A catheter system for protecting cardiac rhythm management leads

Abstract

A catheter system has a catheter assembly including an elongate catheter body having a distal end portion. The system includes an elongate protective cuff within the catheter body, said cuff having an open, delivery, configuration defining an opening along at least a portion of an elongate length of the protective cuff for receiving a length of an electrical lead. The protective cuff is deployable from the catheter and is moveable from the open, delivery configuration to a closed, deployed configuration to contact and engage an electrical lead.

Description

A CATHETER SYSTEM FOR PROTECTING CARDIAC RHYTHM MANAGEMENTLEADSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 609,100, filed December 12, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The present teachings relate to a catheter system, a method of engaging a cardiac electrical lead in a patient’s anatomy, and a method of deploying a protective sleeve or cuff prior to, during, or following a heart valve replacement and / or repair procedure.BACKGROUND

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

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

[0005] Pacemakers consist of an implantable pulse generator which contain a battery and one or two electrical leads. The pulse generator generates the electric current needed to stimulate the myocardium of the heart. The current is delivered to the myocardium via the lead or leads which are guided to the right atrial and / or right ventricular myocardium. The leads enter the heart via the superior vena cava and enter the right atrium. One or more of the leads may pass through the tricuspid valve into the right ventricle. The cardiac 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 cardiac 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 preexisting cardiac leads can obstruct the prosthesis and may prevent the prosthetic heart valve from properly engaging with the native valve annulus. This can result in migration of the prosthetic heart 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 protective cuff deployable from a catheter system and is moveable from an open, delivery configuration to a closed, deployedconfiguration, and wherein the protective cuff comprises an inner surface configured to contact an electrical lead when the protective cuff is in the closed, deployed configuration. In some embodiments, the protective cuff is substantially tubular in the closed, deployed configuration.

[0008] In some embodiments, the protective cuff is configured for transcatheter delivery through a patient’s vasculature.

[0009] In some embodiments, the protective cuff comprises an elongate body.

[0010] In some embodiments, the elongate body defines an opening along at least a portion of the length of the protective cuff for receiving an electrical lead.

[0011] In some embodiments, the elongate body is moveable from the open, delivery configuration in which the elongate body defines the opening to a closed, deployed configuration to narrow or fully close the opening such that the electrical lead is retained within the cuff.

[0012] In some embodiments, the protective cuff can comprise one or more lead- engaging portions configured to engage or capture an electrical lead. In some embodiments, the one or more lead-engaging portions are biased to move from the open, delivery configuration to the closed, deployed configuration to close the opening upon deployment from a catheter system.

[0013] In some embodiments, the one or more lead-engaging portions comprise a shapememory material, for example Nitinol. Shape-memory materials such as Nitinol are biocompatible and are moveable between open and closed configurations. In some embodiments, the shape-memory material is shape set to move the protective cuff from the open, delivery configuration to the closed, deployed configuration as or after the protective cuff is deployed from a catheter delivery system. Advantageously, shape setting the one or more lead-engaging portions helps to facilitate the automatic deployment of the one or more lead-engaging portions.

[0014] In some embodiments, the one or more lead-engaging portions are arranged at or near a first end of the protective cuff and / or a second end of the protective cuff. In some embodiments, one or more of the lead-engaging portions comprise a split ring configured to engage an electrical lead arranged within the protective cuff, when the protective cuff is inthe closed, deployed, configuration. In some embodiments, one or more of the split rings are configured to spiral into the closed, deployed configuration.

[0015] In some embodiments, the one or more lead-engaging portions comprise one or more ribs along a length of the protective cuff. In some embodiments, one or more of the ribs are configured to curl into a coiled closed, deployed configuration.

[0016] In some embodiments, the protective cuff comprises a frame or a frame extending at least partially, for example entirely, within and / or over the protective cuff, and the frame is configured to engage or capture an electrical lead. In some embodiments, the protective cuff comprises an abrasion resistant material extending at least partially thereover. In some embodiments, the abrasion resistant material extends or covers at least partially or entirely over an inner surface or area of the protective cuff. In some embodiments, the protective cuff comprises at least two lead-engaging portions configured to engage or capture an electrical lead, and the abrasion resistant material extends over and / or between the at least two lead-engaging portions. Advantageously, the abrasion resistant material helps to reduce damage to the electrical lead when the lead-engaging portions engage an electrical lead. In some embodiments, the abrasion resistant material extends from an inner surface of the protective cuff to an outer surface of the protective cuff.

[0017] In some embodiments, the abrasion resistant material comprises a textile material. Advantageously, such materials have been found to provide a suitable level of protection for an electrical lead, whilst being biocompatible. In some embodiments, the abrasion resistant material comprises a polymeric material, such as a plastic material, an elastomer, or a hydrogel. Advantageously, such materials have been found to provide a suitable level of protection for an electrical lead, whilst being biocompatible. In some embodiments, the abrasion resistant material comprises one or more of PET, PTFE, and / or ePTFE. Advantageously, such materials have been found to provide a suitable level of protection for an electrical lead, whilst being biocompatible.

[0018] Another aspect of the teachings provides a catheter system configured for delivering and deploying a protective cuff to an electrical lead, the catheter system comprising a handle; a catheter assembly extending distally from the handle, the catheter assembly comprising: a moveable elongate catheter body configured to cover and uncover a protective cuff; a movable cuff dilator arranged within the catheter body and configuredto retain the protective cuff in an open, delivery configuration and to deploy the protective cuff to an electrical lead, wherein the protective cuff is deployed following relative movement between the catheter body and the cuff dilator.

[0019] 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 typically include dislodgement, fracture and / or wear of the pre-existing electrical leads. The protective cuff provides a protective sheath around the existing lead to prevent / minimise wear / damage to the existing electrical leads. The cuff can be fully closed or closed enough to retain the length of electrical lead in the closed, deployed configuration.

[0020] In some embodiments, the cuff dilator is arranged at a distal portion of the catheter body to retain the protective cuff in the open, delivery configuration. The cuff dilator advantageously facilitates the engagement and capture of an existing electrical lead present in the patient’s anatomy.

[0021] In some embodiments, the cuff dilator comprises at least one guide member arranged within the protective cuff to retain the protective cuff in the open, delivery configuration. In some embodiments, the at least on guide member is substantially U- shaped, V-shaped, C-shaped, J-shaped, L-shaped, or T-shaped.

[0022] In some embodiments, the cuff dilator comprises two or more spaced apart dilator arms arranged within and extending at least partially along the protective cuff to retain the protective cuff in the open, delivery, configuration.

[0023] In some embodiments, a distal region of the protective cuff dilator tapers towards a distal end of the protective cuff. In some embodiments, the distal region is U-shaped, V- shaped, curved, conical, semi-circular, hemispherical, or triangular.

[0024] In some embodiments, the catheter assembly comprises an atraumatic tip positioned at or near the end portion of the catheter body.

[0025] Another aspect of the present teachings provides a method of deploying a protective cuff to an electrical lead comprising: obtaining a catheter assembly comprising an elongate catheter body having a distal portion; obtaining a protective cuff comprising an inner surface configured to contact an electrical lead; positioning the protective cuff withinthe catheter body in an open, delivery, configuration so as to define an opening along at least a portion of the protective cuff; at least partially deploying the protective cuff from the catheter assembly; positioning an electrical lead in the protective cuff via the opening; moving the protective cuff from the open, delivery configuration to a closed, deployed configuration to close or narrow the opening; and engaging an electrical lead with the inner surface of the protective cuff.

[0026] In some embodiments, positioning the protective cuff within the catheter body comprises positioning a cuff dilator within the protective cuff to retain the protective cuff in the open, delivery configuration.

[0027] In some embodiments, moving the protective cuff from the open, delivery configuration to a closed, deployed, configuration to close or narrow the opening comprises deploying the protective cuff from the cuff dilator.

[0028] In some embodiments, the deployed protective cuff and electrical lead extend through the annulus of a native heart valve. In some embodiments, the deployed protective cuff and electrical lead extend through a lumen of a prosthetic heart valve.

[0029] Another aspect of the present teachings provides a method of delivering and deploying a valve replacement or repair prosthesis after deploying a protective cuff to an electrical lead comprising: deploying a protective cuff to an electrical lead at a native valve annulus of a patient; obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the valve prosthesis, in some embodiments, 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 valve 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; delivering the valve prosthesis in a compressed, delivery configuration to the native valve annulus, the native valve annulus including an electrical lead having a protective cuff; and deploying the valve prosthesis within the native valve annulus, wherein the electrical lead and protective cuff are positioned between the native valve annulus and the expanded, deployed valve prosthesis.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Embodiments will now be described with reference to the accompanying drawings, in which:

[0031] Figure 1 is a schematic illustration of a heart;

[0032] Figure 2 is a perspective view of a protective cuff according to an embodiment of the present teachings;

[0033] Figure 3 is a schematic view of the protective cuff of Figure 2 in an open delivery configuration and an electrical lead;

[0034] Figure 4 is a schematic view of the protective cuff of Figure 2 in a closed, deployed configuration;

[0035] Figure 5 is a cross-sectional view of Figure 4;

[0036] Figure 6 is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0037] Figure 7 is a schematic view of the distal portion of the catheter system of Figure 6 in a second configuration;

[0038] Figure 8 is a schematic cross-sectional view of the distal portion of the catheter system of Figure 6;

[0039] Figure 9 is a schematic view of a control member of the catheter system of Figure6;

[0040] Figure 10 is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0041] Figure 11A is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0042] Figure 1 IB is a schematic cross-sectional view of a distal portion of the catheter system of Figure 11 A;

[0043] Figure 12 is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0044] Figure 13A is a schematic cross-sectional view of a distal portion of a catheter system of Figure 12;

[0045] Figure 13B is a schematic cross-sectional view of an alternative distal portion of a catheter system of Figure 12;

[0046] Figure 14 is a schematic view of a control member of the catheter systems of Figure 10-13B;

[0047] Figure 15 is a schematic view of a catheter system according to an embodiment of the present teachings during deployment of the protective cuff of Figure 2;

[0048] Figure 16 is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0049] Figure 17 is a schematic view of a control member of the catheter systems of Figure 16;

[0050] Figure 18 is a schematic view of a catheter system of Figure 16 during deployment of the protective cuff of Figure 2;

[0051] Figure 19 is a schematic cross-sectional view of a distal portion of a catheter system according to an embodiment of the present teachings in a first configuration;

[0052] Figure 20 is a schematic view of a control member of the catheter systems of Figure 19;

[0053] Figure 21 is a schematic view of a catheter system of Figure 19 during deployment of the protective cuff of Figure 2;

[0054] Figure 22 is a schematic view of a valve prosthesis in a heart;

[0055] Figure 23 is a schematic view of a cardiac electrical lead passing through a valve prosthesis in a heart;

[0056] Figure 24 is a schematic view of the protective cuff of Figure 2 and a valve prosthesis in a heart;

[0057] Figure 25 is a schematic view of the protective cuff of Figure 2 in a heart;

[0058] Figure 26 is a schematic view of the protective cuff of Figure 2 and a valve prosthesis in a heart.

