Mitral valve spacer device

Abstract

The invention relates to a mitral valve spacer device. An implantable prosthetic spacer device may include an expandable spacer having a plurality of expandable members and a frame including one or more anchors and one or more fasteners. The expandable spacer may be configured to be disposed between natural leaflets of the heart. The implantable prosthetic spacers may be arranged in a symmetric or asymmetric configuration. The expandable spacer is expandable between an unexpanded configuration and an expanded configuration.

Description

[0001] This application is a divisional application. The application date of the original application is March 20, 2019, the application number is 2019800322415, and the name of the invention is “Mitral valve spacer device”. Technical Field

[0002] The present disclosure relates generally to prosthetic devices and related methods for helping to seal native heart valves to prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. Background Art

[0003] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve and mitral valve) play a key role in ensuring an adequate supply of blood flowing forward through the cardiovascular system. These heart valves may be damaged by congenital malformations, inflammatory processes, infectious conditions or diseases, and therefore become less effective. Such damage to the valve can lead to severe cardiovascular damage or death. For many years, the clear treatment for such damaged valves has been surgical repair or replacement of the valves during open heart surgery. However, open heart surgery is highly invasive and prone to many complications. Therefore, elderly and frail patients with defective heart valves often go untreated. Recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a much less invasive manner than open heart surgery. A specific transvascular technique for accessing the natural mitral valve and aortic valve is the transseptal technique. The transseptal technique includes inserting a catheter into the right femoral vein, up along the inferior vena cava and into the right atrium. The septum is then pierced and the catheter is sent to the left atrium, in which case the procedure can be performed in the left side of the heart. Such transvascular techniques have become increasingly popular due to their high success rates.

[0004] A healthy heart is generally conical in shape, tapering to a lower apex. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The anatomical structure of the mitral valve is quite different from other natural heart valves. The mitral valve includes an annular portion, which is the annular portion of the natural valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an oval, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet may be larger than the posterior leaflet, and when the leaflets are close together, a roughly "C" shaped border is formed between the adjacent free edges of the leaflets.

[0005] When functioning properly, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also called "ventricular systole" or "systole"), the increased blood pressure in the left ventricle forces the two leaflets together, closing the one-way mitral valve so that blood cannot flow back into the left atrium and is instead discharged from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral valve annulus toward the left atrium, a number of fibrous cords called chordae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of contraction. Mitral regurgitation is the most common form of valvular heart disease. There are different causes of mitral regurgitation, such as leaflet prolapse, papillary muscle dysfunction, and / or left ventricular dilation causing stretching of the mitral valve annulus. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflet (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation.

[0007] Some prior art techniques for treating mitral regurgitation include suturing portions of the native mitral valve leaflets directly to each other. Other prior art techniques include using spacers implanted between the native mitral valve leaflets. Despite these prior art techniques, there is still a need for improved devices and methods for treating mitral regurgitation. Summary of the invention

[0008] Described herein are embodiments of prosthetic devices primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatus and methods for implanting the same. Prosthetic devices can be used to help restore and / or replace the functionality of a defective native valve.

[0009] An implantable prosthetic device may include one or more expandable spacers and a frame having one or more anchors. The expandable spacers may be configured to be disposed between native leaflets of the heart. The anchors may be coupled to the expandable spacers and may be configured to secure the native leaflets against the expandable spacers.

[0010] In some embodiments, the frame can further include a plurality of fasteners. The fasteners can be coupled to respective anchors and configured to secure the native leaflets to the anchors. The fasteners can be independently movable between an open configuration and a closed configuration.

[0011] In a representative embodiment, an implantable prosthetic device includes: an expandable spacer having an inner cavity, the expandable spacer being expandable between an unexpanded configuration and an expanded configuration, wherein in the expanded configuration, the expandable spacer is configured to be positioned between natural heart valve leaflets to reduce regurgitation therebetween; and a frame comprising: at least one anchor configured to be placed on one side of one of the natural leaflets, and a fastener coupled to the anchor and configured to be placed on the other side of the one natural leaflet, wherein the fastener is movable between an open position and a closed position, wherein when in the closed position, the fastener is configured to retain a portion of the one natural leaflet to the anchor, and wherein the expandable spacer is configured to expand from an unexpanded configuration to an expanded configuration by filling the inner cavity of the expandable spacer with one or more expansion media.

[0012] In some embodiments, the expandable spacer is a sac or other type of expandable or fillable element (e.g., a cloth pocket). In such an embodiment, the expandable spacer can expand between an unexpanded configuration and a fully or partially expanded configuration. In certain embodiments, the expandable spacer can be expanded by expanding the lumen of the expandable spacer with a swelling medium or a plurality of swelling media. The swelling medium can be a fluid and / or a non-fluid. Various fluids can be used, such as saline solution, epoxy resin, blood, and / or other fluids configured for expansion. In some embodiments, the fluid can be a gaseous fluid, such as an inert gas (e.g., a gas that does not chemically react or does not at least undesirably react with the body or parts of the prosthetic spacer device under delivery conditions or after implantation). Suitable gases may include nitrogen, carbon dioxide, helium and argon, including mixtures thereof. Other gases (e.g., oxygen) may be included in a mixture of gases (e.g., air). Non-fluids may be, for example, multiple microbeads, multiple pellets, and / or other non-fluid media configured for expansion. In some embodiments, both fluid and non-fluid media may be used in combination to expand the expandable spacer.

[0013] In some embodiments, the implantable prosthetic device can further include a source of an expansion medium. In some embodiments, the expansion medium can be a saline solution. In other embodiments, the expandable spacer can be configured to receive blood to expand the expandable spacer from an unexpanded configuration to an expanded configuration.

[0014] In some embodiments, the expandable spacer may include a plurality of expandable members, each of which has an inner cavity. The plurality of expandable members may be different structures, or may be a single structure with multiple chambers. The expandable members may move independently between a fully or partially expanded configuration and an unexpanded configuration. The expandable members may expand in a symmetrical configuration or in an asymmetrical configuration.

[0015] In some embodiments, the expandable spacer may include a first expandable member and a second expandable member. In such embodiments, the asymmetric configuration may include, for example, expanding the first expandable member to a fully expanded configuration and the second expandable member in an unexpanded configuration. The symmetric configuration may include, for example, expanding both the first expandable member and the second expandable member to a fully expanded configuration.

[0016] In some embodiments, the inflatable spacer can have a substantially cylindrical shape (i.e., a circular cross-sectional shape taken in a plane perpendicular to an axis extending from a proximal portion to a distal portion of the prosthetic spacer device). In other embodiments, the inflatable spacer can be substantially rectangular, annular, semicircular, or have another shape configured to create a surface against which the native leaflets can abut for engagement. In some embodiments, the inflatable spacer can be a non-uniform shape configured to fill the space between the incompletely engaged, malfunctioning native leaflets. In some embodiments, the inflatable spacer can have tapered ends.

[0017] In some embodiments, the expandable spacer may include one or more expansion valves through which an expansion medium may enter and / or exit the lumen of the expandable spacer and / or the lumen of the expandable member and expand or deflate the expandable spacer and / or the expandable member.

[0018] In some embodiments, the expansion valve can be a slit valve. The slit valve can have a flexible annular seal through which the expansion shaft of the delivery system can extend. When the expansion shaft is removed from the flexible annular seal, the seal can be biased closed, thereby preventing any expansion medium from leaving and / or entering the lumen of the expandable spacer.

[0019] In other embodiments, the expansion valve may be a check valve. The check valve may be configured to prevent the expansion medium from entering the inner cavity of the expandable spacer if the pressure outside the check valve is greater than the opening (or "cracking") pressure of the check valve. If the external pressure is greater than the cracking pressure of the check valve, the valve will open and allow the medium to enter the inner cavity of the expandable spacer.

[0020] In other embodiments, the expansion valve may be a ball valve, a diaphragm valve, a rotary valve, an in-line valve, or other types of valves.

[0021] In some embodiments, the expandable spacer can be formed from a variety of materials, including polymers such as nylon, polyester, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, silicone, urethane, and polycarbonate-based and / or polyether-based thermoplastic polyurethanes (TPU).

[0022] In some embodiments, the lumen of the expandable spacer may contain a matrix material. For example, the lumen may contain a gel foam, a sponge, a coagulant, a hemostatic matrix, and / or spun collagen hemostatic particles. In such embodiments, the matrix material may expand and / or solidify when contacted by the material used to expand the expandable spacer.

[0023] In some embodiments, the implantable prosthetic device may further include a stretchable covering covering the outer surface of the expandable spacer. The stretchable covering may include a material configured to promote tissue ingrowth. In other embodiments, instead of or in addition to the material configured to promote tissue ingrowth, the stretchable covering may include a material configured to delay or prevent tissue ingrowth. In some embodiments, the covering may be elastic. In other embodiments, the expandable spacer may be inelastic and the covering may stretch in at least one direction after one of the expandable members is expanded.

[0024] In some embodiments, an expandable spacer of an implantable prosthetic device can include a longitudinal axis extending from an upstream end to a downstream end of the spacer, and when the spacer is at least partially expanded, the spacer can be configured to form an asymmetric shape about the longitudinal axis.

[0025] In another representative embodiment, an implantable prosthetic device may include: an expandable spacer configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween, the spacer comprising a plurality of expandable members, each of the plurality of expandable members having an inner cavity, each expandable member expandable between an unexpanded configuration and an expanded configuration; and at least one anchor configured to anchor the expandable spacer relative to the native leaflets, wherein each expandable member can be independently expanded into its own expanded configuration.

[0026] In some embodiments, the plurality of expandable members can include a first expandable member and a second expandable member. When the first expandable member and the second expandable member are fully expanded, they can have different sizes and / or shapes.

[0027] In some embodiments, the expandable spacer can form an asymmetrical shape when the expandable member is expanded with different amounts of inflation medium.

