A catheter system for engaging an electrical lead

Abstract

A catheter system has a catheter assembly including an elongate catheter body having a distal end portion. The system includes a cardiac electrical lead-manipulation member comprising a lead-manipulation shaft extending along the catheter body and a lead-engaging member connected to the lead-manipulation shaft, said lead-manipulation member at least partially arranged within the catheter body in a delivery configuration. The lead-manipulation shaft is operable to move the lead-engaging member relative to the catheter body and the lead-engaging member is deployable from the catheter body to move from the delivery configuration to a deployed configuration, wherein the lead-engaging member engages and manipulates a cardiac electrical lead during a medical procedure.

Description

A CATHETER SYSTEM FOR ENGAGING AN ELECTRICAL LEADCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 609,141, filed December 12, 2023, and U.S. Provisional Patent Application Serial No. 63 / 619,086, filed January 9, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present teachings relate to a catheter system for engaging a cardiac electrical lead, a method of engaging a cardiac electrical lead in a patient’s anatomy, and a method of deploying a heart valve 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 semilunar 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, canresult 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 heart via the superior vena cava and enter the right atrium. One or more of the cardiac 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 cardiac 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] One aspect of the teachings provides a catheter system comprising a control handle and a catheter assembly extending distally from the control handle. The catheter assembly comprising an elongate catheter body having a distal end portion and a lead-manipulation member comprising a lead-manipulation shaft extending along the catheter body and a lead- engaging member connected to a distal end of the lead-manipulation shaft. The lead-manipulation member arranged within the catheter body and comprising a collapsed, delivery configuration, and an expanded, deployed configuration, wherein the lead-engaging member is deployable from the catheter body to move from the collapsed, delivery configuration, to the expanded, deployed configuration.

[0008] In some embodiments, the lead-manipulation shaft may be operable to move the lead- engaging member relative to the catheter body. The lead-manipulation shaft of the lead- manipulation member may be rotatable to rotate the lead-engaging member.

[0009] In some embodiments, the lead-engaging member may comprise a wire mesh extending partially or entirely over the lead-engaging member. In some embodiments, only part of the lead-engaging member is expandable and collapsible. In some embodiments, the lead-engaging member comprises a shape-memory material.

[0010] In some embodiments, the lead-engaging member may be cylindrical, tubular, spherical, ovoid, spheroidal, toroidal, polyhedral, or disk shaped in the expanded, deployed configuration. The lead-engaging member may be substantially circular or D-shaped in crosssection at its greatest diameter that is perpendicular to an axis extending from the proximal portion of the lead-engaging member to the distal portion of the lead-engaging member in the expanded, deployed configuration. The lead-engaging member may be configured to narrow or close an opening of the contact surface for retaining an electrical lead therein. The lead- engaging member may comprise a first lead-engaging portion and a second lead-engaging portion configured to engage an electrical lead. The lead-engaging member may comprise a wire mesh extending partially or entirely over the lead-engaging member. The lead-engaging member may be fully or partially expandable and collapsible. The lead-engaging member may comprise a shape-memory material.

[0011] In some embodiments, the lead-engaging member may define one or more contact surfaces configured to receive and engage an electrical lead. The contact surface of the lead- engaging member may comprise a recess, channel, groove, notch, or indentation. The contact surface may comprise an abrasion-control material at least partially thereover. The abrasioncontrol material may comprise a textile material, a polymeric material, an elastomeric material, and / or a hydrogel material. Alternatively, or in addition, the abrasion-control material may comprise one or more of PET, PTFE, and / or ePTFE.

[0012] In some embodiments, the catheter assembly may comprise an atraumatic tip positioned at or near the distal portion of the catheter body.

[0013] In some embodiments, the catheter system may further comprise a valve -retaining member and a heart valve prosthesis releasably coupled to the valve-retaining member wherein the heart valve prosthesis is deployable from the catheter system to move from a collapsed, delivery configuration, to an expanded, deployed configuration.

[0014] In some embodiments, the catheter system may comprise a lead-guiding member.

[0015] Another aspect of the teachings provides a method of engaging an electrical lead in a patient’s anatomy with a catheter system. The method may comprise obtaining a catheter system comprising a catheter assembly having a distal end portion comprising a lead- manipulation member having a compressed, delivery configuration, and an expanded, deployed configuration. Positioning the distal end portion of the catheter assembly near an electrical lead. At least partially deploying the lead-manipulation member from the distal end portion of the catheter assembly to define a recess, channel, notch, groove, or indentation. Positioning the electrical lead into the recess, channel, notch, groove, or indentation and engaging the electrical lead with the lead-manipulation member.

[0016] In some embodiments, the method of engaging an electrical lead may comprise the step of rotating the lead-manipulation member into alignment with the electrical lead before the step of positioning the electrical lead into the recess, channel, notch, groove, or indentation.

[0017] In some embodiments, the method of engaging an electrical lead may comprise the step, after engaging the electrical lead, of rotating and / or moving the lead-manipulation member to position the electrical lead in a desired location.

[0018] In some embodiments, the catheter assembly may further comprise a lead-guiding member having a compressed, delivery configuration, and an expanded, deployed configuration.

[0019] In some embodiments, the method of engaging an electrical lead may comprise the steps of engaging the electrical lead with the lead-guiding member and guiding the electrical lead into alignment with the lead-manipulation member before the step of positioning the electrical lead into the recess, channel, notch, groove, or indentation.

[0020] In some embodiments, the catheter system may further comprise a valve -retaining member and a heart valve prosthesis releasably coupled to the valve-retaining member, the prosthesis comprising a frame having a compressed, delivery, configuration and an expanded, deployed, configuration, wherein the frame defines a central lumen and is configured to anchor the prosthesis in the expanded, deployed, configuration, and a valve body disposedwithin and secured to the frame, the valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame.

[0021] In some embodiments, the method of engaging an electrical lead may comprise deploying the valve prosthesis from the distal portion of the catheter assembly after engaging the electrical lead and positioning the electrical lead in a desired location.

[0022] In some embodiments, the method of engaging an electrical lead may comprise deploying a valve prosthesis from the distal portion of a second catheter assembly after engaging the electrical lead from the distal portion of a first catheter assembly and positioning the electrical lead in a desired location prior to and during deployment of the valve prosthesis.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Embodiments will now be described with reference to the accompanying drawings, in which:

[0024] Figure 1 is a schematic illustration of a heart;

[0025] Figure 2A is a schematic side view of a catheter system according to an embodiment of the present teachings in a closed, delivery configuration;

[0026] Figure 2B is a schematic side view of the catheter system of Figure 2B in an open, delivery configuration;

[0027] Figures 3A and 3B are schematic views of the lead-manipulation member of Figures 2A and 2B in an open configuration and a closed configuration respectively;

[0028] Figure 4 is a schematic view of the lead-manipulation member of Figures 2A and 2B;

[0029] Figure 5 is a schematic view of the catheter system of Figure 2A positioned within a heart;

[0030] Figure 6 is a is schematic view of the lead-manipulation member of Figure 2A positioned within a heart;

[0031] Figure 7 is a schematic view of an embodiment of a lead-manipulation member according to the present teachings;

[0032] Figures 8A and 8B are schematic views of an embodiment of a lead-manipulation member according to the present teachings;

[0033] Figure 9 is a schematic side view of an embodiment of a lead-manipulation member according to the present teachings;

[0034] Figure 10 is a schematic view of a control member of the catheter systems of Figures 2A to 9;

[0035] Figure 11 is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a delivery configuration;

[0036] Figure 12 is a schematic view of the catheter system of Figure 11 comprising the lead- manipulation member in an alternative deployed configuration;

[0037] Figure 13 is a schematic view of the lead-manipulation member of Figure 11 in an alternative deployed configuration;

[0038] Figure 14 is a schematic view of the lead-manipulation member of Figure 11 in an alternative deployed configuration;

[0039] Figure 15 is a schematic view of a control member of the catheter systems of Figures 11 to 14;

[0040] Figure 16 is a schematic view of the catheter system of Figure 11 positioned within a heart;

[0041] Figure 17 is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a deployed configuration;

[0042] Figure 18 is a schematic view of a control member of the catheter system of Figures 17;

[0043] Figure 19 is a schematic view of the catheter system of Figure 17 positioned within in a heart;

[0044] Figure 20 is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a deployed configuration;

[0045] Figure 21 is a schematic view of the catheter system of Figure 20 positioned within in a heart;

[0046] Figures 22A-22C are schematic side views of a lead-manipulation member of the catheter system of Figure 20 in a delivery configuration, an open configuration, and a closed configuration, respectively;

[0047] Figures 23A-23D are schematic views of the lead-manipulation member of Figures 22A-22C engaging an electrical lead;

[0048] Figures 24A and 24B are schematic side views of an alternative catheter system of Figure 20;

[0049] Figure 25 is a schematic view of a control member of the catheter systems of Figures 20-24;

[0050] Figure 26 is a schematic side view of an embodiment of a catheter system according to the present teachings;

[0051] Figures 27A-27C are schematic side views of an embodiment of a catheter system according to the present teachings;

[0052] Figure 28 is schematic view of the catheter system of Figures 27A-27C positioned within in a heart;

[0053] Figure 29 is schematic view of the catheter system of Figures 27A-27C positioned within in a heart;

[0054] Figure 30A is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a delivery configuration;

[0055] Figure 30B is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a deployed configuration;

[0056] Figure 31 is a schematic view of a control member of the catheter systems of Figures 30A and 30B;

[0057] Figure 32 is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a delivery configuration; and

[0058] Figure 33 is schematic view of a catheter system according to an embodiment of the present teachings comprising a lead-manipulation member in a deployed configuration.DETAILED DESCRIPTION OF EMBODIMENT(S)

[0059] 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 distal edges that meet so as 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 so as 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 soas to close the respective valve. Each leaflet is attached to an annular region of the heart structure known as the valve annulus.

[0060] The heart depicted includes pre-existing electrical leads, for example pacemaker leads. In the arrangement shown, the heart includes two cardiac electrical leads LI, L2. Each lead includes an electrode at the distal end thereof and is 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 tines, 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.

[0061] Illustrated embodiments relate to a catheter system for engaging a cardiac electrical lead and moving said cardiac electrical lead to a desired location. In the exemplary illustrated embodiments, the catheter system is used prior to placement of a heart valve prosthesis within a mitral heart or tricuspid heart valve. In alternative embodiments, the catheter system may be used for placement of a heart valve prosthesis 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.

[0062] Referring to figures 2A-3B, a catheter system is illustrated and is indicated generally at 10. The catheter system 10 includes a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 10 includes a lead-manipulation member 18 including a lead-engaging member 20 within the catheter body 14. The lead- engaging member 20 can include a proximal portion 21a, and a distal portion 21b. The lead- engaging member 20 can have a collapsed, delivery configuration, and an expanded, deployed configuration. The lead-engaging member 20 is deployable from the catheter body 14 to move from a collapsed, delivery configuration, illustrated in Figure 2 A, to an expanded, deployed configuration, illustrated in Figure 2B.

[0063] In some embodiments, the catheter system 10 further includes a lead-manipulation shaft 24 configured to couple the lead-manipulation member 18 to the catheter system 10 when the lead-engaging member 20 is in the collapsed, delivery configuration and when the lead-engaging member 20 is in the expanded, deployed configuration. The lead-manipulation shaft 24 is moveable relative to the catheter body 14 so as to move the lead-engaging member 20 relative to the catheter body 14. The lead-manipulation shaft 24 may be manipulated torotate the lead-engaging member 20, for example by rotation of the lead-manipulation shaft 24. Additionally, or alternatively, the lead-manipulation shaft 24 may be moveable so as to distally extend and / or proximally retract the lead-engaging member 20 relative to the distal portion 16 of the catheter body 14.

[0064] In some embodiments, the catheter system 10 may include an atraumatic tip or nose cone 30. The atraumatic tip or nose cone 30 of the catheter system 10 may be positioned at or near the distal portion 16 of the catheter body 14. The atraumatic tip 30 may be used to facilitate advancement of the catheter system 10 through the patient’s skin and vasculature, including within the heart. The atraumatic tip 30 may be configured so as to prevent or reduce intravascular trauma during the delivery of the catheter system 10 to the heart. It may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 30 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In some embodiments, the atraumatic tip 30 may have a guidewire lumen. In some embodiments, the atraumatic tip 30 is taken to mean that the catheter system 10 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the catheter system 10, such as the curved or tapered tip described above. Alternatively, the atraumatic tip may include an atraumatic material, such as hydrophilic-coated tips or silicone tips. In some embodiments, the atraumatic tip 30 may be omitted. In such embodiments, the distal portion 16 of the catheter body 14 may be configured with an atraumatic end portion designed to reduce or prevent intravascular trauma during the delivery of the catheter system 10.

[0065] In some embodiments, the atraumatic tip 30 may be coupled to or attached to a distal end of an inner tip shaft 32. The inner tip shaft 32 is configured to be movable within a lumen of lead-manipulation shaft 24. Relative movement between the catheter body 14 and the atraumatic tip 30 creates space between the distal end portion 16 of the catheter body 14 and the atraumatic tip 30, as is illustrated in Figure 2B. This space enables the lead-engaging member 20 to be deployed from the distal portion 16 of the catheter body 14. The relative movement between the catheter body 14 and the atraumatic tip 30 may be achieved by a distal movement of the inner shaft 32 relative to the catheter body 14 and / or by a proximal retraction of the catheter body 14 relative to the inner shaft 32. The collapsed, delivery configuration of the lead-engaging member 20 is illustrated in Figure 2A, and the expanded, deployed configuration of the lead-engaging member 20 is illustrated in Figures 2B. In some embodiments, the lead-engaging member 20 may comprise a conformable frame. Theconformable frame may include a collapsible and expandable wire frame. The wire frame may, by way of example, include at least one wire loop. In some embodiments, the wire frame may be a wire mesh frame. The wire mesh may extend partially or entirely over the lead-engaging member 20. In some embodiments, only part of the lead-engaging member 20 is expandable and collapsible. For example, only a distal portion of the lead-engaging member 20 may be expandable and collapsible. The lead-engaging member 20 may be formed from a shape-memory material, for example Nitinol. It shall be appreciated that in alternative embodiments, any biocompatible shape-memory material may be used to form the lead-engaging member 20. The lead-engaging member 20 may be provided with one or more shape-memory material portion or regions, or alternatively, the entirety of the lead-engaging member 20 may be formed from the shape-memory material.

