Delivery system for a heart valve device

Abstract

A delivery system for placing an implantable cardiac device at a native location includes a delivery catheter and an attachment assembly. The delivery catheter may include a proximal portion and a distal portion, and the attachment assembly may be at the distal portion of the delivery catheter. The attachment assembly may include an arm pair, wherein each arm pair includes a first arm having a connector and a second arm having a retaining member. Each first arm extends along a corresponding second arm, and the first arm and / or the second arm in each arm pair moves from a locked position to a released position relative to the other. In the locked position, the retaining member docks with the connector to maintain the fit between the implantable device and the connector. In the released position, the position of the retaining member is set relative to the connector so that the implantable device can be mated with the connector.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 850,406, filed May 20, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] A delivery system for implanting a heart valve device via a minimally invasive intravascular approach or via a mini-thoracotomy. Background Art

[0004] The normal function of the mitral valve can be affected by mitral regurgitation, mitral valve prolapse, or mitral stenosis. Mitral regurgitation occurs when the leaflets of the mitral valve fail to coapt into apposition during peak systolic pressure, allowing blood to leak from the left ventricle to the left atrium. Several structural factors may affect the normal closure of the mitral valve leaflets. For example, an enlarged mitral annulus caused by myocardial dilation may prevent the leaflets from coapting properly during systole. Other conditions include stretching or tearing of the chordae tendineae (the tendons connecting the papillary muscles to the underside of the mitral valve leaflets), which may also affect the normal closure of the mitral valve annulus. For example, ruptured chordae tendineae may cause the valve leaflets to prolapse into the left atrium due to insufficient tension on the leaflets. Abnormal regurgitation may also occur when the papillary muscles are damaged (for example, due to ischemia), so that the affected papillary muscles cannot contract sufficiently during systole to achieve normal closure.

[0005] Mitral valve prolapse occurs when the mitral valve leaflets bulge abnormally into the left atrium, which can also lead to mitral regurgitation. The proper function of the mitral valve can also be affected by mitral stenosis, or a narrowing of the mitral valve orifice, which impedes left ventricular filling during diastole.

[0006] Mitral regurgitation is typically treated with diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other treatments, such as surgery (open and endovascular), have also been used to repair or replace the native mitral valve. For example, cinching or resecting a portion of the dilated annulus is a typical repair method.

[0007] Tightening of the annulus has been accomplished by implanting annular or peri-annular rings that are generally fixed to the annulus or surrounding tissue. Other repair procedures also include suturing or clipping the valve leaflets into partial apposition to one another.

[0008] Alternatively, more invasive procedures replace the entire valve with a mechanical valve or biological tissue. These invasive procedures are typically performed through large open-heart surgery and are therefore very painful, have high morbidity, and require a long recovery period.

[0009] However, in many repair and replacement procedures, the durability of the device or the improper sizing of the annuloplasty ring or replacement valve can cause complications. In addition, many repair procedures rely on the skill of the heart surgeon, as improper or inaccurate suture placement can impact the success of the procedure.

[0010] The mitral valve presents unique challenges compared to other heart valves, as a portion of the mitral annulus is limited in radial support from surrounding tissue, and the mitral valve has an irregular, unpredictable shape. For example, the anterior wall of the mitral valve is limited by only a thin wall that separates the mitral annulus from the lower portion of the aortic outflow tract. Thus, significant radial forces on the mitral annulus are not acceptable as they can cause the lower portion of the aortic tract to collapse with potentially fatal consequences. Another challenge of the mitral valve anatomy is that the left ventricular chordae maze makes it more difficult to navigate and set the position of the deployment catheter compared to other heart valves. In view of the difficulties associated with existing procedures, there remains a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves. Additionally, there remains a need for effective and less invasive delivery systems to deliver implantable heart devices to the mitral valve, as it is also difficult to deliver devices to the mitral valve.

[0011] BRIEF DESCRIPTION OF DRAWINGS

[0012] Figure 1 is a schematic view of a mitral valve;

[0013] Figure 2 depicts an implantable device, such as a heart valve device, that can be delivered to a native human heart using a delivery device according to the present technology;

[0014] Figure 3A shows a portion of a delivery catheter and attachment assembly of a delivery system according to the present technology attached to an implantable device;

[0015] Figure 3B is a view of an attachment assembly of a delivery system according to the present technology;

[0016] Figures 3C-3E is a view of a connector of an attachment assembly for attaching a delivery system to an implantable device according to the present technology;

[0017] Figure 3F is a view of a portion of an attachment assembly of a delivery system according to the present technology;

[0018] Figure 3G is a view of an attachment assembly of a delivery system according to the present technology;

[0019] Figures 4A-4F shows aspects of operating a delivery system according to the present technology to set the position of an implantable device relative to the anatomy of a native heart valve;

[0020] Figure 5A and 5B Depiction of a portion of an attachment assembly for attaching a delivery system to an implantable device:

[0021] Figure 6A and 6B Depiction of a portion of an attachment assembly for attaching a delivery system to an implantable device;

[0022] Figure 7 Depiction of a portion of an attachment assembly for attaching a delivery system to an implantable device;

[0023] Figure 8 Depiction of a portion of an attachment assembly for attaching a delivery system to an implantable device;

[0024] Figures 9A-9C Depiction of a portion of an attachment assembly for attaching a delivery system to an implantable device;

[0025] Figure 10A is a detailed view of an attachment assembly according to the present technology;

[0026] Figure 10B is a detailed view of an attachment assembly according to the present technology;

[0027] Figures 11A-11C Depiction of a gimbal joint mechanism for enabling tilt control of an attachment assembly;

[0028] Figure 12 is a detailed view of an attachment assembly according to the present technology; and

[0029] Figure 13 is a detailed view of an attachment assembly according to the present technology. DETAILED DESCRIPTION

[0031] Disclosed herein are examples of delivery systems for implanting a medical device, such as a valve repair device or a prosthetic heart valve, in a native heart. In some embodiments, a delivery system for placing an implantable heart device at a native heart valve includes a delivery catheter and an attachment assembly. The delivery catheter can include a proximal portion and a distal portion, and the attachment assembly can be at the distal portion of the delivery catheter. The attachment assembly can include pairs of arms, where each pair of arms includes a first arm having a connector and a second arm having a retainer. Each first arm extends along a corresponding second arm, and the first arm and / or the second arm in each pair of arms moves relative to the other from a locked position to a released position. In the locked position, the retainers interface with the connectors to retain a mating between the implantable device and the connectors. In the released position, the retainers are positioned relative to the connectors such that the implantable device can be unmated from the connectors.

