AU2015221535B2 - Repositionable endoluminal support structure and its applications - Google Patents

Abstract

The invention provides an implantable medical device, comprising: a frame comprising a first opening, a second opening, and a longitudinal axis there-between, and comprising a plurality of struts interconnected by a plurality of joints, wherein the joints comprise a rotation axis with an orientation substantially normal to an outer surface of the frame; and an actuation mechanism coupled to the frame at two anchor points and configured to selectively actuate expansion and collapse of the frame by applying longitudinal forces to the two anchor points to move the two anchor points longitudinally relative to each other, wherein the actuation mechanism is self-locking to maintain the frame at a desired diameter, wherein the actuation mechanism comprises a rotational interface that comprises a rod and a first threaded mount, wherein the rod comprises a first helical thread, and the first threaded mount is configured to cooperate with the first helical thread, and wherein the implantable medical device is configured to be inserted into a patient.

Description

H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx-4/09/2015 2015221535 04 Sep 2015 - 1 -

REPOSITIONABLE ENDOLUMINAL SUPPORT STRUCTURE AND ITS APPUICATIONS

The entire teachings of U.S. Provisional Application No. 61/082,489, filed on July 5 21, 2008 and entitled Prosthetic Valve with Rotating Leaflets and Retrievable Support by

Jennifer K. White, are incorporated herein by reference. The entire content of the complete specification of Australian patent application no. 2009274131 as originally filed is incorporated herein by reference.

Endoluminal stents can be implanted in a vessel or tract of a patient to help 10 maintain an open lumen. The stents can also be used as a frame to support a prosthetic device or to deliver a therapeutic agent. Stents can be implanted by either an open operative procedure or a closed operative procedure. When an option exists, the less invasive closed procedure is generally preferred because the stent can be guided through a body lumen, such as the femoral artery, to its desired location. Closed procedures typically 15 use one of two techniques.

One closed procedure employs balloon catheterization where an expandable stent encloses an inflatable balloon. In this procedure, the stent is implanted by inflating the balloon, which causes the stent to expand. The actual positioning of the stent cannot be determined until after the balloon is deflated and, if there is a misplacement of the stent, 20 the process cannot be reversed to reposition the stent.

The other closed procedure employs a compressed stent enclosed by a removable sheath. In this procedure, a stent made from a shape memory alloy, such as Nitinol, is held in a compressed state by a sheath. The stent is implanted by withdrawing the sheath, causing the stent to expand to its nominal shape. Again, if there is a misplacement of the 25 stent, the process cannot be reversed to reposition the stent.

Positioning errors are particularly dangerous when the stent is used to support a cardiac valve. Serious complications and patient deaths have occurred due to malpositioning of the valve at the implant site in the body, using the available stent-mounted valves. Malpositioning of the valve has resulted in massive paravalvular leakage, 30 device migration, and coronary artery obstruction. The majority of these complications were unavoidable, but detected at the time of the procedure. However, due to inability to H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -2- reposition or retrieve the device, these problems were impossible to reverse or mitigate during the procedure.

The invention provides an implantable medical device, comprising: a frame comprising a first opening, a second opening, and a longitudinal axis 5 therebetween, and comprising a plurality of struts interconnected by a plurality of joints, wherein the joints comprise a rotation axis with an orientation substantially normal to an outer surface of the frame; and an actuation mechanism coupled to the frame at two anchor points and configured to selectively actuate expansion and collapse of the frame by applying longitudinal forces 10 to the two anchor points to move the two anchor points longitudinally relative to each other, wherein the actuation mechanism is self-locking to maintain the frame at a desired diameter, wherein the actuation mechanism comprises a rotational interface that comprises a 15 rod and a first threaded mount, wherein the rod comprises a first helical thread, and the first threaded mount is configured to cooperate with the first helical thread, and wherein the implantable medical device is configured to be inserted into a patient. Disclosed herein is a support implantable within a biological lumen, comprising: a plurality of elongated strut members interlinked by a plurality of swivel joints 20 forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the strut members such that the strut members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a compressed orientation and an expanded orientation, further comprising an actuator mechanism mounted to two swivel joints aligned on 25 the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis, wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the 30 longitudinal axis from the actuator mechanism, further comprising a prosthetic valve coupled to the plurality of elongated strut H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -3- members interlinked by a plurality of swivel joints, wherein the prosthetic valve comprises: a first structural valve member coupled to the stmt members; a second structural valve member rotatable relative to the first structural valve 5 member; and a plurality of pliable valve members connecting the first structural valve member with the second structural valve member such that rotation of the second structural valve member relative to the first structural valve member urges the valve members between an open and a closed state. 10 Disclosed herein is a support implantable within a biological lumen, comprising: a plurality of elongated strut members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the stmt members such that the stmt members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a 15 compressed orientation and an expanded orientation, further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated stmt members by decreasing distances between swivel joints aligned on the same longitudinal axis, 20 wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism, further comprising a prosthetic valve coupled to the plurality of elongated stmt members interlinked by a plurality of swivel joints, 25 wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures at the intersection of two stmt members.

