A prosthesis for engaging an electrical lead

Abstract

A prosthesis is provided with a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration. The prosthesis includes a lead management arrangement with an engaging member projecting from the frame and moveable relative to the frame between a delivery form and a deployed form, where the engaging member is curved in the deployed form to receive and confine an electrical lead.

Description

A PROSTHESIS FOR ENGAGING AN ELECTRICAL LEADCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 609,118, filed December 12, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The present teachings relate to a prosthesis for engaging an electrical lead, a catheter system containing a prosthesis, and a method of deploying a prosthesis.BACKGROUND

[0003] The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs into systemic circulation. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atrium and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and close in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and calcified which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting,palpitations, anaemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening. Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems.

[0005] Pacemakers consist of an implantable pulse generator which contain a battery and one or two electrical leads. The pulse generator generates the electric current needed to stimulate the myocardium of the heart. The current is delivered to the myocardium via the lead or leads which are guided to the right atrial and / or right ventricular myocardium. The leads enter the heat via the superior vena cava and enter the right atrium. One or more of the leads may pass through the tricuspid valve into the right ventricle. The leads include electrodes at their ends that apply a pacing signal to stimulate contraction of the ventricles. Complications are known to occur in prothesis implantation procedures, such as Transcatheter Tricuspid Valve Replacement (TTVR) and Transcatheter Tricuspid Valve Repair (TTVr), in patients with pre-existing electrical leads, for example pacemaker and / or defibrillator leads. Such complications may include dislodgement of the electrode of the electrical lead from the myocardium, and / or fracture / wear of the electrical leads inhibiting their ability to apply the pacing signal to the myocardium. Additionally, the pre-existing leads can obstruct the prosthesis and may prevent the prosthetic valve from properly engaging with the native valve annulus. This can result in migration of the prosthetic valve and / or dislodgement of the pacing leads.

[0006] The present teachings seek to overcome or at least mitigate one or more problems associated with the prior art.SUMMARY

[0007] A first aspect of the teachings provides a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising: a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration; and a lead management arrangement comprising an engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy, wherein the engaging member is moveablerelative to the frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0008] Complications are known to occur in prothesis implantation procedures, such as Transcatheter Tricuspid or Mitral Valve Replacement (TTVR or TMVR) and Transcatheter Tricuspid or Mitral Valve Repair (TTVr or TMVr), in patients with pre-existing electrical leads, for example pacemaker and / or defibrillator leads. Such complications typically include dislodgement, fracture and / or wear of the pre-existing electrical leads. Additionally, the preexisting leads can obstruct the prosthesis. During prosthesis implantation, additional leads may also be inserted into the anatomy.

[0009] The lead management arrangement manages and controls the placement of preexisting leads and / or additional leads introduced into the anatomy. The engaging member can manipulate the leads to help ensure the leads are positioned in favourable locations to improve ease of prothesis procedures, reduce conduction system disturbances, and reduce damage to existing leads.

[0010] Providing an engaging member that moves between delivery and deployed configurations enables the prosthesis to have a low profile for transcatheter delivery.

[0011] In some embodiments, the engaging member is configured to curve, hook, or loop when moving from the delivery form to the deployed form. The member forming a loop or hook facilitates capture and manipulation of a lead.

[0012] In some embodiments, a first end of the engaging member is connected to the prosthesis and a second end of the engaging member comprises a free end. Advantageously, the free end facilitates the engagement and capture of an existing lead present in the patient’s anatomy. In some embodiments, first and second ends of the engaging member engage with the frame when the engaging member is in the deployed form. Advantageously, this arrangement provides a fixed loop that facilitates receiving a new electrical lead introduced into the patient’s anatomy.

[0013] In some embodiments, the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration. In some embodiments, first and second ends of the engaging member engage with the anchoring frame when the engaging member is in the deployed form. In some embodiments, first and second ends of the engaging member engage with the valve support frame when the engaging member is in the deployed form. In some embodiments, the engaging member is connected to and extends from the valve support frame or the anchoring frame. Insome embodiments, the engaging member extends between the valve support frame and the anchoring frame in the deployed form for guiding an electrical lead between the valve support frame and the anchoring frame.

[0014] In some embodiments, the engaging member is formed from a shape memory material, for example Nitinol. Advantageously, the self-expanding material, for example a shape memory material, does not rely on manual parts to move, and can be automatically deployed without user intervention. Additionally, shape memory materials such as Nitinol are compatible with human anatomy. In some embodiments, the shape-memory material is shape set to move the engaging member from the delivery form to the deployed form. Advantageously, shape setting the engaging member helps to facilitate the automatic deployment of the engaging member.

[0015] In some embodiments, the engaging member comprises a protective lining extending at least partially thereover. Advantageously, the protective lining helps to reduce damage to the electrical leads when the engaging member manipulates the electrical lead. In some embodiments, the lining comprises a textile material. Advantageously, such materials have been found to provide a suitable level of protection for the electrical leads, whilst being biocompatible.

[0016] In some embodiments, the textile material comprises a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. In some embodiments, the lining comprises a hydrogel such as polyethylene glycol or silicone. Advantageously, such materials have been found to provide a suitable level of protection for the electrical leads, whilst being biocompatible.

[0017] In some embodiments, the protective lining at least partially covers a surface of the engaging member that faces a surface of the frame and is configured to engage an electrical lead when the engaging member is in the deployed form. Advantageously, the lined edge of the loop or hook enables the loop or hook to extend around the electrical lead, whilst the lined inner edge engages the electrical lead. This helps to reduce the likelihood of the electrical lead being damaged.

[0018] In some embodiments, the engaging member comprises one or more radiopaque regions for aligning the engaging member with an electrical lead. Advantageously, the markers facilitate alignment and engagement of leads with the engaging member.

[0019] In some embodiments, the frame is an anchoring frame and comprises at least one projecting anchor that projects beyond a radially outer surface of the anchoring frame whenthe frame is in the expanded, deployed, configuration. Advantageously, the anchors limit migration of the prosthesis in varying anatomies and provide a greater surface area to land the implant in the vein or artery.

[0020] In some embodiments, the frame comprises a liner at least partially covering a surface of the frame. Advantageously, the padded material helps to reduce damage to the electrical leads when the engaging member manipulates the electrical lead. In some embodiments, the lead management arrangement comprises first and second spaced apart engaging members, and wherein the protective liner at least partially extends from said first engaging member to said second engaging member.

[0021] In some embodiments, the liner comprises a textile material. Advantageously, such materials have been found to provide a suitable level of protection for the electrical leads, whilst being biocompatible. In some embodiments, the textile material comprises a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. In some embodiments, the lining comprises a hydrogel such as polyethylene glycol or silicone. Advantageously, such materials have been found to provide a suitable level of protection for the electrical leads, whilst being biocompatible.

[0022] In some embodiments, the frame is an anchoring frame and comprises at least one projecting anchor that projects beyond a radially outer surface of the anchoring frame, wherein the lead management arrangement comprises first and second spaced apart engaging members, and wherein a region of the frame extending between said first and second engaging members is devoid of the at least one projecting anchor. Advantageously, as the prongs have been known to cause damage to the leads, the region free from prongs creates a space for receiving the electrical leads whilst minimising damage to the electrical leads.

[0023] In some embodiments, the frame defines an inflow end and an outflow end, wherein the engaging member extends from the inflow end, the outflow end, or from between the inflow and outflow ends. Advantageously, locating the engaging member on the inflow or outflow end may help to simplify attachment and provide compact delivery of the prosthesis. Positioning the engaging member on the radially outer surface of the prosthesis helps to prevent the engaging member from obstructing the internal structure of the prosthesis. Additionally, as some electrical leads are located outside of the prosthesis, the engaging member can be easily deployed to manipulate the electrical leads.

[0024] In some embodiments, the prosthesis comprises a skirt coupled to and covering at least a portion of the frame. In some embodiments, the skirt comprises at least one punctureregion, slit, fenestration, flap, or aperture configured to receive a lead therethrough. Advantageously, the puncture region slit, fenestration, flap, or aperture provides a compact arrangement to secure or constrain electrical leads from excessive or undesired movement or migration using components of the prosthesis.

[0025] In some embodiments, the puncture region, slit, fenestration, flap, or aperture defines a passable portion of the skirt, said passable portion defining a curved, oval, circular, square-shaped, diamond-shaped, semicircular, X-shaped, or T-shaped area. The passable portion may comprise one or more weakened portions, for example perforated portions and / or scored portions.

[0026] In some embodiments, the engaging member is configured and arranged to position an electrical lead in or through the puncture region, slit, fenestration, flap, or aperture. In some embodiments, the frame comprises a brim element extending outwardly from an upstream end of the frame, wherein said brim element is at least partially covered by the skirt and the puncture region, slit, fenestration, flap, or aperture is provided on the skirt covering the brim element. Passable portions or puncture regions, slits, fenestrations, flaps, or apertures may be positioned in various regions of the implant, either alone or in combination with one or more other such portions or regions. In some embodiments that include an anchoring frame spaced radially apart from a valve support frame, for example, passable portions or punction regions may exist in a transition region between the two frames, where sidewalls of an outer anchoring frame extend out away from the inner valve support frame and transition to running substantially parallel to the longitudinal axis of the central lumen of the valve support frame. Such embodiments may help ensure that any lead or leads passing through the passable portion run between the two frames to allow for continuous tissue ingrowth around portions of the anchoring frame that directly contact and anchor to the patient’s anatomy.