[0066] The lead-engaging member 20 includes a contact surface 22, as is illustrated in Figure 3A. The contact surface 22 is configured to receive and engage an electrical lead in the in the expanded, deployed configuration. In embodiments wherein the lead-engaging member 20 is formed from a shape-memory material, the lead-engaging member 20 may be shape set to narrow or close an opening 25 of the contact surface 22. Alternatively, the opening 25 may be manually narrowed or closed, for example using a control member as is discussed in more detail below.

[0067] By way of example, in some embodiments only the contact surface 22 may be formed from the shape-memory material. The contact surface 22 substantially curved to form a C- shape, however it shall be appreciated that any suitable shape of contact surface 22 may be used. For example, the contact surface 22 may be V-shaped or U-shaped, ovular, semicircular, square or an alternative curved or stepped shape. In the embodiment illustrated, one contact surface 22 is provided. It shall be appreciated that in alternative embodiments, the lead-engaging member 20 defines at least two contact surfaces 22 as will be described in more detail below. This may enable the lead-engaging member 20 to engage multiple or differing diameter electrical leads at once. It may also provide users with the option to employ one or more types of lead capture features, depending on how the electrical lead L2 may be orientated within the patient’s anatomy. The lead-engaging member 20 may extend between the proximal portion 21a and the distal portion 21b of the lead-engaging member 20. The contact surface 22 extends partially or entirely between said proximal and distal portions 21a, 21b of the lead-engaging member 20.

[0068] Figure 3A illustrates an embodiment wherein the contact surface 22 extends entirely between said proximal and distal portions 21a, 21b of the lead-engaging member 20. This may be advantageous because a length of the electrical lead L2 contacted by the contact surface 22 is increased. The contact surface 22 extends along an axis substantially perpendicular to the axis extending between proximal and distal portions 21a, 21b of the lead- engaging member 20. It shall be appreciated that in alternative embodiments, the contact surface 22 may extend along an axis offset from the axis extending between proximal and distal portions 21a, 21b of the lead-engaging member 20.

[0069] The contact surface 22 includes a first engaging portion 28a configured to engage the electrical lead L2 arranged within the inner volume enclosed within at least a portion of the contact surface 22, when the lead-engaging member 20 is in the expanded, deployed configuration. The first engaging portions 28a is formed when the lead-engaging member 20 engages the electrical lead L2. The first engaging portion 28a is formed by opposing parts of the lead-engaging member 20 touching at a first location, as is illustrated in Figure 3B.

[0070] As is illustrated in Figure 3A, the contact surface 22 includes a recess, channel, groove, indentation, or notch 28. In the embodiment of Figure 3 A, a notch 28 is provided, however it shall be appreciated that in alternative embodiments, any of the recess, channel, groove, or indention 28 may be provided. The notch 28 extends a greater length along a first axis, which extends from the proximal portion 21a of the lead-engaging member 20 to the distal portion 21b of the lead-engaging member 20 than it does along a second axis, extending perpendicular to the first axis. The notch 28 is defined between the proximal and distal portion 21a, 21b of the lead-engaging member 20. It shall be appreciated that one or more than one recess, channel, groove, or notch 28 may be provided on each of the contact surfaces 22. In some embodiments, the notch 28 is substantially curved to form a C-shape, however it shall be appreciated that any suitable shape of notch 28 may be used. For example, the notch 28 may be V-shaped or U-shaped, ovular, semi-circular, square or an alternative curved or stepped shape.

[0071] In the embodiment illustrated in Figure 3A, one notch 28 is provided, however in alternative embodiments, any suitable number of notches 28 may be provided on the contact surface 22. The notch 28 is located on a circumferential perimeter of the lead-engaging member 20. This enables the lead-engaging member 20 to receive the electrical lead L2 in the opening 25 formed by the notch 28 at the circumferential edge of the lead-engaging member20. It shall be appreciated that in alternative embodiments, the notch 28 may be located at any suitable location on the lead-engaging member 20.

[0072] The contact surface 22 of the lead-engaging member 20 may include an abrasioncontrol material at least partially thereover. The abrasion-control material helps to reduce damage to the electrical lead L2 when the contact surface 22 engages the electrical lead L2. The abrasion-control material extends over, e.g. entirely over, the contact surface 22. In one embodiment, the abrasion-control material extends over an entirety of an outer surface of the lead-engaging member 20, however it shall be appreciated that in alternative embodiment the abrasion-control material may extend over any portion of the lead-engaging member 20. The abrasion-control material may include a textile material, by way of example. The abrasioncontrol material may include a polymeric material. Such materials have been found to provide a suitable level of protection for the electrical leads L2, whilst being biocompatible. The abrasion-control material may include one or more of PET, PTFE and / or ePTFE.

[0073] As described above in relation to the contact surface 22, the lead-engaging member 20 is configured to narrow or close the opening 25 of the contact surface 22, i.e. the opening 25 of the notch 28 in Figure 3A, for retaining the electrical lead L2 therein. The closing or narrowing of the opening 25 forms the engaging portion 28a, as is illustrated in Figure 3B. Opposing parts of the lead-engaging member 20 defining the contact surface 22 touch or overlap to close the opening 25 of the notch 28 and form the engaging portion 28a.

[0074] Referring to Figure 4, a lead-manipulation member 18 is illustrated wherein opposing parts of the lead-engaging member 20 defining the contact surface 22 touch or overlap at a second location to form a second engaging portion 28b. The second engaging portion 28b is configured to engage the electrical lead L2 arranged within a second inner volume enclosed within at least a portion of the contact surface 22. The first and second engaging portions 28a, 28b are spaced apart along an axis substantially perpendicular to an axis extending between the proximal and distal portions 21a, 21b of the lead-engaging member 20, as is illustrated in Figure 4. This arrangement may provide multiple contact regions or varying orientations between portions of the lead-engaging member 20 and the electrical lead L2, which may increase ease-of-use and / or the likelihood that the lead-manipulation member 18 engages the electrical lead L2. Movement of the lead-engaging member 20 between the open, closed, and overlapping configuration may be manually controlled, for example using a control member as is discussed in more detail below.

[0075] Figure 5 illustrates the catheter system 10 positioned within the heart. Figure 6 illustrates the lead-manipulation member 18 positioned within the heart with the lead- engaging member 20 in the expanded, deployed configuration. When the catheter system 10 has been moved to a desired location, the atraumatic tip 30 is advanced and / or the catheter body 14 is retracted to provide space for the lead-engaging member 20 to be deployed from the catheter body 14. However, for reasons of clarity, the lead-engaging member 20 is illustrated in Figure 6 without the catheter body 14 and the atraumatic tip 30 illustrated. The lead-engaging member 20 has been deployed from the catheter system 10 in Figure 6 and moved into alignment with the electrical lead L2. Accordingly, the electrical lead L2 may be moved to the desired location so as to avoid obstructing implantation of the prosthesis. The lead-engaging member 20 may remain in the heart throughout implantation of the prosthesis to retain the lead in the desired location.

[0076] Figure 7 illustrates an additional embodiment wherein at least two contact surfaces 22, 23 are provided (two contact surfaces 22, 23 in Figure 7). The at least two contact surfaces 22, 23 are spaced apart circumferentially around a perimeter of the lead-engaging member 20. This arrangement may enable the lead-engaging member 20 to engage multiple electrical leads L2 at once. For example, the two contact surfaces 22, 23 may be equidistantly spaced apart, located on the same side of the lead-engaging member 20, or located on opposing sides of the lead-engaging member 20. Each of the two contact surfaces 22, 23 may define a notch 28, 29. The notch 29 is of substantially the same configuration as the notch 28 described above.

[0077] Figures 8A and 8B show an alternative catheter system 110 with an alternative lead- manipulation member 118. Identical parts with the embodiment of Figures 2 to 7 are labelled with the same reference numeral, and like parts are labelled with the prefix “1”.

[0078] The lead-engaging member 120 of Figures 8A and 8B is substantially D-shaped in cross-section at its greatest diameter that is perpendicular to the axis extending from the proximal portion 121a of the lead-engaging member 120 to the distal portion 121b of the lead-engaging member 120 in the expanded, deployed configuration. It shall be appreciated that in alternative embodiments, the lead-engaging member 120 may be substantially circular in cross-section at its greatest diameter that is perpendicular to the axis extending from the proximal portion 121a of the lead-engaging member 120 to the distal portion 121b of the lead-engaging member 120 in the expanded, deployed configuration, or any other suitable shape, for example a cross-section with a varying geometry.

[0079] The varying cross-sectional geometry may be uniform or nonuniform. D-shaped cross-sections, as is illustrated in Figure 8B, may be particularly useful when manipulating left-ventricular leads, because, for example, the D-shaped cross-section may be used to confirm the orientation of the lead-engaging member 120 or the catheter system 110. It shall be appreciated that the embodiments of Figures 2 to 7 may also have a varying cross-sectional geometry, for example a circular or D-shaped cross-section.

[0080] The lead-engaging member 120 of Figures 8A and 8B include a first lead-engaging member portion 120a and a second lead-engaging member portion 120b. It shall be appreciated that in alternative embodiments, any suitable number of lead-engaging member portions may be provided, for example three lead-engaging member portions. In some embodiments, the first and second lead-engaging member portions 120a, 120b are spaced apart along the axis extending between the distal portion and the proximal portion of the lead- engaging member 121a, 121b. It shall be appreciated that the first and second lead-engaging member portions 120a, 120b may define any suitable length, or different lengths.

[0081] As is illustrated in Figure 8B, the first and second lead-engaging member portions 120a, 120b may define different shapes. In the embodiment of Figure 8B, the first lead- engaging member portion 120a is substantially disk shaped and the second lead-engaging member portion 120b includes a curved surface such that the lead-engaging member 120a, 120b defines the D-shape described above. It shall be appreciated that in alternative embodiments, the first and / or section lead-engaging member portions 120a, 120b may define any suitable shape.

[0082] The lead-engaging member 120 of Figures 8 A and 8B includes a first contact surface 122 located on the first lead-engaging member portion 120a and a second contact surface 123 located on the second lead-engaging member portion 120b. It shall be appreciated that in alternative embodiments, either of the first and second lead-engaging member portions 120a, 120b may include more than one contact surface 122, 123. The first and second contact surfaces 122, 123 each include at least one recess, channel, groove, or indentation 28 (not shown). The at least one recess, channel, groove, or indentation 28 of the first and second contact surfaces 122, 123 may be aligned in the axis extending between the distal portion 121b and the proximal portion 121a of the lead-engaging member 120. Alternatively, the at least one recess, channel, groove, or indentation 28 of the first and second contact surfaces 122, 123 may be offset relative to the axis extending between the distal portion 121b and the proximal portion 121a of the lead-engaging member 120.

[0083] It shall be appreciated that in alternative embodiments, the first and second lead- engaging member portions 120a, 120b may each include at least two contact surfaces with any suitable number of recesses, channels, grooves, or indentations, 28 as described above in relation to any of the embodiments of Figures 2 to 7.

[0084] Figure 9 shows an alternative catheter system 210 with an alternative lead- manipulation member 218. Identical parts with the embodiment of Figures 2 to 8 are labelled with the same reference numeral, and like parts are labelled with the prefix “2”.

[0085] In the embodiment of Figure 9, the lead-engaging member 220 is substantially cylindrical. It shall be appreciated that the lead-engaging member 220 may be any suitable shape that extends a greater distance in the axis extending between the distal portion 221b and the proximal portion 221a of the lead-engaging member 220 than in an axis perpendicular to the axis extending between the distal portion 221b and the proximal portion 221a of the lead- engaging member 220, for example substantially tubular. The embodiment of Figure 9 may be advantageous because a greater length of the electrical lead L2 may be engaged by the lead-engaging member 220, thereby protecting a greater length of the electrical lead L2 from damage.

[0086] The contact surface 222 includes a notch 28 of substantially the same configuration to the embodiment of Figures 2 to 3B. The notch 28 extends from the distal portion 221b to the proximal portion 221a of the lead-engaging member 220, however it shall be appreciated that in alternative embodiments, the notch 28 may extend partially between the distal portion 221b and the proximal portion 221a of the lead-engaging member 220.

[0087] As described above in relation to the embodiment of Figures 2 to 6 and the embodiment of Figures 8A and 8B, any suitable number of recesses, channels, grooves, or indentations 28 at any of the locations described above may be provided on the lead-engaging member 220.

[0088] Referring to Figure 10, in some embodiments the catheter system 10 includes a control member 44 located at a proximal end of the catheter assembly 12. Stated another way, the catheter assembly 12 extends distally from the control member 44. The control member 44 may be, for example, a control handle 44. The control member 44 is configured to control movement of the catheter system 10 and includes one or more controls 45a-d configured to control one or more components of the catheter system 10. In the embodiment of Figure 10, four controls 45a-d are provided. In alternative embodiments, any suitable number of controls may be provided, for example two, three, five or any alternative number of controls. The atleast one control 45a-d may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any suitable control. The controls 45a-d may be controlled simultaneously. In the exemplary embodiment of Figure 10, the four controls 45a-d are located on the control member 44 and are rotatable relative to the control member 44.

[0089] A first control 45a may be provided to control movement of the catheter body 14. The first control may be configured to distally extend and / or proximally retract the catheter body 14. In some embodiments, the catheter body 14 may include an outer sheath 14a and an inner sheath 14b. In such embodiments, separate controls may be provided to control the inner and outer sheaths 14a, 14b.

[0090] A second control 45b may be provided to control movement of the lead-manipulation shaft 24 relative to the catheter body 14. The second control may be configured to distally extend and / or proximally retract the lead-manipulation shaft 24 relative to the catheter body 14. A third control 45c may be provided to control further movement of the lead- manipulation shaft 24 relative to the catheter body 14. The third control 45c may be configured to control flexing and / or rotation of the lead-manipulation shaft 24 relative to the catheter body 14. A fourth control 45d may be provided to control the distal and proximal movement of the inner tip shaft 32, thereby controlling movement of the atraumatic tip 30.

[0091] Although not illustrated, in some embodiments, a fifth control may be provided to control movement of the lead-engaging member 20, 120, 220. The fifth control may be configured to control movement of the lead-engaging member 20, 120, 220 between the collapsed, delivery configuration and the expanded, deployed configuration. Additionally, or alternatively, the fifth control may be configured to control to the lead-engaging member 20, 120, 220 to move the recess, channel, notch, indentation, or groove 28 between the open configuration to the closed or narrowed configuration and / or to the overlapping configuration. A method of engaging an electrical lead L2 in a patient’s anatomy will be described hereafter. The method shall be described in relation to the embodiment of Figures 2 to 6, however it shall be appreciated that the method is applicable to any of the embodiments described herein and illustrated in the Figures.

