Deployment restraint and delivery system for implantable cardiac device

Abstract

Features for a restraint, such as a cap, are described. The restraint secures a cardiac device in a collapsed delivery configuration for transcatheter delivery to the heart. The restraint may have a tubular sidewall extending from a proximal end to a distal end; a proximal opening defined by the sidewall at the proximal end; and a channel defined by the sidewall and extending distally from the proximal opening. The restraint is configured to receive an implant in the collapsed configuration through the proximal opening to radially constrain the implant within the channel. Among other advantages, the restraint eliminates the need for a surrounding sheath, thereby reducing the delivery profile and size of the overall delivery system. The restraint may have an atraumatic leading edge to reduce the risk of injury to the patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is an international application of and claims the benefit of priority to U.S. Provisional Application Serial No. 62 / 699,887, filed on July 18, 2018, and entitled “Deployment Constraint and Delivery System for Implantable Cardiac Devices,” the entire contents of which are expressly incorporated herein by reference. Technical Field

[0003] The present technology generally relates to implantable arterial medical devices. In particular, features are described for an apparatus for constraining an implant that reduces the cross-sectional profile of a delivery system to, among other things, enable non-invasive delivery of a medical implant through its delivery system, its channels, and the patient's anatomy. Background Art

[0004] Heart valve insufficiency is a serious problem. For example, heart disease can cause the heart chambers to dilate and weaken. With specific reference to the mitral valve, due to aging or disease, the left ventricle dilates and the papillary muscles are displaced. As a result, the mitral valve annulus over-dilates. In this dilated state, the valve leaflets may no longer be able to close or coapt effectively during contraction of the heart. As a result, blood regurgitation (or reverse flow back through the valve that should be closed) occurs during ventricular contraction and reduces cardiac output.

[0005] This condition can be addressed by surgical placement of an implant. This procedure is performed open-heart and is time consuming. In open-heart surgery, the patient undergoes extracorporeal circulation, which has associated risks of morbidity and mortality due to stroke, thrombosis, heart attack, and prolonged recovery time.

[0006] Therefore, improvements in this area are desired. Summary of the invention

[0007] The embodiments disclosed herein each have several aspects, no single one of which is solely responsible for the desirable attributes of the invention. Without limiting the scope of the invention, its more salient features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description of the Invention," it will be understood how the features of the embodiments described herein provide advantages over existing systems, devices, and methods for delivering cardiac implants.

[0008] The following disclosure describes non-limiting examples of some embodiments. For example, other embodiments of the disclosed systems and methods may include or not include the features described herein. In addition, the disclosed advantages and benefits apply only to certain embodiments and should not be used to limit the present invention.

[0009] A deployment restraint is described that can be used with a variety of implants. For example, an annuloplasty ring implant can be used to address heart valve insufficiency. The implant can be delivered via transcatheter delivery. The implant can be delivered minimally invasively or percutaneously, such as transfemoral, transseptal. The implant can be a mechanical device that can extend from the dilated ring of a heart valve to engage tissue of the heart valve annulus and gather it to a smaller diameter. The annular implant is typically compressed and maintained in its compressed state by a sheath for delivery to the valve site. When the sheath is withdrawn, the annular implant returns to its expanded diameter to engage the dilated ring and is then reduced in size to reconfigure the valve annulus to a smaller diameter, thereby reducing and / or eliminating regurgitation.

[0010] However, in practice, the combination of the delivery system, sheath and guide catheter presents a large profile relative to the patient anatomy that it must traverse. It would be preferable to reduce the profile of the overall system.

[0011] A deployment restraint, such as a cap, is described. Among other advantages, the restraint disclosed herein eliminates the need for a surrounding sheath, thereby reducing the size of the overall system. The restraint may also have an atraumatic leading edge to reduce the risk of injury to the patient.

[0012] In one aspect, a delivery system for an implantable cardiac device is described. The system includes an implant and a restraint. The implant has a distal end and a proximal end, and a collapsed configuration and an expanded configuration. The restraint is configured to restrain the distal end of the implant to secure the implant in its collapsed configuration for delivery to an implantation site.

[0013] In some embodiments, the delivery system also includes a delivery catheter and a tether. The delivery catheter has a proximal end, a distal end, and at least one passage extending therethrough. The implant is positioned adjacent to the distal end of the delivery catheter and is constrained in a collapsed configuration by a restraint. The tether is connected to the restraint and extends through the passage of the delivery catheter to the proximal end of the delivery catheter. Manipulating the tether causes the restraint to be advanced distally from the implant and release the implant from the collapsed configuration.

[0014] In some embodiments, the restraint is recessed inwardly to receive the distal end of the implant in its collapsed configuration. The implant can take the form of an annular member having an upper vertex at its proximal end and a lower vertex at its distal end, and the restraint can be recessed inwardly to receive the lower vertex of the annular member when the implant is in its collapsed configuration. The restraint can have a shaped leading edge to reduce trauma to the patient's anatomical structure during the delivery of the implant. The delivery system can also include a guide catheter, in which the delivery system, the implant, and the restraint pass.

[0015] In some embodiments, the restraint may also include a distal front portion, a middle portion, and a proximal cuff portion. The distal front portion of the restraint may be shaped in a circular manner to reduce trauma to the patient's anatomical structures. The proximal cuff portion may be shaped so as to be tapered radially inwardly in a shaped configuration to assist in retracting the unconstrained configuration of the implant into the guide catheter. The restraint may be configured to surround the distal end of the implant.

[0016] In another aspect, the restraint comprises a tubular sidewall, a proximal opening and a passage. The tubular sidewall extends from the proximal end to the distal end. The proximal opening is defined by the sidewall at the proximal end. The passage is defined by the sidewall and extends distally from the proximal opening. The restraint is configured to receive an implant in a collapsed configuration through the proximal opening to radially constrain the implant in the passage. The restraint can be used with various transcatheter delivery systems to deliver implants.

[0017] In some embodiments, the restraint also includes a distal wall at the distal end of the restraint. The proximal end of the restraint may include a series of proximally extending tabs that define a series of gaps between adjacent tabs. The tabs may be configured to extend proximally in a loaded configuration to receive an implant and to tilt radially inward in a set, e.g., heat set configuration, after receiving the implant.

[0018] In some embodiments, the delivery system includes an implant, which includes a tubular frame, an axis and a collar. The tubular frame has a proximal end, a distal end and a central channel extending through it. The frame includes a first pair of adjacent pillars combined at a proximal vertex. The shaft is carried by the proximal vertex, the shaft extends along the axis of rotation and has an external thread, and the shaft is configured to rotate around the axis of rotation. The collar is carried by the frame and has an opening extending axially through it, in which the shaft is received. The collar has a complementary surface structure for engaging the external thread of the shaft, and the collar is configured to at least partially surround the first pair of adjacent pillars. Rotation of the shaft around the axis of rotation in a first rotational direction advances the collar toward the distal end of the frame along the first pair of adjacent pillars to reduce the angle between the first pair of adjacent pillars.

[0019] In some embodiments, the delivery system includes an implant wherein rotation of the shaft about the rotation axis in a second rotational direction opposite the first rotational direction advances the collar distally along the first pair of struts to allow an increase in the angle between the first pair of adjacent struts.

[0020] In some embodiments, the delivery system includes an implant including an anchor coupled to a frame, the anchor configured to engage tissue of the mitral annulus. The frame may include a second pair of adjacent struts joined at a distal apex, wherein the anchor is coupled to the distal apex. The anchor may be a helical anchor.