[0028] In some embodiments, the plurality of expandable members may include a first expandable member and a second expandable member, the first expandable member and the second expandable member extending radially outward from a central longitudinal axis of the spacer on diametrically opposite sides of the longitudinal axis. In some embodiments, each expandable member may include a first opposing major surface and a second opposing major surface, the first opposing major surface and the second opposing major surface being configured to engage with the native leaflets when the spacer is implanted between the leaflets, each expandable member having a width measured from the first major surface to the second major surface, and each expandable member being configured to increase in width when it is expanded.

[0029] In some embodiments, the expandable spacer may include a first media channel and a second media channel. The first media channel may be adapted to receive a pressurized inflation medium and allow the medium to flow into the first expandable member, and the second media channel may be adapted to receive a pressurized inflation medium and allow the medium to flow into the second expandable member.

[0030] In some embodiments, an anchor of an expandable prosthetic device can include at least two anchors configured to anchor to a native leaflet.

[0031] In another representative embodiment, an implantable prosthetic device includes an expandable spacer, a plurality of anchors, and a plurality of fasteners. The expandable spacer is configured to be arranged between the natural leaflets of the heart. The anchor is coupled to the expandable spacer and is configured to anchor the expandable spacer relative to the natural leaflets. The fastener is configured to secure the natural leaflets to the anchor and has a fixed end and a free end. The fixed end is coupled to the anchor. The free end has barbs. The free end can pivot between an open configuration and a closed configuration relative to the fixed end. The free end can be axially moved from a first position in which the barbs engage the tissue of the natural leaflets to a second position in which the barbs disengage the tissue of the natural leaflets in the open configuration.

[0032] In another representative embodiment, an assembly includes an implantable prosthetic spacer device and a delivery device. The implantable prosthetic device has an expandable spacer and a frame, the frame including a plurality of anchors, a plurality of fasteners, a first loop, and a second loop. The first end of the anchor is coupled to the first end of the expandable spacer, and the second end of the anchor is coupled to the first loop. The second loop is coupled to the second end of the expandable spacer, and the fastener is coupled to the anchor. The delivery device has a first axis, a second axis, and a plurality of fastener control members. The fastener control member is releasably coupled to the fastener of the prosthetic device. Actuating the fastener control member moves the fastener between an open configuration and a closed configuration.

[0033] In some embodiments, the delivery device further comprises one or more expansion shafts for expanding the expandable spacer and / or the expandable member. The expansion shaft is configured to releasably couple the expandable spacer, thereby allowing a medium for expanding the expandable spacer to enter its lumen.

[0034] In some embodiments, the delivery device further comprises a medium source, and the expansion shaft can be releasably coupled to the medium source.The medium source can be configured to supply and / or withdraw a medium to expand and / or deflate the expandable spacer.

[0035] In some embodiments, the delivery device is configured to move the first axis and the second axis relative to each other to move the prosthetic device between a first configuration in which the anchor is in a radially compressed configuration and a second configuration in which the anchor is in a radially expanded, axially compressed configuration and at least partially overlaps the expandable spacer to capture the native leaflet between the anchor and the expandable spacer.

[0036] In some embodiments, the delivery device further comprises a fastener control mechanism, and the fastener control member is releasably coupled to the fastener control mechanism. The fastener control mechanism is configured such that the fastener control members can be actuated simultaneously or individually.

[0037] In another exemplary embodiment, an assembly includes a prosthetic spacer device and a delivery device. The delivery device includes an outer shaft, an actuating shaft, and a plurality of tethers. The outer shaft has a first cavity and a plurality of second cavities arranged radially outward from the first cavity. The actuating shaft extends through the first cavity. The actuating shaft is axially movable relative to the outer shaft and is releasably coupled to the prosthetic device. The tethers extend through the second cavity and are releasably coupled to the prosthetic device. Tensioning the tethers moves the implantable prosthetic device and the outer shaft toward each other. Loosening the tethers allows the implantable prosthetic device and the outer shaft to be spaced apart from each other.

[0038] In some embodiments, each of the tethers is disposed in two second lumens that are circumferentially offset by approximately 180 degrees.

[0039] In some embodiments, the prosthetic spacer device further includes a plurality of fasteners. The fasteners are coupled to respective anchors and are configured to secure the native leaflets to the anchors. The fasteners are movable between an open configuration and a closed configuration. The outer shaft of the delivery device further includes a plurality of third cavities arranged radially outward from the first cavity. The delivery device further includes a plurality of control members extending through the third cavities and releasably coupled to the fasteners of the prosthetic device. Tensioning the control member moves the fasteners to the open configuration. Relaxing the control member allows the fasteners to move to the closed configuration.

[0040] In some embodiments, each of the control members is disposed in two third cavities that are circumferentially offset by approximately 180 degrees.

[0041] In another representative embodiment, a combination includes an implantable prosthetic spacer device and a delivery device. The implantable prosthetic spacer device has an expandable spacer, the expandable spacer including a plurality of expandable members, a plurality of anchors, a plurality of fasteners, a first loop, and a second loop. The first end of the anchor is coupled to the first end of the expandable spacer, and the second end of the anchor is coupled to the first loop. The second loop is coupled to the second end of the expandable spacer, and the fastener is coupled to the anchor and can be independently moved between an open configuration and a closed configuration. The delivery device has a first shaft, a second shaft, a plurality of tethers, and a plurality of fastener control members. The first shaft is releasably coupled to the first loop of the prosthetic device by the tether, the second shaft is releasably coupled to the second loop of the prosthetic device, and the fastener control member is releasably coupled to the fastener of the prosthetic device. Actuating the fastener control member moves the fastener between the open configuration and the closed configuration. Tightening the tether moves the prosthetic device and the first shaft toward each other, while loosening the tether allows the prosthetic device and the first shaft to be spaced apart from each other.

[0042] In a representative embodiment, a method for implanting a prosthetic spacer device to improve coaptation of a native heart valve leaflet may include advancing a delivery apparatus and an implantable prosthetic device into a patient's body, the implantable prosthetic device including an expandable spacer including at least first and second expandable members, placing the expandable spacer between the native heart valve leaflets, and at least partially expanding at least the first expandable member with an expansion medium such that the spacer assumes an asymmetric configuration against which the native leaflets may coapt.

[0043] In some embodiments, the method can further include anchoring the prosthetic device against tissue in the heart with an anchor of the prosthetic device to support the septum between the native leaflets.

[0044] In some embodiments, the asymmetric configuration of the spacer can be asymmetric about a central longitudinal axis of the spacer, the central longitudinal axis extending from an upstream end to a downstream end of the spacer. In some embodiments, the asymmetric configuration can be asymmetric about a transverse axis of the spacer. In some embodiments, the method can further include expanding the second expandable member to produce a symmetrical configuration against which the native leaflet can engage.

[0045] The various innovations of the present disclosure may be used in combination or alone. This summary is provided to introduce a selection of concepts in a simplified form, which will be further described in the detailed description below. This summary is neither intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present invention will become more apparent through the detailed description below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 Exemplary embodiments of a delivery assembly including a delivery apparatus and a prosthetic spacer device are illustrated.

[0047] Figure 2 Exemplary embodiments of prosthetic spacer devices are illustrated.

[0048] Figure 3 yes Figure 2 A side elevation view of a prosthetic spacer device showing a covering thereon.

[0049] Figure 4A is a side elevation view of an exemplary embodiment of a prosthetic spacer device in an asymmetric expanded configuration.

[0050] Figure 4B yes Figure 4A A plan view of the prosthetic spacer device.

[0051] Figure 5A is in a symmetrically expanded configuration Figure 4A Side elevation view of a prosthetic spacer device.

[0052] Figure 5B yes Figure 5A A plan view of the prosthetic spacer device.

[0053] Figure 6 yes Figure 2 Partial cross-section of a prosthetic spacer device.

[0054] Figure 7 FIG. 1 is a diagram showing a prosthetic spacer device releasably coupled to a delivery device. Figure 1 A perspective view of the distal portion of the delivery assembly.

[0055] Figure 8 Figure 2 shows a prosthetic spacer device released from a delivery device. Figure 1 A perspective view of the distal portion of the delivery assembly.

[0056] Fig. 9 is a perspective view of a distal portion of another exemplary delivery assembly showing a prosthetic spacer device releasably coupled to a delivery apparatus.

[0057] Fig.10 yes Figure 1 A plan view of the axis of the delivery device.

[0058] Figure 11-15 An example of a method for repairing a native mitral valve (partially shown) of a heart Fig.11 Exemplary procedures for delivering the assembly.

[0059] Fig.16 It is implanted in the native mitral valve Figure 5A A plan view of the prosthetic spacer device.

[0060] Fig.17 It is implanted in the native mitral valve Figure 4A A plan view of the prosthetic spacer device.

[0061] Fig.18 is a side elevation view of an embodiment of a prosthetic spacer device in an asymmetric expanded configuration.

[0062] Fig.19 yes Fig.18 A plan view of the prosthetic spacer device. DETAILED DESCRIPTION

[0063] General considerations

[0064] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or require any one or more problems to be solved.

[0065] Although some of the operations in the disclosed embodiments are described in a specific sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless the specific language set forth below requires a specific order. For example, in some cases, the operations described sequentially may be rearranged or performed simultaneously. In addition, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary according to the specific implementation scheme and can be easily discerned by a person of ordinary skill in the art.

[0066] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including". Further, the term "coupled" generally refers to physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and in the absence of specific language to the contrary, does not exclude the presence of intervening elements between the coupled or associated items.

[0067] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal movement of a device is the movement of the device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal movement of the device is the movement of the device away from a user and toward an implantation site (e.g., entering the patient's body). Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0068] As used herein, the term "about" refers to the listed value and any value within 10% of the listed value. For example, "about 100 degrees" means any value between 90-110 degrees (including 90 degrees and 110 degrees).

[0069] Exemplary Embodiments

[0070] Described herein are embodiments of prosthetic spacer devices primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, and apparatus and methods for implanting the prosthetic spacer devices. Prosthetic spacer devices can be used to help restore and / or replace the functionality of a defective native valve.

