Delivery system for delivering a prosthetic heart valve to a native heart valve of a heart

Abstract

Disclosed herein are delivery systems for delivering a prosthetic heart valve to a native heart valve of a heart. An exemplary delivery system can include a shaft portion having at least one shaft, at least one steering wire, and at least one pull wire. The system can also include a handle portion coupled with a proximal end of the shaft portion and a capsule portion coupled with a distal end of the shaft portion. The capsule portion can be configured to house a prosthetic heart valve. At least one portion of the delivery system can be configured to engage with the prosthetic heart valve when the prosthetic heart valve is implanted in a native heart valve of a heart.

Description

Technical Field

[0001] This disclosure generally relates to implantable cardiac devices, and more particularly to delivery systems for artificial heart valves. Background Technology

[0002] Over time, delivery systems have been used to deploy implants to various parts of the body. For example, delivery systems can be used to deliver implants to the brain, ears, spine, various muscles, and more. Conventional systems are typically designed to deliver implants while attempting to minimize potential damage to the body during delivery. However, most systems are unsuccessful in minimizing such damage. Furthermore, implants can be released into the body by the delivery system, and their position cannot be adjusted or retrieved after deployment. Summary of the Invention

[0003] This disclosure provides delivery systems and methods for delivering prostheses, such as artificial heart valves. Some embodiments include methods for delivering the prosthesis into the body and / or securing the prosthesis to natural tissue, and / or removing the prosthesis from the body.

[0004] In one aspect, this disclosure features a delivery system for delivering an artificial heart valve to a natural heart valve in the heart. The system may include a shaft portion having at least one shaft, at least one steering line, and at least one traction line. The system may also include a handle portion coupled to a proximal end of the shaft portion and a sac-like portion coupled to a distal end of the shaft portion. The sac-like portion may be configured to receive the artificial heart valve. At least one portion of the delivery system may be configured to engage with the artificial heart valve when it is implanted into a natural heart valve in the heart.

[0005] Various implementations of the delivery system may include one or more of the following features.

[0006] The sac-like portion may include a tubular portion comprising an expandable frame configured to expand beyond the periphery of the tubular portion. The expandable frame includes a plurality of frame members, and one or more frame members are coupled to corresponding one or more portions of the artificial heart valve. One or more frame members include fasteners, and each fastener is configured to attach to the artificial heart valve. The delivery system may include a tube configured to maintain contact between each fastener and the artificial heart valve. At least one traction wire may be attached to the tube.

[0007] The shaft portion includes an inner shaft, and the distal portion of the inner shaft is disposed within the lumen of the tubular portion. The capsule portion may include a tapered head member coupled to the distal portion of the inner shaft. At least a portion of the tapered head member is disposed within the tubular portion. The shaft portion may include a plurality of nested shafts, and the plurality of nested shafts include an inner shaft. At least one of the plurality of nested shafts may include at least one of an inner liner or an outer liner. The tubular portion may be configured to adjust the position of the artificial heart valve relative to the handle portion. The steering line may be configured to deflect the shaft portion at an angle of up to approximately 125 degrees relative to the longitudinal axis of the handle portion. The steering line may be configured to deflect the shaft portion at an angle of up to approximately 30 degrees relative to the longitudinal axis of the handle portion.

[0008] At least one steering line may include a first steering line and a second steering line. The first steering line is configured to flex the shaft portion relative to the longitudinal axis of the handle portion in a first plane, and the second steering line is configured to flex the shaft relative to the longitudinal axis in a second plane. The proximal end of at least one traction line may be disposed within the handle portion, and the distal end of at least one traction line may be disposed within the capsule portion. The traction lines may be configured to control the release of the artificial heart valve from the delivery system. The delivery system may include at least one tether for attaching the shaft portion to the artificial heart valve.

[0009] At least one shaft may include an inner shaft disposed within the lumen of an outer shaft. The inner shaft may include at least one pin coupled to at least one filament, the outer shaft may include at least one opening, the at least one filament is configured to pass through the at least one opening, and displacement of the inner shaft within the outer shaft may disengage the at least one filament from the at least one pin. The sac-like portion may include a flexible tube configured to flex in at least one plane. The flexible tube may include a metal tube defining a first plurality of incisions along a first side and a second plurality of incisions along a second side, and the first side may be opposite to the second side. At least one portion of the delivery system may be configured to recapture the artificial heart valve. At least one portion of the delivery system may be configured to approach a natural blood vessel to deliver the artificial heart valve to the heart.

[0010] In another aspect, this disclosure is characterized by a method for delivering an artificial heart valve to a natural heart valve. The method includes: advancing the artificial heart valve through a natural blood vessel and approaching a natural heart valve via a delivery system comprising a sac-like portion that houses the artificial heart valve; and implanting the artificial heart valve into the natural heart valve such that a portion of the delivery system engages with the artificial heart valve upon implantation.

[0011] Various implementations of methods for delivering artificial heart valves may include one or more of the following features.

[0012] The method may include expanding an expandable frame of the sac-like portion, wherein the expandable frame defines space for placing the artificial heart valve. The method may maintain engagement with the artificial heart valve via one or more hooks of the expandable frame during the implantation step. The method may release the artificial heart valve from the delivery system by retracting at least one traction line of the delivery system, wherein the traction line is coupled to one or more hooks of the expandable frame. An advancing step may include orienting the sac-like portion toward the natural heart valve via at least one steering line of the delivery system. The method may include recaptured the artificial heart valve after implantation into the natural heart valve. Attached Figure Description

[0013] Non-limiting embodiments of the invention will be described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component is generally indicated by a single reference numeral. For clarity, not every component is labeled in every drawing, nor is it necessary to show every component of every embodiment of the invention, so that those skilled in the art can understand the invention without illustration. In the drawings:

[0014] Figure 1 It is a cross-sectional view of the heart, depicting the anatomy of the right side of the heart during normal physiological periods and during disease states of tricuspid regurgitation.

[0015] Figure 2 This is a cross-sectional view of the heart, showing the venous pathways leading to the right side of the heart.

[0016] Figure 3 This is a perspective view of the delivery system according to the implementation method.

[0017] Figure 4 According to the implementation method Figure 3 A cross-sectional view of the axial portion of the delivery system.

[0018] Figure 5 According to the implementation method Figure 3 A three-dimensional view of the distal end of the delivery system.

[0019] Figure 6 According to the implementation method Figure 3 A cross-sectional view of the capsule-shaped portion of the delivery system.

[0020] Figure 7A According to the implementation method Figure 3 A side view of the distal end of the third axis of the delivery system.

[0021] Figure 7B According to the implementation method Figure 3A side cross-sectional view of the distal end of the third axis of the delivery system.

[0022] Figure 7C According to the implementation method Figure 3 A three-dimensional view of the distal end of the third axis of the delivery system.

[0023] Figure 7D According to the implementation method Figure 3 A side view of the distal end of the third axis of the delivery system.

[0024] Figure 7E According to the implementation method Figure 3 A cross-sectional side view of the distal end of the third axis of the delivery system.

[0025] Figures 8A to 8B The illustration shows the implementation method. Figure 3 Two cross-sectional views of the distal ends of the second and third axes of the delivery system.

[0026] Figure 8C This is a perspective view of an artificial heart valve attached to a delivery system according to an embodiment.

[0027] Figure 8D This is a perspective view of an artificial heart valve attached to a delivery system according to an embodiment.

[0028] Figure 9 According to the implementation method Figure 3 Cross-sectional view of the distal ends of the second and third axes of the delivery system.

[0029] Figure 10 According to the implementation method Figure 3 Cross-sectional view of the distal ends of the second and third axes of the delivery system.

[0030] Figures 11A to 11B The illustration shows a configuration according to an embodiment of attaching an artificial heart valve to two filamentary elements of a delivery system.

[0031] Figure 12 According to the implementation method Figure 3 Cross-sectional view of the distal ends of the second and third axes of the delivery system.

[0032] Figures 13A to 13B According to the implementation method Figure 3 Two views of the distal end of the second axis of the delivery system.

[0033] Figure 14 This is a side view of an artificial heart valve attached to a delivery system according to an embodiment.

[0034] Figure 15This is a cross-sectional side view of a sac-like member having an open distal end in the delivery system according to an embodiment.

[0035] Figure 16 This is another top view of the sac-like member with a notched distal end of the delivery system according to the embodiment.

[0036] Figure 17 This is a side view of a delivery system according to an embodiment, having a slot at the distal end and a bladder-like component with a mating attachment.

[0037] Figure 18 This is a side view of a bladder-shaped component with an expandable support structure in a delivery system according to an embodiment.

[0038] Figure 19 This is another side view of a bladder-like member with an expandable support structure according to an embodiment of a delivery system, wherein the expandable support structure is in an open position and the bladder-like member has a lining material that contacts the inner surface of the bladder-like member.

[0039] Figure 20 It is a perspective view of a sac-like member of a delivery system according to an embodiment, having a groove originating from a first side of an axial cross-sectional plane and terminating on a second side of an axial cross-sectional plane.

[0040] Figure 21 According to the implementation method Figure 3 The delivery system is shown in a three-dimensional view of an expandable frame in a stacked configuration.

[0041] Figure 22 According to the implementation method Figure 3 The delivery system is shown in a three-dimensional view of an expandable frame in an expanded configuration.

[0042] Figure 23 According to the implementation method Figure 3 A three-dimensional view of the delivery system in a compressed configuration of an expandable frame.

