US20200138567A1 - Mitral valve spacer device - Google Patents

Abstract

A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control. The first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally pulls both the first clasp control member and the second clasp control member, and such that when the first side portion and the second side portion are uncoupled, individual proximal movements of the first side portion and the second side portion independently pull the first clasp control member and the second clasp control member, respectively.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 15/973,892, filed on May 8, 2018, which claims the benefit of U.S. Provisional Application Nos. 62/659,253, filed Apr. 18, 2018, 62/571,552, filed Oct. 12, 2017, and 62/504,389, filed May 10, 2017, which applications are incorporated by reference herein.
FIELD
• This disclosure generally relates to prosthetic devices and related methods for helping to seal native heart valves to prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.
BACKGROUND
• The native heart valves (i.e., the aortic, pulmonary, tricuspid and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death. For many years, the definitive treatment for such damaged valves was surgical repair or replacement of the valve during open heart surgery. However, open heart surgeries are highly invasive and are prone to many complications. Therefore, elderly and frail patients with defective heart valves often went untreated. More recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. One particular transvascular technique that is used for accessing the native mitral and aortic valves is the transseptal technique. The transseptal technique comprises inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium. Such transvascular techniques have increased in popularity due to their high success rates.
• A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting free edges of the leaflets when they are closed together.
• When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
• Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles and/or stretching of the mitral valve annulus resulting from dilation of the left ventricle. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation.
• Some prior techniques for treating mitral regurgitation include stitching portions of the native mitral valve leaflets directly to one another (known as an “Alfieri” stitch). Other prior techniques include the use of a leaflet clip, such as the MitraClip®, that is clipped onto the coaptation edges of the native mitral valve leaflets and hold them together to mimic an Alfieri stitch. Unfortunately, the MitraClip® device suffers from a number of drawbacks. For example, securing the leaflets directly to each other can place undue stress on the leaflets, which can cause tearing and single leaflet detachment. Also, the MitraClip® device has a relatively narrow profile and can only capture a very small area of the leaflets, which can create areas of the stress on the leaflets and possible trauma to the leaflets. Fastening the leaflets directly to each other also prevents the captured portions of the coaptation edges from separating during ventricular diastole, which can inhibit antegrade blood flow through the mitral valve.
• Moreover, the procedure for implanting the MitraClip® device is relatively difficult and time consuming for a number of reasons. For example, it is difficult to properly position the device so that the clipping members are behind the native leaflets, which are moving during the cardiac cycle. Further, when positioning or retrieving the MitraClip® device the clipping members can become entangled or catch onto adjacent tissue, such as the chordae tendineae. Removing the device from the entangled tissue can be difficult and can cause trauma to the tissue. Another drawback is that a single MitraClip® device typically will not adequately reduce mitral regurgitation because only a very small area of the leaflets are held together. As such, multiple devices, such as two to four devices, typically are required to adequately address the regurgitation, which further adds to the complexity and time of the procedure.
• Furthermore, it is difficult to manipulate the distal end portion of the MitraClip® delivery system within the small confines of the left atrium. For example, the MitraClip® delivery system does not permit independent positioning of the implant in the anterior-posterior directions, superior-inferior directions, and the medial-lateral directions. Due to limitations of the MitraClip® delivery system, adjustment of the delivery system in the medial-lateral direction, for example, will change the superior-inferior positioning of the implant. Thus, positioning the implant at the desired location along the coaptation edge using the MitraClip® delivery system is difficult and/or time consuming.
• Accordingly, there is a continuing need for improved devices and methods for treating mitral valve regurgitation.
SUMMARY
• Described herein are embodiments of prosthetic devices that are primarily intended to be implanted at one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatuses and methods for implanting the same. The prosthetic devices can be used to help restore and/or replace the functionality of a defective native valve.
• An implantable prosthetic device can include a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member can be configured to be disposed between native leaflets of a heart. The anchors can be coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps can be coupled to a respective anchor and configured to secure the native leaflets to the anchors. The clasps can be independently movable between an open configuration and a closed configuration.
• In one representative embodiment, an implantable prosthetic device comprises a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member is configured to be disposed between native leaflets of a heart. The anchors are coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps are coupled to a respective anchor and are configured to secure the native leaflets to the anchors. The clasps are independently movable between an open configuration and a closed configuration.
• In some embodiments, the prosthetic device is movable between a compressed configuration, in which the spacer member is radially compressed and is axially spaced relative to at least a portion of the anchors, and an expanded configuration, in which the spacer member expands radially outwardly relative to the compressed configuration and overlaps the at least a portion of the anchors.
• In some embodiments, the anchors are pivotable relative to the spacer member between a first configuration and a second configuration. An angle between the first portions of the anchors and the spacer member is greater than approximately 120 degrees when the anchors are in the first configuration.
• In some embodiments, the anchors have first portions, second portions, and joint portions disposed between the first portions and the second portions. The first portions are coupled to the spacer member.
• In some embodiments, the at least a portion of the anchors is the second portions of the anchors.
• In some embodiments, the first portions are spaced relative to the second portions in the compressed configuration and overlap with the second portions in the expanded configuration.
• In some embodiments, the anchors are pivotable relative to the spacer member between a first configuration and a second configuration. An angle between the first portions of the anchors and the spacer member is approximately 180 degrees when the anchors are in the first configuration, and the angle between the first portions of the anchors and the spacer member is approximately 0 degrees when the anchors are in the second configuration.
• In some embodiments, the clasps comprise attachment portions and arm portions, the attachment portions are coupled to the anchors, and the arm portions are pivotable relative to the attachment portions between the open configuration and the closed configuration.
• In some embodiments, the clasps are configured to capture the native leaflets between the attachment portions and the arm portions.
• In some embodiments, the clasps are configured to be biased to the closed configuration.
• In some embodiments, the clasps are configured to have a preload when the clasps are in the closed configuration.
• In some embodiments, the clasps comprise barbs configured to engage tissue of the native leaflets.
• In some embodiments, the spacer member and the anchors are formed from a single, unitary piece of material.
• In some embodiments, the spacer member and the anchors includes braided or woven material comprising nitinol.
• In some embodiments, the prosthetic device is configured for implantation in a native mitral valve and to reduce mitral regurgitation.
• In another representative embodiment, an implantable prosthetic device comprises a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member is configured to be disposed between native leaflets of a heart. The anchors are coupled to the spacer member and configured to secure the native leaflets against the spacer member. The anchors are pivotable relative to the spacer body between a first configuration and a second configuration. An angle between at least a portion of the anchors and the spacer member is approximately 180 degrees when the anchors are in the first configuration, and the angle between the at least a portion of the anchors and the spacer member is approximately 0 degrees when the anchors are in the second configuration. The clasps are coupled to a respective anchor and are configured to secure the native leaflets to the anchors. The clasps are movable between an open configuration and a closed configuration.
• In some embodiments, the anchors have first portions, second portions, and joint portions disposed between the first portions and the second portions. The first portions are coupled to the spacer member. The at least a portion of the anchors is the first portions of the anchors.
• In some embodiments, the clasps are separately movable between an open configuration and a closed configuration.
• In another representative embodiment, an assembly comprises an implantable prosthetic device and a delivery apparatus. The implantable prosthetic device has a spacer member, a plurality of anchors, a plurality of clasps, a first collar, and a second collar. The first end portions of the anchors are coupled to a first end portion of the spacer member, and second end portions of the anchors are coupled to the first collar. The second collar is coupled to a second end portion of the spacer member, and the clasps are coupled to the anchors. The delivery apparatus has a first shaft, a second shaft, and a plurality of clasp control members. The first shaft is releasably coupled to the first collar of the prosthetic device, the second shaft is releasably coupled to the second collar of the prosthetic device, and the clasp control members are releasably coupled to the clasps of the prosthetic device. Actuating the clasp control members moves the clasps between an open configuration and a closed configuration.
• In some embodiments, the delivery apparatus is configured such that moving the first shaft and the second shaft relative to each other moves the prosthetic device between a first configuration, in which anchors are in a radially compressed, axially elongate configuration, and a second configuration, in which the anchors are in a radially expanded, axially compressed configuration and at least partially overlap the spacer member to capture native leaflets between the anchors and the spacer member.
• In some embodiments, the delivery apparatus further comprises a clasp control mechanism, and the clasp control members are releasably coupled to the clasp control mechanism. The clasp control mechanism is configured such that the clasp control members can be actuated either simultaneously or separately.
• In some embodiments, the clasp control members comprise a first clasp control member and a second clasp control member. The clasp control mechanism comprises a first side portion, a second side portion, and a removable pin selectively coupling the first and second side portions. The first clasp control member is releasably coupled to first side portion of the clasp control mechanism, and the second clasp control member is releasably coupled to the second side portion of the clasp control mechanism.
• In some embodiments, the delivery apparatus further comprises a locking mechanism coupled to the first shaft and the second shaft and configured to selectively prevent relative axial movement between the first shaft and the second shaft.
• In some embodiments, the locking mechanism comprises a rotatable knob.
• In some embodiments, the locking mechanism is configured to be selectively movable from a lock configuration to a release configuration. The locking mechanism prevents relative axial movement between the first shaft and the second shaft in the lock configuration, and the locking mechanism allows relative axial movement between the first shaft and the second shaft in the release configuration.
• In some embodiments, the locking mechanism comprises a knob, a drive screw, and a guide pin. The knob is rotatably coupled to the second shaft and the drive screw, the drive screw is coupled to the first shaft, and the guide pin is coupled to the second shaft and configured to prevent relative rotational movement between the knob and the drive screw. Rotating the knob relative to the second shaft and the drive screw results in relative axial movement between the first shaft and the second shaft.
• In some embodiments, the first shaft and the first collar are threadably coupled.
• In some embodiments, the first collar comprises a lumen. The first shaft comprises a radially expandable member dispose at the distal end portion of the first shaft. The expandable member is configured such that the expandable member can be inserted through the lumen of the first collar when the expandable member is a compressed state and such that the expandable member cannot be withdrawn through the lumen of the first collar when the expandable member is inserted through the lumen of the first collar and the expandable member is an expanded state.
• In another representative embodiment, an implantable prosthetic device comprises a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member is configured to be disposed between native leaflets of a heart. The anchors are coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps are configured to secure the native leaflets to the anchors and have fixed end portions and free end portions. The fixed end portions are coupled to the anchors. The free end portions have barbs. The free end portions are pivotable relative to the fixed end portions between an open configuration and a closed configuration. The free end portions are axially movable in the open configuration from a first position in which the barbs engage tissue of the native leaflets to a second position in which the barbs disengage the tissue of the native leaflets.
• In another representative embodiment, an implantable prosthetic device comprises a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member is configured to be disposed between native mitral valve leaflets of a heart. The anchors are coupled to the spacer member. The anchors are configured to secure the native mitral valve leaflets against the spacer member during ventricular systole and to allow the native mitral valve leaflet to move away from the spacer member during ventricular diastole. The clasps are coupled to a respective anchor and configured to secure the native leaflets to the anchors. The clasps are movable between an open configuration and a closed configuration.
• In yet another representative embodiment, an implantable prosthetic device comprises a spacer member, a sleeve, a plurality of anchors, and a piston. The spacer member is configured to be disposed between native leaflets of a heart. The sleeve is coupled to and disposed radially within the spacer member. The anchors are configured to secure the native leaflets against the spacer member and having first end portions and second end portions. The first end portions are coupled to the spacer member. The anchors are movable between an elongate configuration and a foreshortened configuration. The piston is coupled to the second end portions of the anchors. The piston is axially movable relative to the cylinder between a first configuration and a second configuration. The anchors are in the elongate configuration when the piston is in the first configuration. The anchors are in the foreshortened configuration when the piston is in the second configuration.
• In another representative embodiment, an assembly comprises the prosthetic device of the previous paragraph and a delivery apparatus. The delivery apparatus comprises an outer shaft, an actuation shaft, and a plurality of tethers. The outer shaft has a first lumen and a plurality of second lumens disposed radially outwardly from the first lumen. The actuation shaft extends through the first lumen. The actuation shaft is axially movable relative the outer shaft and releasably coupled to the piston of the prosthetic device. The tethers extend through the second lumens and are releasably coupled to the prosthetic device. Tensioning the tethers moves the implantable prosthetic device and the outer shaft toward each other. Slackening the tethers allows the implantable prosthetic device and the outer shaft to be space from each other.
• In some embodiments, each of the tethers is disposed in two of the second lumens that are circumferentially offset by approximately 180 degrees.
• In some embodiments, the prosthetic device further comprises a plurality of clasps. The clasps are coupled to a respective anchor and are configured to secure the native leaflets to the anchors. The clasps are movable between an open configuration and a closed configuration. The outer shaft of the delivery apparatus further comprises a plurality of third lumens disposed radially outwardly from the first lumen. The delivery apparatus further comprises a plurality of control members extending through the third lumens and releasably coupled to the clasps of the prosthetic device. Tensioning the control members move the clasps to the open configuration. Slackening the control members allows the clasps to move to the closed configuration.
• In some embodiments, each of the control members is disposed in two of the third lumens that are circumferentially offset by approximately 180 degrees.
• In some embodiments, each of the second lumens is circumferentially offset relative to an adjacent second lumen by approximately 90 degrees. Each of the third lumens is circumferentially offset relative to an adjacent third lumen by approximately 90 degrees. Each of the second lumens is circumferentially offset relative to an adjacent third lumen by approximately 45 degrees.
• In another representative embodiment, an assembly comprises an implantable prosthetic device and a delivery apparatus. The implantable prosthetic device has a spacer member, a plurality of anchors, a plurality of clasps, a first collar, and a second collar. The first end portions of the anchors are coupled to a first end portion of the spacer member, and second end portions of the anchors are coupled to the first collar. The second collar is coupled to a second end portion of the spacer member, and the clasps are coupled to the anchors and are independently movable between an open configuration and a closed configuration. The delivery apparatus has a first shaft, a second shaft, a plurality of tethers, and a plurality of clasp control members. The first shaft is releasably coupled to the first collar of the prosthetic device by the tethers, the second shaft is releasably coupled to the second collar of the prosthetic device, and the clasp control members are releasably coupled to the clasps of the prosthetic device. Actuating the clasp control members moves the clasps between an open configuration and a closed configuration. Tensioning the tethers moves the prosthetic device and the first shaft toward each other, and slackening the tethers allows the prosthetic device and the first shaft to be spaced from each other.
• In another representative embodiment, a handle for a delivery apparatus comprises a main body and an anchor actuation mechanism coupled to the main body. The anchor actuation mechanism is configured to be coupled to anchors of a prosthetic spacer device and to move the anchors of the prosthetic spacer device between a closed configuration and an open configuration. The anchor actuation mechanism includes a knob and a mode selector button configured to move the anchors actuation mechanism between a first mode of operation and a second mode of operation. When the anchor actuation mechanism is in the first mode of operation, the knob is rotatable relative to the main body, and rotation of the knob moves the anchors of the prosthetic spacer device between the closed configuration and the open configuration. When the anchor actuation mechanism is in the second mode of operation, the knob is axially slidable relative to the main body, and axially sliding the knob moves the anchors of the prosthetic spacer device between the closed configuration and the open configuration.
• In some embodiments, the handle further comprises a clasp actuation mechanism coupled to the main body. The clasp actuation mechanism is configured to be coupled to claps of the prosthetic spacer device and configured to move the clasps of the prosthetic spacer device between a closed configuration and an open configuration.
• In one representative embodiment, a positioning tool for a delivery apparatus comprises a main body and one or more projections. The main body is configured to be releasably coupled to a first portion of a handle of the delivery apparatus. The projections extend from the main body and are configured to releasably engage a second portion of the handle of the delivery apparatus. The positioning tool prevents relative movement between the first and second portions of the handle of the delivery apparatus when the positioning tool is coupled thereto.
• 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 key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates an exemplary embodiment of a prosthetic spacer device, showing a first configuration.
• FIG. 2 is a perspective view of the prosthetic spacer device ofFIG. 1, showing a second configuration.
• FIG. 3 is a perspective view of the prosthetic spacer device ofFIG. 1, showing a third configuration.
• FIG. 4 is a plan view of a clasp of the prosthetic spacer device ofFIG. 1, showing a first configuration.
• FIG. 5 is a perspective view of the clasp of the prosthetic spacer device ofFIG. 1, showing a second configuration.
• FIG. 6 illustrates another exemplary embodiment of a prosthetic spacer device.
• FIG. 7 is a side elevation view of the prosthetic spacer device ofFIG. 6.
• FIG. 8 is a side elevation view of the prosthetic spacer device ofFIG. 7, showing a cover thereon.
• FIG. 9 illustrates another exemplary embodiment of a prosthetic spacer device.
• FIG. 10 illustrates another exemplary embodiment of a prosthetic spacer device.
• FIG. 11 illustrates an exemplary embodiment of a delivery assembly comprising the prosthetic spacer device ofFIG. 6 (shown in partial cross-section) and a delivery apparatus.
• FIG. 12 is a perspective view of a distal end portion of the delivery assembly ofFIG. 11, showing the prosthetic spacer device releasably coupled to the delivery apparatus.
• FIG. 13 is a perspective view of the distal end portion of the delivery assembly ofFIG. 11, showing the prosthetic spacer device released from the delivery apparatus.
• FIG. 14 is a cross-sectional view of a coupler of the delivery apparatus ofFIG. 11.
• FIG. 15 is a perspective view of the delivery assembly ofFIG. 11, with the prosthetic spacer device shown in partial cross-section and some components of the delivery apparatus shown schematically.
• FIG. 16 is a plan view of a shaft of the delivery apparatus ofFIG. 11.
• FIG. 17 is a side elevation view of a proximal end portion of the delivery apparatus ofFIG. 11.
• FIG. 18 is a cross-sectional view of the proximal end portion of the delivery apparatus ofFIG. 11, taken along the line18-18 shown inFIG. 17.
• FIG. 19 is an exploded view of the proximal end portion of the delivery apparatus ofFIG. 11.
• FIGS. 20-29 illustrate an exemplary procedure of the delivery assembly ofFIG. 11 being used to repair a native mitral valve of a heart, which is partially shown.
• FIG. 30 illustrates another exemplary embodiment of a handle for the delivery apparatus ofFIG. 11.
• FIG. 31 is an exploded view of the handle ofFIG. 30.
• FIG. 32 illustrates other exemplary embodiments of a coupler and a proximal collar for the delivery assembly ofFIG. 11, showing the coupler releasably coupled to the proximal collar.
• FIG. 33 is a perspective view of the coupler and proximal collar ofFIG. 32, showing the coupler released from the proximal collar.
• FIG. 34 illustrates other exemplary embodiments of a distal collar, actuation shaft, and release wire for the delivery assembly ofFIG. 11, showing the distal collar releasably coupled to the actuation shaft by the release wire.
• FIG. 35 is a perspective view of the distal collar, actuation shaft, and the release wire ofFIG. 32, showing the distal collar released from the actuation shaft and the release wire.
• FIG. 36 illustrates other exemplary embodiments of a coupler, a proximal collar, a distal collar, and an actuation shaft of the delivery assembly ofFIG. 11.
• FIG. 37 is a perspective view of the coupler and proximal collar ofFIG. 36.
• FIG. 38 illustrates another exemplary embodiment of a clasp control member of the delivery apparatus ofFIG. 11.
• FIG. 39 is a detail view of the clasp control member ofFIG. 38, taken from theperspective39 shown inFIG. 38.
• FIG. 40 illustrates an exemplary embodiment of a guide rail for the clasp control member ofFIG. 38.
• FIG. 41 illustrates another exemplary embodiment of a shaft of the delivery apparatus ofFIG. 11.
• FIGS. 42-45 illustrate another exemplary delivery assembly and its components.
• FIGS. 46-54 illustrate another exemplary handle for a delivery apparatus and its components.
• FIGS. 55-61D illustrate another exemplary handle for a delivery apparatus and its components.
• FIGS. 62-75 illustrate another exemplary handle for a delivery apparatus and its components.FIGS. 73-75 also illustrate an exemplary embodiment of a clasp positioning tool.
DETAILED DESCRIPTIONGeneral Considerations
• For purposes of this description, certain aspects, advantages, and novel features of the embodiments 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 embodiments, 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 embodiments require that any one or more specific advantages be present or problems be solved.
• Although the operations of some of the disclosed embodiments 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.
• 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.
• 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 (e.g., 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 (e.g., 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.
• As used herein, the term “approximately” means the listed value and any value that is within 10% of the listed value. For example, “approximately 100 degrees” means any value between 90-110 degrees, inclusive.
Exemplary Embodiments
• Described herein are embodiments of prosthetic spacer devices that are primarily intended to be implanted at one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatuses and methods for implanting the same. The prosthetic spacer devices can be used to help restore and/or replace the functionality of a defective native valve.
• A prosthetic spacer device comprises a spacer member and at least one anchor. In certain embodiments, the prosthetic spacer device further comprises at least one clasp and at least one collar.
• The spacer member can be configured to be positioned within the native valve orifice to fill a space between improperly functioning native leaflets that do not naturally coapt completely. As such, the spacer member helps create a more effective seal between the native leaflets and prevents or minimizes regurgitation (e.g., mitral regurgitation). The spacer member can comprise a structure that is impervious to blood and that allows the native leaflets to close around the sides of the spacer member to block retrograde blood flow (e.g., blood flowing from the left ventricle back into the left atrium during ventricular systole).
• The spacer member can have various shapes. In some embodiments, the spacer member can have an elongated cylindrical shape having a round cross-sectional shape. In other embodiments, the spacer member can have an ovular cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes.
• Configuring a prosthetic spacer device with a spacer member can, for example, reduce the need to implant multiple prosthetic spacers devices in a patient to reduce regurgitation compared to devices that clip the native leaflets directly to each other.
• In certain embodiments configured for implantation in a native mitral valve, the spacer member can have an atrial or upper end positioned in or adjacent to the left atrium of the heart, a ventricular or lower end positioned in or adjacent to the left ventricle of the heart, and an annular side surface that extends between the native mitral leaflets.
• The anchor can be configured to secure the prosthetic spacer device to one or more of the native leaflets such that the spacer member is positioned between the native leaflets. The anchor can be configured to be positioned behind a native leaflet when implanted such that the native leaflet is captured between the anchor and the spacer member.