[0027] In some embodiments, wherein the prosthesis is a valve prosthesis and the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration, and wherein the prosthesis comprises a prosthetic valve component disposed within and secured to the valve support frame, the prosthetic valve component being configured to prevent blood flow in one direction to convey blood flow through the central lumen of the frame.

[0028] In some embodiments, the engaging member includes an atraumatic tip. This arrangement enables the engaging member to avoid causing trauma to an electrical lead confined by the engaging member.

[0029] In some embodiments, in the deployed form, the engaging member extends at least partially along an axis extending between an inflow and an outflow end of the frame. This arrangement enables the engaging member to guide an electrical lead through the prosthesis.

[0030] In some embodiments, the prosthesis comprises one or more radiopaque or echogenic markers for aligning the prosthesis with a native annulus.

[0031] In some embodiments, the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a snare region, wherein the snare region is configured and arranged to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration. In some embodiments, the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a loop-like region, wherein the loop-like region comprises an indentation or notch configured to engage an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0032] A second aspect of the teachings provides a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising: a valve support frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the valve support frame defines a central lumen and is configured to anchor the prosthesis in the expanded, deployed; and a lead management arrangement comprising an engaging member projecting from the valve support frame for engaging an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the valve support frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0033] In some embodiments, the engaging member extends radially outward from the valve support frame, curves, and further extends radially inward toward the valve support frame to form a snare region, wherein the snare region is configured to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0034] In some embodiments, the valve support frame is at least partially covered with a skirt that comprises a puncture region, slit, fenestration, flap, or aperture suitable for an electrical lead to be passed through. In some embodiments, the valve support frame is at least partially covered with a fabric that comprises a puncture region marked by a radiopaque target that may be cauterized or otherwise punctured to allow an electrical lead to be pass through.

[0035] In some embodiments, the puncture region, slit, fenestration, flap, or aperture defines a passable portion of the skirt, said passable portion defining a curved, oval, circular, square-shaped, diamond-shaped, semicircular, X-shaped, or T-shaped area. The passable portion may comprise one or more weakened portions, for example perforated portions and / or scored portions.

[0036] A third aspect of the teachings provides a delivery catheter system comprising: a catheter assembly comprising an elongate catheter body having a distal end portion; and a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, said prosthesis comprising a frame having a compressed, delivery, configuration and an expanded, deployed, configuration, wherein the frame defines a central lumen, and a lead management arrangement comprising an engaging member moveable relative to the frame between a delivery form and a deployed form, wherein the prosthesis is positioned within the catheter body with the frame in the compressed, delivery, configuration and the engaging member in the delivery form, wherein the prosthesis is deployable from the catheter body so as to enable the engaging member to move from the delivery form to the deployed form in which the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0037] In some embodiments, the prosthesis is deployable from the catheter body to enable the engaging member to move from the delivery form to the deployed form with the frame in the compressed, delivery, configuration. In some embodiments, the prosthesis is deployable from the catheter body to enable the frame to move from the compressed, delivery, configuration to the expanded, deployed, configuration.

[0038] In some embodiments, the catheter assembly comprises an atraumatic tip positioned at or near the distal end portion of the catheter body.

[0039] In some embodiments, the prosthesis is a valve prosthesis and the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration, and wherein the prosthesis comprises a prosthetic valve component disposed within and secured to the valve support frame, the prosthetic valve component being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the valve support frame.

[0040] In some embodiments, the elongate catheter body comprises a first housing and a distal capsule defining a second housing, wherein the second housing is configured to retain the frame in the compressed, delivery, configuration and retain the engaging member in thedelivery form. In some embodiments, the first and second housings are configured to move in opposite directions to deploy the prosthesis such that when the second housing is moved in a distal direction it no longer retains the engaging member in the delivery form.

[0041] In some embodiments, the elongate catheter body comprises a first housing and a second housing, said first housing arranged within the second housing, and wherein the first housing is configured to retain the frame in the compressed, delivery, configuration and the second housing is configured to retain the engaging member in the delivery form. In some embodiments, the first and second housings are configured to move independently to deploy the frame and the engaging member, such that when the second housing is moved it no longer retains the engaging member in the delivery form and when the first housing is moved it no longer retains the frame in the compressed, delivery, configuration.

[0042] A fourth aspect of the teachings provides a kit of parts comprising: a delivery catheter system comprising a catheter assembly comprising an elongate catheter body having a distal end portion; and a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration, and a lead management arrangement comprising an engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead, and wherein the prosthesis is configured to be able to be positioned within the catheter body with the frame in the compressed, delivery, configuration and the engaging member in the delivery form.

[0043] A fifth aspect of the teachings provides a method of deploying a valve prosthesis comprising: obtaining a catheter assembly comprising an elongate catheter body having a distal portion; obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration, and a lead management arrangement comprising an engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy; positioning the valve prosthesis within the catheter body in the compressed, delivery, configuration; deploying the valve prosthesis from the catheter body to deploy the engaging member and enable the engaging member to move from a delivery formto a deployed form in which the engaging member is curved for receiving and confining an electrical lead; engaging an electrical lead with the engaging member; and deploying the valve prosthesis from the catheter body to enable the frame to move from the compressed, delivery configuration to the expanded, deployed configuration.

[0044] In some embodiments, the method comprises the step, after engaging an electrical lead with the engaging member, of rotating the valve prosthesis to position the electrical lead in a desired location. In some embodiments, the method comprises the step of rotating the valve prosthesis into alignment with the electrical lead.

[0045] In some embodiments, the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a snare region, wherein the snare region is configured and arranged to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration. In some embodiments, the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a loop-like region, wherein the loop-like region comprises an indentation or notch configured to engage an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0046] In some embodiments, the engaging member extends radially outward from the valve support frame, curves, and further extends radially inward toward the valve support frame to form a snare region, wherein the snare region is configured to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Embodiments will now be described with reference to the accompanying drawings, in which:

[0048] Figure 1 is a schematic illustration of a heart;

[0049] Figure 2 is a side view of a prosthesis;

[0050] Figure 3 is a cross-sectional side view of the prosthesis of Figure 2;

[0051] Figure 4 is a schematic view of a delivery catheter system according to an embodiment in a first configuration including an atraumatic tip;

[0052] Figure 5 is a schematic view of the delivery catheter system of Figure 4 in a second configuration;

[0053] Figure 6 is a schematic view of the delivery catheter system of Figure 4 in a third configuration;

[0054] Figures 7A and 7B are a side views of a prosthesis according to an embodiment;

[0055] Figure 8 is a schematic view of the delivery catheter system of Figure 4 in a heart;

[0056] Figure 9 is a schematic view of the delivery catheter system of Figure 4 in a heart with a prosthesis positioned at a native valve of a patient;

[0057] Figure 10A is a schematic view of the delivery catheter system according to an embodiment in a first configuration;

[0058] Figure 10B is a schematic view of the delivery catheter system of Figure 9A in a second configuration;

[0059] Figure 11 is a schematic view of a prosthesis according to an embodiment positioned at a native valve of a patient;

[0060] Figures 12A and 12B are a schematic views of a prosthesis according to an embodiment;

[0061] Figure 13 is a schematic view of a prosthesis according to an embodiment;

[0062] Figure 14A-D are schematic views of the prosthesis of Figure 13 engaging an electrical lead;

[0063] Figure 15 is a schematic view of the prosthesis of Figure 13 positioned at a native valve of a patient;

[0064] Figure 16 is a schematic view of a valve prosthesis according to an embodiment;

[0065] Figures 17A and 17B are schematic views of a prosthesis according to an embodiment;

[0066] Figures 18 and 19 are schematic views of a valve prosthesis according to an embodiment; and

[0067] Figure 20 is a schematic view of an engaging member of a prosthesis according to an embodiment.DETAILED DESCRIPTION OF EMBODIMENT(S)

[0068] Figure 1 is a schematic sectional illustration of a human heart. The human heart includes right and left atriums (RA, LA, respectively), and right and left ventricles (RV, LV, respectively). Disposed between the left atrium and left ventricle is the mitral valve (MV). As left atrial pressure increases above that of left ventricle, the mitral valve opens and blood passes into the left ventricle. The mitral valve is formed from a pair of leaflets having distaledges that meet to close the mitral valve. Each leaflet is attached to an annular region of the heart structure known as the mitral valve annulus. Disposed between the right atrium and the right ventricle is the tricuspid valve (TV). As right atrial pressure increases above that of right ventricle, the tricuspid valve opens and blood passes into right ventricle. The tricuspid valve is formed from three leaflets having distal edges that meet to close the tricuspid valve. Each leaflet is attached to the tricuspid valve annulus. In addition to mitral valve and tricuspid valve, the heart includes the aortic valve and the pulmonary valve. The aortic valve permits one-way flow of blood from the left ventricle to the aorta. The pulmonary valve permits one-way flow of blood from right ventricle to pulmonary artery. Each of the aortic valve and the pulmonary valve are formed from three leaflets having distal edges that meet to close the respective valve . Each leaflet is attached to an annular region of the heart structure known as the valve annulus.

[0069] The heart includes pre-existing electrical leads, for example pacemaker leads. In the arrangement shown, the heart includes two electrical leads LI, L2. Each lead includes an electrode at the distal end thereof and are connected to a pulse generator (not shown). The leads LI, L2, enter the right atrium via the superior vena cava. A first lead LI is directed to the right atrial myocardium. A second lead L2 passes through the tricuspid valve TV, enters the right ventricle RV and is directed to the right ventricular myocardium. The electrodes of the first and second leads LI, L2 are attached to the myocardium by screws and / or anchors (not shown). The pulse generator generates the electric current to deliver a pacing signal needed to stimulate the myocardium of the heart.

