Multi-device steerable catheter for multi-device implantation

Abstract

A system for implanting two or more implants into a heart of a patient may include a multi-device steerable guide catheter ("MDSGC"), a transcatheter edge-to-edge repair ("TEER") implant delivery device, and an additional implant delivery device for implanting an additional medical device. The additional medical device may be a collapsible and expandable prosthetic transcatheter aortic valve repair ("TAVR") device or a collapsible and expandable left atrial appendage ("LAA") occluder device. The MDSGC may have a first handle and may be steerable, the TEER delivery device may have a second handle, and the additional delivery device may have an additional handle. The system may include a fixation device to capture native heart valve leaflets therebetween as part of a TEER procedure. The TEER delivery device and the additional delivery device may each have a catheter sized and shaped to pass through an interior of a catheter of the MDSGC.

Description

ABTEVA-0076PCT 15897WOO1Multi-Device Steerable Catheter for Multi-Device ImplantationCross-Reference to Related Applications

[0001] This application claims priority to filing date of U.S. Provisional Patent Application No. 63 / 724,448, filed November 25, 2024, the disclosure of which is hereby incorporated by reference herein.Background of the Disclosure

[0002] The cardiac cycle is divided into two phases — diastole and systole. Diastole is generally characterized by the muscular relaxation of the heart and the filling of its chambers with blood. On the other hand, systole is generally characterized by the muscular contraction of the ventricles which pumps blood from the ventricles to the arteries. During ventricular systole, ventricular pressure increases relative to atrial pressure resulting in the closure of the mitral valve and the tricuspid valve, and the opening of the aortic and pulmonary valve. The mitral valve separates the left atrium from the left ventricle, and the tricuspid valve separates the right atrium from the right ventricle. The aortic valve separates the left ventricle from the aorta, and the pulmonary valve separates the right ventricle from the pulmonary artery. The mitral and tricuspid valves operate as check valves preventing blood from flowing back into the atria during ventricular contraction. The aortic and pulmonary valves operate as check valves preventing blood from flowing back into the ventricles during ventricular relaxation.

[0003] All of the heart valves may be susceptible to disease. For example, valvular insufficiency may appear in one or both of the mitral and tricuspid valves which may result in a regurgitative flow back into the atrium across the affected valve. Such regurgitative flow can be in the form of mitral valve regurgitation (“MVR”) and / or tricuspid valve regurgitation (“ VR”). Left untreated, MVR and TVR can lead to severe health consequences, such as progressive heart failure, cardiac arrythmias, pulmonary hypertension, stroke, and endocarditis, to name a few. Aortic stenosis (“AS”) is a condition in which the aortic valve narrows, making it difficult for blood to flow from the left ventricle to the aorta. Multivalvular disease is the presence of a combination of stenotic or regurgitant lesions on two or more valves in a patient’s heart. An estimated 10% of patients undergoing a valvular procedure may have multivalvular disease. AS affects approximately 2% of the population between 65 and 75 years and 6% of the population over 75 years old. Functional mitral regurgitation (“FMR”) is present in 20-80%ABTEVA-0076PCT 15897WOO1 of patients with AS. Currently, although there are options available for treating these disease states individually, there are few or no options available for treating the conditions concomitantly.

[0004] Treatment options for MVR may include replacement and / or repair of the mitral valve, which may include open-heart surgical options and catheter-based options. Catheterbased repair procedures are sometimes referred to as transcatheter edge-to-edge repair (“TEER”). Treatment options for AS may include replacement of the aortic valve, which may include open-heart surgical options or catheter-based options. Catheter-based options may include transcatheter aortic valve repair (“TAVR”).

[0005] Another structure in the heart is the left atrial appendage (“LAA”). The LAA is a normal anatomical structure in which there is a sac in the muscle wall of the left atrium. When a patient experiences atrial fibrillation (“AFib”), a blood clot may be formed within the LAA which may become dislodged and enter into the blood stream, which could result in a stroke. Treatment options for AFib include drug-based treatments such as blood thinners, or devicebased interventions to close off the LAA. For example, one device-based intervention is the transcatheter implantation of a self-expanding occluder that is implanted into the LAA to close off blood from between the left atrium and the LAA. The prevalence of MVR in patients with AFib is also high, with a large proportion of patients that are suitable candidates of LAA occlusion having MVR. Again, although there are options available for treating MVR and AFib individually, there are few or no options available for treating the conditions concomitantly.Brief Summary of the Disclosure

[0006] According to one aspect of the disclosure, a system may be for implanting two or more implants into a heart of a patient. The system may include a multi-device steerable guide catheter (“MDSGC”) including a first handle and a first catheter extending from the first handle, the MDSGC including a first steering actuator configured to deflect a distal end portion of the first catheter, the first catheter having a length sufficient to extend from a femoral vein access site of the patient to a left atrium of the patient. For example, the length may be at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, or at least 100 cm, although these lengths are merely exemplary. The system may also include a transcatheter edge-to-edge repair (“TEER”) implant delivery device including a second handle and a second catheter extending from the second handle. The system may further include a fixation device having proximalABTEVA-0076PCT 15897WOO1 elements and distal elements configured to capture free edges of native heart valve leaflets therebetween as part of a TEER procedure, the fixation device being configured to releasably couple to the second catheter, the second catheter being sized and shaped to pass through an interior of the first catheter while the fixation device is releasably coupled to the second catheter. In some examples, the first catheter may have an outer diameter of about 20 French, about 22 French, about 24 French, about 26 French, about 28 French, or about 30 French, although these outer diameters are merely exemplary. In some examples, the second catheter may have an outer diameter of about 8 French, about 10 French, about 12 French, about 14 French, about 16 French, or about 18 French, although these outer diameters are merely exemplary. The system may further include an additional implant delivery device including an additional handle and an additional catheter extending from the additional handle. The system may further include an additional medical device configured to be releasably coupled to the additional catheter, the additional catheter being sized and shaped to pass through the interior of the first catheter while the additional medical device is releasably coupled to the additional catheter. In some examples, the additional catheter may have sizing similar to the options provided above in connection with the second catheter. The additional medical device may be (i) a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device or (ii) a collapsible and expandable left atrial appendage (“LAA”) occluder device.

[0007] The system may include a stabilizer that includes a distal attachment site, the MDSGC including a first attachment assembly configured to reversibly couple the MDSGC to the stabilizer at the distal attachment site. The stabilizer may include a proximal attachment site positioned proximally to the distal attachment site, and the additional implant delivery device may include a second attachment assembly configured to reversibly couple the additional implant delivery device to the stabilizer at the proximal attachment site while the MDSGC is coupled to the stabilizer at the distal attachment site. The additional medical device may be the TAVR device, the additional implant delivery device may be a TAVR delivery device, and the additional catheter may include an inflatable balloon at a distal end portion thereof, and the TAVR device may be configured to be crimped over the inflatable balloon while the inflatable balloon is deflated to releasably couple the TAVR device to the distal end portion of the additional catheter. The additional medical device may be the LAA occluder device, the additional implant delivery device may be an LAA occluder delivery device, and the additional catheter may include an outer catheter and a delivery cable, the LAA occluderABTEVA-0076PCT 15897WOO1 device configured to be threadedly coupled to the delivery cable to releasably couple the LAA occluder device to the distal end portion of the additional catheter. The additional medical device may be the TAVR device, and the system may further include an LAA occluder delivery device including an LAA occluder delivery device handle and an LAA occluder delivery device catheter extending from the LAA occluder delivery device handle, and an LAA occluder device configured to be releasably coupled to the LAA occluder delivery device catheter, the LAA occluder delivery device catheter being sized and shaped to pass through the interior of the first catheter while the LAA occluder device is releasably coupled to the LAA occluder delivery device catheter. In some examples, the LAA occluder delivery device catheter may have an outer diameter of about 8 French, about 10 French, about 12 French, about 14 French, about 16 French, or about 18 French, although these outer diameters are merely exemplary. While the TAVR delivery device is coupled to the stabilizer at the proximal attachment site, the TAVR delivery device may be translatable a limited length into the first catheter without decoupling from the stabilizer. This limited length may correspond to a length over which the catheter has freedom of movement / translation relative to the stabilizer to which it is coupled. While the LAA occluder delivery device is coupled to the stabilizer at the proximal attachment site, the LAA occluder delivery device may be translatable a limited length into the first catheter without decoupling from the stabilizer. This limited length may correspond to a length over which the catheter has freedom of movement / translation relative to the stabilizer to which it is coupled. The first steering actuator may be configured to deflect the distal end portion of the first catheter so that the distal end portion of the first catheter is substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of a mitral valve of the patient. The first steering actuator may be configured to deflect the distal end portion of the first catheter so that the distal end portion of the first catheter is substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of an ostium leading to the LAA of the patient.

[0008] According to another aspect of the disclosure, a method of implanting two or more implants into a heart of a patient may include accessing an atrial septum of the patient via a femoral vein of the patient, creating an opening in the atrial septum leading from a right atrium of the patient to a left atrium of the patient, and advancing a first catheter of a multidevice steerable guide catheter (“MDSGC”) through the femoral vein, into the right atrium, through the opening in the atrial septum, and into the left atrium. While a distal end of the firstABTEVA-0076PCT 15897WOO1 catheter is positioned within the left atrium, the distal end of the first catheter may be deflected using a first steering actuator on a first handle of the MDSGC to be substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of a mitral valve of the patient. While the distal end of the first catheter is positioned within the left atrium, a transcatheter edge-to-edge repair (“TEER”) implant delivery device may be advanced through the first catheter while a fixation device is coupled to a second catheter of the TEER implant delivery device. After the fixation device exits the distal end of the first catheter, the fixation device may be deployed from the second catheter so that proximal elements and distal elements of the fixation device capture free edges of native heart valve leaflets of the mitral valve therebetween, thereby performing a TEER procedure. While the distal end of the first catheter is positioned within the left atrium, an additional implant delivery device may be advanced through the first catheter while an additional medical device is coupled to an additional catheter of the additional implant delivery device. After the additional implant delivery device exits the distal end of the first catheter, the additional medical device may be deployed from the additional catheter to implant the additional medical device into the heart of the patient, thereby performing an additional heart implant procedure. The additional medical device may be (i) a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device and the additional heart implant procedure may be a TAVR procedure, or (ii) the additional medical device may be a collapsible and expandable left atrial appendage (“LAA”) occluder device and the additional heart implant procedure may be an LAA occlusion procedure.

[0009] The additional heart implant procedure may be a TAVR procedure, and the TAVR procedure may be performed prior to the TEER procedure. The additional heart implant procedure may be an LAA occlusion procedure, and the LAA occlusion procedure may be performed prior to the TEER procedure. The additional heart implant procedure may be an LAA occlusion procedure, and the LAA occlusion procedure may be performed after the TEER procedure. The method may also include deflecting the distal end of the first catheter, using the first steering actuator on the first handle of the MDSGC, to be substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of an ostium of the LAA of the patient. Prior to performing the additional heart implant procedure, a first attachment assembly of the MDSGC may be coupled to a distal attachment site of a stabilizer. Advancing the additional implant delivery device through the first catheter may be performed after the first attachment assembly of the MDSGC is coupled to the distal attachment site of the stabilizer.ABTEVA-0076PCT 15897WOO1Prior to deploying the additional medical device from the additional catheter, a second attachment assembly of the additional implant delivery device may be coupled to a proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site. The method may also include translating the additional implant delivery device into the first catheter while the additional implant delivery device is coupled to the stabilizer at the proximal attachment site. The method may further include, prior to deploying the fixation device from the second catheter, coupling an attachment assembly of the TEER implant delivery device to the proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site.Brief Description of the Drawings

[0010] Fig. 1A is a cross-sectional representation of a heart illustrating its four valves.