Disclosed herein is a support implantable within a biological lumen, comprising: a plurality of elongated stmt members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints 30 cooperate with the stmt members such that the stmt members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -4- compressed orientation and an expanded orientation, further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal 5 axis, wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism, further comprising a prosthetic valve coupled to the plurality of elongated stmt 10 members interlinked by a plurality of swivel joints, wherein the prosthetic valve includes a skirt material coupled to the stmt members. Disclosed herein is a method of fabricating a support implantable within a biological lumen, comprising: interlinking a plurality of elongated stmt members with a plurality of swivel joints 15 at three locations of each elongated stmt member, such that the swivel joints cooperate with the stmt members to adjustably define a tubular shaped structure between a compressed orientation and an expanded orientation, wherein the tubular shaped structure comprises a longitudinal axis, and wherein the stmt members are swivelable in a plane parallel to the longitudinal axis; and 20 coupling an adjustment mechanism to the stmt members configured to exert a force to urge the stmt members about the swivel joints within a range of motion, wherein the tubular shaped structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force from the adjustment mechanism parallel to the longitudinal axis. 25 Disclosed herein is a support implantable within a biological lumen, comprising: a plurality of elongated stmt members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the stmt members such that the stmt members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a 30 compressed orientation and an expanded orientation, further comprising an actuator mechanism mounted to two swivel joints aligned on H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -5- the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis, wherein the tubular support structure is incrementally and reversibly adjustable 5 between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism, further comprising a prosthetic valve coupled to the plurality of elongated stmt members interlinked by a plurality of swivel joints, wherein at least one of the plurality of elongated stmt members is a multi-ply stmt, 10 and wherein the prosthetic valve comprises a plurality of leaflets, and wherein at least one of the leaflets is sandwiched between a multi-ply stmt.

An endoluminal support structure or stent in accordance with certain examples disclosed herein solves certain deficiencies found in the prior art. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. 15 A particular example includes a support apparatus implantable within a biological lumen. The support apparatus can include a plurality of elongated stmt members interlinked by a plurality of swivel joints, wherein the swivel joints can cooperate with the stent members to adjustably define a shaped structure between a compressed orientation and an expanded orientation. 20 More particularly, the shaped structure can be one of a cylindrical, a conical, or an hourglass shape. A swivel joint can form a scissor mechanism with a first stmt member and a second stmt member. Furthermore, the stmt members can be arranged as a series of linked scissor mechanisms. The apparatus can further include an actuation mechanism to urge the swivel joints within a range of motion. 25 The apparatus can also include a prosthetic valve coupled to the shaped structure.

Another particular example can include a medical stent implantable within a biological lumen. The medical stent can include a plurality of elongated stmt members, including a first stmt member and a second stmt member, and a swivel joint connecting the first stmt member and the second stmt member. In particular, the swivel joint can form a 30 scissor mechanism with the first stmt member and the second stmt member. The swivel H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_ I .docx-4/09/2015 2015221535 04 Sep 2015 -6- joint can bisect the first strut member and the second strut member. The swivel joint can interconnect a first end of the first stmt member with a first end of the second stmt member.

The plurality of stmt members can be arranged as a series of linked scissor mechanisms. The stmt members can also be non-linear. The stmt members can be arranged to 5 form one of a cylindrical, a conical, or an hourglass shape.

The stent can further include an adjustment mechanism to exerting a force to urge the stmt members about the swivel joint within a range of motion.

The stent can include a prosthetic valve coupled to the stmt members.

Specific examples can include prosthetic valves that are rotatable or conventional. 10 A rotatable prosthetic valve can include a first structural member coupled to the stmt members, a second structural member rotatable relative to the first structural member, and a plurality of pliable valve members connecting the first structural member with the second structural member such that rotation of the second structural member relative to the first structural member can urge the valve members between an open and a closed state. In 15 particular, the rotation of the second structural member can be responsive to the natural flow of a biological fluid. A conventional prosthetic valve can include a plurality of pliable valve leaflets having commissures at the intersection of two stmt members. The prosthetic valve can further include a skirt material coupled to the stmt members. A particular advantage of a support stmcture in accordance with examples disclosed 20 herein is that it enables a prosthetic valve to be readily retrieved and repositioned in the body. If following deployment, the valve is mal-positioned or deemed dysfunctional, the support stmcture allows the valve to be readily repositioned and re-deployed at a new implant site, or removed from the body entirely. This feature of the device can prevent serious complications and save lives by enabling the repair of mal-positioned devices in the body. 25 The invention will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: FIG. 1 is a perspective view of a particular endoluminal support stmcture. FIG. 2 is a perspective view of a four stmt section of the stent of FIG. 1. FIG. 3 is a perspective view of a compressed support stmcture of FIG. 1. 30 FIG. 4 is a perspective view of the support stmcture of FIG. 1 in a fully expanded state. H:\sbt\lnterwoven\NRPortbl\DCOSBT\8379124_1 .docx.-4/09/2015 2015221535 04 Sep 2015 -7- FIG. 5 is a perspective view of the support structure of FIG. 2 having a particular actuator mechanism. FIG. 6 is a perspective view of the support structure of FIG. 2 having another particular actuator mechanism. 5 FIG. 7 is a perspective view of a particular support structure and control catheter assembly usable with the actuator mechanisms of FIGs. 5 and 6. FIG. 8 is a perspective view of a particular rotating prosthetic valve assembly. FIG. 9 is a perspective view of the valve assembly of FIG. 8 while being closed. FIG. 10 is a perspective view of the valve assembly of FIG. 8 once completely 10 closed. FIG. 11 is a perspective view of the valve of FIGs. 8-10 in combination with the support structure of FIG. 1. FIG. 12 is a perspective view of the valve of FIG. 11 in the open position. FIG. 13 is a perspective view of a traditional tissue valve mounted to the support 15 structure of FIG. 1. FIG. 14 is a perspective view of the valve structure of FIG. 13 having a full inner skirt. FIG. 15 is a perspective view of the valve structure of FIG. 13 having a full outer skirt. 20 FIG. 16 is a perspective view of the arrangement of strut members in a conical shaped support structure configuration. FIG. 17 is a perspective view of an hourglass-shaped support structure configuration.

Particular embodiments of the invention include endoluminal support structures 25 (stents) and prosthetic valves. FIG. 1 is a perspective view of a particular endoluminal support structure. As shown, the support structure 10 is a medical stent that includes a plurality of longitudinal strut members 11 interconnected by a plurality of swivel joints 15. In particular, the swivel joints 15 allow the interconnected strut members 11 to rotate relative to each other. As 30 shown, there are eighteen struts 11.