[0032] Figure 1 A mitral valve that can be accessed by a delivery system according to the present technology is shown. The anterior leaflet has a semicircular shape and is attached to two-fifths of the annular circumference. The movement of the anterior leaflet defines the important boundary between the inflow (diastole) and outflow (systole) tracts of the left ventricle. The posterior leaflet of the mitral valve has a crescent shape and is attached to approximately three-fifths of the annular circumference. The posterior leaflet typically has two well-defined indentations that divide the leaflet into three separate sectors, labeled P1 (lateral sector), P2 (middle sector), and P3 (medial sector). The three corresponding segments of the anterior leaflet are labeled A1 (anterior segment), A2 (middle segment), and A3 (posterior segment). The leaflet indentations help open the posterior leaflet during diastole.

[0033] like Figure 1 As shown, the mitral valve has anterolateral and posteromedial commissures, which define a distinct region where the anterior and posterior leaflets meet upon insertion into the annulus. Sometimes the commissures are present as well-defined leaflet segments, but usually this region is a subtle structure that can be identified using two anatomical landmarks: (a) the axis of the corresponding papillary muscle and (b) the commissural chordae tendineae, which have a distinctive fan-shaped configuration. Several millimeters of valve tissue separate the free edges of the commissures from the annulus.

[0034] The mitral valve is the atrioventricular valve that separates the left atrium from the left ventricle. The mitral annulus forms the anatomical junction between the left ventricle and left atrium. The fixed ends of the leaflets are attached to the annulus. The anterior portion of the mitral annulus is attached to the fibrous trigone, which is generally more developed than the posterior annulus. The right fibrous trigone is a dense junctional area between the mitral, tricuspid, and noncoronary valves of the aortic valve, and the membranous septum. The left fibrous trigone is located at the junction of the left fibrous borders of the aortic and mitral valves.

[0035] The mitral annulus is poorly developed at the insertion site of the posterior leaflet. This segment is not attached to any fibrous structure, and the fibrous skeleton in this region is discontinuous. When mitral regurgitation occurs with left atrial or left ventricular dilatation, the posterior portion of the annulus tends to increase its circumference. The mitral annulus is saddle-shaped, and during systole, the commissural region moves proximally, that is, toward the top of the atrium, while the annulus also narrows the circumference. Both of these processes contribute to leaflet coaptation, which can be adversely affected by annular dilatation and calcification. The mitral annulus is surrounded by several important anatomical structures, including the aortic valve, the coronary sinus, and the circumflex artery. Therefore, cardiac devices implanted at the mitral valve need to be positioned to accommodate the asymmetric anatomy of the mitral valve without affecting the surrounding cardiac structures.

[0036] Figure 2is an isometric view of an example of an implantable device 200, such as an artificial leaflet device, that can be delivered to a heart using a delivery system according to the present technology. The implantable device 200 can be an artificial leaflet device having an atrial fixation member 202 and a baffle 214 depending from the atrial fixation member 202 in a downstream direction. The atrial fixation member 202 can be configured to set and maintain the position of the baffle 214 in a desired position relative to the native valve anatomy, the baffle 214 being configured to displace at least a portion of a native leaflet of the heart valve and to create an artificial engagement surface for at least a portion of one or more other native leaflets of the heart valve. The baffle 214 can have a normally closed clip 220 depending from a posterior surface thereof (see Figure 4C ), the normally closed clip 220 can be opened to engage the ventricular side of one of the native leaflets. A tendon (made of suture or nitinol wire) can actuate the clip by a lever attached to the clip. The lever can be a nitinol wire or a laser-cut nitinol or cobalt-chromium sheet. Additional implantable devices that can be used with a delivery system according to the present technology are described in PCT / US2018 / 043566, which is incorporated herein by reference in its entirety. Any of several artificial valve replacement devices can similarly be used with a delivery system according to the present technology, including a complete mitral valve replacement device. And, in addition to the mitral valve, other valves (such as the tricuspid valve, the aortic valve, and the pulmonary valve) can also be delivered using a delivery system according to the present technology.

[0037] The implantable device 200 is configured relative to a flow axis VA in the direction of blood flow from the atrium to the ventricle and a transverse axis HA that is angled (e.g., orthogonal) to the flow axis VA. The implantable device 200 has a rear side P, an anterior side A, an upper end S, and a lower end I. The implantable device 200 has a proximal or leading end facing the atrium and a distal or trailing end facing the ventricle. The uppermost row of struts of the atrial fixation member 202 of the implantable device 200 includes a plurality of inverted V-shaped structures or crown points (e.g., V-shapes) 202V. One or more V-shapes 202V may each include a connector 205 at the apex of the inverted V-shaped crown point. The connector 205 is sized to mate with a mating feature on the delivery system (described below).

[0038] Implantable device 200 can be inserted via a femoral vein sheath to pass through the inferior vena cava to the right atrium. Implantable device is then inserted through a transseptal puncture into the left atrium. In several applications, it is desirable to deliver implantable device 200 to a target location within the mitral valve to function properly. This means proper placement along the flow axis, correct radial placement relative to the central axis of the valve, correct rotational orientation to a particular landmark such as the middle (P2) portion of the native posterior leaflet, and correct angular placement relative to the flow axis and transverse axis. The position of implantable device 200 can also need to be repositioned during the delivery process. For example, the position of implantable device 200 can initially be set distal to the left ventricle of the heart to engage one or more native valve leaflets, then moved proximally toward the left atrium of the heart to finally set its position before release from the delivery system. Releasing implantable device 200 from the delivery system should not exert excessive force on implantable device 200 or cause implantable device 200 to move after being placed in the desired location and desired orientation relative to the native valve. In addition, the delivery system should allow implantable device to be re-sheathed, repositioned, and / or removed before release from the delivery system. Delivery systems of the present technology can achieve all of the above advantages in a user-friendly system. Additionally, several embodiments of delivery systems according to the present technology have a small overall diameter, such as about 15 to 30 French.

