is in a predetermined position within the lumen of the delivery catheter 120, the artificial heart valve device is "loaded" in the delivery catheter, and the catheter 120 and the funnel 106 "can be disconnected. This is shown in Figure 12F and step 412.

[0076] In all embodiments, when the contracted artificial heart valve device is "loaded" within the lumen of the delivery catheter, the artificial heart valve device can be delivered through the patient's vasculature to the heart chamber of interest via the delivery catheter using any acceptable access route and / or delivery technique. The acceptable access routes and / or delivery techniques include, but are not limited to: transapical; transfemoral; transatrial and transseptal delivery techniques.

[0077] The description of the invention and its applications as described herein is illustrative and is not intended to limit the scope of the invention. Within the concept of the invention, the features of various embodiments can be combined with other embodiments. Variations and modifications of the embodiments disclosed herein are possible, and those of ordinary skill in the art will understand the actual alternatives and equivalents of the various elements of the embodiments when studying this patent document. These and other variations and modifications can be made to the embodiments disclosed herein without departing from the scope and spirit of the invention.

Claims

1. A loading system for an expandable and contractible artificial heart valve device, the loading system comprising: A sealable container including a self-sealing access opening at the bottom side of the sealable container and a sealable opening provided at a side portion of the sealable container and above the bottom side of the sealable container; A loading funnel including a cylindrical portion and a conical portion, including a lumen therethrough and an upper opening portion, operatively connected to the sealable container, the loading funnel extending through the self-sealing access opening at the bottom side of the sealable container; An expanded expandable and contractible artificial heart valve device disposed within the sealable container; A delivery catheter including a lumen therethrough and operatively and fluidly communicating with and engaging the cylindrical and conical portions of the loading funnel, and the delivery catheter extending through the self-sealing access opening of the container; A pull wire disposed within the lumen of the delivery catheter and attached to the expanded artificial heart valve device when disposed within the upper opening portion of the loading funnel, the pull wire adapted to pull and contract the artificial heart valve device first through the conical portion of the loading funnel, then through the cylindrical portion of the loading funnel, and subsequently into the lumen of the delivery catheter; and A fluid injection line in fluid communication with the interior of the sealable container, adapted to introduce a biocompatible fluid into the interior of the sealable container to submerge the expandable and contractible artificial heart valve device disposed therein, Wherein the expandable and contractible artificial heart valve device includes an external stent frame and an internal valve support disposed within the external stent frame, The expandable and contractible artificial heart valve device is oriented within the loading funnel such that the internal valve support enters the cylindrical portion of the valve support before the external stent frame.

2. The loading system according to claim 1, wherein, The self-sealing access opening includes a valve.

3. The loading system according to claim 1, wherein The pull wire is detachable from the artificial heart valve device.

4. The loading system according to claim 1, wherein, The loading funnel is configured to ensure that during contraction and loading of the expandable and contractible artificial heart valve device into the lumen of the delivery catheter, the loading force is evenly distributed around the artificial heart valve device.

5. A loading system for an expandable and contractible artificial heart valve device, the loading system comprising: A loading funnel adapted to hold an expandable and contractible artificial heart valve device therein and including a lumen therethrough and a self-sealing access opening included in the lumen of the loading funnel; A connection base adapted to be connected to the upper opening of the loading funnel; A magnetic coupler adapted to connect the loading funnel to the connection base to define a watertight interior; A delivery catheter including a lumen operatively connected to the loading funnel and in fluid communication with the watertight interior; A pull wire connected to the expanded expandable and contractible artificial heart valve device, the artificial heart valve device disposed within the watertight interior and adapted to be fully submerged in a biocompatible fluid; and A series of ribs, which are arranged in the connection base, and the series of ribs are configured to support the expandable and contractible artificial heart valve device when the loading funnel is connected to the connection base; Wherein, the pull wire can be removed from the artificial heart valve device and is adapted to contract and pull the artificial heart valve device through the inner cavity of the loading funnel and into the inner cavity of the delivery catheter.

6. The loading system according to claim 5, wherein, The self-sealing access opening includes a valve.

7. The loading system according to claim 5, wherein The loading funnel is configured to ensure that during the contraction and loading of the expandable and contractible artificial heart valve device into the inner cavity of the delivery catheter, the loading force is evenly distributed around the artificial heart valve device.

8. The loading system according to claim 5, wherein, The expandable and contractible artificial heart valve device includes an external stent frame and an internal valve support member disposed within the external stent frame, and the expandable and contractible artificial heart valve device is oriented in the loading funnel such that the internal valve support member enters the inner cavity of the delivery catheter after the external stent frame.

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