The strut members 11 are fabricated from a rigid or semi-rigid biocompatible H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379l24_l.docx.-4/09/2015 2015221535 04 Sep 2015 -8- material, such as plastics or other polymers and metal alloys, including stainless steel, tantalum, titanium, nickel-titanium (e.g. Nitinol), and cobalt-chromium (e.g. ELGILOY). The dimensions of each strut can be chosen in accordance with its desired use. In a particular embodiment, each strut member is made from stainless steel, which is 0.005-5 0.020 inch thick. More particularly, each strut is 0.010 inch thick 300 series stainless steel.

While all struts 11 are shown as being of uniform thickness, the thickness of a strut can vary across a strut, such as a gradual increase or decrease in thickness along the length of a strut. Furthermore, individual struts can differ in thickness from other individual struts in the same support structure. 10 As shown, each strut member 11 is bar shaped and has a front surface Ilf and a back surface lib. The strut members can however be of different geometries. For example, instead of a uniform width, the struts can vary in width along its length. Furthermore, an individual strut can have a different width than another strut in the same support structure. Similarly, the strut lengths can vary from strut to strut within the same 15 support structure. The particular dimensions can be chosen based on the implant site.

Furthermore, the struts can be non-flat structures. In particular, the struts can include a curvature, such as in a concave or convex manner in relationship to the inner diameter of the stent structure. The struts can also be twisted. The non-flatness or flatness of the struts can be a property of the material from which they are constructed. For 20 example, the struts can exhibit shape-memory or heat- responsive changes in shape to the struts during various states. Such states can be defined by the stent in the compressed or expanded configuration.

Furthermore, the strut members 11 can have a smooth or rough surface texture. In particular, a pitted surface can provide tensile strength to the struts. In addition, roughness 25 or pitting can provide additional friction to help secure the support structure at the implant site and encourage irregular encapsulation of the support structure 10 by tissue growth to further stabilize the support structure 10 at the implant site over time.

In certain instances, the stent could be comprised of struts that are multiple members stacked upon one another. Within the same stent, some struts could include 30 elongated members stacked upon one another in a multi-ply configuration, and other struts H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -9- could be one-ply, composed of single-thickness members. Within a single strut, there can be areas of one-ply and multi-ply layering of the members.

Each stmt member 11 also includes a plurality of orifices 13 spaced along the length of the strut member 11. On the front surface Ilf, the orifices are countersunk 17 to 5 receive the head of a fastener. In a particular embodiment, there are thirteen equally spaced orifices 13 along the length of each stmt member 11, but more or less orifices can be used. The orifices 13 are shown as being of uniform diameter and uniform spacing along the stmt member 11, but neither is required.

The stmt members 11 are arranged as a chain of four-bar linkages. The stmt 10 members 11 are interconnected by swivelable pivot fasteners 25, such as rivets, extending through aligned orifices 13. It should be understood that other swivelable fasteners 25 can be employed such as screws, bolts, ball-in-socket structures, nails, or eyelets, and that the fasteners can be integrally formed in the stmts 11 such as a peened semi-sphere interacting with an indentation or orifice, or a male-female coupling. In addition to receiving a 15 fastener, the orifices 13 also provide an additional pathway for tissue growth-over to stabilize and encapsulate the support structure 10 over time. FIG. 2 is a perspective view of a four stmt section of the stent of FIG. 1. As shown, two outer stmt members 11-1, 11-3 overlap two inner stmt members 11-2, 11-4, with their back surfaces in communication with each other. 20 In particular, the first stmt member 11-1 is swivelably connected to the second stmt member 11-1 by a middle swivel joint 15-1 using a rivet 25-1, which utilizes orifices 13 that bisect the stmt members 11-1, 11-2. Similarly, the third stmt member 11-3 is swivelably connected to bisect the fourth stmt member 11-4 by a middle swivel joint 15-7 using a rivet 25-7. It should be understood that the middle swivel joints 15-1, 15-7 function 25 as a scissor joint in a scissor linkage or mechanism. As shown, the resulting scissor arms are of equal length. It should also be understood that the middle joint 15-1, 15-7 need not bisect the joined stmt members, but can instead utilize orifices 13 offset from the longitudinal centers of the stmt members resulting in unequal scissor arm lengths.

In addition to the middle scissor joint 15-1, the first stmt member 11-1 is 30 swivelably connected to the third stmt member 11-3 by a distal anchor swivel joint 15-5, located near the distal ends of the stmt members 11-1, 11-3. Similarly, the first stmt H:\sbt\lnterwoven\NRPortbl\DCC\SBT\8379124_l .docx-4/09/2015 2015221535 04 Sep 2015 - 10- member 11-1 is swivelably connected to the fourth stmt member 11-4 by a proximal anchor swivel joint 15-3, located near the proximal ends of the stmt members 11-1, 11-4. To reduce stresses on the anchor rivets 25-3, 25-5, the distal and proximal ends of the struts 11 can be curved or twisted to provide a flush interface between the joined struts. 5 As can be seen, the support stmcture 10 (FIG. 1) is fabricated by linking together a serial chain of scissor mechanisms. The chain is then wrapped to join the last scissor mechanism with the first scissor mechanism in the chain. By actuating the linkage the links can be opened or closed, which results in expanding or compressing the stent 10 (FIG. 1).