[0039] Figures 3A-3C An example of a distal portion of a delivery system 300 of the present technology is depicted. Referring to Figure 3A , system 300 includes a delivery catheter 302 and an attachment assembly 310 configured to (a) securely hold implantable device 200 as it passes through the vasculature (or through a previously placed guide through the vasculature and interatrial septum), and (b) selectively release implantable device 200 at a desired target site. Delivery catheter 302 can have a proximal portion P and a distal portion D, and attachment assembly 310 can be at the distal portion D of delivery catheter 302. System 300 can optionally include at least one cinch tube CT containing a double length suture loop CTS for radially compressing atrial fixation member 202. System 300 can also optionally include a tendon tube TT containing a double length suture loop TTS for opening the clip on the posterior side of flap 214. The tendon pathway can be configured to actuate the tendon to open the clip. The optional cinch tube CT and tendon tube TT can extend through a lumen 303 in delivery catheter 302. It is also possible to provide suture loops CTS and TTS within a lumen defined in the wall of delivery catheter 302 or within a central lumen of delivery catheter 302, with short flexible tubes extending distally from the catheter tip to the implant.

[0040] Referring to Figure 3B, the attachment assembly 310 has a connector mechanism 320 and a locking mechanism 330. The connector mechanism 320 may have a first actuator 321 (only the distal portion is shown), a first arm 322 extending from the distal end of the first actuator 321, and a connector 324 at the end of each first arm 322. The first actuator 321 may be a first tube or a first hub. The locking mechanism 330 may have a second actuator 331 (only the distal portion is shown), a second arm 332 extending from the distal end of the second actuator 331, and a retaining member 334 at the end of each second arm 332. The second actuator 331 may be a second tube or a second hub. Each first arm 322 may be aligned with a corresponding second arm 332 such that the attachment assembly 310 has several pairs of first arms 322 and second arms 332, respectively. The first arms 322 and second arms 332 may be directly stacked above / below each other as shown, or they may be side by side, or they may have other suitable configurations. In Figure 3B In the illustrated embodiment, the attachment assembly 310 has eight arm pairs of first and second arms 322 / 332, but it may have any number of arm pairs, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more.

[0041] Figure 3C 3 is a detailed view showing the interface between the connector 324 and the retaining member 334 of a single arm pair 322 / 332. In some embodiments, the connector 324 is a C-shaped member having fingers 325 extending from the corresponding first arm 322 and a central opening 326 between the distal ends of the fingers 325. In some embodiments, the retaining member 334 is configured to slide over the connector 324 to move from a locked position ( Figure 3C The second arm 332 may have an extension 335 at its end.

[0042] Figure 3D is an implantable device 200 ( Figure 2 ) is a detailed view of the interface between connector 205, connector 324, and retaining member 334. The C-shaped configuration of fingers 325 can be configured to receive connector 205 of implantable device 200. For example, connector 205 can have a head 206 configured to be retained between fingers 325 and a neck 207 configured to extend through opening 326 between fingers 325. Figure 3DThe retainer 334 is shown in a locked position, wherein the retainer 334 securely holds the head 206 of the connector 205 between the fingers 325. In the locked position, the retainer 334 prevents the connector 205 from mating with the connector 324. To move to the release position, the retainer 334 is positioned proximally relative to the connector 324 along the longitudinal dimension of the first arm 322 so that the head 206 and the neck 207 can mate with the connector 324. For example, the first actuator 321 and the second actuator 331 ( Figure 3B ) can move relative to each other so that the first arm 322 and the second arm 332 ( Figure 3B ) slide relative to each other along their longitudinal dimension. In one embodiment, the second actuator 331 is pulled proximally relative to the first actuator 321, causing the retaining member 334 to move proximally relative to the connector 324. In another embodiment, the first actuator 321 is pushed distally relative to the second actuator 331, causing the connector 324 to move distally relative to the retaining member 334. In either case, the connector 324 is positioned distally of the retaining member 334 so that the connector 205 can mate with the connector 324.

[0043] Figure 3E Detailed view of another configuration of connector 324 at the end of one of first arms 322 and another configuration of connector 205 of implantable device 200. In this embodiment, connector 324 is a hook-shaped member having a neck 327 and a head 328, and connector 205 is a mating hook-shaped member having a neck 207 and a head 206. Connector 205 mates with connector 324 such that heads 328 and 206 mate with each other to prevent implantable device 200 from being moved when retaining member 334 is in position. Figure 3E The locked position shown is engaged with the connector 324.

[0044] The first arm 322 and the second arm 332 may be as shown in FIG. Figure 3B Alternatively, the first arm 322 and the second arm 332 may be as shown. Figure 3F The attachment assembly 310 is shown extending in a spiral arrangement. When compressed into the delivery catheter, the spiral arrangement of the first arm 322 and the second arm 332 can be more Figure 3B The radial delivery arms shown are more flexible in the axial direction.

[0045] The length of the pair of first arm 322 and second arm 332 may be as follows: Figure 3C The pairs of first and second arms 322, 332 may be all identical, or the pairs of first and second arms 322, 332 may have different lengths at different locations around the delivery catheter 302. For example, referring to Figure 3GThe pair of first and second arms 322, 332 on one side can be shorter than the pair of first and second arms 322, 332 on the other side. In a particular example, the attachment assembly 310 can have a pair of anterior arms 322 / 332A that are longer than a pair of posterior arms 322 / 332P and a pair of commissure arms 322 / 332C. The length of the pair of commissure arms 322 / 332C can be between the lengths of the pair of anterior arms 322 / 332A and the pair of posterior arms 322 / 332P, respectively. If the pairs of arms are of different lengths, the first and second actuation members 321, 331 can be offset from the central axis of the valve, i.e., off-center, respectively. For example, it can be preferable to have the first and second actuation members 321, 331 closer to the posterior leaflet of the native mitral valve, respectively, to better control the position of the implantable device 200. If the pairs of arms 322 / 332 are of different lengths, the atrial fixation member 202 can be accommodated in the sheath in a tilted orientation when the implantable device 200 is collapsed into the sheath, which can result in the diameter of the implantable device 200 being further compressed.

[0046] Although the system 300 is depicted as having multiple pairs of first and second arms 322, 332, a single pair of first and second arms 322, 332 can be sufficient. It should be understood that the first and second arms 322, 332 can cooperate with all of the V-shapes 202V Figure 2 described above, or only some of them (e.g., as few as a single V-shape 202V). The shape of the V-shapes 202V that are not attached to a pair of arms can be designed such that when the arms pull the implantable device 200 together into the sheath, the unattached V-shapes also collapse into the sheath at the same time.