[0070] Illustrated embodiments relate to a transcatheter prosthesis. In the exemplary illustrated embodiments, the prosthesis is in the form of a heart valve prosthesis configured for placement within a mitral heart valve or a tricuspid heart valve. In alternative embodiments, the transcatheter heart valve may be configured for placement within a pulmonary, or aortic valve, or may be utilized with any transcatheter prosthesis configured for placement within a venous valve or within other body passageways where it is deemed useful.

[0071] Referring to Figures 2 and 3, a prosthesis is illustrated and is indicated generally at 10. The prosthesis 10 is configured to be radially compressed into a reduced-diameter, or crimped, delivery configuration for delivery within a vasculature (not shown) and to return to an expanded, deployed configuration, as is illustrated in Figure 3. Stated another way, the prosthesis 10 has a compressed, delivery configuration for delivery within a vasculature and an expanded, deployed configuration for deployment at a native heart valve. When in the delivery configuration, the prosthesis 10 has a low profile suitable for delivery to anddeployment within a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of the native heart valve of a heart, for example via any one of a transseptal, retrograde, or transapical approach.

[0072] The prosthesis 10 includes a stent or frame 12. In some embodiments, the frame 12 may be a single frame that anchors to the native anatomy, and to which is attached prosthetic-valve material, such as bovine, porcine, or equine tissue. As one example, the single frame may be a cylindrical frame, being definable in terms of a lateral surface and two end surfaces constituting planes intersecting the lateral surface. For example, it may be a rightcircular cylindrical frame, an oblique cylindrical frame, an elliptical cylindrical frame, a parabolic cylindrical frame, or a hyperbolic cylindrical frame, such as an hourglass-shaped frame. It may be balloon-expandable or self-expanding. The end surfaces may be parallel or offset planes when compared to one another. In some embodiments, the frame 12 may be a dual frame. In these embodiments, the frame 12 includes a valve support or inner frame 14. The frame 12 includes an anchoring frame or outer frame 16. The inner frame 14 is at least partially surrounded (e.g., radially) by and coupled to the outer frame 16, when the prosthesis 10 is in the radially expanded configuration. The prosthesis 10 includes a prosthetic valve component 18 including at least one leaflet 20 disposed within and secured to the frame 12. The outer frame 16 is configured to anchor the prosthesis 10 in the expanded, deployed configuration while allowing the inner frame 14 to remain in a substantially undeformed configuration that allows the prosthetic valve component 18 to function as intended. In dualframe embodiments, the inner and outer frames may be connected to one another through rivets, hooks, buttons, or otherwise.

[0073] In the embodiment illustrated, the outer frame 16 is coupled or connected to the inner frame 14 at or near to the outflow end of the inner frame 14 by rivets 23. It will be appreciated that in alternative embodiments, the outer frame 16 may be connected to the inner frame 14 at any suitable location and by any suitable attachment means or mechanism, such as by rivets or sutures at or near the inflow end of the inner frame 14, or at another alternative or additional point between or at or near the inflow and outflow ends. In some alternative embodiments, for example, the inner and outer frames are made of a single continuous tube, such as where the frame 12 includes an outer frame 16 that is defined by a portion of the frame 14 that is everted so as to radially surround the inner frame 14. Put another way, in some alternative embodiments, the outer frame 16 may extend from an end of the inner frame 14 and be folded over so as to radially surround the inner frame 14 (e.g., such that the inner frame14 is at least partially positioned within the outer frame 16). In such embodiments, the outer frame 16 may extend from the inflow end of the inner frame 14 or the outflow end of the inner frame 14.

[0074] In some dual -frame embodiments, the inner frame 14 may have a tubular or cylindrical shape. The inner frame 14 defines a central lumen 21 from an inflow end to an outflow end thereof. The inner frame 14 is configured to support the prosthetic valve component 18 therein. In an embodiment, the outflow end has a diameter that is substantially the same as a diameter of the inflow end and substantially resists deformation when the outer frame 16 is deformed by the native anatomy surrounding the heart valve.

[0075] In some embodiments, the outer frame 16 may be tubular or cylindrical shape, such as a right cylindrical shape or a cylinder shape with an hourglass, hyperbolic, or conical profile, for example. The outer frame 16 functions as an anchor for the prosthesis 10 to secure its deployed position within a native annulus. The outer frame 16 is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve or native tricuspid valve. At the inflow end of the inner frame 14, the outer frame 16 is radially spaced a distance S from the inner frame 14 to mechanically decouple the inflow end of the inner frame 14 from the outer frame 16. In some embodiments, in cross-section, or viewed along its longitudinal axis, the outer frame 16 may be D-shaped, cylindrical, elliptical, or irregularly shaped. The outer frame 16 may also have an angled or irregular side profile. The outer frame may have a cross-section taken through a plane normal to the longitudinal axis of its inner lumen that is circular, D-shaped, V-shaped, indented, convex, concave, or any other suitable shape. The sidewalls 25 of the outer frame 16 may extend out away from the inner stent at a transition region 31 and transition to running substantially parallel to the longitudinal axis of the central lumen 21. Alternatively, the sidewalls 25 of the outer frame 16 may take on various other profiles, including hourglass, indented, convex, concave, or another suitable profile. As another example, the outflow end of the outer frame 16 may be angled across one or both of its proximal or distal edges, such that the longitudinal length along an outer side wall of the outer frame is nonuniform around its circumference. This can be useful, for example, in that it can provide additional frame-profile options that may reduce obstruction of surrounding anatomy, such as the left or right ventricular outflow tracts (LVOT and RVOT, respectively) if they prosthetic valve is implanted in either the mitral or tricuspid annulus.

[0076] In some embodiments, some or all of the frame 12 may be sealed by a cover, such as a skirt 28. In some embodiments, a skirt of fabric or tissue may be connected to the frame12 in a manner that controls paravalvular leakage or flow. A skirt may be attached to an inner surface, an outer surface, or an inner and an outer surface of the frame 12 around a circumference or a portion thereof. In some embodiments, the prosthetic valve component 18 may be attached to the skirt or to the skirt and frame 12. The skirt may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. The inner skirt may be formed from a polymeric material. The skirt may be a fabric, for example a low-porosity woven or braided fabric. Examples of such materials are polyethylene terephthalate (PET), polyester, Dacron fabric, or PTFE. The prosthesis 10 may include an inner skirt 22. The inner skirt 22 is coupled to the inner frame 14. In the embodiment shown, the inner skirt 22 is coupled to an inner surface of the inner frame 14 to line a portion thereof. Alternatively, the inner skirt 22 may be coupled to an outer surface of the inner frame 14. The inner skirt 22 creates fluid boundaries of a one-way fluid passage when attached to the inner frame 14 and combined with the prosthetic valve component 18. In one embodiment, the inner skirt 22 may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. In some embodiments, the inner skirt 22 may be provided with a coating of a surface coating material. Put another way, the inner skirt 22 may have a layer of a coating material on a surface thereon. The surface coating material may comprise a polymeric material. The surface coating material may comprise one or more of: PTFE; polyurethane; silicone; and hydrogels.

[0077] The outer frame 16 in some embodiments such as the one shown includes one or more cleats, prongs, anchors, barbs, spikes 24 or other fixation mechanism that extend outward from an exterior side thereof to engage and / or pierce heart tissue. Put another way, the anchoring frame may have at least one projecting anchor that projects beyond a radially outer or lateral surface of the anchoring frame when the frame 12 is in the expanded, deployed, configuration. In embodiments including prongs, for example, the prongs 24 may be arranged in one or more rows, columns, or in other patterns.

[0078] The frame 12 may be formed from a self-expanding or balloon-expandable material, or a combination of both. The inner frame 14 and / or the outer frame 16, in embodiments having both inner and outer frames, may be formed from a self-expanding material, for example. In such embodiments, or in other embodiments including a frameformed with a self-expanding material, the self-expanding material may be provided in the form of a shape-memory material, for example Nitinol™. The shape-memory material may be a shape-memory polymer, or a shape-memory alloy, such as Nitinol. Any portion of the frame 12 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or any number of other materials or combination of materials. A suitable biocompatible material would be selected to provide the prothesis 12 to be configured to be compressed into a reduced-diameter crimped configuration for transcatheter delivery to a native valve, whereby release from a delivery catheter returns the prosthesis to an expanded, deployed configuration. In alternative embodiments, the frame (i.e., the inner and / or outer frame) may be formed from an expandable material. In such embodiments, the frame may be expanded by an expanded means, such as a balloon. Any portion of the frame 12 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.

[0079] The prosthesis 10 in this embodiment includes an optional brim or rim element 26. The exemplary brim 26 shown here extends outwardly from an inflow / upstream end of the outer frame 16. The brim element 26 includes a brim frame 27. In the embodiment shown, the brim frame includes overlapping, 180° out of phase sinusoidal wire forms. In alternative embodiment, only a single sinusoidal wire brim frame may be used, although it will be appreciated that any suitable brim frame may be used in embodiments that include the optional brim. The brim frame is attached to the outer frame 16 by an outer skirt 28. The outer skirt 28 may be any suitable biocompatible material, for example a low-profde fabric used in bioprosthetic implants, such as woven polyethylene terephthalate (PET) fabric. The brim element 26 may act as an atrial retainer, if present. It may also aid in visualizing the prosthesis and its placement or orientation during the implant procedure under fluoroscopy, ultrasound, or another appropriate live-visualization technique. In order to provide this function, the optional brim element 26 may be configured to engage tissue above or on a native annulus, such as a supra-annular surface or some other tissue in the atrium, to thereby provide a featurefor visualization, inhibit downstream migration of the prosthesis 10, assist with sealing to prevent regurgitation, or any combination of these benefits.