[0092] 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 theheart. The guidewire is directed into the right atrium RA and may be directed to the native tricuspid valve TV of the patient. Once the guidewire is positioned, the entry point is dilated to permit entry of the catheter assembly 12 of the catheter system 10 into the vasculature, The catheter assembly 12 is advanced over the guidewire through the entry point, through the vasculature including the femoral vein and inferior vena cava, and into the right atrium RA. It will be understood that the catheter body 14 may be positioned within the desired area of the heart via different methods or routes. For example, and not by way of limitation, another possible path to the right atrium RA would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium RA. A possible path to the mitral valve MV would be through the femoral artery into the aorta, through the aortic valve into the left ventricle LV, and then to the mitral valve MV. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter assembly 12 may be advanced through the left ventricle LV to the mitral valve MV. In addition, although described with the use of a guidewire, in another embodiment hereof, the catheter assembly 12 may access the heart without the use of a guidewire.

[0093] The method includes obtaining a catheter system 10 including an elongate catheter body 14 having a distal portion 16, and a lead-manipulation member 18, 118, 218 including a lead-engaging member 20, 120, 220 at least partially arranged within the catheter body 14 and including a compressed, delivery configuration, and an expanded, deployed configuration. An example of such a catheter assembly 12 positioned in the heart of the patient is illustrated in Figures 5 and 6.

[0094] As is illustrated in Figure 2A, the lead-engaging member 20 is positioned within the catheter body 14 in the compressed, delivery configuration. The lead-engaging member 20 is then at least partially deployed from the catheter assembly 12 to enable the lead-engaging member 20 to move into the expanded, deployed configuration to define the recess, channel, notch, groove, or indentation 28.

[0095] The lead-manipulation member 18 may be rotated into alignment with the electrical lead L2, for example by moving the lead-manipulation shaft 24 to move the lead- manipulation member 18 into alignment with the electrical lead L2.

[0096] The electrical lead L2 is positioned in the recess, channel, notch, indentation, or groove 28 and the electrical lead L2 is engaged. To engage the electrical lead L2, the recess, channel, notch, indentation, or groove 28 is moved from the open configuration to the closed or narrowed configuration of Figure 2B. The lead-engaging member 20 may be movedautomatically to close or narrow the recess, channel, notch, indentation, or groove 28 and form the engaging portion 28a. Alternatively, the lead-engaging member may be moved manually, for example using the control member. The electrical lead L2 may then be moved, for example by rotating the lead-manipulation member 18, to position the electrical lead L2 in the desired location. The lead-manipulation shaft 24 may be moved to rotate the electrical lead L2 to the desired location.

[0097] It shall be appreciated that for lead-engaging member 20 with more than one contact surface 22, 23 the method may be repeated to engage an additional electrical lead. Alternatively, for lead-engaging member 20 with one contact surface 22, the method may be repeated to engage an additional electrical lead L2 with the same contact surface.

[0098] A method of deploying a heart valve prosthesis will be described hereafter. The method shall be described in relation to the embodiments of Figures 2 to 10 however it shall be appreciated that the method is applicable to any of the embodiments described herein and illustrated in the Figures.

[0099] The method includes the steps outlined above of engaging the electrical lead L2, or more than one electrical lead L2.

[0100] The method further includes the step of obtaining a prosthesis, for example a heart valve prosthesis (not shown). The prosthesis has a compressed, delivery configuration and an expanded deployed configuration. The prosthesis includes 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 is provided with a valve body disposed within and secured to the frame. The valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame. In some embodiments, the valve prosthesis may be positioned within a catheter body of a further, or second, catheter assembly, in the compressed, delivery configuration. In alternative embodiments, the valve prosthesis may be positioned within the catheter body 14 in the compressed, delivery configuration.

[0101] The heart valve prosthesis is positioned in a native annulus of the patient. The valve prosthesis is deployed from a distal portion 16 of a catheter body 14. The valve prosthesis may be fully deployed from the distal portion 16 of the catheter body 14 after allowing the lead-engaging member 20 to move from the compressed, delivery configuration to the expanded, deployed configuration.

[0102] Figures 11-15 show an alternative catheter system 310 with an alternative lead- manipulation member 318. Identical parts with the embodiments of Figures 2 to 10 are labelled with the same reference numeral, and like parts are labelled with the prefix “3”.

[0103] Referring to Figures 11-15, a catheter system is illustrated and indicated generally at 310. The catheter system 310 includes a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 310 includes a lead-manipulation member 318 including a lead-engaging member 320 having two lead-engaging member portions 320a, 320b at least partially arranged within the catheter body 14 in a delivery configuration, illustrated in Figure 11, and deployable from the catheter body 14 to move from the delivery configuration to the deployed configuration, illustrated in Figures 12-14. The lead-engaging member portions 320a, 320b deflect radially outward relative to the catheter body 14 when moving from the delivery configuration to the deployed configuration for moving an electrical lead L2 away from the distal portion 16. The lead-engaging member portions 320a, 320b may be configured to curve or curl into the deployed configuration. The distal portion 16 of the catheter body 14 includes a distal opening for receiving the lead- engaging member portions 320a, 320b such that the lead-engaging member portions 320a, 320b are deployed therefrom.

[0104] The lead-engaging member portions 320a, 320b of Figures 11-14 include a first lead- engaging member portion 320a and a second lead-engaging member portion 320b. It shall be appreciated that in alternative embodiments, any suitable number of lead-engaging member portions may be provided, for example three lead-engaging member portions. In the illustrated embodiment of Figures 11 - 14, the first and second lead-engaging member portions 320a, 320b are circumferentially spaced apart. It shall be appreciated that the first and second lead-engaging member portions 320a, 320b may define any suitable length, or different lengths.

[0105] As is illustrated in Figures 11-14, the first and second lead-engaging member portions 320a, 320b may define different shapes. It shall be appreciated that in alternative embodiments, the first and / or section lead-engaging member portions 320a, 320b may define any suitable shape.

[0106] In some embodiments, the catheter system 310 includes a lead-manipulation shaft 24 configured extending along the catheter body 14 and connected to the lead-engaging member portions 320a, 320b of the lead-manipulation member 318. The lead-manipulation shaft 24 is operable such that the lead-engaging member portions 320a, 320b are moveable relative tothe catheter body 14. The lead-manipulation shaft 24 is configured to couple the lead- engaging member portions 320a, 320b to the catheter system 310. The lead-manipulation shaft 24 may be rotatable to rotate the lead-engaging member portions 320a, 320b relative to the catheter body 14. Additionally, or alternatively, the lead-manipulation shaft 24 may be moveable so as to distally extend and / or proximally retract the lead-engaging member portions 320a, 320b relative to the distal portion 16 of the catheter body 14. Thus, through manipulation of the lead-manipulation shaft 24 movement of the lead-engaging member portions 320a, 320b are able to be controlled. This facilitates engaging of an electrical lead L2 with the lead-engaging member portions 320a, 320b by enabling the lead-engaging member portions 320a, 320b to be moved towards said electrical lead L2. Control of the movement of the lead-engaging member portions 320a, 320b also facilitates moving an electrical lead L2 into a desired location after said electrical lead L2 has been engaged by the lead-engaging member portions 320a, 320b.

[0107] In some embodiments, the catheter system 310 may include an atraumatic tip 330. The atraumatic tip 330 of the catheter system 310 may be positioned at or near the distal portion 16 of the catheter body 14. The atraumatic tip 330 may be used to facilitate advancement of the catheter system 310 through the patient’s skin and vasculature, including within the heart. The atraumatic tip 330 may be configured so as to prevent or reduce intravascular trauma during the delivery of the catheter system 310 to the heart. It may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 330 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In some embodiments, the atraumatic tip 330 may have a guidewire lumen. In some embodiments, the atraumatic tip 330 is taken to mean that the catheter system 310 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the catheter system 310, such as the curved or tapered tip described above. It will be understood that the taper and / or curvature of the atraumatic tip may be varied depending upon the sizing / configuration as required. In some embodiments, the atraumatic tip 330 may include an atraumatic material, such as hydrophilic -coated tips or silicone tips. In some embodiments, the atraumatic tip 330 may be omitted. In such embodiments, the distal portion 16 of the catheter body 14 may be configured with an atraumatic end portion designed to reduce or prevent intravascular trauma during the delivery of the catheter system 310.

[0108] In some embodiments, the atraumatic tip 330 may be coupled to or attached to a distal end of an inner tip shaft 32, which is movable within a lumen of lead-manipulation shaft 24.Relative movement between the catheter body 14 and the atraumatic tip 330 creates space between the distal end portion 16 of the catheter body 14 and the atraumatic tip 330, as is illustrated in Figures 12-14. This enables the lead-engaging member portions 320a, 320b to be deployed from the distal portion 16 of the catheter body 14. The relative movement between the catheter body 14 and the atraumatic tip 330 may be achieved by a distal movement of the inner shaft 32 and the atraumatic tip 330 relative to the catheter body 14 and / or by a proximal retraction of the catheter body 14 and the distal portion 16 relative to the atraumatic tip 330. In some embodiments, the atraumatic tip 330 may also act as a capsule or compartment for housing or retaining a compressed heart valve prosthesis 35, as is illustrated in Figures 11-12. In some embodiments, the valve prosthesis 35 is positioned on and retained by a valve-retaining member 40 of the catheter system 310. The valve-retaining member 40 may have one or more valve retention members (not shown) for releasably coupling the valve prosthesis 35 to the valve -retaining member 40. In some embodiments, the valve-retaining member 40 may comprise a shaft. The valve-retaining shaft 40 may be configured to be independently movable within a lumen of lead-manipulation shaft 24. The inner tip / capsule shaft 32 may be configured to be independently movable within a lumen of valve -retaining shaft 40. The lead-manipulation shaft 24 and the valve-retaining shaft 40 can be movable relative to each other. The inner tip / capsule shaft 32 and the valve-retaining shaft 40 can be movable relative to each other. When the valve prosthesis is positioned in a native annulus of the patient, the tip / capsule 330 can be moved relative to valve-retaining shaft 40, thereby allowing deployment of the valve prosthesis 35. The relative movement between the valve prosthesis 35 and the atraumatic tip / capsule 330 may be achieved by a distal movement of the inner shaft 32 relative to the valve -retaining shaft 40 and / or by a proximal retraction of the valve -retaining shaft 40 relative to the inner shaft 32.

[0109] In some embodiments, the lead-engaging member portions 320a, 320b may include an atraumatic surface 29. The atraumatic surface 29 may be positioned at or near the distal end of the lead-engaging member portions 320a, 320b. Alternatively, the atraumatic surface 29 may extend over an entirety of the lead-engaging member portions 320a, 320b or partially over the lead-engaging member portions 320a, 320b, for example over outer surfaces of the lead-engaging member portions 320a, 320b. The atraumatic surface 29 may be used to facilitate the advancement of the lead-engaging member portions 320a, 320b through the patient’s skin and vasculature, including within the heart. The atraumatic surface 29 may be configured to prevent or reduce intravascular trauma during movement of the lead-engagingmember portions 320a, 320b through the heart. In some embodiments, the atraumatic surface 29 may be an atraumatic end region of the lead-engaging member portions 320a, 320b, for example a curved on tapered end region. It will be understood that the taper and / or curvature of the atraumatic end region may be varied depending upon the sizing / configuration required. It shall be appreciated that the curve or taper may extend over an entirety of the lead-engaging member portions 320a, 320b, or partially over the lead-engaging member portions 320a, 320b, for example over outer surfaces of the lead-engaging member portions 320a, 320b. The atraumatic surface 29 is taken to mean that the lead-engaging member portions 320a, 320b include at least one feature for reducing or preventing intravascular trauma during the delivery of the lead-engaging member portions 320a, 320b, such as the curved or tapered end region described above. Alternatively, the atraumatic surface 29 may include an atraumatic material, such as a hydrophilic-coated surface or a silicone surface. Such atraumatic surfaces 29 may extend partially or over the entirety of the lead-engaging member portions 320a, 320b. For example, the hydrophilic -coated surface or silicone surface may extend over the end region of the lead-engaging member portions 320a, 320b, or over the outer surfaces of the lead-engaging member portions 320a, 320b.

[0110] The lead-engaging member portions 320a, 320b may be formed from a shape-memory material, for example Nitinol. It shall be appreciated that in alternative embodiments, any biocompatible shape-memory material may be used to form the lead-engaging member portions 320a, 320b. The lead-engaging member portions 320a, 320b may be provided with one or more shape-memory portions or regions, or alternatively, the entirety of the lead- engaging member portions 320a, 320b may be formed from the shape-memory material. The shape-memory material may be shape set to move the lead-engaging member portions 320a, 320b from the delivery configuration to the deployed configuration. Shape setting the lead- engaging member portions 320a, 320b helps to facilitate the deployment of the lead-engaging member portions 320a, 320b. It shall be appreciated that in alternative embodiments, any biocompatible shape-memory material may be used to form the lead-engaging member portions 320a, 320b, for example Elgiloy. In some embodiments, the lead-engaging member portions 320a, 320b may be formed from an alternative material, for example stainless steel, in combination with the one or more shape-memory material portions or regions. The shapememory portions or regions may form a shape-memory spring. It shall be appreciated that in some embodiments, the control member 44 may be used to move the lead-engaging member portions 320a, 320b from the delivery configuration to the deployed configuration.

[0111] The lead-engaging member portions 320a, 320b may include a protective lining (not shown) extending at least partially thereover. The protective lining may extend over an inner region of the lead-engaging member portions 320a, 320b, by way of example. The protective lining helps to reduce damage to the electrical lead L2 when the lead-engaging member portions 320a, 320b manipulate the electrical lead L2. It shall be appreciated that in alternative embodiments, the protective lining may be omitted.

[0112] The protective lining may include a textile material, by way of example. The textile material may include a polymeric material such as polyethylene terephthalate, polytetrafluoroethylene, or expanded polytetrafluoroethylene. The protective lining may include a hydrogel such as polyethylene glycol or silicone. Such materials have been found to provide a suitable level of protection for the electrical leads L2, whilst being biocompatible.

[0113] The lead-engaging member portions 320a, 320b may include one or more radiopaque regions (not shown) for aligning the lead-engaging member portions 320a, 320b with the electrical lead L2. The radiopaque regions facilitate alignment and engaging of the electrical leads L2 with the lead-manipulation member 318. The one or more radiopaque regions may be any suitable radiopaque marker. The one or more radiopaque regions may be distributed partially along the lead-engaging member portions 320a, 320b, for example evenly distributed along the lead-engaging member portions 320a, 320b.