• In some embodiments, a first end portion of the anchor can be attached to a lower end portion of the spacer member, and a second end portion of the anchor can be attached to a first collar disposed below the lower end portion of the spacer member. In some embodiments, the prosthetic spacer device can comprise a second collar attach to an upper end portion of the spacer member.
• The first and/or second collars can be configured to releasably connect the prosthetic spacer device to a delivery apparatus. In some embodiments, the first and second collars can be independently movable relative to each other.
• In certain embodiments, a clasp is attached to the anchor. The clasp can be configured to capture and secure a native leaflet to the anchor. In some embodiments, the prosthetic spacer device comprises more than one clasp. In certain embodiments, the clasps are independently or separately actuatable relative to each other and/or the anchors.
• FIGS. 1-5 show an exemplary embodiment of aprosthetic spacer device100 and its components. Referring toFIG. 1, theprosthetic spacer device100 can comprise aspacer member102, a plurality of paddles or anchors104 (e.g., two in the illustrated embodiment), a plurality of clasps106 (e.g., two in the illustrated embodiment), afirst collar108, and asecond collar110. As best shown inFIG. 3,first end portions112 of theanchors104 can be coupled to and extend from afirst end portion114 of thespacer member102, andsecond end portions116 of theanchors104 can be coupled to thefirst collar108. Thesecond collar110 can be coupled to asecond end portion118 of thespacer member102.
• Thespacer member102 and theanchors104 can be coupled together in various ways. For example, as shown in the illustrated embodiment, thespacer member102 and theanchors104 can be coupled together by integrally forming thespacer member102 and theanchors104 as a single, unitary component. This can be accomplished, for example, by forming thespacer member102 and theanchors104 from a braided or woven material, such as braided or woven nitinol wire. In other embodiments, thespacer member102 and theanchors104 can be coupled together by welding, fasteners, adhesive, and/or other means for coupling.
• Referring toFIG. 2, theanchors104 can comprisefirst portions120 andsecond portions122 separated byjoint portions124. In this manner, theanchors104 are configured similar to legs in that thefirst portions120 are like upper portions of the legs, thesecond portions122 are like lower portions of the legs, and thejoint portions124 are like knee portions of the legs.
• In some embodiments, the first andsecond portions120,122 can be separate components that are coupled together by thejoint portions124. For example, in one particular embodiment, the first andsecond portions120,122 can be plates or shafts that are coupled together by a cloth covering which acts, among other things, as thejoint portions124.
• Theanchors104 can be configured to move between various configurations by axially moving thefirst collar108 and thus theanchors104 relative to thespacer member102 along a longitudinal axis extending between the first andsecond end portions114,118 of thespacer member102. For example, theanchors104 can be positioned in a straight or substantially straight or unfolded configuration by moving thefirst collar108 away from thespacer member102 such that theanchors104 are taut. In the straight configuration, thejoint portions124 of theanchors104 are adjacent the longitudinal axis of the spacer member102 (e.g., similar to the configuration shown inFIG. 20).
• From the straight configuration, theanchors104 can be moved to a fully folded configuration (e.g.,FIG. 1) by moving thefirst collar108 toward thespacer member102. Initially as thefirst collar108 moves toward thespacer member102, theanchors104 bend at thejoint portions124, and thejoint portions124 move radially outwardly relative to the longitudinal axis of thespacer member102 and axially toward thefirst end portion114 of thespacer member102, as shown inFIGS. 2-3. As thefirst collar108 continues to move toward thespacer member102, thejoint portions124 move radially inwardly relative to the longitudinal axis of thespacer member102 and axially toward thesecond end portion118 of thespacer member102, as shown inFIG. 1.
• In some embodiments, an angle between thefirst portions120 of theanchors104 and thespacer member102 can be approximately 180 degrees when theanchors104 are in the straight configuration (see, e.g.,FIG. 20), and the angle between thefirst portions120 of theanchors104 and thespacer member102 can be approximately 0 degrees when theanchors104 are in the fully folded configuration. Theanchors104 can be positioned in various partially folded configurations such that the angle between thefirst portions120 of theanchors104 and thespacer member102 can be approximately 10-170 degrees or approximately 45-135 degrees.
• Configuring theprosthetic spacer device100 such that theanchors104 can extend to a straight or approximately straight configuration (e.g. approximately 120-180 degrees relative to the spacer member102) can provide several advantages. For example, this can reduce the radial crimp profile of theprosthetic spacer device100. It can also make it easier to capture the native leaflets by providing a larger opening in which to capture the native leaflets. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that theprosthetic spacer device100 will become entangled in native anatomy (e.g., chordae tendineae) when positioning and/or retrieving theprosthetic spacer device100 into the delivery apparatus.
• Referring again toFIG. 2, theclasps106 can compriseattachment portions126 andarm portions128. Theattachment portions126 can be coupled to thefirst portions120 of theanchors104 in various ways such as with sutures, adhesive, fasteners (e.g., plates129), welding and/or means for coupling.
• Thearm portions128 can pivot relative to theattachment portions126 between an open configuration (e.g.,FIG. 2) and a closed configuration (FIGS. 1 and 3). In some embodiments, theclasps106 can be biased to the closed configuration. In the open configuration, theattachment portions126 and thearm portions128 are pivoted away from each other such that native leaflets can be positioned between theattachment portions126 and thearm portions128. In the closed configuration, theattachment portions126 and thearm portions128 are pivoted toward each other, thereby clamping the native leaflets between theattachment portions126 and thearm portions128.
• Referring toFIGS. 4-5, each attachment portion126 (only one shown inFIGS. 4-5) can comprise one or more openings130 (e.g., three in the illustrated embodiment). At least some of theopenings130 can be used to couple theattachment portions126 to theanchors104. For example, sutures and/or fasteners can extend through theopenings130 of theclasps106 and through theanchors104 to secure theattachment portions126 to theanchors104.
• Each of thearm portions128 can comprise twoside beams132 that are spaced apart from each other to form aslot134. Theslot134 can be configured to receive theattachment portion126. Thearm portion128 can also include afixed end portion136 that is coupled to theattachment portion126 and afree end portion138 disposed opposite thefixed end portion136.
• Thefree end portion138 of eacharm portion128 can comprise gripper elements such asbarbs140 and/or other means for frictionally engaging native leaflet tissue. The gripper elements can be configured to engage and/or penetrate the native leaflet tissue to help retain the native leaflets between theattachment portions126 andarm portions128 of theclasps106.
• Thefree end portion138 can also comprise an eyelet oropening142, which can be used to couple thefree end portion138 to an actuation mechanism configured to pivot thearm portions128 relative to theattachment portions126. Additional details regarding coupling theclasps106 to the actuation mechanism are provided below.
• In some embodiments, theclasps106 can be formed from a shape memory material such as nitinol, stainless steel, and/or shape memory polymers. In certain embodiments, theclasps106 can be formed by laser-cutting a piece of flat sheet of material (e.g., nitinol) in the configuration shown inFIG. 4 and then shape-setting theclasp106 in the configuration shown inFIG. 5.
• Shape-setting theclasps106 in this manner can provide several advantages. For example, theclasps106 can be compressed from the shape-set configuration (e.g.,FIG. 5) to the flat configuration (e.g.,FIG. 4), which reduces the radial crimp profile of theclasps106. Also, this also improves trackability and retrievability of theprosthetic spacer device100 relative to a catheter shaft of a delivery apparatus becausebarbs140 are pointing radially inwardly toward theanchors104 when theprosthetic spacer device100 is advanced through or retrieved into the catheter shaft (see, e.g.,FIG. 20). This thus prevents or reduces the likelihood that theclasps106 may snag or skive the catheter shaft.
• In addition, shape-setting theclasps106 in the configuration shown inFIG. 5 can increase the clamping force of theclasps106 when theclasps106 are in the closed configuration. This is because thearm portions128 are shape-set relative to theattachment portions126 to a first position (e.g.,FIG. 5) which is beyond the position thearm portions128 can achieve when theclasps106 are attached to the anchors104 (e.g.,FIG. 3) because theanchors104 prevent thearm portions128 from further movement toward the shape-set configuration. This results inarm portions128 having a preload (i.e., the clamping force is greater than zero) when theclasps106 are attached to theanchors104 and in the closed configuration. Thus, shape-setting theclasps106 in theFIG. 5 configuration can increase the clamping force of theclasps106 compared to clasps that are shape-set in the closed configuration. In this manner, the connection between thearm portion128 and theattachment portion126 functions as a spring hinge to bias thearm portion128 to the closed configuration.
• The magnitude of the preload of theclasps106 can be altered by adjusting the angle in which thearm portions128 are shape-set relative to theattachment portions126. For example, increasing the relative angle between thearm portions128 and theattachment portions126 increases the preload, and decreasing the relative angle between thearm portions128 and theattachment portions126 decreases the preload. Other techniques and mechanisms can be used to bias theclasps106 to the closed position, such as by coupling a spring (e.g., a torsion spring) or another type of biasing element between thearm portion128 and theattachment portion126. Still alternatively, theclasps106 can be connected to correspondinganchors104 withoutattachment portions126 and biasing elements can be used to bias theclasps106 to the closed configuration against the anchors.
• In some embodiments, thesecond collar110 and/or thespacer member102 can comprise ahemostatic sealing member144 configured to reduce or prevent blood from flowing through thesecond collar110 and/or thespacer member102. For example, in some embodiments, the sealingmember144 can comprise a plurality offlexible flaps146, as shown inFIG. 1. Theflaps146 can be configured to pivot from a sealed configuration to an open configuration to allow a delivery apparatus to extend through thesecond collar110. When the delivery apparatus is removed, theflaps146 can be configured to return to the sealed configuration from the open configuration.
• FIGS. 6-8 show an exemplary embodiment of aprosthetic spacer device200. Theprosthetic spacer device200 can comprise aspacer member202, a plurality ofanchors204, a plurality ofclasps206, a first ordistal collar208, and a second orproximal collar210. These components of theprosthetic spacer device200 can be configured substantially similar to the corresponding components of theprosthetic spacer device100.
• Theprosthetic spacer device200 can also include a plurality ofanchor extension members212. Each of theanchor extension members212 can be configured as a loop shaped structure having a first or fixedend portion214 coupled to and extending from thedistal collar208 and second orfree end portion216 disposed opposite thefixed end portion214. Theanchor extension members212 can be configured to extend circumferentially farther around thespacer member202 than theanchors204. For example, in some embodiments, each of theanchor extension members212 can extend around approximately half the circumference of the spacer member202 (as best shown inFIG. 7), and theanchors204 can extend around less than half of circumference of the spacer member202 (as best shown inFIG. 6). Theanchor extension members212 can also be configured to extend laterally (i.e., perpendicular to a longitudinal axis of the spacer member202) beyond an outer diameter of thespacer member202.
• Theanchor extension members212 can further be configured such thatfree end portions216 of theanchor extension members212 are disposed axially adjacent ajoint portion218 of theanchors204 and radially between first andsecond portions220,222 of theanchors204 when theprosthetic spacer device200 is in a folded configuration (e.g.,FIGS. 6-8).
• Configuring theanchor extension members212 in this manner provides increased surface area compared to theanchors204 alone. This can, for example, make it easier to capture and secure the native leaflets. The increased surface area can also distribute the clamping force of theanchors204 andanchor extension members212 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.
• The increased surface area of theanchor extension members212 can also allow the native leaflets be to clamped to theprosthetic spacer device200 such that the unclamped portions of the native leaflets coapt together at a location adjacent theprosthetic spacer device200, as opposed to against thespacer member202. This can, for example, improve sealing of the native leaflet and thus prevent or further reduce mitral regurgitation.
• Referring toFIG. 8, theprosthetic spacer device200 can also include acover224. In some embodiments, thecover224 can be disposed on thespacer member202, theanchors204, and/or theanchor extension members212. Thecover224 can be configured to prevent or reduce blood-flow through theprosthetic spacer device200 and/or to promote native tissue ingrowth. In some embodiments, thecover224 can be a cloth or fabric such PET, velour, or other suitable fabric. In other embodiments, in lieu of or in addition to a fabric, thecover224 can include a coating (e.g., polymeric) that is applied to theprosthetic spacer device200. It should be noted that theprosthetic spacer device200 is shown without thecover224 inFIGS. 6-7 and 12-13 and with thecover224 inFIGS. 8, 11, and 20-27. In some embodiments, thecover224 can have a porosity selected to allow blood to flow through thespacer member202 for a predetermined length of time (e.g., one or more days, weeks, or months). Endothelialization of the spacer device over time can slowly and gradually reduce the amount of regurgitant blood flow through the spacer member, which can reduce the amount of stress on the left ventricle following implantation. Further details of a cover that permits regurgitant blood flow through the spacer member for a predetermined period of time are disclosed in U.S. Provisional Application No. 62/555,240, filed Sep. 7, 2017, which application is incorporated by reference herein.
• FIG. 9 shows an exemplary embodiment of aprosthetic spacer device300 comprising anannular spacer member302, a fabric cover (not shown) covering the outer surface of thespacer member302, and anchors304 extending from thespacer member302. The cover or additional covers may also extend over theanchors304. The ends of eachanchor304 can be coupled to respective struts of thespacer member302 byrespective sleeves306 that can be crimped around the end portions of theanchors304 and the struts of thespacer member302. Mounted on the frame of thespacer member302 can be one or more barbs orprojections308. The free ends of theprojections308 can comprise various shapes including rounded, pointed, barbed, etc. Theprojections308 can exert a retaining force against native leaflets by virtue of theanchors304, which are shaped to force the native leaflets inwardly into thespacer member302 in the area below the free ends of theanchors304.
• FIG. 10 shows an exemplary embodiment of aprosthetic spacer device400. Theprosthetic spacer device400 can comprise anannular spacer member402, a fabric cover (not shown) covering the spacer member, and anchors404 extending from thespacer member402 and can be configured similar to theprosthetic spacer device300. The cover may also cover the outer surfaces of the anchors.
• Theanchors404 of theprosthetic spacer device400 can be configured similar to theanchors304 of theprosthetic spacer device300 except that the curve at the free end of eachanchor404 is wider and has a larger radius than theanchors304. As such, theanchors404 cover a relatively larger portion of thespacer member402 than theanchors304. This can, for example, distribute the clamping force of theanchors404 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. It can also improve sealing because the native leaflets are clamped against theprosthetic spacer device400 such that the native leaflets coapt together at a location adjacent theprosthetic spacer device400, as opposed to against thespacer member402.
• Also, mounted on the frame of thespacer member402 can be one or more barbs orprojections406. The free ends of theprojections406 can comprisestoppers408 configured to limit the extent of theprojections406 that can engage and/or penetrate the native leaflets.
• Additional details regarding the prosthetic spacer devices can be found, for example, in U.S. Patent Application Publication No. 2016/0331523 and U.S. Provisional Application No. 62/161,688, which applications are incorporated by reference herein.
• A prosthetic spacer device (e.g., thedevices100,200,300,400) can be coupled to a delivery apparatus to form a delivery assembly. The delivery apparatus can be used to percutaneously deliver, position, and/or secure the prosthetic spacer device within a patient's native heart valve region.
• FIG. 11-27 shows anexemplary delivery assembly500 and its components. Referring toFIG. 11, thedelivery assembly500 can comprise theprosthetic spacer device200 and adelivery apparatus502. Thedelivery apparatus502 can comprise a plurality of catheters and one or more catheter stabilizers. For example, in the illustrated embodiment, thedelivery apparatus502 includes afirst catheter504, asecond catheter506, athird catheter508, andcatheter stabilizers510. Thesecond catheter506 extends coaxially through thefirst catheter504, and thethird catheter508 extends coaxially through the first andsecond catheters504,506. Theprosthetic spacer device200 can be releasably coupled to a distal end portion of thethird catheter508 of thedelivery apparatus502, as further described below.
• Each of thecatheter stabilizers510 can be used to hold a corresponding catheter stationary relative to the patient and other components of the delivery apparatus during a procedure. Thestabilizers510 can be positioned on a common table or support platform, which in turn can be placed on the operating table. For example, after manually inserting a catheter into the vasculature of a patient and positioning the distal end of the catheter at a desired location within the patient's body, the medical practitioner can then place the catheter in acorresponding stabilizer510, freeing the practitioner's hands for manipulating another catheter during the procedure. Further details regarding the catheter stabilizers and a support platform for supporting the stabilizers are disclosed in U.S. Application No. 62/491,392, filed Apr. 28, 2017, which application is incorporated by reference herein.
• In the illustrated embodiment, thedelivery assembly500 is configured, for example, for implanting theprosthetic spacer device200 in a native mitral valve via a transseptal delivery approach. In other embodiments, thedelivery assembly500 can be configured for implanting theprosthetic spacer device200 in aortic, tricuspid, or pulmonary valve regions of a human heart. Also, thedelivery assembly500 can be configured for various delivery methods, including transseptal, transaortic, transventricular, etc.
• Referring toFIG. 13, the first ordistal collar208 of theprosthetic spacer device200 can include abore226. In some embodiments, thebore226 can comprise internal threads configured to releasably engage corresponding external threads of anactuation shaft512 of thedelivery apparatus502, as best shown inFIG. 12.
• Referring again toFIG. 13, the second orproximal collar210 of theprosthetic spacer device200 can include acentral opening228 that is axially aligned with thebore226 of thedistal collar208. Thecentral opening228 of theproximal collar210 can be configured to slidably receive theactuation shaft512 of thedelivery apparatus502, as best shown inFIG. 12. In some embodiments, theproximal collar210 and/or thespacer member202 can have a sealing member (not shown, but see, e.g., the sealingmember144 shown inFIG. 1) configured to seal thecentral opening228 when theactuation shaft512 is withdrawn from thecentral opening228.
• As best shown inFIG. 13, theproximal collar210 can also include a plurality of bosses orprojections230 and a plurality ofguide openings232 formed in theprojections230. Theprojections230 can extending radially outwardly and can be circumferentially offset (e.g., by 90 degrees) relative to theguide openings232. Theguide openings232 can be disposed radially outwardly from thecentral opening228. Theprojections230 and theguide openings232 of theproximal collar210 can be configured to releasably engage acoupler514 of thedelivery apparatus502, as shown inFIG. 12.
• Referring again toFIG. 11 and as mentioned above, thedelivery apparatus502 can include the first andsecond catheters504,506. The first andsecond catheters504,506 can be used, for example, to access an implantation location (e.g., a native mitral valve region of a heart) and/or to position thethird catheter508 at the implantation location.
• The first andsecond catheters504,506 can comprise first and second sheaths orshafts516,518 extending fromhandles517,519, respectively. The first andsecond catheters504,506 can be configured such that thesheaths516,518 are steerable. For example, although not shown, thesecond catheter506 can comprise one or more pull wires, and one or more flexible, axially non-compressible pull wire sleeves (e.g., helical coils). The pull wires and the sleeves can extend through a portion of theshaft518, and the sleeves can move freely relative to the shaft518), as further described in U.S. Patent Application Publication No. U.S. 2016/0158497, which application is incorporated by reference herein. This can, for example, allow a steerabledistal end portion518aof theshaft518 to be deflected, moved, and/or rotated in one or more directions (e.g., in the medial/lateral and/or anterior/posterior directions to track the “C”-shape of the coaptation line between the native mitral valve leaflets between the posteromedial commissure and the anterolateral commissure), while also keeping a distal end portion of the implant catheter (e.g., the third catheter508) and the thus the prosthetic spacer device coaxial relative to the mitral valve in one or more other directions (e.g., the inferior/superior directions).
• Additional details regarding thefirst catheter504 can be found, for example, in U.S. patent application No. U.S. Ser. No. 15/796,436, filed Oct. 27, 2017, which application is incorporated by reference herein. Additional details regarding thesecond catheter506 can be found, for example, in U.S. Patent Application Publication No. U.S. 2016/0158497.
• Referring still toFIG. 11,delivery apparatus502 can also include thethird catheter508, as mentioned above. Thethird catheter508 can be used, for example, to deliver, manipulate, position, and/or deploy theprosthetic spacer device200 at the implantation location, as further described below.
• Referring toFIG. 15, thethird catheter508 can comprise the inner oractuation shaft512, thecoupler514, anouter shaft520, a handle522 (shown schematically), andclasp control members524. Aproximal end portion520aof theouter shaft520 can be coupled to and extend distally from thehandle522, and adistal end portion520bof theouter shaft520 can be coupled to thecoupler514. Aproximal end portion512aof theactuation shaft512 can coupled to anactuation knob526. Theactuation shaft512 can extend distally from the knob526 (shown schematically), through thehandle522, through theouter shaft520, and through thecoupler514. Theactuation shaft512 can be moveable (e.g., axially and/or rotationally) relative to theouter shaft520 and thehandle522. Theclasp control members524 can extend through and be axially movable relative to thehandle522 and theouter shaft520. Theclasp control members524 can also be axially movable relative to theactuation shaft512.
• In some embodiments, theouter shaft520 of thethird catheter508 can be configured to be steerable. For example, although not shown, thethird catheter508 can comprise a pull wire, and a flexible, axially non-compressible pull wire sleeve (e.g., a helical coil).
• As best shown inFIGS. 12-13, theactuation shaft512 of thethird catheter508 can be releasably coupled to thedistal collar208 of theprosthetic spacer device200. For example, in some embodiments, thedistal end portion512bof theactuation shaft512 can comprise external thread configured to releasably engage the interior threads of thebore226 of theprosthetic spacer device200. As such, rotating theactuation shaft512 in a first direction (e.g., clockwise) relative to thedistal collar208 of theprosthetic spacer device200 releasably secures theactuation shaft512 to thedistal collar208. Rotating theactuation shaft512 in a second direction (e.g., counterclockwise) relative to thedistal collar208 of theprosthetic spacer device200 releases theactuation shaft512 from thedistal collar208.
• Referring now toFIG. 12-14, thecoupler514 of thethird catheter508 can be releasably coupled to theproximal collar210 of theprosthetic spacer device200. For example, in some embodiments, thecoupler514 can comprise a plurality offlexible arms528 and a plurality ofstabilizer members530. Theflexible arms528 can compriseapertures532, ports533 (FIG. 13), and eyelets534 (FIG. 14).
• Theflexible arms528 can be configured to pivot between a first or release configuration (FIG. 13) and a second or coupled configuration (FIGS. 12 and 14). In the first configuration, theflexible arms528 extend radially outwardly relative to thestabilizer members530. In the second configuration, theflexible arms528 extend axially parallel to thestabilizer members530 and theeyelets534 radially overlap, as best shown inFIG. 14. Theflexible arms528 can be configured (e.g., shape-set) so as to be biased to the first configuration.
• Theprosthetic spacer device200 can be releasably coupled to thecoupler514 by inserting thestabilizer members530 of thecoupler514 into theguide openings232 of theprosthetic spacer device200. Theflexible arms528 of thecoupler514 can then be pivoted radially inwardly from the first configuration to the second configuration such that theprojections230 of theprosthetic spacer device200 extend radially into theapertures532 of theflexible arms528. Theflexible arms528 can be retained in the second configuration by inserting thedistal end portion512bof theactuation shaft512 throughopenings536 of theeyelets534, which prevents theflexible arms528 from pivoting radially outwardly from the second configuration to the first configuration, thereby releasably coupling theprosthetic spacer device200 to thecoupler514.
• Theprosthetic spacer device200 can be released from thecoupler514 by proximally retracting theactuation shaft512 relative to thecoupler514 such that thedistal end portion512bof theactuation shaft512 withdraws from theopenings536 of theeyelets534. This allows theflexible arms528 to pivot radially outwardly from the second configuration to the first configuration, which withdraws theprojections230 of theprosthetic spacer device200 from theapertures532 of theflexible arms528. Thestabilizer members530 can remain inserted into theguide openings232 of theprosthetic spacer device200 during and after theflexible arms528 are released. This can, for example, prevent theprosthetic spacer device200 from moving (e.g., shifting and/or rocking) while theflexible arms528 are released. Thestabilizer members530 can then be withdrawn from theguide openings232 of theprosthetic spacer device200 by proximally retracting thecoupler514 relative to theprosthetic spacer device200, thereby releasing theprosthetic spacer device200 from thecoupler514.
• Referring toFIG. 15, theouter shaft520 of thethird catheter508 can be an elongate shaft extending axially between theproximal end portion520a, which is coupled thehandle522, and thedistal end portion520b, which is coupled to thecoupler514. Theouter shaft520 can also include anintermediate portion520cdisposed between the proximal anddistal end portions520a,520b.
• Referring toFIG. 16, theouter shaft520 can comprise a plurality of axially extending lumens, including anactuation shaft lumen538 and a plurality of control member lumens540 (e.g., four in the illustrated embodiment). In some embodiments, theouter shaft520 can comprise more (e.g., six) or less (e.g., two) than fourcontrol member lumens540.
• Theactuation shaft lumen538 can be configured to receive theactuation shaft512, and thecontrol member lumens540 can be configured to receive one or moreclasp control members524. Thelumens538,540 can also be configured such that theactuation shaft512 andclasp control members524 can be movable (e.g., axially and/or rotationally) relative to therespective lumens538,540. In particular embodiments, thelumens538,540 can comprise a liner or coating configured to reduce friction within thelumens538,540. For example, thelumens538,540 can comprise a liner comprising PTFE.