[0071] The prosthetic spacer device can be coupled to a delivery apparatus to form a delivery assembly. The delivery apparatus can be used to percutaneously deliver, position and / or secure the prosthetic spacer device within the region of a patient's native heart valve.

[0072] Figure 1 An exemplary embodiment of a delivery assembly 100 and its components is shown. The delivery assembly 100 may include a prosthetic spacer device 102 and a delivery device 104. The delivery device 104 may include a plurality of catheters and a catheter stabilizer. For example, in the illustrated embodiment, the delivery device 104 includes a first catheter 106, a second catheter 108, a third catheter 110, and a catheter stabilizer 112. The second catheter 108 extends coaxially through the first catheter 106, and the third catheter 110 extends coaxially through the first catheter 106 and the second catheter 108. The prosthetic spacer device 102 can be releasably coupled to a distal portion of the third catheter 110 of the delivery device 104, as further described below.

[0073] In the illustrated embodiment, the delivery device 104 is configured to implant the prosthetic spacer device 102 in a native mitral valve, for example, via a transseptal delivery approach. In other embodiments, the delivery device 104 can be configured to implant the prosthetic spacer device 102 in the aortic, tricuspid, or pulmonary valve regions of a human heart. Furthermore, the delivery device 104 can be configured for a variety of delivery methods, including transseptal, transaortic, transventricular, etc.

[0074] The first catheter 106 and the second catheter 108 may be used, for example, to access an implantation site (eg, the native mitral valve region of the heart) and / or to position the third catheter 110 at the implantation site.

[0075] The first catheter 106 and the second catheter 108 may include a first sheath 114 and a second sheath 116, respectively. The first catheter 106 and the second catheter 108 may be configured so that the sheaths 114, 116 are manipulable. Additional details about the first catheter 104 can be found in, for example, U.S. Patent Application Publication No. 2018 / 0126124. Additional details about the second catheter 106 can be found in, for example, U.S. Patent No. 10,076,638.

[0076] Still reference Figure 1 As mentioned above, the delivery device 104 may also include a third catheter 110. The third catheter 110 may be used, for example, to deliver, manipulate, position, and / or deploy the prosthetic spacer device 102 at an implantation site. The third catheter 110 may include an inner shaft or actuation shaft 118, a coupling 120, an outer shaft 122, a handle 124, and a buckle control member 126. The proximal portion 122a of the outer shaft 122 may be coupled to the handle 124 and extend distally from the handle 124. The distal portion 122b of the outer shaft 122 may be coupled to the coupling 120, which can be releasably coupled to the proximal portion of the prosthetic spacer device 102. The proximal portion 118a of the actuation shaft 118 may be coupled to an actuation knob 128. The actuation shaft 118 may extend distally from the knob 128, through the handle 124, through the outer shaft 122, and through the coupling 120. The actuation shaft 118 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 122 and the handle 124. The distal portion of the actuation shaft 118 can be releasably coupled to the distal portion of the prosthetic spacer device 102. The buckle control member 126 can extend through the handle 124 and the outer shaft 122 and can be axially movable relative to the handle 124 and the outer shaft 122. The buckle control member 126 can also be axially movable relative to the actuation shaft 118. The buckle control member 126 can be releasably coupled to the prosthetic spacer device 102.

[0077] In a specific embodiment, the delivery device 104 may include one or more expansion shafts (not shown). The expansion shaft can be releasably coupled to the prosthetic spacer device 102 and in fluid communication with the prosthetic spacer device 102. In this manner, an expansion medium (e.g., a saline solution) can flow from a medium source (e.g., a reservoir) through the expansion shaft and flow to the prosthetic spacer device 102 to expand the prosthetic spacer device 102, and / or can flow from the prosthetic spacer device 102 through the expansion shaft and flow to the medium source to deflate the prosthetic spacer device 102. In some embodiments, the expansion shaft can extend through the third catheter 110 and / or be formed integrally with the third catheter 110.

[0078] The components of the delivery device 104 can be formed from a variety of materials, including metals and polymers. For example, in one embodiment, the proximal portion 122a of the outer shaft 122 can include stainless steel, and the distal and intermediate portions can include PEBA (e.g., ). The outer shaft 122 may also include an outer covering or coating, such as a polymer, that is reflowed over these portions.

[0079] The delivery device 104 can be releasably coupled to the prosthetic spacer device 102. In some embodiments, such as Figure 1 , a coupling 120 can be used to couple the prosthetic spacer device 102 to a portion of an outer shaft 122. In other embodiments, the prosthetic spacer device 102 can be coupled to the delivery device 104 via a plurality of tethers. The couplings and tethers will be described in more detail below.

[0080] In general, the prosthetic spacer device includes a frame having one or more anchors and an expandable spacer. In some embodiments, the expandable spacer may include a plurality of expandable members, as described in more detail below. In certain embodiments, the frame may further include at least one fastener and at least one collar. In some embodiments, the frame may include a plurality of anchors and / or a plurality of fasteners.

[0081] Figure 1-3 An exemplary embodiment of a prosthetic spacer device 102 and its components is shown. Referring now to Figure 2 , the prosthetic spacer device 102 may include a frame 130 coupled to an expandable spacer 132.

[0082] refer to Figure 6, the frame 130 may include one or more anchors 134 (e.g., two in the illustrated embodiment). In some embodiments, the frame 130 may further include a plurality of fasteners 136 (e.g., two in the illustrated embodiment), a first collar 138 located at the distal end of the prosthetic spacer device 102, and a second collar 140 located at the proximal end of the prosthetic spacer device 102. In some embodiments, the frame 130 may omit these elements, for example, one or more of the fasteners 136 and / or the first collar 138 and the second collar 140.

[0083] The anchors 134 and / or fasteners 136 of the frame 130 can be configured to secure the prosthetic spacer device 102 to one or more of the native leaflets such that the expandable spacer 132 is located between the native leaflets (e.g., see Fig.13 ). The anchor 134 can be configured to be positioned posterior to the native leaflet (e.g., on the ventricular side) when implanted so that the anchor 134 anchors the expandable spacer 132 relative to the native leaflet (see, e.g. Fig.14 ). In some embodiments, the anchor 134 and the expandable spacer 132 can be configured such that the native leaflet is captured between the anchor 134 and the expandable spacer 132.

[0084] The anchor 134 can be configured to move between various configurations by axially moving the first collar 138, and therefore the anchor 134, relative to the expandable spacer 132, along a longitudinal axis extending between the first end 132a and the second end 132b of the expandable spacer 132. For example, the anchor 134 can be positioned in a substantially straight, unfolded configuration in which the joint portions 134c of the anchor are adjacent to the longitudinal axis of the expandable spacer 132 (e.g., Fig.11 Optionally, the anchor 134 may be positioned in a fully collapsed configuration (eg, Fig. 9 ).

[0085] In certain embodiments, a fastener 136 is attached to the anchor 134. The fastener 136 can be configured to capture and secure the native leaflet to the anchor 134, e.g. Fig.13 In certain embodiments, the fasteners 136 can be independently or individually actuated so that each of the native leaflets can be captured sequentially.

[0086] Reference again Figure 6, the fastener 136 may include an attachment portion 136a and an arm portion 136b. The attachment portion 136a can be coupled to the anchor 134 in various ways, such as by sutures, adhesives, fasteners, welding, and / or means for coupling. The arm portion 136b can pivot between an open configuration and a closed configuration. In the open configuration, the attachment portion 136a and the arm portion 136b pivot away from each other so that the natural leaflet can be positioned between the attachment portion 136a and the arm portion 136b. In the closed configuration, the attachment portion 136a and the arm portion 136b pivot toward each other, thereby sandwiching the natural leaflet between the attachment portion 136a and the arm portion 136b.

[0087] In some embodiments, the buckle 136 can be formed of a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, the buckle 136 can be formed by laser cutting a flat sheet of material (e.g., nitinol) and then shaping the buckle 136.

[0088] Reference again Figure 2 In some embodiments, the prosthetic spacer device 102 can further include an anchor extension member 142 (eg, Figure 2 The anchor extension member 142 can be configured as a ring having a first or fixed end 142a connected to and extending from the first loop 138 and a second or free end 142b disposed opposite the fixed end 142a. The anchor extension member 142 can be configured to extend circumferentially further around the expandable spacer 132 than the anchor 134.

[0089] The anchor extension member 142 can further be configured such that when the prosthetic spacer device 102 is in the folded configuration (eg, Figure 2 ), the free end 142b is axially arranged adjacent to the engagement portion 134c of the anchor 134, and radially arranged between the first portion 134a and the second portion 134b of the anchor 134.

[0090] Configuring the anchor extension member 142 in this manner provides increased surface area compared to the anchor 134 alone. This can, for example, make it easier to capture and secure the native leaflet. The increased surface area can also distribute the clamping force of the anchor 134 and the anchor extension member 142 on the native leaflet over a relatively larger surface of the native leaflet to further protect the native leaflet tissue.

[0091] In some embodiments, the second collar 140 and / or the expandable spacer 132 may include a hemostatic sealing member (not shown) configured to reduce or prevent blood flow through the second collar 140 and / or into the expandable spacer 132. For example, in some embodiments, the sealing member may include a plurality of flexible flaps. The flaps may be configured to pivot from a sealing configuration to an open configuration to allow the delivery device to extend through the second collar 140. When the delivery device is removed, the flaps may be configured to return to the sealing configuration from the open configuration.

[0092] In other embodiments, for example, Figure 7 and Figure 8 As shown in FIG. 1 , the prosthetic device may include a third collar 144 coupled to the distal portion of the expandable spacer 132 (eg, see FIG. 1 ). Figure 7 The anchor 134 may be coupled to the third loop 144 by integrally forming the third loop 144 and the anchor 134 as a single, unitary component (see, e.g., Figure 7 and Figure 8 ). In other embodiments, the third collar 144 and the anchor 134 may be coupled together by welding, fasteners, adhesives, and / or other means for coupling. In still other embodiments, the third collar 144 may be omitted, and the anchor 134 may be directly coupled to the first end 132a of the expandable spacer 132.