[0047] Figures 4A-4F A number of stages of delivery and deployment of the implantable device 200 using the delivery catheter 302 and the attachment assembly 310, and an embodiment of the steerable guide catheter 410 or the coaxial guide catheter series, are shown. Reference is made to FIGS. 1-9. Figure 4A The guide catheter 410 can be inserted to pass through the venous system to the right atrium, and then across the interatrial septum S into the left atrium LA. In some embodiments, the distal portion of the guide catheter 410 can be positioned such that its distal-most end (e.g., the end furthest from the user) is in the left atrium. For example, the guide catheter 410 can be extended to a position as shown in FIG. 10, or the position of the guide catheter 410 can be further set in the left atrium LA to at least generally follow the flow axis of the native heart valve (e.g., the mitral valve MV). Figure 4A Figure 4A ​extends along a substantially vertical axis VA. This alignment can be achieved via a combination of twisting the guide catheter 410, pre-shaping the end of the guide catheter 410, and the steerable features of the guide catheter 410 that are configured to deflect along one or more axes. In some embodiments, however, the guide catheter 410 can not have this full steerable capability, and the position of its distal tip can be closer, potentially requiring additional positioning via the delivery catheter.

[0048] One optional steerable feature of the delivery catheter 302 is that it can be twisted to rotate the implantable device 200 to align with a particular location of the heart valve. Another optional steerable feature of the delivery catheter 302 is to adjust the angle of the implantable device 200 to be canted relative to the tip (longitudinal axis) of the delivery catheter 302. Various embodiments of this angular steerable feature are described below with respect to Figures 11A-13 The delivery system can also have a cover sheath (not shown) that is coaxially positioned over the delivery catheter 302 and inside the guide catheter 410. The cover sheath can be advanced over the implantable device 200 to collapse the implantable device 200 for delivery, repositioning, and retrieval, if needed. The cover sheath can also be deflected in one or more directions. Duckbill valve-like features can be incorporated at the proximal end of the guide catheter 410 to maintain hemostasis during and after introduction of the cover sheath.

[0049] Referring to Figure 4B , the guide catheter 410 can be placed across the atrial septum S via a trans-femoral approach (or across the atrial roof in a trans-atrial approach). The steerable guide catheter 410 can be deflected in one or more directions and can be advanced through the septum toward the mitral valve to facilitate the preferred positioning of the implantable device 200. The delivery catheter 302 can then be advanced through the steerable guide catheter 410 and into the left atrium LA.

[0050] Referring to Figure 4C , the arm pairs 322 / 332 are at least partially unsheathed so that their positions are set distal to the sheath of the delivery catheter 302 within the atrium. At this point, the atrial fixation member 202 is partially expanded and exposes the clips 220 that are coupled to the flaps 214.

[0051] Referring to Figure 4D , the direction of the implantable device 200 can be determined as needed by rotating the delivery catheter 302 within the cover sheath of the delivery catheter 302, rotating the cover sheath within the guide catheter 410, steering the cover sheath and / or the guide catheter 410, and / or pulling / pushing control wires (not shown). As Figure 4DFurther shown, the clip 220 coupled to the flapper 214 can be opened and positioned to capture the posterior leaflet between the clip 220 and the flapper 214. The implantable device 200 can be advanced to a desired axial position within the native mitral valve when rotated and radially aligned. Once the position of the clip 220 is set below the desired native leaflet, it can be closed. Once the position of the atrial fixation member 202 is set within the mitral valve, a cinching suture (not shown) can be used to control the expansion of the atrial fixation member 202. Alternatively, further unsheathing of the first arm 322 and the second arm 332 can provide controlled final expansion of the implantable device 200 without reliance on a cinching suture.

[0052] Figure 4E The procedure is shown after the implantable device 200 has fully expanded and the clip 220 has clamped the native leaflet to the flapper 214. The performance of the implantable device 200 can then be assessed via TEE echocardiography, and the implantable device 200 can be released, repositioned, or resheathed and removed. If the implantable device 200 is ready to be released, the cinching line can be released and withdrawn through the delivery catheter 302.

[0053] Figure 4F The procedure is shown after the attachment assembly 310 Figures 3A-3G ) has been actuated such that the connector 205 of the implantable device 200 has been decoupled from the connector 324 of the attachment assembly 310. The delivery catheter 302 can then be removed through the guide catheter 410, and the guide catheter 410 can then be withdrawn from the patient.

[0054] Figure 5A is an isometric view of an attachment assembly 510 shown in a locked position in accordance with the present technology, Figure 5B is an isometric view of an attachment assembly 510 in a released position in accordance with the present technology. The attachment assembly 510 can be used in place of the attachment assembly 310 described above. The attachment assembly 510 includes a connector mechanism 520 having a first arm 522, an opening 523 in the first arm, and a connector 524. The connector 524 can be a spring wire having a base 525 Figure 5B ) and a latch 526. The attachment assembly 510 can also include a locking mechanism 530 having a second arm 532 with a retainer 534. The second arm 532 can be a tube, and the retainer 534 can be a distal portion of the tube. The first arm 522 of the connector assembly 520 can extend through a lumen of the second arm 532.

[0055] In Figure 5AIn the illustrated locked position, the second arm 532 covers the base 525 of the connector 524 such that the position of the latch 526 is disposed through (a) the hole 211 in the connector 205 of the implantable device 200 and (b) the opening 523 at the distal portion of the first arm 522. The latch 526 accordingly secures the connector 205 to the first arm 522 in the locked position. To move the attachment assembly 510 to the unlocked position, the second arm 532 is moved proximally and / or the first arm 522 is moved distally such that at least a portion of the base 525 of the connector 524 is disengaged from the retainer 534. The connector 524 can be formed of stainless steel, nickel-titanium alloy, or other suitable material such that the base 525 moves the connector 524 to the unlocked position (arrow U), in which the latch 526 can be disengaged from the opening 523 and the hole 211. The connector 205 can then be disengaged from the connector mechanism 520 to deploy the implantable device 200. Figure 5B In the illustrated open position, the first arm 522 is moved distally and / or the second arm 532 is moved proximally such that at least a portion of the base 525 of the connector 524 is disengaged from the retainer 534. The connector 524 can be formed of stainless steel, nickel-titanium alloy, or other suitable material such that the base 525 moves the connector 524 to the open position (arrow O), in which the latch 526 can be disengaged from the opening 523 and the hole 211. The connector 205 can then be disengaged from the connector mechanism 520 to deploy the implantable device 200.