• Referring still toFIGS. 15-16, theouter shaft520 can be formed from various materials, including metals and polymers. For example, in one particular embodiment, theproximal end portion520acan comprise stainless steel and the distal andintermediate portions520b,520ccan comprise PEBA (e.g., PEBAX®). Theouter shaft520 can also comprise an outer covering or coating, such as a polymer that is reflowed over theportions520a,520b, and520c.
• Theouter shaft520 can include one ormore coil portions542 disposed radially outwardly from thelumens538,540. For example, in one particular embodiment, theouter shaft520 can comprise afirst coil542a, asecond coil542b, and athird coil542c. Thefirst coil542acan be the radially outermost coil, thethird coil542ccan be the radially innermost coil, and thesecond coil542bcan be radially disposed between thefirst coil542aand thethird coil542c.
• Thecoil portions542 can comprise various materials and/or configurations. For example, thecoil portions542 can be formed from stainless steel. In one particular embodiment, the first andthird coils542a,542ccomprise stainless steel coils wound in a left hand configuration, and thesecond coil542bcomprises a stainless steel coil wound in a right hand configuration.
• Thecoil portions542 can also comprise various pitches. The pitch of one or more of thecoil portions542 can be the same or different than the pitch of one or moreother coil portions542. In one particular embodiment, the first andsecond coils542a,542bcan have a first pitch (e.g., 0.74 in.), and the third coil can comprise a second pitch (e.g., 0.14 in.).
• Theouter shaft520 can also comprise atie layer544 disposed radially inwardly from thethird coil542c. Thetie layer544 can be formed of various materials including polymers, such as PEBA (e.g., PEBAX®).
• As shown inFIGS. 17-19, thehandle522 of thethird catheter508 can include ahousing546, anactuation lock mechanism548, aclasp control mechanism550, and aflushing mechanism552. Referring toFIG. 17, a distal end portion of thehousing546 can be coupled to theproximal end portion520aof theouter shaft520. Theactuation lock mechanism548, theclasp control mechanism550, and aflushing mechanism552 can be coupled to a proximal end of thehousing546. Theactuation lock mechanism548 can be configured to selectively lock the position of theactuation shaft512 relative to thehousing546 and theouter shaft520. Theclasp control mechanism550 can also be coupled to proximal end portions of theclasp control members524 and can be configured to secure theclasp control members524 relative to thehandle522 and to move theclasp control members524 relative to theouter shaft520 and theactuation shaft512. Theflushing mechanism552 can be configured for flushing (e.g., with a saline solution) theouter shaft520 prior to inserting theouter shaft520 into a patient's vasculature.
• As best shown inFIGS. 18-19, thehousing546 of thehandle522 can comprise amain body554 and anose portion556 coupled to a distal end portion of themain body554. Themain body554 and thenose portion556 can be coupled together in various manners, includingfasteners558 and/or pins560 (e.g., as shown in the illustrated embodiment), adhesive, and/or other coupling means. Thehousing546 can be formed from various materials, including polymers (e.g., polycarbonate).
• Themain body554 of thehousing546 can comprise a plurality of lumens, including anactuation shaft lumen562, control member lumens564 (FIG. 19), and aflushing lumen566 that is fluidly connected to the actuation shaft lumen562 (FIG. 18). As best shown inFIG. 19, themain body554 can also include a plurality of tubes (e.g., hypotubes), including anactuation tube568 andcontrol member tubes570 that are disposed at least partially in theactuation shaft lumen562 and thecontrol member lumens564, respectively. Thetubes568,570 can be axially movable (e.g., slidable) relative thelumens562,564, respectively.
• The proximal end of theactuation tube568 can extend proximally from themain body554 and can be coupled to theknob526 and to theproximal end portion512aof theactuation shaft512. The proximal ends of thecontrol member tubes570 can extend proximally from themain body554 and can be coupled to theclasp control mechanism550 and theclasp control members524.
• The distal ends of thetubes568,570 can compriseflanges572,574 configured to engage a stopper to limit the axial movement of thetubes568,570 relative to thehousing546. For example, theflanges572,574 can be configured to contact respective surfaces of the main body554 (e.g., a lip) to prevent totubes568,570 from withdrawing completely from the proximal ends of thelumens562,564, respectively.
• Theactuation tube568 can be configured to receive and be coupled to the proximal end portion of theactuation shaft512. Thecontrol member tubes570 can be configured to receive portions of theclasp control mechanism550, as further described below. Thetubes568,570 can be formed from various materials, including polymers and metals (e.g., stainless steel).
• In some embodiments, themain body554 can include a plurality of seal members576 (e.g., O-rings) configured to prevent or reduce blood leakage through the lumens and around the shafts and/or tubes. The seal members can be secured relative to themain body554, for example, by fasteners578 (e.g., hollow-lock or socket-jam set screws).
• As best shown inFIG. 19, thenose portion556 of thehousing546 can comprise a plurality of lumens, including anactuation shaft lumen580 andcontrol member lumens582. Theactuation shaft lumen580 of thenose portion556 can be extend coaxially with theactuation shaft lumen562 of themain body554. Proximal ends of thecontrol member lumens582 of thenose portion556 can be aligned with thecontrol member lumens564 of themain body554 at the proximal end of the nose portion556 (i.e., thelumens582,564 are in the same plane). Thecontrol member lumens582 can extend towards each other from their proximal ends at an angle (i.e., relative to thecontrol member lumens564 of the main body554), and distal ends of thecontrol member lumens582 can intersect theactuation shaft lumen580 of thenose portion556 at a location near the distal end of thenose portion556. In other words, the proximal ends of thelumens582 are in a first plane that is parallel to a longitudinal axis of the catheter (i.e., the plane of thecontrol member lumens564 of the main body554), and the distal ends of thelumens582 are in a second plane that is parallel to a longitudinal axis of the catheter (i.e., the plane of theactuation shaft lumen562 of the main body554).
• As best shown inFIG. 18, theactuation shaft lumen580 of thenose portion556 can be configured to receive the proximal end portion of theouter shaft520. The proximal end portion of theouter shaft520 can be coupled to thenose portion556 in various ways such as with adhesive, fasteners, frictional fit, and/or other coupling means.
• Referring still toFIG. 18, theactuation lock mechanism548 of thehandle522 can be coupled to the proximal end portion of themain body554 of thehousing546 and to theactuation tube568. Theactuation lock mechanism548 can be configured to selectively control relative movement between theactuation tube568 and thehousing546. This, in turn, selectively controls relative movement between the actuation shaft512 (which is coupled to the actuation tube568) and the outer shaft520 (which is coupled to thenose portion556 of the housing546).
• In some embodiments, theactuation lock mechanism548 can comprise a lock configuration, which prevents relative movement between theactuation tube568 and thehousing546, and a release configuration, which allows relative movement between theactuation tube568 and thehousing546. In some embodiments, theactuation lock mechanism548 can be configured to include one or more intermediate configurations (i.e., in addition to the lock and release configuration) which allow relative movement between theactuation tube568 and thehousing546, but the force required to cause the relative movement is greater than when the actuation lock mechanism is in the release configuration.
• As shown inFIG. 18 of the illustrated embodiment, theactuation lock mechanism548 can comprise a lock (e.g., a Tuohy-Borst adapter)584 and a coupler (e.g., a female luer coupler)586. Thecoupler586 can be attached to the distal end of thelock584 and coupled to the proximal end of themain body554 of thehousing546. Theactuation tube568 can extend coaxially through thelock584 and thecoupler586. As such, rotating aknob588 of thelock584 in a first direction (e.g., clockwise) can increase the frictional engagement of thelock584 on theactuation tube568, thus making relative movement between theactuation tube568 and thehousing546 more difficult or preventing it altogether. Rotating aknob588 of thelock584 in a second direction (e.g., counterclockwise) can decrease the frictional engagement of thelock584 on theactuation tube568, thus making relative movement between theactuation tube568 and thehousing546 easier.
• In other embodiments,actuation lock mechanism548 can comprise other configurations configured for preventing relative movement between theactuation tube568 and thehousing546. For example, theactuation lock mechanism548 can include a lock configured similar to a stopcock valve in which a plunger portion of valve selectively engages theactuation tube568.
• In some embodiments, theactuation lock mechanism548 can include a release member (e.g., a set screw or a pin). The release member can extend into thehousing546 and can selectively engage theactuation tube568. When the release member is engaged with the actuation tube568 (e.g., by inserting the release member into thehousing546 and into contact with the actuation tube568), the release member can, for example, prevent theactuation tube568 and thus theactuation shaft512 from being completely withdrawn from theirrespective lumens568,580 (e.g., when actuating the anchors204). When the release member is released from the actuation tube568 (e.g., by withdrawing it from thehousing546 and/or moving it out of contact with the actuation tube546), theactuation tube568 and thus theactuation shaft512 can be completely withdrawn from theirrespective lumens568,580 (e.g., when releasing theprosthetic spacer device200 from the delivery apparatus502).
• Theclasp control mechanism550 can comprise anactuator member590 and one or more locking members592 (e.g., two in the illustrated embodiment). A distal end portion of theactuator member590 can be coupled to thecontrol member tubes570, which extend from the proximal end of themain body554 of thehousing546, as best shown inFIG. 18. The lockingmembers592 can be coupled to a proximal end portion of theactuator member590.
• As shown in the illustrated embodiment, theactuator member590 can, optionally, comprise afirst side portion594 and asecond side portion596 selectively coupled to thefirst side portion594 by a connectingpin598. Theactuator member590 can be configured such that the first andsecond side portions594,596 move together when the connectingpin598 is inserted through the first andsecond side portions594,596. When the connectingpin598 is withdrawn, the first andsecond side portions594,596 can be moved relative to each other. This can allow the clasp control members524 (which are releasably coupled to the first andsecond side portions594,596 by the locking members592) to be individually actuated.
• The connection between the first andsecond side portions594,596 can be configured such that the first andsecond side portions594,596 can move axially (i.e., proximally and distally) but not rotationally relative to each other when the connectingpin598 is withdrawn. This can be accomplished, for example, by configuring thefirst side portion594 with keyed slot or groove and configuring thesecond side portion596 with a keyed projection or tongue that corresponds to the keyed slot or groove of thefirst side portion594. This can, for example, prevent or reduce the likelihood that theclasp control members524 from twisting relative to theouter shaft520.
• The first andsecond side portions594,596 can include axially extendinglumens501. Distal ends of thelumens501 can be configured to receive the proximal end portions of thecontrol member tubes570. Proximal ends of thelumens501 can be configured to receive portions of the lockingmembers592. As noted above, the proximal end portions of theclasp control members524 extend throughrespective locking members592.
• The lockingmembers592 can be configured to selectively control relative movement between aclasp control member524 and the respective first orsecond side portion594,596 of theactuator member590. The lockingmembers592 can comprise a lock configuration, which prevents relative movement between aclasp control member524 and the respective first orsecond side portion594,596, and a release configuration, which allows relative movement between aclasp control member524 and the respective first orsecond side portion594,596. In some embodiments, the lockingmembers592 can also comprise one or more intermediate configurations (i.e., in addition to the lock and release configuration) which allows relative movement between aclasp control member524 and the respective first orsecond side portion594,596, but the force required to cause the relative movement is greater than when the lockingmembers592 are in the release configuration.
• As shown in the illustrated embodiment, the lockingmembers592 can be configured similar to stopcock valves. Thus,rotating knobs503 in a first direction (e.g., clockwise) can increase the frictional engagement between the lockingmembers592 on theclasp control members524 and make relative movement between aclasp control member524 and the respective first orsecond side portion594,596 more difficult or prevent it altogether. Rotatingknobs503 in a second direction (e.g., counterclockwise) can decrease the frictional engagement between the lockingmembers592 on theclasp control members524 and make relative movement between aclasp control member524 and the respective first orsecond side portion594,596 easier. In other embodiments, the lockingmembers592 can comprise other configurations configured for preventing relative movement between the lockingmembers592 on theclasp control members524.
• Theflushing mechanism552 can comprise aflushing tube505 and a valve507 (e.g., a stopcock valve). A distal end of theflushing tube505 can be coupled to and in fluidic communication with theflushing lumen566 and thus with theactuation shaft lumen562 of themain body554. A proximal end of theflushing tube505 can be coupled to thevalve507. In this manner, theflushing mechanism552 can be configured for flushing (e.g., with a saline solution) theouter shaft520 prior to inserting theouter shaft520 into a patient's vasculature.
• Theclasp control members524 can be configured to manipulate the configuration of theclasps206, as further described below. As best shown inFIG. 15, each of theclasp control members524 can be configured as a suture (e.g., wire or thread) loop. Proximal end portions of theclasp control members524 can extend proximally from the proximal end portion of theclasp control mechanism550 and can be releasably coupled to the lockingmembers592 of theclasp control mechanism550.
• From the lockingmembers592, theclasp control members524 can form loops extending distally through thelumens501 of theclasp control mechanism550, through thecontrol member tubes570, thecontrol member lumens564,582 of thehandle522, and through thecontrol member lumens540 of theouter shaft520. Theclasp control members524 can extend radially outwardly from thelumens540, for example, through the ports533 (FIG. 13) of thecoupler514. Theclasp control members524 can then extend throughopenings234 of the clasps206 (e.g., similar to theopenings142 of the prosthetic spacer device100). Theclasp control members524 can then extend proximally back to thecoupler514, radially inwardly through theports533 of thecoupler514, and then proximally through theouter shaft520 and thehandle522, and to the lockingmembers592 of theclasp control mechanism550.
• InFIG. 15, theclasp control members524 are shown slacken and theclasps206 are partially open in order to illustrate theclasp control members524 extending through theopenings234 of theclasps206. However, ordinarily when theclasp control members524 are slacken, theclasps206 would be in the closed configuration.
• As shown in the illustrated embodiment, each of theclasp control members524 can extend through multiplecontrol member lumens540 of theouter shaft520. For example, each of theclasp control members524 can be looped through two of thelumens540. In other embodiments, each of theclasp control members524 can be disposed in a singlecontrol member lumen540. In yet other embodiments, multipleclasp control members524 can be disposed in a singlecontrol member lumen540.
• With theclasp control members524 coupled to theclasps206, theclasp control mechanism550 can be used to actuate theclasps206 between open and closed configurations. Theclasps206 can be opened by moving theactuator member590 proximally relative to theknob526 and thehousing546. This increases tension of theclasp control members524 and causes theclasp206 to move from the closed configuration to the open configuration. Theclasps206 can be closed by moving theactuator member590 distally relative to theknob526 and thehousing546. This decreases tension on theclasp control members524 and allows theclasp206 to move from the open configuration to the closed configuration. Theclasps206 can be individually actuated by removing the connectingpin598 and moving the first orsecond side portions594,596 relative to each other, theknob526, and thehousing546.
• When thehandle522 is assembled as best shown inFIG. 17-18, theactuation shaft512 can extend distally from theknob526, through theactuation tube568, through theactuation lumens562,580 of thehousing546, through theactuation shaft lumen538 of theouter shaft520, and through thecoupler514.
• FIGS. 20-27 show thedelivery assembly500 being used, for example, to implant theprosthetic spacer device200 in nativemitral valve600 of aheart602 using a transseptal delivery approach. Although not shown, a guide wire can be inserted into the patient's vasculature (e.g., a femoral vein) through an introducer sheath. The guide wire can be advanced through the femoral vein, through the inferior vena cava, into the right atrium, through the interatrial septum604 (e.g., via the fossa ovalis), and into theleft atrium606. Thefirst sheath516 of thefirst catheter504 can be advanced over the guide wire such that a distal end portion of thefirst sheath516 is disposed in theleft atrium606, as best shown inFIG. 20.
• With theprosthetic spacer device200 coupled to the third catheter508 (e.g., as shown inFIG. 12) and configured in a radially compressed, delivery configuration, theprosthetic spacer device200 can be loaded into thesecond sheath518 of thesecond catheter506, which retains theprosthetic spacer device200 in the delivery configuration. In this manner, the distal end portion of thesecond sheath518 serves as a delivery capsule for theprosthetic implant200. In some embodiments, the radially compressed, delivery configuration can be an axially elongate configuration (e.g., similar to the configuration shown inFIG. 20). In other embodiments, the radially compressed, delivery configuration can be an axially foreshorten configuration (e.g., similar to the configuration shown inFIG. 22). Thesecond catheter506 along with theprosthetic spacer device200 and thethird catheter508 can then be advanced together through thefirst catheter504 until a distal end portion of thesecond sheath518 extends outwardly from the distal end portion of thefirst sheath516 and is disposed in theleft atrium606, as shown inFIG. 20.
• As shown inFIG. 20, theprosthetic spacer device200 can be advanced from thesecond sheath518 by distally advancing theouter shaft520 and theactuation shaft512 of thethird catheter508 relative to thesecond sheath518 and/or retracting thesecond sheath518 relative to theouter shaft520 and theactuation shaft512, thus forcing theanchors204 out of thesecond sheath518. Once exposed from thesecond sheath518, theanchors204 can be folded by retracting theactuation shaft512 of thethird catheter508 relative to theouter shaft520 of thethird catheter508 and/or by advancing theouter shaft520 relative to theactuation shaft512, causing theanchors204 to bend from the configuration shown inFIG. 20, to the partially folded configuration shown inFIG. 21, and then to the fully folded configuration shown inFIG. 22. This can be accomplished, for example, by placing theactuation lock mechanism548 in the release configuration (e.g., by rotating theknob588 counterclockwise relative to the handle522) and then moving theknob526 proximally relative to thehousing546. At any point in the procedure, the physician can lock the relative position of theactuation shaft512 and theouter shaft520, and thus the position of theanchors204, by actuating theactuation lock mechanism548.
• Theprosthetic spacer device200 can then be positioned coaxial relative to the nativemitral valve600 by manipulating (e.g., steering and/or bending) thesecond sheath518 of thesecond catheter506, as shown inFIG. 22. The curvature of thesecond sheath518 can be adjusted (e.g., with the steering mechanism) so that a distalsteerable section518aextends at about a 90-degree angle relative to asection518bthat extends proximally from thesteerable section518a. Advantageously, this positions the steerabledistal section518aand theprosthetic spacer device200 along an axis that is substantially perpendicular to a plane defined by the native mitral valve. Stated another way, the axis extending through the steerabledistal section518aand theprosthetic spacer device200 is coaxial or substantially parallel to the flow path of the native mitral valve.
• Retracting or advancing thesecond sheath518 of thesecond catheter506 and theouter shaft520 of the third catheter508 (e.g., in the directions shown by the arrow521) relative to thefirst sheath516 of thefirst catheter504 and theleft atrium606 moves theouter shaft520 of thethird catheter508 and theprosthetic spacer device200 in the medial and lateral directions (e.g., in the directions shown byarrow523 inFIG. 28) relative to thenative leaflets608. As thesecond sheath518 andouter shaft520 are advanced and/or retracted, the positioning of theprosthetic spacer device200 relative to the native mitral valve in the superior/inferior directions (e.g., up/down in the orientation shown inFIG. 22) remains at least substantially constant, and/or thesecond sheath518 does not “whip” due to the configuration of the steering mechanism of thesecond catheter506, which is described above. Rotating (which can also be referred to as “torquing”) thesecond sheath518 of the second catheter506 (e.g., in the directions shown by thearrow525 inFIG. 22) relative to thefirst sheath516 of thefirst catheter504 and theleft atrium606 pivots theouter shaft520 of thethird catheter508 and theprosthetic spacer device200 in the anterior/posterior directions (e.g., in the directions shown byarrow527 inFIG. 28). Theprosthetic spacer device200 can also be rotated (e.g., by rotating the housing546) relative to the nativemitral valve600 in order to align theanchors204 withnative leaflets608 of the nativemitral valve600. The positioning of theprosthetic spacer device200 relative to the native mitral valve in the superior/inferior directions (e.g., up/down in the orientation shown inFIG. 22) can be adjusted by retracting/advancing theouter shaft520 of thethird catheter508 relative to the second sheath of thesecond catheter506. Thus, one advantage of the disclosed delivery apparatus is that the positioning of the prosthetic spacer device can be adjusted independently in three directions (i.e., the medial/lateral, anterior/posterior, and superior/inferior directions). For example, actuating the delivery apparatus such that the prosthetic spacer device moves in the medial/lateral directions does not affect the positioning of the prosthetic spacer device in the anterior/posterior directions or the superior/inferior directions. The three-way and/or independent maneuverability of thedelivery apparatus502 therefore allows the practitioner to accurately and/or precisely position theprosthetic spacer device200 at the desired implantation location relative to the native leaflets (e.g., at the A2/P2 positions near the center of a coaptation line612 (FIG. 28) of the native leaflets) in a relatively quick and/or easy manner.
• Theanchors204 of theprosthetic spacer device200 can then be partially opened (i.e., moved radially outwardly relative to the spacer member202) to the configuration shown inFIG. 23 by moving theknob526 distally relative to thehousing546. Theprosthetic spacer device200 can then be advanced through the annulus of the nativemitral valve600 and at least partially into theleft ventricle610 by advancing thehandle522 of thethird catheter508 relative to thesecond catheter506. Theprosthetic spacer device200 can then be partially retracted such that theanchors204 are positioned behind the ventricular portions of the native leaflets608 (e.g., at the A2/P2 positions) and thespacer member202 is disposed on the atrial side of thenative leaflets608. Alternatively, theprosthetic spacer device200 can be advanced through the native valve in the fully folded configuration (as shown inFIG. 22), after which theanchors204 can be opened.
• In this configuration, thenative leaflets608 can be secured relative to theanchors204 by capturing the native leaflets with theclasps206. Thenative leaflets608 can be captured simultaneously or separately by actuating theactuator member590. For example,FIG. 24 shows separate leaflet capture. This can be accomplished by removing the connectingpin598 from theactuator member590 and moving the first orsecond side portions594,596 relative to each other, theknob526, and thehousing546. Moving the first orsecond side portions594,596 distally relative to theknob526 and thehousing546 closes theclasps206 on the native leaflets608 (e.g., as shown by theleft clasp206 as illustrated inFIG. 24). Moving the first orsecond side portions594,596 proximally relative to theknob526 and thehousing546 opens the clasps206 (e.g., as shown by theright clasp206 as illustrated inFIG. 24). Once aclasp206 is closed, a physician can re-open theclasp206 to adjust the positioning of theclasp206.
• As theclasps206 re-open, theclasps206 initially move radially inwardly toward the spacer member202 (e.g., as shown with theright clasp206 inFIG. 24) until theclasps206 contact the spacer member202 (e.g., as shown inFIG. 23). In some instances,barbs236 of theclasps206 may retain and pull thenative leaflets608 toward thespacer member202 as theclasps206 are re-opened. Once theclasps206 contact thespacer member202, further tensioning theclasp control member524 moves theclasps206 slightly proximally relative to the spacer member202 (and causes theanchors204 to slightly unfold). The proximal movement of theclasps206 can, for example, withdraw thebarbs236 from thenative leaflets608, which can facilitate repositioning and/or retrieval of theprosthetic spacer device200.
• With both of thenative leaflets608 secured within theclasps206, the physician can move theknob526 proximally relative to thehousing546. This pulls theanchors204 and thus thenative leaflets608 radially inwardly against thespacer member202, as shown inFIG. 25. The physician can then observe the positioning and/or reduction in regurgitation. If repositioning or removal is desired the physician can re-open theanchors204 and/or theclasps206.
• Once the desired positioning and/or reduction in regurgitation is achieved, the physician can release theprosthetic spacer device200 from thedelivery apparatus502. Theclasps206 can be released from thedelivery apparatus502 by releasing theclasp control members524 from the lockingmembers592 and unthreading theclasp control members524 from theopenings234 of theclasps206. Thedistal collar208 of theprosthetic spacer device200 can be released from thedelivery apparatus502 by rotating theknob526 in the second direction relative to thehousing546 such that theactuation shaft512 withdraws from thebore226. Theactuation shaft512 can then be retracted proximally through theprosthetic spacer device200 by pulling theknob526 proximally relative to thehousing546. Theproximal collar210 of theprosthetic spacer device200 can be released from thedelivery apparatus502 by retracting theactuation shaft512 proximally relative to thecoupler514 such that the distal end portion of theactuation shaft512 withdraws from theeyelets534 of thecoupler514. This allows theflexible arms528 of thecoupler514 to move radially outwardly away from theprojections230 of theproximal collar210. Thestabilizer members530 of thecoupler514 can then be withdrawn from theguide openings232 of theproximal collar210 by pulling thehousing546 proximally, thereby releasing theprosthetic spacer device200 from thedelivery apparatus502 as shown inFIG. 26.
• Theshafts512,520 of thethird catheter508 can then be retracted proximally into thesecond sheath518 of thesecond catheter506, and thesecond sheath518 of thesecond catheter506 can be retracted proximally into thefirst sheath516 of thefirst catheter504. Thecatheters504,506,508 can then be retracted proximally and removed from the patient's vasculature.
• With theprosthetic spacer device200 implanted at the A2/P2 position, the nativemitral valve600 can, in some embodiments, comprise a double orifice during ventricular diastole, as shown inFIG. 27. During ventricular systole, thenative leaflets608 can coapt together and/or against theprosthetic spacer device200 to prevent or reduce mitral regurgitation, as shown inFIG. 28.
• In other embodiments, theanchors204 can move radially outwardly relative to thespacer member202 to a partially open configuration during ventricular diastole such that the nativemitral valve600 has a single orifice, as shown inFIG. 29. Theanchors204 can move radially inwardly relative to thespacer member202 to a closed configuration during ventricular systole such that thenative leaflets608 coapt together and/or against theprosthetic spacer device200 to prevent or reduce mitral regurgitation, as shown inFIG. 28. As theanchors204 open and close during the natural cardiac cycles, theclasps206 can retain thenative leaflets608 against theanchors204, as shown inFIGS. 28-29.