[0059] Figures 27A-27C are schematic side views of a catheter system according to an embodiment of the present teachings;

[0060] Figure 28 is a schematic cross-sectional view of a distal portion of a catheter system of Figures 27A-27C;

[0061] Figure 29 is a schematic view of the catheter system of Figures 27A-27C being moved into alignment with an electrical lead;

[0062] Figure 30 is a schematic view of the catheter system of Figures 1K- 1C engaging an electrical lead;

[0063] Figures 31 A and 3 IB are schematic views of the catheter system of Figures 27A- 27C with the protective sleeve being deployed;

[0064] Figure 32 is a perspective view of a protective cuff according to an embodiment of the present teachings;

[0065] Figure 33 is a perspective view of a protective cuff according to an embodiment of the present teachings;

[0066] Figures 34A-34C are schematic side views of a protective cuff detachment device according to an embodiment of the present teachings;

[0067] Figure 35A is a schematic view of the protective cuff of Figures 32 and 33 and a valve prosthesis in a heart;

[0068] Figure 35B is a schematic view of the protective cuff detachment device of Figures 34A-34C with the protective sleeve of Figures 32 and 33 arranged over an electrical lead;

[0069] Figure 35C is a schematic view of the protective cuff detachment device of Figures 34A-34C with the protective sleeve of Figures 32 and 33 where a distal portion of the protective sleeve is detached from a proximal portion of the protective sleeve; and

[0070] Figure 35D is a schematic view of the distal portion of the protective sleeve of Figures 32 and 33 and a valve prosthesis in a heart.DETAILED DESCRIPTION OF EMBODIMENT(S)

[0071] Figure 1 is a schematic sectional illustration of a human heart. The human heart includes right and left atriums RA, LA, and right and left ventricles RV, LV. 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 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 formedfrom three leaflets having distal edges that meet to close the tricuspid valve. Each leaflet is attached to the tricuspid valve annulus. In addition to mitral valve and tricuspid valve, the heart includes the aortic valve and the pulmonary valve. The aortic valve permits one-way flow of blood from the left ventricle to the aorta. The pulmonary valve permits one-way flow of blood from right ventricle to the branches of the pulmonary artery. Each of the aortic valve and the pulmonary valve are formed from three leaflets having distal edges that meet to close the respective valve. Each leaflet is attached to an annular region of the heart structure known as the valve annulus.

[0072] The heart, illustrated in Figure 1, includes pre-existing cardiac electrical leads, for example pacemaker leads. In the arrangement illustrated, the heart includes two electrical leads LI, L2. Each lead includes an electrode at the distal end thereof and are connected to a pulse generator (not illustrated). 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 illustrated). The pulse generator generates the electric current to deliver a pacing signal needed to stimulate the myocardium of the heart.

[0073] Illustrated embodiments relate to a catheter system for delivering a protective cuff and deploying said protective cuff on an electrical lead LI, L2. In the exemplary illustrated embodiments, the protective cuff is configured for placement within a tricuspid heart valve. In alternative embodiments, the protective cuff may be placed within a mitral heart valve or may be configured for placement within a pulmonary, or aortic valve, or may be utilized within a venous valve or within other body passageways where it is deemed useful.

[0074] Figure 2 illustrates one embodiment of a protective cuff or sleeve 10, which defines an elongate body defining an opening 28 extending therealong. The protective cuff or sleeve 10 defines an inner surface 36 configured to contact an electrical lead when the protective cuff or sleeve 10 is in a closed, deployed configuration. The protective cuff or sleeve 10 may be provided with one or more engaging portions 30 configured to engage or capture an electrical lead LI, L2. The engaging portions 30 may be formed from a shapememory material, for example Nitinol. The shape-memory material may be shape set to move the protective cuff 10 to the closed, deployed configuration as or after the cuff 10 is deployed from a delivery system. In some embodiments, the protective cuff or sleeve 10 may be provided with one or more lead-engaging portions 30 that are biased to move to the closed, deployed configuration to close the opening 28 upon deployment from a delivery system.

[0075] In the illustrated embodiment, the lead-engaging portions 30 of the protective cuff 10, which are configured to move the protective cuff 10 into the closed configuration, are illustrated as being positioned at or near the opposing ends of the protective cuff 10. In alternative embodiments, it will be appreciated that any suitable number of these lead- engaging portions of the protective cuff 10 may be provided, and they may be arranged at any location along the length of the protective cuff 10.

[0076] In the illustrated embodiment, the lead-engaging portions 30 are provided in the form of split rings 40, 42 configured to engage an electrical lead arranged within the internal volume defined by the protective cuff 10, when the protective cuff is in the closed, deployed configuration. A first split ring 40 is arranged at or near a proximal or first end of the protective cuff 10 and a second split ring 42 is arranged at or near a distal or second end of the protective cuff 10. In some embodiments, a pair of lead-engaging portions 30 may be provided at or near the proximal end and / or the distal end of the protective cuff. Additionally, or alternatively, one or more lead-engaging portions 30 may be provided along the length of the protective cuff 10, for example in a central region of the protective cuff 10. In some embodiments, the lead-engaging portions 30 may be any suitable shape such as curved, oval, semi-circular, hexagonal, square, or any other suitable shape that is capable of being retained in an open, delivery configuration by the cuff delivery system and moved into a closed, deployed configuration as or after the protective cuff 10 is deployed from the cuff delivery system.

[0077] In some embodiments, one or more of the lead-engaging portions 30 may be shape set to curl into a coiled configuration so that when the protective cuff 10 is released from a cuff delivery system, it will curl or spiral under the bias provided by the one or more lead-engaging portions 30.

[0078] In some embodiments, only one lead-engaging portion 30 may be provided along the protective cuff 10, for example, at or near the proximal end of the protective cuff 10, at or near the distal end of the protective cuff 10, at a central region of the protective cuff 10, or at any suitable location along the protective cuff 10. In alternative embodiments, three, four, five or any suitable number of lead-engaging portions 30 may be provided on or along the protective cuff 10.

[0079] In some embodiments, the protective cuff 10 may include a frame extending at last partially or entirely within or over the protective cuff 10. The frame may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape set to move the protective cuff 10 into the closed, deployed configuration as or after the protective cuff 10 is deployed from a cuff delivery system. In embodiments wherein the protective cuff 10 includes a frame, the frame may act as a lead-engaging portion of the protective cuff 10.

[0080] In some embodiments, the lead-engaging portion may include one or more ribs 38 configured to engage or capture an electrical lead LI, L2. The ribs 38 may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape set to move the protective cuff 10 to the closed, deployed configuration as or after the protective cuff 10 is deployed from a cuff delivery system. The one or more ribs 38 may be arranged along the length of the protective cuff 10. The one or more ribs 38 may extend across an inner surface of the cuff 10. In some embodiments, the ribs 38 may be shape set to curl into a coiled configuration so that when the protective cuff 10 is released from a cuff delivery system, the protective cuff 10 will curl or spiral under the bias provided by the one or more ribs 38.

[0081] Referring to Figures 3-5, the protective cuff 10 moves from an open configuration into a closed, deployed configuration to engage the electrical lead L2. The protective cuff 10 includes an inner surface configured to contact the electrical lead L2 when the protective cuff 10 is in the closed, deployed configuration.

[0082] The protective cuff 10 is substantially tubular in the closed, deployed configuration. In the illustrated embodiment, the protective cuff 10 is configured to spiral into the closed, deployed configuration so as to spiral around the electrical lead L2. Inalternative embodiments, the protective cuff 10 may be configured to narrow or close the opening 28 to retain the electrical lead L2 therein.

[0083] In some embodiments, the protective cuff 10 may be provided with an abrasion resistant material on the elongate body thereof. This abrasion resistant material may be formed from a material that is configured and arranged to reduce damage to the electrical lead L2 when the protective cuff 10 engages the electrical lead L2. The abrasion resistant material may be at least partially or entirely formed from a textile material. In some embodiments, the abrasion resistant material be formed at least partially from polymeric material, such as plastics, elastomers, or hydrogels. In exemplary embodiments, the abrasion resistant material may be formed from one or more of PET, PTFE, and / or ePTFE.

[0084] In some embodiments, the abrasion resistant material extends over an entirety of an inner surface of the protective cuff 10. In some embodiments, the abrasion resistant material may extend from the inner surface of the protective cuff 10 to an outer surface of the protective cuff 10. The elongate body of the protective cuff 10 may be formed from the abrasion resistant material. In embodiments of the protective cuff 10 having multiple lead- engaging portions 30, the abrasion resistant material may extend between or over the lead- engaging portions 30 to varying degrees. In embodiments containing lead-engaging portions 30 at or near the proximal and distal ends of the protective cuff 10, the abrasion resistant material extends between and over the lead-engaging portions 30 to extend over substantially all of the protective cuff 10. In embodiments of the protective cuff 10 including one or more lead-engaging ribs 38, the abrasion resistant material may extend between or over the lead-engaging ribs 38 to varying degrees.

[0085] In embodiments where the protective cuff 10 includes a frame, the abrasion resistant material covers an area of an inner surface of the frame of the protective cuff 10. In some embodiments, the abrasion resistant material covers all or an entirety of the inner surface of the frame. In some embodiments, the abrasion resistant material covers all or an entirety of an outer surface of the frame, for example, a part of or all of the outer surface of the frame.

[0086] Referring now to Figures 6-9, when configured for transcatheter delivery, the protective cuff 10 is at least partially or entirely arranged within a catheter delivery system 12 for delivery within a patient’s vasculature. The catheter system 12 is configured fordelivering and deploying the protective cuff 10 within a patient. The catheter system 12 includes a control or actuation member 44, a catheter assembly 14 extending distally from the control member 44, the catheter assembly 14 including an elongate catheter body 16 having a distal end portion 18. The control member 44 may be, for example, a control handle 44.

[0087] In some embodiments, the catheter assembly 14 may include an atraumatic tip 20 coupled to or attached to a distal end of an inner tip shaft 22, the inner tip shaft 22 extending distally from the control member 44. Relative movement between the catheter body 16 and the atraumatic tip 20 creates space between the distal end portion 18 of the catheter body 16 and the atraumatic tip 20. The relative movement between the catheter body 16 and the atraumatic tip 20 may be achieved by a distal movement of the atraumatic tip 20 relative to the catheter body 16 and / or by a proximal retraction of the catheter body 16 relative to the atraumatic tip 20.

[0088] As illustrated in Figure 6, the atraumatic tip 20 and catheter body 16 may have a first configuration in which the distal end portion 18 of the catheter body 16 is flush with, and abuts, the atraumatic tip 20. In a second configuration, as is illustrated in Figure 7, the distal end portion 18 of the catheter body 16 may be spaced apart from the atraumatic tip 20, for example to enable the protective cuff 10 to be deployed. The atraumatic tip 20 may be used to facilitate the advancement of the catheter system 12 through the patient's skin and vasculature, including within the heart. The atraumatic tip 20 may be configured to prevent or reduce intravascular trauma during delivery of the catheter system 12 to the heart. The atraumatic tip 20 may also assist steering and encourage deflection through relatively narrow vessels. In some embodiments, the atraumatic tip 20 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In one embodiment, the inner tip shaft 22 and the atraumatic tip 20 may have a lumen with a distal opening 21 for accommodating a guidewire 24 or other elements or substances. The guide wire 24 may run or pass through a lumen of inner tip shaft 22 and out the distal opening 21 of atraumatic tip 20, as illustrated in Figure 7. It will be understood that the taper and / or curvature of the atraumatic tip 20 may be varied depending upon the sizing / configuration as required.