[0080] In some embodiments, the prosthesis 10 may be provided with one or more radiopaque or echogenic markers for aligning the prosthesis 10 with a native annulus. For example, some embodiments include a brim 26. The brim 26 may include one or more wires 27 or other radiopaque or echogenic markers. The wires 27 may form the brim frame.

[0081] The prosthetic valve component 18 of the valve prosthesis 10 is capable of regulating flow therethrough via valve leaflets that may form a replacement valve. In the illustrated embodiment, the valve component 18 is shown has having three leaflets, although other numbers of leaflets, such as in a single leaflet or bicuspid leaflet configuration, may alternatively be used. When deployed in situ, the prosthetic valve component 18 in a closed state is configured to block blood flow in one direction to regulate blood flow through a lumen 21 of the inner frame 14. The prosthetic valve component 18 includes valve leaflets 20, e.g., three valve leaflets 20. The valve leaflets 20 are disposed to coapt within an upstream portion of the inner frame 14. The orientation of the leaflets 20 within the inner frame 14 depends upon on which end of the transcatheter valve prosthesis 10 is the inflow end and which end of the transcatheter valve prosthesis 10 is the outflow end, thereby ensuring one-way flow of blood through the transcatheter valve prosthesis 10. In some embodiments, the valve leaflets 20 may be attached to the inner skirt 22. The valve leaflets 20 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0082] In the embodiments of Figures 4 to 15, the catheter system 30 and the prosthesis 10 are configured to receive, engage, confine, manipulate and / or move a pre-existing electrical lead LI, L2 within a patient’s anatomy. Stated another way, the catheter system 30 and the prosthesis 10 may be introduced into a patient’s anatomy after the electrical leads LI, L2 have been implanted in the patient’s anatomy to engage said electrical leads.

[0083] Referring to Figures 4 to 6, for delivery, the transcatheter valve prosthesis 10 is radially compressed into a reduced-diameter crimped configuration onto a delivery cathetersystem 30 for delivery within a vasculature. The delivery catheter system 30 is configured for delivering and deploying the prosthesis 10 within a patient. The delivery catheter system 30 has a catheter assembly 32 including an elongate catheter body 34 having an end portion 36. In some embodiments, the catheter system 30 may include an atraumatic tip 38. The atraumatic tip 38 may be positioned at the end portion 36 of the catheter body 34. As shown in Figure 4, it may have a configuration in which it is flush with end portion 36, but in another configuration, it may extend away from the end portion 36. The atraumatic tip 38 may be used to facilitate the advancement of the catheter system 30 through the patient’s skin and vasculature. The atraumatic tip 38 may be configured to prevent intravascular trauma during delivery of the catheter system 30 to the native valve annulus. In some embodiments, the atraumatic tip 38 may be a flexible curved or tapered tip (i.e., a flexible curved or tapered distal end face). In one embodiment, the atraumatic tip 38 may have a distal opening 40 for accommodating a guidewire 42. It will be understood that the taper and / or curvature of the atraumatic tip 38 may be varied depending upon the sizing / configuration as required. In some embodiments, the atraumatic tip 38 may be omitted.

[0084] The catheter system 30 is illustrated in a first configuration where the prosthesis 10 is illustrated as being positioned at least partially, for example entirely, within the catheter body 34. The prosthesis 10 has a compressed delivery configuration and an expanded, deployed configuration. When the prosthesis 10 is contained within the catheter body 34, as is illustrated in Figure 4, the prosthesis 10 is in the compressed delivery configuration. A delivery configuration may be one in which at least a part, for example all, of the prosthesis 10 is in a radially compressed configuration. It will be understood that the prosthesis 10 may remain in the delivery configuration when the prosthesis 10 is partially deployed from the catheter body 34, as is illustrated in Figures 5 and 6.

[0085] The prosthesis 10 includes a lead management arrangement. The lead management arrangement manages and controls the relative location of pre-existing implanted leads and / or additional, later implanted, leads introduced into the anatomy. This can help to manipulate, protect, and hold the leads so as to help ensure the leads are positioned in favourable locations to improve ease of prothesis procedures, reduce conduction system disturbances at the implant location, whether such disturbances occur through unintended or undesirable interaction with the pacemaker lead or through undesirable or unintended interaction with the native anatomy and local nervous system. Lead management arrangements are also beneficial to prevent, limit, or reduce damage to implanted or temporary electrical leads.

[0086] The leads management arrangement depicted includes a lead engaging member 44, which may be referred to as engaging member 44, projecting from the frame 12. This is useful for engaging an electrical lead in a patient’s anatomy. The lead engaging member 44 may have a first end connected to the frame 12 and a second end defining a free end. In other embodiments, the first and second ends of the lead engaging member 44 may engage with the frame 12 when the prosthesis 10 is in a deployed configuration. The engaging member 44 is configured for engaging and / or manipulating an electrical lead within a patient’s anatomy. In some embodiments, the engaging member 44 may project from the outer or anchoring frame 16, in other embodiments the engaging member 44 may extend from the inner frame 14, extend between the inner and outer frames 14, 16, or extend from any part of the frame 12, such as from both the inner and outer frames 14, 16. In the embodiment illustrated, the prosthesis 10 includes two engaging members 44, but alternative embodiments may include one, three, four or any suitable number of engaging members 44. In some embodiments, the prosthesis may include exactly one, two, three, or four lead engaging members 44. If there are multiple lead engaging members 44, in some embodiments they may be confined to one circumferential region of the prosthesis 10. Stated another way, they may not be spaced around the entire circumference or even a majority of the circumference of the prosthesis 10. The engaging member 44 includes an atraumatic tip 45. Providing the engaging member 44 with an atraumatic tip 45 helps to reduce / avoid causing trauma to an electrical lead confined by, in proximity to, or manipulated by the engaging member. In some embodiments, the engaging member 44 is a single wire. In other embodiments, the engaging member 44 is multiple wires bound together. In other embodiments, the engaging member 44 is multiple wires intertwined with one another. In other embodiments, the engaging member 44 is one or more loops in proximity to one another. In still other embodiments, the engaging member 44 is a wire framework. In other embodiments, the engaging member 44 is a wire framework that includes a spherical tip 45. In other embodiments, a spherical tip 45 of the engaging member 44 is covered or coated with a fabric or other material. Some embodiments include multiple engaging members 44 having one or more of the above configurations together, such as an engaging member 44 with multiple wires intertwined with one another as well as an additional engaging member 44 with a single-loop framework having spherical beads affixed along all or a portion of its length.

[0087] The engaging member 44 may have various lengths. In some embodiments, the engaging member 44 has a length that is similar to the length of a frame supporting a valve.In some embodiments, the engaging member 44 has a length that is shorter than the length of a frame supporting a valve. In some embodiments, the engaging member 44 has a length that is longer than the length of a frame supporting a valve. In embodiments including a plurality of engaging members 44, said engaging members may have the same or different lengths.

[0088] The engaging member 44 is moveable relative to the frame 12 between a delivery form and a deployed form. In a first configuration of the catheter system 30, as is illustrated in Figure 4, the prosthesis 10 is entirely contained within the catheter body 34 and the engaging member 44 is in the delivery form. In the delivery form, the engaging member 44 is aligned longitudinally with the frame 12. Put another way, when the engaging member 44 is in the delivery form, the engaging member 44 may not substantially overlap with the frame 12. This may allow the prosthesis 10 to take on a compressed profile of lower diameter than if the engaging member 44 substantially overlapped with the frame 12 when compressed within the catheter assembly 32.

[0089] In a second configuration of the catheter system 30, as is illustrated in Figure 5, the prosthesis 10 is partially deployed from the catheter body 34, the engaging member 44 may extend from the distal end 36 of the catheter body 34 but may remain in the delivery form. Further deployment of the prosthesis 10, with the catheter system 30 in a third configuration as is illustrated in Figure 6, enables the engaging member 44 to move from the delivery form into a deployed form. The engaging member 44 is configured to curve, hook, or loop when moving from the delivery form to the deployed form, for example to form a curve, hook, loop, spiral or any other curved form. This motion can occur due to spring action, shape setting, or to the active rotation or bending of a hinge or clip, for example.

[0090] In some embodiments, the engaging member 44 may be formed, at least in part from a shape-memory material. The shape-memory material may be a shape-memory polymer, or a shape-memory alloy, such as Nitinol™. The shape-memory material may be shape set to move the engaging member 44 from the delivery form to the deployed form. The shape set portions of the engaging member 44 may move the engaging member 44 from the delivery form to the deployed form when released under certain temperature conditions, such as within the human body. Any portion of the engaging member 44 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or any number of other materials or combination of materials.

[0091] Upon deployment of the prosthesis 10 from the catheter assembly 32, the prosthesis 10 returns to an expanded, deployed configuration with the engaging members 44 in the deployed form, as is illustrated schematically in Figures 7A and 7B. The engaging members 44 extend from the frame 12, such as the inflow end or outflow end or from a point between the inflow and outflow ends, or a standalone frame for both anchoring to the anatomy and supporting a valve, for example. The engaging members 44 may extend from the inner frame 14 (as illustrated in Figure 7B), from the outer frame 16, from both the inner frame 14 and the outer frame 16, or from a connection between the inner frame 14 and the outer frame 16 (as is illustrated in Figure 7A), for example. The engaging members 44 are curved so as to extend towards the outflow end of the prosthesis 10. In alternative embodiments, it will be appreciated that the engaging members 44 may extend from the outflow end of the prosthesis 10 and be curved so as to extend the inflow end of the prosthesis 10. In further alternative embodiments, the engaging members 44 may extend from any part of the frame 12 and may be oriented to extend along any direction relative to the prosthesis 10.