[0021] In some embodiments, the delivery system includes an implant, which includes a tubular frame, a shaft and a collar. The tubular frame includes a first pair of adjacent pillars joined at a vertex. The shaft is carried by the frame and extends along the axis of rotation, and the shaft has a radial engagement structure. The collar is carried by the frame and at least partially surrounds the first pair of adjacent pillars, and the collar has an internal complementary surface structure for engaging the radial engagement structure of the shaft. Rotation of the shaft about the axis of rotation advances the collar along the first pair of pillars to change the angle between the first pair of adjacent pillars.

[0022] In another aspect, a method of delivering an implantable cardiac device to a valve annulus includes the steps of percutaneously delivering a delivery catheter to an implantation site, the delivery catheter having a proximal end and a distal end, and at least one passage extending therethrough, the delivery catheter including an implant positioned proximal to the distal end of the delivery catheter, wherein a restraint coupled to the delivery catheter by a tether restrains the implant in a collapsed configuration. The method includes manipulating one of the implant or the tether to advance the restraint distally of the implant to release the implant from the collapsed configuration. In some embodiments, the method also includes retracting the restraint proximally through the implant and the delivery catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] According to the following description and the appended claims in conjunction with the accompanying drawings, the foregoing and other features of the present invention will become more apparent. It should be understood that these drawings only depict several embodiments according to the present invention and should not be considered to limit its scope, and the present invention will be described with additional specificity and detail by using the drawings. In the following specific embodiments, reference is made to the drawings that form a part thereof. In the drawings, similar symbols generally identify similar components unless otherwise indicated by the context. The illustrative embodiments described in the specific embodiments, drawings and claims are not meant to be restrictive. Other embodiments may be utilized and other changes may be made without departing from the spirit and scope of the subject matter described herein. It will be readily understood that, as generally described herein and shown in the drawings, the various aspects of the present invention may be arranged, replaced, combined and designed in various different configurations, all of which may be clearly anticipated and constitute a part of this description.

[0024] Figure 1A is a side view of an embodiment of a constraint after the constraint has been advanced distally by a push wire to release the implant.

[0025] Figure 1B yes Figure 1A Proximal view of the restraint.

[0026] Figure 1C It is possible to Figure 1A A proximal end view of another embodiment of a constraint for use with an implant.

[0027] Figure 2A and Figure 2B 1 are sequential side views of the implant in a collapsed configuration loaded into the proximal end of the constraint of FIG. 1 .

[0028] Figure 3 is a perspective view of another embodiment of a restraint having a proximally extending tab and shown in a shaped configuration.

[0029] Figure 4 having proximally extending tabs that expand radially to receive the implant in a collapsed configuration Figure 3 Side view of the restraint.

[0030] Figure 5A is a partial perspective view of an embodiment of a delivery system for delivering a cardiac implant, the system having a sheath to constrain the implant during delivery to the heart.

[0031] Figure 5B is like Figure 5A The view taken along line 5B-5B shown in Figure 5A A cross-sectional view of the system.

[0032] Fig. 6A is a partial perspective view of an embodiment of a delivery system for delivering a cardiac implant, the system having an embodiment of a constraint and a reduced size guide catheter.

[0033] Figure 6B is like Fig. 6A Taken along line 6B-6B shown in Fig. 6A A cross-sectional view of the system.

[0034] Figure 7 is a perspective view of an embodiment of an exemplary implant having a frame, collar, and anchor for reshaping a heart valve annulus that may use the constraints disclosed above.

[0035] Figure 8 is a perspective view of an embodiment of an implant having a rotatable threaded shaft for use with an axially translatable collar according to aspects disclosed herein.

[0036] Fig. 9 is a perspective view of an embodiment of an implant having a rotatable threaded shaft for use with an axially translatable collar at the distal end of a frame and an anchor and housing assembly according to aspects disclosed herein.

[0037] Figures 10A to 10E are sequential perspective views of an embodiment of a delivery system with imaging capabilities illustrating embodiments of methods for delivering, positioning, and anchoring various implants that may use embodiments of the constraints described herein. DETAILED DESCRIPTION

[0038] The following detailed description relates to certain specific embodiments of the development. In this specification, reference is made to the accompanying drawings, in which, for clarity, the same parts or steps may be represented by the same numbers. References to "one embodiment", "embodiment" or "in some embodiments" throughout the specification indicate that the specific features, structures or characteristics described in conjunction with the embodiment are included in at least one embodiment of the present invention. The phrases "one embodiment", "embodiment" or "in some embodiments" appearing in various places in the specification do not necessarily all refer to the same embodiment, nor are they necessarily separate or alternative embodiments that are mutually exclusive with other embodiments. In addition, various features that may be exhibited by some embodiments but not by other embodiments are described. Similarly, various requirements are described, which may be requirements of some embodiments but may not be requirements of other embodiments. Reference will now be made in detail to embodiments of the present invention, examples of which are shown in the accompanying drawings. Whenever possible, the same reference numerals will be used in all drawings to refer to the same or similar parts.

[0039] A deployment constraint is described that can be used with various implants. For example, an annuloplasty ring implant can be used to address heart valve insufficiency. The implant can be delivered via transcatheter delivery. The surgeon positions the implant proximate to the valve annulus, secures it in place and adjusts the implant to restore the valve annulus to approximately its native configuration to restore valve leaflet function.

[0040] The implant can be delivered minimally invasively (e.g., transapical) or percutaneously, such as transfemoral, transseptal. The implant can also be surgically implanted. In addition, it should be appreciated that the implant can be deployed to treat mitral or tricuspid insufficiency.

[0041] The implant can be a mechanical prosthetic device that can extend around the expansion ring of the heart valve, thereby engaging the tissue of the heart valve ring and gathering it to a smaller diameter. More specifically, the prosthesis can be a "ring-shaped" design, in which the ring-shaped member can be formed by a shape memory material. The ring-shaped member can extend beyond the distal end of the delivery catheter. The sheath can surround the delivery catheter and extend beyond the distal end of the delivery catheter. The ring-shaped implant can be compressed and maintained in its compressed state by the sheath to be delivered to the valve site. When the sheath is withdrawn, the ring-shaped implant returns to its expanded diameter as formed to engage the expansion ring. An anchor is then advanced from the ring-shaped member to penetrate the tissue of the heart valve ring. Subsequently, the ring-shaped prosthesis is forced to reduce in size. This reconfigures the valve ring to reduce it to a smaller diameter, thereby reducing and / or eliminating regurgitation.

[0042] However, in practice, the combination of the delivery system, sheath and guide catheter presents a large profile relative to the patient anatomy that it must traverse. It would be preferable to reduce the profile of the overall system.

[0043] This article describes a restraint that can be used with various implants. For example, the restraint can be used with the implant described later below. Figure 7 1 to 12. As another example, the restraint can be used with an implantable device that is delivered proximate to and above the heart valve (tricuspid or mitral) annulus. The implant is then implanted in the annular heart tissue just above the plane of the valve orifice. Details of some embodiments of implants, such as annular implantable heart valve annuloplasty rings or prostheses, are described in, for example, U.S. Patent Application No. 15 / 352,288, entitled "Implantable Device and Delivery System for Reshaping the Heart" and filed on November 15, 2016, and U.S. Provisional Patent Application No. 62 / 457,441, entitled "Implantable Device and Delivery System for Reshaping the Heart Valve Annulus," filed on February 10, 2017, the disclosures of each of which are incorporated herein by reference in their entirety and form a part of this specification.