[0043] Figure 24 According to the implementation method Figure 3 The delivery system is shown in a side view of an expandable frame in an expanded configuration, wherein at least one tube is configured to surround at least one arm of the expandable frame.

[0044] Figure 25 According to the implementation method Figure 3 A three-dimensional view of the sheath of the delivery system.

[0045] Figure 26 According to the implementation method Figure 3 A side cross-sectional view of the sheath of the delivery system.

[0046] Figure 27 According to the implementation method Figure 3 The delivery system is shown in a side view of an expandable frame in a stacked configuration, wherein at least one tube has an attachment member that traverses the expandable frame on the inner side and a distal post that traverses the expandable frame on the inner side.

[0047] Figures 28A to 28B This is a side cross-sectional view of an embodiment of the fasteners connecting the delivery system to the artificial heart valve according to the embodiment.

[0048] Figures 29A to 29C An artificial heart valve, according to an embodiment, is depicted attached to a delivery system that moves from an expanded configuration to a deployed configuration.

[0049] Figures 30A to 30C An artificial heart valve, according to an embodiment, is depicted attached to a delivery system that moves from a deployment configuration to an implantation configuration. Detailed Implementation

[0050] The detailed description below depicts various configurations of the subject matter and is not intended to represent only possible configurations of the subject matter. The detailed description includes specific details to provide a thorough understanding of the subject matter. Therefore, dimensions regarding certain aspects may be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid confusion with the concepts of the subject matter.

[0051] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure can be implemented in different ways and variations, and depending on the desired application or implementation.

[0052] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of this disclosure. However, it will be apparent to those skilled in the art that embodiments of this disclosure can be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure this disclosure.

[0053] Because aortic and mitral valve replacements are often the focus of device development, there is a need for solutions for tricuspid regurgitation (TR), especially since increasing evidence suggests that TR is associated with higher mortality and that TR should not be left untreated even if other heart valves have been treated.

[0054] Examples of an artificial tricuspid valve and methods for implanting such an artificial tricuspid valve can be found in International Application No. PCT / US2020 / 024765 entitled “PROSTHETICHEART VALVE”, filed on March 25, 2020, the entire contents of which are incorporated herein by reference.

[0055] The tricuspid valve is located in the atrioventricular position, on the right side of the heart, between the right atrium (RA) and right ventricle (RV). Figure 1 As shown in the figure. Figure 1 Side-view cross-sectional views of two forms 100a and 100b of a natural heart are shown. Form 100a depicts the normal anatomy of a natural heart, in which blood flows from the right atrium 102 through the tricuspid valve 104 into the right ventricle 106, and then through the pulmonary valve into the pulmonary artery. The atrioventricular septum 107 separates the right atrium 102 from the rest of the heart, such as the left atrium (LA). Form 100b depicts a natural heart with tricuspid valve regurgitation, in which blood leaks from the right ventricle 106 through the tricuspid valve 104 and into the right atrium 102. Figure 1 The image also depicts two leaflets 108 of a natural tricuspid valve 104. In form 100b, the leaflets 108 are shown having cords 110 attached to the ventricular side of the leaflets and used to control the opening of the valve 104.

[0056] While valve 104 can be surgically accessed, less invasive approaches have the potential to reduce perioperative and postoperative mortality associated with tricuspid valve surgery, and there is currently no transcatheter solution for complete tricuspid valve replacement. Transcatheter approaches to the right heart are common, and the most frequently used methods are access to the superior vena cava (SVC) via an incision in the jugular vein or to the inferior vena cava (IVC) via an incision in the femoral vein near the groin. Figure 2 As described herein. While the innovations described herein are primarily intended for the delivery of artificial heart valves to the natural tricuspid valve, innovative aspects of such delivery systems can provide relevant improvements to delivery systems intended for reaching other anatomical targets, such as any of the other three valves of the heart (i.e., the pulmonary valve, aortic valve, and mitral valve). For example, the delivery system described herein can be used as described or, with further modifications, for treating septal defects in the natural heart or for accessing the left side of the natural heart via, for example, transseptal puncture. Additionally, the term "tricuspid valve" will be used herein with reference to artificial valves primarily intended for tricuspid valve locations but also applicable to other heart valves.

[0057] Delivery system for artificial heart valves

[0058] Based on various aspects of this disclosure, a delivery system for an artificial tricuspid valve is provided herein. Figure 3 As shown, the delivery system 300 includes a distal end and a proximal end, a handle portion 302 near the proximal end, a shaft portion 304 away from the handle portion, and a sac-like portion 306 away from the shaft portion. The delivery system 300 is configured to approach a natural blood vessel, such as an IVC or SVC, enter the right atrium of a natural heart, and deliver the artificial tricuspid valve to the natural tricuspid valve of the natural heart. The delivery system 300 is also configured to flex the shaft portion of the delivery system to an angle of at least 125 degrees in a first plane. In some cases, the shaft portion 304 may flex to an angle of approximately 125 degrees (e.g., ±5 degrees, ±10 degrees, etc.). The delivery system 300 may be configured to flex the shaft portion 304 of the delivery system to an angle of at least 30 degrees in a second plane. In some cases, the shaft portion may flex to an angle of approximately 30 degrees in the second plane (e.g., ±1 degree, ±3 degrees, etc.). The delivery system 300 may be configured to increase or decrease the depth of the artificial heart valve relative to the handle portion of the delivery system.

[0059] In some embodiments, the delivery system described herein is configured to deliver an implant (e.g., an artificial heart valve, a heart valve repair device, etc.) to a location within the subject. In some embodiments, the delivery system described herein is configured to adjust the position of the implant before, during, or after deployment. In some embodiments, the delivery system described herein is configured to retrieve the implant. The delivery system described herein offers several advantages over prior implant delivery systems. For example, advantageously, the delivery system described herein can be used to deliver, adjust the position of, and / or retrieve the implant after deployment without damaging natural tissue. In one exemplary set of embodiments, as described in more detail below, the delivery system is configured to deploy the implant such that the implant attaches to the natural leaflet of a natural heart valve. Other deployments and configurations are also possible and are described in more detail below.

[0060] As used herein, "patient" or "subject" generally refers to any animal, such as a mammal (e.g., a human). Non-limiting examples of subjects include humans, non-human primates, cattle, horses, pigs, sheep, goats, dogs, cats, or rodents such as mice, rats, hamsters, birds, fish, or guinea pigs. Generally, the inventions described herein are intended for human use. However, other subjects are also possible. In some embodiments, the subject may exhibit health benefits following, for example, the implantation of the valve described herein.

[0061] Although various examples of artificial tricuspid valves constructed for replacement of natural tricuspid valves are described herein, it should be understood that the uses of artificial tricuspid valves disclosed herein can be appropriately modified to replace other natural heart valves (e.g., other atrioventricular valves) and / or can be appropriately modified in any other non-heart valve.

[0062] In some exemplary embodiments, the delivery system is configured to deploy a biodynamic artificial tricuspid valve. As referred to herein, the term "biodynamic" with respect to an artificial tricuspid valve means that the configuration of the artificial tricuspid valve allows it to remain axially stable within the natural tricuspid valve of the heart without direct attachment to the natural annulus or natural cords of the natural tricuspid valve, but allows the artificial tricuspid valve to move within the natural tricuspid valve in response to alternating pressure gradients across the natural heart valve during the cardiac cycle, thereby preserving the natural motion of the natural annulus. Specifically, the artificial tricuspid valve is axially stable within the natural tricuspid valve by gripping the natural leaflets of the natural tricuspid valve rather than by annular forces or direct annular or chordal attachments. As referred to herein, the term "axially stable" with respect to an artificial tricuspid valve located within the natural tricuspid valve means that a portion of the artificial tricuspid valve is positioned between any two diametrically opposed points on the natural annulus of the natural tricuspid valve.

[0063] In some embodiments, the artificial tricuspid valve includes one or more support structures. For example, as discussed in further detail below, in some cases, the artificial tricuspid valve may include one, two, three, or more than three support structures. In some embodiments, at least one of the one or more support structures includes a tubular portion having an atrial end and a ventricular end. In some embodiments, the tubular portion of one or more support structures defines an elongated central channel of the artificial heart valve. In some embodiments, the central axis (also referred to as the “longitudinal axis”) of the elongated central channel extends within the elongated central channel from the atrial end of the tubular portion to the ventricular end of the tubular portion. When the artificial tricuspid valve is in implantation configuration in the heart’s natural tricuspid valve, blood typically flows from the heart’s atria along the central axis of the elongated central channel through the elongated central channel of the artificial tricuspid valve to the heart’s ventricles. Furthermore, in some other embodiments, multiple leaflet elements are attached to one or more support structures and disposed within the elongated central channel to control blood flow through the elongated central channel.

[0064] In some embodiments, a ventricular arm extending from a first end of a tubular portion of one or more support structures extends into the ventricle of the heart to contact the ventricular surface of the natural leaflet, while an atrial arm extending from a second end of a tubular portion of one or more support structures opposite to the first end extends into the atrium to contact the atrial surface of the natural leaflet. Advantageously, in some embodiments, the various features of the prosthetic tricuspid valve described herein configure the valve for transcatheter implantation, repositioning, and / or removal. For example, the prosthetic tricuspid valve described herein can be easily positioned and deployed in a wide variety of patients, and such prosthetic tricuspid valves have the ability to control deployment, assess full function, and / or retain the implant for recapture and removal before full release.