[0092] In the arrangement shown, the catheter assembly 32 includes a catheter body 34 that is configured to retain the frame 12 in the compressed, delivery, configuration and retain the engaging member 44 in the delivery form. A proximal retraction of the catheter body 34 enables the engaging member 44 to move from the delivery form to the deployed form. Further proximal retraction of the catheter body 34 enables the frame 12 to move from the compressed, delivery, configuration to the expanded, deployed configuration. In alternative embodiments, wherein the elongate catheter body 34 may include a first housing and a second housing, said first housing arranged within the second housing. The first housing may be configured to retain the frame 12 in the compressed, delivery, configuration and the second housing may be configured to retain the engaging member 44 in the delivery form. In such embodiments, the first and second housings may be configured to move independently to deploy the frame 12 and the engaging member 44, such that when the second housing is moved (e.g. proximally retracted) it no longer retains the engaging member 44 in the delivery form and when the first housing is moved (e.g. proximally retracted) it no longer retains the frame 12 in the compressed, delivery, configuration.

[0093] Figures 8 and 9 schematically show the prosthesis 10 engaging an electrical lead LI, L2 in a patient’s anatomy and being positioned within an annulus, for example the tricuspid valve annulus TV. It will be understood that the annulus is a schematic representation of a native valve annulus of a patient, for example a tricuspid valve TV of a patient. Asdepicted in Figure 9, a user deploys lead engaging members 44 to engage a lead LI, L2 within a right atrium RA. The two engaging members 44 here are illustrated as being of roughly equivalent length, each having a spherical tip portion 45. These engaging members 44 wrap at least partially around lead LI, L2 to grasp it. The user then advances the catheter assembly 30 through the tricuspid valve TV annulus and into the right ventricle RV. Once in the RV, as depicted in Figure 9, one of the lead engaging members 44 is manipulated to also grasp a leaflet or portion of the annulus, so as to secure the lead LI, L2 to the anatomy in that location.

[0094] In embodiments containing two engaging members 44, a first engaging member 44A may be of a different size to a second engaging member 44B. Alternatively or additionally, the first and second engaging members 44A, 44B may be moveable independently from each other. For example, in some embodiments, the first engaging member 44A may be controlled, moved, or articulated to engage the electrical lead LI, L2 and the second engaging member 44B may be controlled, moved, or articulated to grasp a leaflet or portion of the annulus, for example. In other exemplary embodiments, the first and second engaging members 44A, 44B may be operated independently to engage different electrical leads present within the patient’s anatomy.

[0095] Referring to Figures 10A and 10B, a delivery catheter system 130 is illustrated. Features common to the delivery catheter system 30 described with reference to Figures 4 to 6 are identified with like reference numerals with the prefix ‘ 1 ’ and only differences are discussed.

[0096] The delivery catheter system 130 is configured for delivering and deploying the prosthesis 10 within a patient. The delivery catheter system 130 has a catheter assembly 132 including an elongate catheter body 134 having a distal end portion 136. It will be understood that the prosthesis 10 includes all of the features of the prosthesis 10 discussed with reference to Figures 2 and 3 and is similar to the prosthesis 10 described with reference to Figures 2, 3, 7A and 7B.

[0097] In this embodiment, the catheter assembly 132 includes a first housing 134 and a capsule 150. The capsule defines a second housing 150 and serves to house prosthesis 10. The first housing depicted in this embodiment is a catheter body 134 having a distal end portion 136. The capsule 150 is arranged distal to the catheter body 134. The prosthesis 10 is positioned within the second housing 150. The second housing 150 is configured to retain the frame 12 in the compressed delivery configuration and the lead engaging member 44 in the delivery form. The first and second housings 134, 150 may be configured to move in oppositedirections to deploy the prosthesis 10. In such embodiments, when the second housing 150 is moved in a distal direction relative to the prosthesis 10, or when the prosthesis 10 is moved in a proximal direction relative to the second housing 150, the prosthesis 10 is deployed from a proximal end 152 of the second housing 150. This may be done in a similar manner to what has been described with reference to Figures 4 to 6, for example.

[0098] Figure 11 schematically shows the prosthesis 10 deployed and engaging an electrical lead LI, L2 in a patient’s anatomy and being positioned within an annulus. It will be understood that the annulus is a schematic representation of a native valve annulus of a patient, for example a tricuspid valve TV of a patient. Engaging member 44 may also sandwich a leaflet (not shown) to the annulus, thus serving to both clamp leads LI, L2 into place and position the leaflet in a matter that best helps control blood flow through and / or around the prosthesis 10.

[0099] Upon deployment of the prosthesis 10 from the catheter assembly 132, the prosthesis 10 returns to an expanded, deployed configuration with the lead engaging members 44 in the deployed form, as is illustrated schematically in Figure 11. In this embodiment, the engaging members 44 extend from an outflow end of the frame 12 that is facing the right ventricle RV. The engaging members 44 are curved in this embodiment so as to extend towards the inflow end of the prosthesis 10, which is facing the right atrium RA. In alternative embodiments, it will be appreciated that the engaging members 44 may extend from the inflow end of the prosthesis 10 or from a middle portion of the prosthesis and be curved so as to extend toward the any other portion of the prosthesis 10, such as a middle portion, the inflow end, or the outflow end. In the embodiment illustrated, there is exactly one lead engaging member 44, however, as described above, there may be two, three, four, or more engaging members 44 or exactly two, three, or four engaging members 44.

[0100] Referring to Figures 12A and 12B, in some embodiments, the frame 12 may include a bridge or liner 54 or bridge portion at least partially covering a surface of the frame 12 or extending from one portion of the frame to another. The liner 54 in the depicted embodiment provides a protective layer or padding that helps to reduce damage to the electrical leads when the engaging member(s) 44 manipulates the electrical lead. A fabric bridge portion, for example, could serve the same purpose while spanning a gap from one portion of self-expanding material to another. In the arrangement shown, the liner 54 is provided on the outer or anchoring frame 16. The liner 54 comprises a textile material. Textile materials have been found to provide a suitable level of protection for the electrical leads,whilst being biocompatible. The textile material may be formed from a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. Alternatively, or in combination, the lining 54 may include a hydrogel such as polyethylene glycol or silicone.

[0101] The liner 54 of this embodiment may be arranged on the frame 12 so as to be adjacent or near the engaging member(s) 44. In embodiments containing first and additional spaced apart engaging members 44, the protective liner 54 may at least partially, or entirely, extend from said first engaging member 44 to said second engaging member 44. In this way, an electrical lead engaged between the first and second engaging members 44 would be arranged along the liner 54, so as to reduce damage to the electrical lead. In some embodiments, the liner 54 may only be present between engaging members 44 (e.g., in areas where an electrical lead is to be confined) and not on other areas of the prosthesis. If the liner 54 extends completely between two engaging member 44, then the engaging members 44 themselves may serve as a visual aid to locate the liner region (e.g., if the engaging members 44 are radiopaque). If the liner 54 does not extend fully between two engaging members, or if additional visualization is desired, radiopaque markers may be present on the liner 54, frame, or liner of the prosthesis to identify the region covered by the liner 54.

[0102] In embodiments where the prosthesis includes the anchors 24 extending from the frame 12, a region of the frame extending between said first and second engaging members 4 may be devoid of any anchors 24 or may include anchors that are especially atraumatic. As some prongs have been known to cause damage to the leads, a region free from prongs creates a space for receiving the electrical leads whilst minimising or avoiding damage to the electrical leads. In such embodiments, the region devoid of the anchors 24 may be partially, for example entirely covered by the protective lining. In other embodiments, the region may only be devoid of traumatic anchors and there may not be an additional liner or padding. Similar to the liner 54, the region without traumatic anchors may be identified by the engaging arms 44 (e.g., region between two arms) and / or it may be identified by radiopaque markers. In embodiments where there is a liner 54 and a region devoid of anchors 24, there may be a region with a liner but no anchors 24 (or with atraumatic anchors) and a region with no liner but with anchors (e.g., traumatic anchors). In embodiments where atraumatic anchors are used in the lead- engaging region, the prosthesis may include traumatic anchors in the non-engaging regions to thus have two types of anchors.

[0103] Referring to Figure 13, in some embodiments, the lead management arrangement may include a lead engaging member 44 projecting from the inner or valve support frame 14 for engaging an electrical lead in a patient’s anatomy. In these embodiments, the engaging member 44 may extend radially outward from the inner or valve support frame 14. In the deployed form, the engaging member 44 curves, and further extends radially inward toward the valve support frame 14 to form a snare region. An atraumatic tip 45 may be located on the end of the engaging member that extends radially inward toward the frame, which may be a free end of the engaging member. The snare region is configured to ensnare an electrical lead when the deployed prosthesis 10 is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0104] Referring to Figures 14A to 14D, engaging of an electrical lead with the prosthesis 10 of Figure 13 is shown schematically. As is illustrated in Figure 14A, the prosthesis 10 is positioned such that the lead engaging member 44 is adjacent to an electrical lead LI, L2. In the embodiment shown, the engaging member 44 is U-shaped, and as the prosthesis is rotated clockwise, such that the electrical lead LI, L2 contacts the engaging member 44 so as to deform said engaging member 44, as is shown in Figure 14B. Further rotation of the prosthesis 10 causes the electrical lead LI, L2 to move into the snare region (e.g., by moving past the free end, which may then return to its previous shape) so as to be contained and / or restrained in said snare region, as is illustrated in Figures 14C and 14D. Although only one engaging member 44 is illustrated, it will be appreciated that any suitable number of engaging members 44 may be provided. In alternative embodiments containing a brim element 26, the engaging member may extend from the brim frame so as to define the snare region in the deployed form.