Returning to FIG. 1, by utilizing the swivel joints 15, the diameter of the stent can 10 be compressed for insertion through a biological lumen, such as an artery, to a selected position. The stent can then be expanded to secure the stent at the selected location within the lumen. Furthermore, after being expanded, the stent can be recompressed for removal from the body or for repositioning within the lumen. FIG. 3 is a perspective view of a compressed support stmcture of FIG. 1. When 15 compressed, the stent 10 is at its maximum length and minimum diameter. The maximum length is limited by the length of the stmt members, which in a particular embodiment is 15 mm. The minimum diameter is limited by the width of the stmt members, which in a particular embodiment is 0.052 inch. FIG. 4 is a perspective view of the support structure of FIG. 1 in a fully expanded 20 state. As shown, the frilly expanded support structure 10 forms a ring, which can be used as an annuloplasty ring.

In particular, if one end of the stent circumference is attached to tissue, the compression of the stent will enable the tissue to cinch. Because the stent has the ability to have an incremental and reversible compression or expansion, the device could be used to 25 provide an individualized cinching of the tissue to increase the competency of a heart valve. This could be a useful treatment for mitral valve diseases, such as mitral regurgitation or mitral valve prolapse.

While the support structure 10 can be implanted in a patient during an open operative procedure, a closed procedure will often be more desirable. As such, the support 30 stmcture 10 can include an actuation mechanism to allow a surgeon to expand or compress the support structure from a location remote from the implant site. Due to the properties of H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 - 11 - a scissor linkage wrapped into a cylinder (FIG. 1), actuation mechanisms can exert work to expand the stent diameter by either increasing the distance between neighbouring scissor joints and decreasing the distance between the anchor joints. FIG. 5 is a perspective view of the support structure of FIG. 2 having a particular 5 actuator mechanism. As shown, the actuator mechanism 30 includes a dual-threaded rod 32 positioned on the inside of the support structure 10 (FIG. 1). It should be understood, however, that the actuator mechanism 30 can instead be positioned on the outside of the support structure 10. Whether positioned on the inside or outside, the actuator mechanism 30 operates in the same way. 10 The rod includes right-hand threads 34R on its proximal end and left-hand threads 34L on its distal end. The rod 32 is mounted the anchor points 15-3, 15-5 using a pair of threaded low-profile support mounts 35-3, 35-5. Each end of the rod 32 is terminated by a hex head 37-3, 37-5 for receiving a hex driver (not shown). As should be understood, rotating the rod 32 in one direction will urge the anchor points 25-3, 25-5 15 outwardly to compress the linkages while rotating the rod 32 in the opposite direction will urge the anchor points 25-3, 25-5 inwardly to expand the linkages. FIG. 6 is a perspective view of the support structure of FIG. 2 having another particular actuator mechanism. As shown, the actuator mechanism 30' includes a single-threaded rod 32' positioned on the inside of the support structure 10 (FIG. 1). The rod 32' 20 includes threads 34' on one of its ends. The rod 32' is mounted to low-profile anchor points 15-3, 15-5 using a pair of support mounts 35'-3, 35'-5, one of which is threaded to mate with the rod threads 34'. The unthreaded end of the rod 32' includes a retaining stop 39' that bears against the support mount 35'-5 to compress the support structure. Each end of the rod 32' is terminated by a hex head 37-3, 37'-5 for receiving a hex driver (not 25 shown). Again, rotating the rod 32' in one direction will urge the anchor points 25-3, 25-5 outwardly to compress the linkages while rotating the rod 32' in the opposite direction will urge the anchor points 25-3, 25-5 inwardly to expand the linkages.

In addition, because the struts overlap, a ratcheting mechanism can be incorporated to be utilized during the sliding of one strut relative to the other. For example, the stent 30 could lock at incremental diameters due to the interaction of features that are an integral part of each strut. An example of such features would be a male component (e.g. bumps) H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 - 12- on one strut surface which mates with the female component (e.g. holes) on the surface of the neighboring strut surface, as the two stmts slide pass one another. Such structures could be fabricated to have an orientation, such that they incrementally lock the stent in the expanded configuration as the stent is expanded. Such a stent could be expanded using a 5 conventional balloon or other actuation mechanism described in this application.

Because the support structure 10 of FIGs. 5 and 6 are intended to be implanted during a closed surgical procedure, the actuator mechanism is controlled remotely by a surgeon. In a typical procedure, the support structure 10 is implanted through a body lumen, such as the femoral artery using a tethered endoluminal catheter. As such, the 10 actuator mechanism 30 can be controlled via the catheter. FIG. 7 is a perspective view of a particular support structure and control catheter assembly usable with the actuator mechanisms of FIGs. 5 and 6. The control catheter 40 is dimensioned to be inserted with the support structure through a biological lumen, such as a human artery. As shown, the control catheter 40 includes a flexible drive cable 42 having a 15 driver 44 on its distal end that removably mates with a hex head 37, 37' of the actuator mechanism (FIGs. 5 and 6). The proximal end of the cable 42 includes a hex head 46. In operation, the proximal hex head 46 of the cable 42 is rotated by a surgeon, using a thumb wheel or other suitable manipulator (not shown). Rotation of the hex head 46 is transferred by the cable 42 to the driver head 44 to turn the actuator rod 30, 30' (FIGs. 5 and 6). 20 The cable 42 is encased by a flexible outer sheath 48. The distal end of the outer sheath 48 includes a lip or protuberance 49 shaped to interface with the support structure 10. When the cable 42 is turned, the outer sheath lip 49 interacts with the support structure 10 to counteract the resulting torque.

By employing threads, the rod is self-locking to maintain the support structure in 25 the desired diameter. In a particular embodiment, the rod 32, 32' has a diameter of 1.0 mm and a thread count of 240 turns/inch. While a threaded rod and drive mechanism are described, other techniques can be employed to actuate the linkages depending on the particular surgical application. For example, the actuator mechanism can be disposed within the thickness of the stmt members, instead of inside or outside of the stent. For 30 example, worm gears or a rack and pinion mechanism can be employed as known in the art. One of ordinary skill in the art should recognize other endoluminal actuation H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx-4/09/2015 2015221535 04 Sep 2015 - 13 - techniques. In other situations, the support structure can be implanted during an open procedure, which may not require an external actuation mechanism.

