Heart valve repair devices and methods

Abstract

Methods and assemblies are disclosed for reducing regurgitation through a native heart valve. An implantable device for treating a native heart valve comprises a support member with a coiled section and an expandable member extending radially around the support member in a portion of the coiled section. The expandable member defines an inner lumen and is movable from a delivery configuration to a deployed configuration, where the inner lumen has a first diameter in the delivery configuration and a second, smaller diameter in the deployed configuration. The second diameter is adjusted to adjust an inward radial force applied to the native valve, increasing tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native valve, thereby reducing backflow through the native valve.

Description

Attorney Docket No: THVMC-23550WO01 HEART VALVE REPAIR DEVICES AND METHODS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 625,096, filed on January 25, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to heart valve repair devices and methods. BACKGROUND

[0003] Native heart valves (e.g., the aortic, pulmonary, tricuspid and mitral valves) regulate the flow of blood in the human body by temporarily opening to permit forward flow of blood and then closing to prevent backward flow (or regurgitation) of blood. However, various congenital, inflammatory, infectious, and / or other conditions can cause these native heart valves to malfunction. For example, a defective native heart valve may not fully close when it is supposed to, thereby resulting in some undesirable regurgitation of blood. As another example, calcium deposits can collect around the native heart valve, thereby narrowing the opening of the valve (referred to as “stenosis”) and restricting blood-flow through the valve. Such conditions can eventually lead to serious malfunctioning of the heart, requiring repair and / or replacement of the native valve. Accordingly, devices and methods for repairing a malfunctioning native heart valve are desirable. SUMMARY

[0004] The present disclosure relates to devices and methods for reducing regurgitation through a native valve. Specifically, the present disclosure is directed to an implantable and expandable coil device implanted around the native valve leaflets, the native chordae tendineae, or both theAttorney Docket No: THVMC-23550WO01 native valve leaflets and the native chordae tendineae of the native heart valve. When expanded, the coil device can apply an adjustable inward radial force on a native heart valve, increasing tension within the native valve leaflets and / or the native chordae tendineae to reduce regurgitation. In some instances, a prosthetic heart valve can be deployed within the coil device, the coil device acting as a docking device for the prosthetic heart valve.

[0005] An implantable device for treating a native heart valve can comprise a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end. In addition to these components, the implantable device can comprise one or more of the components disclosed herein.

[0006] In some examples, the implantable device can comprise a balloon.

[0007] In some examples, the balloon can extend radially around at least a portion of the coiled section of the support member.

[0008] In some examples, the balloon can define an inner lumen of the implantable device.

[0009] In some examples, the balloon can move from a delivery configuration to a deployed configuration.

[0010] In some examples, the inner lumen can have a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration.

[0011] In some examples, the second inner diameter can be smaller than the first inner diameter.

[0012] In some examples, the balloon can comprise an inflation port through which a fluid can be injected to expand the balloon.

[0013] In some examples, the balloon can comprise a first segment and a second segment.

[0014] In some examples, the first segment of the balloon can move from the delivery configuration to the deployed configuration defining the second inner diameter.Attorney Docket No: THVMC-23550WO01

[0015] In some examples, the second segment of the balloon can move to a deployed configuration defining third inner diameter.

[0016] In some examples, the third inner diameter can be different than the second inner diameter.

[0017] In some examples, the device can further comprise an additional balloon extending radially around at least a portion of the coiled section of the support member.

[0018] In some examples, the additional balloon can move to a deployed configuration defining a fourth diameter.

[0019] In some examples, the balloon can comprise a cover disposed over at least a portion of the balloon.

[0020] In some examples, the coiled section of the support member can encircle native leaflets and native chordae tendineae of the native heart valve.

[0021] In some examples, the coiled section and the balloon in the deployed configuration together can apply an inward radial force on the native heart valve to increase tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native valve.

[0022] In some examples, the inward radial force can be adjusted.

[0023] In some examples, the coiled section of the support member can receive a prosthetic heart valve and secure the prosthetic heart valve relative to the native anatomy.

[0024] In some examples, the implantable device can comprise a braid extending radially around at least a portion of the coiled section of the support member.

[0025] In some examples, the braid can be movable from a delivery configuration to a deployed configuration.Attorney Docket No: THVMC-23550WO01

[0026] In some examples, the braid can comprise a first end portion and a second end portion, where the first end portion can be fixed to the support member and the second end portion can translate axially along the support member to expand the braid.

[0027] In some examples, the second end portion can be fixed to the coiled section of the support member after the braid is expanded.

[0028] In some examples, a cover can be disposed over at least a portion of the braid.

[0029] In some examples, the braid can comprise a lead screw mechanism or a ratcheting mechanism to translate the second end axially along the support member during expansion.

[0030] In some examples, an implantable device for treating a native heart valve comprises a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end, and a balloon comprising a wall and extending radially around at least a portion of the coiled section of the support member, where the balloon defines an inner lumen of the implantable device. The balloon is movable from a delivery configuration to a deployed configuration, where the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.

[0031] In some examples, an implantable device for treating regurgitation in a native heart valve comprises a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end, and an expandable member extending radially around at least of portion of the coiled section of the support member, where the expandable member defines an inner lumen of the implantable device. The expandable member is movable from a delivery configuration to a deployed configuration, where the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter. The implantable device applies an inward radial force on the native heart valve to increase tension within the nativeAttorney Docket No: THVMC-23550WO01 valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native heart valve.

[0032] In some examples, an implantable device for treating regurgitation in a native heart valve comprises one or more of the acts or components recited in Examples 1-19 below.

[0033] A method of reducing regurgitation through a native heart valve can comprise positioning an implantable device around native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve. In addition to this step, the method of reducing regurgitation through a native heart valve can further comprise one or more of the steps disclosed herein.

[0034] In some examples, the implantable device can be in a delivery configuration and can comprise a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end.

[0035] In some examples, the implantable device can comprise an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, where the inner lumen can have a first diameter in the delivery configuration.

[0036] In some examples, the method can further comprise expanding the expandable member from the delivery configuration to a deployed configuration, where the inner lumen can comprise a second diameter in the deployed configuration.

[0037] In some examples, the second diameter can be smaller than the first diameter such that the expandable member can urge the native leaflets inwardly and reduce regurgitation through the native heart valve.

[0038] In some examples, the method can further comprise adjusting the second diameter to vary an inward radial force applied to the native valve to alter tension within the native valveAttorney Docket No: THVMC-23550WO01 leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation.

[0039] In some examples, the expandable member can comprise an inflatable balloon.

[0040] In some examples, the method can further comprise attaching an inflation tube to an inflation port extending through a balloon wall to add or remove a fluid within the balloon.

[0041] In some examples, the method can further comprise using the inflation tube to adjust a volume of the fluid within the balloon to vary the second diameter.

[0042] In some examples, the method can further comprise inserting a prosthetic heart valve within an annulus of the native heart valve as part of a subsequent procedure, where the coiled section of the support member and the balloon can encircle the native heart valve and the prosthetic heart valve.

[0043] In some examples, the method can further comprise deflating the balloon before inserting the prosthetic heart valve within the annulus.

[0044] In some examples, the method can further comprise expanding the balloon after inserting the prosthetic heart valve, where the second diameter can be configured to cooperate with the prosthetic heart valve to secure the prosthetic valve in place.

[0045] In some examples, the expandable member can further comprise a second balloon and the method can further comprise attaching a second inflation tube to a second inflation port extending through a second balloon wall to add or remove a fluid within the second balloon.

[0046] In some examples, the method can further comprise using the second inflation tube to adjust a volume of the fluid within the second balloon to vary a third diameter.

[0047] In some examples, the expandable member can comprise a braid.Attorney Docket No: THVMC-23550WO01

[0048] In some examples, the method can further comprise inserting a prosthetic heart valve within the annulus of the native heart valve as part of a subsequent procedure, where the coiled section of the support member and the braid can encircle the native heart valve and cooperate with the prosthetic heart valve within the annulus to secure the prosthetic valve in place.

[0049] In some examples, the method can further comprise relaxing the braid before inserting the prosthetic heart valve into the annulus.

[0050] In some examples, the method can further comprise expanding the braid after inserting the prosthetic heart valve, where the second diameter can be configured to cooperate with the prosthetic heart valve to secure the prosthetic valve in place.

[0051] In some examples, a method of reducing regurgitation through a native heart valve comprises positioning an implantable device around native leaflets native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve, where the implantable device is in a delivery configuration and comprises a support member. The support member comprises a first end, a second end, and a coiled section disposed between the first end and the second end and an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, where the inner lumen has a first diameter in the delivery configuration. The method further comprises expanding the expandable member from the delivery configuration to a deployed configuration, where the inner lumen comprises a second diameter in the deployed configuration that is smaller than the first diameter such that the expandable member urges the native leaflets inwardly and reduces regurgitation through the native heart valve.

[0052] In some examples, a method of reducing regurgitation through a native heart valve comprising one or more of the acts or components recited in Examples 20-35 below.

[0053] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify keyAttorney Docket No: THVMC-23550WO01 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 disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] FIG. 1 is a schematic view of an example of a delivery apparatus and an expandable coil device during an implantation procedure within a patient’s native mitral valve.

[0055] FIG. 2 is a detail view of the heart and the expandable coil device of FIG. 1, where the heart is shown in cross-section and the expandable coil device comprises a balloon, and where the balloon is shown in a deflated state.

[0056] FIG. 3 is a perspective view of the expandable coil device of FIG. 2, showing the native valve leaflets and the native chordae tendineae of the native valve from the left ventricle.

[0057] FIG. 4 is a detail view of the expandable coil device and the native heart valve of FIG. 2 with a balloon inflation tube, before expanding the balloon.

[0058] FIG. 5 is a perspective view of the expandable coil device with the balloon in a deflated state.