[0011] Fig. IB is a cross-sectional representation of a heart illustrating the left ventricle and left atrium during systole.

[0012] Fig. 2A is a flowchart showing example steps of a concomitant TAVR and TEER procedure.

[0013] Fig. 2B is a flowchart showing example steps of a concomitant TEER and EAA occlusion procedure.

[0014] Fig. 2C is a flowchart showing example steps of a concomitant LAA occlusion and TEER procedure.

[0015] Fig. 3 shows a cross-section of a heart after a transseptal puncture has been made to gain access to the left atrium.

[0016] Fig. 4A is a partial perspective view of a multi-device steerable guide catheter (“MDSGC”) including an exemplary distal attachment assembly thereof.

[0017] Fig. 4B illustrates the distal attachment connected to an outer guide catheter handle of the MDSGC.

[0018] Fig. 4C is a partial cross-sectional view of the distal attachment assembly of Fig. 4B taken along a midline thereof.

[0019] Fig. 5 shows a cross-section of the heart after a distal end of the MDSGC has been positioned within the left atrium.

[0020] Fig. 6A is a perspective view of a stabilizer.ABTEVA-0076PCT 15897WOO1

[0021] Fig. 6B is a partial perspective view of a distal attachment of the stabilizer of Fig. 6A.

[0022] Fig. 6C is a partial perspective view of a proximal attachment of the stabilizer of Fig. 6A.

[0023] Figs. 7A and 7B illustrate the distal attachment assembly of Figs. 4B-4C being attached to the distal attachment Fig. 6A.

[0024] Fig. 7C is a perspective view of the MDSGC of Fig. 4A coupled to the stabilizer of Fig. 6A.

[0025] Fig. 8A is a perspective view of an example of a prosthetic heart valve.

[0026] Fig. 8B is a top view of the prosthetic heart valve of Fig. 8A mounted on an example of a portion of a delivery system.

[0027] Fig. 8C is an enlarged view of the handle of the delivery system shown in Fig. 8B.

[0028] Fig. 8D is an enlarged view of a distal end of the delivery system shown in Fig. 8B.

[0029] Fig. 9A is a perspective view of the handle of the valve delivery system of Fig. 8C attached to the stabilizer of Fig. 6A.

[0030] Fig. 9B shows a cross-section of the heart after a distal end of the valve delivery system shown in Fig. 8B has been advanced through the MDSGC positioned within the left atrium.

[0031] Fig. 10A is a side view of a TEER delivery device assembled to a TEER guide catheter.

[0032] Fig. 10B is a perspective view of a portion of the TEER delivery device of Fig. 10 A.

[0033] Fig. 10C is a side view of a distal end the TEER delivery device and TEER guide catheter of Fig. 10A relative to a distal end of an inner guide catheter of the MDSGC of Fig. 4A.

[0034] Fig. 10D is a perspective view of an example of a fixation device for use with the TEER delivery device of Figs. 10A-10C.

[0035] Fig. 11 A is a perspective view showing the TEER delivery device and the TEER guide catheter of Fig. 10A inserted into the MDSGC of Fig. 4A and coupled to the stabilizer of Fig. 6A.ABTEVA-0076PCT 15897WOO1

[0036] Figs. 11B-11C illustrate a proximal attachment assembly of the TEER guide catheter of Fig. 10A attached to a proximal attachment of the stabilizer of Fig. 6A.

[0037] Fig. 12A is a cross-section of the heart showing the fixation device of Fig. 10D positioned relative to leaflets of the mitral valve via the TEER delivery device extending through the MDSGC.

[0038] Figs. 12B-12C illustrate views of the leaflets of the mitral valve secured between proximal elements and distal elements of the fixation device of Fig. 10D.

[0039] Fig. 13 A is a side view of an LAA occluder in an expanded condition according to an example of the disclosure.

[0040] Fig. 13B is a side view of a LAA occluder delivery system according to an example of the disclosure.

[0041] Fig. 13C is an enlarged view of an example connection between the LAA occluder delivery system of Fig. 13B and the LAA occluder of Fig. 13A.

[0042] Fig. 14A is a cross-section of the heart showing a distal end of the MDSGC of Fig. 4A positioned adjacent the LAA, with a distal end of a LAA occluder delivery system positioned through and beyond the distal end of the MDSGC.

[0043] Fig. 14B is a cut-away view showing the LAA occluder of Fig. 13A being deployed from the LAA occluder delivery system of Figs. 13B-13C into the LAA via the MDSGC.

[0044] Fig. 15A is a diagram of a system according to an aspect of the disclosure, the system including a MDSGC, a TEER implant delivery device, a fixation device, an additional implant delivery device, and an additional medical device.

[0045] Fig. 15B shows a representative example of a stabilizer as an optional component of the system of Fig. 15 A.

[0046] Fig. 15C shows additional optional details of the stabilizer shown in Fig. 15B.

[0047] Fig. 1 D is a diagram of the system shown in Fig. 15 A in which the additional implant delivery device is a TAVR delivery device and the additional medical device is a TAVR device.

[0048] Fig. 15E is a diagram of the system shown in Fig. 15A in which the additional implant delivery device is an LAA occluder delivery device and the additional medical device is an LAA occluder device.ABTEVA-0076PCT 15897WOO1

[0049] Fig. 15F is a diagram of the system shown in Fig. 15A in which the additional medical device is a TAVR device, and the system also includes an LAA occluder delivery device and an LAA occluder device.

[0050] Fig. 15G is a diagram of the system shown in Fig. 15D, with the TAVR delivery device coupled to the stabilizer shown in Fig. 15C.

[0051] Fig. 15H is a diagram of the system shown in Fig. 15E, with the LAA occluder delivery device coupled to the stabilizer shown in Fig. 15C.

[0052] Fig. 151 is a diagram of a distal end portion of a first catheter of the MDSGC shown in Fig. 15A deflected to be substantially coaxial with a central longitudinal axis of a mitral valve of a patient.

[0053] Fig. 15J is a diagram of a distal end portion of a first catheter of the MDSGC shown in Fig. 15A deflected to be substantially coaxial with a central longitudinal axis of an ostium leading into a LAA of a patient.Detailed Description

[0054] The valves of a heart H are illustrated in Figs. 1 A and IB. These valves include the mitral valve MV, the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV. The mitral valve MV separates the left atrium LA and the left ventricle LV, the tricuspid valve TV separates the right atrium RA and the right ventricle RV, and the aortic valve AV separates the left ventricle LV and the aorta A. The mitral valve MV and the tricuspid valve TV are sometimes referred to as the atrioventricular valves. The mitral valve MV is a bicuspid valve in that it has two leaflets referred to as the posterior leaflet PL and the anterior leaflet AL. The tricuspid valve TV typically has three leaflets referred to as the anterior leaflet AL, the posterior leaflet PL, and the septal leaflet SL. However, studies have shown that, although the TV is typically composed of three leaflets of unequal size, in many cases, two or more than three leaflets may be present as anatomic variants in healthy subjects. Thus, reference herein to the tricuspid valve TV should be understood to refer to the atrioventricular valve located between the right atrium RA and right ventricle RV regardless of the number of leaflets be it two, three, or more than three leaflets. However, exemplary embodiments discussed herein refer to the usual anatomic structure of the tricuspid valve TV that includes three leaflets.

[0055] As illustrated in Fig. IB, the anterior leaflet AL and posterior leaflet PL of the mitral valve MV extend from a valve annulus AN to respective free edges FE. The free edgesABTEVA-0076PCT 15897WOO1FE are secured to the lower portions of the left ventricle LV through chordae tendineae CT (referred to hereinafter as the chordae). The chordae CT include a plurality of branching tendons that are attached to papillary muscles PM at the lower portions of the left ventricle LV and extend upwardly to the lower surfaces of each of the valve leaflets where they are attached. The three leaflets of the tricuspid valve TV similarly extend from a valve annulus AN to respective free edges FE which are secured via chordae to the papillary muscles of the right ventricle RV.

[0056] Fig. IB also illustrates a representative example of the LAA extending from the left atrium LA. It should be understood that the LAA shown in Fig. IB is merely representative of a general shape and position of the LAA. LAAs may have highly varied shapes from patient to patient, although the general position of the LAA (including the ostium leading to the LAA) is typically near where the left pulmonary veins open into the left atrium LA.

[0057] TEER procedures are often performed by obtaining access to the femoral vein, and advancing a fixation device into the right atrium RA via the inferior vena cava IVC, and then crossing the atrial septum S to gain access to the left atrium LA and the mitral valve MV.

[0058] TAVR procedures are often performed by obtaining access to the femoral artery, and advancing a prosthetic heart valve in a retrograde direction to and around the aortic arch until the prosthetic heart valve is positioned within or adjacent to the aortic valve AV, at which time the prosthetic heart valve may be deployed into the aortic valve AV. Because TEER procedures and TAVR procedures are typically performed using entirely different vascular access routes to the mitral valve MV and aortic valve AV, respectively, these two treatments are typically not performed in a single procedural session, even for patients who are appropriate candidates to receive both treatments. Even if these two treatments were performed in a single procedural session, currently available systems do not provide any meaningful efficiencies because different delivery device systems are used in different vascular access routes.

[0059] LAA occlusion procedures are often performed by obtaining access to the femoral vein, and advancing an occlusion device into the right atrium RA via the inferior vena cava IVC, and then crossing the atrial septum S to gain access to the left atrium LA and the LAA. In other words, TEER procedures and LAA occlusion procedures typically use the same venous access route. Although efficiencies may be gained by using a single guide catheter to perform concomitant LAA occlusion and TEER procedures, such devices and methods do not currently exist.ABTEVA-0076PCT 15897WOO1

[0060] One or more examples of a multi-device steerable guide catheter (“MDSGC”) 1000 are described below that allow for a single guide catheter that can be used to perform at least two concomitant procedures, including TEER, TAVR, and LAA occlusion. Specific examples of possible sequences of using the MDSGC 1000 for multiple procedures are shown in Figs. 2A-2C, although it should be understood that other combinations TEER, TAVR, and LAA occlusion may be performed, and such combinations may be performed in orders other than those shown in Figs. 2A-2C once the MDSGC 1000 has accessed the left atrium LA. Before going into detail regarding individual procedural steps and related devices for use in those procedural steps, three exemplary methods of treatment are generally described below.

[0061] Fig. 2A, for example, shows a method 10A in which, in step 100, access is gained to the left atrium LA via a venous access route to the inferior vena cava IVC, and via a transseptal puncture through from the right atrium RA, through the atrial septum S, and into the left atrium LA. In method 10A, after access is gained to the left atrium, the MDSGC 1000 is positioned within the left atrium LA in step 200 using the same access route of step 100. Once the MDSGC 1000 has gained access to the left atrium LA, a TAVR procedure may be first performed in step 300A, followed by a TEER procedure in step 400A. As is described in greater detail below, when performing TAVR and TEER procedures concomitantly via a transseptal route, it is generally preferable to perform the TAVR procedure prior to the TEER procedure since the TEER procedure may limit the space available for devices to pass through the mitral valve MV. However, despite this preference, in other examples of performing TAVR and TEER procedures concomitantly, the TEER procedure may be performed prior to the TAVR procedure. And although method 10A is shown as a combined TAVR and TEER procedure, a third LAA occlusion procedure (as described in greater detail) could also be performed using the MDSGC, without any restriction to the order of the LAA occlusion procedure relative to the TAVR and TEER procedures. In other words, the procedures may be carried out in the order TAVR procedure, TEER procedure, then LAA occlusion procedure. The procedures may be carried out in the order TAVR procedure, LAA occlusion procedure, then TEER procedure. The procedures may be carried out in the order TEER procedure, TAVR procedure, then LAA occlusion procedure. The procedures may be carried out in the order TEER procedure, LAA occlusion procedure, then TAVR procedure. The procedures may be carried out in the order LAA occlusion procedure, TEER procedure, then TAVR procedure.ABTEVA-0076PCT 15897WOO1The procedures may be carried out in the order LAA occlusion procedure, TAVR procedure, then TEER procedure.