[0065] In some embodiments, the delivery system 300 disclosed herein includes one or more axes. Figure 4 The diagram shows a cross-sectional view of the following embodiment: In this embodiment, the shaft portion 304 of the delivery system 300 includes a first shaft 602a, a second shaft 602b, a third shaft 602c, a fourth shaft 602d, a fifth shaft 602e, and a sixth shaft 602f (collectively referred to as 602, of which only 602f is shown), a first steering line 604a, a second steering line 604b, a third steering line 604c, a fourth steering line 604d, and a fifth steering line 604e (collectively referred to as 604), and three traction lines 606a, 606b, and 606c (collectively referred to as 606). Figure 4 In this embodiment, the first shaft 602a is located within the cavity of the second shaft 602b, the second shaft 602b is located within the cavity of the third shaft 602c, the third shaft 602c is located within the cavity of the fourth shaft 602d, the fourth shaft 602d is located within the cavity of the fifth shaft 602e, and the fifth shaft 602e is located within the cavity of the sixth shaft 602f. Figure 4 In this embodiment, the three traction lines 606 and the three steering lines 604 are located within the lumen of the sixth shaft 602f, but outside the fifth shaft 602e. Any of the shaft 602, traction lines 606, and / or steering lines 604 described herein may include an inner liner and / or an outer liner. Note that the lines used as steering and traction lines can be any type of tether or linkage, such as tethers, ropes, cables, cords, chains, etc. The inner and / or outer liners may be made of silicone, polyurethane (PU), polyethylene (PE), polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), nylon, polyether block amide (PEBA), polyamide, other polymeric materials, hydrogel materials such as silicone hydrogel, or other flexible materials.

[0066] In some embodiments, one or more of the traction line 606 or the steering line 604 may include one or more lumens, such as a central lumen. In some embodiments, one or more of the traction line 606 and / or the steering line 604 may include solid lines, strips, flat lines, elliptical lines, lines with a generally rectangular cross-section, etc. Any of the shafts may be made of a biocompatible material, preferably a metallic material such as nitinol, stainless steel, titanium, or gold.

[0067] exist Figure 4 In the illustrated embodiment, the first steering line 604a is radially positioned at approximately 180 degrees to the third steering line 604c, the second steering line 604b is radially positioned at approximately 90 degrees to both the first steering line 604a and the second steering line 604c, and the three traction lines 606 are positioned at approximately 90 degrees to both the first steering line 604b and the second steering line 604c. In other embodiments, the steering lines 604 and traction lines 606 may be positioned at different radial locations.

[0068] In some embodiments, any one of the shaft 602, traction line 606, and steering line 604 may be configured to extend from the handle portion of the delivery system through the shaft portion 304 to the capsule portion 306 of the delivery system. Each of the shaft 602, traction line 606, and steering line 604 includes a distal end and a proximal end, wherein the proximal end of the shaft 602, traction line 606, and / or steering line 604 may be located within the handle portion 302 of the delivery system, and the distal end of the shaft 602, traction line 606, and / or steering line 604 may be located within the shaft portion 304 and / or capsule portion 306 of the delivery system. Figure 4 In one embodiment, the proximal ends of the three traction wires 606 are located within the handle portion 302 of the delivery system, and the distal ends of the three traction wires 606 are located within the capsule portion 306 of the delivery system and configured to control the attachment of the delivery system to the artificial heart valve. In some embodiments, the delivery system may include fewer than three or more traction wires 606. For example, the delivery system may include six or nine traction wires 606.

[0069] exist Figure 4 In one embodiment, the distal ends of the three steering lines 604 are attached to the fifth shaft 602e and configured to be bent in the shaft portion 304 and / or the bladder portion 306 of the delivery system by traction of one or more proximal ends of the steering lines 604. Figure 4In one embodiment, the first turning line 604a and the third turning line 604c are configured to achieve a first bend in the sixth axis 602 of the delivery system along a first direction of the first plane, and a second bend in the sixth axis 602 of the delivery system along a second direction of the first plane that is substantially opposite to the first direction of the first plane. The second turning line 604b is configured to achieve a third bend in the sixth axis 602 of the delivery system along a first direction of a second plane that is substantially transverse to the first plane. Some embodiments may include fewer than three turning lines 604; for example, the delivery system may include only... Figure 4 The first turning line 604a and Figure 4 The third steering line 604c. Some embodiments may include more than three steering lines 604; for example, a fourth steering line may be included to achieve a fourth bend in the sixth axis of the delivery system along a second direction substantially opposite to the first direction of the second plane. In some embodiments, the steering lines 604 may be surrounded by a protective tube, which is expected to protect the steering lines 604 from damage, especially when the axial portion of the delivery system moves into a bent configuration. In some embodiments, the protective tube may have a coil or helical shape.

[0070] In some embodiments, the delivery system disclosed herein is configured to deliver an artificial heart valve from a coiled configuration to an expanded configuration, in which the artificial heart valve is enclosed within a sac-like portion 306 of the delivery system, and in the expanded configuration, the artificial heart valve is located outside the sac-like portion 306. The delivery system is also configured to position the artificial heart valve in a deployment configuration within a native tricuspid valve, in which the artificial heart valve engages with one or more components of the sac-like portion 306 of the delivery system. When in the deployment configuration, one or more aspects of the artificial heart valve are in direct communication with one or more aspects of the native tricuspid valve, such as one or more native leaflets, the annulus, one or more cords, or surrounding tissues of the native heart. The advantage of the delivery system described herein is the ability to maintain engagement with the artificial heart valve in the deployment configuration, which allows for assessment of the hemodynamic function of the native heart valve before disconnection and reconnection of the artificial heart valve in the native heart to an implantation configuration.

[0071] In some implementations, the delivery system is configured to position the artificial tricuspid valve from a deployment configuration to an expansion configuration, or from a deployment configuration to a coiled configuration, or from an expansion configuration to a coiled configuration. In this way, the operator of the delivery system retains the ability to completely remove the delivery system and the artificial heart valve from the body after observing a hemodynamic assessment of the artificial heart valve, which may be in the best interest of patient safety.

[0072] Figure 5A sac-like portion 306 is depicted in one embodiment, wherein the sac-like portion 306 includes: a tube 1102 configured to receive an artificial heart valve; and an expandable frame 1104 configured to fit inside the tube 1102. Figure 4 First axis 602a, Figure 4 The second shaft 602b and Figure 4 The third shaft 602c, wherein the first shaft 602a is configured to fit inside the lumen of the second shaft 602b, the second shaft 602b is configured to fit inside the third shaft 602c, and the third shaft 602c is configured to fit inside the expandable frame 1104. The bladder portion 306 also includes a tapered head member 1106, which in some embodiments is rigidly connected to the distal portion of the first shaft 602a. In some embodiments, tube 1102 may include a single lumen having a distal end, a proximal end, and an intermediate portion disposed between the distal end and the proximal end, wherein a first shaft 602a, a second shaft 602b, a third shaft 602c, and a fourth shaft 602d are configured to extend distally beyond the distal end of tube 1102 through the lumen of tube 1102, a fifth shaft 602e is configured to extend within the lumen of tube 1102 into the intermediate portion of tube 1102, and a sixth shaft 602f is configured to extend within the lumen of tube 1102 and be rigidly attached to the intermediate portion of tube 1102 such that the distal end of the sixth shaft 602f is close to the distal end of the fifth shaft 602e. In some embodiments, the distal end of the delivery system may be positioned at an angle between 70 and 90 degrees to the central axis (also referred to as the longitudinal axis) of the intermediate portion of the delivery system. In a preferred embodiment, the distal end is angled at approximately 75 degrees (e.g., ±5 degrees) to the central axis, which may be desirable for positioning the artificial heart valve within the natural tricuspid valve when approaching it via the SVC. In some embodiments, the distal end of the delivery system may be positioned at an angle between 90 and 130 degrees to the central axis of the middle portion of the delivery system. In a preferred embodiment, the distal end is angled at approximately 125 degrees (e.g., ±5 degrees) to the central axis, which may be desirable for positioning the artificial heart valve within the natural tricuspid valve when approaching it via the IVC.

[0073] In some embodiments, the bladder portion 306 further includes an inner tube 1108, which includes one or more (e.g., two or more, three or more, four or more) openings 1110. In some embodiments, the bladder portion 306 also includes a pin 1112, which is movable independently of the inner tube 1108 and disposed within the inner tube 1108. The openings and the pin are described in more detail below.

[0074] In some embodiments, the distal portion of the first axis 602a has at least one bend, which may help prevent the sac-like portion 306 of the delivery system from damaging the tissue of the natural heart or natural blood vessels, or from becoming entangled in the tissue of the natural heart or natural blood vessels. In some embodiments, the first axis 602a may be configured to deliver contrast agent to the natural heart, which may be desirable for visualizing cardiac hemodynamics using fluorescence imaging before or after implantation of a natural heart valve.

[0075] Figure 5 The tapered head member 1106 has a distal portion, an intermediate portion, and a proximal portion, wherein the distal portion has a smaller diameter than the intermediate portion, and the proximal portion has a smaller diameter than the intermediate portion. In some embodiments, the proximal portion is configured to be securely nested within the tube of the sac-like portion, such as... Figure 6 As shown. Figure 6 As shown, the maximum diameter of the middle portion is larger than the maximum diameter of the proximal portion of the tapered head member, and the diameter of the proximal portion is sized to fit snugly within the distal portion of the tube, while the maximum diameter of the middle portion is sized to approximately match the outer diameter of the distal portion of the tube. In this way, the tapered head member can be securely nested within the tube to prevent unintentional disengagement from the tube, which could otherwise expose the distal edge of the tube and potentially cause damage to natural tissues during use.