[0114] Figure 11 illustrates the lead-engaging member portions 320a, 320b arranged within the catheter body 14 in the delivery configuration. In the illustrated embodiment, the catheter body 14 includes an outer sheath 14a and an inner sheath 14b, and the lead-engaging member portions 320a, 320b are arranged within the inner sheath 14b.

[0115] In some embodiments, for example as is illustrated in Figures 11-12, the catheter system 310 includes a heart valve prosthesis 35 releasably coupled to the catheter assembly and arranged within the atraumatic tip / capsule 330. The heart valve prosthesis 35 may be in a compressed, delivery configuration within the atraumatic tip / capsule 330, and may be deployable from the atraumatic tip / capsule 330 to move into an expanded, deployed configuration. The heart valve prosthesis 35 may include 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 heart valve prosthesis 35 is provided with a valve body disposed within and secured to the frame, the valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame. It shall be appreciated that in alternative embodiments, the valveprosthesis 35 may be omitted from the catheter system 310 and deployed from a separate catheter system.

[0116] In the illustrated embodiment, the lead-manipulation member 318 includes two lead- engaging member portions 320a, 320b. The lead-engaging member portions 320a, 320b may be arranged to oppose each other. It shall be appreciated that in alternative embodiments, the lead-manipulation member 318 may include any suitable number of lead-engaging member portions, for example, one, three, or four lead-engaging member portions, or ay suitable number of lead-engaging member portions. In embodiments including a plurality of lead- engaging member portions, said lead-engaging member portions may be equally spaced apart. In embodiments including a plurality of lead-engaging member portions, said lead-engaging member portions may be substantially the same shape, as is illustrated in Figures 12-14. In alternative embodiments, however, differently shaped and / or configured lead-engaging member portions may be provided.

[0117] The lead-engaging member portions 320a, 320b of Figures 11-14 include a frame, for example, a wire frame. The wire frame may be in the form of a loop. The first and second loops 320a, 320b increase the contact surface area between the lead-engaging member portions 320a, 320b and the electrical lead L2, which facilitates capture and manipulation of the electrical lead L2. The first and second loops 320a, 320b may define a recess, channel, indentation, notch, or groove (not shown) for receiving an electrical lead L2 in the deployed configuration. The recess, channel, indentation, notch, or groove may be provided at any suitable location on the lead-engaging member portions 320a, 320b. It shall be appreciated that more than one recess, channel, indentation, notch, or groove may be provided on each lead-engaging member portion 320a, 320b. The recess, channel, indentation, notch, or groove may form, by way of example, a C-shape, V, shaped, U-shape, ovular, semi-circular, square or an alternative curved or stepped shape.

[0118] Figures 12-14 illustrate the lead-engaging member portions 320a, 320b in the deployed configuration. Each lead-engaging member portion 320a, 320b is retained in a delivery configuration by the catheter body 14 when it is within said catheter body 14. When the lead-engaging member portions 320a, 320b are deployed from the catheter body 14 they curve into the deployed configuration shown in Figures 13 and 14. Stated another way, when the lead-engaging member portions 320a, 320b are deployed from the catheter body 14 they curve or deflect radially outwardly into the deployed configuration. The movement enables the lead-engaging member portions 320a, 320b to move an electrical lead L2 away from thetip / capsule 330 and / or the distal portion of the catheter body 14, and so away from the valve prosthesis to be deployed. The lead-engaging member portions 320a, 320b may extend substantially perpendicular to the catheter body 14 or the lead-manipulation shaft 24, as is illustrated in Figures 12-14.

[0119] In some alternative embodiments, for example as is illustrated in Figure 13, the lead- engaging member portions 320a, 320b may evert when moving into the deployed configuration. Stated another way, the lead-engaging member portions 320a, 320b may curve so as to overlap a portion of the lead-manipulation shaft 24 and / or catheter body 14 in the deployed configuration. In some embodiments, the lead-engaging member portions 320a, 320b may curve so as to contact an external surface of the lead-manipulation shaft 24 and / or the catheter body 14 in the deployed configuration. Configuring the lead-engaging member portions 320a, 320b in this way may work to confine an electrical lead between one or more lead-engaging member portions and the lead-manipulation shaft 24 and / or catheter body 14. In other embodiments, for example as is illustrated in Figure 14, the lead-engaging member portions 320a, 320b may be configured to curl so as to define a hook or snare configured to receive and ensnare an electrical lead L2.

[0120] Referring to Figure 15, in some embodiments the catheter system 310 includes a control member 44 located at a proximal end of the catheter assembly 12. Stated another way, the catheter assembly 12 extends distally from the control member 44. The control member 44 may be, for example, a control handle 44. The control member 44 is configured to control movement of the catheter system 310 and includes one or more controls 46a-d configured to control one or more components of the catheter system 310. In the embodiment of Figure 15, four controls 46a-d are provided. In alternative embodiments, any suitable number of controls may be provided, for example two, three, five or any alternative number of controls. The at least one control 46a-d may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any suitable control. The controls 46a-d may be controlled simultaneously. In the exemplary embodiment of Figure 15, the four controls 46a-d are located on the control member 44 and are rotatable relative to the control member 44.

[0121] A first control 46a may be provided to control movement of the catheter body 14. The first control may be configured to distally extend and / or proximally retract the catheter body 14. In some embodiments, the catheter body 14 may include an outer sheath 14a and an inner sheath 14b. In such embodiments, separate controls may be provided to control the inner and outer sheaths 14a, 14b.

[0122] A second control 46b may be provided to control movement of the lead-manipulation shaft 24. The second control 46b may be configured to distally extend, proximally retract, flex and / or rotate the lead-manipulation shaft 24. Stated another way, the second control 46b may be configured to control movement of the lead-engaging member portions 320a, 320b via the lead-manipulation shaft 24. The third control 46c may be configured to control movement of the valve-retaining shaft 40. The third control may be configured to distally extend and / or proximally retract the valve-retaining shaft 40. A fourth control 46d may be provided to control the distal and proximal movement of the inner tip / capsule shaft 32, thereby controlling movement of the atraumatic tip / capsule 330.

[0123] A method of engaging an electrical lead L2 in a patient’s anatomy will be described hereafter.

[0124] 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 TV of the patient. Once the guidewire is positioned, the entry point is dilated to permit entry of the catheter body 14 of the catheter system 12 into the vasculature, The catheter body 14 is advanced over the guidewire through the entry point, through the vasculature including the femoral vein and inferior vena cava, and into the right atrium RA. It will be understood that the catheter body 14 may be positioned within the desired area of the heart via different methods or routes. For example, and not by way of limitation, another possible path to the right atrium RA would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium RA. A possible path to the mitral valve MV would be through the femoral artery into the aorta, through the aortic valve into the left ventricle LV, and then to the mitral valve MV. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter body 14 may be advanced through the left ventricle LV to the mitral valve MV. In addition, although described with the use of a guidewire, in another embodiment hereof, the catheter body 14 may access the heart without the use of a guidewire.

[0125] In an embodiment, the method of engaging an electrical lead L2 within a patient includes obtaining a catheter system 310 including an elongate catheter body 14 having adistal portion 16, and a lead-manipulation member 18 including lead-engaging member portions 320a, 320b at least partially arranged within the catheter body 14 in a delivery configuration. The method is applicable to any of the embodiments described herein and in relation to any of the Figures.

[0126] The distal portion 16 of the catheter body 14 is moved at or near to the electrical lead L2 in the patient’s anatomy. It shall be appreciated that the catheter body 14 may be distally extended, proximally retracted, rotated and / or flexed to move the catheter body 14 into position with an electrical lead L2. The lead-engaging member portions 320a, 320b are deployed from the distal portion 16 of the catheter body 14. The deployment of the lead- manipulation member 318 may include moving the lead-engaging member portions 320a, 320b relative to the catheter body 14, for example via the lead-manipulation shaft 24. The lead-engaging member portions 320a, 320b may be extended and / or rotated. It shall be appreciated that the lead-engaging member portions 320a, 320b may be partially deployed from the catheter body 14 and the lead-engaging member portions 320a, 320b are moved into alignment with the electrical lead L2 before complete deployment of the lead-engaging member portions 320a, 320b.

[0127] The lead-engaging member portions 320a, 320b may be moved from the delivery configuration to the deployed configuration so as to deflect radially outward relative to the catheter body 14 and move the electrical lead L2 away from the distal portion 16 of the catheter body 14. The method may additionally or alternatively include any one of, or any combination of, flexing, rotating, distally extending, proximally retracting, spiralling, curving and / or curling of the lead-engaging member portions 320a, 320b to move the lead-engaging member portions 320a, 320b into alignment with the electrical lead L2 and to engage the electrical lead L2. Exemplary positions of the lead-engaging member portions 320a, 320b in the deployed configuration for engaging the electrical lead L2 are illustrated in Figures 12-14. In some embodiments, the electrical lead L2 may be engaged by the lead-engaging member portions 320a, 320b and moved towards, or into contact with, the catheter body 14 or the lead-manipulation shaft 24. Alternatively, the electrical lead L2 may be engaged by the lead- engaging member portions 320a, 320b such that the electrical lead is radially spaced apart from the catheter body 14 and / or the lead-manipulation shaft 24.

[0128] In embodiments wherein more than one lead-manipulation member is provided, the lead-engaging member portions 320a, 320b may be moved independently such that only oneof the lead-manipulation members engages the electrical lead L2. In this way, different lead- manipulation members may be controlled to engage different electrical leads within a patient.

[0129] A method of deploying a valve prosthesis 35 will be described hereafter. The method is applicable to any of the embodiments described herein and in relation to the Figures. The method includes the steps outlined above of engaging an electrical lead L2.

[0130] The method further includes the step of obtaining a prosthesis 35, for example a heart valve prosthesis, having a compressed, delivery configuration and an expanded, deployed configuration. The heart valve prosthesis includes 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 heart valve prosthesis is provided with a valve body disposed within and secured to the frame. The valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame. The heart valve prosthesis is positioned within the catheter body 14 in the compressed, delivery configuration. In some embodiments, the heart valve prosthesis 35 is positioned on and retained by a valve-retaining member 40 of the catheter system 310. The valve-retaining member 40 may have one or more valve retention members (not shown) for releasably coupling the valve prosthesis 35 to the valve-retaining member 40. In some embodiments, the valve -retaining member 40 may comprise a shaft. The valve -retaining shaft 40 may be configured to be movable within a lumen of lead-manipulation shaft 24. The inner tip / capsule shaft 32 may be configured to be movable within a lumen of valve-retaining shaft 40. The inner tip / capsule shaft 32 and valve-retaining shaft 40 can be movable relative to each other. As is illustrated in Figure 16, following the positioning of the valve prosthesis in a native annulus of the patient, the tip / capsule 330 is moved relative to valve-retaining shaft 40, thereby allowing deployment of the heart valve prosthesis 35. The relative movement between the heart valve prosthesis 35 and the atraumatic tip / capsule 330 may be achieved by a distal movement of the inner tip / capsule shaft 32 relative to the valve -retaining shaft 40 and / or by a proximal retraction of the valve-retaining shaft 40 relative to the inner tip / capsule shaft 32.

[0131] Figures 17-19 show an alternative catheter system 310. Identical parts with the embodiments of Figures 2 to 16 are labelled with the same reference numeral, and like parts are labelled with the prefix “3”.

[0132] Referring to Figures 17-19, a catheter system is illustrated and indicated generally at 310. The catheter system 310 includes a catheter assembly 12 including an elongate catheterbody 14 having a distal portion 16. The catheter system 310 includes a lead-manipulation member 318 including a lead-engaging member 320 having two lead-engaging member portions 320a, 320b at least partially arranged within the catheter body 14 in a delivery configuration, and deployable from the catheter body 14 to move from the delivery configuration to the deployed configuration, illustrated in Figures 17. The lead-engaging member portions 320a, 320b deflect radially outward relative to the catheter body 14 when moving from the delivery configuration to the deployed configuration for moving an electrical lead L2 away from the distal portion 16. The lead-engaging member portions 320a, 320b may be configured to curve or curl into the deployed configuration. The distal portion 16 of the catheter body 14 includes a distal opening for receiving the lead-engaging member portions 320a, 320b such that the lead-engaging member portions 320a, 320b are deployed therefrom.

[0133] In some embodiments, for example as is illustrated in Figures 17, the catheter system 310 includes a heart valve prosthesis 35 arranged within a valve sheath / capsule 50. The heart valve prosthesis 35 may be contained in a compressed, delivery configuration within the valve sheath / capsule 50, and may be deployable from the valve sheath / capsule 50 to move into an expanded, deployed configuration. The heart valve prosthesis 35 may include 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 heart valve prosthesis 35 is provided with a valve body disposed within and secured to the frame, the valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame. It shall be appreciated that in alternative embodiments, the valve prosthesis 35 may be omitted from the catheter system 310 and deployed from a separate catheter system.

[0134] As is illustrated in Figures 17-19, the lead-manipulation shaft 24 may be moveable to distally extend and / or proximally retract the lead-engaging member portions 320a, 320b relative to the distal portion 16 of the catheter body 14. Thus, through manipulation of the lead-manipulation shaft 24, movement of the lead-engaging member portions 320a, 320b may be controlled. This facilitates engaging of an electrical lead L2 with one or more of the lead- engaging member portions 320a, 320b by enabling the lead-engaging member portions 320a, 320b to be moved towards said electrical lead L2, as is illustrated in Figure 19. Control of the movement of the lead-engaging member portions 320a, 320b also facilitates moving anelectrical lead L2 into a desired location after said electrical lead L2 has been engaged by the lead-engaging member portions 320a, 320b.

[0135] In some embodiments, the catheter system 310 may include an atraumatic tip 30. During delivery, the atraumatic tip 30 of the catheter system 310 may be positioned at or near the distal portion 16 of the catheter body 14. The atraumatic tip 30 may be used to facilitate advancement of the catheter system 310 through the patient’s skin and vasculature, including within the heart. The atraumatic tip 30 may be configured so as to prevent or reduce intravascular trauma during the delivery of the catheter system 310 to the heart. It may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 30 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In some embodiments, the atraumatic tip 30 may have a guidewire lumen. In some embodiments, the atraumatic tip 30 is taken to mean that the catheter system 310 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the catheter system 310, such as the curved or tapered tip described above. It will be understood that the taper and / or curvature of the atraumatic tip may be varied depending upon the sizing / configuration as required. In some embodiments, the atraumatic tip 30 may include an atraumatic material, such as hydrophilic-coated tips or silicone tips. In some embodiments, the atraumatic tip 330 may be omitted. In such embodiments, the distal portion 16 of the catheter body 14 may be configured with an atraumatic end portion designed to reduce or prevent intravascular trauma during the delivery of the catheter system 310.