[0044] Figure 1A is a side view of an embodiment of the constraint 100 after the constraint 100 has been advanced distally by a push wire 110 or other form of tether to release the implant 10 . Figure 1B is a proximal end view of the constraint 100. The implant 10, which may be an annular member or a prosthesis, may have a series of struts 12, a proximal apex or upper crown 14, and a distal apex or lower crown 16. The implant 10 may be formed of a metal alloy, such as a nickel-titanium alloy. The distal apex 16 may have an anchor attachment interface, such as a plurality of circular openings, to rotatably receive a helical anchor therethrough to engage tissue proximate the valve annulus.

[0045] The implant 10 may have an upper or proximal apex 14 that forms a window for receiving a threaded shaft. The threaded shaft may be secured to a collar (e.g., as shown below) mounted on the apex 14. Figure 7 12) threaded engagement. The collar can be threadedly advanced by rotating the threaded shaft to advance the collar axially along the post 12 to change the angle of the post, as further described below.

[0046] The restraint 100 may include a sidewall 102 extending from a proximal end 104 to a distal end 106. The sidewall 102 may be tubular. The tubular may include circular, round, segmented, polygonal, closed shapes, other suitable shapes, or combinations thereof. The sidewall 102 may extend longitudinally about an axis. The axis may be concentric with the sidewall 102. The sidewall 102 may include an extrusion of PEEK, PEBAX, polyethylene, nylon, or other known catheter shaft materials, or may include a metal tube, such as stainless steel or a titanium alloy. In some embodiments, the sidewall 102 may be rigid, semi-rigid, soft, other types of materials, or combinations thereof.

[0047] The constraint 100 may include an opening 108 at the proximal end 104. The opening 108 may be defined by the proximal end of the side wall 102. The opening 108 may be configured to receive the implant 10 therein, wherein the implant 10 is in a collapsed delivery configuration. The constraint 100 may include an end wall 112 at the distal end 106. The end wall 112 may close the distal end 106 of the constraint 100. The proximal surface of the end wall 112 may serve as a stop surface that the implant 10 contacts when the implant 10 is fully inserted into the constraint 100. Depending on the desired performance, the distal surface of the end wall 112 may include an atraumatic nose cone.

[0048] The restraint 100 may include a channel 116 such as Figure 1B The passage 116 may be an opening extending distally through the restriction 100 from the proximal opening 108. The passage 116 may extend from the opening 108 to the end wall 112.

[0049] like Figure 1A As shown, the restraint 100 may include a leading edge 114 at the distal end 106. The edge 114 may be at the intersection of the side wall 102 and the end wall 112. The edge 114 may be rounded in a side view, as shown. In some embodiments, the collar 114 may be rounded, beveled, other rounded shapes, other suitable shapes, or combinations thereof. The edge 114 may provide an atraumatic distal end 106 of the restraint 100. The restraint 100 may have a "bullnose" distal end 106. The atraumatic distal end 106 may reduce the risk of injury when releasing the restraint 100 distally. The atraumatic tip may assist in advancing the delivery system through the patient's anatomy to minimize damage to cardiac structures, such as the left atrium.

[0050] The push wire 110 can be integral with the constraint 100 and can be manually manipulated to advance (or retract) the constraint 100. The wire 110 can have sufficient compressive stiffness (column strength) to apply a distal force to the implant 10 to advance the constraint 100 distally from the distal end of the implant 10. If desired, the wire 110 can be cannulated (e.g., a hypotube) to allow for injection of medication.

[0051] Figure 1C 1 is a proximal end view of an embodiment of a constraint 100A having a plurality of internal recesses 118. As shown, the constraint 100A may have an internal recess 118 for receiving the distal apex 16 ( Figure 1A ). The recesses 118 may be along the inner surface 103 or the surface of the sidewall 102. There may be a plurality of recesses 118, which are spaced circumferentially along the sidewall 102 and extend in the axial direction. There may be at least two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen or more recesses 118. The radially inwardly protruding ridges of the inner surface 103 may extend between adjacent recesses 118. The ridges of the inner surface 103 may be appropriately sized to allow the implant 10 to be securely inserted into the constraint 100.

[0052] The sidewall 102 can provide a radially inward reaction force as a reaction to the radially outward force from the collapsed implant 10. Therefore, the sidewall 102 can provide sufficient radial resistance or rigidity to fix the implant 10 in the collapsed configuration. The sidewall 102 can have a fixed shape. In some embodiments, the sidewall 102 can be flexible or conformable.

[0053] In some embodiments, the sidewall 102 may include an annular band or ring of material configured to secure the distal end of the implant 10 with or without the end wall 112. For example, the restraint 100 may be an axially shortened sidewall 102 having an axial length of only about 1 cm, only about 5 mm, or 3 mm, or less, which surrounds only a short axial portion of the distal end of the implant 10. The implant 10 may have a sufficiently rigid strut 12 that only a portion of the distal end of the implant 10 is constrained to maintain the implant 10 in a collapsed configuration. The ring may be attached to the push wire 110 by solder, crimping, or threaded engagement with the end wall 112 or with the sidewall 102. The push wire 110 may be advanced distally to advance the ring distally and release the implant 10.

[0054] Figure 2A and Figure 2B 1 is a sequential side view of the implant 10 in its collapsed configuration loaded into the proximal end 104 of the constraint 100. The implant 10 is compressed in the collapsed delivery configuration. Figure 2B 10, the distal end or distal apex 16 of the implant 10 is received through the opening 108 and into the passage 116 within the restraint 100. The restraint 100 secures the implant 10 in a substantially collapsed state, such as Figure 2BThe push wire 110 can be manipulated and advanced axially distally, thereby moving the constraint 100 axially and distally away from the implant 10, thereby removing the restraining force on the implant 10 to allow it to return to its expanded shape, similar to Figure 1A The shapes shown in .

[0055] In some embodiments, when the restraint 100 is advanced distally, the implant 10 can be fixed to prevent it from being advanced distally. For example, the implant 10 can be fixed by a delivery catheter or a releasable tether. In some embodiments, the restraint 100 is configured to slide away from the fixed implant 10 with a specific force applied distally to overcome the frictional force in the proximal direction acting on the inner surface 103 of the restraint 100 by the radially outward force of the implant 10. In some embodiments, the restraint 100 can be released from the implant 10 by retracting the implant 10 proximally while advancing the restraint 100 distally or maintaining the axial position of the restraint 100.

[0056] After the implant 10 is released from the restraint 100, the restraint 100 may remain in a distal position relative to the implant 10, such as Figure 1A . In some embodiments, the restraint 100 can be advanced further distally, for example, into the ventricle. In some embodiments, the restraint 100 can be retracted proximally so as not to interfere with implantation of the implant 10. The restraint 100 can be retracted proximally through the expanded implant 10. The restraint 100 can be retracted by advancing the push wire 110 proximally back into the delivery catheter.