[0076] Refer again Figure 5 The tapered head member 1106 can be made of any type of flexible material such as PTFE, polyester, silicone, PU, ​​PE, PVC, PTFE, ETFE, FEP, PEBA, polyamide, or hydrogel materials. In a preferred embodiment, the tapered head member 1106 is made of urethane or polyurethane (PU). In some embodiments, the tapered head member 1106 may also include a coating, cover, liner, or film configured to increase the lubricity of the tapered head member 1106, which can facilitate insertion of the delivery system into a blood vessel passing through the body. In some embodiments, the tapered head member 1106 may also include one or more radiopaque components, for example, at the distal and / or proximal ends of the tapered head member 1106, which can be expected to facilitate easy identification of the entire length of the tapered head member 1106 using fluorescence imaging.

[0077] In some embodiments, one or more pins located at the distal end of the second axis are configured to engage one or more arms of the artificial heart valve. In some embodiments, the delivery system (e.g., via one or more pins) is configured to raise and / or lower the arms of the artificial heart valve (e.g., so that the artificial heart valve can be positioned). In an exemplary set of embodiments, the delivery system is configured to engage one or more arms of the artificial heart valve (e.g., the atrial arm group and / or ventricular arm group of the artificial heart valve) so that one or more arms can be raised or lowered. Advantageously, the delivery system described herein can be configured to raise and / or lower the arms of the artificial heart valve so that the artificial heart valve can be positioned (repositioned) into a final anchored state (e.g., attached to the natural leaflet of a natural heart valve).

[0078] In some implementation methods, such as Figures 7A to 7B In the illustrated embodiment, the second shaft 602b of the capsule portion 306 of the delivery system further includes one or more generally cylindrical pins 2302, each pin having a proximal end face and a distal end face. One or more pins may be located at the distal end of the second shaft. In some embodiments, the distal end of each of the one or more pins 2302 may extend further distally than the distal end of the second shaft. In some embodiments, one or more pins 2302 may include three pins, which may be equidistantly spaced around the periphery of the second shaft and aligned in a direction parallel to a third shaft. In some embodiments, the distal ends of the three pins 2302 may be substantially parallel. In some embodiments, one or more pins may be rigidly connected to the second shaft, for example, by welding, brazing, adhesive bonding, or other mechanical connections. In some embodiments, one or more pins and the second shaft may be formed from a single component, for example, by laser cutting, machining, electrical discharge machining (EDM), casting, extrusion, etc.

[0079] In some implementation methods, such as Figures 7C to 7E In the illustrated embodiments, the third shaft 602c includes a proximal end and a distal end. In some embodiments, the distal end of the third shaft includes one or more openings 2502. In some embodiments, the one or more openings may include three openings, which may be equidistantly spaced around the circumference of the third shaft 602c. In some embodiments, the one or more openings 2502 are located near the distal end of the third shaft 602c. In some embodiments, the shape of the third shaft 602c defines a generally rectangular shape for the one or more openings 2502; however, in other embodiments, the openings 2502 may have circular, elliptical, or other geometric shapes.

[0080] In some implementation methods, such as Figures 7C to 7EIn the embodiments depicted, the distal ends of one or more pins 2302 of the second shaft 602b are positioned further distally than the distal end of the third shaft 602c. In some embodiments, the distal end of the third shaft 602c is positioned further distally than the distal end of the second shaft.

[0081] exist Figure 8A and Figure 8B In some embodiments, the sac-like portion 306 of the delivery system may further include one or more filamentous elements 2802 having a first end and a second end, wherein the first end may be configured to attach to one or more pins 2302 of a second shaft, and the second end may be configured to attach to a portion of an artificial heart valve. Figure 8A and Figure 8B In some embodiments, one or more filamentary elements 2802 may be fed through one or more openings 2502 of the third shaft 602c. The second shaft 602b may be configured to move axially relative to the third shaft 602c such that, as the distal end of the second shaft 602b moves proximally relative to the distal end of the third shaft 602c, the distal ends of one or more pins 2302 may move further proximally than the position of one or more openings 2502 of the second shaft 602b. In this way, the relative movement of the second shaft 602b and the third shaft 602c may cause one or more filamentary elements 2802 to be released from one or more pins 2302 of the second shaft 602b. In some embodiments, the first and / or second ends of the filamentary elements 2802 may be configured to form loops, which may facilitate attachment to one or more pins 2302 or to an artificial heart valve. In some embodiments, the second axis 602b and / or the third axis 602c may be configured to prevent axial movement beyond a certain distance, for example, to prevent the second axis 602b from moving too far distally relative to the third axis 602c, which could otherwise pose a risk of damaging the artificial heart valve and / or one or more filamentary elements 2802.

[0082] Figure 9 The embodiment includes one or more filamentary elements 2802, each filamentary element 2802 including a first end, a second end, and an intermediate portion disposed between the first end and the second end, wherein the first end is attached to a portion of a second shaft and the second end is attached to one or more pins of the second shaft. The intermediate portion of the one or more filamentary elements is configured to exit a distal end of a third shaft, attach to a portion of an artificial heart valve, and pass through one or more openings in the third shaft. Figure 9In one embodiment, the first end is securely attached to the second shaft, and the second end is attached to one or more pins of the second shaft, such that when the distal end of one or more pins is further proximal than one or more openings in the third shaft, the second end can become unattached to one or more pins, for example, in Figure 8A and Figure 8B The release of one or more filamentous elements shown in the figure.

[0083] exist Figure 10 In one embodiment, a first end and a second end of one or more filamentary elements are rigidly attached to a portion of a second shaft. A middle portion of the filamentary element is configured to exit the distal end of a third shaft, attach to a portion of an artificial heart valve, and pass through one or more openings in the third shaft. The middle portion of the filamentary element is also configured to attach to one or more pins on the first shaft, such that proximal movement of the distal end of the first shaft relative to the distal end of the second shaft can cause the filamentary element to be released from one or more pins on the first shaft.

[0084] Figure 8A An embodiment of the delivery system is depicted, wherein one or more filamentary elements 2802 include nine filamentary elements having a first set of ends for attachment to an artificial heart valve and a second set of ends for attachment to pins of a second axis. In some such embodiments, a third axis includes three openings, wherein three filamentary elements are attached to each pin of the second axis, and three intermediate portions of the filamentary elements each pass through one of the openings of the third axis. The second and third axes may be configured to move axially relative to other elements of the delivery system to convert the artificial heart valve from an expansion configuration to a deployment configuration and vice versa. The second and third axes may also be configured to move axially relative to each other to convert the artificial heart valve from a deployment configuration to an implantation configuration.

[0085] Figure 8D Implementations of the delivery system are depicted, wherein one or more filamentary elements comprise six filamentary elements having a first set of ends attached to an artificial heart valve and a second set of ends attached to pins of a second axis. In some such implementations, the third axis includes three openings, wherein two filamentary elements are attached to each pin of the second axis, and two intermediate portions of the filamentary elements each pass through one of the openings of the third axis. The method of tracing the filamentary elements to pass through portions of the artificial heart valve, as shown in 8D, can advantageously reduce the number of filamentary elements required, or can advantageously reduce the time required to attach the filamentary elements to the delivery system and / or the artificial heart valve. Other implementations may include more or fewer filamentary elements and openings, wherein filamentary elements of different configurations exit through the openings.

[0086] In some implementation methods, such as Figure 11A and Figure 11B In the illustrated embodiment, the artificial heart valve may include one or more filamentous elements, each filamentous element having a first end with a first ring and a second end with a second ring. Figure 11A and Figure 11B In one embodiment, a first ring may be attached to an artificial heart valve, and a second ring may be attached to one or more pins of a second axis. The second and third axes may be operated as described above to disengage one or more second rings from one or more pins of the second axis, thereby releasing and implanting the artificial heart valve and one or more filamentary elements.

[0087] In some implementations, the artificial heart valve may have a circumferentially asymmetrical shape, which may require a different attachment-to-delivery system approach than that previously described herein. Figure 13A and Figure 13B One embodiment includes nine filamentary elements, wherein two of the filamentary elements have the same size and are shorter than the other seven filamentary elements that have the same size. In this embodiment, the filamentary elements can be included as components of a delivery system or as components of an artificial heart valve. Filamentary elements of different lengths are configured in such a way that the delivery system is attached to an artificial heart valve with anchoring members of different lengths. Figure 12 The document also depicts a capsule-like portion of the delivery system in which a second shaft comprises one or more pins of varying lengths, wherein the distal end of the first pin extends further distally than the distal ends of the second and third pins. Figure 12 In one embodiment, one or more openings on the third axis also have different axial positions; the first opening is positioned more distally than the second opening. Other embodiments may have openings with different combinations, openings at different positions circumferentially around the third axis and axially along the length of the third axis, different numbers of pins, pins of different lengths, and / or distal ends of one or more pins at different axial positions. In this way, the anchoring members of the artificial heart valve can be controlled regardless of the length or shape of each anchoring member in the anchoring structure.

[0088] Figure 13A and Figure 13B Another embodiment is depicted, in which the pins of the second axis have different axial lengths. In this embodiment, four pins are included, which may be desirable for attachment to an artificial heart valve having three anchoring members with different lengths and / or shapes and / or circumferential positions.