Although there are other uses for the described support structure, such as drug delivery, a particular embodiment supports a prosthetic valve. In particular, the support 5 structure is used in combination with a prosthetic valve, such as for an aortic valve replacement. FIG. 8 is a perspective view of a particular rotating prosthetic valve assembly. The prosthetic valve 100 comprises a three leaflet configuration shown in an open position. The leaflets are derived from a biocompatible material, such as animal pericardium (e.g. 10 bovine, porcine, equine), human pericardium, chemically-treated pericardium, gluteraldehyde-treated pericardium, tissue engineered materials, a scaffold for tissue engineered materials, autologous pericardium, cadaveric pericardium, Nitinol, polymers, plastics, PTFE, or any other material known in the art.

The leaflets 101a, 101b, 101c are attached to a stationary cylindrical member 105 15 and a non-stationary cylindrical member 107. One side of each leaflet 101 is attached to the non-stationary cylindrical member 107. The opposing side of each leaflet 101 is attached to the stationary cylindrical member 105. The attachment of each leaflet 101 is in a direction generally perpendicular to the longitudinal axis of the cylindrical members 105, 107. In this embodiment, each leaflet 101 is pliable, generally rectangular in 20 shape, and has a 180 degree twist between its attachments to stationary member 105 and non- stationary member 107. Each leaflet 101 has an inner edge 102 and an outer edge 103, with the edges 102c, 103c of one leaflet 101c being referenced in the figure. As known in the art, the leaflets can be fabricated from either biological or non-biological materials, or a combination of both. 25 One way to actuate the valve to close is by utilizing the forces exerted by the normal blood flow or pressure changes of the cardiac cycle. More specifically, the heart ejects blood through the fully open valve in the direction of the arrow shown in FIG. 8. Shortly thereafter, the distal or downstream blood pressure starts to rise relative to the proximal pressure across the valve, creating a backpressure on the valve. 30 FIG. 9 is a perspective view of the valve assembly of FIG. 8 while being closed.

That backpressure along the direction of the arrow causes the axially displacement of the H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx-4/09/2015 2015221535 04 Sep 2015 - 14- leaflets 101 and non-stationary member 107 towards the stationary cylindrical member 105. As the leaflets 101 move from a vertical to horizontal plane relative to the longitudinal axis, a net counter-clockwise torque force is exerted on the non-stationary member 107 and leaflets 101. The torque force exerts a centripetal force on the 5 leaflets 101. FIG. 10 is a perspective view of the valve assembly of FIG. 8 once completely closed. Complete closure of the valve 100 occurs as the leaflets 101 displace to the center of the valve and the non-stationary cylindrical member 107 rests upon the stationary member 105, as shown. 10 The function of the valve 100 opening can be understood by observing the reverse of the steps of valve closing, namely following the sequence of drawings from FIG. 10 to FIG. 8.

In considering the valve 100 as an aortic valve replacement, it would remain closed as shown in FIG. 10, until the heart enters systole. During systole, as the myocardium 15 forcefully contracts, the blood pressure exerted on the valve's proximal side (the side closest to the heart) is greater than the pressure on the distal side (downstream) of the closed valve. This pressure gradient causes the leaflets 101 and non-stationary cylindrical member 107 to displace away from the stationary member 105 along the axial plane. The valve 100 briefly assumes the half-closed transition state shown in FIG. 9. 20 As the leaflets 101 elongate from a horizontal to vertical orientation along the axial plane, a net torque force is exerted on the leaflets 101 and non-stationary cylindrical member 107. Since the valve 100 is opening, as opposed to closing, the torque force exerted to open the valve is opposite to that exerted to close the vlave. Given the configuration of embodiment shown in FIG. 9, the torque force that opens the valve would 25 be in clockwise direction.

The torque forces cause the leaflets 101 to rotate with the non-stationary member 107 around the longitudinal axis of the valve 100. This, in turn, exerts a centrifugal force on each leaflet 101. The leaflets 101 undergo radial displacement away from the center, effectively opening the valve and allowing blood to flow away from the 30 heart, in the direction shown by the arrow in FIG. 8. H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_1 .docx-4/09/2015 2015221535 04 Sep 2015 - 15 -

To summarize, the valve passively functions to provide unidirectional blood flow by linking three forces. Axial, torque, and radial forces are translated in a sequential and reversible manner, while encoding the directionality of prior motions. First, the axial force of blood flow and pressure causes the displacement of the leaflets 101 and non-stationary 5 members 107 relative to the stationary member 105 along the axial plane. This is translated into a rotational force on the leaflets 101 and non-stationary member 107. The torque force, in turn, displaces the leaflets 101 towards or away from the center of the valve, along the radial plane, which closes or opens the valve 100. The valve 100 passively follows the pathway of opening or closing, depending on the direction of the axial force 10 initially applied to the valve by the cardiac cycle.

In the body, the stationary cylindrical member 105 can secured and fixed in position at the implant site, while the non-stationary member 107 and distal ends of leaflets 101 are free to displace along the axial plane. In using the prosthetic valve as an aortic valve replacement, the stationary member 105 would be secured in the aortic root. 15 As the blood pressure or flow from the heart, increases, the valve 100 changes from its closed configuration to the open configuration, with blood ejecting through the valve 100.