[0089] The elongate protective cuff 10 has an open, delivery configuration and a closed, deployed configuration for engaging an electrical lead (not illustrated). The protective cuff10 defines an inner surface configured to contact an electrical lead when the protective cuff 10 is in a closed, deployed configuration. In Figure 6, the catheter system 12 is illustrated in a first configuration where the protective cuff 10 is entirely within the catheter body 16. The protective cuff 10 is retained in the open, delivery configuration when it is within the catheter assembly 14. The protective cuff 10 is deployable from the catheter assembly 14 and is moveable from the open, delivery configuration to a closed, deployed configuration for engaging an electrical lead, for example L2.

[0090] The catheter assembly 14 includes a cuff dilator 26 extending from the control member 44 and configured to retain the protective cuff 10 in the open, delivery configuration. In the embodiment illustrated, the cuff dilator 26 extends within the catheter body 16 along all or substantially all of the length of the protective cuff 10. The cuff dilator 26 may include at least one radiopaque additive, for example barium sulphate or titanium oxide. The radiopaque additive improves visibility of the cuff dilator 26 within the patient’s anatomy.

[0091] In the open, delivery configuration, the elongate protective cuff 10 defines an opening 28 along at least a portion the protective cuff 10 for receiving a length of electrical lead. The cuff dilator 26 is arranged within the protective cuff 10 to retain the protective cuff 10 in the open, delivery configuration. The cuff dilator 26 is arranged within the protective cuff 10 and abuts against internal surfaces of the protective cuff 10 to retain the protective cuff 10 in the open, delivery configuration.

[0092] In the illustrated embodiment, the cuff dilator 26 is provided in the form of a substantially U-shaped or V-shaped body. The cuff dilator 26 includes a pair of spaced apart dilator arms 27 that extend at least partially along or within the cuff dilator 26. The dilator arms 27 abut against and engage substantially opposing internal surfaces of the protective cuff 10 to urge the protective cuff 10 into the open, delivery configuration and to retain the protective cuff 10 in said open, delivery configuration. Although the cuff dilator is illustrated as having a substantially U-shaped or V-shaped body, in alternative embodiments, the cuff dilator 26 may be J-shaped, U-shaped, C-shaped, T-shaped, or may be substantially conical, hemispherical or any other suitable shape. In some embodiments, the cuff dilator 26 may include two or more of the substantially U-shaped, V-shaped body,J-shaped, L-shaped, C-shaped, or T-shaped guide members. In some embodiments, the cuff dilator 26 may be a solid rod-shaped body.

[0093] In the illustrated embodiment, the spaced apart dilator arms 27 are connected at a distal region of the cuff dilator 26 to the form the substantially U-shaped or V-shaped cuff dilator 26 body. In some embodiments, the dilator arms 27 may be arranged to be substantially parallel so as to define a proximal region of the cuff dilator 26 having a substantially constant diameter. The dilator arms 27 are arranged within the protective cuff 10 and spaced apart by a distance capable of urging the protective cuff 10 into the open, delivery configuration.

[0094] A distal region 29 of the cuff dilator 26 may be tapered so as to reduce in diameter towards the distal end of the cuff dilator 26. The dilator arms 27 may be angled, curved and / or stepped inwardly in said distal region 29 to define the reduction in diameter of the cuff dilator 26 towards the distal end thereof. In the illustrated embodiment, the distal region 29 of the cuff dilator 26 is substantially V-shaped, but may be any suitable shape such as semi-circular, semioval, triangular, cone-shaped, or any other suitable shape where the diameter of the distal region 29 reduces towards a distal end of the cuff dilator 26. Providing a distal region 29 of the cuff dilator that has a dimeter that reduces towards the distal end of the cuff dilator 26 provides a more controlled deployment of the cuff dilator 26 and more controlled movement from the open, delivery configuration to the deployed, closed configuration. Additionally, the likelihood of damage to the protective cuff 10 as it moves over the cuff dilator 26 is reduced.

[0095] As illustrated in Figure 8, a cuff dilator 26 in the form of spaced apart dilator arms 27 enables the cuff dilator 26 to be positioned away from the opening 28 of the protective cuff 10, whilst retaining said protective cuff 10 in the open, delivery configuration. This helps to provide an unobstructed opening 28 of the protective cuff 10, which facilitates positioning of an electrical lead within the protective cuff 10. The tapered contour of the cuff dilator 26 allows the distal portion of the protective cuff 10 to contract as it is deployed from the cuff dilator 26 to wrap around an electrical lead during deployment.

[0096] In alternative embodiments, the cuff dilator 26 may not be provided as a single body and may instead be provided in the form of two or more guide members, for example,two, three, four, or any suitable number of guide members. The guide members may be arranged so as to be positioned away from the opening 28 of the protective cuff 10 so as not to obstruct said opening 28. In some embodiments, the guide members may be provided in the form of separate dilator arms 27. As has been described above, the dilator arms 27 may extend within the protective cuff 10 and abut against internal surfaces of said protective cuff to retain the protective cuff in the open, delivery configuration. Each dilator arm 27 may extend partially or entirely along the length of the protective cuff 10, and each dilator arm 27 may extend by a different amount along the protective cuff 10. Each dilator arm 27 may define a distal region 29 that is angled, curved, stepped, or otherwise arranged such that the spacing between said dilator arms 27 reduces towards a distal end of the cuff dilator 26.

[0097] In further alternative embodiments, a single guide member may be provided. The single guide member may be in the form of an elongated body where opposing side edges of said body engage and abut against opposing internal sides of the protective cuff 10, to retain said protective cuff 10 in the open, delivery configuration. The single guide member may be in the form of a conical and / or cylindrical body, where opposing side edges of said body engage and abut against opposing internal sides of the protective cuff 10, to retain said protective cuff 10 in the open, delivery configuration.

[0098] Relative movement between the protective cuff 10 and the cuff dilator 26 results in the protective cuff 10 being released or moved from the cuff dilator 26 to transition the protective cuff 10 from an open, delivery configuration into a closed, deployed configuration. The relative movement between the protective cuff 10 and the cuff dilator 26 may be achieved by a distal movement of the protective cuff 10 relative to the cuff dilator 26 and / or by a proximal retraction of the cuff dilator 26 relative to the protective cuff 10. This relative movement results in the cuff dilator 26 being retracted through the protective cuff 10, such that the protective cuff 10 is released or moved from the substantially parallel dilator arms 27 and travels along and over the tapered distal region 29 of cuff dilator 26. This movement of the protective cuff 10 over the distal region 29 and off of the cuff dilator enables the protective cuff to transition from the open, delivery configuration into the closed, deployed configuration as the cuff dilator 26 no longer urges against the internal surfaces of the protective cuff.

[0099] The catheter assembly 14 may be provided with a cuff stopper 31 extending distally from the control member 44 and being arranged within the catheter body 16. The cuff stopper 31 may be arranged to abut against a proximal end of the protective cuff 10 to hold the protective cuff 10 in place. In some embodiments, the cuff stopper 31 and catheter body 16 are movable relative to each other. The catheter body 16 may be retracted proximally relative to the cuff stopper 31 to move the catheter body 16 proximally relative to the protective cuff 10 to uncover or release the protective cuff 10 to thereby allow deployment of the protective cuff 10 to an electrical lead. Additionally, or alternatively, the cuff stopper 31 may be moved distally relative to the catheter body 16 to uncover or release the protective cuff 10. The catheter body 16 may be moved distally relative to the cuff stopper 31 to move the catheter body 16 distally relative to the protective cuff 10 to cover, protect, or encapsulate the protective cuff 10 during delivery of the protective cuff 10. Additionally, or alternatively, the cuff stopper 31 may be retracted proximally relative to the catheter body 16 to cover, protect, or encapsulate the protective cuff 10.

[0100] In some embodiments, the cuff stopper 31 and cuff dilator 26 are movable relative to each other. The cuff stopper 31 may be moved or extended distally relative to the cuff dilator 26 to move or release the protective cuff 10 from the cuff dilator 26. Additionally, or alternatively, the cuff dilator 26 may be moved or retracted proximally relative to the cuff stopper 31 to move or release the protective cuff 10 from the cuff dilator 26. It will be appreciated that the cuff stopper 31 may be arranged to abut against the protective cuff 10 only (i.e., to not abut against the cuff dilator 26) to enable the cuff stopper 31 to hold or move the protective cuff 10 relative to the cuff dilator 26. In some embodiments, cuff dilator 26 extends through cuff stopper 31.

[0101] In embodiments where the cuff dilator 26 extends along an entirety of the protective cuff 10, substantially all of the protective cuff 10 may be opened to define the opening 28. Alternatively, in embodiments where the cuff dilator 26 extends only along a portion of the protective cuff 10, only a portion of the protective cuff 10 may be opened to define the opening 28. In such embodiments, the protective cuff 10 may be distally extended and / or the cuff dilator 26 may be proximally retracted to deploy the protective cuff 10, and this relative movement between the protective cuff 10 and the cuff dilator 26 results in theopening 28 moving proximally along the protective cuff 10 to enable an electrical lead to be received within the protective cuff 10.

[0102] Referring to Figure 9, the catheter system 12 may include an actuation or control member 44 located at a proximal end portion of the catheter assembly 14. The catheter assembly 14 may be proximally and distally moved via pushing and pulling of the actuation or control member 44. The actuation or control member 44 in the embodiment of Figure 8 may be, for example, a control handle 44. The control handle 44 may include at least one control 45a-d configured to control movement of at least one or more components of the catheter assembly 14. The at least 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 other suitable control member. It shall be appreciated that any suitable actuation or control member 44 may be used to control movement of the catheter system 12.

[0103] In the embodiment illustrated in Figure 9, four controls 45a-d are provided. In alternative embodiments any suitable number of controls may be provided, for example two, three, five controls or any alternative number of controls. Each of the controls 45a-d may control one or more movement of the catheter body 16, the atraumatic tip 20, the cuff stopper 31, and / or the cuff dilator 26. The controls 45a-d may be controlled simultaneously. In the exemplary embodiment of Figure 9, the four controls 45a-d are located on the control handle 44 and are rotatable relative to the control handle 44.

[0104] In some embodiments, a first control 45a may be provided to control movement of the catheter body 16. The first control 45a may be configured to distally extend and / or proximally retract the catheter body 16. A second control 45b may be provided to control movement of the cuff stopper 31. The second control 45b may be configured to distally extend and / or proximally retract the cuff stopper 31. A third control 45c may be provided to control movement of the cuff dilator 26. The third control 45c may be configured to distally extend and / or proximally retract the cuff dilator 26. A fourth control 45d may be provided to control movement of the inner tip shaft 22. The fourth control 45d may be configured to distally extend and / or proximally retract the inner tip shaft 22 thereby controlling the distal and proximal movement of the atraumatic tip 20.