[0062] Fig. 2B shows an example method 10B that includes the same two steps 100, 200 for positioning the MDSGC 1000 into the left atrium EA. However, after the MDSGC 1000 is positioned within the left atrium LA, a TEER procedure may be performed using the MDSGC 1000 in step 400B followed by an LAA occlusion procedure using the MDSGC 1000 in step 500B. Fig. 2C shows another example of a method 10C that is the same as 10B, except that the step of performing the LAA occlusion procedure using the MDSGC 1000 (in step 500C) is performed first and then, in step 400C, the TEER procedure is performed using the MDSGC 1000. It should be understood that a TAVR procedure, using the MDSGC 1000, may be added to either method 10B or method 10C and may be performed in any order relative to the TEER procedure and the LAA occlusion procedure, although as noted above it may be preferable to perform any TAVR procedure through the MDSGC 1000 prior to performing a TEER procedure through the MDSGC 1000.

[0063] Fig. 3 shows an example of a stage of step 100 in which access to the left atrium LA is gained via transseptal puncture. In particular, Fig. 3 shows an example of an access catheter AC having been routed through the femoral vein, into the right atrium RA via the inferior vena cava IVC, toward the atrial septum S, and a needle N having been advanced from the access catheter AC so that it penetrates through the atrial septum S at the fossa ovalis FO into the left atrium LA. At this point, a guidewire may be exchanged for the needle N with the guidewire remaining for guiding later access to the left atrium LA. It should be understood that the crossing or piercing step may be performed with objects other than a needle, including for example via the use of radiofrequency (“RF”) energy, laser(s), or ultrasound energy.

[0064] In each of methods 10A, 10B, and 10C, after gaining access to the left atrium LA via a transseptal puncture, the MDSGC 1000 is advanced to the left atrium LA in preparation for one or more of TAVR, TEER, and / or LAA occlusion. Figs. 4A-4C illustrates one example of MDSGC 1000 and exemplary components thereof. MDSGC 1000 may generally include one or more of an outer guide catheter handle 1100 and an outer guide catheter 1300 extending distally therefrom.

[0065] Outer guide catheter 1300 may have a proximal end 1301, a distal end 1302, and a central lumen extending therethrough. Distal end 1302 of catheter 1300 may be sized to be passable to a body cavity, typically through a body lumen such as a vascular lumen,ABTEVA-0076PCT 15897WOO1 including the femoral vein. Outer guide catheter 1300 may be pre-curved and / or have steering mechanisms to position distal end 1302 in desired directions. Outer guide catheter 1300 may have a length sufficient to allow it to extend from a femoral vein access site (e.g. at or near a groin of the patient) into the left atrium LA of the patient. For example, the length may be at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, or at least 100 cm, although these lengths are merely exemplary. However, it should be understood that the length may also be such that the outer guide catheter 1300 may extend into the left ventricle LV of the patient.

[0066] Steering of outer guide catheter 1300 may be achieved by actuation of one or more steering mechanisms. Actuation of the steering mechanisms may be achieved with the use of one or more actuators which may be located on outer guide catheter handles 1100. Outer guide catheter handle 1100 may be connected to proximal end 1301 of outer guide catheter 1300 and may remain outside of a patient's body during use. Outer guide catheter handle 1100 may include one or more steering actuators or steering knobs 1102 which may be used to bend, arc, or reshape outer guide catheter 1300, such as to form a primary curve. The steering mechanisms may generally rely on one or more steering wires that extend from the steering knob 1102, through the wall of outer guide catheter 1300, and to one or more steering rings at or near the distal end 1 02 of the outer guide catheter 1 00. In these examples, actuating the steering knob 1102 in a particular direction will tension one or more steering wires to cause deflection in a first direction, while actuating the steering knob 1102 in the opposite direction may cause deflection in a second direction opposite (or generally opposite) the first direction. Examples of steering mechanisms are provided in U.S. Patent No. 7,226,467 and in U.S. Pub. No. 2023 / 0131595, the disclosures of which are hereby incorporated by reference herein.

[0067] Figs. 4B and 4C depict one example of a distal attachment assembly 1200. Distal attachment assembly 1200 can be positioned distal of outer guide catheter handle 1100. Distal attachment assembly 1200 may also have a snap-fit mechanism or the like. Distal attachment 1200 may generally include one, or any two, or more of a bushing 1210, a housing 1220, and a connection mechanism for connecting to a stabilizer 2000, described in greater detail below.

[0068] Bushing or shaft 1210 may define an opening 1212, which may optionally be a central opening 1212, through which outer guide catheter 1300 may extend, as shown in the example of Fig. 4B. Bushing 1210 may extend into outer guide catheter handle 1100. Bushing 1210 may be connected to a distal end of outer guide catheter handle 1100. The connectionABTEVA-0076PCT 15897WOO1 may be via a collar 1112. The collar 1112 may have a set screw that rotationally and translationally secures bushing 1210.

[0069] Housing or support body 1220 may, in one example, surround the portion of bushing 1210 extending from outer guide catheter handle 1 100. Housing 1220 may include a lower housing portion 1220a and an upper housing portion 1220b. As shown in the example of Fig. 4B, one or more O-rings 1240 may be positioned between bushing 1210 and housing 1220. For example, distal attachment 1200 may have four O-rings 1240 with two O-rings 1240 located at a proximal location and two O-rings 1240 located at a distal position. This distribution of O-rings 1240 helps to ensure even distribution of load / compression. However, other configurations are contemplated, such as two or more O-rings 1240 distributed at even intervals along a length of bushing 1210. To help contain O-rings 1240, lower housing portion 1220a and bushing 1210 may have corresponding lips 1215, 1225. The lips 1215, 1225 may prevent proximal-distal travel of O-rings 1240. O-rings 1240 may be made from a material that enhances friction, such as silicone, for example. This arrangement helps provide rotational friction between housing 1220 and bushing 1210. The arrangement may prevent unintentional rotation of outer catheter 1300 (and a secondary or tertiary catheter extending through outer catheter 1 00) while utilizing outer guide catheter handle 1 100 (and while using a handle of the second catheter). In other words, O-rings 1240 help to provide constant, or ongoing, friction to prevent unintentional rotation outer catheters 1300 and any secondary or tertiary catheter being used with outer catheter 1300. This O-ring configuration may also help coaxially correct outer guide catheters 1300 and a secondary or tertiary guide catheter extending through outer guide catheter 1300 to help keep them coaxially aligned. Furthermore, O-rings 1240 may help protect outer catheter 1300 by removing direct contact of catheter 1300 with overlying components. This arrangement may promote handle torque transmission directly to O-rings 1240 rather than directly from handle 1100 to outer catheter 1300 in order to brake the system.

[0070] Lower housing portion 1220a may include a connection mechanism for connecting distal attachment 1200 to stabilizer 2000, for example. In the depicted embodiment, the connection mechanism may include a dynamic pin or first engagement member 1226a and a static pin or second engagement member 1226b, for example. Static pin 1226b may extend through a first opening 1224 in lower housing 1220a, while dynamic pin 1226a may extend through a second opening 1222 in lower housing 1220a, as best shown in the example of Fig. 4C. In one example, second opening 1222 may be an elongate opening or elongate slot allowingABTEVA-0076PCT 15897WOO1 pin 1226a to dynamically move in a proximal-distal direction. Lower housing 1220a may include a chamber 1228 with a spring or other biasing element 1250 disposed therein, for example. Spring 1250 may bias dynamic pin 1226a in a first position or proximal position. When the spring bias is overcome, dynamic pin 1226a may move to a second position which is closer to static pin 1226b than the first position. Thus, pins 1226a, 1226b have a first configuration when pin 1226a is in the first position and a second configuration when pin 1226a is in the second position.

[0071] Fig. 5 shows a cross-section of the heart H after the distal end 1302 of the outer guide catheter 1300 of MDSGC 1000 has been positioned within the left atrium LA. The illustration of Fig. 5 may be generally representative of step 200 in methods 10A, 10B, and 10C, although the exact positioning and curvature of the distal end 1302 of the outer guide catheter 1300 may be different depending on which treatment procedure is being performed first. In order to position the distal end 1302 of the outer guide catheter 1300 in the left atrium LA, it may be advanced through the femoral vein over a guidewire which was placed as part of step 100, and advanced over the guidewire and through the atrial septum S until it reaches the left atrium LA. If a TEER procedure or TAVR procedure is being performed first (e.g. as in methods 10A and 10B), the steering knob 1 102 may be actuated or rotated to deflect the distal end 1302 into alignment with the mitral valve MV, for example by being substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of the mitral valve MV. However, in other embodiments, as described in greater detail below, the distal end 1302 of the outer guide catheter 1300 may instead be advanced into or adjacent the ostium of the LAA first, with or without deflection, so that the distal end 1302 of the outer guide catheter 1300 is substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) the central longitudinal axis of the ostium of the LAA. After the distal end 1302 of the outer guide catheter 1300 of the MDSGC 1000 has crossed into the left atrium LA, either before or after performing any steering or deflection, any remaining guidewires and / or dilators may be removed from the outer guide catheter 1300 and from the patient, leaving the MDSGC 1000 as the primary guide catheter for using a secondary or tertiary delivery device, such as a TAVR, TEER, or LAA occlusion delivery device. It should be understood that although one particular curvature or deflection of the distal end 1302 of the outer guide catheter 1300 is shown in Fig. 5, other types and configurations of steering and / or curvature may be suitable. For example, the curvature of the distal portion (e.g. the distal end 1302) may be fixed, including in anABTEVA-0076PCT 15897WOO1 anterior / posterior and / or medial / lateral direction. In some examples, the curvature may be achieved by either one, two, or more steering actuators, including for example a first steering actuator (e.g. steering knob) that controls anterior / posterior deflection and / or a second steering actuator (e.g. steering knob) that controls medial / lateral deflection. In some examples, the outer guide catheter 1300 may alternatively or additionally have a proximal articulation section that enables the distal end 1302 to extend more deeply to gain access to aortic valve AV through mitral valve MV annulus e.g. similar to the configuration of steering catheter 3135 shown and described in connection with Fig. 9B).

[0072] After the distal end 1302 of the outer guide catheter 1300 of the MDSGC 1000 has crossed into the left atrium LA, the MDSGC 1000 may be coupled to a stabilizer 2000 to stabilize the MDSGC 1000 while a secondary device is used with MDSGC 1000. However, it should be understood that the use of the stabilizer 2000 is optional.

[0073] Figs. 6A-6C depict stabilizer 2000 according to an embodiment of the present disclosure. Stabilizer 2000 may generally include one, any two, or more of a base 2010, one or more support arms 2020, a distal attachment 2030, and a proximal attachment 2040.

[0074] Base or platform 2010 may be a plate with a flat bottom for placement on a flat surface of a table or the like. Base 2010 may define a longitudinal axis A3. Base 2010 may include one or more handles 2012 for manipulating stabilizer 2000. For example, as shown in Fig. 6A, base 2010 may include one or more of handles 2012 at proximal and distal ends of base 2010.

[0075] Support arm 2020 may extend upwardly from base 2010. Support arm 2020 may support both distal attachment 2030 and proximal attachment 2040, as shown in the example of Fig. 6A. However, in other embodiments, separate support arms 2020 may extend from base 2010 that may separately support distal and proximal attachments 2030, 2040.