Specific advantages of the rotating valve of FIGs. 8-10, along with further embodiments, are described in the above-incorporated parent provisional patent application. 20 FIG. 11 is a perspective view of the valve of FIGs. 8-10 in combination with the support structure of FIG. 1. As shown in the closed position, the valve's stationary member 105 is attached to the support structure 10. The valve's non-stationary member 107 is not attached to the support structure 10. This enables the non-stationary member 107 to displace along the axial plane along with the leaflets 101 during valve opening or 25 closing. In this particular embodiment, the valve 100 occupies a position that is closer to one end of the support structure 10, as shown. FIG. 12 is a perspective view of the valve of FIG. 11 in the open position. As noted above, the non-stationary member 107 is not attached to support structure 10, and is thus free to displace along the axial plane, along with the leaflets 101. In this particular 30 embodiment, during full opening, non-stationary member 107 and the leaflets 101 remain within the confines of the support structure 10. H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -16-

The stented valve 110 can be implanted during a closed procedure as described above. However, because of the operation of the non-stationary member within the body of the stent, the actuator mechanism to compress and expand the stent would not be disposed within the stent. 5 Further embodiments of the stented valve 110, positioning of the valve in the body, and procedures for implantation are described in the above-incorporated parent provisional patent application. In addition, a tissue valve can be draped on the support structure. Additional embodiments should be apparent to those of ordinary skill in the art. FIG. 13 is a perspective view of a traditional tissue valve mounted to the support 10 structure of FIG. 1. As shown, a stented valve 120 includes a prosthetic tissue valve 121 attached to a support structure 10, such as that described above.

The tissue valve 121 includes three pliable semi-circular leaflets 121a, 121b, 121c, which can be derived from biocompatible materials as noted with reference to FIG. 8. Adjacent leaflets are attached in pairs to commissures 123x, 123y, 123z on the support 15 structure 10. In particular, the commissures 123x, 123y, 123z correspond with spaced-apart distal anchor points 13x, 13y, 13z on the support structure 10. In an 18-strut stent, the commissures are attached the structure 10 via corresponding fasteners 25 at every third distal anchor point.

From the commissures, the leaflet sides are connected to the adjacent diagonal 20 struts. That is, the sides of the first leaflet 121a are sutured to the struts 11-Xa and H-Za, respectively; the sides of the second leaflet 121b are sutured to the struts 11-Xb and H-Yb, respectively; and the sides of the third leaflet 121c are sutured to the struts 11-Yc and 11-Zc, respectively. Those sutures end at the scissor pivot points on the diagonal struts.

In the configuration shown, neighboring struts 11 are attached to one another in a 25 manner that creates multiple arches 128 at the ends of the stent. Posts for leaflet attachment, or commissures, are formed by attaching neighboring leaflet to each of the struts that define a suitable arch 128x, 128y, 128z. In the configuration shown, there are three leaflets 121a, 121b, 121c, each of which is attached to a strut along two of its opposing borders. The commissures are formed by three equi-distance arches 128x, 128y, 30 128z in the stent. H:\sbt\lnterwoven\NRPortbl\DCC\SBT\8379124_ I .docx-4/09/2015 2015221535 04 Sep 2015 - 17- 10 20 25 30

The angled orientation of a strut in relationship to its neighboring strut enables the leaflets 121a, 121b, 121c to be attached to the stent in a triangular configuration. This triangular configuration simulates the angled attachment of the native aortic leaflet. In the native valve this creates an anatomical structure between leaflets, known as the inter-leaflet trigone. Because the anatomical inter-leaflet trigone is believed to offer structural integrity and durability to the native aortic leaflets in humans, it is advantageous to simulate this structure in a prosthetic valve. One method of attachment of the leaflets to the struts is to sandwich the leaflet between a mutli-ply strut. The multiple layers are then held together by sutures. Sandwiching the leaflets between the struts helps to dissipate the forces on leaflets and prevent the tearing of sutures through the leaflets. The remaining side of each leaflet 121a, 121b, 121c is sutured annularly across the intermediate strut members as shown by a leaflet seam. The remaining open spaces between the struts are draped by a biocompatible skirt 125 to help seal the valve against the implant site and thus limit paravalvular leakage. As shown, the skirt 125 is shaped to cover those portions of the stent below and between the valve leaflets. In more detail, the skirt 125 at the base of the valve is a thin layer of material that lines the stent wall. The skirt material can be pericardial tissue, polyester, PTFE, or other material or combinations of materials suitable for accepting tissue in growth, including chemically treated materials to promote tissue growth or inhibit infection. The skirt layer functions to reduce or eliminate leakage around the valve, or "paravalvular leak". To that end, there are a number of ways to attach the skirt material layer to the stent, including: • the skirt layer can be on the inside or the outside of the stent; • the skirt layer can occupy the lower portion of the stent; • the skirt layer can occupy the lower and upper portion of the stent; • the skirt layer can occupy only the upper portion of the stent; • the skirt layer can occupy the area between the struts that define the commissure posts; • the skirt layer can be continuous with the leaflet material; • the skirt layer can be sutured to the struts or a multitude of sites; or H:\sbt\lnterwoven\NRPortbl\DCC\SBT\8379l24_l.docx-4/09/2015 2015221535 04 Sep 2015 - 18 - • the skirt layer can be secured to the lower portion of the stent, and pulled or pushed up to cover the outside of the stent during the deployment in the body.

The above list is not necessarily limiting as those of ordinary skill in the art may recognize alternative draping techniques for specific applications. 5 FIG. 14 is a perspective view of the valve structure of FIG. 13 having a full inner skirt. A stented valve 120' includes a prosthetic tissue valve 12Γ having three leaflets 121a', 121b', 121c'attached to a support structure 10. A skirt layer 125' covers the interior surface of the stent 10. As such, the valve leaflets 121a', 121b', 121c' are sutured to the skirt layer 125'. 10 FIG. 15 is a perspective view of the valve structure of FIG. 13 having a full outer skirt. A stented valve 120" includes a prosthetic tissue valve 121" having three leaflets 121a", 121b", 121c" attached to a support structure 10, such as that described in FIG. 13. A skirt layer 125" covers the exterior surface of the stent 10.