[0057] Figure 3 1 is a perspective view of another embodiment of a restraint 120. The restraint 120 may have the same or similar features and / or functions as the restraint 100, 100A, and vice versa. The restraint 120 may be made of a shape memory nickel-titanium alloy. Figure 3 The restraint 120 is shown in a heat set or shaped configuration. The restraint 120 may have Figure 3 The proximal extending tab 142 shown in the shaped configuration extends proximally from the proximal end of the sidewall 102. The restraint 120 includes a distal end 130 and a proximal end 140. The distal end 130 can have an atraumatic rounded distal portion or leading edge. The proximal end 140 can have a proximally grooved and tapered cuff portion. The proximal end 140 can include a series of tabs 142 extending proximally and radially biased inwardly to produce a conical proximal end surface. The tabs 142 can be separated by gaps 144 between adjacent tabs 142. There can be at least two, four, six, eight, ten, twelve or more tabs 142 and a corresponding number of gaps 144.

[0058] Figure 41 is a side view of a restraint 120 having a radially expanded proximally extending tab 142. Tab 142 can be expanded to receive implant 10 in a collapsed configuration through proximal opening 108. Restraint 120 can receive distal end or distal apex 16 ( Figure 1A After the restraint 120 is displaced distally from the implant 10, the proximal end 140 may return to Figure 3 This shape can, for example, assist in retracting the constraint 10 through the implant 10 and into the delivery guide catheter by reducing the risk of the constraint 120 hooking on the implant 10, thereby facilitating guiding the constraint 120 back into the delivery catheter, etc.

[0059] The constraints 100, 100A, 120 provide a number of advantages. For example, as more clearly shown in and described with respect to Figures 5 and 6, the constraints reduce the overall profile (eg, diameter) of the delivery system, and more specifically the guide catheter.

[0060] Figure 5A is a partial perspective view of an embodiment of a delivery system 501 for delivering a cardiac implant. Figure 5B It is along the system 501 Figure 5A The system 501 includes a sheath 510 to constrain the implant 10 during delivery of the implant 10 to the heart. The system 501 includes a delivery catheter 520 having a series of channels 522 that accommodate drivers 524 for actuating the anchors and / or collars of the implant, as described below with respect to Figures 7 to 9 Further described. The sheath 510 extends distally beyond the delivery catheter 520 and the driver 524, thereby surrounding the delivery catheter 520 and the implant 10, which is connected to the driver 524 and extends distally beyond the delivery catheter 520. The sheath 510 is used to constrain the implant 10 during delivery of the implant 10 to the implantation site adjacent to the heart valve ring. Due to the presence of the sheath 510, a guide catheter 500 with a sufficiently large width can be used to accommodate the delivery catheter 520 and the sheath 510. In some embodiments, the guide catheter 500 is a 33 French delivery catheter.

[0061] Fig. 6A is a partial perspective view of an embodiment of a delivery system 601 for delivering a cardiac implant. Figure 6B It is along the system 601 Fig. 6A A cross-sectional view taken at section 6B-6B of FIG. Figure 5A and Figure 5B Compared to system 501, system 601 utilizes the deployable restraints and reduced size guide catheters described herein. Fig. 6A and Figure 6BAs shown, the delivery system 601 includes a push wire 110, which can be attached to the constraint 100 and used to constrain the implant instead of the sheath 510. Here, the push wire 110 extends through the central channel 521 of the delivery catheter 520. The constraint 100 constrains the implant 10 ( Figure 1A ), thereby making the sheath 510 unnecessary. In this regard, a smaller width catheter 600, such as a 28 French guide catheter, can now be used to advance the delivery catheter 520, push wire 110, and constraint 100 from outside the patient's body and into the patient's atrium. Thus, the constraint can significantly reduce the overall diameter of the guide catheter, for example, by more than 15% or more. Any of the constraints described herein can be used with the system 601, such as constraint 100, 100A, or 120, etc.

[0062] The discrete nature of the deployable restraint 100, 100A, or 120 also allows for easier navigation within the channel of the guide catheter and the patient's anatomy, including the bends and turns of the atrium. It is also within the scope of the present invention that one or more tethers (push wires, etc.) may be incorporated into the system to move the restraint 100, 100A, or 120. The tethers may be contained in one or more channels of the delivery catheter, for example, as described above.

[0063] Figures 7 to 9 Various implants are shown that may include constraints as described in various embodiments herein to secure the implant during deployment. Figure 7 is a perspective view of an embodiment of an implant 700 having a frame, collar, and anchor for reshaping a heart valve annulus that may utilize the constraints disclosed above. Figure 7 , implant 700 is an implantable device. Implant 700 forms a cavity or opening 703 extending through implant 700. For description, a geometric reference longitudinal axis is shown. Implant 700 can now be described with reference to this axis. Unless otherwise specified, "axial" refers to movement roughly parallel to the axis in an upward or downward direction. Opening 703 extends axially between the upper portion 702 of implant 700 and the lower portion 704 of implant 700. The upper and lower portions 702, 704 may include various features of implant 700. The terms "upper", "upward", etc. refer to a direction generally toward the upper or proximal end 702, and the terms "lower", "downward", etc. refer to a direction generally toward the lower or distal end 704, unless otherwise specified. "Proximal" refers to a direction in an upward direction, and "distal" refers to a direction in a downward direction. The terms "interior", "inward", etc. refer to a direction generally toward the axis, and the terms "exterior", "outward", etc. refer to a direction generally away from the axis. Unless otherwise stated, these geometric references are generally applicable, either explicitly or as indicated by the context.

[0064] Implant 700 includes a frame 710. The frame 710 extends circumferentially around an axis and extends axially along a portion of the axis. The axis can be defined by the frame 710. The frame 710 is generally symmetrical with respect to the axis. However, the frame 710 does not need to be symmetrical with respect to the axis. The frame 710 has a generally tubular shape. "Tubular" includes circular, as well as other circular or other closed shapes. The frame 710 is generally circular around the axis. The frame 710 can be circular, round, elliptical, segmented, other shapes or combinations thereof. The frame 710 can change shape, size, configuration, etc. The frame 710 can have various shapes, sizes, configurations, etc. at various stages of use, for example, before delivery, during delivery, after engagement with tissue, after the contraction ring, after contraction, during use when implanted, etc.

[0065] Implant 700 includes one or more struts 712. The struts 712 can form all or part of the framework 710. The struts 712 are elongated structural members. The struts 712 and / or other parts of the framework 710 are formed of metal alloys. The struts 712 and / or other parts of the framework 710 can be formed of nickel-titanium alloys. In some embodiments, the struts 712 and / or other parts of the framework 710 are formed of other metals, metal alloys, plastics, polymers, composite materials, other suitable materials or combinations thereof. There are sixteen struts 712. In some embodiments, there can be less than or more than sixteen struts 712. In some embodiments, there can be at least two, four, six, eight, ten, twelve, fourteen, eighteen, twenty, twenty-two, twenty-four, twenty-six, twenty-eight, thirty or more struts 712.

[0066] Pillar 712 can be a part of the same whole piece of material (e.g., tube blank). Therefore, pillar 712 can refer to different parts of the same expansion assembly. Pillar 712 can be formed by the same piece of material. Pillar 712 can be formed separately and permanently attached together, for example, by welding, etc. In some embodiments, pillar 712 can be a separate component that is detachably connected together by other components of implant 700. For example, pillar 712 can be kept together via various components described herein, such as collar 718, anchor 720, other features or combinations thereof. In some embodiments, a separate pillar unit can include two or more pillars such as permanently attached together at the apex, and a separate unit can be permanently or detachably connected together to form frame 710. In some embodiments, pillar 712 can be attached by hinges, pins or other suitable means.