• Configuring theprosthetic spacer device200 in this manner allows thenative leaflets608 to move naturally upon implantation. This can, for example, promote antegrade blood flow during ventricular diastole, while still reducing or preventing retrograde blood flow during ventricular systole. It can also reduce or prevent native tissue damage to the native leaflets. Overtime, endothelialization can form a tissue bridge between the anchors and the spacer member.
• FIGS. 30-31 show another exemplary embodiment of ahandle700 for thedelivery apparatus502, in particular for use with thethird catheter508. Referring toFIG. 30, thehandle700 can comprise ahousing702, anactuation control mechanism704, theclasp control mechanism550, and a flushing mechanism (not shown, but see, e.g., theflushing mechanism552 inFIG. 17). Thehousing702 can include amain body706 and thenose portion556. Thenose portion556 of thehousing702 can be coupled to a proximal end portion of theouter shaft520. Theactuation control mechanism704, theclasp control mechanism550, and aflushing mechanism552 can be coupled to a proximal end of themain body706 of thehousing702.
• Thehandle700 can be configured similar to thehandle522, except that thehandle700 is configured such that rotational movement of a first knob718 of theactuation control mechanism704 relative to thehousing702 causes axial movement of theactuation tube568 and theactuation shaft512; whereas, thehandle522 is configured such that axial movement of the knob526 (e.g., pushing and pulling) relative to thehousing546 causes axial movement of theactuation tube568 and theactuation shaft512.
• As mentioned above, thehousing702 can include amain body706 and thenose portion556. Referring toFIG. 31, themain body706 of thehousing702 can comprise anactuation lumen708,control member lumens710, and aflange portion712. Theflange portion712 can extend axially from a proximal end portion of themain body706 and annularly around theactuation lumen708.
• Theflange portion712 of themain body706 can comprise one or morecircumferential grooves714, a bore (not shown), and aguide pin716. Thegrooves714 can be configured to interact with theactuation control mechanism704, as further described below. The bore can extend radially inwardly from an outside diameter to an inside diameter of theflange portion712 and can be configured to receive theguide pin716. Theguide pin716 can be partially disposed in the bore and can extend radially inwardly from the bore such that theguide pin716 protrudes into theactuation lumen708.
• Referring still toFIG. 31, theactuation control mechanism704 can comprise a first knob718, attachment pins720, adrive screw722, acollet724, and asecond knob726. The first knob718 can have adistal end portion728 and a proximal end portion730. The first knob718 can be configured such that the inside diameter of thedistal end portion728 is relatively larger than the inside diameter of the proximal end portion730. Thedistal end portion728 can compriseside openings732 that extend radially inwardly from an outside diameter to the inside diameter of thedistal end portion728.
• Referring again toFIG. 30, the inside diameter of thedistal end portion728 can be configured such that thedistal end portion728 of the first knob718 can extend over theflange portion712 of themain body706. The openings732 (FIG. 31) can be configured to axially align with thegrooves714 when the first knob718 is disposed over theflange portion712. The attachment pins720 can be configured so as to extend through theopenings732 of the first knob718 and intogrooves714 of theflange portion712. In this manner, the attachment pins720 allow relative rotational movement and prevent relative axial movement between the first knob718 and theflange portion712.
• The inside diameter of the proximal end portion730 of the first knob718 can have internal threads (not shown) configured to engage correspondingexternal threads734 of thedrive screw722. As best shown inFIG. 31, thedrive screw722 can have aslot736 that extends axially across theexternal threads734. Theslot736 can be configured to receive theguide pin716 of theflange portion712. As such, when thehandle700 is assembled (FIG. 30) and the first knob718 is rotated relative to theflange portion712, theguide pin716 prevents thedrive screw722 from rotating together with the first knob718 and causes thedrive screw722 to move axially relative to the first knob718 and theflange portion712. In this manner, rotating the first knob718 in a first direction (e.g., clockwise) moves the drive screw distally relative to thehousing702, and rotating the first knob718 in a second direction (e.g., counterclockwise) moves the drive screw proximally relative to thehousing702.
• Thedrive screw722 can also have alumen738, as shown inFIG. 31. Thelumen738 can be configured such that theactuation tube568 can extend through thedrive screw722. Thelumen738 can be configured such that adistal end portion740 of thecollet724 can also be inserted into a proximal end portion of thelumen738.
• Thesecond knob726 can comprise a first,distal portion742 and a second,proximal portion744. Thedistal portion742 can include internal threads (not shown) corresponding to theexternal threads734 of thedrive screw722. Theproximal portion744 can comprise a conical inside surface configured to engage aproximal end portion746 of thecollet724.
• When assembled (FIG. 30), theactuation tube568 can extend through thelumen738 of thedrive screw722, through thecollet724, and through thesecond knob726. Thesecond knob726 can be disposed over thecollet724 and the internal threads of thedistal portion742 of the second knob can threadably engage theexternal threads734 of thedrive screw722. Accordingly, rotating thesecond knob726 in a first direction (e.g., clockwise) relative to thedrive screw722 causes theproximal portion744 of thesecond knob726 to move toward theproximal end portion746 of thecollet724 and thus urges thecollet724 radially inwardly against theactuation tube568. As a result, theactuation tube568 and thedrive screw722 move axially together when the first knob718 is rotated relative to thehousing702. Rotating thesecond knob726 in a second direction (e.g., counterclockwise) relative to thedrive screw722 causes thedistal portion742 of thesecond knob726 to move away from theproximal end portion746 of thecollet724 and thus allows thecollet724 to move radially outwardly relative to theactuation tube568. As a result, theactuation tube568 and thedrive screw722 can move relative to each other.
• In lieu of or in addition to thecollet724, theactuation control mechanism704 of thehandle700 can include a release member (e.g., a set screw or a pin). The release member can extend into the housing702 (e.g., near the proximal end of the housing702) and can selectively engage (e.g., threadably) thedrive screw722 and theactuation tube568. When the release member is engaged with thedrive screw722 and the actuation tube568 (e.g., by inserting the release member into thehousing702 and into contact with thedrive screw722 and the actuation tube568), the release member can, for example, prevent theactuation tube568 from moving relative to thedrive screw722, thus preventing theactuation shaft512 from being completely withdrawn from theirrespective lumens568,580 (e.g., when actuating the anchors204). When the release member is released from thedrive screw722 and the actuation tube568 (e.g., by withdrawing it from thehousing702 and/or moving it out of contact with the actuation tube546), theactuation tube568 and thus theactuation shaft512 can move relative to thedrive screw722 and can therefore be completely withdrawn from theirrespective lumens568,580 (e.g., when releasing theprosthetic spacer device200 from the delivery apparatus).
• With theprosthetic spacer device200 coupled to theactuation shaft512 and theouter shaft520 of thedelivery apparatus502, the physician can use theactuation control mechanism704 of thehandle700 to manipulate theanchors204 of theprosthetic spacer device200 relative to thespacer member202 of theprosthetic spacer device200. Theactuation control mechanism704 can be activated by rotating thesecond knob726 in the first direction relative to thedrive screw722 to secure theactuation tube568 and thus theactuation shaft512 to thedrive screw722. The physician can then rotate the first knob718 relative to thehousing702, which causes thedrive screw722 and thus theactuation tube568 and theactuation shaft512 to move axially relative to the relative to thehousing702 and thus theouter shaft520. This, in turn, causes the anchors204 (which are coupled to theactuation shaft512 via the distal collar208) to move relative to the spacer member202 (which is coupled to theouter shaft520 viacoupler514 and the proximal collar210).
• Theprosthetic spacer device200 can be released from thedelivery apparatus502 by rotating thesecond knob726 in the second direction relative to thedrive screw722. This allows theactuation tube568 and thus theactuation shaft512 to move relative to thedrive screw722. Theshafts512,520 of thedelivery apparatus502 can then be removed from therespective collars208,210 of theprosthetic spacer device200, as described above.
• Configuring a delivery apparatus with theactuation control mechanism704 can provide several advantages. For example, the rotational forces required to actuate the first knob718 of thehandle700 can be less than the axial forces required to actuate theknob526 of thehandle700.
• Theactuation control mechanism704 can also provide relatively more precise control of theanchors204 because the axial movement of theactuation shaft512 is controlled by rotation of the first knob718 and the thread pitch of thedrive screw722 rather than be axial movement of theknob526. In other words, theactuation control mechanism704 can be configured, for example, such that one rotation of the first knob718 moves theactuation shaft512 a small axial distance (e.g., 1 mm); whereas, it may be relatively more difficult to axially move theknob526 and thus theactuation shaft512 in small increments (e.g., 1 mm).
• Additionally, theactuation control mechanism704 can prevent or reduce inadvertent movement and release of theactuation shaft512. For example, because theactuation control mechanism704 requires rotational movement of the first knob718 to move theactuation shaft512, it can prevent or reduce the likelihood that theactuation shaft512 will move if theknob526 is inadvertently contacted. Also, the physician has to rotate thesecond knob726 to release theactuation tube568 from thedrive screw722 by before the physician can rotate theknob526 to release theactuation shaft512 from thedistal collar208 of theprosthetic spacer device200 and proximally retract theactuation shaft512. This two-step release process could reduce the likelihood of a physician inadvertently releasing theprosthetic spacer device200 from thedelivery apparatus502.
• FIGS. 32-33 show exemplary embodiments of acoupler800 and aproximal collar802. Although not shown, thecoupler800 can be coupled to the distal end portion of the outer shaft520 (FIG. 16) in a manner similar to thecoupler514. As shown, theproximal collar802 can be coupled to a proximal end portion of thespacer member202 in a manner similar to the proximal collar210 (FIG. 13). As such, thecoupler800 and theproximal collar802 can be used, for example, in lieu of thecoupler514 and theproximal collar210 of thedelivery assembly500, respectively, to releasably couple theprosthetic spacer device200 to the outer shaft520 (FIG. 16).
• Referring toFIG. 33, thecoupler800 can comprise an axially-extendinglumen804 and a plurality of radially-extendingopenings806. Thelumen804 can be configured to receive the actuation shaft512 (FIG. 32). Theopenings806 can be configured to receive theproximal collar802, as further described below.
• Theproximal collar802 can comprise a plurality of proximally-extending tabs orfingers808.Free end portions810 of thefingers808 can have radially-extendingprojections812 formed thereon. Thefingers808 can be configured to pivot between a first or resting state (FIG. 33) and a second or deflected state (FIG. 32). In the first state, thefree end portions810 of thefingers808 press radially inwardly against each other. In the second state, thefree end portions810 of thefingers808 are radially spaced from each other.
• Referring toFIG. 32, thecoupler800 and theproximal collar802 be releasably coupled together by positioning thefingers808 of theproximal collar802 within thecoupler800. Theactuation shaft512 can then be advanced through thelumen804 of thecoupler800 and through thefingers808 of theproximal collar802, thus causing thefree end portions810 of thefingers808 to pivot radially-outwardly from the first state to the second state. Theprojections812 of thefingers808 and theopenings806 of thecoupler800 can be rotationally aligned such that theprojections812 extend into theopenings806, thereby releasably coupling thecoupler800 to theproximal collar802. Thecoupler800 can be released from theproximal collar802 by retracting theactuation shaft512 from thefingers808 of theproximal collar802. This allows thefree end portions810 of thefingers808 to pivot from the second state back to the first state and causes theprojections812 of thefingers808 to withdraw from theopenings806 of thecoupler800, thus releasing thecoupler800 from theproximal collar802.
• In some embodiments, thefingers808 of theproximal collar802 can be configured to create a hemostatic seal when thefingers808 are in the first state. This can, for example, prevent or reduce blood from flowing through theproximal collar802 when theprosthetic spacer device200 is implanted in a patient.
• FIGS. 34-35 show exemplary embodiments of adistal collar900, anactuation shaft902, and a release member (e.g., a wire)904, which can be used, for example, with thedelivery assembly500. Although not shown, thedistal collar900 can be coupled to the distal end portion of theprosthetic spacer device200. A proximal end portion (not shown) of theactuation shaft902 can be coupled to theactuation tube568 and theknob526. From the proximal end portion, theactuation shaft902 can extend distally through the handle522 (FIG. 17), through the outer shaft520 (FIG. 17), and into the prosthetic spacer device200 (FIG. 12). A distal end portion of theactuation shaft902 can be releasably coupled to thedistal collar900 of theprosthetic spacer device200. As such, thedistal collar900 and theactuation shaft902 can be used, for example, in lieu of thedistal collar208 and theactuation shaft512 of thedelivery assembly500, respectively.
• Referring toFIG. 35, thedistal collar900 can comprise acentral bore906 and a tab ortongue908 formed (e.g., laser cut) in aside surface910 of thedistal collar900. Thetongue908 can have anopening912 formed (e.g., laser cut) therein.
• Thecentral bore906 can be configured to receive a distal end portion of theactuation shaft902. Thetongue908 can be pivotable relative to theside surface910 of thedistal collar900 from a first or resting configuration (FIG. 35) to a second or deflected configuration (FIG. 34). In the first configuration, thetongue908 can be flush with theside surface910. In the second configuration, thetongue908 can extend radially inwardly relative to theside surface910 so as to protrude into thecentral bore906. Thetongue908 can be biased (e.g., shaped set) toward the first configuration.
• Thetongue908 can be used, for example, to releasably couple thedistal collar900 to theactuation shaft902, as shown inFIG. 34. For example, theactuation shaft902 can be inserted into thecentral bore906 of thedistal collar900. Thetongue908 can then be pushed radially inwardly from the first configuration to the second configuration such that thetongue908 presses against theactuation shaft902 and frictionally retains theactuation shaft902 relative to thecollar900. Therelease member904 can then be advanced distally such that adistal end portion914 of therelease member904 extends through theopening912 of thetongue908. Thus, therelease member904 retains thetongue908 in the second configuration against theactuation shaft902, thereby releasably coupling thedistal collar900 to theactuation shaft902.
• Thedistal collar900 can be released from theactuation shaft902 by retracting therelease member904 proximally such that thedistal end portion914 of therelease member904 withdraws from theopening912 of thetongue908. This allows the tongue to move radially outwardly from the second state back to the first state, thereby releasing thedistal collar900 from theactuation shaft902.
• This configuration can provide several advantages. For example, in some embodiments, thedistal collar900 and theactuation shaft902 can be formed without threads. Removing the threads can make manufacturing thedistal collar900 and theactuation shaft902 easier and/or less expensive. Removing the threads from theactuation shaft902 can also reduce the likelihood theactuation shaft902 could catch or snag on another component of thedelivery assembly500.
• FIGS. 36-37 show exemplary embodiments of acoupler1000, aproximal collar1002, adistal collar1004, and anactuation shaft1006, which can be used, for example, with thedelivery assembly500. Referring toFIG. 36, thecoupler1000 can be coupled to the distal end portion of theouter shaft520. Theproximal collar1002 can be coupled to the proximal end portion of the prosthetic spacer device200 (shown schematically in partial cross-section), and thedistal collar1004 can be coupled to the to the distal end portion of theprosthetic spacer device200. A proximal end portion (not shown) of theactuation shaft1006 can be coupled to theactuation tube568 and theknob526. From the proximal end portion, theactuation shaft1006 can extend distally through the handle522 (FIG. 17), through the outer shaft520 (FIG. 17), and into the prosthetic spacer device200 (FIG. 12). A distal end portion of theactuation shaft1006 can be releasably coupled to thedistal collar1004 of theprosthetic spacer device200. As such, thecoupler1000, theproximal collar1002, thedistal collar1004, and theactuation shaft1006 can be used, for example, in lieu of thecoupler514, theproximal collar210, thedistal collar208, and theactuation shaft512 of thedelivery assembly500, respectively.
• Referring toFIG. 37, thecoupler1000 can comprise aconnection portion1008, a plurality of pins1010 (e.g., three in the illustrated embodiment), and one or more securing members1012 (e.g., three in the illustrated embodiment). Thepins1010 and the securing members can be coupled to and extend distally from theconnection portion1008.
• Theconnection portion1008 can have an axially-extendinglumen1014 configured to slidably receive theactuation shaft1006. In some embodiments, theconnection portion1008 can also have a recessed outwardly facing surface1015 (FIG. 37) configured to be inserted into the distal end portion of theouter shaft520, as shown inFIG. 36.
• As best shown inFIG. 37, thepins1010 can be spaced circumferentially relative to each other and relative to the securingmembers1012. The securingmembers1012 can be spaced circumferentially relative to each other. In some embodiments, thepins1010 and the securingmembers1012 can be arranged in an alternating type pattern (e.g., pin-securing member-pin and so on) on theconnection portion1008.
• Referring toFIG. 36, thepins1010 can be configured to extend intoopenings1016 of theproximal collar1002. In certain embodiments, the securingmembers1012 can be suture loops. The securingmembers1012 can be configured to extend through theopenings1016 of theproximal collar1002 and around theactuation shaft1006. For clarity, only one securingmember1012 is shown extending around theactuation shaft1006 inFIG. 36.
• Referring again toFIG. 37, in addition to theopenings1016, theproximal collar1002 can comprise acentral lumen1018 disposed radially inward from theopenings1016. Thecentral lumen1018 can extend axially and can be configured to slidably receive theactuation shaft1006, as shown inFIG. 36.
• Thedistal collar1004 can be configured in a sleeve-like manner such that theactuation shaft1006 can slidably extend through thedistal collar1004, as shown inFIG. 36.
• Theactuation shaft1006 can comprise a radially-expandable portion1020 disposed at or near thedistal end portion1022 of theactuation shaft1006. The radially-expandable portion1020 can be configured to be selectively expandable from a compressed configuration to an expanded configuration. For example, the radially-expandable portion1020 can be an inflatable balloon or an expandable mesh (e.g., braided) basket.
• The radially-expandable portion1020 can be configured such that an outside diameter of the radially-expandable portion1020 is less than the inside diameter of thedistal collar1004, thecentral lumen1018 of theproximal collar1002, and thelumen1014 of thecoupler1000 when the radially-expandable portion1020 is in the compressed configuration. When the radially-expandable portion1020 is in the expanded configuration, the outside diameter of the radially-expandable portion1020 is greater than the inside diameter of thedistal collar1004. Thus, in the expanded configuration, the radially-expandable portion1020 can prevent thedistal end portion1022 from moving proximally relative to thedistal collar1004.
• As shown inFIG. 36, theprosthetic spacer device200 can be releasably coupled to theouter shaft520 and theactuation shaft1006 by inserting thepins1010 and the securingmembers1012 throughrespective openings1016 in theproximal collar1002. With the radially-expandable portion1020 in the compressed configuration, theactuation shaft1006 can be advanced distally through thelumen1014 of thecoupler1000, through thecentral lumen1018 and the securingmembers1012 of theproximal collar1002, and through thedistal collar1004 such that the radially-expandable portion1020 is disposed distal relative to thedistal collar1004. The radially-expandable portion1020 of theactuation shaft1006 can then be expanded from the compressed configuration to the expanded configuration, thus releasably coupling theprosthetic spacer device200 to theouter shaft520 and theactuation shaft1006.
• Theprosthetic spacer device200 can be released from theouter shaft520 and theactuation shaft1006 by compressing the radially-expandable portion1020 of theactuation shaft1006 and proximally retracting theactuation shaft1006 through thedistal collar1004, through the securingmembers1012 and thecentral lumen1018 of theproximal collar1002. Theouter shaft520 can then be retracted proximally relative to theprosthetic spacer device200 such that thepins1010 and the securingmembers1012 withdraw from theopenings1016 in theproximal collar1002, thus releasing theprosthetic spacer device200 from theouter shaft520 and theactuation shaft1006.
• FIGS. 38-39 show an exemplary embodiment ofclasp control members1100, which can be used, for example, in lieu of theclasp control members524 of thedelivery assembly500. Referring toFIG. 39, theclasp control members1100 can comprisesleeves1102, connectingmembers1104, andrelease members1106. The connectingmembers1104 and therelease members1106 can extend axially through and can be movable relative to thesleeves1102.
• Proximal end portions (not shown) of thesleeves1102 can be coupled to thecontrol member tubes570, and distal end portions of thesleeves1108 can be releasably coupled to theclasps206 of theprosthetic spacer device200 by the connectingmembers1104 and therelease members1106, as further described below.
• The connectingmembers1104 can, for example, be suture loops that extend distally from theclasp control mechanism550 of thedelivery apparatus502, through thecontrol member tubes570, through thesleeves1102, and through theopenings234 of theclasps206. The connectingmembers1104 can be releasably coupled to theclasps206 theprosthetic spacer device200 by therelease members1106.
• Therelease members1106 can, for example, be wires that extend distally from theclasp control mechanism550 of thedelivery apparatus502, through thecontrol member tubes570, through thesleeves1102, and through the loops of the connectingmembers1104. In this manner, therelease members1106 releasably couple the connectingmembers1104 and thus thesleeves1102 to theclasps206 by preventing the connectingmembers1104 from withdrawing through theopenings234 of theclasps206. The connectingmembers1104 can be released from theclasps206 by withdrawing therelease members1106 from the loops of the connectingmembers1104 and withdrawing the connectingmembers1104 from theopenings234 of theclasps206.
• With thesleeves1102 releasably coupled to theclasps206 of theprosthetic spacer device200 by the connectingmembers1104 and therelease members1106, theclasps206 can be actuated (either together or separately) by moving thesleeves1102 axially relative to theouter shaft520 and theactuation shaft512. This can be accomplished, for example, by moving theactuator member590, which are coupled to thesleeves1102 via thecontrol member tubes570, relative to thehousing546 andactuation tube568. Moving theactuator member590 proximally relative to thehousing546 andactuation tube568 can open theclasps206, and moving theactuator member590 distally relative to thehousing546 andactuation tube568 can close theclasps206.
• Because thesleeves1102 are relatively rigid (e.g., compared to the clasp control members524), thesleeves1102 can be used to push theclasps206 closed (either in lieu of or in addition to the bias of theclasps206 to the closed position). This pushability can help to ensure the native leaflets are captured within theclasps206 and thus secured to theanchors204.
• FIG. 40 shows an exemplary embodiment of aguide rail1200. Theguide rail1200 can, for example, be coupled to arespective clasp206 of theprosthetic spacer device200. In some embodiments, theclasp control member1100 can be releasably coupled to theguide rail1200 in a snare-like manner similar to that described above with respect toFIG. 39.
• Coupling theclasp control member1100 to theguide rail1200 rather than directly to theclasps206 allows theclasp control member1100 to slide longitudinally along theguide rail1200 as theclasp206 moves between the open and the closed configurations. This can, for example, allow theclasp control member1100 to maintain a relatively constant angle relative to theanchors204 as theclasps206 are actuated. For example, theclasp control member1100 can slide outwardly toward afirst side portion1202 of theguide rail1200 when theclasp206 is pulled open, and theclasp control member1100 can slide inwardly toward asecond side portion1204 of theguide rail1200 when theclasp206 is pushed closed. This can therefore reduce the force required to actuate theclasp control member1100.
• FIG. 41 shows an exemplary embodiment of ashaft1300. Theshaft1300 can be used, for example, with thedelivery apparatus502 in lieu of theouter shaft520 of thethird catheter508. Theshaft1300 can comprise a plurality of axially extending lumens, including anactuation shaft lumen1302 and a plurality of control member lumens1304 (e.g., four in the illustratedembodiment1304a,1304b,1304c,1304d—collectively referred to as “the control member lumens1304”) disposed radially outwardly from theactuation shaft lumen1302. The control member lumens1304 can be spaced relative to each other and can be evenly distributed circumferentially around theactuation shaft lumen1302. For example, each of the control member lumens1304 can be located approximately 90 degrees from an adjacent control member lumen1304.
• Theactuation shaft lumen1302 can be configured to receive theactuation shaft512, and the control member lumens1304 can be configured to receive theclasp control members524. Thelumens1302,1304 can also be configured such that theactuation shaft512 andclasp control members524 can be movable (e.g., axially and/or rotationally) relative to thelumens1302,1304, respectively. In particular embodiments, thelumens1302,1304 can comprise a liner or coating (e.g., PTFE) configured to reduce friction between thelumens1302,1304 and theactuation shaft512 andclasp control members524, respectively.
• Each of theclasp control members524 can extend through one or more of the control member lumens1304 and extend around aclasp206 of theprosthetic spacer device200. For example, in some embodiments, eachclasp control member524 can extend through a pair of control member lumens1304 that are circumferentially offset by 90 degrees. In one particular embodiment, a firstclasp control member524 can extend through thelumens1304a,1304band around afirst clasp206 of theprosthetic spacer device200, and a secondclasp control member524 can extend through thelumens1304c,1304dand around asecond clasp206 of theprosthetic spacer device200.
• In such embodiments, when theshaft1300 is deflected in a direction oriented between two lumens corresponding to one of clasp control members524 (e.g., to the right as illustrated inFIG. 41), thelumens1304a,1304bboth foreshorten because they are on the inner diameter of the curve, and thelumens1304c,1304dboth elongate because they are on the outer diameter of the curve. Because theclasp control members524 are free to move axially within the lumens1304, the tension of the first clasp control member524 (which is disposed on the inner diameter of the curve) is reduced and thus thefirst clasp206 can move slightly toward the closed configuration due to the bias of the claps; whereas, the tension of the second clasp control member524 (which is disposed on the outer diameter of the curve) is increased and thus thesecond clasp206 can move slightly toward the open configuration. When theshaft1300 is rotated 180 degrees, thelumens1304a,1304band the firstclasp control member524 move from the inner diameter of the curve to the outer diameter of the curve, thus increasing tension and slightly opening thefirst clasp206, and thelumens1304c,1304dand the secondclasp control member524 move from the outer diameter of the bend to the inner diameter of the bend, thus reducing tension and slightly closing theclasp206.