The tissue valve structures 120, 120', 120" can also be implanted during a closed 15 procedure as described above. However, the actuator mechanism to compress and expand the stent would be attached to avoid the commissure points and limit damage to the skirt layer 125, 125', 125", such as by mounting the actuator mechanism on the outer surface of the stent 10.

While the above-described embodiments have featured a support structure having 20 linear strut bars and equal length scissor arms, other geometries can be employed. The resulting shape will be other than cylindrical and can have better performance in certain applications. FIG. 16 is a perspective view of the arrangement of strut members in a conicalshaped support structure configuration. In the conical structure 10', the strut members 11 25 are arranged as shown in FIG. 2, except that the middle scissor pivots do not bisect the struts. In particular, the middle scissor pivots (e.g. 15'-1, 15'-7) divide the joined strut members (e.g. ll'-l, 1Γ-2 and 1Γ-3, 1Γ4) into unequal segments of 5/12 and 7/12 lengths. When fully assembled, the resulting support structure thus conforms to a conical shape when expanded. For illustration purposes, the stent 10' is shown with a single-threaded 30 actuator rod 32' (FIG. 6), but it is not a required element for this stent embodiment. H:\sbt\lnterwoven\NRPortbl\DCC\SBT\8379124_l .docx-4/09/2015 2015221535 04 Sep 2015 - 19-

The stent 10' can also assume a cone shape in its expanded configuration by imposing a convex or concave curvature to the individual strut members 11 that comprise the stent 10'. This could be achieved by using a material with memory, such as shape-memory or temperature sensitive Nitinol. 5 A valve can be orientated in the cone-shaped stent 10' such that the base of the valve was either in the narrower portion of the cone-shaped stent, with the non-base portion of the valve in the wider portion of the cone. Alternatively, the base of the valve can be located in the widest portion of the stent with the non-base portion of the valve in the less-wide portion of the stent. 10 The orientation of a cone-shaped stent 10' in the body can be either towards or away from the stream of blood flow. In other body lumens (e.g. respiratory tract or gastrointestinal tract), the stent could be orientated in either direction, in relationship to the axial plane. FIG. 17 is a perspective view of an hourglass-shaped support structure 15 configuration. In this configuration, the circumference around the middle pivot points 15"-1, 15"-7, 15"-9 (the waist) is less than the circumference at either end of the stent 10". As shown, the hourglass shaped support structure 10" is achieved by reducing the number of strut members 11" to six and shortening the strut members 11" in comparison to prior embodiments. As a result of the shortening, there are fewer orifices 13" per strut 20 member 11". Because of the strut number and geometry, each strut member 11" includes a twist at points 19" along there longitudinal planes. The twists provide a flush interface between joined strut 15"-3.

An hourglass stent configuration could also be achieved by imposing concave or convex curvatures in individual bars 11". The curvature could be a property of the 25 materials (e.g. shape-memory or heat-sensitive Nitinol). The curvature could be absent in the compressed stent state and appear when the stent is in its expanded state.

It should be noted that any of the above-described support structures can be extended beyond the anchor joints at either of both ends of the stent. By coupling a series of stents in an end-to-end chain fashion, additional stent lengths and geometries can be 30 fabricated. In particular, an hourglass-shaped stent could be achieved by joining two cone- H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -20shaped stents at their narrow ends. The hourglass shape can also be modified by assembling the middle scissor pivots off center as shown in FIG. 14.

Particular embodiments of the invention offer distinct advantages over the prior art, including in their structure and applications. While certain advantages are summarized 5 below, the summary is not necessarily a complete list as there may be additional advantages.

The device allows the user to advert the serious complications that can occur during percutaneous heart valve implantation. Because the device is retrievable and re-positionable during implantation into the body, the surgeon can avoid serious 10 complications due to valve mal-positioning or migration during implantation. Examples of these complications include occlusion of the coronary arteries, massive paravalvular leakage, or arrthymias.

The device can also decrease vascular access complications because of the device's narrow insertion profile. The device's profile is low, in part, due to its unique geometry, 15 which allows neighboring struts in the stent to overlap during stent compression. The device's low profile is further augmented by eliminating the necessity for a balloon or a sheath. The device's narrow profile offers the advantage of widening the vascular access route options in patients. For instance, the device can enable the delivery of the prosthetic valve through an artery in the leg in a patient whom would have previously been 20 committed to a more invasive approach through the chest wall. The device therefore aims to decrease complications associated with the use of large profile devices in patients with poor vascular access.

The tissue valve embodiments can offer improved durability by allowing for attachment of the leaflets to flexible commissural posts. The flexible posts allow 25 dissipation of the stress and strain imposed on the leaflet by the cardiac cycle. The use of multi-ply struts enables the leaflets to be sandwiched in between the struts, which reenforces the leaflet attachments and prevents tearing of sutures. The valve further assumes a desirable leaflet morphology, which further reduces the stress and strain on leaflets. Namely, the angled leaflet attachment to the stent is similar to the native human aortic 30 valve's inter-leaflet trigone pattern. These properties significantly improve the longevity of percutaneous heart valve replacement therapies. H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 2015221535 04 Sep 2015 -21 -

The device could reduce or eliminate arrthymia complications due to the incremental expansion or compression of the stent. The stent can employ a screw mechanism for deployment, which enables the stent to self-lock or un-lock at all radii. This enables more controlled deployment and the potential for individualizing the expansion or 5 compression of the device in each patient. Because the expansion or compression of the device is reversible at any stage during the procedure, the surgeon can easily reverse the expansion of the device to relieve an arrythmia. In addition, if an arrythmia is detected during implantation, the device can be repositioned to further eliminate the problem.