[0059] FIG. 6 is a cross-sectional view of the expandable coil device of FIG. 5.

[0060] FIG. 7 is a detail view of the expandable coil device and the native heart valve of FIG. 2, after expanding the balloon and before removing the balloon inflation tube.

[0061] FIG. 8 is a perspective view of the expandable coil device of FIG. 7 with the balloon in an expanded state.

[0062] FIG. 9 is a cross-sectional view of the expandable coil device of FIG. 8.Attorney Docket No: THVMC-23550WO01

[0063] FIG. 10 is a detail view of the expandable coil device and the native heart valve of FIG. 7, after expanding the balloon and removing the balloon inflation tube.

[0064] FIG. 11 is a detail view of the native heart valve and an example of an expandable coil device comprising a balloon with various diameters, after expanding the balloon and removing the balloon inflation tube.

[0065] FIG. 12 is a detail view of the native heart valve and an example of an expandable coil device comprising a plurality of balloons after expanding the balloons and removing balloon inflation tubes.

[0066] FIG. 13 is a detail view of a native heart valve and an expandable coil device comprising a braid, after inserting the expandable coil device around the native heart valve and before expanding the braid, according to an example.

[0067] FIG. 14 is a detail view of the native heart valve and the expandable coil device of FIG. 13, after expanding the braid.

[0068] FIG. 15 is a schematic view of an example of delivery and deployment of a prosthetic heart valve within an expandable coil device.

[0069] FIG. 16 is a side perspective view of a prosthetic heart valve, according to an example.

[0070] FIG. 17 is a detail view of the native heart in FIG. 15 showing the expandable coil device and the inflation tube of FIG. 4, after deploying the prosthetic heart valve and before expanding the balloon, where the prosthetic valve is shown schematically.

[0071] FIG. 18 is a detail view of the native heart in FIG. 15 showing the expandable coil device and the inflation tube of FIG. 7, after deploying the prosthetic heart valve and expanding balloon.

[0072] FIG. 19 is a top view of the expandable coil device of FIG. 18 with the deployed prosthetic heart valve of FIG. 16.Attorney Docket No: THVMC-23550WO01 DETAILED DESCRIPTION General Considerations

[0073] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0074] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0075] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.Attorney Docket No: THVMC-23550WO01

[0076] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0077] As used herein, “for example” means “for example,” and “e.g.” means “that is.” Examples of the Disclosed Technology

[0078] Described herein are examples of devices and methods for repairing and / or replacing a native heart valve. In some examples, the devices and methods can be used to repair or replace a native valve suffering from regurgitation. In some instances, the native valve can be a native mitral valve. In some instances, the native valve can be a native aortic valve, a native tricuspid valve, or a native pulmonary valve.

[0079] Depicted herein is an exemplary procedure for implantation of an expandable coil device 10 (also referred to herein as a “coil device” or an “implantable device”) around a native heart valve, where the coil device 10 comprises an expandable member, according to an example. During the procedure, a user delivers and implants the expandable coil device around a patient’s native heart valve using a coil delivery apparatus. After implanting and expanding the coil device, the coil delivery apparatus can be removed from the patient.

[0080] FIG. 1 depicts a portion of the implantation procedure where the expandable coil device 10 is being implanted at a mitral valve 12 (also referred to herein as a “valve”) of a heart 14 of a patient 16 using a delivery apparatus 18 (which may also be referred to herein as “catheter” and / or “delivery device”).Attorney Docket No: THVMC-23550WO01

[0081] In general, the delivery apparatus 18 comprises a delivery shaft 20, a handle 22, and a pusher assembly 24. In some examples, the delivery apparatus comprises an inflation assembly 25 comprising an inflation tube 27. The delivery shaft 20 is configured to extend into the patient’s vasculature and provide a passageway for the coil device 10 to reach the implantation site (e.g., the mitral valve 12, in an example). Specifically, the delivery shaft 20 may be configured to be advanced through the patient’s vasculature to the implantation site and may be configured to receive and / or retain the coil device 10 therein. In some examples, the delivery shaft 20 may comprise an outer sheath or shaft that defines a lumen. The pusher assembly 24, the inflation tube 27, and / or the coil device 10 may be configured to be received and / or advanced within the lumen of the delivery shaft 20.

[0082] The handle 22 is configured to be gripped and / or otherwise held by the user to advance the delivery shaft 20 through the patient’s vasculature. Specifically, the handle 22 is coupled to a proximal end 26 of the delivery shaft 20 and is configured to remain accessible to the user (e.g., outside the patient 16) during the coil implantation procedure. In this way, the user can advance the delivery shaft 20 through the patient’s vasculature by exerting a force on (e.g., pushing) the handle 22. In some examples, the delivery shaft 20 may be configured to carry the pusher assembly 24, the inflation tube 27, and / or the coil device 10 with it as it advances through the patient’s vasculature. In this way, the coil device 10, the inflation tube 27, and / or the pusher assembly 24 may move through the patient’s vasculature together with the delivery shaft 20 as the user grips the handle 22 and manipulates the delivery shaft 20 through the patient’s vasculature. In some instances, the various devices can be moved separately.

[0083] In some examples as shown in FIG. 1, the inflation assembly 25 in the delivery apparatus 18 comprises a connector or fitting 29 adjacent to the handle 22. The inflation tube 27 extends from the fitting 29, through the handle 22, and into the delivery shaft 20. A distal end of the inflation tube 27 is coupled to the coil device 10 and the inflation tube 27 can travel with the coil device 10 as it is advanced through the patient’s vasculature by the delivery shaft 20. The inflation assembly 25 is coupled to a hose 31. The hose 31 can, in some instances, be fluidlyAttorney Docket No: THVMC-23550WO01 connected to a fluid reservoir. The fluid reservoir can, for example, provide a fluid source for inflation fluid.

[0084] In some examples, the handle 22 may comprise one or more articulation members 28 that are configured to aid in navigating the delivery shaft 20 through the patient’s vasculature. Specifically, the articulation members 28 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end 30 of the delivery shaft 20 to aid in navigating the delivery shaft 20 through the patient’s vasculature.

[0085] The pusher assembly 24 is configured to deploy and / or implant the coil device 10 at the implantation site (e.g., native valve). Specifically, the pusher assembly 24 is configured to be adjusted by the user to advance the coil device 10 and the inflation tube 27 through the delivery shaft 20 and push the coil device 10 out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 may be configured to extend through the delivery shaft 20, within the lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 also may be coupled to the coil device 10 such that the pusher assembly 24 pushes the coil device 10 through and / or out of the delivery shaft 20 as the pusher assembly 24 advances through the delivery shaft 20. Stated slightly differently, because it is retained by, held, and / or otherwise coupled to the pusher assembly 24, the coil device 10 may advance in lockstep with the pusher assembly 24 through and / or out of the delivery shaft 20.

[0086] The pusher assembly 24 comprises a pusher shaft 32 configured to advance the coil device 10 through the delivery shaft 20 and out of the distal end 30 of the delivery shaft 20. In some examples, the pusher shaft 32 advances through the delivery shaft alongside and parallel to the inflation tube 27. Specifically, the pusher shaft 32 pushes the coil device 10 out of the delivery shaft 20 and positions the coil device 10 at the implantation site.

[0087] In some examples, the pusher assembly 24 may comprise a pusher handle 36 (which may also be referred to herein as “hub assembly 36”) that is coupled to the pusher shaft 32 and that is configured to be gripped and pushed by the user to translate the pusher shaft 32 axially relativeAttorney Docket No: THVMC-23550WO01 to the delivery shaft 20 (e.g., to push the pusher shaft 32 into and / or out of the distal end 30 of the delivery shaft 20).

[0088] The pusher assembly 24 may be removably coupled to the coil device 10 and as such may be configured to release, detach, decouple, and / or otherwise disconnect from the coil device 10 once the coil device 10 has been deployed at the implantation site, leaving the inflation tube 27 still attached to the coil device 10. In an example, the pusher assembly 24 (e.g., pusher shaft 32) may be removably coupled to the coil device 10 via a thread, string, yarn, suture, or other suitable material that is tied or sutured to the coil device 10.

[0089] In some examples, the pusher assembly 24 comprises a suture lock assembly 40 that is configured to receive and / or hold the thread or other suitable material that is coupled to the coil device 10 via the suture. Thus, the thread or other suitable material that forms the suture may extend from the coil device 10, through the pusher assembly 24, to the suture lock assembly 40. The suture lock assembly 40 may also be configured to cut the thread to release, detach, decouple, and / or otherwise disconnect the coil device 10 from the pusher assembly 24. For example, the suture lock assembly 40 may comprise a cutting mechanism that is configured to be adjusted by the user to cut the thread.

[0090] Before inserting the coil delivery apparatus 18 into the vasculature of the patient 16, the user may first make an incision in the patient’s body to access a blood vessel 42. For example, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the blood vessel 42 may be a femoral vein.

[0091] After making the incision at the blood vessel 42, the user may insert an introducer device 44, a guidewire 46, and / or other devices (e.g., the delivery shaft 20, inflation tube 27, and / or pusher shaft 32 of the coil delivery apparatus 18, catheters, and / or other delivery apparatuses, coil device 10, prosthetic valves, etc.) through the incision and into the blood vessel 42. The introducer device 44 (which can include an introducer sheath, not shown in FIG. 1) is configured to facilitate the percutaneous introduction of the guidewire 46 and / or the other devices (e.g., coil delivery apparatus 18) into and through the blood vessel 42 and may extend through only aAttorney Docket No: THVMC-23550WO01 portion of the blood vessel 42 even when it is fully inserted by the user (i.e., it may extend through the blood vessel 42 towards the heart 14, but may stop short of the heart 14).