[0136] In some embodiments, the heart valve prosthesis 35 is positioned on and retained by a valve -retaining member 40 of the catheter system 310. The valve-retaining member 40 may have one or more valve retention members (not shown) for releasably coupling the valve prosthesis 35 to the valve -retaining member 40. In some embodiments, the valve-retaining member 40 may comprise a shaft. The atraumatic tip 30 may be coupled to or attached to a distal end of the valve-retaining shaft 40. The valve -retaining shaft 40 may be configured to be movable within a lumen of the valve sheath / capsule 50. Relative movement between the valve sheath / capsule 50 and the valve -retaining shaft 40 allows the valve prosthesis 35 to be deployed. As is illustrated in Figure 19, following the positioning of the valve prosthesis in a native annulus of the patient, relative movement between the valve sheath / capsule 50 and / or the valve-retaining shaft 40, thereby allows deployment of the heart valve prosthesis 35. The relative movement between the valve sheath / capsule 50 and the heart valve prosthesis 35 maybe achieved by a distal movement of the valve-retaining shaft 40 relative to the valve sheath / capsule 50 and / or by a proximal retraction of the valve sheath / capsule 50 relative to the valve-retaining shaft 40.

[0137] In some embodiments, relative movement between the catheter body 14 and the lead- manipulation shaft 24 creates space between the distal end portion 16 of the catheter body 14 and the distal end of lead-manipulation shaft 24, as is illustrated in Figures 17 and 19. This enables the lead-engaging member portions 320a, 320b to be deployed from the distal portion 16 of the catheter body 14. The relative movement between the catheter body 14 and the lead- manipulation shaft 24 may be achieved by a distal movement of the lead-manipulation shaft 24 relative to the catheter body 14 and / or by a proximal retraction of the catheter body 14 relative to the lead-manipulation shaft 24. In some embodiments, the valve sheath / capsule 50 is configured to be independently movable within a lumen of lead-manipulation shaft 24 and the valve-retaining shaft 40 is configured to be independently movable within a lumen of valve sheath / capsule 50. The lead-manipulation shaft 24 and the valve sheath / capsule 50 are movable relative to each other.

[0138] Referring to Figure 18, in some embodiments the catheter system 310 includes a control member 44 located at a proximal end of the catheter assembly 12. Stated another way, the catheter assembly 12 extends distally from the control member 44. The control member 44 may be, for example, a control handle 44. The control member 44 is configured to control movement of the catheter system 310 and includes one or more controls 47a-d configured to control one or more components of the catheter system 310. In the embodiment of Figure 18, four controls 47a-d are provided. In alternative embodiments, any suitable number of controls may be provided, for example two, three, five or any alternative number of controls. The at least one control 47a-d may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any suitable control. The controls 47a-d may be controlled simultaneously. In the exemplary embodiment of Figure 18, the four controls 47a-d are located on the control member 44 and are rotatable relative to the control member 44.

[0139] A first control 47a may be provided to control movement of the catheter body 14. The first control may be configured to distally extend and / or proximally retract the catheter body 14. In some embodiments, the catheter body 14 may include an outer sheath 14a and an inner sheath 14b. In such embodiments, separate controls may be provided to control the inner and outer sheaths 14a, 14b.

[0140] A second control 47b may be provided to control movement of the lead-manipulation shaft 24. The second control 47b may be configured to distally extend, proximally retract, flex and / or rotate the lead-manipulation shaft 24. Stated another way, the second control 47b may be configured to control movement of the lead-engaging member portions 320a, 320b via the lead-manipulation shaft 24. The third control 47c may be configured to control movement of the valve sheath / capsule 50. The third control may be configured to distally extend and / or proximally retract the valve sheath / capsule 50. A fourth control 47d may be provided to control the distal and proximal movement of the valve-retaining shaft 40.

[0141] A method of engaging an electrical lead L2 in a patient’s anatomy will be described hereafter.

[0142] 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 TV of the patient. Once the guidewire is positioned, the entry point is dilated to permit entry of the catheter body 14 of the catheter system 12 into the vasculature, The catheter body 14 is advanced over the guidewire through the entry point, through the vasculature including the femoral vein and inferior vena cava, and into the right atrium RA. It will be understood that the catheter body 14 may be positioned within the desired area of the heart via different methods or routes. For example, and not by way of limitation, another possible path to the right atrium RA would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium RA. A possible path to the mitral valve MV would be through the femoral artery into the aorta, through the aortic valve into the left ventricle LV, and then to the mitral valve MV. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter body 14 may be advanced through the left ventricle LV to the mitral valve MV. In addition, although described with the use of a guidewire, in another embodiment hereof, the catheter body 14 may access the heart without the use of a guidewire.

[0143] In an embodiment, the method of engaging an electrical lead L2 within a patient includes obtaining a catheter system 310 including an elongate catheter body 14 having a distal portion 16, and a lead-manipulation member 318 including lead-engaging memberportions 320a, 320b at least partially arranged within the catheter body 14 in a delivery configuration. The method is applicable to any of the embodiments described herein and in relation to any of the Figures.

[0144] The distal portion 16 of the catheter body 14 is moved at or near to the electrical lead L2 in the patient’s anatomy. It shall be appreciated that the catheter body 14 may be distally extended, proximally retracted, rotated and / or flexed to move the catheter body 14 into position with an electrical lead L2. The lead-engaging member portions 320a, 320b are deployed from the distal portion 16 of the catheter body 14. The deployment of the lead- manipulation member 318 may include moving the lead-engaging member portions 320a, 320b relative to the catheter body 14, for example via the lead-manipulation shaft 24. The lead-engaging member portions 320a, 320b may be extended and / or rotated. It shall be appreciated that the lead-engaging member portions 320a, 320b may be partially deployed from the catheter body 14 and the lead-engaging member portions 320a, 320b are moved into alignment with the electrical lead L2 before complete deployment of the lead-engaging member portions 320a, 320b.

[0145] The lead-engaging member portions 320a, 320b may be moved from the delivery configuration to the deployed configuration so as to deflect radially outward relative to the catheter body 14 and move the electrical lead L2 away from the distal portion 16 of the catheter body 14. The method may additionally or alternatively include any one of, or any combination of, flexing, rotating, distally extending, proximally retracting, spiralling, curving and / or curling of the lead-engaging member portions 320a, 320b to move the lead-engaging member portions 320a, 320b into alignment with the electrical lead L2 and to engage the electrical lead L2. Exemplary positions of the lead-engaging member portions 320a, 320b in the deployed configuration for engaging the electrical lead L2 are illustrated in Figures 12-14. In some embodiments, the electrical lead L2 may be engaged by the lead-engaging member portions 320a, 320b and moved towards, or into contact with, the catheter body 14 or the lead-manipulation shaft 24. Alternatively, the electrical lead L2 may be engaged by the lead- engaging member portions 320a, 320b such that the electrical lead is radially spaced apart from the catheter body 14 and / or the lead-manipulation shaft 24.

[0146] In embodiments wherein more than one lead-manipulation member is provided, the lead-engaging member portions 320a, 320b may be moved independently such that only one of the lead-manipulation members engages the electrical lead L2. In this way, different lead- manipulation members may be controlled to engage different electrical leads within a patient.

[0147] A method of deploying a valve prosthesis 35 will be described hereafter. The method is applicable to any of the embodiments described herein and in relation to the Figures. The method includes the steps outlined above of engaging an electrical lead L2.

[0148] The method further includes the step of obtaining a prosthesis 35, for example a heart valve prosthesis, having a compressed, delivery configuration and an expanded, deployed configuration. The heart valve prosthesis includes 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 heart valve prosthesis is provided with a valve body disposed within and secured to the frame. The valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame. The heart valve prosthesis is positioned within the catheter body 14 in the compressed, delivery configuration. In some embodiments, the heart valve prosthesis 35 is positioned on and retained by a valve-retaining member 40 of the catheter system 310. The valve-retaining member 40 may have one or more valve retention members (not shown) for releasably coupling the valve prosthesis 35 to the valve-retaining member 40. In some embodiments, the valve -retaining member 40 may comprise a shaft. The valve -retaining shaft 40 is configured to be movable within a lumen of valve sheath / capsule 50. The valve sheath / capsule 50 is configured to be movable within a lumen of lead-manipulation shaft 24. As is illustrated in Figure 19, following the positioning of the valve prosthesis in a native annulus of the patient, the valve sheath / capsule 50 is moved relative to valve-retaining shaft 40, thereby allowing deployment of the heart valve prosthesis 35. The relative movement between the heart valve prosthesis 35 and the valve sheath / capsule 50 may be achieved by a distal movement of the valve -retaining shaft 40 relative to the valve sheath / capsule 50 and / or by a proximal retraction of the valve sheath / capsule 50 relative to the valve-retaining shaft 40.

[0149] Figures 20-25 show an alternative catheter system 410 with an alternative lead- manipulation member 418. Identical parts with the embodiments of Figures 2 to 19 are labelled with the same reference numeral, and like parts are labelled with the prefix “4”.

[0150] Referring to Figures 20 and 21, a catheter system is illustrated and is indicated generally at 410. The catheter system 410 includes a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 410 includes a lead- manipulation member 418 including a lead-engaging member 420. The lead-engaging member 420 is configured to move between an open configuration, in which the lead- engaging member 420 defines a contact surface configured to receive an electrical leadtherein, and a closed configuration, in which the lead-engaging member 420 is configured to engage, retain, grip and / or snare the electrical lead, as is illustrated in Figure 21.

[0151] Referring now to Figures 22A to 22C, the lead-engaging member 420 connected to a lead-manipulation shaft 24. The lead-engaging member 420 is located at or towards a distal end of the lead-manipulation shaft 24. The lead-manipulation shaft 24 extends along the catheter body 14 and is connected to the lead-engaging member 420. The lead-manipulation shaft 24 is operable to move the lead-engaging member 420 relative to the catheter body 14.

[0152] In some embodiments, the lead-manipulation shaft 24 is moveable to rotate the lead- engaging member 420 relative to the catheter body 14. Additionally, or alternatively, the lead- manipulation shaft 24 may be moveable so as to distally extend and / or proximally retract the lead-engaging member 420 relative to the distal portion 16 of the catheter body 14. In some embodiments, the lead-manipulation shaft 24 may be configured to be moveable to orient the lead-engaging member 420 relative to the distal portion 16 of the catheter body 14. In use, moving the lead-manipulation shaft 24, such as through the rotation, extension, retraction and / or bending of the lead-manipulation shaft 24, for example, can be controlled by the surgeon to grasp and hold the electrical leads LI, L2 or move them to a desired location. The lead-manipulation shaft 24 can also be manipulated so as to meet the levels of precision required to grasp and otherwise manipulate the electrical leads LI, L2. Additionally, the lead- manipulation shaft 24 and the lead-engaging member 420 can work together to facilitate precise manipulation of the electrical leads LI, L2, whilst securely engaging the electrical leads LI, L2 within the lead-engaging member 420. The combination of the lead- manipulation shaft 24 and the lead-engaging member 420 also enables the precise removal of electrical leads LI, L2 from the patient’s anatomy.

[0153] In some embodiments, lead-engaging member 420 includes first and second arms 420a, 420b connected by a pivot so as to move between an open and a closed configuration. As such, the first and second arms 420a, 420b are pivotable relative to each other. In some embodiments, the first and second opposing arms 420a, 420b may be biased, for example resiliently biased, into the open or closed configuration. The first and second opposing arms 420a, 420b may be operable to move between the open and closed configuration by an actuation member. For example, the actuation member may include a control member for controlling movement of the first and second opposing arms 420a, 420b between the open and closed configuration.

[0154] In some embodiments, the lead-manipulation shaft 24 may be moveable to flex the lead-engaging member 420 about a plurality of axes, for example to flex the lead-engaging member 420 about at least two axes simultaneously. Such flexing increases reach of the lead- manipulation member 418, thereby increasing the possible locations at which the electrical leads can be positioned. By way of example, the lead-manipulation shaft 24 may be moveable about any of the following axes or in any of the following directions: proximal retraction, distal extension, rotation about the longitudinal axis of the catheter body and / or lateral movement, bending, flexing, or steering of the lead-manipulation shaft 24.

[0155] As discussed above, the lead-engaging member 420 is moveable between open and closed configurations, as discussed above. The lead-engaging member 420 includes a pair of opposing arms 420a, 420b moveable between the open and closed configurations. The first and second opposing arms 420a, 420b are able to take on a compact delivery configuration form within the elongate catheter body 14 and are able to take on a deployed configuration wherein the first and second opposing arms 420a, 420b can securely engage an electrical lead such as L2 to move it to a desired location. Although first and second arms 420a, 420b are illustrated in Figures 20-22C, it shall be appreciated that any number of arms may be provided. For example, three, four, five or any suitable number of arms may be provided. In some embodiments, the lead-engaging member 420 may include two or more pairs of arms, with each pair being capable of engaging the same or a different electrical lead present within a patient’s anatomy.

[0156] In some embodiments, the lead-engaging member 420 may include a delivery configuration, illustrated in Figure 22A. In the delivery configuration, the lead-engaging member 420 is fully closed. In the delivery configuration, the first and second arms 420a, 420b may be in contact with each other to fully close the lead-engaging member 420, or the first and second arms 420a, 420b may be spaced apart by a distance such that the electrical lead L2 cannot be received therein. The delivery configuration helps to enable a low profile for transcatheter delivery. The lead-engaging member 420 is moveable to an open configuration, as is illustrated in Figure 22B. In the open configuration, the first and second arms 420a, 420b of the lead-engaging member 420 are spaced apart and define a contact surface configured to receive an electrical lead therein. The lead-engaging member 420 is moveable to a closed configuration, as is illustrated in Figure 22C. In the closed configuration illustrated in Figure 22C, the lead-engaging member 420 engages the electrical lead L2. It shall be appreciated that in the closed configuration, the lead-engaging member 420 ispartially closed, i.e. closed relative to the open configuration. The partial closure of the lead- engaging member 420 creates the space in which the electrical lead L2 may be received. It shall be appreciated that in some embodiments, the delivery configuration may be the closed configuration. In this alternative embodiment, the snare device does not fully close, and instead moves between the closed configuration of Figure 22C for delivery and engaging of the electrical lead L2, and the open configuration of Figure 22B.