[0105] As illustrated in Figure 10, in some embodiments, the tip shaft 22 is omitted and the distal region 29 of the cuff dilator 26 is a cone-shaped atraumatic tip 20. As illustratedin Figure 10, the cuff dilator 26 includes a pair of spaced apart dilator arms 27 that abut against and engage substantially opposing internal surfaces of the protective cuff 10 to urge the protective cuff 10 into the open, delivery configuration and to retain the protective cuff 10 in said open, delivery configuration. In the illustrated embodiment, the distal ends of the dilator arms 27 are coupled to the atraumatic tip 20.

[0106] As illustrated in Figures 11A and 1 IB, in some embodiments, the tip shaft 22 is omitted and the distal region 29 of the cuff dilator 26 is a cone-shaped atraumatic tip 20 having a slot or groove 33, which helps guide the electrical lead L2 into the opening 28 of protective cuff 10. As illustrated in Figure 11A, the cuff dilator 26 includes a pair of spaced apart dilator arms 27 that abut against and engage substantially opposing internal surfaces of the protective cuff 10 to urge the protective cuff 10 into the open, delivery configuration and to retain the protective cuff 10 in said open, delivery configuration. In the illustrated embodiment, the distal ends of the dilator arms 27 are coupled to the atraumatic tip 20.

[0107] As illustrated in Figure 12, in some embodiments, both the atraumatic tip 20 and the inner tip shaft 22 may be omitted. As illustrated in Figure 12, the catheter system 12 is in a first configuration where the protective cuff 10 is entirely within the catheter body 16. The protective cuff 10 is retained in the open, delivery configuration when it is within the catheter assembly 14. The protective cuff 10 is deployable from the catheter assembly 14 and is moveable from the open, delivery configuration to a closed, deployed configuration for engaging an electrical lead, for example L2.

[0108] The catheter assembly 14 includes a cuff dilator 26 extending from a control member 44 and configured to retain the protective cuff 10 in the open, delivery configuration. As illustrated in Figure 12, the cuff dilator 26 extends within the catheter body 16 along all or substantially all of the length of the protective cuff 10. In some embodiments, as illustrated in Figures 12-13B, the cuff dilator 26 can have an elongated cylindrical shape along at least a portion of its length. In some embodiments, the cuff dilator 26 can have a cone-shaped distal end region 29. The cuff dilator 26 may include at least one radiopaque additive, for example barium sulphate or titanium oxide. The radiopaque additive improves visibility of the cuff dilator 26 within the patient’s anatomy.

[0109] In the open, delivery configuration the elongate protective cuff 10 defines an opening 28 along at least a portion the protective cuff 10 for receiving a length of electricallead. The cuff dilator 26 is arranged within the protective cuff 10 to retain the protective cuff 10 in the open, delivery configuration. As illustrated in Figures 13A and 13B, the cuff dilator 26 is arranged within the protective cuff 10 and abuts against internal surfaces of the protective cuff 10 to retain the protective cuff 10 in the open, delivery configuration. As illustrated in Figure 13B, in some embodiments, the cuff dilator 26 can have a slot or groove 33 to help guide the electrical lead L2 into the opening 28 of the protective cuff 10.

[0110] The distal region 29 of the cuff dilator 26 may be tapered so as to reduce in diameter towards the distal end of the cuff dilator 26. The cuff dilator 26 may be angled, curved and / or stepped inwardly in said distal region 29 to define the reduction in diameter of the cuff dilator 26 towards the distal end thereof. In the illustrated embodiment, the distal region 29 of the cuff dilator 26 is substantially cone-shaped, but may be any suitable shape such as semi-circular, semioval, triangular, or any other suitable shape where the diameter of the distal region 29 reduces towards a distal end of the cuff dilator 26. Providing a distal region 29 of the cuff dilator that has a dimeter that reduces towards the distal end of the cuff dilator 26 provides a more controlled deployment of the cuff dilator 26 and more controlled movement from the open, delivery configuration to the deployed, closed configuration. Additionally, the likelihood of damage to the protective cuff 10 as the cuff dilator 26 and the protective cuff 10 move relative to each other is reduced.

[0111] In some embodiments, the tapered distal end region 29 of the cuff dilator 26 can act or function like an atraumatic tip 20 or the tapered distal end region 29 can be an atraumatic tip 20. The distal end region 29 may be used to facilitate the advancement of the catheter system 12 through the patient's skin and vasculature, including within the heart. The distal end region 29 may be configured to prevent or reduce intravascular trauma during delivery of the catheter system 12 to the heart. In some embodiments, the distal end region 29 may be a flexible curved or tapered tip (i.e. a flexible curved or tapered distal end face). In one embodiment, the cuff dilator 26 and distal end region 29 may have a lumen with a distal opening 21 for accommodating a guidewire 24 or other elements or substances. The guide wire 24 may run or pass through a lumen of the cuff dilator 26 and out a distal opening 21 of the distal end region 29. It will be understood that the taper and / or curvature of the distal end region 29 may be varied depending upon the sizing / configuration as required.

[0112] The catheter assembly 14 may be provided with a cuff stopper 31 extending distally from the control member 44 and being arranged within the catheter body 16. The cuff stopper 31 may be arranged to abut against a proximal end of the protective cuff 10 to hold the protective cuff 10 in place. In some embodiments, the cuff stopper 31 and catheter body 16 are movable relative to each other. The catheter body 16 may be retracted proximally relative to the cuff stopper 31 to move the catheter body 16 proximally relative to the protective cuff 10 to uncover the protective cuff 10 to thereby allow deployment of the protective cuff 10 to an electrical lead. Additionally, or alternatively, the cuff stopper 31 may be moved distally relative to the catheter body 16 to uncover the protective cuff 10. The catheter body 16 may be moved distally relative to the cuff stopper 31 to move the catheter body 16 distally relative to the protective cuff 10 to cover, protect, or encapsulate the protective cuff 10 during delivery of the protective cuff 10. Additionally, or alternatively, the cuff stopper 31 may be retracted proximally relative to the catheter body 16 to cover, protect, or encapsulate the protective cuff 10.

[0113] In some embodiments, the cuff stopper 31 and cuff dilator 26 are movable relative to each other. The cuff stopper 31 may be moved distally relative to the cuff dilator 26 to move, release, or deploy the protective cuff 10 from the cuff dilator 26. Additionally, or alternatively, the cuff dilator 26 may be proximally retracted relative to the cuff stopper 31 and the protective cuff 10 to move, release, or deploy the protective cuff 10 from the cuff dilator 26. It will be appreciated that the cuff stopper 31 may be arranged to abut against the protective cuff 10 only (i.e., to not abut against the cuff dilator 26) to enable the cuff stopper 31 to hold or move the protective cuff 10 relative to the cuff dilator 26. In some embodiments, cuff dilator 26 extends through cuff stopper 31.

[0114] In embodiments where the cuff dilator 26 extends along an entirety of the protective cuff 10, substantially all of the protective cuff 10 may be opened to define the opening 28. Alternatively, in embodiments where the protective cuff 10 resides only at a portion, for example a distal portion, of the catheter body 16, only a portion of the protective cuff 10 may be opened to define the opening 28. In such embodiments, the protective cuff 10 may be distally extended and / or the cuff dilator 26 may be proximally retracted to deploy the protective cuff 10, and this relative movement between the protective cuff 10 and thecuff dilator 26 results in the opening 28 moving proximally along the protective cuff 10 to enable an electrical lead to be received, engaged, or captured within the protective cuff 10.

[0115] The catheter system 12 illustrated in Figures 10-13B can include a control member 44 (as illustrated in Figure 14) located at a proximal end portion of the catheter assembly 14. The catheter assembly 14 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 14. 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 12.

[0116] In some embodiments, the control member 44 of the catheter system 12 can include three controls 46a-c. A first control 46a may be provided to control movement of the catheter body 16. The first control 46a may be configured to distally extend and / or proximally retract the catheter body 16. A second control 46b may be provided to control movement of the cuff stopper 31. The second control 46b may be configured to distally extend and / or proximally retract the cuff stopper 31. A third control 46c may be provided to control movement of the cuff dilator 26. The third control 46c may be configured to distally extended and / or proximally retract the cuff dilator 26.

[0117] As illustrated in Figure 15, relative movement between the protective cuff 10 and the cuff dilator 26 results in the protective cuff 10 being moved or released from the cuff dilator 26 to transition the protective cuff 10 from an open, delivery configuration into a closed, deployed configuration. The relative movement between the protective cuff 10 and the cuff dilator 26 may be achieved by a distal movement or extension of the protective cuff 10 relative to the cuff dilator 26 and / or by a proximal movement or retraction of the cuff dilator 26 relative to the protective cuff 10. This relative movement between the cuff dilator 26 and the protective cuff 10 results in the cuff dilator 26 being retracted through the protective cuff 10. This relative movement of the protective cuff 10 over the distal region 29 and off of the cuff dilator 26 enables the protective cuff 10 to transition from the open, delivery configuration into the closed, deployed configuration as the cuff dilator 26 no longer urges against the internal surfaces of the protective cuff 10. As illustrated in Figure15, the distal portion of the protective cuff 10 contracts as it is deployed from the cuff dilator 26, wherein the protective cuff 10 wraps around the electrical lead L2 during deployment.

[0118] As illustrated in Figure 16, in some embodiments, the distal region 29 of the cuff dilator 26 may include a hook member or feature 32. In the illustrated embodiment, the distal region 29 of the cuff dilator 26 is substantially cone-shaped and includes an extending hook feature 32. The hook feature 32 improves deployment of the protective cuff 10 by hooking onto and guiding electrical lead L2 within the opening 28 of the protective cuff 10. For example, the hook feature 32 is used to hook, snare, or grab the electrical lead L2. The hook feature 32 then helps direct or guide the electrical lead L2 into the opening 28 of the protective cuff 10 as the cuff dilator 26 is retracted or moved proximally relative to protective cuff 10.

[0119] As illustrated in Figures 17, the catheter system 12 illustrated in Figure 16 can include a control member 44 located at a proximal end portion of the catheter assembly 14. The catheter assembly 14 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 14. 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 12.

[0120] In some embodiments, the control member 44 of the catheter system 12 can include four controls 46a-d. A first control 46a may be provided to control movement of the catheter body 16. The first control 46a may be configured to distally extend and / or proximally retract the catheter body 16. A second control 46b may be provided to control movement of the cuff stopper 31. The second control 46b may be configured to distally extend and / or proximally retract the cuff stopper 31. A third control 46c may be provided to control movement of the cuff dilator 26. The third control 46c may be configured to distally extended and / or proximally retract the cuff dilator 26. A fourth control 46d may be provided to also control movement of the cuff dilator 26. The fourth control 46d may be configured to rotate the cuff dilator 26, thereby rotating the hook feature 32.