• In other embodiments, the firstclasp control member524 can extend through thelumen1304a, extend around thefirst clasp206, and extend through thelumen1304c. The secondclasp control member524 can extend through thelumen1304b, extend around thesecond clasp206, and extend through thelumen1304d. Threading eachclasp control member524 through a pair of control member lumens1304 that are circumferentially offset by 180 degrees can provide several advantages. For example, this configuration allows theclasp control members524 to maintain uniform tension on theclasps206 as theshaft1300 is deflected and/or rotated (e.g., during positioning of the prosthetic spacer device200). This is because a length in which each lumen1304 foreshortens/elongates when theshaft1300 is deflected and/or rotated is offset by an equal and opposite length in which a respective, diametrically-opposite lumen1304 elongates/foreshortens and because theclasp control members524 can move relative to the lumens1304 and theclasps206 as the lumens1304 foreshorten/elongate. Theclasps206 of theprosthetic spacer device200 therefore maintain their open and/or closed configuration regardless of the deflection and/or rotation of theshaft1300.
• Theshaft1300 can be formed from various materials, including metals and polymers. For example, in one particular embodiment, theshaft1300 can comprise a first portion orlayer1306, a second portion orlayer1308, and a third portion orlayer1310. Thefirst portion1306 be the radially outermost portion, thethird portion1310 can be the radially innermost portion, and thesecond portion1308 can be disposed radially between the first andthird portions1306,1310. In certain embodiments, the first andthird portions1306,1310 can be formed from polymeric material (e.g., PEBA having a Type D Shore durometer value of 55D), and thesecond portion1308 can be formed from a metallic material (e.g., braided stainless steel).
• Configuring theshaft1300 in this manner can, for example, further improve control of the distal end portion of theshaft1300. For example, this configuration can prevent or reduce “whipping” (e.g., sudden or abrupt movement) at the distal end portion of theshaft1300 when theshaft1300 is rotated at the proximal end portion (e.g., by rotating thehousing546 of the handle522). As such, a physician can more precisely control of the distal end portion of theshaft1300 and thus of a prosthetic spacer device (e.g., the prosthetic spacer device200) during the implantation procedure such as when the physician rotates the prosthetic spacer device to align the anchors of the prosthetic spacer device with the native leaflets.
• It should be noted that in certain embodiments thehousing546 of thehandle522 can comprise fourcontrol member lumens564,582 (i.e., four of each) that are coupled to the control member lumens1304. As such, each longitudinally-extending section of eachclasp control member524 can extend distally in a separate lumen from theclasp control mechanism550 of thehandle522 to theprosthetic spacer device200.
• FIGS. 42-45 show anexemplary delivery assembly1400 comprising aprosthetic spacer device1402 and adelivery apparatus1404. Theprosthetic spacer device1402 can be configured to reduce or prevent regurgitation through a native heart valve (e.g., a native mitral valve). As shown inFIGS. 42-43 and 45, theprosthetic spacer device1402 can be releasably coupled to thedelivery apparatus1404, which can be used to implant the prosthetic spacer device.
• Referring toFIG. 42, theprosthetic spacer device1402 can comprise aspacer member1406, a plurality ofanchors1408, and a plurality ofclasps1410. In some embodiments, thespacer member1406, theanchors1408, and theclasps1410 can be configured in a manner similar to thespacer member202, theanchors204, and theclasps206 of theprosthetic spacer device200, respectively.
• Theprosthetic spacer device1400 can also comprise aproximal collar1412, a sleeve orcylinder1414, and apiston1416. Theproximal collar1412 and thecylinder1414 can be coupled to thespacer member1406, and thepiston1416 can be coupled to theanchors1408.
• Theproximal collar1412 can be coupled to and extend annularly around the proximal end portion (i.e., the upper end portion as illustrated) of thespacer member1406. Theproximal collar1412 can be used, for example, for coupling theprosthetic spacer device1400 to thedelivery apparatus1404, as further described below. In some embodiments, theproximal collar1412 can have connector members for receivingtethers1432 of thedelivery apparatus1404. The connector members can, for example, include openings, eyelets, and/or other suitable means for connecting the tethers to theproximal collar1412.
• Thecylinder1414 can be coupled to and extend coaxially through at least a portion of thespacer member1406. Thecylinder1414 can be coupled to thespacer member1406 in various ways such as with fasteners, sutures, adhesive, welding, and/or other means for coupling. Thecylinder1414 can be sized and configured such thepiston1416 can move axially through thecylinder1414. As such, thecylinder1414 can be used, for example, as a guide for thepiston1416 as theprosthetic spacer device1400 is moved between various configurations such as a foreshortened/functional configuration (e.g.,FIG. 42) and an elongate/delivery configuration (e.g.,FIG. 43).
• Thedistal end portion1418 of thepiston1416 can be coupled todistal end portions1420 of theanchors1408. This can be accomplished in various ways such as with fasteners, sutures, adhesive, welding, and/or other coupling means. Theproximal end portion1422 of thepiston1416 can be coupled to thedelivery apparatus1404. For example, in some embodiments, theproximal end portion1422 of thepiston1416 can comprise a bore oropening1424 having internal threads configured to receive corresponding external threads of anactuation shaft1428 of thedelivery apparatus1404. The piston1416 (in combination with the delivery apparatus) can be used, for example, to move theanchors1408 between various configurations such as a folded/functional configuration (e.g.,FIG. 42) and a straight/delivery configuration (e.g.,FIG. 43).
• Thedelivery apparatus1400 can comprise an implant catheter (e.g., similar to thethird catheter508 of the delivery apparatus502) having anouter shaft1426, anactuation shaft1428, a plurality ofclasp control members1430, and a plurality oftethers1432. Theouter shaft1426 can be used, for example, to position theprosthetic spacer device1402 during the implantation procedure of theprosthetic spacer device1402. Theactuation shaft1428 can be used, for example, to move theprosthetic spacer device1402 between the functional configuration (FIG. 42) and the delivery configuration (e.g.,FIG. 43). Theclasp control members1430 can be used, for example, to move theclasps1410 between an open configuration and a closed configuration. Thetethers1432 can be used, for example, to couple theprosthetic spacer device1402 to theouter shaft1426.
• Referring toFIG. 44, theouter shaft1426 can comprise a plurality of lumens, including anactuation shaft lumen1434, a plurality ofcontrol member lumens1436, and a plurality oftether lumens1438. Theouter shaft1426 can otherwise be configured similar to theouter shaft520 and/or theshaft1300.
• Referring again toFIG. 42, theactuation shaft1428 can be configured similar to theactuation shaft512. In some embodiments, the distal end portion of theactuation shaft1428 can compriseexternal threads1440 configured to threadably mate with the internal threads of theopening1424 in theproximal end portion1422 of thepiston1416.
• In other embodiments, theactuation shaft1428 can be coupled to theanchors1408 of theprosthetic spacer device1402 in various other ways. Although not shown, theprosthetic spacer device1402 can, for example, include a distal collar that is configured similar to thedistal collars108,208,900, and/or1004 in lieu of or in addition to thepiston1416, and theactuation shaft1428 can be configured similar to theactuation shafts512,902, and/or1006.
• Theclasp control members1430 can be configured similar to theclasp control members524 of thedelivery apparatus502. Theclasp control members1430 can extend through thecontrol member lumens1436 of theouter shaft1426 and around theclasps1410 of theprosthetic spacer device1402. Tensioning theclasp control members1430 can move theclasps1410 to the open configuration. Slackening theclasp control members1430 can allow theclasps1410 to move to the closed configuration (due to bias of theclasp1410 toward the closed configuration).
• In some embodiments, each of theclasp control members1430 can extend through two of thecontrol member lumens1436 of theouter shaft1426. In certain embodiments, eachclasp control member1430 can extend through twocontrol member lumens1436 that are circumferentially offset from each other by 180 degrees similar to the manner described above with respect to theshaft1300.
• Thetethers1432 can extend through thetether lumens1438 of theouter shaft1426 and around the proximal end (e.g., through the proximal collar1412) of theprosthetic spacer device1402. Tensioning thetethers1432 can draw the proximal end portion of theprosthetic spacer device1402 toward the distal end portion of the outer shaft1426 (e.g.,FIGS. 42-43. Slackening thetethers1432 can allow the proximal end portion of theprosthetic spacer device1402 to separate from the distal end portion of the outer shaft1426 (e.g.,FIG. 45).
• In some embodiments, each of thetethers1432 can extend through two of thetether lumens1438 of theouter shaft1426. In certain embodiments, eachtether1432 can extend through twotether lumens1438 that are circumferentially offset from each other by 180 degrees.
• Withprosthetic spacer device1402 coupled to thedelivery apparatus1404 by the outer shaft1426 (via the tethers1432), theactuation shaft1428, and theclasp control members1430, thedelivery assembly1400 can be used, for example, to implant theprosthetic spacer device1402 in a native heart valve of a patient's heart. This can be accomplished, for example, by advancing theprosthetic spacer device1402 through the first andsecond catheters504,506 of thedelivery apparatus502 into the patient's heart with theprosthetic spacer device1402 in the delivery configuration (e.g.,FIG. 43). Theprosthetic spacer device1402 can be advanced out of the distal ends of the first andsecond catheters504,506. Theprosthetic spacer device1402 can then be moved from the delivery configuration to the functional configuration (e.g.,FIG. 42) by moving theactuation shaft1428 proximally relative to theouter shaft1426 such that thepiston1416 moves through thecylinder1414 and theproximal end portion1422 of thepiston1416 is disposed adjacent theproximal collar1412.
• Theactuation shaft1428 and/or theclasp control members1430 of thedelivery apparatus1404 can be actuated to capture the native heart valve leaflets with theclasps1410, and the native leaflets can be secured against thespacer member1406. This can be performed in a manner similar to that described above with respect thedelivery assembly500 and shown inFIGS. 22-25.
• With theprosthetic spacer device1402 secured to the native leaflets, the functionality and/or positioning of theprosthetic spacer device1402 can be evaluated. To evaluate, the physician can, for example, release theactuation shaft1428 from thepiston1416 and move the actuation shaft proximally such that the distal end portion of the actuation shaft is disposed within thecentral lumen1434 of theouter shaft1426. Theclasp control members1430 and thetethers1432 can be slackened such that theouter shaft1426 can be retracted away from the proximal end portion of theprosthetic spacer device1402 so that the distal end of theshaft1426 is spaced from theprosthetic spacer device1402. In this manner, theprosthetic spacer device1402 is partially released from thedelivery apparatus1400, but theclasp control members1430 and thetethers1432 remain coupled to theprosthetic spacer device1402. Due to the flexibility and slack of theclasp control members1430 and thetethers1432, theprosthetic spacer device1402 can move and/or function as if it were fully released from thedelivery apparatus1404. As a result, the partially released configuration can, for example, allow the physician to better evaluate the functionality and/or positioning of theprosthetic spacer device1402 prior to fully releasing theprosthetic spacer device1402 than when evaluating theprosthetic spacer device1402 while it is connected to theouter shaft1426 and/or theactuation shaft1428. This is because theouter shaft1426 and/or theactuation shaft1428 are relatively more rigid than theclasp control members1430 and thetethers1432, and can thus alter the position and/or hemodynamics of theprosthetic spacer device1402 compared to when theprosthetic spacer device1402 is partially or fully released from thedelivery apparatus1404.
• If the physician would like to adjust the positioning of theprosthetic spacer device1402, thetethers1432 can be tightened and the distal end portion of theouter shaft1426 can be advanced distally over thetethers1432 such that it abuts the proximal end portion of theprosthetic spacer device1402. Theactuation shaft1428 can be advanced distally through thecentral lumen1434 of theouter shaft1426 and reconnected to theproximal end portion1422 of thepiston1416. Theprosthetic spacer device1402 can then be moved/repositioned relative to the native leaflets by actuating theactuation shaft1428 and/or theclasps control members1430 to manipulate theanchors1408 and/or theclasps1410, respectively. The physician can then re-evaluate the positioning and/or functionality of theprosthetic spacer device1402 and, if desired, make additional adjustments.
• From the partially released configuration, theprosthetic spacer device1402 can be fully released from thedelivery apparatus1404 by withdrawing theclasp control members1430 from theclasps1410 of theprosthetic spacer device1402 and by withdrawing thetethers1432 from proximal end portion of theprosthetic spacer device1402. Theclasp control members1430 and thetethers1432 can then be retracted proximally into thelumens1436,1438 of theouter shaft1426, and the outer shaft together with theactuation shaft1428 can be retracted proximally through the first andsecond catheters504,506 and removed from the patient's body.
• Thetethers1432 can be incorporated into any of the embodiments disclosed herein to allow a prosthetic implant to be implanted while still tethered to the delivery apparatus to evaluate the operation of the implant, and then fully release the implant from the delivery apparatus once the operation of the implant is confirmed by the practitioner.
• FIGS. 46-54 show an exemplary embodiment of ahandle1500 and it components. Thehandle1500 can be used, for example, with thethird catheter508 of thedelivery apparatus502 in lieu of thehandle522. Referring toFIG. 46, thehandle1500 has five main components: aconnection member1502, aflushing mechanism1504, ahousing1506, ananchor actuation mechanism1508, and aclasp actuation mechanism1510.
• The configuration of thehandle1500 is generally similar to the configuration of thehandles522,700. Theanchor actuation mechanism1508 of thehandle1500 is configured to allow a user to actuate anchors of a prosthetic spacer device (e.g., the anchors204) by axially moving (e.g., pushing/pulling) anactuation knob1512 of the anchor actuation mechanism1508 (e.g., similar to the actuation of theknob526 described above) or by rotating the actuation knob1512 (e.g., similar to actuation of the knob718 described above), as further described below. In this manner, theanchor actuation mechanism1508 provides both axial and rotational actuation of theanchor actuation mechanism1508, which is also referred to herein as “hybrid actuation.”
• Referring still toFIG. 46, theconnection member1502 can be coupled the distal end portion of thehousing1506 and to theproximal end portion520aof the outer shaft520 (not shown). Theconnection member1502 can be configured to a provide strain relief to theouter shaft520. Reducing the strain on the outer shaft can, for example, reduce kinking of theouter shaft520 near thehousing1506.
• Referring now toFIG. 47, theconnection member1502 can, for example, have a generally conical shape that tapers radially outwardly from adistal end portion1514 to aproximal end portion1516. Theconnection member1502 can also have one or more slits orgrooves1518, which can facilitate flexing. Theslits1518 can extend circumferentially around theconnection member1502.
• As shown inFIG. 46, theflushing mechanism1504 of thehandle1500 can be coupled to and in fluidic communication with thehousing1506 and the outer shaft (not shown). In this manner, theflushing mechanism1504 can be used to flush the outer shaft (e.g., with a saline solution) prior to inserting thethird catheter508 into a patient's body.
• As shown inFIG. 47, thehousing1506 of thehandle1500 can include anose portion1520 and amain body1522. Thenose portion1520 and themain body1522 can, for example, be coupled together with a fastener (e.g., a bolt)1524. Thenose portion1520 and themain body1522 can include a plurality of lumens, including anactuation shaft lumen1526 andcontrol member lumens1528.Actuation tube1530 can be disposed in and axially movable relative to theactuation shaft lumen1526.Clasp control tubes1532 can be disposed in an axially movable relative to thecontrol member lumens1528.
• Themain body1522 of thehousing1506 can also include aslot1534 and abore1536 that are configured for receiving one or more components of theanchor actuation mechanism1508, as further described below. Theslot1534 can extend radially into and axially along theactuation shaft lumen1526 of thehousing1506. Thebore1536 can be disposed proximal to theslot1534 and can extend radially into theactuation shaft lumen1526 of thehousing1506.
• In some embodiments, thehousing1506 can have a generally triangular cross-sectional shape taken in a plane perpendicular to the longitudinal axis of theactuation lumen1526. In other embodiments, the housing can be a variety of other shapes such as rectangular, circular, etc.
• Theanchor actuation mechanism1508 can be used to move theactuation shaft512 axially relative to the housing1506 (and thus the outer shaft520), and thus theanchors204 of the prosthetic spacer device200 (which can be coupled to the actuation shaft512). Theanchor actuation mechanism1508 can also be used to release the actuation shaft from the prosthetic spacer device. Theanchor actuation mechanism1508 can include theactuation tube1530, adrive screw1538, theactuation knob1512, arelease knob1540, arelease pin1542, abushing1544, amode selector button1546, and a biasing element (e.g., a spring)1548.
• Referring toFIG. 48, theactuation tube1530 can have aflange1550 disposed at the distal end portion of the actuation tube and alumen1552 extending from the distal end portion to a proximal end portion of the actuation tube. Theflange1550 can be used, for example, to couple theactuation tube1530 to therelease pin1542 and thebushing1544. Thelumen1552 can, for example, receive an actuation shaft (e.g., the actuation shaft512).
• As shown inFIG. 48, theflange1550 can have one or more recessed portions or “flats”1554 (e.g., two on diametrically opposite sides of the flange1550). In this manner, theflange1550 of theactuation tube1530 can be inserted into a first opening1556 (FIG. 49) of thebushing1544, and therelease pin1542 can be inserted into a second opening1558 (FIG. 49) of thebushing1544 to coupleactuation tube1530 and thebushing1544 together, as shown inFIG. 51. Referring toFIG. 50, therelease pin1542 can have one or more tabs1560 (e.g., two in the illustrated embodiment) that are spaced apart by agroove1562. Referring again toFIG. 51, thetabs1560 andgroove1562 of therelease pin1542 and/or theflange1550 of theactuation tube1530 can be sized and configured such thattabs1560 of therelease pin1542 extend alongside and engage theflats1554 of theactuation tube1530. In the engaged configuration (e.g.,FIG. 51), therelease pin1542 restricts relative movement (e.g., rotational and axial) between theactuation tube1530 and thebushing1544.
• In some embodiments, therelease pin1542 and thebushing1544 can havelocking elements1564,1566, respectively. Thelocking elements1564,1566 can, for example, help retain therelease pin1542 and thebushing1544 in the engaged configuration. Thelocking elements1566 can be slots formed on an inner surface of thebushing1544 and thelocking elements1564 can be tabs or protrusions formed on therelease pin1542 and sized to be received within correspondingslots1566. Alternatively, thetabs1564 can be formed on the bushing and theslots1566 can be formed on the release pin. Thetabs1564, when received in theslots1566, prevent inadvertent movement of the release pin relative to the bushing, yet allow the release pin to be manually removed from the bushing when so desired by the user.
• Referring toFIG. 47, thedrive screw1538 can comprise alumen1568, adistal portion1570, and aproximal portion1572. Thelumen1568 can extend from thedistal portion1570 of thedrive screw1538 to theproximal portion1572 of thedrive screw1538.
• Thelumen1568 of thedrive screw1538 and/or theactuation tube1530 can be sized and configured such that theactuation tube1530 can extend through thelumen1568 and such that theactuation tube1530 can move rotationally and axially relative to thedrive screw1538.
• Thedistal portion1570 of thedrive screw1538 can comprise threads (e.g., external treads) that are configured to engage corresponding threads (e.g., internal threads) of themode selector button1546, as further described below.
• Theproximal portion1572 of thedrive screw1538 can be fixedly coupled to theactuation knob1512. As such, movement (e.g., rotational and axial) of theactuation knob1512 can result in corresponding movement of thedrive screw1538. In some embodiments, theactuation knob1512 can be fixedly coupled to the drive screw with a fastener (e.g., a set screw), adhesive, and/or other means for fastening. In other embodiments, theactuation knob1512 can be fixedly coupled to thedrive screw1538 by integrally forming theactuation knob1512 and thedrive screw1538 as a single, unitary component.
• Therelease knob1540 can be fixedly coupled to a proximal end portion of theactuation tube1530. As such, movement (e.g., rotational and/or axial) of therelease knob1540 can result in corresponding movement of theactuation tube1530. In some embodiments, theactuation knob1512 can be fixedly coupled to thedrive screw1538 with a fastener (e.g., a set screw), adhesive, and/or other means for fastening.
• Referring toFIG. 52, themode selector button1546 can have anopening1574. Theopening1574 can be elliptical and configured to receive thedrive screw1538. The annular surface defining theopening1574 can have a first portion1576 (i.e., the upper portion in the depicted orientation) and a second portion1578 (i.e., the lower portion in the depicted orientation). Thefirst portion1576 can be generally smooth. Thesecond portion1578 can have threads (e.g., internal threads) configured to engage corresponding threads of thedistal portion1570 of thedrive screw1538, as shown inFIG. 53A. Theopening1574 of thebutton1546 can be sized and configured such that when thefirst portion1576 of thebutton1546 contacts thedrive screw1538, the threads of thesecond portion1578 of thebutton1546 disengage the threads of thedrive screw1538, as shown inFIG. 53B. This configuration allows relative movement (e.g., axial) between thebutton1546 and thedrive screw1538, as further described below.
• Referring toFIGS. 46-47, theanchor actuation mechanism1508 of thehandle1500 can be assembled by inserting thebushing1544 into theactuation lumen1526 of thehousing1506 such that ears1580 (FIG. 49) of thebushing1544 extend out of theslot1534 of thehousing1506. In this manner, theslot1534 of thehousing1506 can act as a track or guide for thebushing1544 that allows relative axial movement of thebushing1544 within theactuation lumen1526 of thehousing1506 and restricts relative rotational movement between thebushing1544 and thehousing1506. In some embodiments, thebushing1544 can have additional mating features (e.g., aslot1582 and/or tabs1584 (FIG. 49)) that can engage with corresponding mating features (e.g., rails1586 and/or notches1588 (FIG. 54)) of theactuation lumen1526 of thehousing1506 to restrict relative rotational movement between thebushing1544 and thehousing1506.
• The biasingmember1548 can be positioned within thebore1536 of thehousing1506, and themode selector button1546 can be disposed on the biasingmember1548 and within thebore1536. Thebutton1546 can then be pressed inwardly relative to thebore1536 of the housing1506 (to overcome the outward force of the biasingmember1548 on the button1546) such that theopening1574 of thebutton1546 radially aligns with theactuation lumen1526 of thehousing1506.
• In this configuration, thedrive screw1538 can be inserted into theactuation lumen1526 of the housing and through theopening1574 of thebutton1546 such that thedistal end portion1570 of thedrive screw1538 abuts thebushing1544.
• Theactuation tube1530 can be inserted through thelumen1568 of thedrive screw1538 such that therelease knob1540 abuts theactuation knob1512 and such that theflange1550 of theactuation tube1530 extends distally from thelumen1568 of thedrive screw1538 and into thefirst opening1556 of thebushing1544. Therelease pin1542 can be inserted into thesecond opening1558 of thebushing1544 and such that thetabs1560 of therelease pin1560 engage theflats1554 of theflange1550, as shown inFIG. 51. Accordingly, with therelease pin1542 engaged, theactuation tube1530 cannot rotate relative tobushing1544 or thehousing1506. Also, theactuation shaft1530 and thedrive screw1538 move together axially. This is because the actuation shaft cannot move proximally relative to thedrive shaft1538 due to the bushing1544 (which cannot extend into thelumen1568 of thedrive screw1538 and because the actuation shaft cannot move distally relative to thedrive shaft1538 due to the release knob1540 (which cannot extend past the actuation knob1512). Thedrive screw1538 can, however, rotate relative to theactuation shaft1530.
• Once assembled (e.g.,FIG. 46), theanchor actuation mechanism1508 can be operated in rotational mode and sliding mode. Due to the biasingmember1548 urging the threadedsecond portion1578 of themode selector button1546 against the threads of the drive screw1538 (see e.g.,FIG. 53A), the default mode of operation is the rotational mode.
• In alternative embodiments, themode selector button1546 can be configured such that the default mode of operation is the sliding mode. This can be accomplished, for example, by switching the placement of the threadedportion1578 and thesmooth portion1576 of thebutton1546.
• In the rotational mode, anchors of a prosthetic spacer device can be actuated by rotating theactuation knob1512 relative to thehousing1506. This moves thedrive screw1538 axially relative to thebutton1546. As thedrive screw1538 moves axially, thedrive screw1538 carries the actuation tube1530 (and theactuation shaft512 which can be coupled to the actuation tube1530) axially along with it. Also, therelease pin1542 moves axially relative to theslot1532, and thebushing1544 moves axially relative to theactuation lumen1526.
• Rotating theactuation knob1512 in a first direction (e.g., clockwise) relative to thehousing1506 can result in the anchors of the prosthetic spacer device opening or unfolding away from the spacer body. Rotating theactuation knob1512 in a second direction (e.g., counterclockwise) relative to thehousing1506 can result in the anchors of the prosthetic spacer device closing or folding toward the spacer body.
• To switch from rotational mode to sliding mode, the user can press themode selector button1546 inwardly relative to thehousing1506. This movement disengages the threads of thebutton1546 from the threads of thedrive screw1538, thereby allowing the user to open the anchors of the prosthetic spacer device by pushing theactuation knob1512 distally relative to thehousing1506 or to close the anchors of the prosthetic spacer device by pulling theactuation knob1512 proximally relative to thehousing1506.
• Due to the dual/hybrid actuation modes, thehandle1500 provides several significant advantages. For example, thehandle1500 allows a user to have both the quick and/or course adjustment of push/pull actuation and the precise and/or fine adjustment of rotational actuation. Thehandle1500 also provides a locking mechanism in either mode of operation because theactuation shaft512 cannot be moved relative to thehousing1506 without the user rotating theactuation knob1512 and/or pressing themode selector button1546 and moving theactuation knob1512 axially.
• To release the actuation shaft from the prosthetic spacer device, the user can withdraw therelease pin1542 from theactuation tube1530, thebushing1544, and theslot1534. This allows the user to rotate the release knob1540 (e.g., counterclockwise) relative to thehousing1506, which in turn, results in theactuation tube1530 and the actuation shaft rotating relative to thehousing1506 and the prosthetic spacer device. This can retract the actuation shaft from the distal collar of the prosthetic spacer device. Therelease knob1540 can then be moved proximally relative to thehousing1506 to withdraw the actuation shaft from the prosthetic spacer device and thecoupler514 of theouter shaft520, thereby releasing the prosthetic spacer device from the delivery apparatus.
• In some embodiments, therelease knob1540 and therelease pin1542 can be a first color (e.g., blue), theactuation knob1512 can be a second color (e.g., black), and themode selector button1546 can be a third color (e.g., gray). This can, for example, provide the user with visual indicators that therelease knob1540 and therelease pin1542 are related (i.e., because they are the same color) and that theactuation knob1512,release knob1540, andmode selector button1546 preform separate functions (i.e., because they are different colors).