[0092] The guidewire 46 on the other hand, is configured to guide the delivery apparatuses (e.g., the coil delivery apparatus 18, prosthetic valve delivery apparatuses, catheters, etc.) and their associated devices (e.g. the coil device, inflation tube, prosthetic heart valve, etc.) to the implantation site within the heart 14, and thus may extend all the way through the blood vessel 42 and into a left atrium 50 of the heart 14. Specifically, the user may advance the guidewire 46 through the blood vessel 42 (e.g., through the femoral vein and inferior vena cava) to a right atrium 52 of the heart 14. The user may make a small incision in an atrial septum 54 of the heart 14 to allow the guidewire 46 to pass from the right atrium 52 to the left atrium 50 of the heart 14 and may then advance the guidewire 46 through the incision in the atrial septum 54 into the left atrium 50. Thus, the guidewire 46 may provide a pathway that the coil delivery apparatus 18 can follow as it advances through the patient’s vasculature to ensure that the coil delivery apparatus 18 does not perforate the walls of the blood vessel 42 and / or other vasculature tissue.

[0093] After positioning the guidewire 46 within the left atrium 50, the user may insert the coil delivery apparatus 18 (e.g., the delivery shaft 20) into the patient 16 by advancing the coil delivery apparatus 18 through the introducer device 44 and over the guidewire 46. The user may continue to advance the coil delivery apparatus 18 through the patient’s vasculature along the guidewire 46 until the coil delivery apparatus 18 reaches the left atrium 50, as illustrated in FIG. 1. Specifically, the user may advance the delivery shaft 20 of the coil delivery apparatus 18 by gripping and exerting a force on (e.g., pushing) the handle 22 of the coil delivery apparatus 18. While advancing the delivery shaft 20 through the patient’s vasculature, the user may adjust the one or more articulation members 28 of the handle 22 to navigate the various turns, corners, constrictions, and / or other obstacles in the patient’s vasculature.

[0094] Once the delivery shaft 20 reaches the left atrium 50, the user may position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12 using the handle 22 (e.g., the articulation members 28). The user may then push the coil deviceAttorney Docket No: THVMC-23550WO01 10 with the inflation tube 27 attached out of the distal end 30 of the delivery shaft 20 with the pusher assembly 24 to deploy and / or implant the coil device 10 at the native valve 12. For example, the user may actuate the pusher handle 36 to axially translate the pusher shaft 32, in a distal direction, relative to the delivery shaft 20, such that the coil device 10 is deployed out of the delivery shaft 20 and moved into a desired position at the implantation site as shown in the detail view of FIG. 2.

[0095] In some examples, the coil device 10 may comprise a filament (also referred to herein as a “support member,” “wire,” or “core”) comprising a first end, a second end, and a coiled section disposed between the first end and the second end. The coil device 10 can further include an inflatable or expandable member surrounding at least a portion of the filament. In some examples, the inflatable or expandable member can surround at least a portion of the coiled section of the filament.

[0096] The filament may be constructed from, formed of, and / or comprise an elastic and / or shape memory material (e.g., Nitinol). As such, the filament can be shape set in its helical (e.g., coiled) form (see e.g., FIG. 5). During delivery, the filament can be straightened and / or bent into other shapes. The filament can return to its original, pre-formed shape (e.g., a coil or helical shape) when it exits the delivery shaft 20 and is no longer constrained by the delivery shaft 20. As one example, the filament of the coil device 10 may originally be formed as a coil, and thus may wrap around the ventricular side of the native leaflets and the native chordae tendineae as shown in a perspective view from the left ventricle in FIG. 3 as the coil device 10 exits the delivery shaft 20 and returns to its original coiled configuration.

[0097] After pushing the coil device 10 into a left ventricle 56 and / or on the ventricular side of the mitral valve leaflets, the user may then release the coil device 10 from the delivery shaft 20 within the left atrium 50, leaving the inflation tube 27 still coupled to the coil device 10 as shown in FIG. 4. Specifically, the user may retract the delivery shaft 20 relative to the coil device 10, away from the posteromedial commissure of the mitral valve 12. In some examples, the user may maintain the position of the pusher shaft 32 (e.g., by exerting a holding and / or pushing forceAttorney Docket No: THVMC-23550WO01 on the pusher shaft 32) while retracting the delivery shaft 20 so that the delivery shaft 20 withdraws and / or otherwise retracts relative to the coil device 10 and the pusher shaft 32. In this way, the pusher shaft 32 may hold the coil device 10 in place while the user retracts the delivery shaft 20, thereby releasing the coil device 10 from the delivery shaft 20. The user may decouple and / or otherwise disconnect the coil delivery apparatus 18 from the coil device 10 by, for example, cutting the thread that is sutured to the coil device 10. In an example, the user may cut the thread with the cutting mechanism of the suture lock assembly 40, leaving the inflation tube 27 intact and attached to the coil device 10.

[0098] In some examples, the coil device 10 is advanced through the delivery shaft 20 into position surrounding the valve leaflets in the left ventricle 56 without the inflation tube 27 attached. The inflation tube 27 can be advanced through the delivery shaft 20 in a subsequent step and attached to the implanted coil device 10 at that time.

[0099] Additional information regarding exemplary delivery apparatus for implanting a coil device can be found, for example, in International Publication No. WO 2020 / 247907, which is incorporated by reference herein.

[0100] Although FIGS. 1-3 show implantation of the coil device 10 surrounding the native mitral valve 12, it is understood that the coil device may be implanted at any native valve of the heart.

[0101] FIG. 4 is a detail view of the coil device 10 and the inflation tube 27 of FIG. 2 after the coil device 10 is released within the left ventricle 56 and into position surrounding the native valve leaflets 58, the native chordae tendineae 60, or both the native valve leaflets 58 and the native chordae tendineae 60. The native valve leaflets 58 are shown for simplicity in FIG. 4 in cross-section. The coil device 10 comprises an expandable member in the form of an inflatable balloon assembly 62 (also referred to herein as a “balloon assembly” or a “balloon”), for example, shown in a delivery configuration in FIG. 4. The coil device 10 and the balloon assembly 62 are shown in FIG. 5 without the native valve structure for clarity. As previously described, due to the shape-memory filament 64, the coil device 10 deploys within the left ventricle 56 into a coil shape surrounding the native valve leaflets 58 and / or the native chordaeAttorney Docket No: THVMC-23550WO01 tendineae 60. The coil shape with the expandable member of the coil device 10 defines an inner lumen L shown in the delivery configuration in FIG. 5.

[0102] The filament 64 has a first end, a second end, and a coiled section disposed between the first and second ends. The balloon assembly 62 has an outermost surface 66 and is configured to extend radially around the filament 64 in at least a portion of the coiled section of the filament 64. In some examples, the balloon assembly 62 extends from the first end of the filament 64 to the second end of the filament 64, as shown in FIG. 5.

[0103] The inner lumen L of the coil device 10 has a first inner diameter D1 in the delivery or non-inflated configuration (see, e.g., FIGS. 4-5). The first inner diameter D1 (also referred to herein as a “delivery diameter”) is defined as a distance between diametrically opposing inner points within the inner lumen L.

[0104] Referring now to FIGS. 5-6, the inflatable balloon assembly 62 comprises a distal end 68 and a proximal end 70. FIG. 5 depicts a perspective view and FIG. 6 depicts a cross-sectional view of the coil device 10. The outermost surface 66 of the balloon assembly 62 surrounds the filament 64 and defines a first outer diameter D2, which corresponds to the delivery or non- inflated configuration. The outermost surface 66 of the balloon assembly 62 defines both the first outer diameter D2 and the first inner diameter D1 of the lumen L. As such, the first outer diameter D2 and the first inner diameter D1 of the lumen L are inversely related. In other words, when the first outer diameter D2 increases due to inflation or expansion, as will be described later herein, the first inner diameter D1 of the lumen L decreases.

[0105] The balloon assembly 62 comprises an inner, radial surface 72 that contacts and attaches to an outer, radial surface 74 of the filament 64 along an interface 76. The interface 76 extends along the balloon assembly 62 from the distal end 68 of the balloon assembly 62 to the proximal end 70 of the balloon assembly 62. The inner, radial surface 72 of the balloon assembly 62 can be bonded or otherwise secured to the outer, radial surface 74 of the filament 64 along the interface 76 or portions of the interface 76.Attorney Docket No: THVMC-23550WO01

[0106] The balloon assembly 62 comprises a balloon wall. The balloon wall can comprise a plurality of layers including an inner balloon layer 78a (also referred to herein as an “inner wall” or “inner layer”) and an outer balloon layer 78b (also referred to herein as an “outer wall” or “outer layer”) as shown in FIG. 6. The inner and outer layers 78a, 78b can comprise a material that is flexible, resilient, and strong such as, for example, silicone, a thermoplastic polyurethane (TPU), polyamide, co-polyamide, polyethylene (PET), polyethylene terephthalate, expanded polytetrafluoroethylene (ePTFE), polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof. In some examples, the balloon material can be consistent throughout the balloon assembly 62 from the distal end 68 to the proximal end 70 of the balloon assembly 62 to ensure even inflation and expansion. In some examples, the balloon material can vary between the distal and proximal ends 68, 70 to vary expansion, as will be described later herein in reference to FIGS. 11-12.

[0107] The inner and outer balloon layers 78a, 78b can be secured to each other at the distal and proximal ends 68, 70 of the balloon assembly 62. The inner and outer layers 78a, 78b can be radially coupled to each other by bonding, heat sealing, or any other means for coupling and sealing. In locations between the distal end 68 and the proximal end 70, the inner and outer balloon layers 78a, 78b can be unattached from each other and arranged to form a space or cavity 80 therebetween to accommodate an inflation fluid.