[0121] As illustrated in Figure 18, relative movement between the protective cuff 10 and the cuff dilator 26 results in the protective cuff 10 being moved or released from the cuff dilator 26 to transition the protective cuff 10 from an open, delivery configuration into a closed, deployed configuration. The relative movement between the protective cuff 10 and the cuff dilator 26 may be achieved by a distal movement or extension of the protective cuff 10 relative to the cuff dilator 26 and / or by a proximal movement or retraction of the cuff dilator 26 relative to the protective cuff 10. This relative movement between the cuff dilator 26 and the protective cuff 10 results in the cuff dilator 26 being retracted through the protective cuff 10. This relative movement of the protective cuff 10 over the distal region 29 and off of the cuff dilator 26 enables the protective cuff 10 to transition from the open, delivery configuration into the closed, deployed configuration as the cuff dilator 26 no longer urges against the internal surfaces of the protective cuff 10. As illustrated in Figure 18, the distal portion ofthe protective cuff 10 contracts as it is deployed from the cuff dilator 26, wherein the protective cuff 10 wraps around the electrical lead L2 during deployment.

[0122] As illustrated in Figures 19-21, in some embodiments, the cuff dilator 26 and distal end region 29 may have a lumen with a distal opening 21 for accommodating a snare member 37. The snare member 37 extends from the control member 44 and runs or passes through the lumen of the cuff dilator 26 and out the distal opening 21 of the distal end region 29. The distal end region of the snare member 37 can form a hook to hook, snare, or grab the electrical lead L2. The snare member 37 then helps manipulate, direct, or guide the electrical lead L2 into the opening 28 of the protective cuff 10 as the cuff dilator 26 is retracted or moved proximally relative to protective cuff 10. The snare member 37 and the cuff dilator 26 are movable relative to each other. The snare member 37 may be retracted proximally or extended distally relative to the cuff dilator 26. For example, during advancement of the catheter system 12 through the patient's skin and vasculature, including within the heart, the snare member 37 may be retracted proximally relative to cuff dilator 26 to prevent or reduce intravascular trauma during delivery of the catheter system 12 to the heart. Following advancement of the catheter system 12 to a position next to the electrical lead L2, the snare member 37 may be extended distally relative to the cuff dilator 26. The snare member 37 may then be manipulated by moving proximally and distally and by rotating the snare member 37 to engage, hook, snare, or grab the electrical lead L2. Thesnare member 37 then helps manipulate, direct, or guide the electrical lead L2 into the opening 28 of the protective cuff 10 as the cuff dilator 26 is retracted or moved proximally relative to protective cuff 10. As illustrated in Figure 21, the distal portion of the protective cuff 10 contracts as it is deployed from the cuff dilator 26, wherein the protective cuff 10 wraps around the electrical lead L2 during deployment.

[0123] The catheter system 12 illustrated in Figures 19-21 can include a control member 44 (as illustrated in Figure 20) located at a proximal end portion of the catheter assembly 14. The catheter assembly 14 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 14. 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 12.

[0124] In some embodiments, the control member 44 of the catheter system 12 can include four controls 47a-d. A first control 47a may be provided to control movement of the catheter body 16. The first control 47a may be configured to distally extend and / or proximally retract the catheter body 16. A second control 47b may be provided to control movement of the cuff stopper 31. The second control 47b may be configured to distally extend and / or proximally retract the cuff stopper 31. A third control 47c may be provided to control movement of the cuff dilator 26. The third control 47c may be configured to distally extended and / or proximally retract the cuff dilator 26. A fourth control 47d may be provided to control movement of the snare member 37. The fourth control 47d may be configured to distally extended and / or proximally retract the snare member 37. The fourth control 47d may also be configured to rotate the snare member 37.

[0125] A method for delivering and deploying the protective cuff 10 in a patient will now be described.

[0126] In an embodiment, a guidewire (not illustrated) 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 otherknown 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 assembly 14 of the catheter system 12 into the vasculature. The catheter assembly 14 is advanced over the guide wire 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 assembly 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 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 assembly 14 may access the heart without the use of a guidewire.

[0127] In an embodiment, the method of delivering a protective cuff 10 to an electrical lead includes obtaining a catheter assembly 14 comprising an elongate catheter body having a distal end portion 18. The method also includes obtaining a protective cuff 10 comprising an engaging portion and moveable from an open, delivery configuration in which the elongate body defines an opening 28 along an elongate length of the protective cuff 10. The protective cuff 10 is positioned within the catheter body 16 in an open, delivery configuration so as to define the opening 28 along an elongate length of the protective cuff 10. The distal end portion 18 of the catheter body 16 may be positioned within the patient’s anatomy so to be near to or adjacent an electrical lead L2. In some embodiments, the protective cuff 10 may be arranged on the cuff dilator 26 in the open, delivery configuration within the catheter body 16 prior to positioning of the catheter body 16 in the right atrium RA. In alternative embodiments, when the catheter body 16 of the catheter assembly 14 is positioned in the right atrium RA the protective cuff 10 is advanced through the catheter body 16 to the distal end portion 18.

[0128] The protective cuff 10 is at least partially deployed from the catheter assembly 14 such that at least a part of the opening 28 of the protective cuff 10 is deployed from the catheter assembly 14. An electrical lead is then positioned within the protective cuff 10 via the opening 28. The protective cuff 10 is moved into the closed, deployed configuration to close the opening 28, and to engage the electrical lead L2 with an inner surface of the protective cuff 10. It will be understood that deployment of a valve prosthesis may occur prior to or after deployment of the protective cuff 10 (i.e., prior to or after implantation of the electrical leads LI, L2 in a patient.

[0129] In the embodiment illustrated in Figure 22, a valve prosthesis 34 may be deployed into the patient’s native heart valve before electrical leads LI, L2 are implanted within a patient. In such embodiments, the method also includes obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, the prothesis comprising a frame having a compressed, delivery configuration and an expanded, deployed configuration, wherein the frame defines a central lumen in the expanded, deployed configuration. The valve prosthesis 34 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 valve prosthesis is positioned within a catheter delivery system in the compressed delivery configuration. The valve prosthesis is positioned at a native valve annulus of a patient and is deployed from the distal portion of the catheter delivery system to enable the frame to move from the compressed, delivery configuration to the expanded, deployed configuration.

[0130] After the prosthesis 34 has been deployed within a patient’s heart valve, the electrical leads LI, L2 may be implanted within the patient. During the implantation of the electrical lead L2, the protective cuff 10 may then be deployed from the catheter system 12, as described above. The electrical lead L2 and the protective cuff 10 are directed through the valve prosthesis 34 to enter the right ventricle RV. In some embodiments, the electrical lead L2 and the protective cuff 10 may be directed to pass through the valve prothesis adjacent a valve commissure of said prosthesis, as is illustrated in Figure 23. Alternatively, the electrical lead L2 and the protective cuff 10 may be directed to pass through an opening in a frame of the valve prosthesis 34, or via any other suitable arrangement. As is illustratedin Figure 24, this results in the protective cuff 10 being arranged on the electrical lead L2 where the electrical lead L2 extends through the valve prosthesis 34.

[0131] In the embodiment illustrated in Figure 25, electrical leads LI, L2 may be implanted within a patient prior to the deployment of a valve prosthesis. In such embodiments, the protective cuff 10 may be deployed from the catheter system 12, as described above, such that the protective cuff 10 is aligned with the native valve annulus of the patient. During deployment of the valve prosthesis 34, the electrical lead L2 and the protective cuff 10 on said electrical lead L2 may be urged onto or against a side of the native valve annulus, as is illustrated in Figure 26. It will be understood that this movement of the electrical lead L2 may be achieved by the valve prosthesis 34 itself manipulating the electrical lead L2 or that the electrical lead L2 may be moved by a separate lead manipulation device. In this embodiment, the protective cuff 10 is arranged to extend along an external portion of the valve prosthesis 34, as illustrated in Figure 26. As such, the valve prosthesis 34 can be implanted in the anatomy of the patient without the electrical lead L2 obstructing the path of the prosthesis 34 and without the prosthesis 34 from damaging or breaking the electrical lead L2.

[0132] Figures 27A-31B show an alternative catheter system 112 with a lead- manipulation member 161. 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 “1”.

[0133] The catheter system 112 is configured for delivering and deploying the protective cuff 10 within a patient. The catheter system 112 includes a control or actuation member 44, a catheter assembly 14 extending distally from the control member 44, the catheter assembly 14 including an elongate catheter body 16 having a distal end portion 18. The control member 44 may be, for example, a control handle 44.

[0134] The catheter assembly 14 may be provided with a cuff stopper 31 extending distally from the control member 44 and being arranged within the catheter body 16. As illustrated in Figure 28, the cuff stopper 31 may be arranged to abut against a proximal end of the protective cuff 10 to hold the protective cuff 10 in place. In some embodiments, the cuff stopper 31 and catheter body 16 are movable relative to each other. The catheter body 16 may be retracted proximally relative to the cuff stopper 31 to move the catheter body 16 proximally relative to the protective cuff 10 to uncover or release the protective cuff 10 tothereby allow deployment of the protective cuff 10 to an electrical lead. Additionally, or alternatively, the cuff stopper 31 may be moved distally relative to the catheter body 16 to uncover or release the protective cuff 10. The catheter body 16 may be moved distally relative to the cuff stopper 31 to move the catheter body 16 distally relative to the protective cuff 10 to cover, protect, or encapsulate the protective cuff 10 during delivery of the protective cuff 10. Additionally, or alternatively, the cuff stopper 31 may be retracted proximally relative to the catheter body 16 to cover, protect, or encapsulate the protective cuff 10.

[0135] The catheter assembly 14 includes the lead-manipulation member 161 including a lead-engaging member 165 having two lead-engaging member portions 165a, 165b at least partially arranged within the catheter body 16 in a delivery configuration, and deployable from the catheter body 16 to allow the lead-engaging member 165 to be positioned next to or adjacent an electrical lead L2, as is illustrated in Figure 29. The lead-engaging member 165 is configured to move between an open configuration, in which the lead-engaging member 165 defines a contact surface 168 configured to receive an electrical lead therein, and a closed configuration, in which the lead-engaging member 165 is configured to engage, retain, grip and / or snare the electrical lead, as is illustrated in Figure 30. The lead-engaging member 165 includes a contact surface 168 having an elongate recess, channel or opening 125 extending along an axis that is parallel to the longitudinal axis of the catheter body 16. The lead-engaging member 165 includes a substantially tubular portion 169 defining the elongate channel, recess or opening 125 for receiving the length of electrical lead L2. In the open configuration, the opening 125 extends at least partially along the tubular portion 169. The opening extends along the axis parallel to the catheter body 16. The lead-engaging member 165 increases the area of contact between the electrical lead L2 and the lead- engaging member 165. In the closed configuration, the lead-engaging member 165 is configured to close such that the tubular portion 169 encloses the length of electrical lead L2.

[0136] As is illustrated in Figures lK-'llC, the lead-engaging member 165 includes first and second lead-engaging member portions or arms 165a, 165b moveable between an open configuration, illustrated in Figure 27C, and a closed configuration, illustrated in Figure 27A. The first and second lead-engaging member portions 165a, 165b of the lead-engaging member 165 are substantially tubular and define a longitudinal slit 167 extending along the lead-engaging member 165. As is illustrated in Figures lK-'llC, the lead- engaging member portions 165a, 165b are configured to pivot or rotate radially outward relative to the catheter body 16 when moving from a closed configuration to an open configuration. The lead-engaging member portions 165a, 165b may be shaped to fit around an electrical lead L2. For example, the lead-engaging member portions 165a, 165b may be curved or semi-circular in shape, as is illustrated in Figures 27A-27C. The distal portion 18 of the catheter body 16 includes a distal opening for receiving the lead-engaging member portions 165a, 165b such that the lead-engaging member portions 165a, 165b are deployed therefrom.