[0067] The elongated middle portion of the strut 712 has a generally rectangular cross-section, but may vary in circumferential width and radial thickness to allow for different beam properties and forces applied as the collar is advanced. As further described, this may facilitate, for example, post-implantation tightening or remodeling of the ring. The long ends of the rectangular cross-section of the strut 712 extend along the circumference of the frame 710. Unless otherwise specified, "circumference" as used herein generally refers to a perimeter or boundary, and may refer to a circular or other circular or non-circular path located in a plane substantially transverse to an axis. The short ends of the rectangular cross-section of the strut 712 extend transversely to the circumference of the frame 710. In some embodiments, other morphologies and / or cross-sectional shapes of the strut 712 may be achieved. The cross-section may be circular, perfectly circular, other shapes, or a combination thereof.

[0068] The pillars 712 extend around the axis to form various shapes of the frame 710. The pillars 712 are arranged so that the wall pattern of the frame 710 can be approximately sinusoidal or zigzag. In some embodiments, the wall pattern can have other suitable shapes, sinusoidal or other shapes. The apex of the sinusoidal frame 710 can be pointed or rounded.

[0069] Pairs of adjacent struts 712 meet at apex. At least a first pair of adjacent struts 712 meet at an upper apex or crown 714 of the upper portion 702 of the implant 700. At least a second pair of adjacent struts 712 meet at a lower apex or crown 716 of the lower portion 704 of the implant 700. The terms "apex", "plural apex", etc. can be used interchangeably with the terms "crown", "plural crowns", etc., as used herein and as used in any reference incorporated herein by reference, unless otherwise noted. The upper crown and lower crowns 714, 716 are sequentially spaced apart along the circumference of the framework 710, wherein one of the upper crowns 714 is followed by one of the lower crowns 716, followed by another in the upper crown 714, etc. In the illustrated embodiment, there are eight upper crowns 714 and eight lower crowns 716. In some embodiments, there may be only about six or four or fewer or more than eight or ten or twelve upper and lower crowns 714, 716, depending on the number of struts 12 and the number of vertices formed.

[0070] The upper crowns 714 are each configured to have a restraint, such as a collar 718, which fits over and / or around the upper crown 714. Thus, the upper crown 714 can include various features, dimensions, etc. as described herein for coupling with the collar 718, as further described. The upper crown 714 is shown partially Figure 7 The upper end of the upper crown 714 can be relative to its Figure 7The position in the implant 700 is moved distally toward the lower portion 704 to expose the upper crown. In some embodiments, one or more of the upper crowns 714 may not have a collar 718. In some embodiments, less than all of the upper crowns 714 are configured to receive the collar 718. In some embodiments, all of the upper crowns 714 may be configured to receive the collar 718, but when implanted, only some of the upper crowns 714 actually include the collar 718.

[0071] At least two and preferably at least four or six or all of the lower crowns 716 are configured to be coupled to anchors 720. Anchors 720 are movably coupled to the lower crowns 716. Anchors 720 engage cardiac tissue (e.g., annuli) to secure implant 700 to the tissue, as described above. Movement of anchors 720 relative to the lower crowns 716 allows anchors 720 to penetrate the tissue. The lower crowns 716 may include various engagement features to allow such movement of anchors 720, such as flanges and / or openings 717. The lower crowns 716 each include a series of openings 717 extending through the lower crowns 716. The openings 717 extend axially in two spaced columns along the lower crowns 716. The openings 717 in each column are alternatively located in the axial direction, as shown, to accommodate receiving anchors 720 therein. Other configurations and / or spacings of openings 717 may be achieved. For clarity, Figure 7 Only some of the openings 717 are marked in FIG. The openings 717 are shown as circular holes. Other shapes of openings 717 can be realized.

[0072] The openings 717 of the lower crowns 716 are configured to rotatably receive the helical segments of the corresponding anchors 720, so that the anchors extend sequentially through the openings 717 when the anchors 720 are moved relative to the struts 712 and when the anchors 720 are fixed relative to the struts 712, as further described herein. In some embodiments, features other than the openings 717 or in addition to the openings 17 can be used to couple the anchors 720 with the corresponding lower crowns 716. In some embodiments, less than all of the upper crowns 716 can be configured to couple with the anchors 720. Thus, one or more of the lower crowns 716 can lack the openings 717 and / or other features for coupling with the anchors 720. In some embodiments, all of the lower crowns 16 can be configured to couple with the anchors 720, but when implanted, only some of the lower crowns 716 actually include the anchors 720.

[0073] The struts 712 can be reconfigured around the upper and lower crowns 714, 716. Pairs of adjacent struts 712 that meet at the upper and lower crowns 714, 716 can be angularly moved relative to each other. This movement can be described as the rotation or pivoting of adjacent struts 712 around the corresponding upper or lower crowns 714, 716. For example, two adjacent struts 712 forming the upper crown 714 can be moved so that the struts 712 effectively rotate relative to each other around the upper crown 714. For example, two adjacent struts 712 forming the lower crown 716 can be moved so that the struts 712 effectively rotate relative to each other around the lower crown 716. The "rotation" of the struts 712 as described includes, for example, clamping the struts 712 together by distal advancement of the collar 718. Therefore, the adjacent struts 712 may not include actual rotatable hinges, pins, or other rotational features. The struts 712 moving closer to reduce the angle between them is described as the "closing" of the struts 712. Moving the struts 712 further apart to increase the angle therebetween is described as “opening” of the struts 712 .

[0074] In the case of no external force applied to the pillar 712, the pillar 712 can be biased into the cross-sectional form of the expansion. External circumferential compression force is applied to the pillar 712 (for example, with the collar 718) so that the pillar 712 moves angularly, for example, to close. In the case of circular implant 700, the movement of the pillar 712 in this closed manner also reduces the perimeter (for example, diameter) of the implant 700. In its free and unconstrained state, the framework 710 can be in an expanded form. Applying a compression circumferential force causes the perimeter of the framework 710 to reduce. The removal or reduction of the circumferential force allows the framework 710 to open. By moving the collar 718 further downward or upward in the axial direction, the circumferential force can be increased or reduced, as further described herein. After axially translating the crown 714 downward, the collar 718 can be locked in place to fix the implant 700 at a specific width.

[0075] The implant 700 includes one or more restraints, such as a slider or collar 718. The terms "collar," "collars," and the like may be used interchangeably with the terms "slider," "sliders," "sliding member," and the like, as used herein and as used in any reference incorporated herein by reference, unless otherwise indicated. Figure 7As shown in , the implant 700 includes eight collars 718. In some embodiments, there may be fewer or more than eight collars 718. The number of collars 718 may correspond to the number of upper crowns 714. In some embodiments, there may be fewer collars 718 than upper crowns 714. Thus, in some embodiments, some upper crowns 714 of the frame 710 may not include collars 718. The collars 718 may translate axially due to an axially applied force. The collars 718 may translate axially due to engagement with the central axis of rotation, as described below with respect to Figure 8 described.