• Additionally or alternatively, therelease knob1540 and therelease pin1542 can have other indicators or features such as lettering (e.g., “Release”), symbols (e.g., an unlocked lock), and/or texturing (e.g., ribs) to make the components easier and/or more intuitive to use. Similarly, themode selector button1546 and/or theactuation knob1512 can have one or more such indicators or features.
• Theclasp control mechanism1510 of thehandle1500 can be configured similar to theclasp control mechanism550 described above.
• FIGS. 55-61D show an exemplary embodiment of ahandle1600 and it components. Thehandle1600 can be used, for example, with thethird catheter508 of thedelivery apparatus502 in lieu of thehandle522. Referring toFIG. 55, thehandle1600 has five main components: aconnection member1602, a flushing mechanism (not shown), ahousing1604, ananchor actuation mechanism1606, and aclasp actuation mechanism1608.
• Thehandle1600 is configured similar to thehandle1500. Theanchor actuation mechanism1606 of thehandle1600 is configured to allow a user to actuate anchors of a prosthetic spacer device (e.g., the anchors204) by axial (i.e., distal/proximal) movement of anactuation knob1610 of theanchor actuation mechanism1606 and by rotational movement (i.e., clockwise/counterclockwise) of theactuation knob1610, as further described below. In this manner, theanchor actuation mechanism1508 provides hybrid anchor actuation (e.g., similar to the handle1500).
• Thehousing1604 of thehandle1600 can include anose portion1612, amain body1614, and asupport portion1616. The distal end of thenose portion1612 can be coupled to theconnection member1602 and/or theouter shaft520, and the proximal end of thenose portion1612 can be coupled to the distal end of themain body1614. Thesupport portion1616 can be coupled to the proximal end of themain body1614.
• Thenose portion1612, themain body1614, and thesupport portion1616 of thehousing1604 can include an actuation lumen (not shown). Thenose portion1612 and themain body1614 can also include a plurality (e.g., two) of clasp control lumens (not shown).
• Themain body1614 of thehousing1604 can have a generally cylindrical or rounded shape. The cylindrical shape can, for example, allow thehandle1600 to be placed or secured to an object (e.g., a table) in any rotational orientation (e.g., when rotating the outer shaft520). The cylindrical shape can also help thehandle1600 maintain its rotational orientation relative to the object because thehandle1600 does not have flat sides for the handle to pivot or flop toward.
• Thesupport portion1616 of thehousing1604 can have a generally rectangular shape. In some embodiments, the edges of thesupport portion1616 can be rounded and have radii similar to the radius of themain body1614.
• Referring toFIG. 56, thesupport portion1616 of thehousing1604 can include aslot1618 extending from the actuation lumen. Theslot1618 can be configured to receive arelease pin1622 and/orbushing1624 of the actuation mechanism1606 (e.g., similar to theslot1534 of the handle1500). Thesupport portion1616 can also include abore1620. Thebore1620 can be configured to receive amode selector button1626 and a biasing member (e.g., a spring)1628 of theactuation mechanism1606.
• Referring toFIG. 56, theactuation mechanism1606 of thehandle1600 can include anactuation tube1630, adrive screw1632, theactuation knob1610, arelease knob1634, arelease pin1622, abushing1624, amode selector button1626, and a biasingmember1628. Theactuation mechanism1606 can be configured, assembled, and operated in a manner similar to theactuation mechanism1508 of thehandle1500. For example,FIGS. 57-59 respectively show detailed views of adistal portion1636 of theactuation tube1630, thebushing1624, and therelease pin1622.FIG. 60 shows thedistal portion1636 of theactuation tube1630 coupled to thebushing1624 by therelease pin1622.FIG. 55 shows theentire actuation mechanism1606 assembled and coupled to thehousing1604.
• Referring toFIG. 55, theclasp control mechanism1608 of thehandle1600 can includeclasp tubes1638,actuators1640, and lockingmembers1642. In the illustrated embodiment, there are twotubes clasp tubes1632, twoactuators1640, and two lockingmembers1642. In other embodiments, theclasp control mechanism1608 can have more (e.g., three) or less (e.g., one) than two of the tubes, actuators, and locking members.
• A distal end portion of each of theclasp tubes1638 can be disposed in and axially moveable relative to a respective control lumen of themain body1614. A proximal end portion of each of theclasp tubes1638 can be coupled to arespective actuator1640. Each of the locking members1642 (e.g., stop cocks) can be coupled to arespective actuator1640. The clasp control members524 (FIG. 15) can extend through theclasp tubes1638 and can be releasably secured to actuators by the lockingmembers1642.
• Theactuators1640 can be selectively coupled together, for example, by aremovable pin1644. As such, theactuators1640 can be moved together to actuate the clasp control members524 (and thus theclasps206 of the prosthetic spacer device) simultaneously when thepin1644 is inserted into theactuators1640. When thepin1644 is removed, the actuators1640 (the clasps206) can be moved individually.
• Referring toFIG. 61A, in some embodiments, each of theactuators1640 can have a retention member (e.g., a pin)1646 disposed on and/or extending from a surface of theactuator1640 that faces thesupport portion1616 of thehousing1604. Theretention member1646 can be configured to engage thesupport portion1616 of thehousing1604 to retain the relative position of theactuators1640 and thehousing1604, which in turn retains the positioning of the clasps of the prosthetic spacer device.
• In some embodiments, theretention members1646 can be sized and/or configured so as to position theclasp tubes1638 slightly off-axis relative to the control lumens of thehousing1604. In this manner, theclasp tubes1638 act as biasing members that force theretention members1646 against thesupport portion1616. This force results in a frictional engagement between theclasp tubes1638 and thesupport portion1616, thus reducing the likelihood that theactuators1640 will be inadvertently moved relative to thesupport portion1616. The frictional engagement can also help to retain the positioning of the clasps of the prosthetic device in the open position by overcoming the tensile force on the clasp control members and the actuators that is caused by the bias of the clasps toward the closed position.
• In other embodiments, theretention members1646 can be sized and/or configured so as to position theclasp tubes1638 coaxial to the control lumens of thehousing1604, and thesupport portion1616 of thehousing1604 can have one or more holding elements (see holdingelements1648a,1648b,1648c, and1648dshown inFIGS. 61A-61D, respectively, and which are also be referred to generically and/or collectively as “the holding elements1648”), that are disposed on and/or extend from a surface of thesupport portion1616 that faces theactuators1640. The holding elements1648 can be configured to engage theactuators1640 and/or theretention members1646 to retain the relative position of theactuators1640 and thehousing1604, which in turn retains the positioning of the clasps of the prosthetic spacer device.
• FIG. 61A shows anexemplary holding element1648a. The holdingelement1648acomprises a projection or ridge that extends toward and/or or engages theretention members1646 of theactuators1640. Thus, in order for theactuators1640 to move relative to thehousing1604, theretention members1646 have to be moved over the holdingelement1648a. As theretention members1646 move over the holdingelement1648a, the clasp tubes1648 are pushed slightly off-axis relative to the control lumens of the housing, thus increasing the frictional engagement between the control lumens and theclasp tubes1638. This in turn makes it relatively more difficult to move theactuators1640 relative to thehousing1604. To open the clasps on the prosthetic spacer device, theactuators1640 are moved to a proximal-most position (as shown inFIG. 61A). The engagement of theretention members1646 with the holdingelement1648aresists movement of theactuators1640 under the tensile force of the clasps, thereby retaining the clasps in their open position. To close the clasps, the user can push theactuators1640 distally (to the left inFIG. 61A) with sufficient force to push theretention members1646 over the holdingelement1648a. If desired, the user can slightly lift the actuators away from thesupport portion1616 while pushing them distally to allow theretention members1646 to clear the holdingelement1648a.
• FIG. 61B shows anotherexemplary holding element1648b, which can be used, for example, in lieu of the holdingelement1648a. The holdingelement1648bhas a relatively gradual-sloped distal portion and a relatively steep-sloped proximal portion. The steep-sloped proximal portion of the holdingelement1648bcan act as a lock to selectively hold the retention members1646 (and thus the actuators1640) in the proximal-most position. Theactuators1640 can be moved from the proximal-most position by applying sufficient distal force (and/or vertical force) onactuators1640 so that theretention members1646 “climb” the steep-sloped proximal portion of the holdingelement1648band move onto the gradual-sloped distal portion of the holdingelement1648b. Once the retention members1648 pass the apex of the holdingelement1648b, the actuators tend to move relatively easily in the distal direction due to the gradual-sloped distal portion (and the tension on the clasp control members524). Theactuators1640 can be moved to the proximal-most position by moving theactuators1640 proximally with sufficient force for theretention members1646 to “climb” the gradual-sloped distal portion of the holdingelement1648band move onto the steep-sloped proximal portion of the holdingelement1648b. Since the gradual-sloped portion is less abrupt than the steep-sloped portion, the force needed to move theactuators1640 proximally over the distal portion of the holdingelement1648bis relatively less noticeable (i.e., seems easier) to a user than the force needed to move theactuators1640 distally of the proximal portion of the holdingelement1648b. This is in contrast to theholding element1648ashown inFIG. 61A, which has similar slopes on the proximal and distal sides of the holdingelement1648a.
• FIG. 61C shows anotherexemplary holding element1648c, which can be used, for example, in lieu of the holdingelements1648a,1648b. The holdingelement1648chas a relatively gradual-sloped distal portion and a relatively steep-sloped proximal portion. The proximal portion of the holdingelement1648chas a slope that is substantially similar to the slope of the proximal portion of the holdingelement1648b(FIG. 61B). The distal portion of the holdingelement1648chas a slope that is even more gradual than the slope of the distal portion of the holdingelement1648bshown inFIG. 61B.
• FIG. 61D shows yet anotherexemplary holding element1648d, which can be used, for example, in lieu of the holdingelements1648a,1648b,1648c. The holdingelement1648dhas a vertically extending wall or lip on the proximal side and a relatively steep-sloped portion on the distal side. As such, to move theactuators1640 distally, a user can lift and move theactuators1640 distally over the holdingelement1648dto allow the clasps to move from their open configuration toward the closed configuration. In this manner, the vertical lip of the holdingelement1648dcan reduce the likelihood that the actuators are inadvertently moved distally compared to the holding elements1684a,1684b, and/or1684c.
• In some embodiments, the holding elements1648 can be configured and/or positioned to retain theactuators1640 near the proximal end of thesupport portion1616. This can, for example, help to retain the clasps of the prosthetic spacer device in the open configuration.
• In certain embodiments, thesupport portion1616 can have a plurality of holding elements1648 at various locations along the length of the support portion. For example, a first holding element can be positioned near the proximal end of the support portion (e.g., to hold theactuators1640 in a proximal-most position to hold the clasps in their open configuration), and a second holding element can be positioned near the distal end of the support portion (e.g., to hold the actuators in a distal-most position to the hold the claps in their closed configuration).
• FIGS. 62-75 show an exemplary embodiment of ahandle1700 and it components. Thehandle1700 can be used, for example, with thethird catheter508 of thedelivery apparatus502 in lieu of thehandle522 to position, secure, and/or deploy a prosthetic spacer device. Referring toFIG. 62, thehandle1700 has five main components: a connection member (which can also be referred to as a strain relief)1702, ahousing1704, ananchor actuation mechanism1706, aclasp actuation mechanism1708, and a flushing mechanism1710 (which is partially shown inFIG. 63).
• Thehandle1700 is configured and functions in a manner that is generally similar to thehandles1500,1600. Theanchor actuation mechanism1706 of thehandle1700 is configured to allow a user to actuate anchors of a prosthetic spacer device (e.g., theanchors204 of the prosthetic spacer device200) by either pushing/pulling anactuation knob1712 of theanchor actuation mechanism1706 while pressing amode selector button1714 or by rotating theactuation knob1712 without pressing themode selector button1714. In this manner, theanchor actuation mechanism1706 provides hybrid anchor actuation (e.g., similar to the handle1600).
• Thehousing1704 of thehandle1700 can include amain body portion1716 and asupport portion1718. The distal end of themain body1716 can be coupled to theconnection member1702 and/or theouter shaft520. Themain body1716 can have afirst portion1716a(i.e., the upper portion in the orientation shown inFIG. 62) and asecond portion1716b(i.e., the lower portion in the orientation shown inFIG. 62). Thesupport portion1718 can extend from the proximal end of the main body1716 (e.g., from thesecond portion1716bof the main body1716). Thesupport portion1718 can have afirst portion1718a(i.e., the upper portion in the orientation shown inFIG. 62) and asecond portion1718b(i.e., the lower portion in the orientation shown inFIG. 62).
• In some embodiments, one or more portions of themain body1716 and/or one or more portions of thesupport portion1720 can be integrally formed (e.g., molded) as a single unitary component or formed as separate components that are coupled together (e.g., with fasteners, frictional engagement (e.g., tabs), adhesive, welding, and/or other means for fastening). For example, as shown inFIGS. 62-63, thesecond portions1716b,1718bof themain body1716 and thesupport portion1718 can be integrally formed, the first andsecond portions1716a,1716bof themain body1716 can be coupled together with fasteners (e.g., screws1720), and the first andsecond portions1718a,1718bof thesupport portion1718 can be coupled together with fasteners (e.g., screws1720). In other embodiments, the first andsecond portions1716a,1716bof themain body1716 can be integrally formed.
• Referring toFIGS. 64-65, thehandle1700 can further comprise various components that are disposed within and/or coupled to thehousing1704. For example, in some embodiments, thehandle1700 can optionally include acoupling member1722, astabilizer member1724, and/or ashaft guide member1726.
• Referring toFIGS. 66-67, thecoupling member1722 can have ashaft portion1728, aflange portion1730 extending radially outwardly from theshaft portion1728, and alumen1732 extending axially through theshaft portion1728 from distal end to a proximal end of thecoupling member1722. In some embodiments, theshaft portion1728 can have projection orridge1734 that extends radially outwardly.
• As shownFIG. 64, theconnection member1702 can extend partially over theshaft portion1728 of thecoupling member1722 and theridge1734 can help prevent relative movement therebetween. Theflange portion1730 can be configured for connecting thecoupling member1722 to the housing1704 (e.g., with a fastener1736). Theouter shaft520 can extend into the distal end portion of thelumen1732, and theactuation shaft512 and theclasp control members524 can extend from the proximal end of theouter shaft520 andlumen1730.
• In certain embodiments, thecoupling member1722 can have adivider1738 that divides thelumen1732 into a plurality of segments. Thedivider1738 can be disposed in a proximal end portion of thelumen1732. In the illustrated embodiment, thedivider1738 is generally “Y”-shaped and thus divides thelumen1732 into threesegments1732a,1732b,1732c. For example, thesegment1732acan be configured for receiving one of theclasp control members524, thesegment1732bcan be configured for receiving another of theclasp control members524, and thesegment1732ccan be configured for receiving theactuation shaft512.
• In particular embodiments, thedivider1738 can be configured to orient the outer shaft520 (and thus the prosthetic spacer device which is coupled to the distal end portion of the outer shaft520) relative to the coupling member1722 (and thus the handle1700) at a pre-determined rotational orientation. This can be accomplished by positioning anaxis1733 of thedivider1738 at an angle θ relative to anaxis1735 of thecoupling member1722. The angle θ between theaxes1733,1735 can in the range of 0-360 degrees. In certain embodiments, the angle θ between theaxes1733,1735 can in the range of 15-90 degrees. In one particular embodiment, the angle θ between theaxes1733,1735 can about 45 degrees. Thecoupling member1722 can be coupled to the outer shaft of the third catheter by aligning pairs of the clasp control lumens of the outer shaft (see e.g., the lumens1304a-1304dof theouter shaft1300 shown inFIG. 41) withrespective segments1732a,1732bof thecoupling member1722. Thecoupling member1722 together with the outer shaft can be coupled to theshaft guide member1726 and thehousing1704. Because thecoupling member1722 can only be coupled to theshaft guide member1726 and thehousing1704 in one rotational orientation (e.g., due to its asymmetrical shape), the rotational orientation of thecoupling member1722 thus determines the rotational orientation of the outer shaft relative to thehandle1700.
• The pre-determined orientation between the outer shaft and thehandle1700 can, for example, be selected (e.g., via the angle θ) to rotationally align the prosthetic spacer device relative to the native anatomy when the prosthetic spacer device is coupled to theouter shaft520 and advanced through a patient's vasculature to an implantation location. For example, for a delivery assembly (e.g., theprosthetic spacer device200 anddelivery apparatus502 with the handle1700) that is configured for implanting a prosthetic spacer device at a patient's native mitral valve via a transseptal delivery approach, thedivider1738 can be oriented with an angle θ that is about 45 degrees as shown inFIG. 67. When oriented in this manner, the prosthetic spacer device will be oriented relative to the native anatomy such that the anchors of the prosthetic spacer device are at least substantially rotationally aligned with the native leaflets of the mitral valve when the prosthetic spacer device is deployed from thesheath518 and positioned coaxially to the mitral valve (see, e.g.,FIGS. 20-23) and thehandle1700 is rotationally oriented such that the clasp actuation mechanism is facing upwardly (e.g., in the orientation shown inFIG. 62).
• This can, for example, reduce the time a physician spends aligning the prosthetic spacer device during the implantation procedure. It can also improve efficiency and precision of the manufacturing process by reducing the amount of guesswork that is needed to orient theouter shaft520 relative to thecoupling member1722.
• Thedivider1738 can also improve hemostatic sealing between theouter shaft520 and thehandle1700, for example, by reducing leakage at the joints of sleeves1740 (FIG. 65) (through which theclasp control members524 extend) and theouter shaft520.
• As shown inFIG. 65, thestabilizer member1724 can be coupled to a distal end portion of theshaft guide member1726, such as by fasteners, adhesive, and/or other coupling means (e.g., tabs1739). Thestabilizer member1724 can include asupport portion1741 that is spaced between the proximal end of the outer shaft520 (FIG. 64) and aport1743 in the distal end portion of theshaft guide member1726. Thestabilizer member1724 can also include anopening1742 through which theactuation shaft512 and itssleeve1744 can extend. In this manner, thestabilizer member1724 can, for example, support the portions of theactuation shaft512 and thesleeve1744 that are disposed between theouter shaft520 and theshaft guide member1726. As such, thestabilizer member1724 can, for example, reduce buckling or kinking of theactuation shaft512 when actuating theanchor actuation mechanism1706. This in turn improves the functionality and/or reliability of theanchor actuation mechanism1706 and thus anchor actuation of the prosthetic spacer device.
• It should be noted that thestabilizer member1724 and thedivider1738 are not shown inFIG. 64 in order to better illustrate other components of thehandle1700.
• Theshaft guide member1726 can include clasp control lumens1746 (e.g., two in the illustrated embodiment), anactuation shaft lumen1748, and aflushing lumen1750. Theclasp control members524 can extend through theclasp control lumens1746 and can be coupled to theclasp control mechanism1708. Theactuation shaft512 can extend through theactuation shaft lumen1748 and can be coupled to theanchor actuation mechanism1706. Theflushing lumen1750 can be coupled to afirst portion1752 of a flushing tube (FIG. 64) and asecond portion1754 of the flushing tube (FIG. 63) of the flushing mechanism1710 (FIG. 63).
• Theanchor actuation mechanism1706 can be coupled to theactuation shaft512. As mentioned above, theanchor actuation mechanism1706 of thehandle1700 is configured to allow a user to actuate theactuation shaft512 and thus the anchors of the prosthetic spacer device by either pushing/pulling theactuation knob1712 of theanchor actuation mechanism1706 while pressing themode selector button1714 or by rotating theactuation knob1712 without pressing themode selector button1714.
• Referring toFIG. 62 and beginning at the proximal end portion and moving toward the distal end portion of thehandle1700, theanchor actuation mechanism1706 can include arelease knob1756, theactuation knob1712, adrive shaft1758, themode selector button1714, and arelease pin1760. Referring toFIGS. 68-69, the anchor actuation mechanism1706 (FIG. 62) can also include distal andproximal actuation sleeves1762,1764, respectively, and aferrule1766 coupled to and extending between thesleeves1762,1764. As shown inFIG. 69, theactuation shaft512 can extend though and be fixedly coupled to thesleeves1762,1764 and theferrule1766. In this manner, theactuation shaft512, thesleeves1762,1764, and theferrule1766 move together both axially and rotationally. Referring toFIG. 75, theanchor actuation mechanism1706 can also include abushing1768. The components and operation of the actuation mechanism are further described below.
• Referring again toFIG. 62, aproximal end portion1758aof thedrive shaft1758 can be disposed outside of thehousing1704, and theactuation knob1712 can be fixedly coupled thereto. Thedrive shaft1758 can extend through aproximal opening1770 of thehousing1704. Referring now toFIG. 75, thedrive shaft1758 can extend through an opening of the mode selector button1714 (not shown, but see, e.g., theopening1574 of themode selector button1546 shown inFIG. 52) and through an opening1772 of thebushing1768. Thedistal end portion1758bof thedrive shaft1758 can be coupled to thebushing1768 such that thedrive shaft1758 can rotate relative to thebushing1768 but cannot move axially relative to thebushing1768. This can be accomplished, for example, by coupling thedistal end portion1758bof thedrive shaft1758 to thebushing1768 with fasteners (e.g., C-clips1774) on the distal and proximal sides of thebushing1768.
• As shown inFIG. 62, thedrive shaft1758 can comprise a threadedportion1776. The mode selector button1714 (which is movably coupled to the housing1704) can comprise a threaded portion configured to threadably engage the threadedportion1776 of thedrive shaft1758 when themode selector button1714 is in a first mode of operation. In the first mode of operation, thedrive shaft1758 can be moved axially relative to themode selector button1714 by rotating theactuation knob1712 relative to thehousing1704. In the illustrated embodiment, the threaded portions of thedrive shaft1758 and themode selector button1714 are “left-hand” threads. As such, rotating thedrive shaft1758 clockwise relative to the modeselector button portion1714 moves thedrive shaft1758 proximally relative to thehousing1704, and rotating thedrive shaft1758 counterclockwise relative to the modeselector button portion1714 moves thedrive shaft1758 distally relative to thehousing1704. In other embodiments, the threaded portions of thedrive shaft1758 and themode selector button1714 can be “right-hand” threads. In those embodiments, rotating thedrive shaft1758 counterclockwise relative to the modeselector button portion1714 moves thedrive shaft1758 proximally relative to thehousing1704, and rotating thedrive shaft1758 clockwise relative to the modeselector button portion1714 moves thedrive shaft1758 distally relative to thehousing1704.
• Themode selector button1714 can also comprise a non-threaded portion configured to engage thedrive shaft1758 when themode selector button1714 is in a second mode of operation. In the second mode of operation, thedrive shaft1758 can be moved axially relative to themode selector button1714 by pushing or pulling theactuation knob1712 relative to thehousing1704. Themode selector button1714 can be biased (e.g., with a biasing member such as a spring) to either the first mode of operation or the second mode of operation as the default mode of operation and can be moved from the default mode of operation to the other mode of operation by pressing themode selector button1714.
• To help keep thedrive shaft1758 and the opening of themode selector button1714 coaxial as thedrive shaft1758 moves axially relative to themode selector button1714 in both the first and second modes of operation, thebushing1768 and thehousing1704 can comprise respective mating features. For example, in the illustrated embodiment, thebushing1768 comprises tabs orprojections1778 that can be disposed in respective slots of thehousing1704, as shown inFIG. 75. Thetabs1778 of thebushing1768 and the slots of thehousing1704 allow thebushing1768 and thus thedrive shaft1758 to move axially relative to thehousing1704 and themode selector button1714 and prevent lateral (e.g., left/right in the orientation shown inFIG. 75) and vertical (e.g., up/down in the orientation shown inFIG. 75) movement therebetween. As a result, thebushing1768 helps to keep thedrive shaft1758 and the opening of themode selector button1714 coaxial. Maintaining coaxiality can, for example, reduce or prevent thedrive shaft1758 from binding relative to themode selector button1714 and/or promote smooth and controllable movement between the components.
• Referring toFIG. 62, theproximal end portion512a(FIG. 15) of theactuation shaft512 and/or the proximal sleeve1764 (FIG. 69) can be fixedly secured (e.g., with a fastener, adhesive, etc.) to therelease knob1756. As best shown inFIG. 71, thedrive shaft1758 can have an axially extendinglumen1780 through which theactuation shaft512, thesleeves1762,1764, and theferrule1766 can extend. The lumen of thedrive shaft1758 can be sized and/or configured such that theactuation shaft512, thesleeves1762,1764, and theferrule1766 are movable (e.g., rotationally and axially) relative to thedrive shaft1758. This can be accomplished by forming thelumen1780 of thedrive shaft1758 with an at least slightly larger diameter than the diameter of theactuation shaft512, thesleeves1762,1764, and theferrule1766. Theproximal sleeve1764 and thedrive shaft1758 can be sized such that when the distal end portion of therelease knob1756 is disposed adjacent or contacting the proximal end portion of the actuation knob1712 (e.g., as shown inFIG. 62), the ferrule1766 (which is coupled to the distal end portion of the proximal sleeve1764) is disposed adjacent thedistal end portion1758bof thedrive shaft1758.
• From theferrule1766, thedistal sleeve1762 and theactuation shaft512 can extend distally through thesupport portion1718 of thehousing1704. As shown inFIGS. 64-65, theactuation shaft512 can extend distally through theactuation shaft lumen1748 of theshaft guide member1726 and into thesleeve1744. Thesleeve1744 and theactuation shaft512 can exit theport1743 of theshaft guide member1726, extend through theopening1742 of thestabilizer member1724, and through the actuation shaft lumen538 (FIG. 16) of theouter shaft520. As shown inFIG. 12, thedistal end portion512bof theactuation shaft512 can extend distally beyond thesleeve1744 and thedistal end portion520bof theouter shaft520 and can be threadably coupled to thedistal collar208 of theprosthetic spacer device200.
• With theactuation shaft512 of thedelivery apparatus502 coupled to thedistal collar208 of theprosthetic spacer device200, theactuation shaft512 can be releasably coupled to theanchor actuation mechanism1706 via therelease pin1760. This can be accomplished by inserting therelease pin1760 through awindow1782 of thesupport portion1718 of thehousing1704 such that therelease pin1760 engages theferrule1766, as shown inFIG. 62.