[0137] It shall be appreciated that the lead-engaging member 165 may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shapeset to move the lead-engaging member 165 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.

[0138] The lead-engaging member portions 165a, 165b of Figures 27A-27C include a first lead-engaging member portion 165a and a second lead-engaging member portion 165b. 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 27A-27C, the first and second lead- engaging member portions 165a, 165b are the same length and are pivotally coupled together. It shall be appreciated that the first and second lead-engaging member portions 165a, 165b may define any suitable length, or different lengths. It shall be appreciated that in alternative embodiments, the first and / or second lead-engaging member portions 165a, 165b may define any suitable shape.

[0139] In some embodiments, the catheter system 112 includes a lead-manipulation shaft 135 configured extending along the catheter body 16 and connected to the lead- engaging member portions 165a, 165b of the lead-manipulation member 160. The lead- manipulation shaft 135 is operable such that the lead-engaging member portions 165a, 165b are moveable relative to the catheter body 16. The lead-manipulation shaft 135 is configured to couple the lead-engaging member portions 165a, 165b to the catheter system 112. Thelead-manipulation shaft 135 may be rotatable to rotate the lead-engaging member portions 165a, 165b relative to the catheter body 16. Additionally, or alternatively, the lead- manipulation shaft 135 may be moveable to distally extend and / or proximally retract the lead-engaging member portions 165a, 165b relative to the distal portion 18 of the catheter body 16. Thus, through manipulation of the lead-manipulation shaft 135, movement of the lead-engaging member portions 165a, 165b can be controlled. This helps facilitate positioning of the lead-engaging member portions 165a, 165b next to or adjacent an electrical lead L2. Control of the movement of the lead-engaging member portions 165a, 165b 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 165a, 165b.

[0140] In some embodiments, the first lead-engaging member portion 165a is moveable relative to the second lead-engaging member portion 165b. For example, in some embodiments, the lead-engaging member portions 165a, 165b may be pivotally coupled together. In some embodiments, the lead-engaging member portions 165a, 165b are configured to oppose each other. In some embodiments, the catheter system 112 includes one or more actuation or control wires 170 configured to extend along the lead-manipulation shaft 135 and / or the catheter body 16 and being connect to the lead-engaging member portions 165a, 165b. Actuation of the one or more control wires 170 controls the opening and closing or pivoting of the lead-engaging members 165a, 165b between the closed, delivery configuration, as is illustrated in Figure 27A, and the open, deployed configuration, as is illustrated in Figure 27C.

[0141] As is illustrated in Figures 1K- 1Q in some embodiments, the catheter system 112 includes a control member 44 located at a proximal end of the catheter assembly 14. Stated another way, the catheter assembly 14 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 112 and includes one or more controls 48a-d configured to control one or more components of the catheter system 112. In the embodiment of Figures lK-'llC, 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 anysuitable control. In some embodiments, the controls 48a-d may be controlled simultaneously and / or independently or separately. In the exemplary embodiment of Figures lK-'llC, the four controls 48a-d are located on the control member 44. Controls 48a-c are rotatable relative to the control member 44. The control 48d is a lever pivotable relative to the handle member 44.

[0142] A first control 48a may be provided to control movement of the catheter body 16. The first control may be configured to distally extend and / or proximally retract the catheter body 16. A second control 48b may be provided to control movement of the cuff stopper 31 relative to the catheter body 16. The second control may be configured to distally extend and / or proximally retract the cuff stopper 31 relative to the catheter body 16. A third control 48c may be provided to control movement of the lead-manipulation shaft 135 relative to the catheter body 16. The third control may be configured to distally extend and / or proximally retract the lead-manipulation shaft 135 relative to the catheter body 16. A fourth control 48d may be provided to control movement of the lead-engaging member 165. The fourth control 48d may be configured for controlling movement of the first and second opposing arms 165a, 165b between the open and closed configuration. For example, the fourth control 48d may include an actuation or control wire 170 coupled to the first and second opposing arms 165a, 165b. It shall be appreciated that any suitable actuation or fourth control 48d may be used. Alternatively, the fourth control 48d may be omitted and the lead-engaging member 165 may move between the open and closed configurations automatically, for example by shape memory portions of the lead-engaging member 165.

[0143] The lead-manipulation shaft 135 may be configured to be operable to distally extend and / or proximally retract relative to the cuff stopper 31. In addition, the cuff stopper may be configured to be operable to distally extend and / or proximally retract relative to the lead-manipulation shaft 135. Relative movement between the cuff stopper 31 and the lead- manipulation shaft 135 results in the ability to move the protective cuff 10 over the lead- engaging member 165. The relative movement between the protective cuff 10 and the lead- engaging member 165 may be achieved by a distal movement of the protective cuff 10 relative to the lead-engaging member 165 and / or by a proximal retraction of the lead- engaging member 165 relative to the protective cuff 10. This relative movement results in the lead-engaging member 165 being retracted through the protective cuff 10, such that theprotective cuff 10 moves or travels along and over the lead-engaging member 165. This movement of the protective cuff 10 over the lead-engaging member 165 enables the protective cuff to transition from the delivery configuration into the deployed configuration.

[0144] Although not illustrated in the Figures, it shall be appreciated that any suitable lead-engaging member 165 may be used to engage the electrical lead L2, for example an alternative arm or grabber. Furthermore, it shall be appreciated that any of the embodiments may include a roughened contact surface for increasing friction between the electrical lead and the lead-engaging member 165.

[0145] As illustrated in Figure 28, the catheter system 112 of Figures 27A-27C includes a protective cuff 10 arranged within the catheter body 16. The catheter system 112 is configured for delivering and deploying the protective cuff 10 within the patient. The protective cuff 10 is extendable and retractable and configured to be deployed over the lead- engaging member 165, and therefore over an engaged or captured electrical lead L2.

[0146] As illustrated in Figures 31A and 3 IB, the protective cuff or sleeve 10 is configured to form a cover over the electrical lead L2, helping to further reduce damage to the electrical lead L2. The protective cuff 10 includes a portion configured to engage the electrical lead L2 when the protective cuff 10 is extended beyond the lead-engaging member 165. The protective cuff 10 can be tracked over the electrical lead L2 until the protective cuff 10 reaches the location of the electrical lead L2 at which a heart valve prosthesis is likely to be implanted. Accordingly, the protective cuff 10 protects the electrical lead L2 from damage from the prosthesis at this location. This arrangement enables the lead- engaging member 165 to engage and to grip or retain the electrical lead L2, and for the protective cuff 10 to be deployed from the catheter body 16 over the lead-engaging member 165 and therefore over an engaged or captured electrical lead L2 to retain the electrical lead L2. The protective cuff 10 is retractable and extendable relative to the lead-engaging member 165 and to the catheter body 16.

[0147] The protective cuff 10 may include an open configuration and a closed configuration for retaining the electrical lead L2 therein. In the embodiment of Figures 31A and 3 IB, the protective cuff 10 may include one or more shape-memory portions, for example Nitinol portions, configured to engage the electrical lead L2 when it is extended beyond the lead-engaging member 165. The one or more shape-memory portions are shapeset to move the protective cuff 10 from the open configuration to the closed configuration. The shape setting of the protective cuff 10 helps to facilitate automatic retention of the electrical lead L2 therein.

[0148] The shape memory material may be shape set to move the protective cuff 10 to the closed configuration as the protective cuff 10 extends beyond the lead-engaging member 165. For example, if the protective cuff 10 includes one or more shape memory ribs that extend across an inner surface of the protective cuff 10, and if those ribs are configured to curl into a coiled configuration during the shape-setting process, then when the protective cuff 10 extends beyond the lead-engaging member 165, it will curl under the bias provided by the shape-set ribs. It shall be appreciated that any exemplary shape-memory portions may be used to move the protective cuff 10 into the closed configuration.

[0149] The protective cuff 10 may include a longitudinal slit or opening configured to receive the electrical lead L2 therein. The longitudinal slit or opening is closed to move the protective cuff 10 from the open into the closed configuration. In the closed configuration, the longitudinal slit or opening may be narrowed, partially closed, or entirely closed. The protective cuff 10 may spiral into the closed configuration to engage the electrical lead L2.

[0150] It shall be appreciated that in alternative embodiments, as illustrated in Figure 32, the protective cuff 10 includes a distal first portion 10a and a proximal second portion 10b. The distal first portion 10a and the proximal second portion 10b are axially aligned to form a substantially tubular protective cuff 10. The distal first portion 10a is detachable from the proximal second portion 10b. As such, the protective cuff 10 can be deployed with the first and second portion 10a, 10b attached, and the distal first portion 10a can be subsequently removed. As illustrated in Figure 32, the distal first portion 10a and the proximal second portion 10b are connected by a frangible portion 10c of the protective sleeve 10. The frangible portion 10c is defined by a region of reduced strength. In the embodiment of Figure 32, the region of reduced strength 10c may include perforations in the protective sleeve 10. In alternative embodiments, the frangible portion 10c may include a region of reduced thickness of the protective sleeve 10.

[0151] In one embodiment, as illustrated in Figure 33, a proximal end 180 of the proximal second portion 10b of protective cuff 10 may be attached to and extend distally from a control or actuation member 44. The control member 44 may be configured to controlthe movement of the protective cuff 10 and / or to control the opening and closing of the protective cuff 10. The control member 44 may include one or more controls 51. In the embodiment of Figure 33, one control 51 is provided. In alternative embodiments, any suitable number of controls may be provided, for example two, three, four, five or any alternative number of controls. The at least one control 51 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. In some embodiments, the controls may be controlled simultaneously and / or independently or separately. In the exemplary embodiment of Figure 33, the control 51 is a lever pivotable relative to the handle member 44.

[0152] Figures 34A-34C show a protective cuff detachment device 200 with a detachment member 220. Identical parts with the embodiments of Figures 2 to 33 are labelled with the same reference numeral, and like parts are labelled with the prefix “2”.

[0153] Figures 34A-34C illustrate a protective cuff detachment device 200. Detachment device 200 includes a detachment member configured to detach the distal first portion 10a from the proximal second portion 10b. Figures 34A-34C illustrate an embodiment wherein a separate detachment member 220 in the form of a clamp is provided. The detachment member 220 is used to detach the distal first portion 10a from the proximal second portion 10b at the frangible portion 10c. In alternative embodiments, the detachment member 220 may include a pull cord (not illustrated). Actuation of the pull cord detaches the distal first portion 10a from the proximal second portion 10b at the frangible portion 10c. In further alternative embodiments, the detachment member 220 may include a cutting device (not illustrated) for cutting the protective sleeve 10 to detach the distal first portion 10a from the proximal second portion 10b.