[0076] The collar 718 is coupled to the corresponding upper crown 714. The collar 718 can be mounted above the upper crown 714. The collar 718 forms an inner opening at least partially through it, and when the collar 718 is mounted above the upper crown 714, the upper crown 714 is received in the inner opening. The collar 718 can have a rectangular profile as shown. In some embodiments, the collar 718 can have other profiles, for example, round, segmented, polygonal, other suitable shapes or combinations thereof. As shown, the profile of the collar 718 can be a closed shape, or it can be an open shape, such as a "C" shape. Therefore, the collar 718 at least partially surrounds the corresponding upper crown 714. As shown, the collar 718 completely surrounds the corresponding upper crown 714. In some embodiments, the collar 718 may not completely surround the upper crown 714. The collar 718 engages with the upper crown 714.

[0077] The collar 718 can engage with circumferentially opposite sides of the upper crown 714 and / or adjacent struts 712. The collar 718 engages with the upper crown 714 and can be pushed downwardly above the upper crown 14 to angularly move the corresponding pairs of adjacent struts 712 toward each other. The collar 718 can apply a compressive circumferential force to the struts 712 to cause the struts 712 to reduce the angle between the struts 712. The circumferential force can be applied inwardly to the struts 712 and toward the upper crown 714. Thus, the vertical force applied to the collar 718 can be converted into a circumferential force on the struts 712. "Circumferential" means that the direction of the force is along the outer perimeter or boundary of the frame 710 when viewed from the top or bottom of the frame 710, and is not meant to limit the shape of the frame 710 to a circle. The movement of the collar 718 on the struts 712 causes the struts 712 to move, for example, rotate, so that the angle between adjacent struts 712 is reduced. A first circumferential force can be applied to one of the struts 712 by the collar 718, and a second circumferential force opposite in direction to the first circumferential force can be applied to an adjacent strut 712 by the same collar 718. The further the collar 718 moves downward on the strut 712, the more the strut 712 moves and the more the angle decreases, which results in a decrease in the width, e.g., diameter, of the frame 710. Thus, due to the movement of the collar 718, the struts 712 move relative to each other around the upper crown 714. The collar 718 can be locked in place, e.g., with a locking tab 719. The collar 718 can include a locking tab 719. The locking tab 719 provides an engagement feature for engaging the collar 718 with the strut 712. After the collar 718 moves on the upper crown 714, the locking tab 719 locks the collar 718 in place on the upper crown 714. The locking tab 719 is biased toward the inner opening formed by the collar 718. The locking tab 719 can be shaped to present an inwardly oriented bias. The collar 718 and / or its features, such as the locking tab 719, are formed of a nickel-titanium alloy, such as Nitinol. In some embodiments, the collar 718 and / or its features, such as the locking tab 719, are formed of other materials, such as metals, other metal alloys, plastics, polymers, composite materials, other suitable materials, or combinations thereof. Further details of various embodiments of the collar 718 and its features, such as the locking tab 719, are described herein.

[0078] Therefore, collar 718 can provide one or more functions for implant 700. In some embodiments, collar 718 can tighten framework 710, as described. In some embodiments, framework 710 can be tightened by features in addition to collar 718 or as an alternative to collar 718, and collar 18 can constrain framework 710 in a tightened state. In some embodiments, collar 718 can therefore not tighten framework 710, but only constrain framework 710 in a tightened state. In some embodiments, collar 718 can tighten framework 710, and constrain framework 710 in a tightened state.

[0079] Implant 700 includes one or more anchors 720. In some embodiments, anchor 720 can be part of an anchor assembly, can include a distal helical portion and a proximal anchor head, and / or can include a proximal coupling, such as in Figure 8 As described in . Figure 7 The anchor 720 has an anchor head 722 attached to its upper or proximal end. Each anchor head 722 may include a support 724 and an engagement structure, such as a hook 726. The support 724 may be a cap portion on the upper end of the anchor 720. The support may be cylindrical. The support 724 may have a width sized to limit the axial advancement of the anchor 720, as described herein. The hook 726 is an elongated overhanging member. The hook 726 may provide engagement for a delivery tool. The hook 726 may interact with the delivery tool to rotate and axially advance the anchor 720. In some embodiments, features other than the hook 726 may be used, for example, an eyebolt.

[0080] The anchor 720 is made of a suitable biocompatible metal alloy, such as stainless steel, cobalt chromium, platinum iridium, nickel titanium, other suitable materials or a combination thereof. Each anchor 720 is sharpened at its distal point or leading end so as to penetrate into the cardiac tissue. The total axial length of each anchor 720 can be about ten to about fifteen millimeters (mm). In some embodiments, the total axial length of the anchor 720 can be shorter than or longer than ten to fifteen millimeters (mm). "Total" axial length refers to the axial length of the anchor 720 from the end of the distal puncture top to the proximal end relative to the head 722. The axial length of the spiral portion of the anchor 720, i.e., the length in the axial direction can be about six to twelve millimeters (mm). In some embodiments, the axial length of the spiral portion of the anchor 720 can be shorter than or longer than six to twelve millimeters (mm). The axial length of the anchor head 722 and / or other non-spiral portions of the anchor 720 can be about three to about four millimeters (mm). In some embodiments, the axial length of the anchor head 20 and / or other non-spiral portions can be shorter than or longer than three to four millimeters (mm). The anchors 720 can extend axially from about four to about seven millimeters (mm) beyond the corresponding lower crowns 716. For example, the helical portion of the anchor 720 can extend from four millimeters to seven millimeters (mm) into the heart tissue. As described above, the frame 710 is shown as having eight upper crowns 714 and eight lower crowns 716 and anchors 720, but for purposes of illustration, this number of vertices is shown and the number can vary, for example, four upper and lower vertices, sixteen upper and lower vertices, etc. In some embodiments, regardless of the number of vertices, each upper crown 714 is equipped with a collar 718 and each lower crown 716 has a corresponding anchor 720 threadedly received through the opening 717 of the anchor 720.

[0081] The anchor 270 is coupled to the lower crown 716. The anchor 720 can be generally helical in shape. As shown, the opening 717 receives the helically wound anchor 720. The openings 717 are spaced apart to accommodate the pitch of the helical anchor 720, for example, the spacing between turns in the helix of the anchor 720. There can be a gap between the inner diameter of the opening 717 and the outer diameter of the anchor 720 to allow the anchor 720 to move freely through the opening 717. There may be a small gap between the inner diameter of the opening 717 and the outer diameter of the anchor 720. In some embodiments, there may be an interference fit or a varying pitch between the opening 717 and the anchor 720 to provide interference between the anchor and the frame. In some embodiments, the anchor 720 may alternatively engage the anchor housing at the lower crown 716, as described below. Fig. 9 As described in .

[0082] Figure 8800, wherein the central lumen extends through the implant 800 along an axis, as shown. The implant 800 can be configured for catheter-based delivery. For example, in treating the mitral valve, a delivery catheter is inserted through a puncture in the femoral vein, after which the catheter is passed through the inferior vena cava, into the right atrium and through the septum separating the right atrium and the left atrium. The catheter is then directed distally toward the mitral annulus so that the distal end of the catheter and the implant 800 are aligned with the mitral annulus.