[0056] Figure 6A and 6B An attachment assembly 610 that can be used in place of the above-described attachment assemblies 310 and 510 is depicted. The attachment assembly 610 can include a connector mechanism having a first arm 622, an opening 623 through a distal portion of the first arm 622, and a connector 624 attached to the first arm 622. The connector 624 can include a base 625 attached to the first arm 622, a latch 626 configured to be received through the hole 211 of the implantable device 200 in the locked position and the opening 623, and a stop 627 between the base 625 and the latch 626. The attachment assembly 610 can further include a locking mechanism having a second arm 632 and a drive 634. The second arm 632 can have a slot 626 in which the base 625 of the connector 624 is received. In the illustrated embodiment, the second arm 632 is biased to the locked position by a spring or other suitable biasing mechanism. Figure 6A In the illustrated embodiment, the latch 626 is removed from the hole 211 and the opening 623 by moving the second arm 632 distally such that the drive 634 engages the stop 627 and the connector 624 is moved outwardly.

[0057] Figure 7 An attachment assembly 710 that can be used in place of the above-described attachment assemblies 310, 510, and 610 is depicted. The attachment assembly 710 includes an arm 722 and a connector 724. The connector 724 can be a helically wound locking suture, cable, or wire 726. A proximal end of the wire 726 is attached to an actuation member outside the body, and the wire 726 extends along and through an eyelet 728 or similar at a distal portion of the arm 722. A distal end of the wire 726 is wrapped around a portion of the implantable device 200 a number of times, thereby securing the implant 200 to the delivery system 300. The implantable device 200 is disengaged from the delivery system 300 by retracting the wire 726, which unwinds the wire from engagement with the implant 200. The wire 726 can be formed of surgical grade stainless steel or nickel-titanium alloy, as described above. or the like, which is preformed into a coil shape. If only one coil of wire 726 is passed through eyelet 728 and wrapped around implant 200, the forces between arm 722 and implantable device 200 may cause wire 726 to unwind, causing the two components to separate prematurely. However, multiple coils of wire 726 passing through arm 722 and implantable device 200 better retain implantable device 200.

[0058] Figure 8 An arm pair of another attachment assembly 810 according to the present technology is depicted. The attachment assembly 810 includes a connector mechanism having a first arm 822 with a connector 824, and a locking mechanism having a second arm 832 with a retainer 834. The first arm 822 can be a tube, and the connector 824 can be an opening at the distal end of the first arm 822. The second arm 832 can be a wire, and the retainer 834 can be a distal portion of the wire. The connector 205 of the implantable device 200 has a head 206 configured to be received in the connector 824 in a locked position and a neck 207 extending along the retainer 834. In operation, the first arm 822 and / or the second arm 832 are moved so that the position of the retainer 834 is set proximal to the head 206. The head 206 can then be de-engaged with the connector 824 to release the implantable device 200 from the attachment assembly 810. The connector 205 and the connector 824 can be made of a material including a superelastic nickel-titanium alloy. The elastic metal or plastic material is formed. Figure 8 The arm pair shown is a single arm pair, and it should be understood that the attachment assembly 810 can have Figure 3B , 3F, or two or more arm pairs (e.g., 2, 3, 4, 5, 6, 7, 8, or more) shown in 3G.

[0059] Figure 9A shows a connector mechanism having a first arm 322 and a connector 324 in accordance with an embodiment of the present technology. Figure 9B Shown with Figure 9A The connector 324 is used together with the connector 205 of the implantable device 200. Figure 9A , the connector 324 has fingers 926 extending from the distal portion of the first arm 322 and a ball 928 at the end of each finger 926. The fingers 926 can be a flexible wire such as stainless steel or And the proximal end of the finger 926 can be attached to the first arm 322 via the hub 929. The connector 205 of the implantable device 200 can include a hole 211 ( Figure 9B ).

[0060] Figure 9COne pair of arms of attachment assembly 910 is shown, which has (a) a locking mechanism including second arm 332 and retainer 334 defined by a distal portion of second arm 332, and (b) Figure 9B The connector mechanism is shown. Figure 9C The pair of arms 322 / 332 shown is a single pair of arms, it should be understood that attachment assembly 910 can have two or more pairs of arms (e.g., 2, 3, 4, 5, 6, 7, 8, or more) arranged as shown in 3F, or 3G, above. Figure 3B

[0061] Figure 9C Attachment assembly 910 is shown in a locked position, with connector 324 Figure 9A inside retainer 334, and the position of ball 928 is set in bore 211 of connector 205. Retainer 334 accordingly retains ball 928 in bore 211 to lock implantable device 200 Figure 2 from attachment assembly 910. Implantable device 200 is released from connector 324 by moving first arm 322 distally and / or second arm 332 proximally such that retainer 334 de-cooperates with ball 928. At this point, fingers 926 can optionally separate from one another via inherent spring force in fingers 926 to de-cooperate ball 928 from bore 211.

[0062] Figure 10A is a detailed cross-sectional view of attachment assembly 310 according to the present technology. Attachment assembly 310 has first arm 322 and second arm 332 as described above. First actuation 321 includes first tube 1010 with support 1012 and drive 1020 with guide 1022, and support 1012 and guide 1022 are arranged such that support 1012 is received in guide 1022. Drive 1020 further includes threaded shaft 1030. Second actuation 331 is threaded bore 1040 that cooperates with threaded shaft 1030. In operation, drive 1020 is rotated in one direction to move second actuation 331 along threaded shaft 1030, which in turn moves second arm 332 along first arm 322 to move retainer 334 Figure 3B and 3C relative to connector 324.

[0063] Figure 10B is a detailed cross-sectional view of attachment assembly 310 according to the present technology. Figure 10B Attachment assembly 310 shown has first actuation 321 including support 1012 defined by a channel and guide 1022 defined by a shoulder, such that guide 1022 is received in support 1012. Figure 10B ​The illustrated attachment assembly 310 also includes a drive member 1020 coupled to a threaded shaft 1030 and a second actuation member 331 having a threaded bore 1040 that mates with the threaded shaft 1030. Figure 10B The operation of the illustrated attachment assembly 310 is similar to Figure 10A the attachment assembly 310 illustrated in Figure 10B A cinch tube CT or tendon tube TT is shown that houses a suture used to cinch an implantable device during delivery. The cinch tube CT or tendon tube TT can be a coiled tube.