• Referring toFIGS. 68-69, therelease pin1760 and theferrule1766 can be configured so as to prevent relative movement (e.g., rotational and/or axial movement) therebetween when therelease pin1760 engages theferrule1766. For example, in some embodiments, theferrule1766 can comprise a first recessedportion1784 having a non-circular (e.g., rectangular, hexagonal, etc.) cross-sectional profile taken in a plane perpendicular to the longitudinal axis of the ferrule. The first recessedportion1784 can, in some instances, be referred to as “a flat.” Therelease pin1760 can have a first pair ofjaws1786 defining a non-circular first notch and configured for engaging a first recessedportion1784 of theferrule1766. Engagement between the non-circular surfaces of therelease pin1760 and theferrule1766 can prevent relative rotational movement between therelease pin1760 and theferrule1766. Engagement between the first pair of j aws1786 andshoulders1788 offerrule1766 can prevent relative axial movement between therelease pin1760 and theferrule1766.
• Referring still toFIGS. 68-69, theferrule1766 can optionally include a second recessedportion1790 having a circular cross-sectional profile taken in a plane perpendicular to the longitudinal axis of the ferrule. Therelease pin1760 can optionally have a second pair ofjaws1792 defining a circular second notch and configured for engaging the second recessedportion1790 of theferrule1766. Therefore, engagement between the second pair ofjaws1792 andshoulders1794 offerrule1766 can prevent relative axial movement between therelease pin1760 and theferrule1766. The circular configuration of the second recessedportion1790 and the second pair ofjaws1792 can, for example, improve the ability of therelease pin1760 and/or theferrule1766 to bear an axial load because the surface area on which the second pair ofjaws1792 contacts theshoulders1794 of theferrule1766 is relatively larger than the surface area on which first pair ofjaws1786 contacts theshoulders1788 of theferrule1766.
• Therelease pin1760 can also prevent relative rotational movement between theactuation shaft512 and thehousing1704 when the release pin is coupled to theferrule1766. This is because therelease pin1760 is disposed in aslot1796 of thesupport portion1718 of thehousing1704 that is defined bysurfaces1798. If a user tries to rotate theactuation shaft512 via therelease knob1756, therelease pin1760 contacts thesurfaces1798 of thehousing1704, which prevent therelease pin1760 rotating relative to thehousing1704. Thus, when therelease pin1760 is coupled to theferrule1766, therelease pin1760 prevents therelease knob1756 from being rotated relative to thehousing1704, which in turn prevents theactuation shaft512 from being released from theprosthetic spacer device200.
• Therelease pin1760 and therelease knob1756 prevent relative axial movement between theactuation shaft512 and thedrive shaft1758 when therelease pin1760 is coupled to theferrule1766. This is because the release knob1756 (which is coupled to theactuation shaft512 via the proximal sleeve1764) contacts theproximal end portion1758aof thedrive shaft1758, thereby preventing theactuation shaft512 from moving distally relative to thedrive shaft1758, and because the release pin1760 (which is coupled to theactuation shaft512 via the ferrule1766) contacts thedistal end portion1758bof thedrive shaft1758, thereby preventing theactuation shaft512 from moving proximally relative to thedrive shaft1758. As a result, theactuation shaft512 moves axially with thedrive shaft1758 when therelease pin1760 is coupled to theferrule1766. Moving thedrive shaft1758 distally relative to thehousing1704 urges thedistal end portion1758bof thedrive shaft1758 against therelease pin1760 and thus moves theactuation shaft512 distally (e.g., to open theanchors204 of the prosthetic spacer device200). Moving thedrive shaft1758 proximally relative to thehousing1704 urges theproximal end portion1758aof thedrive shaft1758 against therelease knob1756 and thus moves theactuation shaft512 proximally (e.g., to close theanchors204 of the prosthetic spacer device200).
• As thedrive shaft1758 and theactuation shaft512 move axially relative to thehousing1704, therelease pin1760 slides axially within theslot1796. In some embodiments, therelease pin1760 can be accessible to the user regardless of the axial position of therelease pin1760 relative to thehousing1704. In such embodiments, the user can remove therelease pin1760 from theferrule1766 at any time, which allows theactuation shaft512 to move independently of thedrive shaft1758. This can be accomplished, for example, by dimensioning thewindow1782 in the axial direction so that therelease pin1760 is accessible to the user regardless of the axial position of thedrive shaft1758.
• In other embodiments, thesupport portion1718 of thehousing1704 can be configured such that therelease pin1760 is accessible to the user at one or more predetermined locations relative to thehousing1704 and/or concealed from the user at one or more other locations. For example, in the illustrated embodiment, therelease pin1760 is accessible to the user (via thewindow1782 of the housing1704) and therefore removable only when the actuation shaft512 (via the drive shaft1758) are in one predetermined location relative to thehousing1704, as shown inFIG. 62. This is because thewindow1782 is only slightly larger than therelease pin1760. When theactuation shaft512 is in other axial positions relative to thehousing1704, therelease pin1760 is not aligned with thewindow1782 and thus concealed from the user by thehousing1704, as shown inFIGS. 70-71. In some embodiments, the predetermined location in which therelease pin1760 is accessible to the user can correspond to the proximal-most position of thedrive shaft1758. This position of the drive shaft corresponds to the position of theactuation shaft512 that places theanchors204 of theprosthetic spacer device200 in the fully closed configuration (e.g.,FIG. 25). In such embodiments, thehousing1704 therefore acts as an additional safeguard to reduce the likelihood that the user will release theactuation shaft512 from the prosthetic spacer device200 (by pulling therelease pin1760 and rotating the release knob1756) before theanchors204 of theprosthetic spacer device200 are secured to the native leaflets of the patient's heart.
• Referring toFIG. 72, theclasp actuation mechanism1708 can include one ormore clasp actuators1701, one ormore clasp tubes1703, and one or more locking members1705 (e.g., stopcocks). For example, in the illustrated embodiment, there are two of each of theclasp actuators1701, theclasp tubes1703, and thelocking members1705. These respective components are individually referred to as “17XXa” or “17XXb” (e.g., afirst clasp actuator1701aand asecond clasp actuator1701b) and collectively as “17XX” (e.g., the clasp actuators1701). As best shown inFIG. 62, distal end portions of theclasp tubes1703 can be movably coupled to the shaft guide member1726 (FIG. 64) and extend proximally from themain body1716 of thehousing1704 generally parallel to thesupport portion1718 of thehousing1704. Theclasp actuators1701 can be fixedly coupled to proximal end portions of theclasp tubes1703. The lockingmembers1705 can be fixedly coupled to theclasp actuators1701.
• Referring toFIG. 72 andFIGS. 64-65, each of the clasp control members524 (only one shown inFIG. 72 in order to show other features of the clasp actuators1701) can form a loop that extends through from arespective clasp actuator1701, through arespective locking member1705, through a lumen (not shown) of theclasp actuator1701, through arespective clasp tube1703, through a respectiveclasp control lumen1746 of theshaft guide member1726, through arespective sleeve1740, through a respective lumen540 (FIG. 16) of theouter shaft520, through an opening238 (FIG. 15) of arespective clasp206 of theprosthetic spacer device200, and then return back to theclasp actuator1701 following the same general path but in reverse order (though the ends of eachclasp control member524 passes through adifferent lumen540 of theouter shaft520, as further described above).
• The lockingmembers1705 can be used to secure theclasp control members524 and their tension relative to theclasp actuation mechanism1708. As such, moving the clasp actuators distally decreases tension on the clasp control members524 (which closes theclasps206 of the prosthetic spacer device200), and moving the clasp actuators proximally increases tension on the clasp control members524 (which opens theclasps206 of the prosthetic spacer device200).
• Referring toFIG. 70, theclasp actuators1701 can also includeretention members1709 that are configured to engage holdingelements1711 disposed on thesupport portion1718 of thehousing1704. Theretention members1709 and the holdingelements1711 can be configured to selectively retain theclasp actuators1701 in the proximal position, which corresponds to the open position of theclasps206 of theprosthetic spacer device200. These features can help prevent theclasps206 from inadvertently closing, for example, due to the tension on theclasp control members524 caused by the bias of theclasps206 toward closed position which may cause theclasp actuators1701 to move distally or due to a user accidentally pushing theclasp actuators1701 distally.
• The first andsecond clasp actuators1701a,1701bcan be selectively coupled together (e.g., with the pin1713) such that the clasp actuators can be moved together (e.g., when thepin1709 is inserted through the clasp actuators) or individually (e.g., when thepin1709 is removed from the clasp actuators).
• In some embodiments, thesupport portion1718 of thehousing1704 can also have astopper1715 disposed at the proximal end of thesupport portion1718, as shown inFIG. 70. Thestopper1715 can, for example, limit movement of theclasp actuators1701 in the proximal direction. Referring toFIG. 72, in certain embodiments, thestopper1715 can have anopening1717 formed therein. Theopening1717 can be configured for receiving and storing thepin1713 when thepin1713 is removed from the clasp actuators1701 (e.g., for individual clasp actuation).
• Theclasp actuators1701 can also include one or more optional features configured for securing the ends of theclasp control members524 to theclasp actuators1701 and/or for releasing the ends of theclasp control members524 from theclasp actuators1701.
• For example, as shown inFIG. 72, eachclasp actuator1701 can have one ormore ridges1719 withnotches1721 formed therein and/or one ormore bosses1731 with channels extending therethrough. One end of theclasp control members524 can extend from arespective locking member1705, through a channel of theboss1731, and through thenotches1721. In this manner, the channel and thenotches1721 can act as guides for theclasp control members524. This can, for example, reduce the likelihood that theclasp control members524 will become entangled with another component of the handle1700 (e.g., the locking members1705). Eachclasp actuator1701 can also have a plurality of spaced-apart openings1723 (e.g., two in the illustrated embodiment) with a post1707 therebetween. In this manner, one end of each of theclasp control members524 can be wrapped around and secured (e.g., tied) to the post1707 of arespective clasp actuators1701.
• The other end of each of theclasp control members524 can extend from arespective locking member1705 and can be coupled (e.g., tied) to thepin1713. Each of theclasp actuators1701 can have an access point (e.g., a slot1725) for accessing a respectiveclasp control member524 in order to release it from theclasp actuator1701. The access point can be disposed between the coupling location (e.g., the openings1723) and the lockingmember1705. As a result, theslot1725 can, for example, provide a location in which the user can access and cut theclasp control member524 with a cutting tool such as a scalpel.
• Theclasp control members524 can be secured to theclasp actuators1701 and/or thepin1713 in various other ways, such as with adhesive, clips, knots, and/or other securing means.
• It should be noted only one clasp control member524 (which is coupled to theclasp actuator1701a) is shown inFIG. 72. This is to better illustrate theridges1719,notches1721,openings1723, andslots1725 of theclasp actuator1701b, which can also have anotherclasp control member524 coupled to and extending therethrough.
• FIGS. 73-75 show an exemplary embodiment of aclasp positioning tool1800 being used, optionally, with thehandle1700. Theclasp positioning tool1800 can be used, for example, to position a clasp actuation mechanism of a handle at a predetermined position relative to an anchor actuation mechanism of the handle while a user removes slack and sets the tension in clasp control members. As such, theclasp positioning tool1800 can help to ensure consistent and precise tension in the clasp control members.
• Although theclasp positioning tool1800 described herein as being used with thehandle1700, theclasp positioning tool1800 can be used and/or adapted for use with various other handles (including thehandles522,700,1500, and/or1600) and/or the handles can be adapted for use with theclasp positioning tool1800.
• Referring toFIG. 73, theclasp positioning tool1800 can include amain body1802 and one or more projections1804 (e.g., two in the illustrated embodiment) extending from themain body1802. Generally speaking, themain body1802 can be configured for releasably coupling theclasp positioning tool1800 to thehousing1704 and for positioning theanchor actuation mechanism1706 relative to thehousing1704, and theprojections1804 can be configured for releasably coupling theclasp positioning tool1800 to theclasp actuation mechanism1708 and for positioning theclasp actuation mechanism1708 relative to thehousing1704.
• Themain body1802 of theclasp positioning tool1800 can comprise afirst opening1806 formed in a side portion and asecond opening1808 formed in a proximal end portion. Thefirst opening1806 can be configured to provide access to themode selector button1714 of thehandle1700, as shown inFIG. 74. Thesecond opening1808 can be configured such that thedrive shaft1758 of theanchor actuation mechanism1706 can extend therethrough and such that theactuation knob1712 cannot extend therethrough, as also shown inFIG. 74. In this manner, themain body1802 can limit movement of theactuation shaft1758 in the distal direction when theactuation knob1712 abuts the proximal end of themain body1802 adjacent thesecond opening1808.
• Referring again toFIG. 73, themain body1802 can include a lip orshoulder1810 that is spaced from the proximal end of themain body1802. The lip orshoulder1810 can be configured to engage the proximal end of thesupport portion1718 of thehousing1704. Accordingly, thelip1810 can limit movement of theclasp positioning tool1800 relative to thehousing1704 in the distal direction.
• Referring toFIG. 75, themain body1802 can also have one ormore flange portions1812 that extend radially inwardly. Theflange portions1812 can be configured for releasably coupling theclasp positioning tool1800 to thehandle1700, as further described below.
• Theprojections1804 can extend outwardly (e.g., vertically in the orientation shown inFIG. 75) from theflange portions1812 of themain body1802. Theprojections1804 can be configured to extend intoopenings1727 of thelocking members1705 of theclasp actuation mechanism1708. In this manner, theprojections1804 can limit movement of theclasp actuators1701 relative to thehousing1704 in distal direction.
• To provide access to theopenings1727 of thelocking members1705 of thehandle1700, thesupport portion1718 of thehousing1704 can haverecesses1729 formed therein, as best shown inFIG. 63. Therecesses1729 can be axially aligned with thewindow1782 of thehousing1704.
• Theclasp positioning tool1800 can be coupled to thehandle1700 by axially aligning the openings1727 (FIG. 63) of thelocking members1705 with therecesses1729 of thehousing1704 and by moving theactuation mechanism1706 distally such that therelease pin1760 is not aligned with thewindow1782 of thehousing1704, as shown inFIG. 73. Theprojections1804 of theclasp positioning tool1800 can then be inserted into theopenings1727, as shown inFIG. 74. Theclasp positioning tool1800 can be secured or locked to the handle1700 (e.g., for shipping) by moving theactuation mechanism1706 proximally such that therelease pin1760 is aligned with thewindow1782 of thehousing1704 and thus with theflanges1812 of theclasp positioning tool1800, as shown inFIG. 73. In the locked configuration, therelease pin1760 prevents theclasp positioning tool1800 from being removed from theopenings1727 of thelocking members1705 because therelease pin1760 obstructs one of therecesses1729 of thehousing1704 and contacts one of theflanges1812 of theclasp positioning tool1800. Although not shown, when theactuation knob1712 is aligned with thewindow1782, theactuation knob1712 is spaced from the proximal end of theclasp positioning tool1800.
• As mentioned above, thehandle1700 can be a part of a delivery apparatus (e.g., thedelivery apparatus502,1404), which, together with a prosthetic spacer device (e.g., theprosthetic spacer device200,1402), can form at least part of a delivery assembly. An exemplary method of assembling the delivery assembly and using thehandle1700 and theclasp positioning tool1800 are described below.
• Theclasp control members524 of thedelivery apparatus502 can be coupled to theclasps206 of theprosthetic spacer device200 by looping theclasp control members524 through theopenings234 of the clasps206 (seeFIG. 15). Theclasp control members524 can be secured to thehandle1700 via the lockingmember1705 and the clasp actuators1701 (seeFIG. 72). At this point, theclasps206 of theprosthetic spacer device200 can be opened and closed by moving theclasp actuators1701 proximally and distally, respectively. Theouter shaft520 ofdelivery apparatus502 can be coupled to theproximal collar210 of theprosthetic spacer device200 via thecoupler514 andactuation shaft512 of the delivery apparatus (seeFIGS. 12-14). Theactuation shaft512 of thedelivery apparatus502 can be coupled to thedistal collar208 of theprosthetic spacer device200 by inserting thedistal end portion512bof theactuation shaft512 into thebore226 of thedistal collar208 and rotating therelease knob1756 in a first direction (e.g., clockwise) relative to the prosthetic spacer device200 (seeFIGS. 14 and 62). At this point, theanchors204 of theprosthetic spacer device200 can be opened and closed by moving therelease knob1756 distally and proximally, respectively.
• With thedelivery apparatus502 and theprosthetic spacer device200 releasably coupled together, theactuation shaft512 can be releasably coupled to theanchor actuation mechanism1706 of thehandle1700. This can be accomplished, for example, with at least some of the following acts. Theactuation knob1712 can be positioned such that thedistal end portion1758bof thedrive shaft1758 is disposed proximal relative to thewindow1782 of the housing1704 (seeFIG. 62). This can be achieved by rotating theactuation knob1712 in the first direction (e.g., clockwise) relative to thehousing1704 and/or by pressing themode selector button1714 and moving theactuation knob1712 proximally relative to thehousing1704. The ferrule1766 (which is coupled to theactuation shaft512 and the release knob1756) can be exposed from thelumen1780 of thedrive shaft1758 and axially aligned with thewindow1782 of thehousing1704 by positioning the distal end of therelease knob1756 adjacent the proximal end of theactuation knob1712. With thedrive shaft1758 and theferrule1766 in this position, therelease pin1760 can be coupled to theferrule1766 by inserting therelease pin1760 through thewindow1782 of the housing1704 (seeFIG. 62) and urging thejaws1786,1792 of therelease pin1760 over the respective recessedportions1784,1790 of the ferrule1766 (seeFIG. 68). With therelease pin1760 coupled to theferrule1766, the actuation shaft512 (and thus theanchors204 of the prosthetic spacer device200) moves axially with thedrive shaft1758 of theanchor actuation mechanism1706.
• Once theactuation shaft512 is coupled to theanchor actuation mechanism1706, rotating theactuation knob1712 in a second direction (e.g., counterclockwise) relative to thehousing1704 and/or pressing themode selector button1714 and moving theactuation knob1712 distally relative to thehousing1704 results in theanchors204 moving toward the open configuration (seeFIG. 20). Rotating theactuation knob1712 in the first direction (e.g., clockwise) relative to thehousing1704 and/or by pressing themode selector button1714 and moving theactuation knob1712 proximally relative to thehousing1704 results in theanchors204 moving toward the closed position (seeFIG. 25).
• Theclasp positioning tool1800 can be coupled and secured to thehandle1700 as described above (seeFIGS. 73-75). An assembly comprising the delivery apparatus, the prosthetic spacer device, and theclasp positioning tool1800 can be packaged and/or delivered to a user in this configuration.
• To prepare the delivery assembly for implantation, the user can remove slack and/or adjust the tension of theclasp control members524 with theclasp positioning tool1800. This can be accomplished by moving thedrive shaft1758 of thehandle1700 distally from proximal-most position (which is used to secure theclasp positioning tool1800 to thehandle1700 due to therelease pin1760 axially aligning with theflange1812 of theclasp positioning tool1800 until the distal end of theactuation knob1712 contacts the proximal end of theclasp positioning tool1800. This can be accomplished by rotating theactuation knob1712 in the second direction (e.g., counterclockwise) relative to thehousing1704 and/or pressing themode selector button1714 and moving theactuation knob1712 distally relative to thehousing1704. This moves theanchors204 of theprosthetic spacer device200 from the fully closed configuration (e.g.,FIG. 25) to an at least partially open configuration (e.g.,FIG. 23). With theanchors204 in this position, the user can open the lockingmembers1705 of theclasp actuation mechanism1708 and remove slack and/or otherwise adjust the tension of theclasp control members524. The users can then retain the desired tension on theclasp control members524 by closing thelocking members1705, which prevents theclasp control members524 from moving relative to theclasp actuation mechanism1708 of thehandle1700. Both of the first end portions of theclasp control members524 can then be coupled (e.g., tied) to thepin1713 of the clasp actuation mechanism1708 (seeFIG. 72). Each of the second end portions of theclasp control members524 can be coupled to arespective clasp actuator1701 by positioning theclasp control member524 in thenotches1721, looping theclasp control member524 throughopenings1723, and tying theclasp control member524 to itself. Securing the end portions of theclasp control members524 can, for example, reduce the risk that theclasp control members524 will be released from theclasps206 even if thelocking members1705 are opened. Separating the ends of eachclasp control member524 from each other (i.e., by tying one end to theclasp actuators1701 and the other end to the pin1713), can make it easier to cut the clasp control members524 (e.g., during the release procedure).
• Theclasp positioning tool1800 can be removed from thehandle1700 by withdrawing theprojections1804 of theclasp positioning tool1800 from theopenings1727 of thehandle1700 and by removing themain body1802 from thehousing1704 of thehandle1700.
• Theflushing mechanism1710 can be used to flush the delivery assembly (e.g., with a saline solution).
• Theprosthetic spacer device200 can be positioned in the delivery configuration by moving theactuation knob1712 and theclasp actuators1701 to the distal-most position. This elongates theanchors204 and closes the clasps206 (seeFIG. 20).
• Theprosthetic spacer device200, which is coupled to the third catheter508 (FIG. 11), can be inserted through the first andsecond catheters504,506 (seeFIG. 11) and positioned adjacent an implantation location (seeFIG. 20). Thecatheters504,506,508 (including the handle1700) can be used to position theprosthetic spacer device200 relative to native heart valve leaflets (seeFIGS. 20-22).
• At the implantation location, theanchor actuation mechanism1706 of thehandle1700 can be used to manipulate theanchors204 of theprosthetic spacer device200 between the elongate, delivery configuration (e.g.FIG. 20), a positioning configuration (e.g.,FIG. 22), and a leaflet-capture configuration (e.g.,FIG. 23). Rotating theactuation knob1712 in the first direction (e.g., clockwise) relative to thehousing1704 and/or pressing themode selector button1714 and moving theactuation knob1712 proximally relative to thehousing1704 closes theanchors204, and rotating theactuation knob1712 in the second direction (e.g., counterclockwise) relative to thehousing1704 and/or pressing themode selector button1714 and moving theactuation knob1712 distally relative to thehousing1704 opens theanchors204.
• With theanchors206 of theprosthetic spacer device200 positioned behind respective native leaflets, theclasp actuation mechanism1708 of thehandle1700 can be used to manipulate theclasps206 of theprosthetic spacer device200 between the closed configuration (e.g.,FIGS. 20-22 shows theclasps206 in the closed configuration) and the open configuration (e.g.,FIG. 23 shows theclasps206 in the open configuration) to capture the native leaflets within arespective clasp206. Moving theclasp actuators1701 proximally relative to thehousing1704 opens theclasps206 of theprosthetic spacer device200. Moving theclasp actuators1701 distally relative to thehousing1704 closes theclasps206 of theprosthetic spacer device200. Positioning theclasp actuators1701 such that theretention members1709 of theclasp actuators1701 are disposed proximally relative to the holdingelements1711 of thehousing1704 retains theclasp actuators1701 in the proximal-most position, which retains theclasps206 of theprosthetic spacer device200 in the open configuration. Lifting theclasp actuators1701 over the holdingelements1711 of thehousing1704 and moving theclasp actuators1701 from the proximal-most position allows theclasp actuators1701 to move freely relative to the housing, which allows opening and closing of theclasps206 of theprosthetic spacer device200. Both clasps206 of theprosthetic spacer device200 can manipulated simultaneously when theclasp actuators1701 are coupled together by the pin1713 (FIG. 72). Eachclasp206 of theprosthetic spacer device200 can be manipulated independently when thepin1713 is removed from theclasp actuators1701.
• Once the native leaflets are captured withinrespective clasps206 of theprosthetic spacer device200, theanchor actuation mechanism1706 of thehandle1700 can be used to manipulate theanchors204 of theprosthetic spacer device200 from the leaflet-capture configuration (e.g.,FIGS. 23-24) to a closed configuration (e.g.,FIG. 25). This can be accomplished by rotating theactuation knob1712 in the first direction (e.g., clockwise) relative to thehousing1704 and/or pressing themode selector button1714 and moving theactuation knob1712 proximally relative to thehousing1704. This in turn draws the native leaflets inwardly toward thespacer member202 of theprosthetic spacer device200, as shown inFIG. 25.
• The user can re-open theanchors204 and/or theclasps206 to reposition and/or retrieve theprosthetic spacer device200 by manipulating theanchor actuation mechanism1706 and/or theclasp actuation mechanism1708.
• Once thespacer device200 is implanted at the desired location, the user can release the delivery apparatus from theprosthetic spacer device200. One aspect of the release procedure is releasing theclasp control members524 from theclasps206. This can be accomplished by opening thelocking members1705 of thehandle1700. The user can cut the second end portions of theclasp control members524 free from theirrespective clasp actuator1701 by inserting a scalpel into the slots1725 (FIG. 62) of theclasp actuators1701 and into contact with theclasp control members524. The user can then pull on the first end portions of theclasp control members524 at least until the second end portions withdraw from theopenings234 of theclasps206 of theprosthetic spacer device200.
• A second aspect of the release procedure is releasing thedistal end portion512bof theactuation shaft512 from thedistal collar208 of theprosthetic spacer device200. This can be accomplished by moving theactuation knob1712 to the proximal-most position relative to thehousing1704. This axially aligns therelease pin1760 with thewindow1782 of thehousing1704, which ensures that theanchors204 of theprosthetic spacer device200 are in the fully closed configuration. The user can grasp therelease pin1760 and separate it from theferrule1766 by withdrawing it through thewindow1782 of thehousing1704. With therelease pin1760 removed, theactuation shaft512 and thus therelease knob1756 can rotate relative to the housing and can move proximally relative to thehousing1704, thedrive shaft1758, and theactuation knob1712. The user can therefore remove theactuation shaft512 from thedistal collar208 of theprosthetic spacer device200 by rotating therelease knob1756 of thehandle1700 in the second direction (e.g., counterclockwise) relative to thehousing1704.
• A third aspect of the release procedure is releasing theouter shaft520 from theproximal collar210 of theprosthetic spacer device200. This can be accomplished by moving therelease knob1756 of thehandle1700 proximally until thedistal end portion512bof theactuation shaft512 is disposed proximal to thecoupler514 of the delivery apparatus and then moving thehousing1704 of the handle1700 (and thus the outer shaft520) proximally relative to theprosthetic spacer device200.
• With the delivery apparatus released from theprosthetic spacer device200, thecatheters504,506,508 of thedelivery apparatus504 can be removed from the patient.
• 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, the features of theprosthetic spacer device100 can be combined with theprosthetic spacer device200, and vice versa. As another example, any one or more of the features of a handle of a delivery apparatus (e.g., thehandles522,700,1500,1600, and/or1700) can be combined with any one or more of the features of another handle.
• In view of the many possible embodiments to which the principles of the disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims (20)