[0076] Proximal attachment or first attachment 2040 may include one, any two, or more of a first rail or first member 2042a, a second rail or second member 2042b, a first end wall 2044a, and a second end wall 2044b. First and second rails 2042a, 2042b may extend parallel (+ / - 5 degrees) to each other between first and second end walls 2044a, 2044b. First and second rails 2042a, 2042b may each have a planar upper surface 2043 and planar lower surface (not shown) according to one example of the disclosure. End walls 2044a, 2044b and rails 2042a, 2042b may define an elongate slot 2046 that may be rectangular in shape, as shown in the example of Fig. 6C. However, elongate slot 2046 may also have other shapes, such as oval orABTEVA-0076PCT 15897WOO1 pill-shaped, for example. Elongate slot 4046 may have a width slightly wider than a width of fingers (e.g. fingers 4234a, 4234b) of a proximal attachment (e.g. attachment assembly 4200) of a secondary or tertiary catheter, described in greater detail below. Additionally, elongate slot 2046 may have a length 1.2 which may be defined from first end wall 2044a to second end wall 2044b. As explained in more detail below, this length L2 may correspond to a distance that a secondary or tertiary catheter may translate relative to outer guide catheter 1300. In this regard, first and second end walls 2044a, 2044b form stop surfaces for a proximal attachment assembly and correspondingly a translational limit for a handle of a secondary or tertiary catheter handle. Proximal attachment 2040 may also include proximal and distal tabs 2048a, 2048b extending downward therefrom, for example. Such tabs 2048a, 2048b may be used as leverage points for manual manipulation and translation of a secondary or tertiary catheter handle when a proximal attachment assembly of the secondary or tertiary catheter is connected to proximal attachment 2040. In one example, proximal attachment 2040 extends along a longitudinal axis A4 which may form an acute angle relative to axis A3 of base 2010.

[0077] Distal attachment or second attachment 2030 may include a pair of attachment members 2032 and a recess 2031 extending therebetween. As shown in the example of Fig. 6B, each attachment member 2032 may include a first hook or first capture member 2034a and a second hook or second capture member 2034b. First capture member 2034a extends in a distal direction while second capture member 2034b extends in a proximal direction such that each capture member 2034a, 2034b defines a corresponding recess 2035a, 2035b for receipt of dynamic pin 1226a and static pin 1226b, respectively. Additionally, first capture member 2034a may include a cam surface 2038 that slopes in a proximal to distal direction. Such cam surface 2038 may be configured to deflect dynamic pin 1226a of distal attachment assembly 1200 from its first position to its second position thereby allowing dynamic pin 1226a to pass by first hook 2034a and into its corresponding recess 2035a where it returns to the first position or somewhere between the first and second positions. Each attachment member 2032 may also include an intermediate projection 2036 that defines sloped surface 2037 that is sloped toward second hook 2034b in various examples. This sloped surface 2037 may direct static pin 1226b of distal attachment assembly 1200 into recess 2035b. Attachment members 2032 may be laterally offset from each other and may extend parallel relative to each other (+ / - 5 degrees) so as to define recess 2031 which may be configured to receive lower housing portion 1220a of distal attachment assembly 1200 according to various examples of the disclosure.ABTEVA-0076PCT 15897WOO1

[0078] Stabilizer 2000 may be made from a single sheet of metal material such that at least the base 2010, support arm 2020, and proximal attachment 2040 are stamped from the single sheet of metal material and bent into their depicted configuration according to one example of the disclosure. Distal attachment 2030 may be separately manufactured and connected to support arm 2020, such as by welding, for example. However, in other embodiments distal attachment 2030 may also be stamped out of the single sheet of metal material. The depicted configuration of stabilizer 2000 may reduce welding points, which may be potential points of failure, and may reduce cleaning and sterilization risks.

[0079] Figs. 7A and 7B illustrate one example of the connection between distal attachment 2030 of stabilizer 2000 and distal attachment assembly 1200 of MDSGC 1000. In this regard, distal attachment assembly 1200 may be attached to distal attachment 2030 first before the proximal attachment assembly of the secondary or tertiary delivery catheter is coupled to the proximal attachment 2040. This may be achieved by sliding static pin 1226b along sloped surface 2037 of intermediate projection 2036 and in the distal direction until pin 1226b is fully received within recess 2035b and captured by first hook 2034b, as illustrated in the example of Fig. 7A. At this point, distal attachment assembly 1200 may be rotated about first pin 1226b in a downward direction until dynamic pin 1226a contacts cam surface 2038. Further downward rotation causes cam surface 2038 to urge dynamic pin 1226a from its first position to its second position which clears first hook 2034a allowing dynamic pin 1226a to be received within recess 2035a. Once dynamic pin 1226a is received within recess 2035a, it returns to the first position or somewhere between the first and second positions thereby locking distal attachment assembly 1200 to distal attachment 2030 of stabilizer 2000, as illustrated in the example of Fig. 7B. Fig. 7C illustrates an example of the MDSGC 1000 having been coupled to the stabilizer 2000.

[0080] It should be understood that the initial access to the left atrium LA via transseptal puncture (an example of which is shown in Fig. 3), the following advancement of the MDSGC 1000 into the left atrium LA (an example of which is shown in Fig. 5), and the optional coupling of the MDSGC 1000 to the stabilizer 2000 in preparation of further procedural steps (an example of which is shown in Fig. 7C), may be generally applicable to any of the methods described herein. It is this initial step that may help allow for two or more procedures to be performed on the patient’s heart H through the MDSGC 1000, which may eliminate the requirement of a dedicated delivery system for each individual procedure.ABTEVA-0076PCT 15897WOO1

[0081] Referring back to Fig. 2A, once the MDSGC 1000 is in the left atrium LA, in some examples a TAVR procedure may be performed through the MDSGC 1000 to replace the native aortic valve AV with a prosthetic aortic valve, such as prosthetic heart valve 3000 shown in Fig. 8A. Prosthetic heart valve 3010 may be a balloon-expandable prosthetic aortic valve, although in other examples it may be a self-expandable or mechanically-expandable prosthetic heart valve, intended for replacing a native aortic valve AV or another native heart valve. Prosthetic heart valve 3010 is shown in an expanded condition in Fig. 8A. Prosthetic heart valve 3010 may extend between an inflow end 3012 and an outflow end 3014. Prosthetic heart valve 3010 may include a collapsible and expandable frame 3020, an inner cuff or skirt 3060, an outer cuff or skirt 3080, and a plurality of prosthetic leaflets 3090. The prosthetic heart valve 3010 may include three prosthetic leaflets 3090 coupled to the inner skirt 3060 and frame 3020 to form a valve element that allows blood to flow from the inflow end 3012 toward the outflow end 3014, with the prosthetic leaflets 3090 being able to coapt with each other to prevent blood from flowing from the outflow end 3014 to the inflow end 3012. The inner skirt 3060 may help prevent blood from flowing around the outside of the prosthetic leaflets 3090 through the openings in the frame 3020. The outer skirt 3080 may function to contact the native anatomy to help prevent paravalvular leakage.

[0082] Fig. 8B illustrates one example of a valve delivery system 3100, with the prosthetic heart valve 3010 crimped over a balloon on a distal end of the delivery system 3100. Although delivery system 3100 and various components thereof are described below, it should be understood that delivery system 3100 is merely one example of a prosthetic heart valve delivery catheter that may be appropriate for use in delivering and deploying a prosthetic heart valve. As should become clear from the description below, the valve delivery system 3100 may be a secondary catheter configured for use with the MDSGC 1000,

[0083] In some examples, delivery system 3100 includes a handle 3110 and a delivery catheter 3130 extending distally from the handle 3110. The delivery system 3100 may exclude a dedicated introducer since the MDSGC 1000 may function as an introducer, and may also exclude a guidewire due to the guiding provided by the MDSGC 1000.

[0084] In some examples, the delivery catheter 3130 is steerable. For example, one or more steering wires may extend through a wall of the delivery catheter 3130, with one end of the steering wire coupled to a steering ring coupled to the delivery catheter 3130, and another end of the steering wire operable coupled to a steering actuator on the handle 3110. In suchABTEVA-0076PCT 15897WOO1 examples, as the steering actuator is actuated, the steering wire is tensioned or relaxed to cause deflection or straightening of the delivery catheter 3130 to assist with steering the delivery catheter 3130 to the desired position within the patient. For example, Fig. 8C is an enlarged view of the handle 31 10. Handle 3110 may include a steering knob 31 12 that, upon rotation, tensions or relaxes the steering wires to deflect the distal end of the delivery catheter 3130. However, it should be understood that the steering functionality may be omitted in some examples, and in other examples steering actuators other than knobs may be utilized. Further, in some examples, the delivery catheter 3130 includes an outer catheter 3132, and an inner catheter 3134. A separate steering catheter 3135 may be provided. For example, as shown in Fig. 8B, the steering catheter 3135 may be positioned outside of the outer catheter 3132 and may terminate just proximal to the balloon. With this configuration, deflection of the steering catheter 3135 will also cause deflection of the outer catheter 3132 and the inner catheter 3134 which are both nested within the steering catheter 3135. In some examples, the handle may include a window 3118 that allows viewing of an indicator that corresponds to the amount of catheter deflection. For example, a carrier to which the indicator is attached may be attached to the steering wire. In some examples, when there is minimum (or zero) tension on the steering wire, the indicator is at the far distal position within window 31 18, but as deflection is actuated, for example by drawing a carrier proximally (and tensioning the steering wire as the carrier draws proximally), the indicator will move proximally along window 3118, giving the user a readily-apparent indication of the amount of deflection applied to the catheter at any given moment.

[0085] Still referring to Figs. 8B-8C, the valve delivery system 3100 may include additional functionality to assist with positioning the prosthetic heart valve 3010. For example, in the illustrated example, handle 3110 includes a commissure alignment actuator 3114. The commissure alignment actuator 3114 may be positioned near a proximal end of the handle or at any other desired location. In the illustrated example, the commissure alignment actuator 3114 is in the form of a rotatable knob, although other forms may be suitable. The commissure alignment knob 3114 may be rotationally coupled to a portion of the delivery catheter 3130 supporting the prosthetic heart valve 3010. For example, the commissure alignment actuator 3114 may be rotationally coupled to an inner catheter 134 which supports the prosthetic heart valve 3010 in the crimped condition. With this configuration, rotating the commissure alignment knob 3114 may cause the inner catheter 3134 to rotate about its longitudinal axis,ABTEVA-0076PCT 15897WOO1 and thus cause the prosthetic heart valve 3010 to rotate about its longitudinal axis. If a commissure alignment actuator 3114 is included, it may be used to help ensure that, upon deployment of the prosthetic heart valve 3010 into the native valve annulus, the commissures of the prosthetic heart valve are in rotational alignment with respective ones of the native valve commissures (e.g. within + / - 2.5 degrees of rotational alignment, within + / - 5 degrees of rotational alignment, within + / - 10 degrees of rotational alignment, within + / - 15 degrees of rotational alignment, etc.). Although commissure alignment actuator 3114 is shown in this example as a knob positioned at or near a proximal end of the handle 3110, it should be understood that the actuator 3114 may take forms other than a knob, may be positioned at other suitable locations, and may be omitted entirely if desired.