[0064] Figures 11A-11C is a close-up view of a gimbal joint according to the present technology configured to manipulate an attachment assembly in multiple directions. Figures 11A-11C Like reference numbers in Figure 11A illustrate an example gimbal joint 1110a that includes a spacer 1112, a first hinge 1120a, a second hinge 1120b, a first control line 1130a, and a second control line 1130b. The first hinge 1120a and the second hinge 1120b can be flexible posts made of a metal, such as stainless steel or a nickel-titanium alloy (e.g., Nitinol®). The first hinge 1120a connects the spacer 1112 to the delivery catheter 302 and the second hinge 1120b connects the spacer 1112 to the attachment assembly 310. The first hinge 1120a and the second hinge 1120b can be offset from each other relative to the perimeter of the spacer. For example, the first hinge 1120a and the second hinge 1120b can be offset by 180 degrees or another suitable orientation. The spacer 1112 can have a bore 1114 through which the first control line 1130a and the second control line 1130b pass. The first control line 1130a can be attached to the first actuation member 321 and the second control line 1130b can be attached to the second actuation member 331. The control lines 1130a and 1130b can also extend through a central lumen of the delivery catheter 302 or through one or more auxiliary lumens formed in the sidewall of the delivery catheter 302. The control lines 1130a and 1130b can be flexible or rigid such that they can be pushed and / or pulled to impart a steering force to the attachment assembly 310.

[0065] In operation, the first control line 1130a and the second control line 1130b can be manipulated to change the angular orientation of the attachment assembly 310. For example, the first control line 1030a and the second control line 1030b can be pulled / pushed such that the attachment assembly 310 rotates relative to the spacer 1012.

[0066] Figure 11BAn example universal joint 1110b is shown that includes a ball 1140 and a socket 1150 that cooperate to form a ball-and-socket joint. The ball 1140 is attached to the second actuator 322 and the socket 1150 is attached to or integrally formed with the delivery catheter 302. The delivery catheter 302 can include a central lumen, and the socket 1150 can be an enlarged portion of the central lumen that is slightly larger than the ball 1140. The control wires 1130a and 1130a can extend through the delivery catheter 302, such as through one or more auxiliary lumens formed in the sidewall of the delivery catheter 302. The ball-and-socket universal joint 1110b allows the attachment assembly 310 to be tilted relative to the longitudinal axis of the delivery catheter 302, and also allows the delivery catheter 302 to be twisted. The first and second arms 322, 332 are reoriented by twisting the delivery catheter 302 and by pulling / pushing one or more control wires 1130a and 1130b.

[0067] Figure 11C An example universal joint 1110c is shown, which includes a flexible inner shaft 1160 attached to or integrally formed with the attachment assembly 310 at a flexible joint 1162. The flexible inner shaft 1160 can be coaxially received in the central lumen 303 of the delivery catheter 302. The universal joint 1110c can also include at least two control wires 1130a and 1130b, whose distal ends are slidably received in arcuate slots 1164a and 1164b, respectively, formed in the attachment assembly 310. The control wires 1130a and 1130b extend through the delivery catheter 302 to an actuator (not shown) outside the patient's body. The arcuate slots 1164a and 1164b allow the control wires 1130a and 1130b to move relative to the inner shaft 1160, so that the steering direction can remain constant even when the distal tip is rotated.

[0068] The control wires 1130a and 1130b can extend through one or more lumens formed in the sidewall of the delivery catheter 302. The control wires 1130a and 1130b can be flexible or rigid so that a pushing force can be transmitted to the attachment assembly 310. In operation, the attachment assembly 310 is oriented to a desired position by twisting the inner shaft 1160 and by pulling / pushing one or more control wires 1130a and 1130b.

[0069] Figure 12 is a detailed view of an attachment assembly 310 in accordance with the present technology. Figure 12The illustrated attachment assembly 310 has a universal joint 1200 that defines a portion of the first actuation member 321. The universal joint 1200 has a first band 1210, a second band 1212, and a third band 1214. In the illustrated embodiment, the first band 1210 is an upper band that can be on a distal portion of the outer tube, the third band 1214 is a lower band from which the first arm 322 can extend, and the second band 1212 is an intermediate band between the first band 1210 and the third band 1214. The universal joint 1200 also includes a first flex joint 1216 between the first band 1210 and the second band 1212 and a second flex joint 1218 between the second band 1212 and the third band 1214. The first flex joint 1216 and the second flex joint 1218 are offset from one another by an amount, such as 30°, 45°, 60°, 75°, 90°, 105°, 120°, 135°, or 150°. In many cases, the first flex joint 1216 and the second flex joint 1218 can be offset from one another by 90° as illustrated. Figure 12 The first band 1210 can have first through holes 1220a and 1220b, and the second band 1212 can have a through hole 1222. The attachment assembly 310 can also include a control line 1230a and a control line 1230b. The control line 1230a passes through the holes 1220a and 1222 and is attached to the third band 1214 opposite the second flex joint 1218. The control line 1230b passes through the through hole 1220a and is attached to the second band 1212 opposite the first flex joint 1216. The attachment assembly 310 can also include a second actuation member 331 defined by a tube that passes through the universal joint 1200 and a second arm 332 that extends from the second actuation member 331.

[0070] In operation, the orientation of the attachment assembly 310 can be angularly determined by manipulating the control lines 1230a and 1230b. For example, the control line 1230a can be pulled / pushed such that the second flex joint 1218 bends and the third band 1214 moves in the plane of the second flex joint 1218 (as indicated by arrow M in Figure 12 and / or the control line 1230b can be pulled / pushed such that the first flex joint 1216 bends and the second band 1212 moves in the plane of the first flex joint 1216 (orthogonal to the plane of arrow M). This allows an operator to angularly set the position of the attachment assembly 310 as the implantable device 200 approaches the heart valve.

[0071] Figure 13 is a detailed view of the attachment assembly 310 in accordance with the present technology. Figure 13The illustrated attachment assembly 310 has a ball joint 1300 that defines a portion of the first actuation member 321. The ball joint 1300 can include a cup 1310, a ball 1312 configured to be rotatably received by the cup 1310, and an opening 1314 through the ball 1312. The cup 1310 can be a distal portion of an outer tube that defines the first actuation member 321, and the ball 1312 can define a hub from which the first arm 322 extends. The second actuation member 331 can extend through the opening 1314 of the ball 1312, and the second arm 332 can extend from the second actuation member 331. In operation, one or both of the first and second actuation members 321 / 331 can be pushed / pulled to move the first and / or second arms 322 / 332 relative to one another to release the implantable device from the attachment assembly 310. The angular orientation of the ball 1312 relative to the cup 1310 can be controlled using one or more control lines 1330a and / or 1330b at different circumferential locations of the ball 1312.