[0089] Figure 14 Another embodiment is depicted, in which the artificial heart valve has anchoring members of different lengths. In this embodiment, the expandable frame of the delivery system includes at least one crossbar positioned between two axial guide members of the expandable frame. This embodiment also includes one or more filamentary elements, wherein a first end of one or more filamentary elements is attached to one or more pins on a second axis of the delivery system, and a middle portion of one or more filamentary elements is configured to contact the proximal side of at least one crossbar when the attachment point of one or more filamentary elements to one or more pins is further distal than at least one crossbar member. In this way, the delivery system can be configured to balance tension in one or more filamentary elements when attached to anchoring members of different lengths of the artificial heart valve.

[0090] In some embodiments, the filamentous element has a first end with a first ring, a second end with a second ring, and an intermediate portion. The delivery system can be connected to an artificial heart valve by means of multiple filamentous elements, wherein the first end of the filamentous element is connected to the artificial heart valve, and the second end of the filamentous element is connected to a pin on a second shaft of the delivery system. In this embodiment, at least one filamentous element is also shown, wherein the second end is disengaged from the delivery system.

[0091] One or more filamentary elements (also referred to as tethers) can be made of any type of biocompatible filament, rope, thread, cable, or cord, for example, using materials such as PTFE, polyester, silicone, PU, ​​PE, PVC, PTFE, ETFE, FEP, PEBA, polyamide, hydrogel materials, nylon, stainless steel, gold, platinum, titanium, other biocompatible metals, or natural fibers such as silk. In some embodiments, one or more filamentary elements can be made of bioabsorbable materials such as Polysorb (synthetic absorbable surgical sutures) or Vicryl (Vicryl sutures). One or more filamentary elements can be made of continuous materials, such as those similar to threads or rods, or can be woven from more than one single segment of material, such as those similar to cables, cords, ropes, etc.

[0092] In some embodiments, the second or third axis may include one or more longitudinal ribs configured to allow the second or third axis to bend along a plane perpendicular to the cross-sectional plane of the one or more longitudinal ribs. This may facilitate allowing the second or third axis to flex and thus position the artificial heart valve inside the natural heart.

[0093] Figures 15 to 18Multiple embodiments of the tube comprising the capsule portion of the delivery system described herein are depicted. In some embodiments, the tube includes: a distal portion; a first rib segment including one or more longitudinal ribs adjacent to the distal portion; a first annular portion adjacent to the first rib segment; a second rib segment adjacent to the first annular portion; a second annular portion adjacent to the second rib segment; a third rib segment adjacent to the second annular portion; and a proximal end portion. In some embodiments, the first annular portion, the second annular portion, and the proximal portion include at least one opening configured to allow the inner liner and the outer liner (also not shown) of the tube to contact each other, thereby facilitating the securing of the inner liner to the outer liner. The first rib segment, the second rib segment, and the third rib segment each include one or more longitudinal ribs configured to allow these rib segments to bend along a plane perpendicular to the cross-sectional plane of the one or more longitudinal ribs, thereby positioning the artificial heart valve inside the natural heart. In some embodiments, the tube includes one, two, or more than three rib segments. In some embodiments, the tube includes one or more annular portions. In some embodiments, the distal portion further includes one or more openings. In some embodiments, either the annular portion or the proximal portion is uninterrupted in the circumferential direction, i.e., either the annular portion or the proximal portion does not include openings. In some embodiments, the axial length of each rib segment is longer than the axial length of each annular portion or the axial length of the distal or proximal end. However, in some embodiments, the axial length of one or more annular portions or the axial length of the distal or proximal end may be greater than the axial length of one or more rib segments. In some embodiments, the openings may be circular in shape, such as... Figure 16 As shown in the illustration, however, in other embodiments, the opening may have a rectangular shape, an elliptical shape, a dog bone shape, etc.

[0094] Figure 15 The embodiment depicts a cross-sectional side view of a tube including an open distal end of the delivery system, which may be intended to facilitate the artificial heart valve's entry from an expanded configuration into a coiled configuration within the inner portion of the tube. The open distal end may help reduce the forces on the delivery system as the artificial heart valve enters the tube of the sac-like portion of the delivery system, and allow the artificial heart valve to have a smaller maximum diameter when in a compressed configuration.

[0095] Figures 16 to 18Several embodiments of the distal end of the tube in the delivery system are described, the distal end being configured to have a diameter increased relative to the diameter of the rest of the tube, which may be expected to facilitate the movement of the artificial heart valve from an expanded configuration to a coiled configuration within the inner portion of the tube. In some embodiments, the distal end includes one or more protrusions separated by one or more notches. Figure 16 An embodiment of the distal end of a tube for a delivery system is depicted, wherein the distal end includes nine protrusions separated by nine notches. Figure 16 The implementation may be advantageous for use with artificial heart valves having the same number of anchoring members (e.g., nine anchoring members) configured to engage with the delivery system disclosed herein for conversion from an expanded configuration to a coiled configuration within the inner portion of the tube. In some embodiments, the delivery system has a generally sinusoidal distal end. In some embodiments, the delivery system includes a frame with a sinusoidal distal end.

[0096] Figure 17 An embodiment of the distal end of a tube in a delivery system is depicted, wherein the distal end includes one or more protrusions separated by one or more notches, each protrusion including one or more circumferential guide attachments. In this embodiment, one or more attachments are generally T-shaped and have a distal end whose axial width is greater than the axial width of the proximal ends of the one or more attachments. The one or more attachments can be configured to engage with one or more other attachments, such as... Figure 17 As shown in the figure. Figure 17 The implementation can be configured to allow one or more protrusions at the distal end of the tube to expand radially, increasing the diameter of the distal end relative to the diameter of the rest of the tube. This radial expansion is limited by the relative positions of one or more adjacent circumferential guide attachments. As the distal end of the tube expands, the undersides of the circumferential guide attachments eventually contact each other, thereby preventing further expansion of the distal end of the tube. In different implementations, the size and shape of the circumferential guide attachments can be modified as needed to allow different maximum expansion diameters at the distal end of the tube.

[0097] Figure 18Embodiments of the distal end of a tube in a delivery system are depicted, wherein the distal end includes a support. In some embodiments, the support includes one or more distal tips and one or more proximal tips, wherein one or more proximal tips are attached to the tube of the delivery system. In some embodiments, the proximal tips are directly attached to the tube at one or more proximal tips. In some embodiments, the proximal tips of the support are attached to the tube via one or more axial guide members. The tube may be configured to allow the support to expand radially such that the axial distance between one or more distal tips and one or more proximal tips decreases, and the diameter of the support increases relative to the diameter of the tube. In some embodiments, the stent includes two or more sets of distal apexes and one or more sets of proximal apexes, wherein the two or more sets of distal apexes include at least a first set of distal apexes and a second set of distal apexes, and the two or more sets of proximal apexes include at least a first set of proximal apexes and a second set of proximal apexes, wherein the first set of distal apexes is more distal than the first set of proximal apexes, the first set of proximal apexes is more distal than the second set of distal apexes, and the second set of distal apexes is more distal than the second set of proximal apexes, and so on. The number of apexes and apex sets of the stent, as well as the height, width, thickness, and shape of the stent, can be adjusted to increase or decrease the diameter of the stent during radial expansion. Figure 19 A support for the tube of a delivery system is depicted, wherein the support is in an expanded configuration. Figure 19 The text also describes a liner that can be configured to cover the inner and / or outer surfaces of the tube of the delivery system, and can be configured to expand as the support expands into an expanded configuration.

[0098] In some embodiments, the delivery system includes a generally sinusoidal distal end and a proximal end, the proximal end including one or more axially guided protrusions. In some embodiments, the tube of the delivery system may be configured with two distinct structures located at the distal and proximal ends, which is advantageous in that it allows either the distal or proximal end to be located at its furthest point relative to the delivery system, thereby reducing the number of tube components that must be kept available for testing different types of tubes.

[0099] In some embodiments, the capsule-like portion of the delivery system includes a notched distal end and an outer liner covering the outer surface of the tube. In some embodiments, the tube may also include an inner liner, which may be continuous with the outer liner. In some embodiments, the inner and outer liners may contact each other between adjacent longitudinal ribs or through any of the openings in the aforementioned tube. In some embodiments, the inner and / or outer liners may be configured to increase the stiffness of the tube of the delivery system or limit the maximum deflection of the tube. In some embodiments, the outer liner may be configured to increase the lubricity of the tube, which may be expected to facilitate access of the delivery system through natural blood vessels. In some embodiments, the inner and / or outer liners may include one or more layers. In some embodiments, the inner and / or outer liners may include one or more axial guide bands. In some embodiments, the inner and / or outer liners may include one or more radial guide bands. In some embodiments, the inner and / or outer liners may include one or more radially wound bands.

[0100] In some embodiments, the artificial heart valve is in a coiled configuration within a tube of the delivery system, wherein the tube includes a distal end that includes a stent and an outer liner.

[0101] In some embodiments, the delivery system tube includes a distal end having a circumferential guide attachment and a liner, and wherein rib sections are bent along a plane perpendicular to the cross-sectional plane of one or more longitudinal ribs.

[0102] Figure 20 An embodiment of a delivery system tube is depicted, wherein longitudinal ribs are configured to achieve a greater degree of curvature than the aforementioned tubes. In some embodiments, one or more openings may be positioned along the axial guide ridge of the tube. Figure 20 In this embodiment, one or more openings are located at the proximal end and / or distal end of the tube. One or more openings may be configured to allow the outer liner and inner liner to contact each other.