[0157] When configured for transcatheter delivery, the lead-manipulation member 418 may be at least partially, for example entirely, arranged within the catheter system 410. The lead- manipulation member 418 is deployable from the catheter body 14. Providing a lead- engaging member 420 that moves between an open and closed configuration and / or is deployable from the catheter system 410 enables the catheter system 410 to have a low profile for transcatheter delivery. In the closed configuration, opposing parts or arms of the lead- engaging member 420 move towards each other to engage, retain, grip, and / or snare the electrical lead positioned therebetween. The lead-engaging member 420 may move back into the open configuration to release the electrical lead L2, for example prior to removal of the lead-engaging member 420 from the patient’s anatomy. Alternatively, the lead-engaging member 420 may continue to engage, retain, grip, and / or snare the electrical lead as it is removed from the patient’s anatomy so as to remove the electrical lead L2 from the patient’s anatomy.

[0158] In some embodiments, the first and second arms 420a, 420b are moved between the open and closed configuration using an actuating wire (not shown). Alternatively, or additionally, the first and second arms 420a, 420b may be formed from a shape-memory material, and the first and second arms 420a, 420b may automatically move between the open and closed configurations. The lead-engaging member 420 may be provided with one or more shape-memory material portions or regions. The shape-memory material may be shape set to move the lead-engaging member 420 from the open configuration to the closed configuration to capture or engage the electrical lead L2. The shape-memory material may be Nitinol, for example. It shall be appreciated that in alternative embodiments, any biocompatible shapememory material may be used to form the lead-engaging member 420.

[0159] In some embodiments, the catheter system 410 may include an atraumatic tip 30 (not shown). The atraumatic tip of the catheter system 410 may be positioned at or near the distal portion 16 of the catheter body 14. The atraumatic tip 30 as described earlier may be used to facilitate the advancement of the catheter system 410 through the patient’s skin andvasculature, including within the heart. The atraumatic tip 30 may be configured so as to prevent or reduce intravascular trauma during the delivery of the catheter system 410 to the heart. It may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 30 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). The atraumatic tip 30 can include a distal opening. The distal opening (not shown) may extend down the catheter body to form a central lumen. The distal opening may also accommodate a guidewire or other elements or substances, as will be described in more detail below. It will be understood that the taper and / or curvature of the atraumatic tip 30 may be varied depending upon the sizing / configuration as required. The atraumatic tip 30 is taken to mean that the catheter system 410 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the catheter system 410, such as the curved or tapered tip described above. Alternatively, the atraumatic tip 30 may include an atraumatic material, such as hydrophilic-coated tips or silicone tips. In some embodiments, the atraumatic tip 30 may be omitted, meaning a separate atraumatic tip 30 may be omitted, and in such embodiments the distal end 16 of the catheter body 14 may be configured with an atraumatic end portion designed to reduce or prevent intravascular trauma during the delivery of the catheter system 410.

[0160] In some embodiments, the lead-engaging member 420 may include an atraumatic surface 29, as is illustrated in Figure 20. The atraumatic surface 29 may be positioned at or near the distal portion 16 of the catheter body 14. Alternatively, the atraumatic surface 29 may extend over an entirety of an outer surface the lead-engaging member 420 or partially over the lead-engaging member 420. The atraumatic surface 29 may be used to facilitate the movement of the lead-engaging member 420 within a patient’s vasculature, including within the heart. The atraumatic surface 29 may be configured so as to prevent or reduce intravascular trauma during movement of the lead-engaging member 420 through the heart. In some embodiments, the atraumatic surface 29 may be an atraumatic end region of the lead- engaging member 420, for example a curved or tapered end region. It will be understood that the taper and / or curvature of the atraumatic end region may be varied depending upon the sizing / configuration required. It shall be appreciated that the curve or taper may extend over an entirety of the lead-engaging member 420, or partially over the lead-engaging member 420, for example over the outer surfaces of the lead-engaging member 420. The atraumatic surface 29 is taken to mean that the lead-engaging member 420 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the lead-engagingmember 420, such as the curved or tapered end region described above. Alternatively, the atraumatic surface 29 may include an atraumatic material, such as a hydrophilic-coated surface or a silicone surface. Such atraumatic surfaces 29 may extend partially or over the entirety of the lead-engaging member 420. For example, the hydrophilic -coated surface or silicone surface may extend over the end region of the lead-engaging member 420, or over the outer surfaces of the lead-engaging member 420.

[0161] As shown in Figures 23A-23D, the first and second opposing arms 420a, 420b define an opening 25 therebetween for receiving the electrical lead L2 therethrough. The first and second arms 420a, 420b may be any suitable shape for engaging the electrical lead L2. In some embodiments, the first and second arms 420a, 420b can curve towards each other such that a width between a central portion of the first and second arms 420a, 420b is greater than a width between proximal and distal end portions of the first and second arms 420a, 420b. As such, when the first and second arms 420a, 420b are in the closed position described above, the electrical lead can be retained within the channel 25 defined between the first and second opposing arms 420a, 420b, and restricted from leaving the first and second arms 420a, 420b. It shall be appreciated that in alternative embodiments, other suitable shapes of first and second arms 420a, 420b may be provided. For example, the first and second arms 420a, 420b may be substantially L-shaped, may be curved, or may form a V-shape, a U-shape or an O- shape.

[0162] The lead-engaging member 420 may be used to introduce slack into the electrical lead L2, for example as is illustrated in Figures 23A to 23D. The introduction of slack into the electrical lead L2 is advantageous because it helps to ensure that the electrical lead L2 is not pulled out of the heart wall when being manipulated or while receiving an outside force, and it also reduces strain on the electrical lead L2. To introduce slack into the electrical lead L2, the lead-engaging member 420 is moved into the closed configuration, as is illustrated in Figure 23 A, to engage an electrical lead L2. The lead-engaging member 420 is rotated whilst engaging the electrical lead L2, as is illustrated in Figures 23B and 23C. It shall be appreciated that any suitable movement of the lead-engaging member 420 may be used to introduce slack into the electrical lead L2. Once the lead-engaging member 420 has been rotated, the lead-engaging member 420 is moved into the open configuration and the electrical lead L2 is released, as is illustrated in Figure 23D. It shall be appreciated that the step of introducing slack may be repeated to introduce slack at multiple locations of the electrical lead L2, or to introduce slack to different electrical leads LI.

[0163] Referring now to Figures 24A and 24B, lead-engaging member 420 includes a contact surface, which includes a first contact surface 422 located on the first arm 420a, and a second contact surface 423 located on the second arm 420b. The first and / or second contact surfaces 422, 423 may include a roughened surface configured to increase friction between the first and second contact surfaces 422, 423 and the electrical lead L2. For example, in some embodiments, the first and second contact surfaces 422, 423 may be undulating, curved, serrated, or include any other form of textured surface. Contact surfaces 422, 423 may include one or more teeth, serrations, recesses, channels, grooves, or indentations 28 to receive the electrical lead therein, in the open configuration. In other embodiments, the contact surfaces may be substantially smooth. In some embodiments, the contact surfaces 422, 423 include an elongate recess, channel, groove, or indentation 28 extending along an axis that is parallel to a longitudinal axis of the catheter body 14. In some embodiments, the contact surfaces 422, 423 include an elongate recess, channel, indentation or groove 28 extending along an axis that is perpendicular to the longitudinal axis of the catheter body 14.

[0164] Referring again to Figures 24A and 24B, in some embodiments the catheter system 410 may include at least one lead-guiding member 434 extending from an outer surface thereof for guiding an electrical lead L2 to the lead-engaging member 420. In the embodiment shown, the at least one lead-guiding member 434 extends from an outer surface of the catheter body 14. The lead-guiding member 434 allows the surgeon to capture the electrical lead L2, and subsequently guide the electrical lead L2 into the lead-engaging member 420. The lead-guiding member 434 may include a first lead-guiding member portion 434a and a second lead-guiding member portion 434b. The first and second lead-guiding member portions 434a, 434b are located on opposing sides of the catheter body 14. It shall be appreciated that in alternative embodiments, any suitable number of lead-guiding members 434 of any suitable configuration may be provided. For example, the lead-guiding member 434 may be one or more hooks or loops. Furthermore, the lead-guiding member 434 may be located at any suitable location on the catheter body 14 or the catheter assembly 12. For example, the first and second lead-guiding member portions 434a, 434b may be located on the same side of the catheter body 14, towards the proximal end 32 of the catheter body 14 or towards the distal portion 16 of the catheter body 14.

[0165] The first and second lead-guiding member portions 434a, 434b are moveable between a deployed configuration, illustrated in Figure 24B, wherein the lead-guiding member portions 434a, 434b at least partially extend outwardly from the outer surface of the catheterbody 14, and a delivery configuration, illustrated in Figure 24A. In the delivery configuration, the first and second lead-guiding member portions 434a, 434b may be located within the catheter body 14 or alongside the outside of the catheter body. In the deployed configuration of Figure 24B, the first and second lead-guiding member portions or arms 434a, 434b are substantially curved. The first and second lead-guiding member portions or arms 434a, 434b curve towards one another. When in the deployed configuration, the first and second lead- guiding portions or arms 434a, 434b intersect so as to define an enclosed space therein for receiving the electrical lead L2. The first and second lead-guiding portions or arms 434a, 434b may also be curved in the delivery configuration. It shall be appreciated that in alternative embodiments, the first and second lead-guiding member portions or arms 434a, 434b may be any suitable shape, for example substantially straight, L-shaped, or an alternative curved shape.

[0166] The first and second lead-guiding member portions 434a, 434b may extend through an aperture, opening or slot in the catheter body 14 to move into the deployed configuration. Alternatively, the first and second lead-guiding member portions 434a, 434b may compress or fold back on themselves in the delivery configuration and overlie the outer surface of the catheter body 14. The delivery configuration of the first and second lead-guiding member portions 434a, 434b enables a low profile for transcatheter delivery. The first and second lead-guiding member portions 434a, 434b may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape set to move the first and second lead-guiding member portions 434a, 434b from an open configuration to a closed configuration and / or from the delivery configuration to the deployed configuration.

[0167] The first and second lead-guiding member portions 434a, 434b may be moveable by a lead-guiding shaft 80. The lead-guiding shaft 80 may be moveable to retract, extend, open, close, flex and / or rotate the lead guiding member 434. In some embodiments, the lead- guiding shaft 80 and the first and / or second lead-guiding member portions 434a, 434b are moveable within the central lumen of the catheter body 14 for receiving the lead- manipulation member 418. In alternative embodiments, the lead-guiding shaft 80 and the first and / or second lead-guiding member portions 434a, 434b are located in a sidewall lumen of the catheter body 14. It shall be appreciated that in alternative embodiments, the lead-guiding shaft 80 may be omitted.

[0168] As is illustrated in Figure 25, in some embodiments, the catheter system 410 includes a control member 44 located at a proximal end of the catheter assembly 12. Stated anotherway, the catheter assembly 12 extends distally from the control member 44. The control member 44 may be, for example, a control handle 44. The control member 44 is configured to control movement of the catheter system 410 and includes one or more controls 48a-d configured to control one or more components of the catheter system 410. In the embodiment of Figure 25, four controls 48a-d are provided. In alternative embodiments, any suitable number of controls may be provided, for example two, three, five or any alternative number of controls. The at least one control 48a-d may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any suitable control. The controls 48a-d may be controlled simultaneously. In the exemplary embodiment of Figure 25, the four controls 48a-d are located on the control member 44 and are rotatable relative to the control member 44.

[0169] A first control 48a may be provided to control movement of the catheter body 14. The first control may be configured to distally extend and / or proximally retract the catheter body 14. A second control 48b may be provided to control movement of the lead-manipulation shaft 24 relative to the catheter body 14. The second control may be configured to distally extend and / or proximally retract the lead-manipulation shaft 24 relative to the catheter body 14. A third control 48c may be provided to control movement of the lead-engaging member 420. The third control 48c may be configured for controlling movement of the first and second opposing arms 420a, 420b between the open and closed configuration. For example, the third control 48c may include an actuation or control wire 70 coupled to the first and second opposing arms 420a, 420b. A fourth control 48d may be provided to control the movement of a lead-guiding shaft 80 coupled to the first and second lead-guiding member portions 434a, 434b and / or to control the movement of the first and / or second lead-guiding member portions 434a, 434b directly.

[0170] Figure 26 shows an alternative catheter system 510 with an alternative lead- manipulation member 518. Identical parts with the embodiments of Figures 2 to 25 are labelled with the same reference numeral, and like parts are labelled with the prefix “5”.

[0171] Figure 26 illustrates an alternative embodiment catheter system 510 including a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 510 includes a lead-manipulation member 518 including a lead-engaging member 520. The lead-engaging member 520 is configured to move between an open configuration, in which the lead-engaging member 520 defines a contact surface configured to receive an electrical lead therein, and a closed configuration, in which the lead-engagingmember 520 is configured to engage, retain, grip and / or snare the electrical lead, as is illustrated in Figure 26. The lead-engaging member 520 includes a contact surface 522 having an elongate recess, channel or opening extending along an axis that is perpendicular to the longitudinal axis of the catheter body 14. The lead-engaging member 520 is substantially T- shaped, however the lead-engaging member 520 may be substantially L-shaped. The T-shape or L-shape forms a cover over the electrical lead L2, thereby helping to protect the electrical lead L2 from damage whilst moving the electrical lead L2 to the desired location.

[0172] The lead-engaging member 520 includes a substantially tubular portion 560 defining the elongate channel, recess or opening 25 for receiving the length of electrical lead L2. In the open configuration, an opening 25 (not shown) extends at least partially along the tubular portion 560. The opening 25 extends along the axis perpendicular to the catheter body 14. The lead-engaging member 520 increases the area of contact between the electrical lead L2 and the lead-engaging member 520. In the closed configuration, the lead-engaging member 520 is configured to close such that the tubular portion 560 encloses the length of electrical lead L2. In alternative embodiments, the lead-engaging member 520 may be configured to narrow or close the opening 25 to retain the electrical lead therein. In some embodiments, the lead-engaging member 520 is configured to spiral around the electrical lead.

[0173] It shall be appreciated that the lead-engaging member 520 may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape-set to move the lead-engaging member 520 between the open and closed position. In the closed position, the opening may be completely closed, or alternatively the opening may be narrowed or partially closed.

[0174] Figures 27A-27C show an alternative catheter system 610 with an alternative lead- manipulation member 618. Identical parts with the embodiments of Figures 2 to 26 are labelled with the same reference numeral, and like parts are labelled with the prefix “6”.