The device can reduce or eliminate paravalvular leak due to the device's ability to 10 be accurately positioned, and re-positioned, if necessary. That can considerably decrease the occurrence and severity of paravalular leaks.

The device eliminates balloon-related complications. The screw mechanism of deployment exploits the mechanical advantage of a screw. This provides for forceful dilation of the stent. The lever arms created by the pivoting of the struts in the scissor 15 linkage of the stent, transmits a further expansion force to the stent. The stent is expanded without the need for a balloon. In addition, the ability of the device to be forcefully dilated reduces or eliminates the need for pre- or post-ballooning during the implantation procedure in patients.

The device has more predictable and precise positioning in the body because the 20 difference between the height of the stent in the compressed and expanded position is small. This "reduced foreshortening" helps the surgeon to position the device in the desirable location in the body. The ability to re-position the device in the body further confers the ability to precisely position the device in each individual.

In addition to the mechanical advantages, the device enables a wider population of 25 patients to be treated by a less invasive means for valve replacement. For example, the device enables patients with co-morbidites, whom are not candidates for open chest surgical valve replacement, to be offered a treatment option. The device's ability to assume a narrow profile also enables patients who were previously denied treatment due to poor vascular access (e.g. tortuous, calcified, or small arteries), to be offered a treatment option. 30 The durability of the valve should expand the use of less-invasive procedures to the population of otherwise healthy patients, whom would otherwise be candidates for open 2015221535 04 Sep 2015 H:\sbt\Interwoven\NRPortbl\DCC\SBT\8379124_l.docx.-4/09/2015 -22- chest surgical valve replacement. The device's ability to be forcefully expanded, or assume hourglass, or conical shapes, potentially expands the device application to the treatment of patients diagnosed with aortic insufficiency, as well as aortic stenosis.

The device can also provide a less invasive treatment to patients with degenerative 5 prosthesis from a prior implant, by providing for a "valve-in- valve" procedure. The device could be accurately positioned inside the failing valve, without removing the patient's degenerative prosthesis. It would help the patient by providing a functional valve replacement, without a "re-do" operation and its associated risks.

While this invention has been particularly shown and described with references to 10 particular embodiments, it will be understood by those skilled in the art that various changes in form and details may be made to the embodiments without departing from the scope of the invention encompassed by the appended claims.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and 15 "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an 20 acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Claims (21)

1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. An implantable medical device, comprising: a frame comprising a first opening, a second opening, and a longitudinal axis therebetween, and comprising a plurality of stmts interconnected by a plurality of joints, wherein the joints comprise a rotation axis with an orientation substantially normal to an outer surface of the frame; and an actuation mechanism coupled to the frame at two anchor points and configured to selectively actuate expansion and collapse of the frame by applying longitudinal forces to the two anchor points to move the two anchor points longitudinally relative to each other, wherein the actuation mechanism is self-locking to maintain the frame at a desired diameter, wherein the actuation mechanism comprises a rotational interface that comprises a rod and a first threaded mount, wherein the rod comprises a first helical thread, and the first threaded mount is configured to cooperate with the first helical thread, and wherein the implantable medical device is configured to be inserted into a patient.
2. 2. The implantable medical device of claim 1, wherein the actuation mechanism is fixedly attached to the frame.
3. 3. The implantable medical device of claim 2, wherein the actuation mechanism is fixedly attached to an inner surface of the frame.
4. 4. The implantable medical device of any one of the preceding claims, wherein the actuation mechanism is configured to asymmetrically apply longitudinally oriented force along a circumference of the frame.
5. 5. The implantable medical device of claim 4, wherein the longitudinally oriented force is applied to a single longitudinal region of the frame.
6. 6. The implantable medical device of claim 5, wherein the frame is configured to circumferentially expand or collapse from the force applied along the single longitudinal region of the frame.
7. 7. The implantable medical device of claim 1, wherein the actuation mechanism is configured to expand the frame when manipulated in a first direction and to collapse the frame when manipulated in a second direction.
8. 8. The implantable medical device of claim 7, wherein the first direction and the second direction are opposite directions.
9. 9. The implantable medical device of any one of the preceding claims, wherein the rod further comprises a second helical thread configured with an opposite thread direction of the first helical thread.
10. 10. The implantable medical device of claim 9, wherein the actuation mechanism comprises a second threaded mount configured to cooperate with the second helical thread.
11. 11. The implantable medical device of claim 10, wherein the plurality of struts comprises first, second, third and fourth strut members.
12. 12. The implantable medical device of claim 11, wherein the first threaded mount is coupled to the first and second strut members.
13. 13. The implantable medical device of claim 12, wherein the second threaded mount is coupled to the third and fourth strut members, and wherein the first strut member articulates with the third strut member, and the second strut member articulates with the fourth strut member.
14. 14. The implantable medical device of any one of the preceding claims, wherein the rod further comprises a first end adjacent to the first helical thread, wherein the first end comprises a non-circular cross-sectional shape.
15. 15. The implantable medical device of any one of the preceding claims, wherein the first helical thread comprises a thread count of at least about 240 tums/inch.
16. 16. The implantable medical device of any one of the preceding claims, wherein the actuation mechanism is located along an inner surface of the frame.
17. 17. The implantable medical device of any one of the preceding claims, wherein each of the plurality of strut members articulates with three other strut members.
18. 18. The implantable medical device of any one of the preceding claims, wherein the plurality of joints comprises rivet members.
19. 19. The implantable medical device of claim 18, wherein the rivet members are located in openings in the plurality of strut members.
20. 20. The implantable medical device of any one of the preceding claims, further comprising a leaflet valve attached to the frame.
21. 21. The implantable medical device of claim 20, wherein the leaflet valve comprises pericardial tissue.