[0093] Reference again Figure 2 , the frame 130 can be coupled to the expandable spacer 132. The frame 130 can be coupled to the expandable spacer 132 by fasteners, adhesives, sutures, and / or other coupling means. In some embodiments, the first end 134a of the anchor 134 can be coupled to and extend from the first end 132a of the expandable spacer 132, and the second end 134b of the anchor 134 can be coupled to the first loop 138. The second loop 140 can be coupled to the second end 132b of the expandable spacer 132.

[0094] The expandable spacer 132 can be configured to be positioned within the native valve orifice to fill the space between the non-functioning native leaflets that are unable to fully coapt naturally. As a result, the expandable spacer 132 can help form a more effective seal between the native leaflets and prevent or minimize regurgitation (e.g., mitral regurgitation). In some embodiments, the expandable spacer 132 may include a shape and / or structure that allows the native leaflets to close around the sides of the expandable spacer 132 to prevent retrograde blood flow (e.g., blood flowing from the left ventricle back into the left atrium during ventricular systole).

[0095] The expandable spacer 132 can expand and deflate between an unexpanded configuration and an expanded configuration. The unexpanded configuration can be used, for example, to reduce the radial profile of the prosthetic spacer device 102 as it is advanced through the patient's vasculature to an implantation site. The expanded configuration can be used, for example, to prevent regurgitation through the native valve leaflets.

[0096] In certain embodiments, the expandable spacer 132 can be expanded by introducing an expansion medium such as an expansion fluid and / or a non-fluid. The expansion fluid can be, for example, a saline solution, a curable epoxy resin, blood, and / or other materials configured for expansion. Conversely, the spacer 132 can be deflated by removing the fluid from the spacer. In some embodiments, if the material forming the expandable spacer 132 is sufficiently strong, the expansion fluid can be a gaseous fluid, such as an inert gas (e.g., a gas that does not chemically react or does not at least undesirably react with the body or components of the prosthetic spacer device under delivery conditions or after implantation). Suitable gases may include nitrogen, carbon dioxide, helium, and argon, including mixtures thereof. Other gases (such as oxygen) may be included in a mixture of gases (such as air). The non-fluid can be, for example, a plurality of granules and / or a plurality of microbeads. Embodiments that use a non-fluid to expand the expandable spacer 132 can, for example, allow for the use of a relatively simple seal because the seal does not need to maintain fluid pressure of the inflation fluid and / or does not need to maintain hemostasis to maintain the expandable spacer 132 in the expanded configuration. Combinations of fluids (e.g., saline solution and curable epoxy), combinations of non-fluids (e.g., microbeads and pellets), and / or combinations of fluids and non-fluids (e.g., saline solution and microbeads) can be used to expand the expandable spacer 132.

[0097] In some embodiments, the expandable spacer 132 may be impermeable to blood. In other embodiments, the expandable spacer 132 may be partially or completely permeable to blood, thereby filling the lumen or chamber 146 of the expandable spacer 132 with blood (see Figure 6 ).

[0098] In some embodiments, the expandable spacer 132 can be a bladder or other type of expandable or fillable element. The expandable spacer 132 can be constructed of any suitable material. In some embodiments, the material is a flexible, compliant (conformable), and / or stretchable material that can expand as an increasing amount of medium is placed in the hollow inner portion of the expandable spacer. Suitable materials include polymers such as nylon, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene, silicone, urethane, polycarbonate-based and / or polyether-based thermoplastic polyurethane (TPU).

[0099] In some embodiments, the expandable spacer 132 can be constructed of a cloth or fabric such as polyethylene terephthalate (PET), velvet, and / or other suitable cloth or fabric. In some cases, the cloth or fabric can form a bag configured to receive a non-fluid expansion medium (e.g., beads and pellets) that fills the expandable spacer 132 and thereby expands the expandable spacer 132.

[0100] In a particular embodiment, the spacer 132 is formed of a single layer 133 of material (e.g., a polymer layer) that is shaped to define the inner cavity 146. In some embodiments, the layer 133 is substantially inelastic, such that the layer 133 does not stretch when filled with an inflation medium. In other embodiments, the layer 133 is elastic and is able to stretch when inflated with an inflation medium. In alternative embodiments, the spacer 132 may include multiple layers forming a laminated structure.

[0101] The use of the expandable spacer 132 allows the prosthetic spacer device 102 to be inserted with a minimal profile (e.g., diameter) and expanded once the prosthetic spacer device is in a selected position (e.g., within the heart). The use of the expandable spacer can, for example, create a better sealing surface for the native leaflets and / or reduce mitral regurgitation.

[0102] The degree of expansion of the expandable spacer 132 can vary. For example, the expandable spacer 132 can expand from an unexpanded configuration to a diameter of 2-20 mm, or in some embodiments to a diameter of 5-15 mm. In a specific embodiment, the expandable spacer 132 can be expanded to 5 mm, 7.5 mm, 10 mm, and / or 12 mm. This adjustable expandability can, for example, allow the expandable spacer 132 to be adjusted in the patient's body during the implantation procedure to adapt to the variability of the anatomical structure of a particular patient. This in turn reduces the need to remove and / or replace the inappropriate size of the prosthetic spacer device during the delivery procedure of a larger or smaller device. Since the spacer can be adjusted to a certain range of sizes, it also provides a more precise fit. For example, the expandable spacer 132 of the prosthetic spacer device 102 can be expanded to 8 mm; while other devices may only provide a size of 5 mm or 10 mm, which is too small or too large for an 8 mm reflux orifice. In some embodiments, the size of the spacer 132 can be adjusted by adding or removing an expansion medium in a subsequent procedure. For example, if the regurgitation orifice enlarges during the patient's lifetime, the spacer 132 may be further expanded in a subsequent procedure.

[0103] The adjustable nature of the expandable spacer 132 also reduces the need to use multiple prosthetic devices at a single regurgitant location. Using only one prosthetic spacer device can, for example, make the implantation procedure relatively easier, reduce the risk of device migration, and / or reduce undesirable interference with antegrade flow through the valve.

[0104] In certain embodiments configured for implantation in a native mitral valve, the expandable spacer 132 may have an atrial end portion or upper end portion located in or adjacent to the left atrium of the heart, a ventricular end portion or lower end portion located in or adjacent to the left ventricle of the heart, and a central portion extending between the leaflets of the native mitral valve.

[0105] refer to Figure 6 , the expandable spacer 132 can have an inner cavity 146 through which the actuation shaft 118 can extend. In other embodiments, the expandable spacer 132 can include an inner shaft extending from a first end 132a of the cavity through the cavity 146 to a second end 132b, wherein the shaft defines an inner cavity through which the actuation shaft 118 can extend.

[0106] like Figure 1-3 As shown in , in some embodiments, when fully or partially expanded, the expandable spacer 132 can have a symmetrical shape (e.g., oval, cylindrical, rectangular, etc.) about the transverse axis and / or the longitudinal axis of the prosthetic spacer device 102. In other embodiments, when fully or partially expanded, the expandable spacer 132 can have an asymmetrical shape about the transverse axis and / or the longitudinal axis of the prosthetic spacer device 102. In the partially expanded state, the expandable spacer 132 can be partially filled with an expansion medium, thereby allowing the shape of the expandable spacer 132 to change in situ, such as when the native mitral valve leaflets are coapted around the expandable spacer.

[0107] The inflatable spacer 132 may have a variety of shapes. In some embodiments, the inflatable spacer 132 may have a cylindrical shape (i.e., having a circular cross-sectional shape taken in a plane perpendicular to the longitudinal axis of the prosthetic spacer device 102). In other embodiments, the inflatable spacer 132 may be substantially rectangular, elliptical, annular, semicircular, or have another shape configured to produce a surface against which the natural leaflets can engage. In some embodiments, the inflatable spacer 132 may be an uneven shape that is configured to fill the space between non-functioning natural leaflets that cannot fully engage. In some embodiments, the inflatable spacer may have tapered ends and / or tapered sides. In a specific embodiment, when the spacer 132 is expanded, the spacer has a variable width or diameter along its length, wherein the diameter or width is the largest at the middle portion 132c between the first end 132a and the second end 132b of the spacer. The spacer tapers from the middle portion 132c to the first and second ends, the first and second ends having a diameter or width that is smaller than the diameter of the middle portion.

[0108] refer to Figures 4A-5B , shows a representative embodiment of a prosthetic spacer device 102 for improving the coaptation of a natural or artificial heart valve leaflet. The prosthetic spacer device 102 may include an expandable spacer 132, the expandable spacer 132 including a plurality of expandable members 200 (e.g., 2-4 members), each expandable member 200 having an inner cavity or chamber that can be filled with an expansion medium. The expandable members 200 can be different structures or can be a single structure with multiple chambers. The expandable members 200 can be coupled to the frame 130, and in some embodiments, the expandable members can be coupled together. To better illustrate the expandable members, in Figures 4A-5B The anchor extension member 142 is not shown.

[0109] For example, in Figures 4A-5BIn the embodiment, the prosthetic spacer device 102 has an expandable spacer including two expandable members 200a, 200b. The first expandable member 200a and the second expandable member 200b can be parts of an integral expandable body or structure, such as a sac. For example, the integral body can be formed by a single polymer layer or a laminated structure, and then fluidly divided into multiple chambers, such as by bonding the opposite sides of the body to each other (e.g., by welding or, for example, adhering using an adhesive such as epoxy resin). In other embodiments, the first expandable member 200a and the second expandable member 200b may include separate expandable bodies or structures (e.g., separate sacs) and may be appropriately fixed to each other (e.g., by mechanical means and / or using an adhesive and / or other type of bonding mechanism). Although the spacer device in the illustrated configuration includes two expandable members, in other embodiments, the spacer device may have any number of expandable members, such as three, four, five, six, or more expandable members.