[0086] Still referring to Figs. 8B-8C, the delivery system 3100 may include even further functionality to assist with positioning the prosthetic heart valve 301 . For example, in the illustrated example, handle 3110 includes an axial alignment actuator 3116. The axial alignment actuator 3116 may be positioned near a proximal end of the handle, including distal to the commissure alignment actuator 3114, or at any other desired location. In the illustrated example, the axial alignment actuator 3116 is in the form of a rotatable knob, although other forms may be suitable. The axial alignment knob 3116 may be operably coupled to a portion of the delivery catheter 3130 supporting the prosthetic heart valve 3010. For example, the axial alignment actuator 3116 may include internal threads that engage external threads (or another component, such as individual extensions, which may be cylindrical extensions that fit between internal threads of the actuator) of a carriage. The carriage may be coupled to an inner catheter 3134 which supports the prosthetic heart valve 3010 in the crimped condition. In such an example, the carriage may be rotatably fixed to the handle 3110. With this configuration, rotating the axial alignment knob 3116 may cause the carriage to advance distally or retract proximally as the inner threads of the axial alignment knob 3116 mesh with the external threads of the carriage, but the carriage is prevented from rotating. As the carriage advances distally or retracts proximally, the inner catheter 3134 may correspondingly advance distally or retract proximally, and thus cause the prosthetic heart valve 3010 to advanced distally or retract proximally. It should be understood that, if axial alignment actuator 3116 is included, it may have a small total range of motion, including for example between about 2mm and about 15mm of range of motion, including about 7.5mm range of motion. In other words, the rough or coarse axial alignment between the prosthetic heart valve 3010 and native valve annulus may beABTEVA-0076PCT 15897WOO1 achieved by physically advancing the entire delivery catheter 3130 by pushing it through the vasculature while holding the handle 3110. However, for fine and more controlled adjustment of the axial position of the prosthetic heart valve 3010 relative to the native valve annulus, which may be performed just prior to or during deployment of the prosthetic heart valve 3010, the axial alignment knob 3116 may be used. If an axial alignment actuator 3116 is included, it may be used to help ensure that, upon deployment of the prosthetic heart valve 3010 into the native valve annulus, the inflow end of the of the prosthetic heart valve is in axial alignment with the inflow aspect of the native valve annulus (e.g. within + / - 0.5mm of axial alignment, within + / - 1.0mm of axial alignment, within + / - 1.5mm of axial alignment, within + / - 2.0 mm of axial alignment, etc.). Although axial alignment actuator 3116 is shown in this example as a knob positioned at or near a proximal end of the handle 3110, it should be understood that the actuator 3116 may take forms other than a knob, may be positioned at other suitable locations, and may be omitted entirely if desired.

[0087] In addition to steering and positioning actuators, delivery system 3100 may include a balloon actuator 3120. In the illustrated example, balloon actuator 3120 is positioned on the handle 3110 near a distal end thereof, and is provided in the form of a switch. Balloon actuator 3120 may be actuated to cause inflation or deflation of a balloon 3136 that is part of the delivery system 3100. For example, the delivery system 3100 may include a balloon that overlies a distal end of inner catheter 3134 and which receives the prosthetic heart valve 3010 in a crimped condition thereon. In the example illustrated in Fig. 8D, the balloon includes a proximal pillowed portion 3136a, a distal pillowed portion 3136b, and a central portion over which the prosthetic heart valve 3010 is crimped. The proximal pillow 3136a and the distal pillow 3136b may form shoulders on each side of the prosthetic heart valve 3010, which may help ensure the prosthetic heart valve 10 does not move axially relative to the balloon and / or inner catheter 3134 during delivery. Also illustrated in Fig. 8D is a tapered distal tip 3138 which may help the delivery system 3100 to smoothly advance through the MDSGC 1000.

[0088] In order to deploy the prosthetic heart valve 3010, the balloon 3136 is inflated, for example by actuating the balloon actuator 3120 to force fluid (such as saline, although other fluids, including liquids or gases, could be used) into the balloon 3136 to cause it to expand, causing the prosthetic heart valve 3010 to expand in the process. For example, the balloon actuator 3120 may be pressed forward or distally to cause fluid to travel through an inflation lumen within delivery catheter 3130 to inflate the balloon. In some embodiments, the balloonABTEVA-0076PCT 15897WOO1 actuator 3120 may take the form of a "momentary switch" in which pushing the balloon actuator 3120 forward engages inflation, pulling the balloon actuator 3120 proximally engages deflation, and releasing the balloon actuator 3120 pauses inflation. This particular example of functionality may allow the physician to precisely control the amount of fluid dispensed while reducing the occurrence of over- or under-inflation, for example because the system automatically pauses inflation when the switch is released. The physical form factor of the balloon actuator 3120 may be any suitable desired form factor, including for example a rocker switch, a push button, etc. In some embodiments a second balloon actuator or button may be provided, either on the balloon actuator 3120 or elsewhere on the handle 3110, with the second balloon actuator allowing for a change (e.g. increase or decrease) in the rate of inflation, for example to a pre-programmed faster or slower rate of inflation.

[0089] Referring briefly to Fig. 8C, an inflation lumen 3184 may extend from the handle 3110 and couple to an inflation media reservoir, which may be part of a motorized system that, upon actuation of balloon actuator 3120, causes the inflation media reservoir to advance fluid through the handle 3110 and the delivery system 3100 to inflate the balloon to deploy the prosthetic heart valve 3010. In other examples, a manual inflation source such as a manual syringe may be coupled to the inflation lumen 3184, and motorized components may be omitted.

[0090] Referring briefly to Fig. 2A, in the example method 10A, after step 200 is complete and the MDSGC 1000 is positioned within the left atrium LA, and optionally after the MDSGC 1000 is coupled to the stabilizer 2000 (e.g. as shown in Fig. 7C), the leading end of the valve delivery system 3100, which may be the tapered distal tip 3138, may be inserted into the proximal end of the MDSGC 1000 and advanced through the outer guide catheter 1300 of the MDSGC 1000 while the prosthetic heart valve 3010 is crimped over the deflated balloon of the valve delivery system 3100. Steering may be performed, for example using steering knob 3112, to assist the distal end of the valve delivery system 3100 follow the contours of the outer guide catheter 1300. The valve delivery system 3100 may be advanced until the distal end of the valve delivery system 3100 extends beyond the distal end 1302 of the outer guide catheter 1300. Near this point, if desired, the handle 3110 of the valve delivery system 3100 may be coupled to the stabilizer 2000. For example, the handle 110 may include an attachment assembly 3190 configured to couple to the proximal attachment 2040 of the stabilizer 2000 in a similar or identical fashion as described below for the proximal attachment assembly 4200 ofABTEVA-0076PCT 15897WOO1 the TEER guide catheter 4000. In some examples, if the handle 3110 is coupled to the proximal attachment 2040 of the stabilizer 2000 via attachment assembly 3190, the handle 3110 is capable of translating relative to the stabilizer 2000 along the length L2 of the slot 2046 of the proximal attachment 2040.

[0091] One example of the handle 3110 of the valve delivery system 3100 coupled to the proximal attachment 2040 of the stabilizer 2000 is shown in Fig. 9A. Whether or not the valve delivery system 3100 is coupled to the stabilizer 2000, once the distal end of the valve delivery system 3100 exits the outer catheter 1300 of the MDSGC 1000, the user may steer the valve delivery system 3100 (e.g. by using steering knob 3112) and advance the valve delivery system 3100 in the antegrade direction until the prosthetic heart valve 3010 crimped on the valve delivery system 3100 is positioned within the native aortic valve AV, as shown in Fig. 9B. In some examples, this final distal advancement of the valve delivery system 3100 may be performed by one or more of (i) manually advancing the handle 3110, (ii) advancing the handle 3110 within the slot 2046 of the proximal attachment 2040, and (iii) actuating the axial alignment actuator 3116. Once the prosthetic heart valve 3010 is in the desired position, it may be deployed, for example by activating balloon actuator 3120 to force inflation media from a reservoir into the balloon over which the prosthetic heart valve 3010 is collapsed (e.g. in the case of motorized deployment) or by manually advancing inflation media to the balloon, for example by depressing the plunger of a saline syringe that is operably coupled to the handle 3110. Once the prosthetic heart valve 3010 is deployed, the valve delivery system 3100 may be removed from the patient by withdrawing the valve delivery system 3100 through the MDSGC 1000 (which may include detaching the handle 3110 from the stabilizer 2000), while the MDSGC 1000 remains in place, ready to be used with another procedure. Referring back to Fig. 2A, at this point in method 10 A, step 300 A may be complete, and step 400 A may begin. However, it should be understood that although step 300A is shown and described as being performed with one particular balloon-expandable prosthetic heart valve, it should be understood that step 300A may be performed with other balloon-expandable prosthetic heart valves, or other self-expandable or otherwise expandable prosthetic heart valves.

[0092] It should be understood that although one particular curvature or deflection of the distal end 1302 of the outer guide catheter 1300 is shown in Fig. 9B, other types and configurations of steering and / or curvature may be suitable. For example, the curvature of the distal portion (e.g. the distal end 1302) may be fixed, including in an anterior / posterior and / orABTEVA-0076PCT 15897WOO1 medial / lateral direction. In some examples, the curvature may be achieved by either one, two, or more steering actuators, including for example a first steering actuator (e.g. steering knob) that controls anterior / posterior deflection and / or a second steering actuator (e.g. steering knob) that controls medial / lateral deflection. In some examples, the outer guide catheter 1300 may alternatively or additionally have a proximal articulation section that enables the distal end 1302 to extend more deeply to gain access to aortic valve AV through mitral valve MV annulus. In some examples, either alternatively or additionally to outer guide catheter 1300 having the ability to extend more deeply through the mitral valve MV, the steering to extend more deeply through the mitral valve MV may be a property of a delivery catheter 3130, which is shown in Fig. 9B having been advanced through the lumen of the outer guide catheter 1300. In some examples, the lengths of the catheter shafts (e.g. the length of outer guide catheter 1300 and the length of delivery catheter 3130) may be matched to allow for the additional distance inside the anatomy and relative lengths of each handle.

[0093] Referring again to Fig. 2A, after the TAVR procedure is performed through the MDSGC 1000 in step 300A, a TEER procedure may be performed through the MDSGC 1000 in step 400A. One example of a TEER procedure, along with exemplary components that may be used in the TEER procedure, is described below.

[0094] Fig. 10A illustrates a side view of an example of a TEER guide catheter 4000 assembled with a TEER delivery device 5000 for delivering a leaflet clip or fixation device 6000. TEER guide catheter 4000, which may also be referred to as an inner guide catheter assembly 4000, may generally include one or more of an inner guide catheter handle 4100 and an inner guide catheter 4300 extending distally therefrom. Inner guide catheter handle 4100 may be connected to proximal end 4301 of the inner guide catheter 4300 and may optionally join with outer guide catheter handle 1100 to form one larger handle. Inner guide catheter handle 4100 may include one or more steering actuators 4102, 4104 which may be used to bend, arc, or reshape inner guide catheter 4300, such as to form a secondary curve and move or sweep distal end 4302 of inner guide catheter 4300 through one or more angles of motion.

[0095] Figs. 10A-10C also show portions of an example of a TEER delivery device 5000, which may include a handle 5010 and a delivery catheter 5020 which may extend distally from the handle 5010. TEER delivery device 5000 may also include various elements which may extend from respective controls in handle 5010 and through delivery catheter 5020 to aABTEVA-0076PCT 15897WOO1 fixation device 6000 coupled to delivery catheter 5020, as shown in Fig. 10C, for controlling different aspects of the fixation device 6000.