[0108] In some examples, as shown in FIG. 6 and FIG. 9, the cavity 80 can extend radially around the filament 64 symmetrically. In some examples, not shown herein, the cavity 80 can be arranged asymmetrically on radial portions of the filament 64. For example, the cavity can be arranged on radial portions of the filament 64 defining the inner diameter of the lumen L. In other words, a radially asymmetric cavity 80 can be configured to cause radially inward inflation of the coil device 10 into the lumen L while an outer surface of the coil device 10 remains unchanged.

[0109] In some examples, the balloon assembly 62 can comprise one or more additional components and / or layers. For example, the balloon assembly 62 can further comprise an outerAttorney Docket No: THVMC-23550WO01 cover 82 extending over at least a portion of the outer balloon layer 78b between the distal and proximal ends 68, 70 of the balloon assembly 62. The outer cover 82 can comprise a fabric, a coating, or combinations thereof. The outer cover 82 can be arranged over the outer balloon layer 78b or over portions of the outer balloon layer 78b. The outer cover 82 can provide a frictional surface against which the native heart structure can interface during deployment and expansion. The outer cover 82 can promote tissue ingrowth and visualization under different imaging modalities, in some instances.

[0110] The balloon assembly 62 can comprise additional layers including inner layers disposed between the inner, radial surface 72 of the balloon assembly 62 and the outer, radial surface 74 of the filament 64. In some instances, the balloon assembly 62 can comprise radially uneven layers, where layers can vary in thickness around a radius of the balloon assembly 62. In some instances, layers can be disposed around portions of a radius of the balloon assembly 62. Regardless of layer construction, the outermost surface 66 of the balloon assembly 62 defines both the outer diameter D2 and the inner lumen diameter D1.

[0111] As seen in FIG. 5, the balloon assembly 62 further includes an inflation port 84 at the proximal end 70, where the inflation port 84 can extend through the proximal end 70 of the balloon assembly 62, a sidewall of the balloon assembly 62 adjacent to the proximal end 70, or through a sidewall of the balloon assembly 62 at locations between the distal and proximal ends 68, 70 with user access. The inflation port 84 can comprise an opening extending through at least a portion of the balloon assembly 62. In the example of FIGS. 5-6, the inflation port 84 extends through the outer cover 82 and the outer wall 78b, providing fluid access between the inflation tube 27 and the cavity 80 for inflation.

[0112] The inflation port 84 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self-sealing cover or any other fluid fitting known in the art to which the inflation tube 27 can couple without leaking. The fitting or interface between the inflation port 84 and the inflation tube 27 can be configured for a one-time connection or repeat connections. When the inflation tube 27 is coupled to the inflation port 84,Attorney Docket No: THVMC-23550WO01 fluid can be delivered from the inflation assembly 25 in the delivery apparatus 18 to the balloon assembly 62 through the inflation port 84 without leaking into the surrounding environment of the heart.

[0113] With the coil device 10 in place surrounding the native leaflets 58 and / or the native chordae tendineae 60 as shown in FIG. 4 and the inflation tube 27 coupled to the inflation port 84, the balloon assembly 62 can be inflated or expanded to a deployed configuration. FIG. 7 shows a detail view of the balloon assembly 62 in a deployed configuration with the native valve 12. FIG. 8 shows a perspective view of the balloon assembly 62 in the deployed configuration without the native valve 12 for clarity.

[0114] To expand the coil device 10 using an inflation fluid, the user can inject fluid through the inflation tube 27 and the inflation port 84, filling the cavity 80 between the inner and outer balloon layers 78a, 78b. FIG. 9 shows the coil device 10 of FIG. 8 in cross section, where the cavity 80 is shown filled with an inflation fluid 86. As a result of the inflation fluid 86 filling the cavity 80 of the balloon assembly 62, the balloon assembly 62 increases in diameter to a second outer diameter D4. The second outer diameter D4 is larger than the first outer diameter D2 in FIG. 6 due to the inflation fluid 86 within.

[0115] The inflation fluid 86 can comprise any bio-compatible and / or bio-safe fluid including saline, a foaming fluid, a self-hardening fluid, a radiopaque fluid, or a combination thereof. If a radiopaque fluid is used, the real-time injection of the inflation fluid 86 and the second outer diameter D4 during and after expansion can be monitored, providing the user with visibility into the size and shape of the balloon assembly 62 (and the coil device 10) during deployment. In some examples, radiopaque markers can be included on layers of the balloon assembly 62 to allow the user to monitor the size and shape of the balloon assembly 62 (and the coil device 10) during inflation, with or without a radiopaque inflation fluid. This real-time, visual feedback can allow the user to adjust the second outer diameter D4 by increasing or decreasing the amount of inflation fluid 86 within the cavity 80 until a desired, second outer diameter D4 is achieved.Attorney Docket No: THVMC-23550WO01

[0116] As the balloon assembly 62 is inflated with the inflation fluid 86, the second outer diameter D4 increases, resulting in a decrease in the diameter of the inner lumen L. A second inner diameter D3 (also referred to herein as a “deployed diameter”) of the lumen L is shown in FIG. 8. The deployed diameter D3 is smaller than the delivery diameter D1 of FIG. 5. The deployed diameter D3 results in an increase in the radially inward force applied on the native heart valve by the coil device 10. This radially inward force squeezes the native valve leaflets 58 and / or the native chordae tendineae 60 in a radially inward direction, creating tension in the native valve 12. An increase in tension in the native valve 12 can improve native leaflet coaptation and / or close gaps between the native valve leaflets 58, thereby preventing or reducing the likelihood of regurgitation. The inward force and added tension in the native valve leaflets 58 and native chordae tendineae 60 can tighten the native valve leaflets 58 and the chordae tendineae 60, further contributing to a reduction in regurgitation.

[0117] As previously described, inflation of the balloon assembly 62 can be monitored in real- time by the user, allowing the user to view the effects of inflation on the native valve leaflets 58 and the native chordae tendineae 60 during inflation. FIGS. 6 and 9 show a first outer diameter D2 and a second outer diameter D4, but it is understood that the balloon assembly 62 can assume any outer diameter size between a minimum diameter and a maximum diameter, where the maximum diameter can be specified to prevent excessive tension applied to the native chordae tendineae 60 during inflation. The user can observe operation of the native valve 12, including any reduction in regurgitation, and vary a volume of inflation fluid 86 within the balloon assembly 62 to adjust the radially inward force applied to the native valve leaflets 58 and / or the native chordae tendineae 60, thereby optimizing valve function.

[0118] After implanting the coil device 10 and deploying the balloon assembly 62 to a desired diameter, the user can decouple and / or otherwise disconnect the inflation tube 27 from the inflation port 84 on the deployed balloon assembly 62 as shown in FIG. 10. The inflation port 84 can comprise a valve element that engages when the inflation tube 27 is removed, such that the valve closes the inflation port 84 and prevents fluid ingress or egress therethrough. In an example, the inflation port 84 comprises a self-sealing cover that, when the inflation tube isAttorney Docket No: THVMC-23550WO01 removed, seals any aperture, preventing leakage. Once the inflation tube 27 is detached from the inflation port 84, the inflation tube 27 can be removed from the body, leaving the deployed coil device 10 in place as shown in FIG. 10.

[0119] The expandable member of the coil device 10 can comprise other balloon configurations. In some instances, it may be desirable to adjust the coil device 10 to fit with a particular anatomy of a patient, where patient anatomy can vary from patient to patient. It is also possible that a single patient’s anatomy can vary over time. In some examples, a native valve can benefit from increased inward force or reduced inward force in locations of the native valve due to changes in the native valve or installation of other devices, such as prosthetic heart valves. Therefore, it may be desirable for the coil device 10 to impart varied or non-uniform inward forces on the native valve leaflets 58 and / or the chordae tendineae 60. For example, it may be desirable to impart larger inward forces toward an inflow end of the native valve than at an outflow end of the native valve, or vice versa, by expanding the coil device 10 unevenly or non-uniformly.

[0120] The example shown in FIG. 11 illustrates the native heart valve 12, for example a mitral valve, with native valve leaflets 58 and chordae tendineae 60 surrounded by the coil device 10. The coil device 10 defines a lumen L and, according to an example shown in FIG. 11, comprises a balloon assembly 88 with non-uniform expansion. The balloon assembly 88 comprises a single balloon with a lower, outflow segment 90a and an upper, inflow segment 90b. Each of the outflow and inflow segments 90a, 90b extends a length of the coil device 10. The outflow and inflow segments 90a, 90b can transition therebetween gradually along a transition length or can transition in a step-wise manner. The lengths of the outflow and inflow segments 90a, 90b can be the same. In some instances, the length of the outflow segment 90a can be greater than the length of the inflow segment 90b, or vice versa. The lengths of the outflow and inflow segments 90a, 90b and the length of transition therebetween can be specified to suit a native valve configuration.

[0121] The balloon assembly 88, in some instances, can comprise a single inflation port 92. The inflation port 92 can extend through an end of the balloon assembly 88 or a sidewall of theAttorney Docket No: THVMC-23550WO01 balloon assembly 88 at a location with user access. The inflation port 92 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self- sealing cover or any other fluid fitting known in the art to which an inflation tube can couple without leaking.

[0122] When the balloon assembly 88 is inflated with an inflation fluid through the inflation port 92, the inflow segment 90b is configured to have greater expansion than the outflow segment 90a, as seen in FIG 11. An inner diameter of the lumen L at the location of segment 90b after inflation is smaller than an inner diameter of the lumen L after inflation at the location of the segment 90a. The smaller lumen inner diameter results in a greater inward, radial force applied to the native valve 12 by segment 90b than the inward, radial force applied by segment 90a. In some examples, segment 90a can be configured to have greater expansion instead, resulting in a greater inward radial force at an outflow section of the native valve 12. In this way, different expansions across the balloon assembly 88 can therefore result in different inward radial forces applied to the native valve 12 and can be specified to suit a native valve configuration.