[0175] Referring to Figures 1K- 1C, an alternative catheter system is illustrated and indicated generally at 610. The catheter system 610 includes a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 610 includes a lead-manipulation member 618 including a lead-engaging member 620 having two lead- engaging member portions 620a, 620b at least partially arranged within the catheter body 14 in a delivery configuration, and deployable from the catheter body 14 to allow the lead- engaging member 620 to be positioned next to or adjacent an electrical lead L2, as is illustrated in Figure 28. The lead-engaging member 620 is configured to move between anopen configuration, in which the lead-engaging member 620 defines a contact surface 622 configured to receive an electrical lead therein, and a closed configuration, in which the lead- engaging member 620 is configured to engage, retain, grip and / or snare the electrical lead, as is illustrated in Figure 29. The lead-engaging member 620 includes a contact surface 22 having an elongate recess, channel or opening 25 extending along an axis that is parallel to the longitudinal axis of the catheter body 14. The lead-engaging member 620 includes a substantially tubular portion 660 defining the elongate channel, recess or opening 25 for receiving the length of electrical lead L2. In the open configuration, the opening 25 extends at least partially along the tubular portion 660. The opening extends along the axis parallel to the catheter body 14. The lead-engaging member 620 increases the area of contact between the electrical lead L2 and the lead-engaging member 620. In the closed configuration, the lead- engaging member 620 is configured to close such that the tubular portion 660 encloses the length of electrical lead L2.

[0176] As is illustrated in Figures 1K- 1Q, the lead-engaging member portions 620a, 620b are configured to pivot or rotate radially outward relative to the catheter body 14 when moving from the closed configuration to the open configuration. The lead-engaging member portions 620a, 620b may be shaped to fit around an electrical lead L2. For example, the lead- engaging member portions 620a, 620b may be curved or semi-circular in shape, as is illustrated in Figures 27A-27C. The distal portion 16 of the catheter body 14 includes a distal opening for receiving the lead-engaging member portions 620a, 620b such that the lead- engaging member portions 620a, 620b are deployed therefrom.

[0177] It shall be appreciated that the lead-engaging member 620 may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape-set to move the lead-engaging member 620 between the open and closed position. In the closed position, the opening may be completely closed, or alternatively the opening may be narrowed or partially closed.

[0178] The lead-engaging member portions 620a, 620b of Figures 27A-27C include a first lead-engaging member portion 620a and a second lead-engaging member portion 620b. It shall be appreciated that in alternative embodiments, any suitable number of lead-engaging member portions may be provided, for example three lead-engaging member portions. In the illustrated embodiment of Figures 1K- 1Q, the first and second lead-engaging member portions 620a, 620b are the same length and are pivotally coupled together. It shall be appreciated that the first and second lead-engaging member portions 620a, 620b may defineany suitable length, or different lengths. It shall be appreciated that in alternative embodiments, the first and / or second lead-engaging member portions 620a, 620b may define any suitable shape.

[0179] In some embodiments, the catheter system 610 includes a lead-manipulation shaft 24 configured extending along the catheter body 14 and connected to the lead-engaging member portions 620a, 620b of the lead-manipulation member 618. The lead-manipulation shaft 24 is operable such that the lead-engaging member portions 620a, 620b are moveable relative to the catheter body 14. The lead-manipulation shaft 24 is configured to couple the lead- engaging member portions 620a, 620b to the catheter system 610. The lead-manipulation shaft 24 may be rotatable to rotate the lead-engaging member portions 620a, 620b relative to the catheter body 14. Additionally, or alternatively, the lead-manipulation shaft 24 may be moveable to distally extend and / or proximally retract the lead-engaging member portions 620a, 620b relative to the distal portion 16 of the catheter body 14. Thus, through manipulation of the lead-manipulation shaft 24, movement of the lead-engaging member portions 620a, 620b can be controlled. This helps facilitate positioning of the lead-engaging member portions 620a, 620b next to or adjacent an electrical lead L2. Control of the movement of the lead-engaging member portions 620a, 620b also facilitates moving an electrical lead L2 into a desired location after said electrical lead L2 has been engaged by the lead-engaging member portions 620a, 620b.

[0180] In some embodiments, the first lead-engaging member portion 620a is moveable relative to the second lead-engaging member portion 620b. For example, in some embodiments, the lead-engaging member portions 620a, 620b may be pivotally coupled together. In some embodiments, the lead-engaging member portions 620a, 620b are configured to oppose each other. In some embodiments, the catheter system 610 includes an actuation or control wire 70 configured extending along the lead-manipulation shaft 24 and / or the catheter body 14 and connected to the lead-engaging member portions 620a, 620b. Actuation of control wire 70 controls the opening and closing or pivoting of the lead- engaging members 620a, 620b between the closed, delivery configuration, as is illustrated in Figure 27A, and the open, deployed configuration, as is illustrated in Figure 27C.

[0181] As is illustrated in Figures 1K- 1Q, in some embodiments, the catheter system 610 includes a control member 44 located at a proximal end of the catheter assembly 12. Stated another way, the catheter assembly 12 extends distally from the control member 44. The control member 44 may be, for example, a control handle 44. The control member 44 isconfigured to control movement of the catheter system 610 and includes one or more controls 49a-c configured to control one or more components of the catheter system 610. In the embodiment of Figures 1K- 1Q, three controls 49a-c are provided. In alternative embodiments, any suitable number of controls may be provided, for example two, four, five or any alternative number of controls. The at least one control 49a-c may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any suitable control. The controls 49a-c may be controlled simultaneously. In the exemplary embodiment of Figures 1K- 1Q, the three controls 49a-d are located on the control member 44. Controls 49a and 49b are rotatable relative to the control member 44. The control 49c is a lever pivotable relative to the handle member 44.

[0182] A first control 49a may be provided to control movement of the catheter body 14. The first control may be configured to distally extend and / or proximally retract the catheter body 14. A second control 49b may be provided to control movement of the lead-manipulation shaft 24 relative to the catheter body 14. The second control may be configured to distally extend and / or proximally retract the lead-manipulation shaft 24 relative to the catheter body 14. A third control 49c may be provided to control movement of the lead-engaging member 620. The third control 49c may be configured for controlling movement of the first and second opposing arms 620a, 620b between the open and closed configuration. For example, the third control 49c may include an actuation or control wire 70 coupled to the first and second opposing arms 620a, 620b.

[0183] A method of engaging an electrical lead L2 in a patient’s anatomy will be described hereafter.

[0184] 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 TV of the patient. Once the guidewire is positioned, the entry point is dilated to permit entry of the catheter body 14 of the catheter system 610 into the vasculature. The catheter body 14 is advanced over the guidewire through the entry point, through the vasculature including the femoral vein and inferior vena cava, and into the right atrium RA. It will be understood that the catheter body 14 may be positioned within the desired area of theheart via different methods or routes. For example, and not by way of limitation, another possible path to the right atrium RA would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium RA. A possible path to the mitral valve MV would be through the femoral artery into the aorta, through the aortic valve into the left ventricle LV, and then to the mitral valve MV. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter body 14 may be advanced through the left ventricle LV to the mitral valve MV. In addition, although described with the use of a guidewire, in another embodiment hereof, the catheter body 14 may access the heart without the use of a guidewire.

[0185] In an embodiment, the method of engaging an electrical lead L2 within a patient includes obtaining a catheter system 610 including an elongate catheter body 14 having a distal portion 16, and a lead-manipulation member 618 including a lead-engaging member 620 including lead-engaging member portions 620a, 620b at least partially arranged within the catheter body 14 in a delivery configuration. The method is applicable to any of the embodiments described herein and in relation to any of the Figures.

[0186] The distal portion 16 of the catheter body 14 is moved at or near to the electrical lead L2 in the patient’s anatomy. It shall be appreciated that the catheter body 14 may be distally extended, proximally retracted, rotated and / or flexed to move the catheter body 14 into position with an electrical lead L2. The lead-engaging member 620 is deployed from the distal portion 16 of the catheter body 14, as is illustrated in Figure 28. The deployment of the lead-engaging member 620 may include moving the lead-engaging member 620 relative to the catheter body 14, for example via the lead-manipulation shaft 24. The lead-engaging member 620 may be extended and / or rotated, for example via the lead-manipulation shaft 24. It shall be appreciated that the lead-engaging member 620 may be partially deployed from the catheter body 14 and the lead-engaging member 620 moved into alignment with the electrical lead L2 before complete deployment of the lead-engaging member 620.

[0187] The lead-engaging member portions 620a, 620b may be moved from the closed, delivery configuration to the open configuration to deflect radially outward relative to the catheter body 14 to create an opening 25 for engaging the electrical lead L2. In the open configuration, as is illustrated in Figure 27C, the lead-engaging member 620 defines an opening 25 and a contact surface 22 configured to receive the electrical lead L2 therein. Upon snaring or capturing the electrical lead L2 within opening 25, the lead-engaging member portions 620a, 620b are moved from the open configuration to the closed configuration, inwhich the lead-engaging member 620 is configured to engage, retain, and / or grip the electrical lead L2, as is illustrated in Figure 29. Upon engagement of the electrical lead L2 with the lead-engaging member 620, the lead-manipulation shaft 24 may be manipulated to move the electrical lead L2 into a desired location.

[0188] In some embodiments, the method of engaging an electrical lead may comprise deploying a valve prosthesis from the distal portion of a second catheter assembly after engaging the electrical lead from the distal portion of a first catheter assembly and positioning the electrical lead in a desired location prior to and during deployment of the valve prosthesis. For example, upon engagement of the electrical lead L2 with the lead-engaging member 620 and manipulating or moving the electrical lead L2 into a desired location within the heart via the lead-manipulation shaft 24 of the catheter system 610. A heart valve prosthesis may be delivered and deployed from a separate catheter system. Following deployment of the heart valve prosthesis, the lead-engaging member 620 may be disengaged from the electrical lead L2 and the catheter system 610 may be removed from the patient.

[0189] Figures 30A-321 show an alternative catheter system 710 with an alternative lead- manipulation member 718. Identical parts with the embodiments of Figures 2 to 29 are labelled with the same reference numeral, and like parts are labelled with the prefix “7”.

[0190] As illustrated in Figures 30A and 30B, the catheter system 710 includes a catheter assembly 12 including an elongate catheter body 14 having a distal portion 16. The catheter system 710 includes a lead-manipulation member 718 including a lead-engaging member 720 within the catheter body 14. The lead-engaging member 720 can have a delivery configuration and a deployed configuration. The lead-engaging member 720 is deployable from the catheter body 14 to move from a straight delivery configuration, illustrated in Figure 30A, to a spiral or hooked deployed configuration, illustrated in Figure 30B.

[0191] In some embodiments, the catheter system 710 further includes a lead-manipulation shaft 24 configured to couple the lead-manipulation member 718 to the catheter system 710 when the lead-engaging member 720 is in the delivery configuration and when the lead- engaging member 720 is in the deployed configuration. The lead-manipulation shaft 24 is moveable relative to the catheter body 14 so as to move the lead-engaging member 720 relative to the catheter body 14. The lead-manipulation shaft 24 may be manipulated to rotate the lead-engaging member 720, for example by rotation of the lead-manipulation shaft 24. Additionally, or alternatively, the lead-manipulation shaft 24 may be moveable so as todistally extend and / or proximally retract the lead-engaging member 720 relative to the distal portion 16 of the catheter body 14.

[0192] In some embodiments, the catheter system 710 may include an atraumatic tip or nose cone 30. The atraumatic tip or nose cone 30 of the catheter system 710 may be positioned at or near the distal portion 16 of the catheter body 14. The atraumatic tip 30 may be used to facilitate advancement of the catheter system 710 through the patient’s skin and vasculature, including within the heart. The atraumatic tip 30 may be configured so as to prevent or reduce intravascular trauma during the delivery of the catheter system 710 to the heart. It may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 30 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In some embodiments, the atraumatic tip 30 may have a guidewire lumen. In some embodiments, the atraumatic tip 30 is taken to mean that the catheter system 710 includes at least one feature for reducing or preventing intravascular trauma during the delivery of the catheter system 710, such as the curved or tapered tip described above. Alternatively, the atraumatic tip may include an atraumatic material, such as hydrophilic-coated tips or silicone tips. In some embodiments, the atraumatic tip 30 may be omitted. In such embodiments, the distal portion 16 of the catheter body 14 may be configured with an atraumatic end portion designed to reduce or prevent intravascular trauma during the delivery of the catheter system 710.

[0193] In some embodiments, the lead-engaging member 720 may be formed from a shapememory material, for example Nitinol. It shall be appreciated that in alternative embodiments, any biocompatible shape-memory material may be used to form the lead-engaging member 720. The lead-engaging member 720 may be provided with one or more shape-memory material portion or regions, or alternatively, the entirety of the lead-engaging member 720 may be formed from the shape-memory material.

[0194] The lead-engaging member 720 includes a contact surface 22, as is illustrated in Figures 30A and 30B. The contact surface 22 is configured to receive and engage an electrical lead in the in the spiral, deployed configuration. In embodiments wherein the lead-engaging member 720 is formed from a shape-memory material, the lead-engaging member 720 may be shape set to form a spiral when extended distal of the catheter body 14.

[0195] As illustrated in Figure 30A and 30B, in some embodiments, the lead-manipulation member 718 can comprise a lead snare member 37. The lead snare member 37 can extend from a control member 44, as illustrated in Figure 31, and can run through or pass through alumen of the catheter body 14 and out a distal opening of the atraumatic tip 30. The distal end region of the lead snare member 37 can form a spiral or hook to hook, snare, or grab the electrical lead L2. The lead snare member 37 can be used to manipulate, direct, or guide the electrical lead L2 into a desired position and / or location within a patient’s heart. For example, during advancement of the catheter system 710 through the patient's skin and vasculature, including within the heart, the lead snare member 37 may be retracted proximally relative to the atraumatic tip 30 to prevent or reduce intravascular trauma during delivery of the catheter system 710 to the heart. Following advancement of the catheter system 710 to a position next to the electrical lead L2, the lead snare member 37 may be extended distally relative to the atraumatic tip 30. The lead snare member 37 may then be manipulated by moving proximally and distally and by rotating the lead snare member 37 to engage, hook, snare, or grab the electrical lead L2. The lead snare member 37 then helps manipulate, direct, or guide the electrical lead L2 into the desired position and / or location within the patient’s heart.

[0196] The catheter system 710 illustrated in Figures 30A and 30B can include a control member 44 (as illustrated in Figure 31) located at a proximal end portion of the catheter assembly 12. The catheter assembly 12 may be proximally and distally moved via pushing and pulling of the control member 44. The control member 44 may include at least one control configured to control movement of at least one or more components of the catheter assembly 12. The at least one control may, by way of example, be any one or combination of a lever, a slider, a dial, a trigger, a button, or any other suitable control member. It shall be appreciated that any suitable control member 44 may be used to control movement of the catheter system 710.