1. A delivery system comprising:

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

a first clasp control member that extends into the distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

a second clasp control member that extends into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising

a first side portion connected to the first clasp control; and

a second side portion connected to the second clasp control;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally pulls both the first clasp control member and the second clasp control member, and such that when the first side portion and the second side portion are uncoupled, individual proximal movements of the first side portion and the second side portion independently pull the first clasp control member and the second clasp control member, respectively.

2. The delivery system ofclaim 1 wherein the first clasp control member comprises a suture.

3. The delivery system ofclaim 1 wherein the first side portion and the second side portion are releasably connected by a pin.

4. The delivery system ofclaim 1 wherein the first side portion and the second side portion are constrained to proximal and distal movement relative to one another when the first side portion and the second side portion are released.

5. The delivery system ofclaim 1 wherein the first clasp control member extends through a first control member lumen in the handle, and the second clasp control member extends through a second control member lumen in the handle.

6. The delivery system ofclaim 5 wherein at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

7. The delivery system ofclaim 1 wherein the elongate shaft is flexible.

8. The delivery system ofclaim 1 further comprising an anchor actuation shaft in a lumen of the elongate shaft, wherein the anchor actuation shaft extends out of the proximal portion of the elongate shaft, and wherein the anchor actuation shaft extends out of the distal portion of the elongate shaft.

9. A delivery assembly comprising:

a first clasp that is moveable between an open position and a closed position, wherein the first clasp is configured to be securable to a first native valve leaflet by moving the first clasp from the open position to the closed position of the first clasp;

a first clasp control member coupled to the first clasp, wherein applying tension to the first clasp control member moves the first clasp to the open position;

a second clasp that is moveable between an open position and a closed position, wherein the second clasp is configured to secure a second native valve leaflet by moving the second clasp from the open position to the closed position of the second clasp;

a second clasp control member coupled to the second clasp, wherein applying tension to the second clasp control member moves the second clasp to the open position;

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

wherein the first clasp control member extends from the first clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

wherein the second clasp control member extends from the second clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising

a first side portion connected to the first clasp control member; and

a second side portion connected to the second clasp control member;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally tensions both the first clasp control member and the second clasp control member to move both the first and second clasps to the open position, and such that when the first side portion and the second side portions are uncoupled, individual proximal movements of the first side portion and the second side portion individually tension the first clasp control member and the second clasp control member to independently open the first and second clasps, respectively.

10. The delivery assembly ofclaim 9 wherein the first clasp control member comprises a suture.

11. The delivery assembly ofclaim 9 wherein the first side portion and the second side portion are releasably connected by a pin.

12. The delivery assembly ofclaim 9 wherein the first side portion and the second side portion are constrained to proximal and distal movement relative to one another when the first side portion and the second side portion are released.

13. The delivery assembly ofclaim 9 wherein the first clasp control member extends through a first control member lumen in the handle, and the second clasp control member extends through a second control member lumen in the handle.

14. The delivery assembly ofclaim 13 wherein at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

15. The delivery assembly ofclaim 9 wherein the elongate shaft is flexible.

16. The delivery assembly ofclaim 9 wherein the first clasp and the second clasp are coupled to a spacer.

17. The delivery assembly ofclaim 9 further comprising an anchor actuation shaft in a lumen of the elongate shaft, wherein the anchor actuation shaft extends out of the proximal portion of the elongate shaft, and wherein the anchor actuation shaft extends out of the distal portion of the elongate shaft.

18. A delivery assembly comprising:

a pair of anchors that are moveable between an open position and a closed position;

an anchor actuation shaft operably coupled to the pair of anchors;

a first clasp that is moveable between an open position and a closed position;

a first clasp control member coupled to the first clasp configured such that applying tension to the first clasp control member moves the first clasp to the open position;

a second clasp that is moveable between an open position and a closed position, a second clasp control member coupled to the second clasp configured such that applying tension to the second clasp control member moves the second clasp to the open position;

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

wherein the anchor actuation shaft extends into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and into the handle;

wherein axial movement of the anchor actuation shaft relative to the elongate shaft moves the pair of anchors between the open position and the closed position;

wherein the first clasp control member extends from the first clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

wherein the second clasp control member extends from the second clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising:

a first side portion connected to the first clasp control member; and

a second side portion connected to the second clasp control member;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally tensions both the first clasp control member and the second clasp control member to move both the first and second clasps to the open position, and such that when the first side portion and the second side portions are uncoupled, individual proximal movements of the first side portion and the second side portion individually tension the first clasp control member and the second clasp control member to independently open the first and second clasps, respectively.

19. The delivery assembly ofclaim 18 wherein the first clasp control member extends through a first control member lumen in the handle, the second clasp control member extends through a second control member lumen in the handle, and at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

20. The delivery assembly ofclaim 18 wherein the first clasp control member extends through a first control member lumen in the handle;

wherein the second clasp control member extends through a second control member lumen in the handle;

wherein the anchor actuation shaft extends through an anchor actuation shaft lumen in the handle;

wherein a first portion of the first control member lumen is parallel to the anchor actuation shaft lumen; and

wherein a second portion of the first control member lumen extends at an angle relative to the anchor actuation shaft lumen.

Images