[0110] Whether the expansion members are different parts of the same expandable structure or separate expandable structures, in some embodiments, the expandable members can be in fluid communication with each other, while in other embodiments, the expandable members can be fluidly separated or sealed from each other. When the expandable members are in fluid communication with each other, they can be shaped or configured to expand to different volumes to achieve an overall asymmetric shape, as discussed further below.

[0111] In some embodiments, the spacer 132 defines a longitudinally extending opening or cavity between the expandable members 200, extending from the collar 140 to the collar 138, through which the actuation shaft 118 can extend. In some embodiments, the expandable spacer 200 can be coupled to a centrally disposed shaft or sleeve 206 ( Figure 4A ), the actuation shaft 118 can extend through the shaft or sleeve. The shaft 206 can be coupled to the expandable spacer 200 in various ways, such as by fasteners, sutures, adhesives, and / or other means for coupling. The shaft 206 can extend axially from one collar 138 to another collar 140.

[0112] Still reference Figures 4A-5B , the expandable member 200 can extend laterally from opposite sides of the shaft 206 and the collars 138, 140 when expanded, and can be flush or at least substantially flush with the shaft 206 when unexpanded. Figure 4A-4B , expandable member 200a is expanded and extends from shaft 206 in length dimension L (measured from the center or midpoint of prosthetic spacer device 102 to outer edge 210 of expandable member 200) and in width dimension W (measured between opposing major surfaces 202, 204), and expandable member 200b is unexpanded and substantially flush with shaft 200b. Figure 5A-5B In the embodiment, both expandable members 200a, 200b are expanded. The expandable members 200a, 200b can be configured so that each of the expandable members 200a, 200b can extend in length L, width W, and / or height H to a degree that is greater than or equal to 100%. Figures 4A-5B For example, the extent to which one or more of the expandable members extend when expanded may vary from 1 to 50%. Figure 4A-4B The expandable members 200a depicted may be larger or smaller, and the extent to which one or more of the expandable members when not expanded may be greater than 200a. Figure 4A-4B The expandable member 200b depicted is larger or smaller.

[0113] The expandable members 200 can partially expand, fully expand, and / or deflate independently of one another. In some embodiments, each of the expandable members 200 can be deflated and / or partially or fully expanded independently of one another to create various symmetrical or asymmetrical configurations. Figure 4A and 4B An exemplary asymmetric configuration is shown, which is achieved by expanding the first expandable member 200a to an expanded configuration and maintaining the second expandable member 200b in an unexpanded configuration.

[0114] Figure 5A-5B The same device is shown in an exemplary symmetrical configuration, achieved by expanding both the first expandable member 200a and the second expandable member 200b to their expanded configurations. Figures 4A-5B The first expandable member 200a and the second expandable member 200b are both shown to have substantially the same size and shape, but in other embodiments, the first expandable member 200a can have a different shape and / or configuration than the second expandable member 200b. This can provide additional adjustability of the prosthetic spacer device 102, for example.

[0115] refer to Figure 4A and 4B , when fully expanded, each member 200a, 200b may have a height H (measured from the upstream end to the downstream end of the member), a length L (measured in the radial direction from the center or midpoint of the prosthetic spacer device 102 to the outer edge of the member), and a width W (measured between the two major surfaces 202, 204 of the member). In embodiments where one or more of the dimensions H, L, and / or W are not constant, the dimensions may be nominal values ​​or average values, or may be measured at specific locations. For example, if the width W at the outer edge is less than the width at one or more other locations, the width W may be measured at the midpoint of the length (i.e., L / 2).

[0116] In some embodiments, each member 200a, 200b has the same size and shape when fully expanded. In some embodiments, each member 200a, 200b has the same shape when fully expanded, but one member has one or more of the dimensions H, L, or W that are different from the other member. For example, one member may be longer, wider, and / or taller than the other member. In still other embodiments, the members 200a, 200b may have different shapes when fully expanded. For example, one member may have Figures 4A-5B The shapes shown in FIG. 1 are shown in FIG. 3 , while other components may have different shapes, such as a circular or oval cross-section.

[0117] In embodiments configured for implantation in a native mitral valve, the height H may generally correspond to the superior / inferior anatomical direction, the length L may correspond to the medial / lateral anatomical direction, and the width W may correspond to the anterior / posterior anatomical direction. In embodiments configured for implantation in other locations, the height H, length L, and width W may correspond to other anatomical directions.

[0118] In a specific embodiment, the height H may be in the range of about 2.5 mm to about 20 mm, and more specifically in the range of about 5 mm to about 15 mm, with 11 mm being a specific example; the length L may be in the range of about 1 mm to about 20 mm, and more specifically in the range of about 2.5 mm to about 15 mm, with 10 mm being a specific example; the width W may be in the range of about 1 mm to about 15 mm, and more specifically in the range of about 2 mm to about 10 mm, with 5 mm being a specific example.

[0119] In some embodiments, the length L can be greater than the width W when the expandable member 200 is expanded.

[0120] The shapes and configurations of the symmetrical and asymmetrical expandable spacers allow for variability in the positioning of the prosthetic spacer device 102 along the native leaflet. Based on the in vivo echo images, the physician can decide whether symmetrical or asymmetrical expansion of the prosthetic spacer device 102 would be more beneficial to the patient. In patients where anatomical considerations limit possible attachment locations, the ability to asymmetrically expand the expandable spacer (e.g., by expanding one or more expandable members 200) can reduce the need for additional implants and thereby reduce the risks associated therewith. For example, a physician can attach the prosthetic spacer device 102 to the native leaflet at a position (e.g., toward the Al / Pl position of the native leaflet when implanted in the mitral valve) that deviates from the regurgitant position (e.g., at the A2 / P2 position of the native mitral leaflet) and asymmetrically expand the expandable spacer so that the expandable spacer blocks regurgitation in the A2 / P2 position but does not block the Al / P1 position. In addition, the adjustable nature of the expandable spacer allows repositioning and / or readjustment of the prosthetic spacer device 102 during implantation, as described in more detail below. This may also allow adjustment of the prosthetic spacer device 102 after initial implantation (eg, during a subsequent procedure).

[0121] Expanding the expandable members 200a, 200b to different sizes creates an asymmetry about the longitudinal axis of the prosthetic device. In other embodiments, instead of or in addition to having longitudinal asymmetry, the prosthetic device 102 may include expandable members that are arranged to provide asymmetry about a transverse axis (an axis parallel to the length L) and perpendicular to the longitudinal axis (an axis parallel to the height H). For example, in some embodiments, the prosthetic device may include an expandable member at the upstream end of the device and a separate expandable member at the downstream end of the device. The expandable members at the upstream and downstream ends may be expanded to different volumes to achieve asymmetry about a transverse axis that bisects the device midway between the upstream and downstream ends of the prosthetic device.

[0122] As described above, the spacer device can be releasably coupled to the delivery apparatus 104. In some embodiments, the delivery apparatus 104 can be used to expand and / or deflate the expandable spacer.

[0123] In some embodiments, the second collar 140 can facilitate expansion of the prosthetic spacer device 102 via the delivery apparatus 104. Figure 6, the second collar may include a central opening configured to slidably receive, for example, an actuation shaft 118, which may be used to deliver an inflation medium during an implantation procedure to inflate the expandable spacer 132. For example, a proximal portion of the actuation shaft 118 may be fluidly connected to a source of medium and may include one or more side openings 147 spaced along the length of the portion of the shaft located within the lumen 146 of the spacer. Pressurized inflation medium from the source of medium may flow through the lumen of the actuation shaft 118, through the openings 147, and into the expandable spacer 132.

[0124] In such an embodiment, the second collar 140 may include a sealing member (not shown), such as a hemostatic sealing member. In a specific example, the sealing member can be a slit valve formed of an elastomer (e.g., rubber) or other self-sealing material, which defines a central opening for receiving the actuation shaft 118. The slit valve can be housed within the outer ring of the collar 140. When formed of an elastomeric material, the central hole of the slit valve can be expanded to accommodate the passage of the actuation shaft 118 (or a separate expansion shaft of a delivery device) into the prosthetic device 102. When inserted through the central hole, the slit valve can seal around the outer surface of the shaft. When the shaft is withdrawn from the prosthetic device 102, the central hole of the slit valve is closed under the elasticity of the elastomeric material.

[0125] In an embodiment where the expandable spacer includes multiple expandable members (e.g., two), the actuation shaft may, for example, be formed with a first cavity and a second cavity that separately deliver the expansion medium to the first expandable member and the second expandable member, respectively. The first cavity may extend from the proximal end of the actuation shaft through the actuation shaft to a first side opening formed in the shaft at an appropriate position within the first expandable member. The second cavity may extend from the proximal end of the actuation shaft through the actuation shaft to a side opening formed in the shaft at an appropriate position within the second expandable member. In this way, the expansion medium can be delivered to the first expandable member and the second expandable member simultaneously or continuously through a separate media path. Instead of a separate cavity, the expansion medium can be delivered to the first expandable member and the second expandable member via a separate catheter or tube extending through the collar or away from the collar.

[0126] Reference now Figure 4A In some embodiments, the second collar 140 and / or another portion of the prosthetic spacer device 102 may include an expansion valve 151 that can be used to control the flow of an inflation medium into the expandable members 200a, 200b. The expansion valve 151 can be a slit valve, a check valve, and / or another type of valve configured to regulate or control the expansion and / or deflation of the expandable member(s).

[0127] In embodiments where the expandable spacer includes a plurality of expandable members, each expandable member may have a corresponding expansion valve 151. For example, Figure 4A As shown in , the collar 140 accommodates a first expansion valve 151a and a second expansion valve 151b, each of which controls the flow of an expansion medium to a respective expandable member 200a, 200b via a respective medium path 153a, 153b that may be formed in the central shaft 206. In some embodiments, the expansion valve 151 may be an elastic slit valve as described above, and may be configured to allow a respective expansion shaft to be inserted through the valve, into the medium path 153a, 153b, to deliver the expansion medium to the expandable member 200a, 200b. In other embodiments, the expansion valves 151a, 151b may be check valves configured to form a releasable connection with the respective expansion shaft. For example, during delivery and deployment of the prosthetic valve, the respective expansion shaft may be screwed into the expansion valve, and then after the prosthetic device 102 is deployed, the respective expansion shaft may be unscrewed from the expansion valve and removed from the patient.