[0096] The TEER delivery device handle 5010 may include a housing, a positioner assembly 5100, a gripper control assembly 5200, a delivery catheter fastening assembly 5500, and a flush port 5302a. Positioner assembly 5100 may be configured to actuate an actuator rod extending therefrom in a proximal-distal direction for moving distal elements 6120 between open, closed, and inverted positions. Positioner assembly 5100 may also be configured to release the actuator rod from fixation device 6000 for deployment of fixation device 6000. Delivery device handle 5010 may also include a deployment control system 5170 that may be coupled to positioner assembly 5100 for prevention of inadvertent deployment of fixation device 6000 until desired. Proximal element lines may extend from gripper control assembly 5200, and gripper control assembly 5200 may be configured to actuate the proximal elements lines to move proximal elements 6140 between raised and lowered positions. A lock line may extend from lock knob 5410, and lock knob 5410 may be configured to actuate the lock line and correspondingly a locking mechanism of fixation device 6000 between the locked and unlocked configuration. During a transcatheter procedure, it may be desirable to advance or retract delivery catheter 5020 relative to inner guide catheter assembly 4000 and / or MDSGC 1000 to help position fixation device 6000 within a target valve.

[0097] Delivery catheter fastening assembly 5500 may be configured to selectively secure and unsecure delivery catheter 5020 so that it can be freely advanced or retracted relative to inner guide catheter assembly 4000 and / or MDSGC 1000 and secured in a desired position so that delivery catheter 5020 is constrained from axially translating relative to inner guide catheter assembly 4000 and / or MDSGC 1000. For example, fastening assembly 5500 may be rotated to increase or decrease compression on a brake shaft 5030. When the friction is sufficiently reduced, handle 5010 may be translated in a proximal or distal direction along brake shaft 5030 which correspondingly advances delivery catheter 5020 proximally or distally through brake shaft 5030. The maximum travel length of handle 5010 relative to brake shaft may be LI, which may be about 3 to 4 inches, for example.

[0098] Positioner assembly 5100 may generally include a slider 5110, an actuator knob 5120, and a bearing 5150. In operation, positioner assembly 5100 may be utilized to move distal elements 6120 between the open, closed, and inverted positions. In one example, rotating actuator knob 5120 in the first direction may translate an internal actuator rod proximally whichABTEVA-0076PCT 15897WOO1 may move distal elements 6120 from the closed to open position and from the open position to the inverted position. On the other hand, rotating actuator knob 5120 in the second direction may advance the actuator rod distally which may move distal elements 620 from the inverted position to the open position and from the open position to the closed position. When it has been determined that the valve leaflets have been sufficiently grasped by fixation device 6000, fixation device 6000 may be released from delivery catheter 5020. In one example, this may be achieved by releasing a handle of deployment control system 5170 from slider 5110. Additional details of examples of a TEER guide catheter 4000 and a TEER delivery device 5000 are provided in U.S. Provisional Patent Application No. 63 / 656,690, filed June 6, 2024, the disclosure of which is hereby incorporated by reference herein.

[0099] An example fixation device 6000 is shown in Figs. 10C-10D. Generally, fixation device 6000 may include distal elements 6120 that include elongate arms 6121 each having a proximal end portion 6121a and a distal end portion 6121b. Each proximal end portion 6121a may be rotatably connected to a coupling member 6160. Fixation device 6000 may also include a pair of proximal elements 6140, which may each have one or more frictional elements 6145 extending therefrom. In use, the distal elements 6120 may be positioned on outflow surfaces of a pair of native heart valve leaflets, and the proximal elements 6140 may be positioned on inflow surfaces of the pair of native heart valve leaflets, with the leaflets being clipped or sandwiched or otherwise secured between the elements to achieve edge-to-edge repair of the native leaflets. Movement of the distal elements 6120 may be achieved by movement of a stud 6131. Stud 6131 may be rotatably attached to links or legs 6130 via a rivet or other joint 6135, while opposite ends of the links or legs 6130 may be attached to the distal elements 6120 via additional rivets or joints 6135. With this configuration, movement of a delivery system shaft 6111 distally will tend to close the distal elements 6120, while movement of the delivery system shaft 61 11 proximally will tend to open the distal elements 6120. The fixation device 6000 may include a locking mechanism 6116 to lock the distal elements at a particular desired closing angle. Additional details of examples of fixation device 6000 are provided in U.S. Provisional Patent Application No. 63 / 656,690, filed June 6, 2024, the disclosure of which is hereby incorporated by reference herein.

[0100] Referring back to Fig. 2A, after completing the TAVR procedure in step 300A and removing the valve delivery system 3100 from the MDSGC 1000, the TEER procedure may be performed in step 400A using the MDSGC 1000 which is still in place and which mayABTEVA-0076PCT 15897WOO1 still be coupled to stabilizer 2000. For example, with the fixation device 6000 coupled to delivery catheter 5020 and with the TEER delivery device 5000 assembled to the TEER guide catheter 4000, the system may be advanced into and through the MDSGC 1000 until the fixation device 6000 extends beyond the distal end 1302 of the outer guide catheter 1300 of the MDSGC 1000.

[0101] While the fixation device 6000 is near the distal end 1302 of the outer guide catheter 1300, if desired, the TEER guide catheter 4000 (and / or the TEER delivery device 5000) may be coupled to the stabilizer 2000, for example as shown in Fig. 1 1 A. In one example, an attachment assembly 4200 may be coupled to the proximal attachment 2040 of the stabilizer 2000.

[0102] Figs. 1 IB - 11 C show one example of attaching the attachment assembly 4200 to the proximal attachment 2040. In this regard, proximal attachment assembly 4200 may be lowered toward elongate slot 2046 of proximal attachment 2040. As proximal attachment assembly 4200 is lowered, fingers 4234a, 4234b may be received within elongate slot 2046. Rails 2042a, 2042b may engage sloped surfaces of capture members 4222 and urge them inwardly until the capture members 4222 clear the bottom surface of the rails 2042a, 2042b. An internal biasing member may urge the capture members 4222 outwardly so that they cannot be pulled back through the elongate slot 2046. The attachment assembly 4200 may be translatable along the length L2 of the elongate slot 2046 without decoupling from the stabilizer 2000. It should be understood that other delivery devices, including the valve delivery system 3100 and the LAA delivery system 8000 may utilize similar attachment assemblies.

[0103] Whether or not the stabilizer 2000 is used to secure the TEER delivery device 5000 and / or the TEER guide catheter 4000, the TEER guide catheter 4000 and the TEER delivery device 5000 may be manipulated to position the fixation device 6000 in the desired position relative to the leaflets LF of the mitral valve MV, for example as shown in Fig. 12 A, and to fix or clip the edges of the leaflets LF between the proximal elements 6140 and the distal elements 6120, for example as shown in Figs. 12B-12C, to create two smaller orifices or openings O within the mitral valve MV. Due to the new openings O each being smaller than the original opening of the mitral valve MV, it may be preferable to perform the TEER procedure 400A only after performing the TAVR 300A procedure due to the reduction in available space, although it should be understood that the order of the TAVR procedure 300A and TEER procedure 400A may be reversed in method 10A in some examples. After theABTEVA-0076PCT 15897WOO1 fixation device 6000 has clipped over the leaflets LF, the fixation device 6000 may be decoupled from the delivery system shaft 6111, and the TEER delivery device 5000 and the TEER guide catheter 4000 may be removed from the body via the MDSGC 1000. In the example of method 10A of Fig. 2A, at this point the MDSGC 1000 may be removed from the patient, with two procedures having been performed with increased efficiency due to the use of the MDSGC 1000 for both the TAVR procedure 300A and the TEER procedure 400A. In some examples, if desired, an LAA occlusion procedure may be performed through the MDSGC 1000 as part of a third procedure. Examples of LAA occlusion procedures using the MDSGC 1000 are described in greater detail below.

[0104] Referring briefly back to Fig. 2B, method 10B may include steps 100 and 200 that are identical to those described above in connection with method 10A. Further, method 10B may include the step 400B of performing a TEER procedure, which may be performed in the same way as described above for step 400A of method 10A. After the TEER procedure 400B is completed, and the TEER guide catheter 4000 and TEER delivery device 5000 are removed from the MDSGC 1000, an LAA occlusion procedure 500B may be performed through the MDSGC 1000. Example components relevant to the LAA occlusion procedure 500B are described below prior to describing an example LAA occlusion procedure 500B.

[0105] Fig. 13 A is a side view of an example of an LAA occluder 7050 in an expanded condition. Occluder 7050 may include a proximal end 7052 and a distal end 7054, with a disc 7056 at proximal end 7052 and a lobe 7058 at distal end 7054. The lobe 7058 may have a proximal edge 7060 (also referred to as a proximal face), a distal edge 7062 (also referred to as a distal face), and a middle or central portion 7064 that define a cavity 7066. The occluder 7050 also includes stabilizing wires 7068 secured to a radially outer or circumferential surface of middle portion 7064. The stabilizing wires 7068 may terminate in a hook 7070 at free ends thereof, and thereby facilitate retention of the occluder 7050 at the LAA and preventing the occluder 7050 from becoming dislodged from the target site after deployment.

[0106] In this particular example of occluder 7050, proximal edge 7060 and distal edge 7062 adjoin middle portion 7064 at a first relatively blunt or sharp (e.g., non- rounded) transition 7072 and a second blunt transition 7074, respectively. First blunt transition 7072 connects proximal edge 7060 to middle portion 7064 by an approximately 90 degree angle. Likewise, second blunt transition 7074 connects distal edge 7062 to middle portion 7064 by an approximately 90 degree angle. First blunt transition 7072 and second blunt transition 7074ABTEVA-0076PCT 15897WOO1 partially define a generally rectangular cross section to lobe 7058, leading to relatively blunt circumferential edges of the device and relatively high radial force applied to the surrounding tissue. In other examples, one or both transitions 7072, 7074 may be provided with a more rounded (e..g. less blunt) transition.

[0107] In some examples, the occluder 7050 is formed by braiding a plurality of strands of wire together to form a braided mesh. In some examples, the strands of wire are strands of a shape-memory metal, such as nitinol, in which case the occluder 7050 may be shape-set, for example by heat treatment, to have a shape similar to that shown in Fig. 13 A. With this configuration, the occluder 7050 may be collapsed to a small diameter for delivery through a catheter, and the occluder 7050 may expand back (or attempt to expand back) to its set-shape upon release from the delivery catheter. In some examples, occlusive materials, such as discs or other shapes of fabrics, may be positioned inside and / or outside the proximal disc 7056 and / or the distal lobe 7058 to enhance the ability to occlude the LAA upon implantation. In some examples, the proximal disc 7056 is configured to cover an ostium of the LAA, while the distal lobe 7058 is configured to be positioned within the LAA, such that a double-sealing effect may be achieved by sealing within the LAA, and further sealing by covering the opening of the LAA. In some examples, the proximal disc 7056 and the distal lobe 7058 may be connected by a narrow waist portion 7059, which may help maintain tension on the proximal disc 7056 to help pull the proximal disc 7056 against the ostium of the LAA to maintain a good seal. It should be understood that occluder 7050 is merely one example of an LAA occluder, and other particular examples of LAA occluders may be used with the methods described herein.

[0108] Fig. 13B shows a schematic diagram of a delivery system 8000 for the occluder 7050. Delivery system 8000 may include a handle 8002 at a proximal end, and a catheter 8004 extending distally from the handle 8002. A delivery cable 8008 may be positioned within the catheter 8004, and the delivery cable 8008 may include a coupling member 8006 at a distal end thereof. The coupling member 8006 may include a threaded end that is threadedly received with an internally threaded hub 7057 connected to the proximal end of the proximal disc 7056. With this configuration, the delivery cables 8008 may be used to push the occluder 7050, while it is maintained in a collapsed condition within the catheter 8004, until the occluder 7050 exits the distal end of the catheter 8004 and expands or reverts back toward its set-shape. While the occluder 7050 is deployed within the LAA and securely anchored to the LAA, the deliveryABTEVA-0076PCT 15897WOO1 cables 8008 may be rotated to decouple the occluder 7050 from the delivery cable 8008. Referring back to Fig. 13B, in some examples, handle 8002 may include an attachment member 8010 which may be substantially similar to the proximal attachment member 4200 of TEER guide catheter 4000.