[0083] Implant 800 is shown as having a frame 810, which has a rotatable shaft 646 and a collar 818 that can be axially translated at a proximal vertex 814. The proximal ends of the rotatable shafts 646 each include a coupling 660, which is used to engage and rotate the shaft 646 by a driver or adjustment catheter. As further described herein, the rotation of the shaft 646 advances the collar 818 along the pillars 812 to change, for example, increase or decrease the angle between the pillars 812 to radially contract or expand the implant 800. Each distal vertex 816 includes a spiral anchor 820 that engages with an opening 817 of the corresponding distal vertex 816. Each anchor 820 includes a spiral portion 826A, a proximal portion 826B, and a distal portion 26C. The distal portion 826C can end at a top 826D. The top 826D can be a sharp point configured to pierce heart tissue. The coupling 824D is on the proximal end of the proximal portion 826B. The coupling 824D can be engaged and rotated by a driver or adjustment catheter to rotate the anchor 820 through the opening 817 and into the tissue. Each coupling 660 and 824D can be engaged and rotated by its own driver or adjustment catheter. Therefore, there may be a driver for each coupling 660, 824D. The collar 818 and anchor 820 are shown in a relatively proximal position and can be adjusted proximally or distally therefrom to achieve various changes in the frame 810. Figure 8 The implant 800 may have any of the same features as any other implant described herein, including but not limited to Figure 7 Implants 700, Fig. 9 Any of the same or similar features and / or functions of implant 900, and vice versa.

[0084] exist Figure 8Each collar 818 and eight shafts 864 are shown in FIG. There may be fewer or more collars 818 and shafts 646, for example, one collar 818 and one shaft 646, which are located at at least two or three or four or each proximal vertex of the frame 810. The threaded shaft 646 is positioned, for example, nested, fixed, retained, etc., within a portion of the frame 810 and located inside the collar 818. In some embodiments, in order to drive the collar 818 above the vertex formed by a pair of adjacent pillars 812, the threaded shaft 646 can be rotated inside the collar 818. The rotational motion of the threaded shaft 646 is transmitted from the external engagement features (such as threads) of the threaded shaft 646 to the corresponding internal features of the collar 818, such as internal threads or teeth, to cause axial movement of the collar 818. When the collar 818 moves distally, it moves the adjacent pillars 812 closer, which reduces the angle between the pillars 812 and causes the implant 800, such as the frame 810, to reduce the width, such as the diameter. The collar 818 can be held or substantially held rotationally fixed relative to the post 812. Thus, for example, the threaded shaft 646 can be rotated while being held axially fixed, and the collar 818 can be translated axially while being held rotationally fixed or substantially rotationally fixed. "Substantially rotationally fixed" means that the collar 818 can be rotated a certain amount before being resisted from further rotational movement, such as due to play between the collar 818 and the post.

[0085] Various modifications of implant 800 can be implemented. For example, in some embodiments, threaded shaft 646 can translate axially. In some embodiments, collar 818 can rotate. In some embodiments, collar 818 can rotate and move axially, while threaded shaft 646 remains rotationally and axially fixed. Mechanical communication between the external thread of threaded shaft 646 and the internal features (such as threads) of collar 818 can be direct communication, such as contact between corresponding threads and features. In some embodiments, mechanical communication can be indirect, such as having an intermediate structure such as a bushing, a coating, etc. between corresponding engagement features. According to the further details and description herein, these and other modifications to implant 800 are still within the scope of the present invention.

[0086] Fig. 9 9 is a perspective view of an implant 900 including a frame 910 formed of struts 912 and having a proximal end 902 and a distal end 904. As depicted, the proximal end 902 of the implant 900 includes a shaft 646 having a proximal coupling 660 and a collar 918 surrounding a pair of adjacent struts 914 at a proximal apex 914. The distal end 904 includes an anchor assembly including an embodiment of an anchor housing 922A and an anchor 920. Fig. 9, which shows the distal end 926A of the anchor 920 extending into and through the housing 922A. Rotation of the driver 924D at the proximal end of the anchor 920 causes the anchor 920 to translate axially through the housing 922A.

[0087] Housing 922A is coupled to distal apex 916 and receives anchor 920 therethrough. Collar 918 and anchor 920 are shown in a relatively proximal position and can be adjusted proximally or distally therefrom to achieve various changes in frame 910. Implant 900 can have the same or similar features and / or functions as any other implant described herein, including but not limited to implants 700 and / or 800, and vice versa.

[0088] exist Fig. 9 In the embodiment of the present invention, implant 900 supports multiple anchor assemblies, each anchor assembly includes anchor 920 and shell 922A. Implant 900 can have one or more in anchor assembly. As shown in the figure, there are eight anchor assemblies. There can be one, two, three, four, five, six, seven, nine, ten, eleven, twelve or more anchor assemblies. Each distal vertex 916 can have one in the anchor assembly. The shell 922A of the anchor assembly is connected to the distal end 904 of implant 900, such as being connected to the corresponding distal vertex 916, for example, being attached thereto.

[0089] The housing 922A can be a separate component attached to the frame 910, or the housing 922A can be integral with the frame 910, such as integral with the distal apex 916. The housing 922A is primarily located on the radially inward side of the distal apex 916. The housing 922A can be completely located on the radially inward side. The housing 922A extends from the apex 916 toward the central longitudinal axis of the implant 900. In some embodiments, the housing 922A can be primarily or completely located on the radially outer side of the distal apex 916.

[0090] Figures 10A to 10E 401 are sequential perspective views of an embodiment of a delivery system 401 with imaging capabilities illustrating an embodiment of a method for delivering, positioning, and anchoring various implants that may include the constraints described herein for resizing a native valve annulus. Figures 10A to 10EThe delivery of an implant 1 for resizing the annulus is depicted, but it should be understood that an implant for replacing a valve may also be delivered using system 410. Implant 1 can be delivered, positioned, and anchored to reshape the valve annulus. Implant 1 can be inserted using delivery system 401 via a blood vessel entering the leg, particularly the femoral vein or iliac vein. System 401 may include various implants, catheters, and other features described herein, such as implant 1, delivery catheter 240, intravascular cardiac echography (ICE) catheter 300, guidewire 306, etc. System 401 may include any of the implants described herein, for example, an implant including a valve annulus remodeling device or a valve replacement including valve leaflets. Fig. 10A The implant in the embodiment may be loaded in a compressed state in a delivery catheter, such as Figure 2B as shown in .

[0091] like Fig. 10A As shown in FIG. 4 , the system 401 is then advanced across the septum separating the upper chambers of the heart. The ICE catheter 300 is advanced to a position above the heart valve annulus, for example, the mitral valve annulus, such as Fig. 10B as shown in . Fig. 10C The implant 1 is shown ejected from the distal end of the delivery system 401 above and adjacent to the mitral annulus, for example, after release of a restraining member, such as in Figure 1A A series of radial images are taken to properly position the anchor 20 for insertion into the mitral annular tissue, such as Fig. 10D Then, a circumferential image is captured, such as Fig.10E , to confirm that all anchors 20 are properly placed and anchored in the mitral annulus tissue above the mitral valve leaflets. If one or more anchors 20 are not properly positioned or anchored, they can be rotationally retracted, repositioned, and re-anchored before removing the drive tube. In addition, circumferential images can be taken prior to anchoring to confirm the position of the lower crown 16 of the implant 1. It should also be understood that treatment of the tricuspid valve can involve inserting the system 401 for access through the jugular vein, whereby the system is advanced along the superior vena cava and into the right atrium adjacent to and above the tricuspid annulus.

[0092] Various modifications to the embodiments described in the present invention will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the spirit and scope of the present invention. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but to the widest scope consistent with the claims, principles and novel features disclosed herein. The word "example" is specifically used herein to mean "used as an example, instance or illustration". Unless otherwise specified, any embodiment described herein as an "example" is not necessarily to be interpreted as being more preferred or advantageous than other embodiments.