[0123] As described previously, to vary expansion across the balloon assembly 88, the outflow and inflow segments 90a, 90b may comprise different materials which, when inflated, expand differently or at different rates. For example, the outflow segment 90a may comprise a stiffer material that resists expansion while the inflow segment 90b may comprise a looser material or a material with more stretch that allows greater expansion with the same fluid, or vice versa.

[0124] In an example, the outflow and inflow segments 90a and 90b may comprise a different configuration of layers. For instance, the outflow segment 90a can comprise a greater number of layers to resist expansion, while the inflow segment 90b can comprise a fewer number of layers, or vice versa. It is also possible that the materials and / or the layers vary radially around the balloon assembly 88, where sections of the balloon assembly 88 located within the inner lumen L can differ in expansion due to varied materials and / or layers from other sections of the balloon assembly 88.Attorney Docket No: THVMC-23550WO01

[0125] In some examples, the balloon assembly 88 may comprise more than two segments of varying expansion capability. For example, the balloon assembly 88 can comprise three or more segments of varying expansion. It is therefore possible to configure the balloon assembly 88 with as many segments of varying expansion in as many sections as desired to optimize inward radial forces applied to the native valve. The various segments can transition gradually or can transition in a step-wise manner.

[0126] It is also possible to vary an inward radial force applied by the coil device 10 by including a plurality of distinct balloon assemblies. In the example of FIG. 12, the coil device 10 defines lumen L and comprises a lower, outflow balloon assembly 94a (also referred to herein as an “outflow balloon assembly” or a “lower balloon assembly”) with an inflation port 96 and an upper, inflow balloon assembly 94b (also referred to herein as an “inflow balloon assembly” or an “upper balloon assembly”) with an inflation port 98. In the example shown in FIG. 12, the outflow and inflow balloon assemblies 94a, 94b are shown separated by a space 100 along the filament 64. In some examples, the outflow and inflow balloon assemblies 94a, 94b may be in abutment without a space therebetween.

[0127] The inflation ports 96 and 98 can extend through an end of their respective balloon assemblies or a sidewall of their respective balloon assemblies at a location with user access. Like previously described inflation ports (any inflation port herein, such as inflation ports 84 and 92, for example) the inflation ports 96 and 98 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self-sealing cover or any other fluid fitting known in the art to which an inflation tube can couple without leaking.

[0128] The expansion of the outflow and inflow balloon assemblies 94a, 94b can be varied by adjusting a volume of inflation fluid in each. For example, by filling the inflow balloon assembly 94b with more inflation fluid than the outflow balloon assembly 94a, the inflow balloon assembly 94b can have greater expansion than the outflow balloon assembly 94a. As such, an inner diameter of lumen L at the location of the inflow balloon assembly 94b after inflation can be smaller than an inner diameter of lumen L after inflation at the location of theAttorney Docket No: THVMC-23550WO01 outflow balloon assembly 94a. The smaller lumen inner diameter results in a greater inward, radial force applied to the native valve 12 by the inflow balloon assembly 94b than by the outflow balloon assembly 94a. In some examples, the outflow balloon assembly 94a can be configured to have greater expansion instead, resulting in a greater inward radial force at an outflow section of the native valve 12. Different expansions across the outflow and inflow balloon assemblies 94a, 94b can therefore result in different inward radial forces applied to the native valve 12 and can be specified to suit a native valve configuration.

[0129] As previously described with respect to previous balloon assemblies (any balloon assembly herein, such as balloon assemblies 62 and 88, for example), the outflow and inflow balloon assemblies 94a, 94b can be configured each with varying materials and layers resulting in varied expansion for the same volume of inflation fluid. In another example, not shown, the coil device 10 may comprise more than two separate balloon assemblies, either separated by spaces therebetween or in abutment, or combinations thereof. Each separate balloon assembly can have an inflation port. It is therefore possible to configure the coil device 10 with as many balloon assemblies as desired to vary and optimize inward radial forces applied to the native valve, from patient to patient, for reduced regurgitation.

[0130] In some examples, the coil device 10 can comprise an expandable member with other forms, for example a braid. FIG. 13 shows the native heart valve 12 with native valve leaflets 58 and native chordae tendineae 60 surrounded by the coil device 10, where the expandable member of the coil device 10 is a braid assembly 102. The braid assembly 102 is shown in FIG. 13 in a delivery configuration (also referred to herein as a “relaxed configuration”). The coil device 10 comprising the braid assembly 102 can be delivered and released in the manner described above in reference to FIGS. 1-3, without the inflation tube 27, inflation assembly 25, hose 31, or fluid reservoir. The braid assembly 102 may comprise a braided structure (also referred to herein as a “braid”), such as a braided wire mesh or lattice.

[0131] In some examples, not shown in FIGS. 13-14, the braid assembly 102 can comprise a cover extending over the braided structure or at least a portion of the braided structure of theAttorney Docket No: THVMC-23550WO01 braid assembly 102. The cover can comprise a fabric, a coating, or combinations thereof. The cover can be arranged over the braided structure or over portions of the braided structure to provide a frictional surface against which the native heart structure can interface during deployment and expansion. The outer cover can promote tissue ingrowth and visualization under different imaging modalities, in some instances.

[0132] In some examples, the braid assembly 102 may comprise inner layers, where the inner layers can be arranged underneath the braided structure or underneath portions of the braided structure. These inner layers may aid in deployment, reduce friction, or help in manufacturing the braid assembly 102, for example. The inner layer(s) can comprise various materials, including polyethylene, expanded polytetrafluoroethylene (ePTFE), and / or biocompatible materials.

[0133] The braid assembly 102, in an example, may have a braided structure comprising a metal alloy with shape memory properties, such as Nitinol. As previously described with respect to FIG. 4, the coil device 10 deploys within the left ventricle 56 into a coil surrounding the native valve leaflets 58 and / or the native chordae tendineae 60 due to the shape-memory filament 64 within. The coil shape and the braid assembly 102 of the coil device 10 defines an inner lumen L shown in the delivery configuration in FIG. 13.

[0134] The braid assembly 102 has an outermost surface 104, which can be an outer surface of the cover (e.g., PET fabric) if included or an outer surface of the braided structure. The outermost surface 104 defines both a first outer diameter D7 of the braid assembly 102 and an inner diameter of the lumen L. The inner diameter of lumen L is defined as a distance between diametrically opposing inner points of the braid assembly 102 within the inner lumen L. As such, the first outer diameter D7 and the inner diameter of the lumen L are inversely related. In other words, when the first outer diameter D7 of the braid assembly 102 increases due to expansion, as will be described later herein, the inner diameter of the lumen L decreases.

[0135] The braid assembly 102 is configured to extend radially around the filament 64 in at least a portion of the coiled section of the coil device 10 and the filament 64. The braid assemblyAttorney Docket No: THVMC-23550WO01 102 of FIG. 13 comprises a distal end portion 106 (also referred to herein as a “first end portion”) and a proximal end portion 108 (also referred to herein as a “second end portion”). In some examples, the braid assembly 102 can extend from the first end of the filament 64 to the second end of the filament 64. In some examples, the braid assembly 102 can extend between a portion of the filament 64 between the first and second ends of the filament 64.

[0136] The braid assembly 102 can be coupled to the filament 64 at its distal end portion 106 using methods known in the art such as one or more of bonding, crimping, stitching, and / or other means for coupling. For example, International Publication No. WO 2022 / 087336, which is incorporated by reference herein, describes various exemplary ways to attach a braided sleeve to a coiled filament.

[0137] In some examples, the braid assembly 102 may be coupled, fixedly attached and / or otherwise permanently secured to the filament 64 at its distal end portion 106. The proximal end portion 108 can move along the filament 64 in a manner that will be discussed later herein. When only the distal end portion 106 of the braid assembly 102 is fixedly coupled to the filament 64, the remainder of the braid assembly 102 may be free to float around, expand away from, and / or axially move relative to the filament 64.

[0138] In some examples, the braid assembly 102 may be tapered at and / or proximate to the distal end portion 106. That is, the braid assembly 102 may narrow (extend radially inwardly towards the filament 64) near and / or at the distal end portion 106. For instance, the braid assembly 102 may be narrowest at the distal end portion 106, such that the distal end portion 106 is narrower than the rest of the braid assembly 102. In some examples, the braid assembly 102 may be tapered at and / or proximate to the proximal end portion 108, narrowing radially inward towards the filament 64. In some examples, both the distal and proximal end portions 106, 108 may be tapered at and / or proximate to their respective ends.

[0139] The braid assembly 102 can comprise means for translating the proximal end portion 108 along the filament 64 for expansion. For example, International Publication No. WOAttorney Docket No: THVMC-23550WO01 2022 / 087336, which is incorporated by reference herein, describes exemplary means for translating and expanding braided sleeves around a coiled filament.

[0140] Shown schematically in FIGS. 13-14, a translation mechanism 109 can be situated at the proximal end portion 108 of the braid assembly 102, for example. The translation mechanism 109 can provide means for translating the proximal end portion 108 of the braid assembly 102 along the filament 64 in a controlled manner. The translation mechanism 109 can also provide means for locking the proximal end portion 108 in position on the filament 64.

[0141] In some examples, the translation mechanism 109 is bonded, crimped, stitched, and / or otherwise mechanically coupled to both the proximal end portion 108 of the braid assembly 102 and the filament 64. In some examples, the translation mechanism 109 comprises interfacing features between the proximal end portion 108 of the braid assembly 102 and the filament 64. The interfacing features can be integrally formed into the proximal end portion 108 of the braid assembly 102 and / or the filament 64. The interfacing features can control translation and positional locking between the proximal end portion 108 of the braid assembly 102 and the filament 64.