[0109] Referring back to Fig. 2B, in method 10B, after step 400B of performing the TEER procedure through the MDSGC 1000 and removing the TEER guide catheter 4000 and TEER delivery device 5000 from the MDSGC 1000, the distal end 1302 of the outer guide catheter 1300 may be re-oriented to be positioned within or adjacent to the LAA, for example using one or more steering knobs 1102 on the handle 1100 of the MDSGC 1000. With the distal end 1302 of the outer guide catheter 1300 being positioned as desired, an example of such positioning being shown in Fig ,14A, the LAA delivery system 8000, with the occluder 7050 attached thereto, may be inserted into the patient through the MDSGC 1000. For example, the occluder 7050 may be coupled to the coupling member 8006 of the delivery cable 8008 while the occluder 7050 remains collapsed within the catheter 8004. Then, the catheter 8004 and delivery cables 8008 may be passed through the handle 1100 of the MDSGC 1000 and may be advanced distally through the outer catheter 1300. The outer catheter 1300 of the MDSGC 1000 may provide guidance so that the catheter 8004 follows the desired trajectory until the distal end of the catheter 8004 exits the distal end 1302 of the MDSGC 1000, for example such that the catheter 8004 is positioned within the LAA or adjacent to the LAA.

[0110] In some examples, when the catheter 8004 is near the distal end 1302 of the outer guide catheter 1300 of the MDSGC 1000, the attachment member 8010 may be coupled to the stabilizer 2000 in substantially similar or identical fashion as described in connection with attaching the proximal attachment member 4200 of TEER guide catheter 4000 to the stabilizer 2000. However, it should be understood that connecting the LAA delivery device 8000 to the stabilizer 2000 is optional. Whether or not the LAA delivery device 8000 is attached to the stabilizer 2000, final positional adjustments (including proximal or distal translation) may be performed to get the distal end of the catheter 8004 in the desired position. The distal end of the catheter 8004 may then be withdrawn while maintaining the delivery cable 8008 in a substantially static position, or otherwise the delivery cables 8008 may be advanced distally while maintaining the catheter 8004 in a substantially static position. As this occurs, the collapsed LAA occluder 7050 exits from the constraints of the catheter 8004, allowing the LAA occluder 7050 to self-expand. For example, as shown in Fig ,14B, the distal lobe 7058 mayABTEVA-0076PCT 15897WOO1 expand into contact with an interior wall of the LAA, while the proximal disc 7056 expands to cover the ostium leading from the left atrium LA to the LAA. In some examples, the delivery cable 8008 may then be gently pulled proximally to help confirm the LAA occluder 7050 is secured within the LAA and / or to help frictionally engage the hooks 7070 of stabilizing members 7068 with the interior walls of the LAA.

[0111] Referring back to Fig. 2B, once the LAA occluder 7050 is deployed within the LAA, the delivery cable 8008 may be rotated to decouple the LAA occluder 7050 from the delivery cable 8008, and the delivery cable 8008 and delivery catheter 8004 may be retracted through the MDSGC 1000 to remove the LAA occluder delivery system 8000 from the patient to complete step 500B. After the steps 400B of the TEER procedure and 500B of the LAA occlusion are performed, the MDSGC 1000 may be removed from the patient to complete the method 10B. As should be understood, the use of the MDSGC 1000, including allowing it to remain in substantially the same position, creates greater efficiencies by allowing the fixation device 6000 to be implanted and the LAA occluder 7050 to be implanted with both systems utilizing the MDSGC 1000 for the implantation.

[0112] Referring back to Fig. 2C, method 10C may be substantially identical to method 10B, with the exception that the LAA occlusion procedure 500C (which may be substantively identical to LAA occlusion procedure 500B) is performed first, followed by the TEER procedure 400C (which may be substantively identical to TEER procedure 400B).

[0113] As should be understood from the above description, the commonality between the specific methods 10A, 10B, and 10C of Figs. 2A-2C is the use of a single MDSGC 1000 that provides transseptal access to the left atrium LA, and performing two different interventions via the MDSGC 1000 for enhanced efficiency due to the use of the common MDSGC 1000. The three examples of interventions among methods 10A-10C include performing a TAVR procedure, performing a TEER procedure, and performing an LAA occlusion procedure. Although each of Figs. 10A-10C include two of these procedures being performed in a specific order, it should be understood that any two procedures could be performed in any desired order, or even all three of these procedures could be performed using the same MDSGC 1000, and in any desired order. However, as noted above, if a TAVR procedure is being performed concomitantly with a TEER procedure, it may be preferable to perform the TAVR procedure first due to the decrease in available open area across the mitral valve MV resulting from the TEER procedure.ABTEVA-0076PCT 15897WOO1

[0114] The paragraphs below address various aspects of the disclosure.

[0115] Paragraph A: According to an aspect of the disclosure, a system 9000 is for implanting two or more implants into a heart of a patient, a representative example of the system 9000 being shown in Fig. 15 A. The system includes a multi-device steerable guide catheter (“MDSGC”) 9010, non-limiting examples of which are described above (e.g. MDSGC 1000) and shown in the figures (e.g. Fig. 4A). The MDSGC 9010 includes a first handle 9012 and a first catheter 9014 extending from the first handle 9012, the MDSGC 9010 including a first steering actuator 9016 configured to deflect a distal end portion 9018 of the first catheter 9014, the first catheter 9014 having a length L sufficient to extend from a femoral vein access site of the patient to a left atrium of the patient. For example, the length may be at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, or at least 100 cm, although these lengths are merely exemplary. The system 9000 includes a transcatheter edge-to-edge repair (“TEER”) implant delivery device 9020, non-limiting examples of which are described above (e.g. TEER delivery device 5000) and shown in the figures (e.g. Fig. 10B). The TEER implant delivery device 9020 includes a second handle 9022 and a second catheter 9024 extending from the second handle 9022. The system 9000 includes a fixation device 9030, non-limiting examples of which are described above (e.g. fixation device 6000) and shown in the figures (e.g. Fig. 10D). The fixation device 9030 has proximal elements 9032 and distal elements 9034 configured to capture free edges of native heart valve leaflets therebetween as part of a TEER procedure, the fixation device 9030 being configured to releasably couple to the second catheter 9024, the second catheter 9024 being sized and shaped to pass through an interior of the first catheter 9014 while the fixation device 9030 is releasably coupled to the second catheter 9024. In some examples, the first catheter 9014 may have an outer diameter of about 20 French, about 22 French, about 24 French, about 26 French, about 28 French, or about 30 French, although these outer diameters are merely exemplary. In some examples, the second catheter 9024 may have an outer diameter of about 8 French, about 10 French, about 12 French, about 14 French, about 16 French, or about 18 French, although these outer diameters are merely exemplary. The system 9000 includes an additional implant delivery device 9040 including an additional handle 9042 and an additional catheter 9044 extending from the additional handle 9042. The system 9000 includes an additional medical device 9050 configured to be releasably coupled to the additional catheter 9044, the additional catheter 9044 being sized and shaped to pass through the interior of the first catheter 9014 while the additional medical device 9050 isABTEVA-0076PCT 15897WOO1 releasably coupled to the additional catheter 9044. In some examples, the additional catheter 9044 may have sizing similar to the options provided above in connection with the second catheter 9O24.The additional medical device 9050 may be a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device, non-limiting examples of which are described above (e.g. prosthetic heart valve 3010) and shown in the figures (e.g. Fig. 8A). The additional medical device 9050 may be a collapsible and expandable left atrial appendage (“LAA”) occluder device, non-limiting examples of which are described above (e.g. LAA occluder 7050) and shown in the figures (e.g. Fig. 13 A).

[0116] Paragraph B: The system 9000 of Paragraph A may also include a stabilizer 9060, non-limiting examples of which are described above (e.g. stabilizer 2000) and shown in the figures (e.g. Fig. 6A). A representative example of the stabilizer 9060 is shown in Fig. 15B, along with the MDSGC 9010, as an optional part of system 9000. The stabilizer 9060 may include a distal attachment site 9062. The MDSGC 9010 may include a first attachment assembly 9013 configured to reversibly couple the MDSGC 9010 to the stabilizer 9060 at the distal attachment site 9062.

[0117] Paragraph C: The system 9000 of Paragraph B, and particularly the stabilizer 6030 thereof, may include a proximal attachment site 9064 positioned proximally to the distal attachment site 9062. The additional implant delivery device 9040 may include a second attachment assembly 9046 configured to reversibly couple the additional implant delivery device 9040 to the stabilizer 9060 at the proximal attachment site 9064 while the MDSGC 9010 is coupled to the stabilizer 9060 at the distal attachment site 9062. Representative examples of these portions of the system 9000 are shown in Fig. 15C.

[0118] Paragraph D: In the system 9000 of any of Paragraphs A-C, the additional medical device may be the TAVR device 9050a, the additional implant delivery device may be a TAVR delivery device 9040a, and the additional catheter 9044 may include an inflatable balloon 9045a at a distal end portion thereof. Non-limiting examples of the TAVR delivery device 9040a are described above (e.g. valve delivery system 3100) and shown in the figures (e.g. Fig. 8B). The TAVR device 9050a may be configured to be crimped over the inflatable balloon 9045a while the inflatable balloon 9045a is deflated to releasably couple the TAVR device 9050a to the distal end portion of the additional catheter 9044. Representative examples of these portions of the system 9000 are shown in Fig. 15D.ABTEVA-0076PCT 15897WOO1

[0119] Paragraph E: In the system 9000 of any of Paragraphs A-C, the additional medical device may be the LAA occluder device 9050b, the additional implant delivery device may be a LAA occluder delivery device 9040b, and the additional catheter 9044 may include an outer catheter 9045b and a delivery cable 9047b. Non-limiting examples of the LAA occluder delivery device 9040b are described above (e.g. LAA occluder delivery system 8000) and shown in the figures (e.g. Fig. 13B). The LAA occluder device 9050b may be configured to be threadedly coupled to the delivery cable 9047b to releasably couple the LAA occluder device 9050b to the distal end portion of the additional catheter 9044. Representative examples of these portions of the system 9000 are shown in Fig. 15E.

[0120] Paragraph F: In the system 9000 of any of Paragraphs A-C, the additional medical device may be the TAVR device 9050a, and the system 9000 may further include an LAA occluder delivery device 9040b including an LAA occluder delivery device handle 9042b and an LAA occluder delivery device catheter 9044b extending from the LAA occluder delivery device handle 9042b. The system 9000 may also include an LAA occluder device 9050b configured to be releasably coupled to the LAA occluder delivery device catheter 9044b, the LAA occluder delivery device catheter 9044b being sized and shaped to pass through the interior of the first catheter 9014 while the LAA occluder device 9050b is releasably coupled to the LAA occluder delivery device catheter 9040b. In some examples, the LAA occluder delivery device catheter 9044b may have an outer diameter of about 8 French, about 10 French, about 12 French, about 14 French, about 16 French, or about 18 French, although these outer diameters are merely exemplary. Representative examples of these portions of the system 9000 are shown in Fig. 15F.

[0121] Paragraph G: In the system 9000 of Paragraph D, while the TAVR delivery device 9040a is coupled to the stabilizer 9060 at the proximal attachment site 9064, the TAVR delivery device 9040a may be translatable a limited length ELI into the first catheter 9014 without decoupling from the stabilizer 9060. This limited length LL1 may correspond to a length over which the first catheter 9014 has freedom of movement / translation relative to the stabilizer 9060 to which it is coupled. Representative examples of these portions of the system 9000 are shown in Fig. 15G.