[0128] In other embodiments, the expandable spacer of the prosthetic spacer device 102 can be expanded by regulating the flow of blood into the spacer rather than introducing an external inflation medium into the body. For example, the inflation valve 151 of the expandable spacer can be a one-way valve, including a check valve, a hemostatic valve, and / or other suitable valves configured to regulate the flow of blood into these components.

[0129] For example, the expandable spacer may include, for example, a check valve (such as represented by valve 151) housed in the second collar 140, which is configured to allow blood to flow through the one or more lumens of the expandable spacer in only one direction through the check valve. The check valve can be configured so that when the pressure at the inflow end of the check valve reaches a minimum threshold (also referred to as a "cracking pressure"), the check valve can move to an open position, thereby allowing blood to pass through the valve and into the lumen of the expandable spacer. The check valve can, for example, be configured to have a cracking pressure that is substantially equivalent to the blood pressure of the patient in whom the spacer device is to be implanted. In this way, when the check valve is exposed to blood (e.g., when the prosthetic spacer device 102 is exposed from the sheath 116 of the delivery device 104 in the left atrium of the patient), the check valve allows the expandable spacer to fill with blood.

[0130] To implant the septum device within the native mitral valve, a one-way valve (e.g., a check valve) can be positioned at or near the upstream end of the septum (e.g., within the collar 140) and can have an opening pressure substantially equivalent to the blood pressure in the left atrium (e.g., 4-12 mmHg) so that during diastole, the septum can be filled with blood flowing from the left atrium to the left ventricle. Alternatively, a one-way valve (e.g., a check valve) can be positioned at or near the downstream end of the septum (e.g., within the collar 138) and can have an opening pressure substantially equivalent to the blood pressure in the left ventricle (e.g., 100-140 mmHg) so that during systole, the septum can be filled with blood in the left ventricle flowing toward the left atrium.

[0131] In some embodiments, the check valve may be a ball check valve, a diaphragm check valve, a swing check valve, an inline check valve, or another type of check valve.

[0132] In some embodiments, the expandable spacer may include a structure-generating material and / or gel arranged within the inner cavity (e.g., the material may fill or partially fill the inner cavity and / or may be an inner coating lining an outer layer) such that when a medium (e.g., a fluid such as blood, saline solution, epoxy resin, gas, etc.) enters the inner cavity of the expandable spacer, the medium contacts the gel and causes the gel to expand and / or solidify within the expandable spacer cavity.

[0133] In other embodiments, the lumen of the expandable spacer may be coated with a coagulant and / or filled with a coagulant such that when blood enters the lumen of the expandable spacer, the blood contacts the coagulant and coagulates within the expandable spacer. The lumen 146 of the expandable spacer 132 may, for example, be coated with and / or filled with a gel foam (e.g., Baxter Gel Foam Plus), a hydrogel, a sponge (e.g., gelatin or other suitable material), a thrombin power (e.g., Baxter thrombin power), a hemostatic matrix (e.g., Baxter FloSeal), spun collagen hemostatic particles, and / or any other suitable material. Using a material that subsequently forms a solid (or at least more rigid) material can help provide additional structural integrity to the expandable spacer, including resistance to changes (deformations) caused by contraction of the heart and fluid flow around the prosthetic spacer device 102.

[0134] Reference now Figure 3In some embodiments, the prosthetic spacer device 102 may include a covering 152. In some embodiments, the covering 152 may be disposed over the expandable spacer 132, the anchor 134, and / or the anchor extension member 142. The covering 152 may be configured to prevent and / or reduce blood flow through the prosthetic spacer device 102 and / or promote and / or prevent or slow the ingrowth of native tissue. In some embodiments, the covering 152 may be a cloth or fabric, such as PET, velvet, or other suitable fabric. In some embodiments, the covering 152 may include: an elastic and / or dynamic material that can stretch in one or two directions to expand and / or contract when adjusting the size of the expandable spacer; a woven material that can expand and / or contract; or a folded or pleated material.

[0135] In other embodiments, the covering 152 may include a coating (e.g., a polymeric coating) applied to the prosthetic spacer device 102 instead of or in addition to the fabric. In some embodiments, the covering 152 may include an elastic cloth covering that forms a smooth, biocompatible outer surface to promote tissue growth. The elastic cloth covering the expandable spacer 132 can be relatively snug fitting around the spacer when the expandable spacer 132 is in an unexpanded state, and can stretch and expand when the spacer is expanded. In this way, if the spacer is under-expanded or not expanded at all, the elastic cloth provides a smooth outer surface around the spacer without folds or wrinkles.

[0136] In some embodiments, a first portion of the covering 152 may be configured to promote tissue ingrowth, while a second portion of the covering may be configured to prevent or slow tissue ingrowth. For example, the covering may include a material configured to promote tissue ingrowth at a location along the outer surface of the expandable spacer 132, and a material configured to slow and / or prevent tissue ingrowth at a location near and / or around the anchor 134. In another embodiment, the covering may include a material configured to promote tissue ingrowth at a location near and / or around the anchor 134, and a material configured to slow and / or prevent tissue ingrowth along the outer surface of the expandable spacer 132. This configuration allows ingrowth on the anchor 134 to secure the prosthetic spacer device 102 in place while preventing or minimizing ingrowth on the central portion of the prosthetic spacer device, thereby mitigating the possibility of mitral stenosis. According to one embodiment, the prosthetic spacer device 102 is Figure 2 , and is shown without an overlay. Figure 3 An overlay 152 is shown.

[0137] In embodiments where the prosthetic spacer device 102 includes a covering 152, the covering 152 can be configured to expand as the expandable spacer 132 expands and as the anchors 134, fasteners 136, and anchor extension members 142 move such that the covering 152 remains adjacent to the prosthetic spacer device 102 and does not billow or otherwise become entangled with components of the prosthetic spacer device.

[0138] As mentioned above, the prosthetic spacer device 102 can be releasably coupled to the delivery device 104 by various means. For example, the delivery device can be releasably coupled to the delivery device by one or more of the following: an actuation shaft, an expansion shaft, a buckle control member, a coupling, and / or a plurality of tethers.

[0139] Reference now Fig.10 , the outer shaft 122 of the delivery device 104 may include a plurality of axially extending lumens, including an actuation shaft lumen 154, a plurality of control member lumens 156 (e.g., four in the illustrated embodiment), and one or more expansion shaft lumens 158 (e.g., two in the illustrated embodiment). In some embodiments, the outer shaft 122 may include more than four (e.g., six) or less than four (e.g., two) control member lumens 156. In some embodiments, the outer shaft may include more than two (e.g., three) or less than two (e.g., one) expansion shaft lumens 158.

[0140] The actuation shaft lumen 154 can be configured to receive the actuation shaft 118, the control member lumen 156 can be configured to receive one or more fastener control members 126, and the expansion shaft lumen 158 can be configured to receive one or more expansion shafts (not shown). The lumens 154, 156, 158 can be configured so that the actuation shaft 118, the fastener control member 126, and the expansion shaft can move relative to the respective lumens 154, 156, 158 (e.g., axially and / or rotationally). In particular embodiments, the lumens 154, 156, 158 can include a lining or coating configured to reduce friction within the lumen. For example, the lumen can include a lining comprising PTFE.

[0141] In some embodiments, Figure 7-8 As shown in , the actuation shaft 118 of the third catheter 110 can be releasably coupled to the first collar 138 of the prosthetic spacer device 102. For example, the distal end portion 118b of the actuation shaft can include external threads configured to releasably engage the internal threads of the first collar 138. Thus, rotating the actuation shaft 118 relative to the first collar 138 in a first direction (e.g., clockwise) can releasably secure the actuation shaft 118 to the first collar 138. Rotating the actuation shaft 118 relative to the first collar 138 in a second direction (e.g., counterclockwise) can release the actuation shaft 118 from the first collar 138.

[0142] Reference now Figure 7 In some embodiments, the third catheter 110 can be releasably coupled to the second collar 140 of the prosthetic spacer device 102 via a coupling 120. The coupling 120 can include a plurality of flexible arms 160 and a plurality of stabilizers 162. The stabilizers 162 of the coupling can be inserted into the openings 141 of the tabs 143 of the second collar 140 ( Figure 8 ), the coupling 120 can be releasably coupled to the prosthetic spacer device 102. The flexible arm 160 can be configured to releasably couple the joint 143. Additional details about the coupling 120 can be found in, for example, U.S. Patent Application Publication No. 2018 / 0325661 and U.S. Patent Application No. 16 / 208,264.

[0143] In some embodiments, in which the delivery device includes a separate expansion shaft for delivering an expansion medium to the plurality of expansion members, a distal portion of the expansion shaft may be used in place of or in addition to the stabilizer member 162, and a sealing member in the receiving shaft collar 140 may be used in place of or in addition to the opening in the second collar 140.

[0144] In other embodiments, Fig. 9 As shown in FIG. 1 , the prosthetic spacer device 102 can be releasably coupled to the delivery device 104 using a plurality of tethers 164. The tethers 164 can extend through a plurality of tether lumens 166 (e.g., Fig.10 The tether 164 can be releasably coupled to the prosthetic spacer device 102. The second collar 140 can have a connector member (not shown) for receiving the tether 164. The connector member can, for example, include an opening, an eyelet, and / or other suitable means for connecting the tether 164 to the second collar 140. Tensioning the tether 164 moves the prosthetic spacer device 102 and the outer shaft 122 toward each other. Loosening the tether 164 allows the prosthetic spacer device 102 and the outer shaft 122 to be spaced apart from each other.