[0197] In some embodiments, the control member 44 of the catheter system 710 can include three controls 53a-c. A first control 53a may be provided to control movement of the catheter body 14. The first control 53a may be configured to distally extend and / or proximally retract the catheter body 14. A second control 53b may be provided to control movement of the lead- manipulation shaft 24 or lead snare member 37. The second control 53b may be configured to distally extend and / or proximally retract the lead-manipulation shaft 24 or lead snare member 37. A third control 53c may be configured to rotate the lead-manipulation shaft 24 or lead snare member 37.

[0198] A method of engaging an electrical lead L2 in a patient’s anatomy will be described hereafter.

[0199] 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 TV of the patient. Once the guidewire is positioned, the entry point is dilated to permit entry of the catheter body 14 of the catheter system 710 into the vasculature. The catheter body 14 is advanced over the guidewire through the entry point, through the vasculature including the femoral vein and inferior vena cava, and into the right atrium RA. It will be understood that the catheter body 14 may be positioned within the desired area of the heart via different methods or routes. For example, and not by way of limitation, another possible path to the right atrium RA would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium RA. A possible path to the mitral valve MV would be through the femoral artery into the aorta, through the aortic valve into the left ventricle LV, and then to the mitral valve MV. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the catheter body 14 may be advanced through the left ventricle LV to the mitral valve MV. In addition, although described with the use of a guidewire, in another embodiment hereof, the catheter body 14 may access the heart without the use of a guidewire.

[0200] In an embodiment, the method of engaging an electrical lead L2 within a patient includes obtaining a catheter system 710 including an elongate catheter body 14 having a distal portion 16, and a lead-manipulation member 718 including a lead-engaging member 720 arranged within the catheter body 14 in a delivery configuration. The method is applicable to any of the embodiments described herein and in relation to any of the Figures.

[0201] The distal portion 16 of the catheter body 14 is moved at or near to the electrical lead L2 in the patient’s anatomy. It shall be appreciated that the catheter body 14 may be distally extended, proximally retracted, rotated and / or flexed to move the catheter body 14 into position with an electrical lead L2. The lead-engaging member 720 is deployed from the distal portion 16 of the catheter body 14, as is illustrated in Figure 30B. The deployment of the lead-engaging member 720 may include moving the lead-engaging member 720 relative to the catheter body 14, for example via the lead-manipulation shaft 24. The lead-engaging member 720 may be extended and / or rotated, for example via the lead-manipulation shaft 24.It shall be appreciated that the lead-engaging member 720 may be partially deployed from the catheter body 14 and the lead-engaging member 720 moved into alignment with the electrical lead L2 before complete deployment of the lead-engaging member 720.

[0202] The lead-engaging member 720 may be moved from the delivery configuration to the deployed configuration for engaging the electrical lead L2. Upon snaring or capturing the electrical lead L2 with the lead-engaging member 720, the lead-manipulation shaft 24 may be manipulated to move the electrical lead L2 into a desired position and / or location.

[0203] In some embodiments, the method of engaging an electrical lead may comprise deploying a valve prosthesis from the distal portion of a second catheter assembly after engaging the electrical lead from the distal portion of a first catheter assembly and positioning the electrical lead in a desired location prior to and during deployment of the valve prosthesis. For example, upon engagement of the electrical lead L2 with the lead-engaging member 720 and manipulating or moving the electrical lead L2 into a desired position and / or location within the heart via the lead-manipulation shaft 24 of the catheter system 710. A heart valve prosthesis may be delivered and deployed from a separate catheter system. Following deployment of the heart valve prosthesis, the lead-engaging member 720 may be disengaged from the electrical lead L2 and the catheter system 710 may be removed from the patient.

[0204] Figures 32 and 33 show an alternative catheter system 810 with an alternative lead- manipulation member 818. Identical parts with the embodiments of Figures 2 to 31 are labelled with the same reference numeral, and like parts are labelled with the prefix “8”.

[0205] As illustrated in Figures 32 and 33, the catheter system 810 includes a lead snare member 37 and a guidewire or stylet 90. The lead snare member 37 of catheter system 810 comprises a lumen 91. Insertion of the guidewire or stylet 90 into lumen 91 and extending the guidewire or stylet 90 along the entire length of the lead snare member 37 will straighten the lead snare member 37 into a delivery configuration. Retracting the guidewire or stylet 90 from the distal end portion of the lead snare member 37 will allow the distal end region 92 to take a pre-configured spiral shape. The distal end region 92 of the lead snare member 37 can form a spiral or hook to hook, snare, or grab the electrical lead L2. The lead snare member 37 can be used to manipulate, direct, or guide the electrical lead L2 into a desired position and / or location within a patient’s heart. For example, during advancement of the catheter system 810 through the patient's skin and vasculature, including within the heart, the guidewire or stylet 90 may be inserted into the distal end region 92 of the lead snare member 37 to prevent or reduce intravascular trauma during delivery of the catheter system 810 to the heart. Followingadvancement of the catheter system 810 to a position next to the electrical lead L2, the guidewire or stylet 90 may be retracted from the distal end region 92 of the lead snare member 37 to allow the distal end region 92 to form a spiral shape. The lead snare member 37 may then be manipulated by moving proximally and distally and by rotating the lead snare member 37 to engage, hook, snare, or grab the electrical lead L2. The lead snare member 37 can then manipulate, direct, or guide the electrical lead L2 into the desired position and / or location within the patient’s heart.

[0206] In some embodiments, the method of engaging an electrical lead may comprise deploying a valve prosthesis from the distal portion of a second catheter assembly after engaging the electrical lead from the distal portion of a first catheter assembly and positioning the electrical lead in a desired location prior to and during deployment of the valve prosthesis. For example, upon engagement of the electrical lead L2 with the lead snare member 37 and manipulating or moving the electrical lead L2 into a desired position and / or location within the heart via the catheter system 810. A heart valve prosthesis may be delivered and deployed from a separate catheter system. Following deployment of the heart valve prosthesis, the lead snare member 37 may be disengaged from the electrical lead L2 and the catheter system 7810 may be removed from the patient.

[0207] 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.

[0208] The following examples are illustrative of the techniques described herein.

[0209] Example 1. A catheter system comprising: a control handle; and a catheter assembly extending distally from the control handle, the catheter assembly comprising: an elongate catheter body having a distal end portion; and a lead-manipulation member comprising a lead-manipulation shaft extending along the catheter body and a lead-engaging member connected to a distal end of the lead-manipulation shaft, the lead-manipulation member arranged within the catheter body and comprising a collapsed, delivery configuration, and an expanded, deployed configuration, wherein the lead-engaging member is deployable from the catheter body to move from the collapsed, delivery configuration, to the expanded, deployed configuration, wherein the lead-manipulation shaft is operable to move the lead-engaging member relative to the catheter body, wherein the lead-engaging member comprises a contact surface in the expanded, deployed configuration configured to receive and engage an electrical lead, and wherein the lead-manipulation member deflects radially outward relativeto the catheter body when moving from the delivery configuration to the deployed configuration for moving an electrical lead away from the distal portion.

[0210] Example 2. The catheter system according to Example 1, wherein lead-engaging member comprises a wire mesh extending partially or entirely over the lead-engaging member.

[0211] Example 3. The catheter system according to Example 1, wherein only part of the lead-engaging member is expandable and collapsible.

[0212] Example 4. The catheter system according to Example 1, wherein the contact surface comprises a recess, channel, groove, notch, or indentation.

[0213] Example 5. The catheter system according to Example 1, wherein the lead-engaging member comprises a shape-memory material.

[0214] Example 6. The catheter system according to Example 1, wherein the lead- manipulation shaft is rotatable to rotate the lead-engaging member.

[0215] Example 7. The catheter system according to Example 1, wherein the lead-engaging member defines at least two contact surfaces.

[0216] Example 8. The catheter system according to Example 1, wherein the lead-engaging member may be cylindrical, tubular, spherical, ovoid, spheroidal, toroidal, polyhedral, or disk shaped in the expanded, deployed configuration.

[0217] Example 9. The catheter system according to Example 1, wherein the lead-engaging member is substantially circular or D-shaped in cross-section at its greatest diameter that is perpendicular to an axis extending from the proximal portion of the lead-engaging member to the distal portion of the lead-engaging member in the expanded, deployed configuration.

[0218] Example 10. The catheter system according to Example 1, wherein the lead-engaging member is configured to narrow or close an opening of the contact surface for retaining an electrical lead therein.

[0219] Example 11. The catheter system according to Example 1, wherein the lead-engaging member comprises a first lead-engaging portion and a second lead-engaging portion configured to engage an electrical lead.

[0220] Example 12. The catheter system according to Example 1, wherein the catheter assembly further comprises an atraumatic tip positioned at or near the distal portion of the catheter body.

[0221] Example 13. The catheter system according to Example 1, wherein the catheter system further comprises a valve-retaining member and a heart valve prosthesis releasably coupled tothe valve-retaining member wherein the heart valve prosthesis is deployable from the catheter system to move from a collapsed, delivery configuration, to an expanded, deployed configuration.

[0222] Example 14. The catheter system according to Example 1, wherein the catheter assembly further comprises a lead-guiding member.

[0223] Example 15. A method of engaging an electrical lead in a patient’s anatomy comprising: obtaining a catheter system comprising a catheter assembly having a distal end portion comprising a lead-manipulation member having a compressed, delivery configuration, and an expanded, deployed configuration, positioning the distal end portion of the catheter assembly near an electrical lead; at least partially deploying the lead-manipulation member from the distal end portion of the catheter assembly to define a recess, channel, notch, groove, or indentation; positioning the electrical lead into the recess, channel, notch, groove, or indentation; and engaging the electrical lead with the lead-manipulation member.

[0224] Example 16. The method of Example 15, comprising the step of rotating the lead- manipulation member into alignment with the electrical lead before the step of positioning the electrical lead into the recess, channel, notch, groove or indentation.

[0225] Example 17. The method of Example 15, comprising the step, after engaging the electrical lead, of rotating and / or moving the lead-manipulation member to position the electrical lead in a desired location.

[0226] Example 18. The method of Example 15, wherein the catheter assembly further comprises a lead-guiding member having a compressed, delivery configuration, and an expanded, deployed configuration.

[0227] Example 19. The method of Example 18, comprising the steps of engaging the electrical lead with the lead-guiding member, and guiding the electrical lead into alignment with the lead-manipulation member before the step of positioning the electrical lead into the recess, channel, notch, groove, or indentation.

[0228] Example 20. The method of Example 15, wherein the catheter system further comprises a valve -retaining member and a heart valve prosthesis releasably coupled to the valve -retaining member, the prosthesis comprising a frame having a compressed, delivery, configuration and an expanded, deployed, configuration, wherein the frame defines a central lumen and is configured to anchor the prosthesis in the expanded, deployed, configuration, and a valve body disposed within and secured to the frame, the valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of theframe, and deploying the valve prosthesis from the valve -retaining member after engaging the electrical lead and positioning the electrical lead in a desired location.

Claims

Claims1. A catheter system comprising: a control handle; and a catheter assembly extending distally from the control handle, the catheter assembly comprising: an elongate catheter body having a distal end portion; and a lead-manipulation member comprising a lead-manipulation shaft extending along the catheter body and a lead-engaging member connected to a distal end of the lead- manipulation shaft, the lead-manipulation member arranged within the catheter body and comprising a collapsed, delivery configuration, and an expanded, deployed configuration, wherein the lead-engaging member is deployable from the catheter body to move from the collapsed, delivery configuration, to the expanded, deployed configuration, wherein the lead-manipulation shaft is operable to move the lead-engaging member relative to the catheter body, wherein the lead-engaging member comprises a contact surface in the expanded, deployed configuration configured to receive and engage an electrical lead, and wherein the lead-manipulation member deflects radially outward relative to the catheter body when moving from the delivery configuration to the deployed configuration for moving an electrical lead away from the distal portion.

2. The catheter system according to claim 1, wherein lead-engaging member comprises a wire mesh extending partially or entirely over the lead-engaging member.

3. The catheter system according to claim 1 or claim 2, wherein only part of the lead- engaging member is expandable and collapsible.

4. The catheter system according to any preceding claim, wherein the contact surface comprises a recess, channel, groove, notch, or indentation.

5. The catheter system according to any preceding claim, wherein the lead-engaging member comprises a shape-memory material.

6. The catheter system according to any preceding claim, wherein the lead-manipulation shaft is rotatable to rotate the lead-engaging member.

7. The catheter system according to any preceding claim, wherein the lead-engaging member defines at least two contact surfaces.

8. The catheter system according to any preceding claim, wherein the lead-engaging member may be cylindrical, tubular, spherical, ovoid, spheroidal, toroidal, polyhedral, or disk shaped in the expanded, deployed configuration.

9. The catheter system according to any preceding claim, wherein the lead-engaging member is configured to narrow or close an opening of the contact surface for retaining an electrical lead therein.

10. The catheter system according to any preceding claim, wherein the catheter system further comprises a valve -retaining member and a heart valve prosthesis releasably coupled to the valve -retaining member wherein the heart valve prosthesis is deployable from the catheter system to move from a collapsed, delivery configuration, to an expanded, deployed configuration.

11. A method of engaging an electrical lead in a patient’s anatomy comprising: obtaining a catheter system comprising a catheter assembly having a distal end portion comprising a lead- manipulation member having a compressed, delivery configuration, and an expanded, deployed configuration, positioning the distal end portion of the catheter assembly near an electrical lead; at least partially deploying the lead-manipulation member from the distal end portion of the catheter assembly to define a recess, channel, notch, groove, or indentation; positioning the electrical lead into the recess, channel, notch, groove, or indentation; and engaging the electrical lead with the lead-manipulation member.

12. The method of claim 11, comprising the step of rotating the lead-manipulation member into alignment with the electrical lead before the step of positioning the electrical lead into the recess, channel, notch, groove or indentation.

13. The method of claim 11 or claim 12, comprising the step, after engaging the electrical lead, of rotating and / or moving the lead-manipulation member to position the electrical lead in a desired location.

14. The method of any one of claims 11 to 13, wherein the catheter assembly further comprises a lead-guiding member having a compressed, delivery configuration, and an expanded, deployed configuration.

15. The method of any one of claims 11 to 14, wherein the catheter system further comprises a valve -retaining member and a heart valve prosthesis releasably coupled to the valveretaining member, the prosthesis comprising a frame having a compressed, delivery, configuration and an expanded, deployed, configuration, wherein the frame defines a central lumen and is configured to anchor the prosthesis in the expanded, deployed, configuration, and a valve body disposed within and secured to the frame, the valve body being configured to prevent blood flow in one direction to convey blood flow through a central lumen of the frame, and deploying the valve prosthesis from the valve -retaining member after engaging the electrical lead and positioning the electrical lead in a desired location.

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