[0103] In some embodiments, the tube may be continuous with one of the shafts of the delivery system. For example, the distal end of the sixth shaft may include the tube, such that the tube and the sixth shaft are continuous. In some embodiments, the outer diameter of the tube may be the same as the outer diameter of one of the shafts of the delivery system. In some embodiments, a liner may be configured adjacent to the outer surface of the tube and one of the shafts of the delivery system, such that the liner spans the proximal end of the tube and the distal end of the shaft of the delivery system. In some embodiments, the tube and the sixth shaft of the delivery system are made of a single shaft having the same outer diameter and the same inner diameter, which may be expected to reduce the loss of deflection angle of the delivery system shaft during the deployment of the artificial heart valve.

[0104] Figures 21 to 23Several views and implementations of the scalable framework 6000 for the delivery system disclosed herein are depicted. Figure 21 An embodiment of the expandable frame 6000, shown in a compressed configuration, is depicted. The expandable frame includes a proximal ring, an expandable support structure, and a cylindrical portion disposed between the proximal ring and the expandable support structure. In some embodiments, the proximal ring includes one or more openings that are spaced apart at intervals around the circumference of the proximal ring of the expandable frame. Figure 21 In the illustrated embodiment, the proximal ring has six openings, which may be desirable for facilitating attachment to one or more shafts of the delivery system, or for guiding cables, wires, ropes, etc., to a more distal portion of the delivery system. The cylindrical portion of the expandable frame may include one or more axial members, each of which may have a proximal end and a distal end. In some embodiments, the proximal and distal ends of one or more axial members may be axially aligned; however, in other embodiments, such as Figure 21 In the illustrated embodiments, the distal ends of one or more axial members may be positioned circumferentially out of phase with the proximal ends of one or more axial members. This may be intended to facilitate the guidance of cables, wires, cords, etc., to more distal portions of the delivery system. In some embodiments, the axial members may be spaced apart by spaces sized such that one or more anchoring members of the artificial heart valve can be nested between adjacent axial members when the artificial heart valve is in a compressed configuration, thereby facilitating the re-entry of the artificial heart valve into the tube of the delivery system.

[0105] The expandable frame may include an expandable support structure configured to expand to a diameter larger than the diameter of the expandable frame in its compressed configuration, such as... Figure 22As shown in the diagram. The expandable support structure can be configured to connect to an artificial heart valve. In some embodiments, the expandable support structure includes a plurality of arms equidistantly spaced around the circumference of the expandable support structure. In some embodiments, the expandable support structure includes at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 arms. In some embodiments, the support structure includes 12 or fewer, 11 or fewer, 10 or fewer, 9 or fewer, 8 or fewer, 7 or fewer, 6 or fewer, 5 or fewer, or 4 or fewer arms. In one exemplary set of embodiments, the expandable support structure includes nine arms. In one exemplary set of embodiments, three of the nine arms further include three distal hooks configured to attach to three anchoring members of the artificial heart valve. In some embodiments, one, two, three, four, five, six, seven, eight, nine, ten, or all of the arms further include one or more distal hooks. In some embodiments, the arms of the expandable support structure include one, two, or more than three hooks, such as six or nine hooks. In some embodiments, the expandable support structure is configured to provide stability to the artificial heart valve when the expandable frame (e.g., via a locking and releasing mechanism including three or more hooks) is attached to the artificial heart valve. For example, where it is not desirable to be theoretically constrained, having three contact points between the expandable frame and the artificial heart valve can form a contact plane to prevent swaying, rotation, and / or other undesirable movements between the expandable frame and the artificial heart valve. In some embodiments, the expandable support structure includes one or more scaffold-like features, such as sinusoidal or zigzag circumferential scaffold patterns, to provide stability to the expandable frame. Such scaffold-like features can advantageously provide support between or within the connection point of the expandable frame and the artificial heart valve, which in some cases helps to stabilize the artificial heart valve. For example, expandable support structures can provide this stability throughout the entire deployment of the artificial heart valve, including providing this stability in both the coiled and deployed configurations of the artificial heart valve.

[0106] Advantageously, the locking / fitting configurations described herein (e.g., including fasteners (e.g., hooks) located on the expandable support structure) are configured to mate with any artificial heart valve. In some embodiments, the artificial heart valve includes mating fasteners (e.g., hooks) that engage with the fasteners of the delivery system. In other embodiments, the artificial heart valve may have any number of configurations such that three or more contact points engage with the fasteners of the delivery system. Advantageously, the delivery systems described herein can be used to deliver, reposition, and / or retrieve a variety of commercially available artificial heart valves and are not limited to the specific heart valve configurations described herein. Based on the teachings of this specification, those skilled in the art will understand how the delivery systems described herein can be selected and deployed such that these delivery systems can engage with other artificial heart valves.

[0107] Figure 23 An embodiment of an expandable frame in a compression configuration is depicted, wherein the cylindrical portion includes three members, the distal and proximal ends of which are axially aligned. In some embodiments, the expandable frame in the compression configuration does not include the cylindrical portion. In some embodiments, the six arms of the expandable support structure include a distal end of each arm, the distal end including a protruding feature that can be configured as an anchoring member for connection to an artificial heart valve.

[0108] Figure 24 yes Figure 3 A side view of the capsule-like portion of a delivery system, wherein the expandable frame is shown in an expanded configuration, and the delivery system includes at least one sheath configured to surround at least one arm of the expandable frame. Figure 24 In one embodiment, the delivery system includes three sheaths, each configured to surround a hook located at the distal end of one of the three arms of the expandable support structure of the expandable frame. The sheaths may be configured to surround at least one mating portion of the artificial heart valve when engaged with the hooks of the expandable support structure, thereby securely attaching the delivery system to the artificial heart valve.

[0109] In some implementations, the sheath may be attached to at least one traction line 606, for example... Figure 24 The traction wire shown may have a sheath configured to move axially in the proximal direction to disengage from at least one mating portion of the artificial heart valve, thereby disconnecting the artificial heart valve from the delivery system. In some embodiments, the traction wire 606 may be pathed through one or more openings in the proximal ring of the expandable frame, which may be intended to help protect at least one traction wire 606 and / or allow for a more direct route of travel.

[0110] In some embodiments, the sheath may be formed into a cylinder with a generally circular cross-sectional profile. In other embodiments, the sheath may have an elliptical or rectangular cross-sectional profile, for example... Figure 24 The implementation shown is illustrated. Figure 25 In one embodiment, the sheath has: a distal end having a circular cross-sectional profile; and a proximal end including a proximal guide protrusion formed to be smaller than the entire circumference of the distal end. This may help ensure that the sheath can slide on at least one arm of the expandable support structure. Figure 25 The diagram also shows a circumferential guide protrusion disposed within the middle portion of the sheath. At least one traction line 606 can be configured to enter a lumen on the proximal side of the adjacent circumferential guide protrusion of the sheath and exit a lumen on the distal side of the adjacent circumferential guide protrusion of the sheath, as shown. Figure 26 As depicted in the side cross-sectional view.

[0111] exist Figure 27 In the implementation method, Figure 3 The expandable frame of the delivery system is shown in a collapsed configuration, wherein at least one traction line 606 is attached to at least one sheath and traverses a component of the cylindrical portion of the expandable frame. Figure 27 In one embodiment, at least one traction wire 606 traverses the inner portion of the expandable frame's cylindrical member and the inner intermediate ring of the expandable frame. In some embodiments, at least one traction wire 606 traverses the outer portion of the expandable frame's cylindrical member and the inner intermediate ring of the expandable frame. In some embodiments, at least one traction wire 606 traverses the inner portion of the expandable frame's cylindrical member and the outer intermediate ring of the expandable frame. Figure 27The embodiments described herein can provide the advantage of protecting at least one traction wire 606 from damage in a compressed or expanded state. The expandable frame disclosed herein is preferably made of nitinol, but may also be made of other biocompatible materials such as stainless steel. In some embodiments, the expandable frame may be directly attached to any of the axes of the delivery system. The expandable frame can also control the expansion of the artificial heart valve. For example, in some embodiments, the expandable frame may be attached (directly or indirectly) to a fourth axis of the delivery system such that translation of the fourth axis relative to the tube of the delivery system in a distal direction causes the expandable frame and the artificial heart to which the expandable frame is attached to to translate away from the distal end of the tube of the delivery system, while also allowing the expandable frame and the artificial heart valve to expand. Therefore, by controlling the translation of the fourth axis of the delivery system relative to the tube of the delivery system, the expansion of the expandable frame and the artificial heart valve can be controlled. Similarly, the retraction of the expandable frame and the artificial heart valve, for example, by translating the fourth axis of the delivery system proximally relative to the tube of the delivery system, can control the overlapping of the expandable frame and the artificial heart valve and / or control its retraction back into the tube of the delivery system.

[0112] Figure 28A and Figure 28BAn embodiment of a fastener 7802 (e.g., a hook) of an expandable frame 6000 is depicted, wherein a sheath 7804 with attached traction wires 606 surrounds the hook. In this embodiment, the fastener 7802 is configured to securely nest with the mating fastener 7806 of the artificial heart valve, while the sheath 7804 is configured to prevent the two fasteners 7802, 7806 from disengaging. In this way, the sheath 7804 provides a locking portion for securing the delivery system to the artificial heart valve until one or more traction wires 606 retract from one or more sheaths, allowing the two hooks to disengage. In some embodiments, by securing the delivery system to the artificial heart valve, the artificial heart valve can be positioned in the implantation location within the natural heart valve while maintaining engagement with the delivery system. In some cases, the artificial heart valve may need to be recaptured, for example, due to improper placement within the natural heart valve, perceived risk to the natural heart, or other reasons. Engagement with the delivery system during implantation allows the delivery system to recapture the artificial heart valve. In some embodiments, the artificial heart valve can be repositioned within the sac-like portion of the delivery system. The recaptured artificial heart valve can be repositioned within the natural heart valve or removed from the body. In some embodiments, the artificial heart valve can be deployed, repositioned (e.g., recaptured and repositioned), and redeployed as many times as appropriate. For example, the delivery system can be used to reposition the placement of the artificial heart valve once, twice, three times, four times, five times, or more (e.g., until the artificial heart valve is positioned in the desired location and / or configuration). In one exemplary set of embodiments, the delivery system deploys the artificial heart valve such that the artificial heart valve attaches to the natural leaflet of the natural heart valve, and if the artificial heart valve does not reliably attach to the natural leaflet, the artificial heart valve can be recaptured and / or repositioned until it attaches to the natural leaflet of the natural heart valve.