[0142] In some instances, the translation mechanism 109 comprises frictional elements located between the proximal end portion 108 of the braid assembly 102 and the filament 64. The frictional elements can impede movement of the proximal end portion 108 of the braid assembly 102 on the filament 64 and retain the proximal end portion 108 in place on the filament 64. A pusher shaft can couple to the translation mechanism 109. The user can push the proximal end portion 108 of the braid assembly 102 toward the distal end portion 106 with the pusher shaft, translating the proximal end portion 108 along the filament 64 and expanding the braid assembly 102. The user can pull the pusher shaft, moving the proximal end portion 108 away from the distal end portion 106 to relax the braid assembly 102. After achieving the desired expansion, the pusher shaft can be decoupled from the translation mechanism 109. The pusher shaft can be recoupled for subsequent pushing / pulling.Attorney Docket No: THVMC-23550WO01

[0143] In some examples, the translation mechanism 109 can comprise a lead screw mechanism with interfacing threaded features that, when actuated, allow the proximal end portion 108 of the braid assembly 102 to translate along the filament 64. The user can couple a tool to the translation mechanism 109, where the tool engages the lead screw mechanism to translate the proximal end portion 108 along the filament 64. After achieving the desired expansion, the tool can be decoupled from the translation mechanism 109. The threaded features retain the proximal end portion 108 in place on the filament 64. The pusher shaft can be recoupled for subsequent repositioning.

[0144] The translation mechanism 109, for instance, can comprise a ratcheting mechanism with interfacing teeth that provide incremental translation and locking between the proximal end portion 108 of the braid assembly 102 and the filament 64. The user can couple a tool to the translation mechanism 109, where the tool engages the ratcheting mechanism to translate the proximal end portion 108 along the filament 64. After achieving the desired expansion, the tool can be decoupled from the translation mechanism 109. The interfacing teeth retain the proximal end portion 108 in place on the filament 64. The tool can be recoupled for subsequent repositioning.

[0145] The translation of the proximal end portion 108 can be continuous along the filament 64. In some instances, the translation of the proximal end portion 108 can be incremental or step- wise along the filament 64.

[0146] When the proximal end portion 108 of the braid assembly 102, which can translate due to the translation mechanism 109, is moved axially along the filament 64 toward the distal end portion 106, which is held in place, the braided structure is longitudinally / axially compressed (i.e., shortened). When longitudinally / axially compressed, the braided structure of the braid assembly 102 is configured to expand radially. The radial expansion of the braid assembly 102 is determined by the displacement of the proximal end portion 108 along the filament 64 and the construction of the braided structure. Some braided wire mesh or lattice configurations mayAttorney Docket No: THVMC-23550WO01 result in greater radial expansion for a given axial displacement and longitudinal compression than other braided wire mesh or lattice configurations.

[0147] FIG. 14 shows the braid assembly 102 of FIG. 13 in an expanded and deployed configuration. FIG. 14 illustrates an axial foreshortening of the braid assembly 102 after the second end portion 108 is translated toward the first end portion 106 by the translation mechanism 109. The first end portion 106 of the braid assembly 102 is shown in a same location on the filament 64 in FIGS. 13-14 while the second end portion 108 is shown in FIG. 14 as longitudinally displaced from its position in FIG. 13.

[0148] The braid assembly 102 in the deployed configuration of FIG. 14 has a second outer diameter D8 that is greater than the first outer diameter D7 of the braid assembly 102 in the relaxed configuration of FIG. 13. As the braid assembly 102 is expanded, the second outer diameter D8 increases, resulting in a decrease in the inner diameter of the lumen L. The decrease in lumen L diameter results in an increase in the radially inward force on the native heart valve provided by the coil device 10. This radially inward force squeezes the native valve leaflets 58 and / or the native chordae tendineae 60 in a radially inward direction, creating tension in the native valve 12. An increase in tension in the native valve 12 can improve native leaflet coaptation and / or close gaps between the leaflets 58, thereby preventing or reducing the likelihood of regurgitation. The inward force and added tension in the native valve leaflets 58 and native chordae tendineae 60 can tighten the native valve leaflets 58 and the chordae tendineae 60, further contributing to a reduction in regurgitation.

[0149] In some examples, portions of the braid assembly 102 may comprise features for monitoring expansion in real-time, for example, radiopaque markers. During deployment, the user can monitor the expansion of diameter D8 along with the function of the native heart valve 12. This real-time feedback allows the user to adjust expansion of the braid assembly 102 during the procedure using the translation mechanism 109. If the native valve 12 requires more tension to reduce regurgitation, the translation mechanism 109 can be engaged to translate the proximal end portion 108 further toward the distal end portion 106, thereby increasing braid compressionAttorney Docket No: THVMC-23550WO01 and expansion. Conversely, if the native valve 12 requires less tension, the translation mechanism 109 can be engaged to translate the proximal end portion 108 away from the distal end portion 106, thereby relaxing the braid. Once the diameter D8 of the braid assembly 102b is optimized for valve function, the position of the proximal end portion 108 can be locked in place. FIGS. 13-14 show a first outer diameter D7 and a second outer diameter D8, but it is understood that the braid assembly 102 can assume any outer diameter size between a minimum diameter and a maximum diameter, where the maximum diameter can be specified to prevent excessive tension applied to the native chordae tendineae 60 during expansion.

[0150] In some examples, a braid assembly can comprise a braid structure with segments of varying wire mesh or lattice configurations. In some examples, a braid assembly can comprise a braid structure with segments of varying materials. As previously described, some braided wire mesh or lattice configurations may result in greater radial expansion for a given axial displacement and longitudinal compression than other braided wire mesh or lattice configurations. Some braid materials may result in greater radial expansion for a given axial displacement and longitudinal compression than other materials. As such, braid structures with segments of varied mesh or lattice configurations and / or materials can result in non-uniform expansion through the braid structure (and the coil device 10) and can be specified to suit a native valve configuration.

[0151] In some examples, the coil device 10 can comprise a plurality of braid assemblies either positioned in abutment or separated by a gap along the filament 64. The plurality of braid assemblies may be expanded at the same time. In some instances, each braid assembly may comprise its own translation mechanism and the plurality of braid assemblies may be expanded independently. Supplying each braid assembly with its own translation mechanism can allow the user to adjust expansion of each braid assembly independently and therefore the inward radial forces applied to the native valve 12 by each braid assembly. It is therefore possible to configure the coil device 10 with as many braid assemblies as desired and with braid structures comprising segments of varied wire mesh or lattice configurations and / or varied materials, to enable the userAttorney Docket No: THVMC-23550WO01 to vary expansion and optimize inward radial forces applied to the native valve 12, from patient to patient, for reduced regurgitation.

[0152] A patient’s anatomy and heart function can vary over time such that a native valve may require more inward force applied or less inward force applied to reduce regurgitation. As such, it may be desirable to further adjust an implanted coil device and repair the native heart valve in a subsequent procedure. A user (e.g., surgeon) can adjust expansion of an existing deployed expandable member (any expandable member described herein, for example the balloon assemblies 62, 88, 94a, and 94b and the braid assembly 102) in a subsequent procedure after initial deployment. In other instances, if additional, subsequent expansion of a coil device is not sufficient for repair, it may be desirable to install other devices, such as prosthetic heart valves, to restore function and reduce regurgitation in the native valve.

[0153] FIG. 15 is a schematic view showing delivery and deployment of a prosthetic heart valve during a subsequent procedure, for example, in the patient 16 of FIG. 1. FIG. 15 shows the coil device 10 already deployed around the native valve 12, according to an example. In FIG. 15 a user is delivering and / or implanting a prosthetic heart valve 110 (which may also be referred to herein as “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic mitral valve”) within a native annulus of the native valve 12 using a prosthetic heart valve delivery apparatus 112.

[0154] Thus, the coil device 10 and prosthetic heart valve 110 may be delivered on different delivery apparatuses in different native valve repair and replacement procedures. Specifically, the coil device 10 may be delivered to the native valve 12 with the delivery apparatus 18 during a first procedure and the prosthetic heart valve 110 may then be delivered with the prosthetic heart valve delivery apparatus 112 in a second, later procedure.

[0155] The prosthetic heart valve delivery apparatus 112 comprises a delivery shaft 114 and a handle 116 coupled to a proximal end 118 of the delivery shaft 114. The delivery shaft 114 is configured to extend into the patient’s vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 110 within the coil device 10 at the native valve 12. The handleAttorney Docket No: THVMC-23550WO01 116 may be the same as, or similar to, the handle 22 of the delivery apparatus 18 and is similarly configured to be gripped and / or otherwise held by the user to advance the delivery shaft 114 through the patient’s vasculature.

[0156] In some examples, the handle 116 may comprise one or more articulation members 120 that are configured to aid in navigating the delivery shaft 114 through the patient’s vasculature. Specifically, the articulation members 120 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end 122 of the delivery shaft 114 to aid in navigating the delivery shaft 114 through the patient’s vasculature.

[0157] In some examples, the prosthetic heart valve delivery apparatus 112 may comprise an expansion mechanism 124 that is configured to radially expand and deploy the prosthetic heart valve 110. For example, the expansion mechanism 124 may comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 110 within the coil device 10. The expansion mechanism 124 may be included in and / or coupled to the delivery shaft 114 at and / or proximate to the distal end 122 of the delivery shaft 114. In some examples, the prosthetic heart valve 110 may be self-expanding and may be configured to radially expand on its own without the expansion mechanism 124. In some examples, the prosthetic heart valve 110 may be mechanically expandable and the prosthetic heart valve delivery apparatus 112 can include one or more mechanical actuators configured to radially expand the prosthetic heart valve 110.