[0105] In alternative embodiments, the engaging member 44 extends radially outward from the outer or anchoring frame 16, curves, and further extends radially inward back toward the anchoring frame 16 to form a snare region. In further alternative embodiments, the engaging member 44 may extend radially outward from the outer or anchoring frame 16, curves, and further extends radially inward toward the anchoring frame 16 to form a loop-like region. The snare or loop-like region may include an indentation or notch configured to engage an electrical lead when the deployed prosthesis 10 is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0106] Although not illustrated, it will be understood that the prosthesis of Figures 13 and 14A-D may include a fabric covering on the engaging member 44 or a lining or bridge on the outer frame 16, as has been discussed with reference to Figures 12A and 12B, for example. Insome such embodiments, a protective lining may be arranged on the outer frame 16 so as to be adjacent, near to, or underneath the snare region defined by the engaging member 44 in the deployed form. It will be further understood that the prosthesis of Figures 13 and 14A-D may include anchors projecting outwardly from the outer frame 16. In such embodiments, a region of the outer frame 16 adjacent, near to, or underneath the snare region defined by the engaging member 44 in the deployed form may be devoid of anchors and / or may include especially atraumatic anchors, such as anchors tipped with loops or spheres.

[0107] Figure 15 schematically show the prosthesis 10 of Figure 13 engaging an electrical lead LI, L2 within the snare region, the prosthesis is shown in a patient’s anatomy and being positioned within an annulus TV. It will be understood that the annulus is a schematic representation of a native valve annulus of a patient, for example a tricuspid valve TV of a patient.

[0108] In some embodiments, the engaging member 44 may extend from the inner frame 14 or outer frame 16 so as to extend between the inner and outer frames 14, 16 in the deployed form, for guiding an electrical lead between said inner and outer frame portions 14, 16.

[0109] In the embodiments of Figures 16, 17A and 17B, the prosthesis 10 may be configured to receive, engage, confine, manipulate and / or move a pre-existing electrical lead LI, L2 within a patient’s anatomy. Stated another way, the catheter system 30 and the prosthesis 10 may be introduced into a patient’s anatomy after the electrical leads LI, L2 have been implanted in the patient’s anatomy to engage said electrical leads. Additionally or alternatively, the prosthesis 10 may be configured to receive, engage, confine, manipulate and / or move electrical leads LI, L2 that are introduced into a patient’s anatomy after the prosthesis 10 has been deployed in a patient’s anatomy.

[0110] Referring to Figure 16, in some embodiments the skirt may be provided with at least one passthrough or puncture region, slit, flap, conduit, hole, fenestration, or aperture 56 configured to receive an electrical lead LI, L2 therethrough. Put another way, the leads management arrangement may include at least one passthrough or puncture region, slit, flap, fenestration, or aperture 56 configured to receive an electrical lead LI, L2 therethrough.

[0111] The number of apertures may match the number of leads intended to be managed (e.g., one aperture if one lead, two apertures if two leads). In the case of a pass-through region, for example, a pre-existing hole or fenestration may be built into the prosthesis. In the case of a puncture region, the prosthesis may include a perforated region or region of thin skirt material meant to be punctured as needed, such as by applying force, for example using anexpandable balloon, or by burning or melting by applying heat using cautery, either in vivo or in vitro. This arrangement a compact arrangement to secure or constrain electrical leads from excessive or undesired movement or migration using components of the prosthesis 10. In some embodiments where the prosthesis 10 includes the brim element 26 extending outwardly from an upstream end of the frame 12, the brim element 26 is at least partially covered by the skirt and the puncture region, slit, flap, fenestration, or aperture 56 is provided on the skirt covering the brim element 26. Put another way, in some embodiments, the brim element 26 includes a puncture region, slit, fenestration, flap, or aperture 56 configured to receive an electrical lead LI, L2 therethrough. In this embodiment, the frame may be at least partially covered with a fabric that comprises a puncture region marked by a radiopaque target that may be cauterized or otherwise punctured to allow an electrical lead to be passed through.

[0112] In some such embodiments, at least one passthrough or puncture region, slit, flap, fenestration, or aperture 56 includes apassable portion marked by its proximity to a radiopaque material or region, such that the passable portion is visible under fluoroscopy in vivo. The passable portion may be a region or zone within a fabric, plastic, silicone, or other skirt material. It may be fabric, plastic, silicone, or other material. In some embodiments the passthrough or puncture region may be a silicone septum or valve through which a pacemaker lead may pass, but through which blood may not pass in one or both directions. The passable portion may be positioned in any location on the prosthesis, such as an inner frame, an outer frame, a brim extending from an inner or outer frame, or a standalone valve-support frame.

[0113] The passable portion can be defined in various shapes. It can be, for example, an area — such as a closed, curved area, a square area, a diamond area, or a semicircular area. It can be an area with some perforated, scored portions, or otherwise weaker portions as well as other portions that are not perforated, scored or otherwise weaker than surrounding portions.

[0114] For example, in some embodiments, the passable portion is defined by a semicircular perforated line that is connected from end to end by an imaginary hinge line or a hinge line defined by sutures, scoring, etching, sutures, or threads or wires, including, but not limited to radiopaque threads or wires. The semicircular line in such embodiments, act as a breakaway region, which separates from surrounding material, whereas the hinge line, whether real or imaginary, remains connected to surrounding tissue such that passing through the passable portion after creating a suitable passageway, such as by puncture or cautery in vivo or in vitro leaves a flap or line of attached material that does not fully breakaway fromsurrounding material. Such embodiments provide advantages such as substantially lowering the risk of embolization in vivo when puncturing a passable area.

[0115] As another example, in some embodiments, the passable portion is defined by an X- or cross- or T-shape or pattern. In some such embodiments, the passable portion includes an X pattern. Some embodiments include a passable portion designed to be dilated using a balloon catheter. For example, a physician utilizes an introducer sheath proximate to a bioprosthetic heart valve implant resting in a native valve annulus. The prosthesis includes a passable portion defined by a perforated X pattern in skirt material covering a brim on the prosthesis, and a location such as where the line or aperture is shown in Fig. 16. The physician passes a balloon catheter through the introducer sheath and proximate to the passable portion. The physician penetrates the passable portion using a rigid tip or extendable and retractable needle on or near the balloon catheter tip. The physician moves the balloon catheter through the penetrated portion until the balloon has partially passed through the penetrated portion. The physician may determine when a balloon is appropriately aligned in this manner with the penetrated portion by referencing, for example, one or more radiopaque portions or bands of the balloon catheter or balloon. For example, a radiopaque band may encircle a balloon catheter shaft that is housed within the expandable balloon portion. Once the balloon is suitably aligned with the penetrated portion, the physician expands the balloon, which further tears or opens the passable portion along the perforated X pattern in the skirt material to create a passthrough or puncture region for a pacemaker lead.

[0116] In some use cases, a physician may navigate a puncturing member, such as a pointed guidewire or catheter with a rigid end portion to the X pattern in any suitable manner,

[0117] In some embodiments, for example those illustrated in Figures 17A and 17B, the brim frame may act as an engaging member configured to engage an electrical lead. As discussed with reference to Figure 16, the electrical lead LI, L2 may be arranged to extend through the passthrough or puncture region, slit, flap, or aperture 56. This passthrough or puncture region, slit, flap, or aperture 56 may be provided on the brim element 26 of the prosthesis 10. A part of the brim frame may be configured to curve in the deployed form to contain and / or retrain the electrical lead, e.g., within a passthrough or puncture region, slit, flap, or aperture 56. As is illustrated in Figure 17B a part of or opposing parts of the brim frame adjacent to the at least one puncture region, slit, flap, or aperture 56 may be configured to curve so as to partially or entirely cover, close or obstruct the at least one puncture region, slit, flap, or aperture 56, for example, so as to contain and / or retain the electrical lead in saidat least one puncture region, slit, flap, or aperture 56. Alternatively, or in combination with, the prosthesis may include an engaging arm 44 configured to position an electrical lead in said at least one puncture region, slit, flap, or aperture 56. The engaging member 44 may also be configured to contain and / or retain the electrical lead in said at least one puncture region, slit, flap, or aperture 56. In such embodiments, the engaging member 44 may be as has been described with reference to Figures 13 and 14A-D, but any of the engaging members described herein may be utilised.

[0118] In the embodiments of Figures 18 to 20, the prosthesis 10 may be configured to receive, engage, confine, and / or manipulate electrical leads LI, L2 that are introduced into a patient’s anatomy after the prosthesis 10 has been deployed in a patient’s anatomy. Stated another way, the prosthesis 10 may be introduced into a patient’s anatomy before the electrical leads LI, L2 have been implanted in the patient’s anatomy.

[0119] Referring to Figure 18, the lead engaging member 44 may have a first end connected to the frame 12 and a second end connected to the frame 12. In the embodiment shown, the first and second ends of the engaging member 44 are connected to the inner frame 14.