[0113] In various implementations, the fastener can be any type of mating element, such as hook, snap, clamp, catch, pin, hook eye, buckle, latch, lock, snap, button, slider, etc.

[0114] The traction wire 606 can be attached to the sheath, for example, by welding, crimping, or adhesive bonding. The sheath can be made of any biocompatible material, but is preferably made of metals such as nitinol, stainless steel, titanium, gold, etc. The traction wire can be made of any biocompatible material including nitinol, stainless steel, titanium, gold, PTFE, polyester, silicone, PU, ​​PE, PVC, PTFE, ETFE, FEP, PEBA, polyamide, hydrogel materials, or natural fibers (e.g., silk). The traction wire can be made of a continuous material, such as a line or rod, or can be braided from more than one single segment of material, such as a cable, cord, rope, etc. In other embodiments, the traction wire 606 can be made of one or more interconnected loops of material. In some embodiments, the traction wire 606 can be made of one or more bodies connected by one or more segments of material.

[0115] In some embodiments, the delivery system includes an adapter configured to attach an expandable frame to a fourth axis of the delivery system. The adapter may be advantageous, for example, when the expandable frame is made of a different material than the fourth axis. For instance, the expandable frame may be made of nitinol and the fourth axis may be made of stainless steel, which may be difficult to connect by conventional means; in such cases, the adapter may be configured to facilitate connection between the two components. In some embodiments, the adapter includes a proximal ring, a distal ring, and a central lumen passing through both the proximal and distal rings. The diameter of the proximal ring is larger than that of the distal ring. One or more axial guide openings may be located on the proximal ring, which may be intended to allow one or more traction wires 606 to pass through one or more axial guide openings. The distal ring may include one or more radial guide openings, which may be used to facilitate attachment to the expandable frame, for example, by welding or inserting another component such as a screw, bolt, rivet, etc. In some embodiments, the adapter includes three axial guide openings and three radial guide openings. The diameter of the central lumen of the adapter can be configured to fit snugly around the outer periphery of the distal end of the fourth axis. The outer diameter of the distal ring of the adapter can be configured to fit snugly within the inner periphery of the proximal ring of the expandable frame. The adapter can be made of a variety of different biocompatible materials, but is preferably made of the same material as the expandable frame or the fourth axis, and preferably of nitinol or stainless steel.

[0116] In some embodiments, the expandable frame may be attached to the distal end of the fourth axis of the system, and the tubes of the first, second, third, fifth, and sixth axes, as well as the capsule portion, may be configured to move axially proximally or distally relative to the fourth axis of the delivery system. In this way, the axial depth of the artificial heart valve can be increased or decreased while maintaining the first curvature and the second curvature of the six axes of the delivery system, thereby achieving better control over the placement of the artificial heart valve within the natural heart.

[0117] In some embodiments, the sixth axis of the delivery system may include an outer liner configured to have different flexibility at different portions along the length of the axis. For example, the liner may be made of more than one material, more than one material hardness tester, and / or more than one thickness, which may be advantageous in achieving the desired level of flexibility of the delivery system's axis in one or more steering planes. In some embodiments, a delivery system in which the distal portion of the axis is made of a first material and the proximal portion of the axis is made of a second material allows the bending region of the axis to be located over a shorter distance, which may have a smaller radius in the distal portion of the axis than in other cases.

[0118] Figures 29A to 30C Various deployment stages of an exemplary implementation of an artificial heart valve are depicted, which is at least initially attached to a delivery system. Figure 29A In this diagram, an artificial heart valve is shown as an expandable frame attached to a delivery system, with multiple arms of the artificial heart valve connected to the delivery system via multiple filamentary elements. As previously described, advancing the expandable frame (and therefore the artificial heart valve) relative to the tube of the delivery system causes both the expandable frame and the artificial heart valve to advance away from the distal end of the tube of the delivery system and expand in the space beyond the distal end of the tube of the delivery system. Figure 29B As depicted, the axis of the delivery system that secures the filamentous element can advance relative to other axes of the delivery system to hinge the arm of the artificial heart valve (e.g., to lower the arm of the artificial heart valve into a deployment configuration). Similarly, the axis of the delivery system that secures the filamentous element can retract relative to other axes of the delivery system to hinge the arm of the artificial heart valve (e.g., to raise the arm of the artificial heart valve into a folded or coiled configuration). In this way, the artificial heart valve can be deployed into the natural tricuspid valve, whereby the artificial heart valve can be completely anchored or secured at, near, or within the natural tricuspid valve, while still retaining the ability to re-hinge the arm of the artificial heart valve to allow for repositioning and subsequent redeployment of the artificial heart valve. This capability allows for assessment of the hemodynamic function of the artificial heart valve before disconnection and reconnection in the natural heart to an implantation configuration. Figure 29C The subsequent steps of releasing the filamentous element to disengage from the arm of the artificial heart valve are depicted. The expandable frame can also be disengaged from the artificial heart valve before or after the release of the filamentous element, as illustrated in [the diagram]. Figure 30C I saw it in the middle.

[0119] Although various embodiments of the invention have been described and illustrated herein, those skilled in the art will readily conceive of various other methods and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is considered to be within the scope of the invention. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications using the teachings of the invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of the invention described herein using only conventional experimentation. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and the invention may be practiced in ways other than those specifically described and claimed within the scope of the appended claims and their equivalents. The invention relates to each individual feature, system, article of manufacture, material, kit, and / or method described herein. Furthermore, any combination of such features, systems, articles of manufacture, materials, kits, and / or methods is also included within the scope of the invention if two or more such features, systems, articles of manufacture, materials, kits, and / or methods are not inconsistent with each other.

[0120] Unless explicitly stated otherwise, the indefinite articles “a” and “an” used in the description and claims herein shall be understood to mean “at least one type”.

[0121] As used herein in the specification and claims, the phrase “and / or” should be understood to mean “any one or both” of the elements so combined—that is, elements that exist in combination in some cases and separately in others. Unless the opposite is explicitly stated, additional elements may optionally exist besides those explicitly identified by the “and / or” clause, whether related to or unrelated to those specifically identified elements. Thus, as a non-limiting example, when used in conjunction with open-ended language such as “comprising,” a reference to “A and / or B” may in one embodiment refer to the presence of A without B (optionally including elements other than B); in another embodiment, it may refer to the presence of B without A (optionally including elements other than A); in yet another embodiment, it may refer to the presence of both A and B (optionally including other elements); and so on.

[0122] As used herein in the specification and claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items from a list, “or” or “and / or” should be understood to be inclusive, i.e., including multiple elements or at least one of the elements in the list, but also including more than one, and optionally including other unlisted items. Terms that explicitly indicate the opposite, such as “only one” or “exactly one” or, when used in a claim, “consisting of…” will refer to the inclusion of multiple elements or exactly one of the elements in the list. Generally, the term “or” as used herein, when preceding exclusive terms such as “any,” “one of,” “only one,” or “exactly one,” should only be interpreted as indicating an exclusive alternative (i.e., “one or the other, but not both”). When used in a claim, “consisting substantially of…” should have its general meaning as used in the field of patent law.

[0123] As used herein in the specification and claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one of each or every element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements referred to by the phrase "at least one," whether or not they are related to those specifically identified elements. Therefore, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") in one embodiment may refer to the presence of at least one A, optionally including more than one A, without the presence of B (and optionally including elements other than B); in another embodiment may refer to the presence of at least one B, optionally including more than one B, without the presence of A (and optionally including elements other than A); in yet another embodiment may refer to at least one A, optionally including more than one A and at least one B, optionally including more than one B (and optionally including other elements); and so on.

[0124] In the claims and in the foregoing description, all transitional phrases such as “comprising,” “including,” “with,” “having,” “containing,” “involving,” “holding,” etc., are understood to be open-ended, meaning including but not limited to. As described in Section 2111.03 of the U.S. Patent Examination Procedure Manual, only the transitional phrases “consisting of” and “consisting substantially of” should be closed or semi-closed transitional phrases, respectively.