[0072] In any of the examples disclosed herein, the control lines 1030a / b, 1130a / b, 1230a / b, and 1330a / b (collectively, “control lines”) can be rods, cables (braided wires), or wires. The control lines can be attached to or integrally formed with the attachment assembly 310. The control lines can be formed of a biocompatible material, such as surgical grade stainless steel or a superelastic nickel-titanium alloy, such as Nitinol®.

[0073] Examples

[0074] For convenience, the above description refers to the Figures 3A-13 Numerous examples of aspects of the subject technology are provided in numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the subject technology.

[0075] 1. A delivery system for implanting a medical device, comprising:

[0076] a delivery catheter having a proximal portion and a distal portion;

[0077] a connector mechanism having first arms and connectors, each first arm having a proximal portion and a distal portion coupled to the delivery catheter, and each connector at the distal portion of a corresponding first arm and configured to mate with the medical device;

[0078] a locking mechanism having second arms and retainers, each second arm having a proximal portion and a distal portion coupled to the delivery catheter, and each retainer at the distal portion of a corresponding second arm and configured to retain a mating between the connectors and the medical device in a locked position; and

[0079] wherein each first arm is associated with a corresponding second arm to define a first arm and second arm pair, wherein the first arm and / or the second arm are moved relative to each other to a release position in which the retaining member of the second arm is moved from the connecting member of the corresponding first arm to release the medical device.

[0080] 2. A delivery system according to claim 1, wherein the delivery catheter has a first actuator and a second actuator, and wherein the first arm is coupled to the first actuator, the second arm is coupled to the second actuator, and the first actuator and / or the second actuator can move relative to the other.

[0081] 3. The delivery system of any of clauses 1-2, wherein the connector mechanism has at least 3 first arms and the locking mechanism has at least 3 second arms.

[0082] 4. The delivery system of any one of clauses 1-3, wherein the first arm and the second arm are substantially straight.

[0083] 5. The delivery system of any one of clauses 1-3, wherein the first arm and the second arm are curved.

[0084] 6. The delivery system of any of clauses 1-5, wherein the connector has fingers configured in a C-shape, and the retaining member is a sleeve that fits over the C-shaped fingers in the locked position.

[0085] 7. The delivery system of any of clauses 1-5, wherein the connector has a head and a neck, and the retaining member is a sleeve that fits over the head in the locked position.

[0086] 8. A delivery system according to any one of clauses 1-5, wherein each first arm has an opening and the connecting member is a spring wire, and each spring wire has a base coupled to the corresponding first arm and a latch configured to be in the opening in the locked position.

[0087] 9. The delivery system of any one of clauses 1-5, wherein each first arm is a tube and the connector is an opening at a distal portion of the tube, and each second arm is a rod within the tube and the retainer is a distal portion of the rod.

[0088] 10. The delivery system of any of clauses 1-5, wherein each connector comprises at least one flexible finger and a ball attached to the finger, and each second arm comprises a tube, the retainer comprising a distal portion of the tube.

[0089] 11. The delivery system of any of clauses 1-10, further comprising a gimbal joint between the delivery catheter and the first and second arms.

[0090] 12. The delivery catheter of any of clause 11, wherein the gimbal joint has a plurality of control lines, a spacer between the delivery catheter and the first and second arms, and a flexure hinge coupling one side of the spacer to the delivery catheter and another side of the spacer to the first and second arms.

[0091] 13. The delivery system of any of clause 12, wherein the flexure hinge comprises a first set of hinges coupling one side of the spacer to the delivery catheter and a second set of hinges coupling another side of the spacer to the first and second arms, and wherein the first set of hinges is circumferentially offset from the second set of hinges.

[0092] 14. The delivery system of any of clause 11, wherein the gimbal joint has a ball coupled to the first and second arms and a socket in the delivery catheter configured to receive the ball.

[0093] 15. The delivery system of any of clause 11, wherein the gimbal joint has a flexible inner shaft coupled to the first and second arms and a control line.

[0094] 16. A delivery system for placing an implantable device, comprising:

[0095] a delivery catheter having a proximal portion and a distal portion; and

[0096] a pair of attachment assemblies, wherein each pair of attachment assemblies includes a first arm having a connector and a second arm having a retainer, wherein (a) each first arm extends along a corresponding second arm, and (b) the first arm and / or the second arm moves relative to the other from a locked position in which the retainer interfaces with the connector to retain a fit between the implantable device and the connector to a released position in which the retainer is positioned relative to the connector such that the implantable device can be un-fitted from the connector.

[0097] 17. The delivery system of clause 16, wherein the connector mechanism has at least 3 first arms and the locking mechanism has at least 3 second arms.

[0098] 18. The delivery system of any of clauses 16-17, wherein the first arms and the second arms are substantially straight.

[0099] 19. The delivery system of any of clauses 16-17, wherein the first arms and the second arms are curved.

[0100] 20. The delivery system of any of clauses 16-19, wherein the link has a finger configured as a C-shape, and the retainer is a sleeve that fits over the C-shaped finger in the locked position.

[0101] 21. The delivery system of any of clauses 16-19, wherein the link has a head and a neck, and the retainer is a sleeve that fits over the head in the locked position.

[0102] 22. The delivery system of any of clauses 16-19, wherein each first arm has an opening and the link is a spring wire, and each spring wire has a base coupled to a corresponding first arm and a latch configured to be in the opening in the locked position.

[0103] 23. The delivery system of any of clauses 16-19, wherein each first arm is a tube and the link is an opening at a distal portion of the tube, and each second arm is a rod within the tube and the retainer is a distal portion of the rod.

[0104] 24. The delivery system of any of clauses 16-19, wherein each link includes at least one flexible finger and a bulb attached to the finger, and each second arm includes a tube, the retainer including a distal portion of the tube.

[0105] 25. The delivery system of any of clauses 16-24, further comprising a gimbal joint between the delivery catheter and the first and second arms.

[0106] 26. The delivery catheter of any of clause 25, wherein the gimbal joint has a plurality of control wires, a spacer between the delivery catheter and the first and second arms, and a flexible hinge coupling one side of the spacer to the delivery catheter and the other side of the spacer to the first and second arms.

[0107] 27. The delivery system of any of clause 26, wherein the flexible hinge includes a first set of hinges coupling one side of the spacer to the delivery catheter and a second set of hinges coupling the other side of the spacer to the first and second arms, and wherein the first set of hinges is circumferentially offset from the second set of hinges.

[0108] 28. The delivery system of any of clause 25, wherein the universal joint has a ball coupled to the first and second arms and a socket configured to receive the ball in the delivery catheter.