[0158] The prosthetic heart valve 110 may be coupled to the delivery shaft 114 at and / or proximate to the distal end 122 of the delivery shaft 114. In examples where the prosthetic heart valve delivery apparatus 112 includes the expansion mechanism 124, the prosthetic heart valve 110 may be mounted on the expansion mechanism 124 in a radially compressed configuration. In some examples, the prosthetic heart valve 110 may be removably coupled to the delivery shaft 114 such that, after the prosthetic heart valve 110 is radially expanded and deployed from the prosthetic heart valve delivery apparatus 112, the prosthetic heart valve delivery apparatus 112Attorney Docket No: THVMC-23550WO01 can be retracted away from the implanted prosthetic heart valve 110 and removed from the patient 16.

[0159] The prosthetic heart valve 110 is configured to be received and / or retained within the native valve 12 and the coil device 10 surrounding the native valve 12 in the left ventricle 56. Although shown with respect to a mitral valve, it is understood that the coil device 10 and prosthetic heart valve 110 can be used in conjunction with any native valve in the heart. As such, the coil device 10 can be configured to receive the prosthetic heart valve 110 and help anchor or dock the prosthetic heart valve 110 to the native valve 12.

[0160] As will be explained in further detail below, in addition to reducing regurgitation, the coil device 10 can also be configured to provide a seal between the prosthetic heart valve 110 and the leaflets of the valve to reduce paravalvular leakage around the prosthetic heart valve 110. Specifically, as introduced above, the coil device 10 may initially constrict the leaflets of the native valve 12. The prosthetic heart valve 110 may then push the leaflets against the coil device 10 as it radially expands within the coil device 10 (e.g., via inflation of the expansion mechanism 124). Thus, the coil device 10 and the prosthetic heart valve 110 may be configured to sandwich the leaflets of the native valve 12 when the prosthetic heart valve 110 is expanded within the coil device 10. In this way, the coil device 10 may provide a seal between the native leaflets of the native valve 12 and the prosthetic heart valve 110.

[0161] FIG. 16 is a perspective view of the prosthetic heart valve 110 of FIG. 15 in a deployed configuration, according to an example. The prosthetic heart valve 110 can include a stent or frame 126 and a valvular structure 128. The valvular structure 128 can include three leaflets 130, 132, and 134, collectively forming a leaflet structure (although a greater or fewer number of leaflets can be used), which can be arranged to collapse in a tricuspid arrangement. The leaflets 130, 132, and 134 are configured to permit the flow of blood from an inflow end 136 to an outflow end 138 of the prosthetic heart valve 110 and block the flow of blood from the outflow end 138 to the inflow end 136 of the prosthetic heart valve 110. The leaflets 130, 132, and 134 can be secured to one another at their adjacent sides to form commissures 140, 142, and 144 ofAttorney Docket No: THVMC-23550WO01 the leaflet structure. The leaflets 130, 132, and 134 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, and / or various other suitable natural or synthetic materials, for example, as described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0162] The frame 126 can be formed with a plurality of circumferentially spaced slots, or commissure windows that are adapted to mount the commissures 140, 142, and 144 of the valvular structure 128 to the frame 126. The frame 126 can be made of any of various suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as known in the art. When constructed of a plastically expandable material, the frame 126 (and thus the prosthetic heart valve 110) can be crimped to a radially compressed state on a delivery apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 126 (and thus the prosthetic heart valve 110) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the prosthetic heart valve 110 can be advanced from the delivery sheath, which allows the prosthetic heart valve 110 to expand to its functional size within the annulus of the native valve 12. The deployed prosthetic valve 110 shown in FIG. 16 is representative of any number of prosthetic valves that may be implanted into a native valve in cooperation with the coil device 10. Examples of suitable prosthetic heart valves can be found in U.S. Patent No 9,393,110 (which is incorporated by reference herein) and International Publication No. WO 2020 / 247907.

[0163] Depending on the size of the prosthetic heart valve 110 for deployment within the native valve 12, it may be necessary to first collapse an expandable member of the coil device 10 to increase an inner diameter of the lumen L. In examples comprising balloon assemblies (any balloon assembly herein, such as balloon assemblies 62, 88, 94a, and 94b, for example), an inflation tube can be reattached to an inflation port for fluid removal from a balloon assembly or assemblies. In examples comprising a braid assembly (any braid assembly herein, such as the braid assembly 102, for example), a translation mechanism (any translation mechanism herein,Attorney Docket No: THVMC-23550WO01 such as translation mechanism 109, for example) can be engaged to relax the braid, thereby releasing tension in the native valve 12, increasing the inner diameter of the coil lumen L, and permitting prosthetic valve deployment within.

[0164] FIG. 17 is a close-up view of the native valve 12 in FIG. 15 showing the expandable coil device 10 with the inflation tube 27 attached. The prosthetic heart valve 110, shown schematically in FIG. 17, is illustrated after insertion and expansion to its functional size within the native annulus of the valve 12. The coil device 10 is shown in this example comprising the inflatable balloon assembly 62 in a non-inflated or deflated configuration, although it is understood that any expandable member herein (for example, balloon assemblies 62, 88, 94a, and 94b or braid assembly 102) can be used.

[0165] As shown in the example of FIG. 17, the coil device 10, which had been previously deployed surrounding the native valve leaflets 58 and / or the native chordae tendineae 60, is shown in a deflated configuration for installation of the prosthetic heart valve 110. The coil device 10 is shown in FIG. 17, for example, after having had a volume of inflation fluid removed before prosthetic valve 110 deployment. The volume of inflation fluid removed depends on the size of the originally deployed balloon assembly 62 and the prosthetic heart valve 110 inserted. It may be necessary to remove all the inflation fluid within the balloon assembly 62 or only a portion of the inflation fluid. It may be that no inflation fluid needs to be removed. The lumen L of the coil device 10 can be sized so that the coil device 10 remains in place surrounding the native valve 12 and the prosthetic valve 110 can be positioned and expanded within the native annulus to a specified size.

[0166] Once the prosthetic valve 110 is positioned and expanded within the native annulus, as shown in FIG. 17, the coil device 10 can be re-expanded or re-inflated. FIG. 18 shows the expandable coil device 10 and the inflation tube 27 of FIG. 7, after deployment of the prosthetic heart valve 110 and expansion or inflation of the balloon assembly 62. The prosthetic heart valve 110 is shown schematically in FIG. 18 for simplicity. FIG. 19 shows a top view of the coil device 10 of FIG. 18 with the deployed prosthetic heart valve 110 as it is shown in FIG. 16.Attorney Docket No: THVMC-23550WO01

[0167] The balloon assembly 62 can also, for example, provide a seal between the native valve 12 and the prosthetic heart valve 110 (thereby reducing paravalvular leakage around the prosthetic heart valve 110) when in a deployed configuration. Inflation of the balloon assembly 62 can be adjusted to modify a shape and / or size of the balloon assembly 62 such that the balloon assembly (and the coil device 10) can apply radially inward force on the valve and seal openings in the native valve 12, thus reducing paravalvular leakage at and / or near commissures. More specifically, the uppermost ventricular side portion of the coil device 10 may help close and / or otherwise seal openings in the native valve 12 that are present beyond the edges of the prosthetic heart valve 110 (i.e., radially outwardly from the prosthetic heart valve 110).

[0168] With these considerations, an expandable member (any expandable member herein, such as the balloon assemblies 62, 88, 94a, and 94b, or the braid assembly 102, for example), can be expanded or inflated to a size and shape suited to squeeze the native valve leaflets 58 and / or the chordae tendineae 60 in a radially inward direction, thereby creating tension in the native valve 12 to reduce regurgitation and reduce paravalvular leakage around the prosthetic heart valve 110.

[0169] Although FIGS. 17-19 show the balloon assembly 62, it is understood that the coil device 10 of FIGS. 17-19 can comprise any expandable member herein (such as the balloon assemblies 88, 94a, and 94b, or the braid assembly 102, for example).

[0170] In this way, a coil device comprising a support member and at least one expandable member (such as the balloon assemblies 62, 88, 94a, and 94b, or the braid assembly 102, for example) can repair or reduce regurgitation through a native valve by applying an inward radial force on the native heart valve to increase tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae. Sterilization

[0171] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system,Attorney Docket No: THVMC-23550WO01 device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques

[0172] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini- thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0173] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrialAttorney Docket No: THVMC-23550WO01 septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0174] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0175] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0176] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. SimulationAttorney Docket No: THVMC-23550WO01

[0177] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0178] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc. Additional Examples of the Disclosed Technology

[0179] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0180] Example 1. An implantable device for treating a native heart valve, the implantable device comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and a balloon comprising a balloon wall and extending radially around at least a portion of the coiled section of the support member, wherein the balloon defines an inner lumen of the implantable device and the balloon is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.

[0181] Example 2. The implantable device of any example herein, particularly example 1, wherein the balloon comprises an inflation port extending through the balloon wall and through which a fluid can be injected to expand the balloon.

[0182] Example 3. The implantable device of any example herein, particularly example 2, wherein the inflation port comprises a seal.Attorney Docket No: THVMC-23550WO01

[0183] Example 4. The implantable device of any example herein, particularly any of examples 1-3, wherein the balloon comprises a first segment and a second segment and the inner lumen has a third inner diameter, wherein the first segment of the balloon is movable from the delivery configuration to the deployed configuration and the second segment of the balloon is movable from the delivery configuration to a deployed configuration defining the third inner diameter, and wherein the third inner diameter is different than the second inner diameter.

[0184] Example 5. The implantable device of any example herein, particularly any of examples 1-4, wherein a balloon wall material comprises silicone, a thermoplastic polyurethane, polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0185] Example 6. The implantable device of any example herein, particularly any of examples 1-5, further comprising a cover disposed over at least a portion of the balloon.

[0186] Example 7. The implantable device of any example herein, particularly example 6, wherein the cover comprises a fabric, a coating, or combinations thereof.