[0125] Unless otherwise specified or indicated, any term used herein relating to the following—for example, one or more articles, structures, forces, fields, flows, directions / trajectories, and / or their sub-components and / or combinations thereof and / or any other tangible or intangible element or element whose shape, orientation, alignment and / or geometric relationship can be characterized by such terminology—should be understood not to require absolute conformity to the mathematical definition of such terminology, but rather to conform to the mathematical definition of such terminology to the extent possible of the subject matter being represented, as understood by one of skill in the art most closely related to such subject matter. Examples of these terms related to shape, orientation, and / or geometric relationship include, but are not limited to, the following descriptive terms: shape—such as circle, square, ring-shaped / ring-shaped, rectangular / rectangular, triangular / triangular, cylindrical / cylindrical, elliptical / elliptical, (n) polygonal / (n) polygonal, etc.; angular orientation—such as perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.; contour and / or trajectory—such as planar / planar, coplanar, hemispherical, hemispherical, linear / linear, etc. Hyperbolic, parabolic, flat, curved, straight, arc-shaped, sinusoidal, tangent / tangential, etc.; direction—such as north, south, east, west, etc.; surface and / or bulk material properties and / or spatial / temporal resolution and / or distribution—such as smooth, reflective, transparent, clear, opaque, rigid, impermeable, homogeneous, inert, non-wetting, insoluble, stable, invariant, constant, homogeneous, etc.; and many other things that are obvious to those skilled in the art. As an example, a manufactured article described herein as a “square” does not require that such an article have perfectly planar or linear faces or edges intersecting at precise 90-degree angles (in fact, such an article may exist only as a mathematical abstraction). Rather, the shape of such an article should be interpreted as approximating a mathematically defined “square” to the extent that it is generally achievable and has been achieved by the described manufacturing techniques, as understood or specifically described by those skilled in the art. As another example, the two or more manufactured articles described herein as “aligned” do not require that such articles have perfectly aligned faces or edges (in fact, such articles can only exist as mathematical abstractions), but rather, the arrangement of such articles should be interpreted as approximating a mathematically defined “alignment” to the extent that the manufacturing techniques described herein are generally feasible and have been realized, as understood or specifically described by those skilled in the art.

[0126] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0127] Phrases such as “aspect” do not imply that this aspect is essential to the subject matter or that this aspect applies to all configurations of the subject matter. Disclosures relating to an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as “one aspect” may refer to one or more aspects, and phrases such as “one or more aspects” may also refer to one aspect. Phrases such as “implementation” do not imply that such implementation is essential to the subject matter or that such implementation applies to all configurations of the subject matter. Disclosures relating to an implementation may apply to all implementations or to one or more implementations. An implementation may provide one or more examples. Phrases such as “one implementation” may refer to one or more implementations, and phrases such as “one or more implementations” may refer to one implementation. Phrases such as “configuration” do not imply that such configuration is essential to the subject matter or that such configuration applies to all configurations of the subject matter. Disclosures relating to a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. A phrase such as "a configuration" can refer to one or more configurations, and a phrase such as "one or more configurations" can refer to one configuration.

[0128] It should be understood that some or all of the steps, operations, or processes can be performed automatically without user intervention. Method claims may be provided to present elements of various steps, operations, or processes in an example sequence, but method claims are not intended to be limited to a particular order or hierarchy presented.

[0129] The title, background, brief description of the drawings, and claims of this disclosure are hereby incorporated in this disclosure and are provided as illustrative examples rather than as limiting descriptions. It should be understood at the time of filing that they are not intended to limit the scope or meaning of the claims. Furthermore, as will be apparent in the detailed description, it provides illustrative examples, and various features are combined in various embodiments for the purpose of simplifying the disclosure. The disclosed method should not be construed as reflecting an intention to require more features than expressly stated in any claim. Rather, as reflected in the following claims, the inventive subject matter lies in all features of fewer than those in a single disclosed configuration or operation. The following claims are hereby incorporated in the detailed description, wherein each claim independently represents a separate claimed subject matter.

Claims

1. A delivery system for delivering an artificial heart valve to a natural heart valve, the system comprising: A shaft portion, the shaft portion comprising at least one shaft, at least one steering line, and at least one traction line; A handle portion, said handle portion being coupled to the proximal end of said shaft portion; and The sac-like portion is connected to the distal end of the shaft portion and configured to accommodate the artificial heart valve; Wherein, the at least one shaft, at least one steering line, and / or at least one traction line are configured to extend from the handle portion of the delivery system through the shaft portion to the bladder portion. The capsule-like portion includes a tubular portion, which in turn includes an expandable frame. The expandable frame comprises multiple frame members. The plurality of said frame members include expandable frame support structures, and wherein the expandable frame support structures are configured to attach to one or more portions of the artificial heart valve. The natural heart valve comprises a plurality of natural leaflets, and the delivery system is configured to deploy the artificial heart valve such that the artificial heart valve grips the plurality of natural leaflets rather than being directly attached to either the annulus of the natural heart valve or any of the natural cords of the natural heart valve. During deployment, the artificial heart valve achieves axial stability within the natural heart valve by gripping multiple natural leaflets of the natural heart valve. After deployment, at least one portion of the delivery system is capable of re-engaging the artificial heart valve, thereby repositioning the artificial heart valve within the natural valve, and / or retracting the artificial heart valve back to the sac portion of the delivery system.

2. The delivery system according to claim 1, wherein, The expandable frame is configured to expand beyond the periphery of the tubular portion.

3. The delivery system according to claim 1, wherein: One or more of the frame members include fasteners, and Each fastener is configured to attach to the artificial heart valve.

4. The delivery system according to claim 3, further comprising: A tube, the tube being configured to maintain contact between each fastener and the artificial heart valve.

5. The delivery system according to claim 4, wherein, The at least one traction line is attached to the tube.

6. The delivery system according to claim 1, wherein: The shaft portion includes an inner shaft, and The distal portion of the inner shaft is disposed within the cavity of the tubular portion.

7. The delivery system according to claim 6, wherein, The sac-like portion includes a tapered head member connected to the distal portion of the inner shaft.

8. The delivery system according to claim 7, wherein, At least a portion of the tapered head member is disposed within the tubular portion.

9. The delivery system according to claim 6, wherein: The shaft portion includes multiple nested shafts, and The plurality of nested axes includes the inner axis.

10. The delivery system according to claim 9, wherein, At least one of the plurality of nested axes includes an outer axis.

11. The delivery system according to claim 1, wherein, The tubular portion is configured to adjust the position of the artificial heart valve relative to the handle portion.

12. The delivery system according to claim 1, wherein, The steering line is configured such that the shaft portion flexes at an angle of 125 degrees relative to the longitudinal axis of the handle portion.

13. The delivery system according to claim 1, wherein, The steering line is configured such that the shaft portion flexes at a 30-degree angle relative to the longitudinal axis of the handle portion.

14. The delivery system according to claim 1, wherein: The at least one turning line includes a first turning line and a second turning line. The first steering line is configured to cause the shaft portion to flex relative to the longitudinal axis of the handle portion in a first plane. The second steering line is configured to cause the shaft portion to flex relative to the longitudinal axis in the second plane.

15. The delivery system according to claim 1, wherein: The proximal end of at least one traction line is disposed within the handle portion, and The distal end of at least one traction wire is disposed within the bladder portion.

16. The delivery system according to claim 1, wherein, The traction wire is configured to control the release of the artificial heart valve from the delivery system.

17. The delivery system of claim 1, further comprising: At least one tether is provided for connecting the shaft portion to the artificial heart valve.

18. The delivery system according to claim 17, wherein, The at least one axis includes: An inner shaft, wherein the inner shaft is disposed within the cavity of the outer shaft, wherein: The inner shaft includes at least one pin, and at least one filament is connected to the at least one pin. The outer shaft includes at least one opening, and the at least one filament is configured to pass through the at least one opening. The displacement of the inner shaft within the outer shaft causes the at least one filament to disconnect from the at least one pin.

19. The delivery system according to claim 1, wherein, The sac-like portion includes a flexible tube configured to flex in at least one plane.

20. The delivery system according to claim 19, wherein: The flexible tube includes a metal tube defining a first plurality of openings along a first side and a second plurality of openings along a second side, and The first side is opposite to the second side.

21. The delivery system according to claim 1, wherein, At least one portion of the delivery system is configured to approximate a natural blood vessel to deliver the artificial heart valve to the heart.

22. A delivery system, comprising: A shaft portion, the shaft portion comprising at least one shaft, at least one steering line, and at least one traction line; A handle portion, said handle portion being coupled to the proximal end of said shaft portion; and The capsule-like portion is connected to the distal end of the shaft portion and configured to accommodate the implant. In this embodiment, at least one portion of the delivery system is configured to engage with the implant, and the implant is deployed within the subject such that it can be repositioned after deployment. The delivery system includes one or more pins, one or more openings, and one or more filamentary elements. The delivery system is configured to deploy the implant such that it grasps multiple natural leaflets of the natural heart valve rather than being directly attached to either the natural annulus or the natural cord of the natural heart valve. During deployment, the implant achieves axial stability within the natural heart valve by grasping multiple leaflets of the natural heart valve. The implant is an artificial heart valve.

23. A delivery system for delivering an artificial heart valve to a natural heart valve, the system comprising: A shaft portion, the shaft portion comprising at least one shaft, at least one steering line, and at least one traction line; A handle portion, which is connected to the proximal end of the shaft portion; as well as A sac-like portion, connected to the distal end of the axial portion and configured to accommodate the artificial heart valve, wherein the sac-like portion includes a tubular portion comprising an expandable frame. The delivery system is configured to deploy the artificial heart valve such that it grasps multiple natural leaflets of the natural heart valve rather than being directly attached to any one of the natural annulus or natural cord of the natural heart valve. During deployment, the artificial heart valve achieves axial stability within the natural heart valve by gripping multiple leaflets. The delivery system is maintained in contact with the artificial heart valve via one or more hooks of the expandable frame.

24. The delivery system according to claim 23, wherein, The expandable frame includes three or more hooks.

25. The delivery system according to claim 23 or 24, further comprising one or more filamentary elements having a first end and a second end, wherein, The first end is attached to one or more pins on the shaft of the delivery system, and the second end is attached to the artificial heart valve.

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