[0154] The protective cuff detachment device 200 is configured for grasping or clamping the protective cuff 10. The protective cuff detachment device 200 includes a control or actuation member 44, a catheter assembly 14 extending distally from the control member 44, the catheter assembly 14 including an elongate catheter body 16 having a distal end portion 18. The control member 44 may be, for example, a control handle 44.

[0155] The catheter assembly 14 includes the detachment member 220 having two detachment member portions 220a, 220b at least partially arranged within the catheter body 16 in a delivery configuration, and deployable from the catheter body 16 to allow thedetachment member 220 to grasp or clamp the protective cuff 10, as is illustrated in Figures 35B and 35C. The detachment member 220 is configured to move between an open configuration, in which the detachment member 220 defines a contact surface 223 configured to receive a protective cuff 10 therein, and a closed configuration, in which the detachment member 220 is configured to grasp, clamp, engage, retain, grip, and / or snare the protective cuff 10, as is illustrated in Figures 34B and 34C. The detachment member 220 includes a contact surface 223 having an elongate recess, channel or opening 225 extending along an axis that is parallel to the longitudinal axis of the catheter body 16. The detachment member 220 includes a substantially tubular portion defining the elongate channel, recess or opening 225 for receiving the length of the protective cuff 10. In the open configuration, the opening 225 extends at least partially along the tubular portion. The opening extends along the axis parallel to the catheter body 16. In the closed configuration, the detachment member 220 is configured to close such that the tubular portion encloses the length of the protective cuff 10.

[0156] As is illustrated in Figures 34A-34C, the detachment member 220 includes first and second protective cuff-engaging member portions or arms 220a, 220b moveable between an open configuration, illustrated in Figure 34C, and a closed configuration, illustrated in Figure 34A. The first and second detachment member portions 220a, 220b of the detachment member 220 are substantially tubular and define a longitudinal slit extending along the detachment member 220. As is illustrated in Figures 34A-34C, the detachment member portions 220a, 220b are configured to pivot or rotate radially outward relative to the catheter body 16 when moving from a closed configuration to an open configuration. The detachment member portions 220a, 220b may be shaped to fit around the protective cuff 10. For example, the detachment member portions 220a, 220b may be curved or semicircular in shape, as is illustrated in Figures 34A-34C. The distal portion 18 of the catheter body 16 includes a distal opening for receiving the detachment member portions 220a, 220b such that the detachment member portions 220a, 220b are deployed therefrom.

[0157] It shall be appreciated that the detachment member 220 may be formed from a shape-memory material, for example Nitinol. The shape-memory material may be shape-set to move the detachment member 220 between the open and closed position. In the closedposition, the opening may be completely closed, or alternatively the opening may be narrowed or partially closed.

[0158] The detachment member portions 220a, 220b of Figures 34A-34C include a first detachment member portion 220a and a second detachment member portion 220b. It shall be appreciated that in alternative embodiments, any suitable number of detachment member portions may be provided, for example three detachment member portions. In the illustrated embodiment of Figures 34A-34C, the first and second detachment member portions 220a, 220b are the same length and are pivotally coupled together. It shall be appreciated that the first and second detachment member portions 220a, 220b may define any suitable length, or different lengths. It shall be appreciated that in alternative embodiments, the first and / or second detachment member portions 220a, 220b may define any suitable shape.

[0159] In some embodiments, the protective cuff detachment device 200 includes a detachment-manipulation shaft 135 configured extending along the catheter body 16 and connected to the detachment member portions 220a, 220b of the detachment member 220. The detachment-manipulation shaft 135 is operable such that the detachment member portions 220a, 220b are moveable relative to the catheter body 16. The detachmentmanipulation shaft 135 is configured to couple the detachment member portions 220a, 220b to the protective cuff detachment device 200. The detachment-manipulation shaft 135 may be rotatable to rotate the detachment member portions 220a, 220b relative to the catheter body 16. Additionally, or alternatively, the detachment-manipulation shaft 135 may be moveable to distally extend and / or proximally retract the detachment member portions 220a, 220b relative to the distal portion 18 of the catheter body 16. Thus, through manipulation of the detachment-manipulation shaft 135, movement of the detachment member portions 220a, 220b can be controlled. This helps facilitate positioning of the detachment member portions 220a, 220b next to or adjacent the protective cuff 10. Control of the movement of the detachment member portions 220a, 220b also facilitates moving the protective cuff 10 and the electrical lead L2 into a desired location after said electrical lead L2 has been engaged by said protective cuff 10 and said protective cuff 10 has been engaged by said detachment member portions 220a, 220b.

[0160] In some embodiments, the first detachment member portion 220a is moveable relative to the second detachment member portion 220b. For example, in someembodiments, the detachment member portions 220a, 220b may be pivotally coupled together. In some embodiments, the detachment member portions 220a, 220b are configured to oppose each other. In some embodiments, the protective cuff detachment device 200 includes one or more actuation or control wires 170 configured to extend along the detachment-manipulation shaft 135 and / or the catheter body 16 and being connected to the detachment member portions 220a, 220b. Actuation of the one or more control wires 170 controls the opening and closing or pivoting of the detachment member portions 220a, 220b between the closed, delivery configuration, as is illustrated in Figure 34A, and the open, deployed configuration, as is illustrated in Figure 34C.

[0161] As is illustrated in Figures 34A-34C, in some embodiments, the protective cuff detachment device 200 includes a control member 44 located at a proximal end of the catheter assembly 14. Stated another way, the catheter assembly 14 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 protective cuff detachment device 200 and includes one or more controls 49a-c configured to control one or more components of the protective cuff detachment device 200. In the embodiment of Figures 34A-34C, 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. In some embodiments, the controls 49a-c may be controlled simultaneously and / or independently or separately. In the exemplary embodiment of Figures 32A-32C, the three controls 49a-c are located on the control member 44. Controls 49a-b are rotatable relative to the control member 44. The control 49c is a lever pivotable relative to the handle member 44.

[0162] A first control 49a may be provided to control movement of the catheter body 16. The first control may be configured to distally extend and / or proximally retract the catheter body 16. A second control 49b may be provided to control movement of the detachment-manipulation shaft 135 relative to the catheter body 16. The second control may be configured to distally extend and / or proximally retract the detachment-manipulation shaft 135 relative to the catheter body 16. A third control 49c may be provided to control movement of the detachment member 200. The third control 49c may be configured forcontrolling movement of the first and second opposing arms 220a, 220b between the open and closed configuration. For example, the third control 49c may include an actuation or control wire 170 coupled to the first and second opposing arms 220a, 220b. It shall be appreciated that any suitable actuation or third control 49c may be used. Alternatively, the third control 49c may be omitted and the detachment member 220 may move between the open and closed configurations automatically, for example by shape memory portions of the detachment member 220.

[0163] A method of protecting an electrical lead L2 in a patient’s anatomy will be described hereafter.

[0164] In an embodiment, a guidewire (not illustrated) is advanced after having been introduced into the vasculature via a percutaneous entry point and tracked through the vasculature into a heart. Intravascular access to the right atrium RA may be achieved via a percutaneous access site to femoral venous access up to the inferior vena cava, or other known access routes. Thereafter, a guidewire is advanced through the circulatory system, eventually arriving at the heart. The guidewire is directed into the right atrium RA and may be directed to the native tricuspid valve of the patient. In some embodiments, the guidewire may traverse the right atrium and is made to traverse, with the aid of a transseptal needle or pre-existing hole, an atrial septum, thereby entering the left atrium LA. Once the guidewire is positioned, the entry port and the atrial septum are dilated to permit entry of the protective cuff 10 into the left atrium LA.

[0165] It will be understood that the protective cuff 10 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 would be through the radial vein into the brachial vein, through the subclavian vein, through the superior vena cava into the right atrium. Yet another possible path would be through the femoral artery into the aorta, through the aortic valve into the left ventricle, and then to the mitral valve. In another embodiment, the left ventricle LV may be accessed via a transapical approach, and the protective cuff 10 may be advanced through the left ventricle LV to the mitral valve. In addition, although described with the use of a guidewire, in another embodiment hereof the protective cuff 10 may access the heart without the use of a guidewire.

[0166] As illustrated in Figure 35A, the protective cuff 10, as illustrated in Figure 33, is moved into alignment with and positioned over to encapsulate the electrical lead L2. The step of moving the protective cuff 10 into alignment with the electrical lead L2 may include extending, retracting, and / or rotating the protective cuff 10 using handle 44. The step of positioning the protective cuff 10 over the electrical lead L2 may include opening and closing the protective cuff 10 using control 51 of handle 44. The protective cuff 10 includes the distal first portion 10a and the proximal second portion 10b. The method includes deploying the protective cuff 10 such that the distal first portion 10a engages the electrical lead L2 and detaching the proximal second portion 10b from the distal first portion 10a.

[0167] Figures 35A-35D show that the electrical lead L2 is moved to one side of a heart valve prosthesis 34. As such, the prosthesis 34 can be implanted in the anatomy of the patient without the electrical lead L2 becoming damaged or broken during the procedure. In such embodiment, the method further includes the step of obtaining a prosthesis 34, for example a valve prosthesis 34. The valve prosthesis 34 has a compressed, delivery configuration and an expanded deployed configuration. The valve prosthesis 34 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 valve prosthesis 34 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 covey blood flow through a central lumen of the frame. The valve prosthesis 34 is positioned within a delivery catheter system in the compressed, delivery configuration. The valve prosthesis is positioned in a native annulus of the patient and is deployed from a distal portion of a catheter body of the catheter system to enable the frame to move from the compressed, delivery configuration to the expanded, deployed configuration.

[0168] It shall be appreciated that in some embodiments, the valve prosthesis 34 is implanted following placement of the protective cuff 10 around the electrical lead L2. It shall be appreciated that in some embodiments, the method includes deploying the protective cuff 10 such that the distal first portion 10a engages the electrical lead L2 and detaching the proximal second portion 10b from the distal first portion 10a prior to the implant of a valve prosthesis 34. It shall be appreciated that in some embodiments, the method includes deploying the protective cuff 10 such that the distal first portion 10a andthe proximal second portion 10b engages the electrical lead L2 prior to the implant of a valve prosthesis 34 and detaching the proximal second portion 10b from the distal first portion 10a occurs following the implant of a valve prosthesis 34.

[0169] In the embodiment of Figures 35A-35D, the step of detaching the distal first portion 10a from the proximal second portion 10b includes clamping the distal first portion 10a with the protective cuff detachment device 200 and retracting the protective cuff 10 to detach the distal first portion 10a from the proximal second portion 10b. When the electrical lead L2 has been retained in the protective cuff 10, the detachment member 220, in the form of a clamp, is moved by the detachment-manipulation shaft 135 to a location outside of the protective cuff 10. The detachment member 220 is used to engage the distal first portion 10a of the protective cuff 10, as illustrated in Figure 35B. The detachment device 220 is moved into a closed position to exert a gripping or clamping force on the distal first portion 10a. To detach the distal first portion 10a from the proximal second portion 10b, a predetermined force is applied between the proximal second portion 10b and the detachment device 200 to detach the distal first portion 10a from the proximal second portion 10b at the frangible portion 10c. The proximal second portion 10b is then removed from the patient’s anatomy, as illustrated in Figure 35C. The detachment device 220 is then moved into an open position to release the distal first portion 10a from the detachment device 220. The distal first portion 10a is then left within the patient’s anatomy to retain the electrical lead L2 in the desired location as illustrated in Figure 35D.