[0187] Example 8. The implantable device of any example herein, particularly any preceding example, wherein the coiled section of the support member is configured to encircle native valve leaflets and native chordae tendineae of the native heart valve, and wherein the coiled section and the balloon in the deployed configuration together are configured to apply an inward radial force on the native heart valve to increase tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae and reduce regurgitation through the native heart valve, wherein the inward radial force can be adjusted by varying the second inner diameter.

[0188] Example 9. The implantable device of any example herein, particularly any preceding example, wherein the coiled section of the support member and the balloon are configured to receive a prosthetic heart valve and to secure the prosthetic heart valve relative to the native anatomy.Attorney Docket No: THVMC-23550WO01

[0189] Example 10. The implantable device of any example herein, particularly any of examples 1-9, wherein the implantable device further comprises an additional balloon extending radially around at least a portion of the coiled section of the support member and the inner lumen has a fourth inner diameter, wherein the additional balloon is movable from the delivery configuration to a deployed configuration defining the fourth inner diameter.

[0190] Example 11. The implantable device of any example herein, particularly example 10, wherein the additional balloon comprises a second inflation port.

[0191] Example 12. An implantable device for treating regurgitation in a native heart valve, the implantable device comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least of portion of the coiled section of the support member, wherein the expandable member defines an inner lumen of the implantable device and the expandable member is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter, and wherein the implantable device applies an inward radial force on the native heart valve to increase tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native heart valve.

[0192] Example 13. The implantable device of any example herein, particularly example 12, wherein the expandable member is a braid.

[0193] Example 14. The implantable device of any example herein, particularly example 13, wherein the braid comprises a first end portion and a second end portion, wherein the first end portion is fixed to the support member and the second end portion can translate axially along the support member to expand the braid.Attorney Docket No: THVMC-23550WO01

[0194] Example 15. The implantable device of any example herein, particularly example 14, wherein the second end portion is fixed to the coiled section of the support member after the braid is expanded.

[0195] Example 16. The implantable device of any example herein, particularly any of examples 13-15, further comprising a cover disposed over at least a portion of the braid.

[0196] Example 17. The implantable device of any example herein, particularly example 16, wherein the cover comprises a fabric, a coating, or combinations thereof.

[0197] Example 18. The implantable device of any example herein, particularly any of examples 14-17, further comprising a lead screw mechanism or a ratcheting mechanism to translate the second end portion axially along the support member during expansion.

[0198] Example 19. The implantable device of any example herein, particularly any of examples 12-18, wherein the coiled section of the support member and the expandable member are configured to receive a prosthetic heart valve and to secure the prosthetic heart valve relative to the native anatomy.

[0199] Example 20. A method of reducing regurgitation through a native heart valve, the method comprising: positioning an implantable device around native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve, wherein the implantable device is in a delivery configuration and comprises: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, wherein the inner lumen has a first diameter in the delivery configuration; and expanding the expandable member from the delivery configuration to a deployed configuration, and wherein the inner lumen comprises a second diameter in the deployed configuration that is smaller than the first diameter such that the expandable member urges the native valve leaflets inwardly and reduces regurgitation through the native heart valve.Attorney Docket No: THVMC-23550WO01

[0200] Example 21. The method of any example herein, particularly example 20, further comprising adjusting the second diameter to vary an inward radial force applied to the native heart valve to alter tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae and reduce regurgitation.

[0201] Example 22. The method of any example herein, particularly any of examples 20 and 21, wherein the expandable member comprises an inflatable balloon.

[0202] Example 23. The method of any example herein, particularly example 22, further comprising attaching an inflation tube to an inflation port extending through a balloon wall to add or remove a fluid within the inflatable balloon.

[0203] Example 24. The method of any example herein, particularly example 23, further comprising using the inflation tube to adjust a volume of the fluid within the inflatable balloon to vary the second diameter.

[0204] Example 25. The method of any example herein, particularly any of examples 23 and 24, wherein the fluid is radiopaque and the method further comprises visually monitoring the volume of the fluid within the inflatable balloon during expansion.

[0205] Example 26. The method of any example herein, particularly any of examples 22-25, further comprising inserting a prosthetic heart valve within an annulus of the native heart valve as part of a subsequent procedure, wherein the coiled section of the support member and the inflatable balloon encircle the native heart valve and the prosthetic heart valve.

[0206] Example 27. The method of any example herein, particularly example 26, further comprising deflating the inflatable balloon before inserting the prosthetic heart valve within the annulus.

[0207] Example 28. The method of any example herein, particularly any of examples 26 and 27, further comprising expanding the inflatable balloon after inserting the prosthetic heart valve,Attorney Docket No: THVMC-23550WO01 wherein the second diameter is configured to cooperate with the prosthetic heart valve to secure the prosthetic heart valve in place.

[0208] Example 29. The method of any example herein, particularly any of examples 22-28, wherein the implantable device further comprises a second balloon.

[0209] Example 30. The method of any example herein, particularly example 29, further comprising attaching a second inflation tube to a second inflation port extending through a wall of the second balloon to add or remove a fluid within the second balloon.

[0210] Example 31. The method of any example herein, particularly example 30, further comprising using the second inflation tube to adjust a volume of the fluid within the second balloon to vary a third diameter.

[0211] Example 32. The method of any example herein, particularly any of examples 20 and 21, wherein the expandable member comprises a braid.

[0212] Example 33. The method of any example herein, particularly example 32, further comprising inserting a prosthetic heart valve within an annulus of the native heart valve as part of a subsequent procedure, wherein the coiled section of the support member and the braid encircle the native heart valve and cooperate with the prosthetic heart valve within the annulus to secure the prosthetic heart valve in place.

[0213] Example 34. The method of any example herein, particularly example 33, further comprising relaxing the braid before inserting the prosthetic heart valve within the annulus.

[0214] Example 35. The method of any example herein, particularly any of examples 33-34, further comprising expanding the braid after inserting the prosthetic heart valve, wherein the second diameter is configured to cooperate with the prosthetic heart valve to secure the prosthetic heart valve in place.Attorney Docket No: THVMC-23550WO01

[0215] Example 36. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0216] Example 37. A prosthetic heart valve of any one of examples 1-36, wherein the prosthetic heart valve is sterilized.

[0217] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one implantable device can be combined with any one or more features of another implantable device. As another example, any one or more features of a method of reducing regurgitation can be combined with any one or more features of another method of reducing regurgitation.

[0218] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. We therefore claim all that comes within the scope and spirit of these claims.

Claims

Attorney Docket No: THVMC-23550WO01 CLAIMS:

1. An implantable device for treating a native heart valve, the implantable device comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and a balloon comprising a balloon wall and extending radially around at least a portion of the coiled section of the support member, wherein the balloon defines an inner lumen of the implantable device and the balloon is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.

2. The implantable device of claim 1, wherein the balloon comprises an inflation port extending through the balloon wall and through which a fluid can be injected to expand the balloon.

3. The implantable device of any of claims 1-2, wherein the balloon comprises a first segment and a second segment and the inner lumen has a third inner diameter, wherein the first segment of the balloon is movable from the delivery configuration to the deployed configuration and the second segment of the balloon is movable from the delivery configuration to a deployed configuration defining the third inner diameter, and wherein the third inner diameter is different than the second inner diameter.

4. The implantable device of any one of claims 1-3, wherein the coiled section of the support member is configured to encircle native valve leaflets and native chordae tendineae of the native heart valve, and wherein the coiled section and the balloon in the deployed configuration together are configured to apply an inward radial force on the native heart valve to increase tension within the native valve leaflets, the native chordae tendineae, or both the nativeAttorney Docket No: THVMC-23550WO01 valve leaflets and the native chordae tendineae and reduce regurgitation through the native heart valve, wherein the inward radial force can be adjusted by varying the second inner diameter.

5. The implantable device of any one of claims 1-4, wherein the coiled section of the support member and the balloon are configured to receive a prosthetic heart valve and to secure the prosthetic heart valve relative to the native anatomy.

6. The implantable device of any of claims 1-5, wherein the implantable device further comprises an additional balloon extending radially around at least a portion of the coiled section of the support member and the inner lumen has a fourth inner diameter, wherein the additional balloon is movable from the delivery configuration to a deployed configuration defining the fourth inner diameter.

7. The implantable device of claim 6, wherein the additional balloon comprises a second inflation port.

8. An implantable device for treating regurgitation in a native heart valve, the implantable device comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least of portion of the coiled section of the support member, wherein the expandable member defines an inner lumen of the implantable device and the expandable member is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter, and wherein the implantable device applies an inward radial force on the native heart valve to increase tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native heart valve.Attorney Docket No: THVMC-23550WO01 9. The implantable device of claim 8, wherein the expandable member is a braid.

10. The implantable device of claim 9, wherein the braid comprises a first end portion and a second end portion, wherein the first end portion is fixed to the support member and the second end portion can translate axially along the support member to expand the braid.

11. The implantable device of claim 10, wherein the second end portion is fixed to the coiled section of the support member after the braid is expanded.

12. The implantable device of any of claims 10-11, further comprising a lead screw mechanism or a ratcheting mechanism to translate the second end portion axially along the support member during expansion.

13. A method of reducing regurgitation through a native heart valve, the method comprising: positioning an implantable device around native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve, wherein the implantable device is in a delivery configuration and comprises: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, wherein the inner lumen has a first diameter in the delivery configuration; and expanding the expandable member from the delivery configuration to a deployed configuration, and wherein the inner lumen comprises a second diameter in the deployed configuration that is smaller than the first diameter such that the expandable member urges the native valve leaflets inwardly and reduces regurgitation through the native heart valve.Attorney Docket No: THVMC-23550WO01 14. The method of claim 13, further comprising adjusting the second diameter to vary an inward radial force applied to the native heart valve to alter tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae and reduce regurgitation.

15. The method of any one of claims 13-14, wherein the expandable member comprises an inflatable balloon.

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