[0120] The engaging member 44 is curved in the deployed form to define a loop configured for receiving an electrical lead therethrough. The engaging member 44 extends from an inflow end of the frame 12 and extends in a direction away from the outflow end of the frame 12. The loop is arranged to direct an electrical lead LI, L2 through the prosthetic valve component 18, as is illustrated in Figure 19. The loop may be configured to align the lead with a valve commissure. In other embodiments, the loop may be arranged to extend radially outwardly to direct the electrical lead to a region between the inner and outer frames 14, 16, or may be arranged to extend radially outwardly to direct the electrical lead along an exterior of the prosthesis 10 or through a brim 26 of the prosthesis 10. In further alternative embodiments, the engaging member 44 may extend from the outer frame 16 or may extend from and between the inner and outer frames 14, 16.

[0121] Referring to Figure 20, in some embodiments, the engaging member 44 may be provided with a protective lining 58 extending at least partially thereover. The protective lining may help to reduce damage to the electrical leads when the engaging member 44 manipulates or contacts the electrical lead initially and / or over time. The lining 58 may be formed at least partially, for example entirely, from a textile material. In such embodiments, the textile material may be formed from a polymeric material, and as an example may include one ormore of polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. Alternatively, or in combination with the textile material, the lining may be formed at least partially, for example entirely, from a hydrogel such as polyethylene glycol or silicone . It will be understood that the engaging member shown in any one of Figures 2 to 19 may be provided with the protective lining.

[0122] In some embodiments, the protective lining 58 at least partially covers a surface of the lead engaging member that faces a surface of the outer or anchoring frame 16. The protective lining 58 may at least partially cover a surface of the engaging member 44 that and is configured and arranged to engage an electrical lead when the engaging member 44 is in the deployed form. The lined edge of the curved, e.g., looped or hooked, engaging member 44 enables the engaging member 44 to extend around the electrical lead, whilst the lined inner edge engages the electrical lead. In embodiments where the lead engaging member 44 is a closed loop, the protective lining may extend radially inward from the loop and may define the aperture through which the lead is received.

[0123] The engaging member 44 illustrated in any of Figures 2 to 19 may be provided with one or more radiopaque regions for aligning the engaging member 44 with an electrical lead. These regions facilitate alignment and engagement of leads with the engaging member 44.

[0124] A method for delivering and deploying the prosthesis 10 to a native valve of a patient will now be described.

[0125] In an embodiment, a guidewire (not shown) is advanced after having been introduced into the vasculature via a percutaneous entry point and tracked through the vasculature into a heart. Intravascular access to the right atrium RA may be achieved via a percutaneous access site to femoral venous access up to the inferior vena cava, or other known access routes. Thereafter, a guidewire is advanced through the circulatory system, eventually arriving at the heart. The guidewire is directed into the right atrium RA and may be directed to the native tricuspid valve of the patient. In some embodiments, the guidewire may traverse the right atrium and is made to traverse, with the aid of a transseptal needle or pre-existing hole, an atrial septum, thereby entering the left atrium LA. Once the guidewire is positioned, the entry port and the atrial septum are dilated to permit entry of the catheter body 34 of the catheter system 30 into the left atrium LA. Once the guidewire is positioned, the prosthesis 10 is advanced through the catheter body 34 to the native valve and is positioned proximate the native mitral or tricuspid valve. It will be understood that the catheter body 34 may bepositioned within the desired area of the heart via different methods or routes. For example, and not by way of limitation, another path would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium. Yet another path would be through the femoral artery into the aorta, through the aortic valve into the left ventricle, and then to the mitral valve. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter body 34 may be advanced through the left ventricle LV to the mitral valve. In addition, although described with the use of a guidewire, in another embodiment hereof the catheter body 34 may access the heart without the use of a guidewire.

[0126] The method includes obtaining a catheter assembly comprising an elongate catheter body having a distal portion. The method also includes obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration, and a lead management arrangement comprising a lead engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy. The valve prosthesis is positioned within the catheter body in the compressed delivery configuration. The valve prosthesis is deployed from the distal portion of the catheter body so by allowing the engaging member to move from a delivery form to a deployed form in which the engaging member is curved for receiving and confining an electrical lead. With the engaging member(s) 44 in the deployed form, an electrical lead is engaged by the engaging member(s) to confine and / or retain said electrical lead. The valve prosthesis 10 is deployed from the catheter body to enable the frame to move from the compressed, delivery configuration to the expanded, deployed configuration and is positioned at a native valve annulus of a patient.

[0127] In some embodiments, the method may include rotating the valve prosthesis to position the electrical lead in a desired location after engaging an electrical lead with the engaging member. In some embodiments, the method may include rotating the valve prosthesis into alignment with an electrical lead prior to engaging said electrical lead. It shall be appreciated that in some embodiments the prosthesis 10 may be implanted prior to the introduction of the electrical leads LI, L2 into the patient’s anatomy, and in such embodiments the step of deploying the prosthesis 10 occurs prior to engagement of the electrical lead.

[0128] Regarding the terms “distal” and “proximal” within this description, unless otherwise specified, the terms can reference a relative position of the portions of the deliverycatheter system with reference to an operator and / or a location in the vasculature or heart. For example, “proximal” can refer to a position closer to the operator of the device or an incision into the vasculature, and “distal” can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter).

[0129] Although the teachings have been described above with reference to one or more preferred embodiments, it will be appreciated that various changes or modifications may be made without departing from the scope as defined in the appended claims.

[0130] Example 1. A prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising: a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration; and a lead management arrangement comprising an engaging member projecting from the frame and configured to engage an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0131] Example 2. The prosthesis of Example 1, wherein the engaging member is configured to curve, hook, or loop when moving from the delivery form to the deployed form.

[0132] Example 3. The prosthesis of Example 1, wherein a first end of the engaging member is connected to the prosthesis and a second end of the engaging member comprises a free end.

[0133] Example 4. The prosthesis of Example 1, wherein first and second ends of the engaging member engage with the frame when the engaging member is in the deployed form.

[0134] Example 5. The prosthesis of Example 1, wherein the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration.

[0135] Example 6. The prosthesis of Example 5, wherein first and second ends of the engaging member engage with the anchoring frame when the engaging member is in the deployed form.

[0136] Example 7. The prosthesis of Example 5, wherein first and second ends of the engaging member engage with the valve support frame when the engaging member is in the deployed form.

[0137] Example 8. The prosthesis of Example 5, wherein the engaging member is connected to and extends from the valve support frame or the anchoring frame.

[0138] Example 9. The prosthesis of Example 5, wherein the engaging member extends between the valve support frame and the anchoring frame in the deployed form for guiding an electrical lead between the valve support frame and the anchoring frame.

[0139] Example lO.The prosthesis of Example 1, wherein the engaging member is formed from a shape memory material, for example Nitinol.

[0140] Example 11. The prosthesis of Example 10, wherein the shape-memory material is shape set to move the engaging member from the delivery form to the deployed form.

[0141] Example 12. The prosthesis of Example 1, wherein the engaging member comprises a protective lining extending at least partially thereover.

[0142] Example 13. The prosthesis of Example 12, wherein the lining comprises a textile material.

[0143] Example 14. The prosthesis of Example 13, wherein the textile material comprises a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene .

[0144] Example 15. The prosthesis of Example 13, wherein the lining comprises a hydrogel such as polyethylene glycol or silicone.

[0145] Example 16. The prosthesis of Example 12, wherein the protective lining at least partially covers a surface of the engaging member that faces a surface of the frame and is configured to engage an electrical lead when the engaging member is in the deployed form.

[0146] Example 17. The prosthesis of Example 1, wherein the engaging member comprises one or more radiopaque regions for aligning the engaging member with an electrical lead.

[0147] Example 18. The prosthesis of Example 1 , wherein the frame is an anchoring frame and comprises at least one projecting anchor that projects beyond a radially outer surface of the anchoring frame when the frame is in the expanded, deployed, configuration.

[0148] Example 19. The prosthesis of Example 18, wherein the lead management arrangement comprises first and second spaced apart engaging members, and wherein a region of the frame extending between said first and second engaging members is devoid of the at least one projecting anchor.

[0149] Example 20. The prosthesis of Example 1, wherein the frame comprises a liner at least partially covering a surface of the frame.

[0150] Example 21. The prosthesis of Example 20, wherein the liner comprises a textile material.

[0151] Example 22. The prosthesis of Example 21, wherein the textile material comprises a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene .

[0152] Example 23. The prosthesis of Example 20, wherein the lining comprises a hydrogel such as polyethylene glycol or silicone.

[0153] Example 24. The prosthesis of Example 20, wherein the lead management arrangement comprises first and second spaced apart engaging members, and wherein the protective liner at least partially extends from said first engaging member to said second engaging member.

[0154] Example 25. The prosthesis of Example 1, wherein the frame defines an inflow end and an outflow end, wherein the engaging member extends from the inflow end, the outflow end, or from between the inflow and outflow ends.

[0155] Example 26. The prosthesis of Example 1, comprising a skirt coupled to and coving at least a portion of the frame.

[0156] Example 27. The prosthesis of Example 26, wherein the skirt comprises at least one puncture region, slit, flap, or aperture configured to receive a lead therethrough.

[0157] Example 28. The prosthesis of Example 27, wherein the engaging member is configured and arranged to position an electrical lead in or through the puncture region, slit, fenestration, flap, or aperture.