[0170] Figures 34A-34C illustrate an embodiment wherein a separate detachment member 220 in the form of a clamp is provided. The detachment member 220 is used to detach the distal first portion 10a from the proximal second portion 10b at the frangible portion 10c. In alternative embodiments, the detachment member 220 may include a pull cord (not illustrated). Actuation of the pull cord detaches the distal first portion 10a from the proximal second portion 10b at the frangible portion 10c. In further alternative embodiments, the detachment member 220 may include a cutting device (not illustrated) for cutting the protective sleeve 10 to detach the distal first portion 10a from the proximal second portion 10b.

[0171] 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.

[0172] The following examples are illustrative of the techniques described herein.

[0173] Example 1. A catheter system for delivering and deploying a protective cuff to an electrical lead comprising: a handle; a catheter assembly extending distally from the handle, the catheter assembly comprising: a movable elongate catheter body configured to cover and uncover a protective cuff; a movable cuff dilator arranged within the catheter body and configured to retain the protective cuff in an open, delivery configuration and to deploy the protective cuff to an electrical lead, wherein the protective cuff is deployed following relative movement between the catheter body and the cuff dilator.

[0174] Example 2. The catheter system according to Example 1, wherein the cuff dilator is arranged at a distal portion of the catheter body to retain the protective cuff in the open, delivery configuration.

[0175] Example 3. The catheter system according to Example 2, wherein the cuff dilator comprises at least one guide member arranged within the protective cuff to retain the protective cuff in the open, delivery configuration.

[0176] Example 4. The catheter system according to Example 3, wherein the at least one guide member is substantially U-shaped, V-shaped, C-shaped, J-shaped, L-shaped, or T-shaped.

[0177] Example 5. The catheter system according to Example 1 , wherein the cuff dilator comprises two or more spaced apart dilator arms arranged within and extending at least partially along the protective cuff to retain the protective cuff in the open, delivery configuration.

[0178] Example 6. The catheter system according to Example 2, wherein a distal region of the cuff dilator tapers towards a distal end of the cuff dilator.

[0179] Example 7. The catheter system according to Example 6, wherein the distal region is U-shaped, V-shaped, curved, conical, semi-circular, hemispherical, or triangular.

[0180] Example 8. The catheter system according to Example 1, wherein the protective cuff comprises one or more engaging portions configured to engage or capture an electrical lead.

[0181] Example 9. The catheter system according to Example 8, wherein the one or more engaging portions comprise a shape memory material, for example Nitinol.

[0182] Example 10. The catheter system according to Example 9, wherein the shapememory material is shape set to move the cuff to the closed, deployed configuration as or after the protective cuff is deployed from the cuff dilator.

[0183] Example 11. The catheter system according to Example 8, wherein the engaging portion is biased to move to the closed, deployed, configuration to close the opening upon deployment from the cuff dilator.

[0184] Example 12. The catheter system according to Example 8, wherein the one or more engaging portions are arranged at or near a first end of the protective cuff and / or a second end of the protective cuff.

[0185] Example 13. The catheter system according to Example 8, wherein one or more of the engaging portions comprise a split ring configured to engage an electrical lead arranged within the protective cuff, when the protective cuff is in the closed, deployed, configuration.

[0186] Example 14. The catheter system according to Example 13, wherein one or more of the split rings are configured to spiral into the closed, deployed configuration.

[0187] Example 15. The catheter system according to Example 8, wherein the one or more engaging portions comprise one or more ribs along a length of the protective cuff.

[0188] Example 16. The catheter system according to Example 15, wherein one or more of the ribs are configured to curl into a coiled closed, deployed configuration.

[0189] Example 17. The catheter system according to Example 1 , wherein the protective cuff comprises a frame extending at least partially, for example entirely, over the protective cuff, and wherein the frame is configured to engage or capture an electrical lead.

[0190] Example 18. The catheter system according to Example 1 , wherein the protective cuff comprises an abrasion resistant material extending at least partially thereover.

[0191] Example 19. The catheter system according to Example 18, wherein the abrasion resistant material extends at least partially over an inner surface of the protective cuff.

[0192] Example 20. The catheter system according to Example 19, wherein the abrasion resistant material extends from the inner surface of the protective cuff to an outer surface of the protective cuff.

[0193] Example 21. The catheter system according to Example 18, wherein the abrasion resistant material comprises a textile material, a polymeric material, such as a plastics material, a hydrogel, or one or more of PET, PTFE and / or ePTFE.

[0194] Example 22. The catheter system according to Example 18, wherein the protective cuff comprises at least two engaging portions configured to engage or capture an electrical lead, and wherein the abrasion resistant material extends over and / or between the at least two engaging portions.

[0195] Example 23. The catheter system according to Example 1, wherein the catheter assembly comprises a movable atraumatic tip positioned at or near the end portion of the catheter body.

[0196] Example 24. The catheter system according to Example 1, wherein the catheter assembly comprises a movable protective cuff stopper arranged within the catheter body.

[0197] Example 25. The catheter system according to Example 1 , wherein the protective cuff is substantially tubular in the closed, deployed, configuration.

[0198] Example 26. A protective cuff deployable from a catheter system and moveable from an open, delivery configuration to a closed, deployed configuration, the protective cuff comprising an inner surface configured to contact an electrical lead when the protective cuff is in the closed, deployed configuration.

[0199] Example 27. A method of deploying a protective cuff to an electrical lead comprising: obtaining a catheter assembly comprising an elongate catheter body having a distal portion; obtaining a protective cuff comprising an inner surface configured to contact an electrical lead; positioning the protective cuff within the catheter body in an open, delivery, configuration so as to define an opening along at least a portion of the protective cuff; at least partially deploying the protective cuff from the catheter assembly; positioning an electrical lead in the protective cuff via the opening; moving the protective cuff from the open, delivery configuration to a closed, deployed, configuration to close or narrow the opening; and engaging an electrical lead with the inner surface of the protective cuff.

[0200] Example 28. The method according to Example 27, wherein positioning the protective cuff within the catheter body comprises positioning a cuff dilator within the protective cuff to retain the protective cuff in the open, delivery configuration.

[0201] Example 29. The method according to Example 28, wherein moving the protective cuff from the open, delivery configuration to a closed, deployed, configuration to close or narrow the opening comprises deploying the protective cuff from the cuff dilator.

[0202] Example 30. A method of delivering and deploying a valve replacement or repair prosthesis after deploying a protective cuff to an electrical lead at a native valve annulus of a patient according to Example 27 comprising: obtaining a valve prosthesis having a compressed, delivery configuration and an expanded, deployed configuration, said valve prosthesis optionally 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 valve 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; delivering the valve prosthesis in a compressed, delivery, configuration to the native valve annulus, the native valve annulus including an electrical lead having a protective cuff; and deploying the valve prosthesis within the native valve annulus, wherein the electrical lead and the protective cuff are positioned between the native annulus and the expanded, deployed valve prosthesis.

[0203] Example 31. The method according to Example 30, wherein valve prosthesis is deployed prior to the deployment of the protective cuff, and wherein the protective cuff extends through the central lumen on the frame.

[0204] Example 32. The method according to Example 30, wherein the valve prosthesis is deployed after the deployment of the protective cuff, and wherein the protective cuff extends along an external portion of the valve prosthesis.

Claims

CLAIMS:

1. A catheter system for delivering and deploying a protective cuff to an electrical lead comprising: a handle; a catheter assembly extending distally from the handle, the catheter assembly comprising: a movable elongate catheter body configured to cover and uncover a protective cuff; a movable cuff dilator arranged within the catheter body and configured to retain the protective cuff in an open, delivery configuration and to deploy the protective cuff to an electrical lead, wherein the protective cuff is deployed following relative movement between the catheter body and the cuff dilator.

2. The catheter system according to claim 1, wherein the cuff dilator is arranged at a distal portion of the catheter body to retain the protective cuff in the open, delivery configuration.

3. The catheter system according to claim 2, wherein the cuff dilator comprises at least one guide member arranged within the protective cuff to retain the protective cuff in the open, delivery configuration, optionally wherein the at least one guide member is substantially U-shaped, V-shaped, C-shaped, J-shaped, L-shaped, or T-shaped.

4. The catheter system according to any preceding claim, wherein the cuff dilator comprises two or more spaced apart dilator arms arranged within and extending at least partially along the protective cuff to retain the protective cuff in the open, delivery configuration.

5. The catheter system according to any one of claims 2 to 4, wherein a distal region of the cuff dilator tapers towards a distal end of the cuff dilator, optionally wherein the distal region is U-shaped, V-shaped, curved, conical, semi-circular, hemispherical, or triangular.

6. The catheter system according to any preceding claim, wherein the protective cuff comprises one or more engaging portions configured to engage or capture an electrical lead.

7. The catheter system according to claim 6, wherein the one or more engaging portions comprise a shape memory material, for example Nitinol, wherein the shapememory material is shape set to move the cuff to the closed, deployed configuration as or after the protective cuff is deployed from the cuff dilator.

8. The catheter system according to claim 6 or claim 7, wherein the engaging portion is biased to move to the closed, deployed, configuration to close the opening upon deployment from the cuff dilator.

9. The catheter system according to any one of claims 6 to 8, wherein one or more of the engaging portions comprise a split ring configured to engage an electrical lead arranged within the protective cuff, when the protective cuff is in the closed, deployed, configuration, optionally wherein one or more of the split rings are configured to spiral into the closed, deployed configuration.

10. The catheter system according to any one of claims 6 to 9, wherein the one or more engaging portions comprise one or more ribs along a length of the protective cuff, optionally wherein one or more of the ribs are configured to curl into a coiled closed, deployed configuration.

11. The catheter system according to any preceding claim, wherein the protective cuff comprises a frame extending at least partially, for example entirely, over the protective cuff, and wherein the frame is configured to engage or capture an electrical lead.

12. The catheter system according to any preceding claim, wherein the protective cuff comprises an abrasion resistant material extending at least partially thereover, optionally wherein the abrasion resistant material extends at least partially over an inner surface of the protective cuff.

13. The catheter system according to any preceding claim, wherein the protective cuff is substantially tubular in the closed, deployed, configuration.

14. A protective cuff deployable from a catheter system and moveable from an open, delivery configuration to a closed, deployed configuration, the protective cuff comprising: an inner surface configured to contact an electrical lead when the protective cuff is in the closed, deployed configuration.

15. A method of deploying a protective cuff to an electrical lead comprising: obtaining a catheter assembly comprising an elongate catheter body having a distal portion; obtaining a protective cuff comprising an inner surface configured to contact an electrical lead; positioning the protective cuff within the catheter body in an open, delivery, configuration so as to define an opening along at least a portion of the protective cuff; at least partially deploying the protective cuff from the catheter assembly; positioning an electrical lead in the protective cuff via the opening; moving the protective cuff from the open, delivery configuration to a closed, deployed, configuration to close or narrow the opening; and engaging an electrical lead with the inner surface of the protective cuff.

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