[0093] Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments, either individually or in any suitable subcombination. Moreover, although the above features may be described as functioning in a certain combination and even initially claimed as such, in some cases one or more features derived from a claimed combination may be removed from that combination, and a claimed combination may be directed to a subcombination or variation of a subcombination.

[0094] Similarly, although operations are depicted in a particular order in the accompanying drawings, this should not be understood as requiring that such operations be performed in the particular order shown or in sequence, or that all of the operations shown be performed to achieve the desired results. Additionally, other implementations are also within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve the desired results.

[0095] Those skilled in the art will understand that, in general, the terms used herein are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "comprising" should be interpreted as "including but not limited to," etc.). Those skilled in the art will further understand that if a specific number in an introduced claim recitation is intended, such intent will be expressly stated in the claim, and in the absence of such statement, no such intent exists. For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of these phrases should not be construed as implying that a claim recitation introduced by the indefinite article "a" or "an" will limit any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be construed to mean "at least one" or "one or more"); this is also true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number in an introduced claim recitation is explicitly stated, those skilled in the art will recognize that such recitation should generally be construed to mean at least one of the stated numbers (e.g., a mere recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). Moreover, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, such a construction is generally intended to allow those skilled in the art to understand that the two recitations are intended to be specific to the claim recitation. In some embodiments, the present invention relates to a system that is used to define the meaning of the convention (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having only A, only B, only C, A and B, A and C, B and C, and / or A, B, and C, etc.). In addition, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, such a structure is generally intended so that one skilled in the art will understand the meaning of the convention (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having only A, only B, only C, A and B, A and C, B and C, and / or A, B, and C, etc.). One skilled in the art will further understand that virtually any transitional word and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both of the terms. For example, the phrase "A or B" would be understood to include the possibility of "A" or "B" or "A and B".

Claims

1. A delivery system for an implantable cardiac device, the delivery system comprising: an implant having a distal end and a proximal end, the implant having a collapsed configuration and an expanded configuration; as well as a restraint having a tubular sidewall defining an opening configured to receive a distal end of the implant, the tubular sidewall configured to surround the distal end of the implant in a collapsed configuration for delivery to an implantation site, The tubular sidewall defines an inner surface surrounding the distal end of the implant and having a plurality of axially extending recesses each configured to receive the distal end of the implant.

2. The delivery system according to claim 1, further comprising: a delivery catheter having proximal and distal ends and at least one passageway extending therethrough, wherein the implant is positioned proximate the distal end of the delivery catheter and is restrained in the collapsed configuration by the restraint; as well as A tether is connected to the restraint and extends through the at least one passageway of the delivery catheter to the proximal end of the delivery catheter, whereby manipulation of the tether advances the restraint distally of the implant and releases the implant from the collapsed configuration. The delivery system of claim 1 , wherein the plurality of recesses are circumferentially spaced apart.

4. A delivery system according to claim 3, wherein the implant includes an annular member having an upper apex at its proximal end and a lower apex at its distal end, and the restraint is recessed inwardly to receive the lower apex of the annular member when the implant is in the collapsed form.

5. The delivery system of claim 1, wherein the restraint has a shaped leading edge to reduce trauma to a patient's anatomy during delivery of the implant.

6. The delivery system of claim 1 further comprising a guide catheter through which the delivery system, the implant, and the restriction are passed.

7. The delivery system of claim 5, wherein the restraint further comprises: distal anterior portion; middle part; as well as The proximal cuff portion, wherein the distal anterior portion of the restraint is shaped in a rounded manner to reduce trauma to the patient's anatomy, and The proximal cuff portion is shaped so as to taper radially inwardly in a shaped configuration to assist in retraction through an unconstrained configuration of the implant and into a guide catheter.

8. The delivery system of claim 1, wherein the constraint is configured to surround a distal end of the implant.

9. The delivery system of claim 1, wherein: The tubular sidewall extends from the proximal end to the distal end; said opening defined by said tubular sidewall being defined at said proximal end of said tubular sidewall; The tubular sidewall defines a passage extending distally from a proximal opening, and The constraint is configured to receive the implant in the collapsed configuration through the proximal opening to radially constrain the implant within the passageway.

10. The delivery system of claim 9, wherein the restriction further comprises a distal wall located at a distal end of the restriction.

11. The delivery system of claim 10, wherein the proximal end of the restriction comprises a series of proximally extending tabs defining a series of gaps between adjacent tabs.

12. The delivery system of claim 11, wherein the series of proximally extending tabs are configured to extend proximally in a loaded configuration to receive the implant and to angle radially inwardly in a shaped configuration after receiving the implant.

13. The delivery system of claim 1, wherein the implant further comprises: a tubular frame having a proximal end, a distal end, and a central passage extending therethrough; The tubular frame includes a first pair of adjacent struts joined at a proximal apex; a shaft carried by the proximal apex, the shaft extending along an axis of rotation and having external threads, the shaft being configured to rotate about the axis of rotation; as well as a collar carried by the tubular frame and having an opening extending axially therethrough to receive the shaft therein, the collar having a complementary surface structure for engaging the external threads of the shaft, the collar being configured to at least partially surround the first pair of adjacent struts, wherein rotation of the shaft about the rotation axis advances the collar along the first pair of adjacent struts to change an angle between the first pair of adjacent struts.

14. The delivery system of claim 13, the implant further comprising an anchor coupled to the tubular frame, the anchor configured to engage tissue of the mitral valve annulus.

15. The delivery system of claim 14, wherein the tubular frame includes a second pair of adjacent struts joined at a distal apex, wherein the anchor is coupled to the distal apex.

16. A deployment constraint for an implant, the constraint comprising: a tubular sidewall extending from the proximal end to the distal end; a proximal opening defined at the proximal end by the tubular sidewall; and a passage defined by the tubular sidewall and extending distally from the proximal opening, the passage being sized to receive the implant and receiving the distal end of the implant with the tubular sidewall extending around and surrounding the distal end of the implant; wherein the tubular side wall defines an inner surface surrounding the distal end of the implant and having a plurality of axially extending recesses, each of the plurality of recesses being configured to receive at least a portion of the implant in a collapsed form through the proximal opening so as to radially constrain the portion of the implant within the channel.

17. The deployment restraint of claim 16, wherein the restraint further comprises a distal wall located at a distal end of the restraint.

18. A deployment restraint according to claim 17, wherein the proximal end of the restraint includes a series of proximally extending protrusions that define a series of gaps between adjacent protrusions, and the series of proximally extending protrusions are configured to extend proximally in a loaded form to receive the implant and to tilt radially inward in a formed form after receiving the implant.

19. The deployment constraint of claim 18, wherein the implant further comprises: a tubular frame having a proximal end, a distal end, and a central passage extending therethrough; The tubular frame includes a first pair of adjacent struts joined at a proximal apex; a shaft carried by the proximal apex, the shaft extending along an axis of rotation and having external threads, the shaft being configured to rotate about the axis of rotation; as well as a collar carried by the frame and having an opening extending axially therethrough in which the shaft is received, the collar having a complementary surface structure for engaging the threads of the shaft, the collar being configured to at least partially surround the first pair of adjacent struts, wherein rotation of the shaft about the rotation axis advances the collar along a first pair of adjacent struts of the tubular frame to change an angle between the first pair of adjacent struts; and An anchor is coupled to the tubular frame, the anchor being configured to engage tissue of the mitral valve annulus.

Images