[0158] Example 29. The prosthesis of Example 27, wherein the frame comprises a brim element extending outwardly from an upstream end of the frame, wherein said brim element is at least partially covered by the skirt and the puncture region, slit, fenestration, flap, or aperture is provided on the skirt covering the brim element.

[0159] Example 30. The prosthesis of Example 27, wherein the puncture region, slit, fenestration, flap, or aperture defines a passable portion of the skirt, said passable portion defining a curved, oval, circular, square-shaped, diamond-shaped, semicircular, X-shaped, or T-shaped area.

[0160] Example 31. The prosthesis of Example 30, wherein the passable portion comprises one or more weakened portions, for example perforated portions and / or scored portions.

[0161] Example 32. The prosthesis of Example 1, wherein the prosthesis is a valve prosthesis and the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration, andwherein the prosthesis comprises a prosthetic valve component disposed within and secured to the valve support frame, the prosthetic valve component being configured to prevent blood flow in one direction to convey blood flow through the central lumen of the frame.

[0162] Example 33. The prosthesis of Example 1, wherein the engaging member includes an atraumatic tip.

[0163] Example 34. The prosthesis of Example 1, wherein, in the deployed form, the engaging member extends at least partially along an axis extending between an inflow and an outflow end of the frame.

[0164] Example 35. The prosthesis of Example 1, comprising one or more radiopaque or echogenic markers for aligning the prosthesis with a native annulus.

[0165] Example 36. The prosthesis of Example 1, wherein the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a snare region, wherein the snare region is configured and arranged to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0166] Example 37. The prosthesis of Example 1, wherein the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a loop-like region, wherein the loop-like region comprises an indentation or notch configured to engage an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0167] Example 38. A prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising: a valve support frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the valve support frame defines a central lumen and is configured to anchor the prosthesis in the expanded, deployed; and a lead management arrangement comprising an engaging member projecting from the valve support frame and configured to engage an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the valve support frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0168] Example 39. The prosthesis of Example 38, wherein the engaging member extends radially outward from the valve support frame, curves, and further extends radially inward toward the valve support frame to form a snare region, wherein the snare region is configuredto ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

[0169] Example 40. The prosthesis of Example 38, wherein the valve support frame is at least partially covered with a skirt that comprises a puncture region, slit, fenestration, flap, or aperture suitable for an electrical lead to be passed through.

[0170] Example 41. The prosthesis of Example 38, wherein the valve support frame is at least partially covered with a skirt that comprises a puncture region marked by a radiopaque target that may be cauterized or otherwise punctured to allow an electrical lead to be pass through.

[0171] Example 42. The prosthesis of Example 41, wherein the puncture region, slit, fenestration, flap, or aperture defines a passable portion of the skirt, said passable portion defining a curved, oval, circular, square-shaped, diamond-shaped, semicircular, X-shaped, or T-shaped area.

[0172] Example 43. The prosthesis of Example 42, wherein the passable portion comprises one or more weakened portions, for example perforated portions and / or scored portions.

[0173] Example 44. A delivery catheter system comprising: a catheter assembly comprising an elongate catheter body having a distal end portion; and a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, said prosthesis comprising a frame having a compressed, delivery, configuration and an expanded, deployed, configuration, wherein the frame defines a central lumen, and a lead management arrangement comprising an engaging member moveable relative to the frame between a delivery form and a deployed form, wherein the prosthesis is positioned within the catheter body with the frame in the compressed, delivery, configuration and the engaging member in the delivery form, wherein the prosthesis is deployable from the catheter body so as to enable the engaging member to move from the delivery form to the deployed form in which the engaging member is curved in the deployed form to receive and confine an electrical lead.

[0174] Example 45. The delivery catheter system of Example 44, wherein the prosthesis is deployable from the catheter body so as to enable the engaging member to move from the delivery form to the deployed form with the frame in the compressed, delivery, configuration.

[0175] Example 46. The delivery catheter system of Example 44, wherein the prosthesis is deployable from the catheter body so as to enable the frame to move from the compressed, delivery, configuration to the expanded, deployed, configuration.

[0176] Example 47. The delivery catheter system of Example 44, wherein the catheter assembly comprises an atraumatic tip positioned at or near the distal end portion of the catheter body.

[0177] Example 48. The delivery catheter system of Example 44, wherein the prosthesis is a valve prosthesis and the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration, and wherein the prosthesis comprises a prosthetic valve component disposed within and secured to the valve support frame, the prosthetic valve component being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the valve support frame.

[0178] Example 49. The delivery catheter system of Example 44, wherein the elongate catheter body comprises a first housing and a distal capsule defining a second housing, wherein the second housing is configured to retain the frame in the compressed, delivery, configuration and retain the engaging member in the delivery form.

[0179] Example 50. The delivery catheter system of Example 49, wherein the first and second housings are configured to move in opposite directions to deploy the prosthesis such that when the second housing is moved in a distal direction it no longer retains the engaging member in the delivery form.

[0180] Example 51. The delivery catheter system of Example 44, wherein the elongate catheter body comprises a first housing and a second housing, said first housing arranged within the second housing, and wherein the first housing is configured to retain the frame in the compressed, delivery, configuration and the second housing is configured to retain the engaging member in the delivery form.

[0181] Example 52. The delivery catheter system of Example 51, wherein the first and second housings are configured to move independently to deploy the frame and the engaging member, such that when the second housing is moved it no longer retains the engaging member in the delivery form and when the first housing is moved it no longer retains the frame in the compressed, delivery, configuration.

[0182] Example 53. A kit of parts comprising: a delivery catheter system comprising a catheter assembly comprising an elongate catheter body having a distal end portion; and a prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in theexpanded, deployed, configuration, and a lead management arrangement comprising an engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead, and wherein the prosthesis is configured to be able to be positioned within the catheter body with the frame in the compressed, delivery, configuration and the engaging member in the delivery form.

[0183] Example 54. A method of deploying a valve prosthesis comprising: obtaining a catheter assembly comprising an elongate catheter body having a distal portion; obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration, and a lead management arrangement comprising an engaging member projecting from the frame for engaging an electrical lead in a patient’s anatomy; positioning the valve prosthesis within the catheter body in the compressed, delivery, configuration; deploying the valve prosthesis from the catheter body to deploy the engaging member and enable the engaging member to move from a delivery form to a deployed form in which the engaging member is curved for receiving and confining an electrical lead; engaging an electrical lead with the engaging member; and deploying the valve prosthesis from the catheter body to enable the frame to move from the compressed, delivery configuration to the expanded, deployed configuration.

[0184] Example 55. The method of Example 54, comprising the step, after engaging an electrical lead with the engaging member, of rotating the valve prosthesis to position the electrical lead in a desired location.

[0185] Example 56. The method of Example 54, comprising the step of rotating the valve prosthesis into alignment with the electrical lead.

Claims

CLAIMS1. A prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising: a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed, configuration; and a lead management arrangement comprising an engaging member projecting from the frame and configured to engage an electrical lead in a patient’s anatomy, wherein the engaging member is moveable relative to the frame between a delivery form and a deployed form, and wherein the engaging member is curved in the deployed form to receive and confine an electrical lead.

2. The prosthesis of claim 1, wherein the engaging member is configured to curve, hook, or loop when moving from the delivery form to the deployed form.

3. The prosthesis of claim 1 or claim 2, wherein first and second ends of the engaging member engage with the frame when the engaging member is in the deployed form.

4. The prosthesis of any preceding claim, wherein the frame comprises an outer anchoring frame and an inner valve support frame radially surrounded by the anchoring frame in the expanded, deployed, configuration.

5. The prosthesis of claim 4, wherein first and second ends of the engaging member engage with the anchoring frame when the engaging member is in the deployed form and / or wherein first and second ends of the engaging member engage with the valve support frame when the engaging member is in the deployed form.

6. The prosthesis of claim 4 or claim 5, wherein the engaging member extends between the valve support frame and the anchoring frame in the deployed form for guiding an electrical lead between the valve support frame and the anchoring frame.

7. The prosthesis of any preceding claim, wherein the engaging member is formed from a shape memory material, for example Nitinol, and wherein the shape-memory material is shape set to move the engaging member from the delivery form to the deployed form.

8. The prosthesis of any preceding claim, wherein the engaging member comprises a protective lining extending at least partially thereover.

9. The prosthesis of any preceding claim, wherein the engaging member comprises one or more radiopaque regions for aligning the engaging member with an electrical lead.

10. The prosthesis of any preceding claim, wherein the frame is an anchoring frame and comprises at least one projecting anchor that projects beyond a radially outer surface of the anchoring frame when the frame is in the expanded, deployed, configuration.

11. The prosthesis of claim 10, wherein the lead management arrangement comprises first and second spaced apart engaging members, and wherein a region of the frame extending between said first and second engaging members is devoid of the at least one projecting anchor.

12. The prosthesis of any preceding claim, comprising a skirt coupled to and coving at least a portion of the frame, wherein the skirt comprises at least one puncture region, slit, flap, or aperture configured to receive a lead therethrough.

13. The prosthesis of claim 12, wherein the engaging member is configured and arranged to position an electrical lead in or through the puncture region, slit, fenestration, flap, or aperture.

14. The prosthesis of any preceding claim, wherein the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a snare region, wherein the snare region is configured and arranged to ensnare an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

15. The prosthesis of any preceding claim, wherein the engaging member extends radially outward from the frame, curves, and further extends radially inward toward the frame to form a loop-like region, wherein the loop-like region comprises an indentation or notch configured to engage an electrical lead when the deployed prosthesis is rotated clockwise or counterclockwise in the expanded, deployed configuration.

Images