[0109] 29. The delivery system of any of clause 25, wherein the universal joint has a flexible inner shaft coupled to the first and second arms and a control wire.

[0110] 30. The delivery system of any of clauses 1-29, wherein the delivery catheter has a first actuation member and a second actuation member, and wherein the first arm is coupled to the first actuation member, the second arm is coupled to the second actuation member, and the first and / or second actuation members can move relative to one another.

[0111] From the foregoing, it will be appreciated that specific embodiments of the new technology have been described herein for purposes of illustration, but that many modifications can be made without deviating from the technology. Therefore, the technology is not limited except in the claims that follow. Moreover, some of the aspects of the new technology described in the context of a particular embodiment can also be combined or eliminated in other embodiments. For example, instead of the mechanical connection mechanisms and locking mechanisms described above, the attachment assembly can have electrolytic separation mechanisms at the end of each first arm. Furthermore, while advantages associated with some embodiments of the new technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the technology and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

1. A delivery system for an implantable medical device, comprising: a delivery catheter having a proximal portion and a distal portion; a connector mechanism having first arms and a connector, each first arm having a proximal portion coupled to the delivery catheter and a distal portion, and each connector at the distal portion of a corresponding first arm and configured to engage the medical device; a locking mechanism having second arms and a retainer, each second arm having a proximal portion coupled to the delivery catheter and a distal portion, and each retainer at the distal portion of a corresponding second arm and configured to maintain the engagement between the connector and the medical device in a locked position; a universal joint between the delivery catheter and the first and second arms, wherein the universal joint is configured to change the angular orientation of the first and second arms; and wherein each first arm is associated with a corresponding second arm to define a first arm and second arm pair, wherein the first arm and / or the second arm are moved relative to each other to a release position in which the retaining member of the second arm is moved from the connecting member of the corresponding first arm to release the medical device.

2. The delivery system according to claim 1, wherein The delivery catheter has a first actuator and a second actuator, and wherein the first arm is coupled to the first actuator, the second arm is coupled to the second actuator, and the first actuator and / or the second actuator can be moved relative to the other.

3. The delivery system according to claim 1, wherein The connector mechanism has at least three first arms and the locking mechanism has at least three second arms.

4. The delivery system according to claim 1, wherein The first arm and the second arm are substantially straight.

5. The delivery system according to claim 1, wherein The first arm and the second arm are curved.

6. The delivery system according to claim 1, wherein The connector has fingers configured in a C-shape, and the retainer is a sleeve mounted on the C-shaped fingers in the locked position.

7. The delivery system according to claim 1, wherein The connector has a head and a neck, and the retaining member is a sleeve mounted on the head in the locked position.

8. The delivery system according to claim 1, wherein Each first arm has an opening and the connector is a spring wire, and each spring wire has a base coupled to the corresponding first arm and a latch configured to be positioned in the opening in the locked position.

9. The delivery system of claim 1, wherein: Each first arm is a tube and the connector is an opening at a distal portion of the tube, and each second arm is a rod within the tube and the retainer is a distal portion of the rod.

10. The delivery system of claim 1, wherein Each connector includes at least one flexible finger and a ball attached to the finger, and each second arm includes a tube, the retainer including a distal portion of the tube.

11. The delivery system of claim 1, wherein The universal joint has a plurality of control lines, a septum between the delivery catheter and the first and second arms, and a flexible hinge coupling one side of the septum to the delivery catheter and another side of the septum to the first and second arms.

12. The delivery system according to claim 11, wherein The flexible hinges include a first set of hinges coupling one side of the septum to the delivery catheter and a second set of hinges coupling another side of the septum to the first and second arms, and wherein the first set of hinges is circumferentially offset from the second set of hinges.

13. The delivery system of claim 1, wherein: The universal joint has a ball coupled to the first and second arms and a socket in the delivery catheter configured to receive the ball.

14. The delivery system of claim 1, wherein The universal joint has a flexible inner shaft coupled to the first and second arms and a control wire.

15. A delivery system for placing an implantable device, comprising: a delivery catheter having a proximal portion and a distal portion; An attachment assembly having arm pairs, wherein each arm pair includes a first arm having a connector and a second arm having a retaining member, wherein (a) each first arm extends along a corresponding second arm, and (b) the first arm and / or the second arm is movable relative to the other from a locked position, in which the retaining member engages the connector to maintain engagement between the implantable device and the connector, to a released position, in which the retaining member is positioned relative to the connector to allow the implantable device to be undocked from the connector; and A universal joint is provided between the delivery catheter and the first and second arms.

16. The delivery system of claim 15, wherein The delivery catheter has a first actuator and a second actuator, and wherein the first arm is coupled to the first actuator, the second arm is coupled to the second actuator, and the first actuator and / or the second actuator can be moved relative to the other.

17. The delivery system of claim 15, wherein The first arm and the second arm are substantially straight.

18. The delivery system of claim 15, wherein The first arm and the second arm are curved.

19. The delivery system of claim 15, wherein The connector has fingers configured in a C-shape, and the retainer is a sleeve mounted on the C-shaped fingers in the locked position.

20. The delivery system of claim 15, wherein The connector has a head and a neck, and the retaining member is a sleeve mounted on the head in the locked position.

21. The delivery system of claim 15, wherein Each first arm has an opening and the connector is a spring wire, and each spring wire has a base coupled to the corresponding first arm and a latch configured to be positioned in the opening in the locked position.

22. The delivery system of claim 15, wherein Each first arm is a tube and the connector is an opening at a distal portion of the tube, and each second arm is a rod within the tube and the retainer is a distal portion of the rod.

23. The delivery system of claim 15, wherein Each connector includes at least one flexible finger and a ball attached to the finger, and each second arm includes a tube, the retainer including a distal portion of the tube.

24. The delivery system of claim 15, wherein The universal joint has a plurality of control lines, a septum between the delivery catheter and the first and second arms, and a flexible hinge coupling one side of the septum to the delivery catheter and another side of the septum to the first and second arms.

25. The delivery system of claim 24, wherein The flexible hinges include a first set of hinges coupling one side of the septum to the delivery catheter and a second set of hinges coupling another side of the septum to the first and second arms, and wherein the first set of hinges is circumferentially offset from the second set of hinges.

26. The delivery system of claim 15, wherein The universal joint has a ball coupled to the first and second arms and a socket in the delivery catheter configured to receive the ball.

27. The delivery system of claim 15, wherein The universal joint has a flexible inner shaft coupled to the first and second arms and a control wire.

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