[0145] Figure 11-17 A delivery device 104 is shown that is used to implant a prosthetic spacer device 102 into a native mitral valve 300 of a heart 302, for example, using a transseptal delivery approach. Although not shown, a guidewire can be inserted into the patient's vasculature (e.g., a femoral vein) through an introducer sheath. The guidewire can be advanced through the femoral vein, through the inferior vena cava, into the right atrium, through the atrial septum 304 (e.g., via the fossa ovalis), and into the left atrium 306. A first sheath 114 of a first catheter 106 can be advanced over the guidewire so that a distal portion of the first sheath 114 is disposed in the left atrium 306, as shown. Fig.11 as shown in .

[0146] After the prosthetic spacer device 102 is coupled to the third catheter 110 (e.g., Figure 7 ) and configured in a radially compressed delivery configuration, the prosthetic spacer device 102 can be loaded into a second sheath 116 of the second catheter 108, which holds the prosthetic spacer device 102 in the delivery configuration. In some embodiments, the radially compressed delivery configuration can be an axially extended configuration (e.g., similar to Fig.11 In other embodiments, the radially compressed delivery configuration can be an axially shortened configuration (e.g., similar to Fig. 9 ). The second catheter 108 can then be advanced through the first catheter 106 along with the prosthetic spacer device 102 and the third catheter 110 so that the distal end portion of the second sheath 116 is exposed from the distal end portion of the first sheath 114, and as shown in FIG. Fig.11 As shown in , it is arranged in the left atrium 306.

[0147] Still reference Fig.11 , the prosthetic spacer device 102 can be exposed from the second sheath 114 by advancing the outer shaft 122 and the actuation shaft 118 of the third catheter 110 distally relative to the second sheath 116 and / or retracting the second sheath 116 relative to the outer shaft 122 and the actuation shaft 118, thereby forcing the anchor 134 to leave the second sheath 116. Once exposed from the second sheath 116, the anchor 134 can be folded by retracting the actuation shaft 118 of the third catheter 110 relative to the outer shaft 122 of the third catheter 110 and / or by advancing the outer shaft 122 relative to the actuation shaft 118, thereby bending the anchor 134 into a Fig.12 At any point in the procedure, the physician can lock the relative positions of the actuation shaft 118 and the outer shaft 122 , thereby locking the position of the anchor 134 , by actuating a locking mechanism (not shown) on the handle 124 of the delivery device 104 .

[0148] The prosthetic spacer device 102 can then be coaxially positioned relative to the native mitral valve 300 by manipulating (e.g., steering and / or bending) the second sheath 116 of the second catheter 108. The prosthetic spacer device 102 can also be rotated relative to the native mitral valve 300 so that the anchors 134 are aligned with the native leaflets 308 of the native mitral valve 300.

[0149] The anchor member 134 can then be partially opened (i.e., moved radially outward relative to the unexpanded expandable spacer 132) to Fig.12. The prosthetic spacer device 102 can then be advanced through the annulus of the native mitral valve 300 and at least partially into the left ventricle 310. The prosthetic spacer device 102 is then partially retracted so that the anchor 134 is positioned behind the ventricular portion of the native leaflet 308 and the expandable spacer 132 is disposed on the atrial side of the native leaflet 308.

[0150] During the implantation procedure, the expandable spacer 132 can be expanded from an unexpanded configuration at different times. For example, in some cases, the expandable spacer 132 can be expanded after the prosthetic spacer device 102 is exposed from the second sheath 116 and before the anchors 134 of the prosthetic spacer device 102 are coupled to the native leaflets 308 and / or the expandable spacer 132 is positioned between the native leaflets 308. In other cases, the expandable spacer 132 can be expanded after the prosthetic spacer device 102 is exposed from the second sheath 116 and before the anchors 134 of the prosthetic spacer device 102 are coupled to the native leaflets 308 and / or the expandable spacer 132 is positioned between the native leaflets 308.

[0151] Reference now Fig.13 , the native leaflets 308 can be fixed relative to the anchor 134 by capturing the native leaflets 308 with the fasteners 136. The native leaflets 308 can be captured simultaneously or individually. For example, Fig.13 Individual leaflet capture is shown. Additional details regarding implantation of a prosthetic spacer device can be found, for example, in U.S. Patent Application Publication 2018 / 0325661.

[0152] After the fastener 136 is closed, the physician can reopen the fastener 136 to adjust the positioning of the fastener. When the fastener is reopened, the fastener moves radially inward toward the expandable spacer 132 until the fastener 136 contacts the expandable spacer 132. With both native leaflets 308 secured within the fastener 136, the anchor 134 (and therefore the native leaflets 308) can be pulled radially inward against the expandable spacer 132, as shown in FIG. Fig.14 As shown in . The expandable spacer 132 can then be expanded. The physician can then observe a reduction in positioning and / or reflux.

[0153] The inner and / or outer surfaces of the prosthetic spacer device 102 may include additional features. For example, a portion of the prosthetic spacer device 102, such as the central portion, may house or support a radiopaque (fluoroscopic) marker or an echogenic marker, which may be used to assist in positioning and placing the prosthetic spacer device 102 during implantation. When the expandable spacer 132 is asymmetrically expanded, the marker may be used to confirm that the expandable spacer is positioned in the desired configuration.

[0154] For descriptive purposes, Figure 11-14 A prosthetic spacer device 102 is shown including a single expandable spacer 132, however, in embodiments where the prosthetic spacer device 102 includes multiple expandable members, the implantation methods described herein can have substantially the same steps.

[0155] In embodiments having multiple expandable members, the physician may expand or deflate each expandable member based on anatomical considerations of the patient. In embodiments having multiple expandable members (e.g., a first expandable member 200a and a second expandable member 200b), the physician may begin by partially or fully expanding one of the expandable members (e.g., the first expandable member 200a). The physician may then monitor the patient for mitral regurgitation. If further sealing of the mitral valve is desired, the physician may, for example, further expand the first expandable member 200a and / or expand the second expandable member 200b such that both members are at least partially expanded (e.g., as shown in FIG. 1 ). Fig.16 ).

[0156] If the positioning of the prosthetic spacer device and / or the reduction in regurgitation is not as desired, the physician may adjust the position of the prosthetic spacer device 102 within the mitral valve by reopening the anchors 134 and / or clasps 136 and releasing the native leaflets 308 and removing and / or repositioning the prosthetic spacer device 102. Additionally, the physician may inflate / deflate the expandable member to adjust the level of mitral regurgitation and / or other considerations.

[0157] The physician may then reassess the positioning and / or function of the prosthetic spacer device and, if necessary, make additional adjustments. The prosthetic spacer device may be adjusted into a variety of configurations. For example, Fig.15 An embodiment of a prosthetic spacer device 102 is shown having two expandable members 200 implanted in a symmetrical configuration, with a first expandable member 200a and a second expandable member 200b both in an unexpanded configuration. Fig.16 The same embodiment is shown in a symmetrical configuration, wherein the first expandable member 200a and the second expandable member 200b are both in a fully expanded configuration, and Fig.17 The same embodiment is shown in an asymmetric configuration, with the first expandable member 200a in an expanded configuration and the second expandable member 200b in an unexpanded configuration.Any combination of unexpanded, partially expanded, and / or fully expanded configurations for the expandable spacer may be used.

[0158] In which a coupling 120 is used (see, e.g. Figure 7-8) In embodiments where the prosthetic spacer device 102 is releasably connected to the delivery device, after the actuation shaft 118 has been proximally retracted, the stabilizer member 162 can be withdrawn from the guide opening in the second collar, thereby releasing the prosthetic spacer device 102 from the delivery device 104. The buckle control member 126 and the expansion shaft can then be proximally retracted into the lumens 156, 158 of the outer shaft 122, and the outer shaft and the actuation shaft 118 can be proximally retracted through the first catheter and the second catheter and removed from the patient's body.

[0159] In embodiments where the prosthetic spacer device is coupled to the delivery device using a plurality of tethers 164, the delivery device may be attached to the prosthetic spacer device in a manner similar to that described above and as described above. Figure 11-15 The delivery device 104 is implanted in the manner shown. However, after positioning, the physician can relax the tether 164, the fastener control member 126, and the expansion shaft so that the outer shaft 122 can be spaced apart from the proximal portion of the prosthetic spacer device 102. In this way, the prosthetic spacer device can be partially released from the delivery device 104, but the tether 164, the fastener control member 126, and the expansion shaft remain coupled to the prosthetic spacer device 102. Due to the flexibility and relaxation of the tether, the fastener control member, and the expansion shaft, the prosthetic spacer device can move and / or function as if it has been fully released from the delivery device. As a result, for example, the partially released configuration can allow the physician to better assess the functionality and / or positioning of the prosthetic spacer device 102 before fully releasing the device, and can reposition the device and / or remove the device, or can deflate / expand the expandable spacer 132 as needed to improve functionality. This is because the outer shaft 122 and / or the actuation shaft 118 are relatively more rigid than the buckle control member 126, tether 164, and expansion shaft, and may therefore change the position and / or hemodynamics of the prosthetic spacer device 102 as compared to when the prosthetic spacer device 102 is partially or completely released from the delivery device 104.

[0160] If the physician wants to adjust the positioning of the prosthetic spacer device 102, the tether 164 can be tightened and the distal portion 122b of the outer shaft 122 can be advanced distally on the tether 164 so that it is adjacent to the proximal portion of the prosthetic spacer device. The actuation shaft 118 can be advanced distally through the central cavity of the outer shaft 122 and reconnected to the first collar 138. The prosthetic spacer device 102 can then be moved relative to the natural leaflet by actuating the actuation shaft 118 and / or the fastener control member 126, thereby respectively manipulating the anchor 134 and / or the fastener 136. The prosthetic spacer device can then be moved relative to the natural leaflet by actuating the actuation shaft 118 and / or the fastener 134, respectively. The physician can then reassess the positioning and / or functionality of the prosthetic spacer device and, if necessary, make additional adjustments.

[0161] After achieving the desired positioning and / or reflux reduction, the physician can release the prosthetic spacer device 102 from the delivery device 104. The fastener 136 can be released from the delivery device 104 by releasing the fastener control member 126 and unthreading the fastener control member 126 from the opening of the fastener. The first collar 138 of the prosthetic spacer device 102 can be released from the delivery device 104 by rotating the knob 128 in a second direction (e.g., counterclockwise) so that the actuation shaft 118 is proximally retracted relative to the first collar 138. The actuation shaft 118 can then be proximally retracted through the prosthetic spacer device 102. The second collar 140 of the prosthetic spacer device can then be released from the delivery device by proximally retracting the actuation shaft 118 relative to the second collar 140.

[0162] The buckle control member, expansion shaft, and tether may then be proximally retracted into the lumens 156, 158, 166 of the outer shaft 122, and the outer shaft along with the actuation shaft 116 may be proximally retracted through the first and second catheters and removed from the patient's body.

[0163] With the prosthetic spacer device implanted at the A2 / P2 position and the delivery apparatus removed, in some embodiments, the native mitral valve may include a double orifice during ventricular diastole. During ventricular systole, the native leaflets 308 may coapt together and / or coapt against the prosthetic spacer device to prevent or reduce mitral regurgitation (see, e.g., Figure 15-17 ).like Figure 15-17 As shown in , different expanded configurations of the prosthetic spacer device create different surfaces against which the native leaflets 308 can engage.

[0164] In some embodiments, during ventricular diastole, the anchors can move radially outward relative to the expandable spacer to a partially open configuration so that the native mitral valve has a single continuous orifice. Configuring the prosthetic spacer device in this manner allows the native leaflets 308 to move naturally. This can, for example, promote antegrade blood flow during ventricular diastole while still reducing or preventing retrograde blood flow during ventricular systole. It can also reduce or prevent native tissue damage to the native leaflets 308.

[0165] In other embodiments, any of the prosthetic spacer devices disclosed herein may include an expandable spacer (having one or more expandable members) and a frame configured to be mounted on only one natural valve leaflet, such as one of the natural mitral valve leaflets. In such an embodiment, the frame may include an anchor and, optionally, a fastener for mounting on one natural leaflet. When so mounted, the prosthetic spacer device may move with the natural leaflet to which it is mounted during the cardiac cycle, while the other natural leaflet may engage against the prosthetic spacer device. In addition, the prosthetic spacer device does not need to be implanted directly on one or more natural leaflets, but instead may include any suitable anchor configured to maintain the expandable spacer between the natural leaflets of the heart valve. For example, the anchor may include a structure configured to engage a portion of a heart wall, such as a portion of a left ventricular wall, or a portion of a valve ring of a natural heart valve. For example, the prosthetic spacer device may include an expandable spacer mounted in the form of an axis on an anchor configured to engage the heart wall. In a specific embodiment, the inflatable spacer is mounted on the upper end of the shaft and the lower end of the shaft is configured to anchor against a wall of the left ventricle, such as the apex. In another example, the inflatable spacer may include a barb or other fixing device to attach to the native leaflet surface. In another example, the frame is configured to engage the inner wall of the left atrium and support the inflatable spacer in the native mitral valve downstream of the frame. More details about anchors for anchoring against different parts of the heart and that can be implemented in prosthetic spacer devices are disclosed in U.S. Patents Nos. 8,758,432 and 8,968,395. In all such examples, the inflatable spacer and / or inflatable member can be expanded and / or deflated in the manner described above.

[0166] The repair devices described herein (e.g., the prosthetic spacer device 102) have been described in the context of repairing a native mitral valve. However, it should be understood that the repair devices can be used to repair other native heart valves, or artificial heart valves or artificial heart valve components (e.g., artificial leaflets), including using various transcatheter techniques (e.g., transatrial, transventricular, etc.). The prosthetic spacer device 102 can be used, for example, to reduce or improve valvular regurgitation by improving the engagement between heart valve leaflets. In the case of artificial heart valve leaflets, after implantation of such leaflets, over time, the leaflets may exhibit altered mechanical or structural properties (e.g., drooping), or the shape of the heart or its components may change, such that the heart valve leaflets (e.g., an artificial leaflet and one or more natural leaflets, or multiple artificial leaflets, optionally with natural leaflets) may no longer engage to the desired extent. The disclosed repair device can be implanted to reposition the artificial leaflet to improve engagement with one or more other leaflets.

[0167] Although the trans-septal delivery technique has been described in detail above, any of a variety of other delivery techniques can be used to deliver the positioning device through the patient's vascular system. In a trans-femoral procedure, the delivery device can be inserted in a retrograde direction through the femoral artery and aorta to reach the heart. Alternatively, the delivery device can be inserted in an antegrade direction through the femoral vein and vena cava to reach the right side of the heart, such as for implanting the positioning device on one of the leaflets of the tricuspid valve. In a trans-ventricular procedure, the delivery device can be inserted through a surgical incision at a position on the chest and the left or right ventricle to access the valves on the left and right sides of the heart. For example, the delivery device can be inserted into the left ventricle through an incision formed on a bare spot on the lower anterior ventricular wall. Similarly, the delivery device can be inserted through a surgical incision on the right ventricular wall to enter the pulmonary valve or tricuspid valve. In a trans-atrial procedure, the delivery device can be inserted through a surgical incision formed in the left or right atrial wall to enter the natural valve on the left or right side of the heart, respectively. In a transaortic procedure, a delivery device may be inserted through a surgical incision made in the ascending aorta and advanced toward the heart. Further details of delivery techniques for accessing the native valves of the heart are disclosed in U.S. Patent No. 9,414,918.

[0168] Figure 18-19 An exemplary prosthetic spacer device 400 is illustrated. The prosthetic spacer device 400 is substantially similar to embodiment 200 except when in an unexpanded configuration. The prosthetic spacer device 400 includes a frame 402, an anchor 404, and an expandable spacer 406 having a plurality of expandable members 408 (e.g., two in the illustrated embodiment: 408a, 408b).

[0169] As shown in the illustrated embodiment, the expandable members 408a, 408b can have respective lengths L a , L b , width W a , W b , and height H a , H b The expandable members 408a, 408b can be configured such that one or more of the length, width, and / or height dimensions of the expandable members are fixed such that the expandable members do not (at least substantially) change in predetermined dimensions when the expandable members move between expanded and unexpanded configurations.

[0170] The expandable members 408a, 408b can be configured such that one or more of the length, width, and / or height dimensions of the expandable members are variable such that the expandable members change when the expandable members move between the expanded configuration and the unexpanded configuration. Figure 18-19In some embodiments, expandable members 408a, 408b are configured such that when the expandable members move between an expanded configuration (e.g., expandable member 408a) and an unexpanded configuration (e.g., expandable member 408b), the length and height dimensions of the expandable members do not change, while the width dimension does change. In some embodiments, the predetermined fixed dimensions of the two expandable members can be the same dimension (e.g., L a and L b ) and / or the same size (e.g., L a =L b In other embodiments, the predetermined fixed size of the expandable spacer may be a different size (eg, L a and W a ) and / or different sizes (e.g., L a ≠L b ).

[0171] Expandable members 408a, 408b can partially expand, fully expand, and / or deflate independently of each other. In some embodiments, each of expandable members 200 can be deflated and / or partially or fully expanded independently of each other to create various symmetrical or asymmetrical configurations. Figure 18-19 An exemplary asymmetric configuration is shown, which is achieved by expanding the first expandable member 408a to an expanded configuration and maintaining the second expandable member 408b in an unexpanded configuration. In the illustrated embodiment, expanding the expandable members 408a, 408b increases the width W a , thereby occupying more space between the opposing leaflets of the regurgitant valve, while the height H a and length L a Remains constant or substantially constant after expansion.

[0172] In other aspects, the prosthetic spacer device 400 can be configured to function substantially similarly to the prosthetic spacer device 200 (eg, expanded and / or deflated, implanted, and repositioned).

[0173] Unless stated otherwise, features described in relation to any example may be combined with other features described in any one or more other examples.

[0174] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. Implantable prosthetic devices, including: an expandable spacer having an inner lumen, the expandable spacer being expandable between an unexpanded configuration and an expanded configuration, wherein in the expanded configuration the expandable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween; and a frame comprising at least one anchor configured to be placed on one side of one of the native leaflets, and a fastener coupled to the anchor and configured to be placed on another side of the one native leaflet, wherein the fastener is movable between an open position and a closed position, wherein when in the closed position, the fastener is configured to retain a portion of a native leaflet to the anchor, and Wherein the expandable spacer is configured to expand from the unexpanded configuration to the expanded configuration by filling an inner lumen of the expandable spacer with an expansion medium.

2. The implantable prosthetic device of claim 1, further comprising a source of the inflation medium, wherein the inflation medium comprises a saline solution.

3. The implantable prosthetic device of claim 1, wherein the expandable spacer is configured to receive blood to expand the expandable spacer from the unexpanded configuration to the expanded configuration.

4. An implantable prosthetic device according to any preceding claim, wherein the expandable spacer comprises an expansion valve.

5. The implantable prosthetic device of claim 4, wherein the expansion valve is a check valve.

6. An implantable prosthetic device according to any preceding claim, wherein the inner cavity comprises a matrix material.

7. An implantable prosthetic device according to any preceding claim, further comprising a stretchable covering covering an outer surface of the expandable spacer.

8. The implantable prosthetic device of claim 7, wherein the stretchable covering comprises a material configured to promote tissue ingrowth.

9. An implantable prosthetic device according to any of the preceding claims, wherein the expandable spacer includes a longitudinal axis extending from an upstream end to a downstream end of the spacer, and when the spacer is at least partially expanded, the spacer is configured to form an asymmetric shape about the longitudinal axis.

10. Implantable prosthetic devices, including: an expandable spacer configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween, the spacer comprising a plurality of expandable members each having an inner lumen, each expandable member being expandable between an unexpanded configuration and an expanded configuration; and At least one anchor configured to anchor the expandable spacer relative to the native leaflet; wherein each expandable member is independently expandable to a respective expanded configuration.

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