[0122] Paragraph H: In the system 9000 of Paragraph E, while the LAA occluder delivery device 9040b is coupled to the stabilizer 9060 at the proximal attachment site 9064, the LAA occluder delivery device 9040b may be translatable a limited length LL2 into the firstABTEVA-0076PCT 15897WOO1 catheter 9014 without decoupling from the stabilizer 9060. This limited length LL2 may correspond to a length over which the LAA occluder delivery device 9040b has freedom of movement / translation relative to the stabilizer 9060 to which it is coupled. Representative examples of these portions of the system 9000 are shown in Fig. 15H.

[0123] Paragraph I: In the system 9000 of any of Paragraphs A-H, the first steering actuator 9016 may be configured to deflect the distal end portion 9018 of the first catheter 9014 so that the distal end portion 9018 of the first catheter 9014 is substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis X of a mitral valve MV of the patient. A representative example of this is shown in Fig. 151.

[0124] Paragraph J: In the system 9000 of any of Paragraphs A-II, the first steering actuator 9016 may be configured to deflect the distal end portion 9018 of the first catheter 9014 so that the distal end portion 9018 of the first catheter 9014 is substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis Y of an ostium O leading to the LAA of the patient. A representative example of this is shown in Fig. 15 J.

[0125] Paragraph K: According to an aspect of the disclosure, a method of implanting two or more implants into a heart of a patient includes accessing an atrial septum of the patient via a femoral vein of the patient. The method includes creating an opening in the atrial septum leading from a right atrium of the patient to a left atrium of the patient. The method includes advancing a first catheter of a multi-device steerable guide catheter (“MDSGC”) through the femoral vein, into the right atrium, through the opening in the atrial septum, and into the left atrium. Non-limiting examples of the MDSGC are described above (e.g. MDSGC 1000, 9010) and shown in the figures (e.g. Fig. 4A, Fig. 15A). While a distal end of the first catheter is positioned within the left atrium, the distal end of the first catheter is deflected using a first steering actuator on a first handle of the MDSGC to be substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of a mitral valve of the patient. While the distal end of the first catheter is positioned within the left atrium, a transcatheter edge-to-edge repair (“TEER”) implant delivery device is advanced through the first catheter while a fixation device is coupled to a second catheter of the TEER implant delivery device. Non-limiting examples of the TEER implant delivery device and the fixation device are described above (e.g. TEER implant delivery device 5000, 9020 and fixation devices 6000, 9030) and shown in the figures (e.g. Figs. 10B, 10D, 15A). After the fixation device exits the distal end of the first catheter, the fixation device is deployed from the second catheter soABTEVA-0076PCT 15897WOO1 that proximal elements and distal elements of the fixation device capture free edges of native heart valve leaflets of the mitral valve therebetween, thereby performing a TEER procedure. While the distal end of the first catheter is positioned within the left atrium, an additional implant delivery device is advanced through the first catheter while an additional medical device is coupled to an additional catheter of the additional implant delivery device. After the additional implant delivery device exits the distal end of the first catheter, the additional medical device is deployed from the additional catheter to implant the additional medical device into the heart of the patient, thereby performing an additional heart implant procedure. The additional medical device may be a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device, non-limiting examples of which are described above (e.g. prosthetic heart valve 3010, 9050a) and shown in the figures (e.g. Figs. 8A, 15D), in which case the additional heart implant procedure is a TAVR procedure. The additional medical device may be a collapsible and expandable left atrial appendage (“LAA”) occluder device, non-limiting examples of which are described above (e.g. LAA occluder 7050, 9050b) and shown in the figures (e.g. Figs. 13A, 15E), in which case the additional heart implant procedure is an LAA occlusion procedure.

[0126] Paragraph L: Tn the method of Paragraph K, the additional heart implant procedure may be the TAVR procedure, and the TAVR procedure may be performed prior to the TEER procedure.

[0127] Paragraph M: In the method of Paragraph K, the additional heart implant procedure may be the LAA occlusion procedure, and the LAA occlusion procedure may be performed prior to the TEER procedure.

[0128] Paragraph N: In the method of Paragraph K, the additional heart implant procedure may be the LAA occlusion procedure, and the LAA occlusion procedure may be performed after the TEER procedure.

[0129] Paragraph O: In the methods of Paragraphs M or N, the distal end of the first catheter may be deflected using the first steering actuator on the first handle of the MDSGC to be substantially coaxial with (or substantially parallel (e.g. + / - 5 degrees) to) a central longitudinal axis of an ostium of the LAA of the patient, for example similar to as shown in Fig. 15.T.ABTEVA-0076PCT 15897WOO1

[0130] Paragraph P: In the method of any of Paragraphs K-O, prior to performing the additional heart implant procedure, a first attachment assembly of the MDSGC may be coupled to a distal attachment site of a stabilizer, for example similar to as shown in Fig. 15B.

[0131] Paragraph Q: In the method of Paragraph P, advancing the additional implant delivery device through the first catheter may be performed after the first attachment assembly of the MDSGC is coupled to the distal attachment site of the stabilizer.

[0132] Paragraph R: In the method of Paragraph Q, prior to deploying the additional medical device from the additional catheter, a second attachment assembly of the additional implant delivery device may be coupled to a proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site, for example similar to as shown in Fig. 15C.

[0133] Paragraph S: In the method of Paragraph R, the additional implant delivery device may be translated into the first catheter while the additional implant delivery device is coupled to the stabilizer at the proximal attachment site, for example similar to as shown in Fig. 15G or 15H.

[0134] Paragraph T: In the method of Paragraph R or S, prior to deploying the fixation device from the second catheter, an attachment assembly of the TEER implant delivery device may be coupled to the proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site.

[0135] Although the subject matter disclosed herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications set forth in this disclosure. It is therefore to be understood that numerous modifications may be made to the exemplary embodiments and that other arrangements may be devised, such as combining one or more features of one embodiment with another embodiment or features from a plurality of embodiments, as an example. Thus, the exemplary embodiments herein are not intended to be exhaustive or to limit the disclosed subject matter to such embodiments.

Claims

ABTEVA-0076PCT 15897WOO1CLAIMS1. A system for implanting two or more implants into a heart of a patient, the system comprising: a multi-device steerable guide catheter (“MDSGC”) including a first handle and a first catheter extending from the first handle, the MDSGC including a first steering actuator configured to deflect a distal end portion of the first catheter, the first catheter having a length sufficient to extend from a femoral vein access site of the patient to a left atrium of the patient; a transcatheter edge-to-edge repair (“TEER”) implant delivery device including a second handle and a second catheter extending from the second handle; a fixation device having proximal elements and distal elements configured to capture free edges of native heart valve leaflets therebetween as part of a TEER procedure, the fixation device being configured to releasably couple to the second catheter, the second catheter being sized and shaped to pass through an interior of the first catheter while the fixation device is releasably coupled to the second catheter; an additional implant delivery device including an additional handle and an additional catheter extending from the additional handle; and an additional medical device configured to be releasably coupled to the additional catheter, the additional catheter being sized and shaped to pass through the interior of the first catheter while the additional medical device is releasably coupled to the additional catheter; wherein the additional medical device is (i) a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device or (ii) a collapsible and expandable left atrial appendage (“LAA”) occluder device.

2. The system of claim 1, further comprising a stabilizer, the stabilizer including a distal attachment site, the MDSGC including a first attachment assembly configured to reversibly couple the MDSGC to the stabilizer at the distal attachment site.

3. The system of claim 2, wherein the stabilizer includes a proximal attachment site positioned proximally to the distal attachment site, the additional implant delivery device including a second attachment assembly configured to reversibly couple the additional implant delivery device to the stabilizer at the proximal attachment site while the MDSGC is coupled to the stabilizer at the distal attachment site.ABTEVA-0076PCT 15897WOO14. The system of any of claims 1-3, wherein the additional medical device is the TAVR device, the additional implant delivery device is a TAVR delivery device, and the additional catheter includes an inflatable balloon at a distal end portion thereof, the TAVR device configured to be crimped over the inflatable balloon while the inflatable balloon is deflated to releasably couple the TAVR device to the distal end portion of the additional catheter.

5. The system of any of claims 1-3, wherein the additional medical device is the LAA occluder device, the additional implant delivery device is an LAA occluder delivery device, and the additional catheter includes an outer catheter and a delivery cable, the LAA occluder device configured to be threadedly coupled to the delivery cable to releasably couple the LAA occluder device to the distal end portion of the additional catheter.

6. The system of any of claims 1-3, wherein the additional medical device is the TAVR device, and the system further comprises: an LAA occluder delivery device including an LAA occluder delivery device handle and an LAA occluder delivery device catheter extending from the LAA occluder delivery device handle; and an LAA occluder device configured to be releasably coupled to the LAA occluder delivery device catheter, the LAA occluder delivery device catheter being sized and shaped to pass through the interior of the first catheter while the LAA occluder device is releasably coupled to the LAA occluder delivery device catheter.

7. fhe system of claim 4, wherein while the TAVR delivery device is coupled to the stabilizer at the proximal attachment site, the TAVR delivery device is translatable a limited length into the first catheter without decoupling from the stabilizer.

8. The system of claim 5, wherein while the LAA occluder delivery device is coupled to the stabilizer at the proximal attachment site, the LAA occluder delivery device is translatable a limited length into the first catheter without decoupling from the stabilizer.ABTEVA-0076PCT 15897WOO19. The system of any of the preceding claims, wherein the first steering actuator is configured to deflect the distal end portion of the first catheter so that the distal end portion of the first catheter is substantially parallel to a central longitudinal axis of a mitral valve of the patient.

10. The system of any of the preceding claims, wherein the first steering actuator is configured to deflect the distal end portion of the first catheter so that the distal end portion of the first catheter is substantially parallel to a central longitudinal axis of an ostium leading to the LAA of the patient.

11. A method of implanting two or more implants into a heart of a patient, the method comprising: accessing an atrial septum of the patient via a femoral vein of the patient; creating an opening in the atrial septum leading from a right atrium of the patient to a left atrium of the patient; advancing a first catheter of a multi-device steerable guide catheter (“MDSGC”) through the femoral vein, into the right atrium, through the opening in the atrial septum, and into the left atrium; while a distal end of the first catheter is positioned within the left atrium, deflecting the distal end of the first catheter, using a first steering actuator on a first handle of the MDSGC, to be substantially parallel to a central longitudinal axis of a mitral valve of the patient; while the distal end of the first catheter is positioned within the left atrium, advancing a transcatheter edge-to-edge repair (“TEER”) implant delivery device through the first catheter while a fixation device is coupled to a second catheter of the TEER implant delivery device, and after the fixation device exits the distal end of the first catheter, deploying the fixation device from the second catheter so that proximal elements and distal elements of the fixation device capture free edges of native heart valve leaflets of the mitral valve therebetween, thereby performing a TEER procedure; and while the distal end of the first catheter is positioned within the left atrium, advancing an additional implant delivery device through the first catheter while an additional medical device is coupled to an additional catheter of the additional implant delivery device, and after the additional implant delivery device exits the distal end of the first catheter, deploying theABTEVA-0076PCT 15897WOO1 additional medical device from the additional catheter to implant the additional medical device into the heart of the patient, thereby performing an additional heart implant procedure; wherein (i) the additional medical device is a collapsible and expandable prosthetic transcatheter aortic valve repair (“TAVR”) device and the additional heart implant procedure is a TAVR procedure, or (ii) the additional medical device is a collapsible and expandable left atrial appendage (“LAA”) occluder device and the additional heart implant procedure is an LAA occlusion procedure.

12. The method of claim 11, wherein the additional heart implant procedure is the TAVR procedure, and the TAVR procedure is performed prior to the TEER procedure.

13. The method of claim 11, wherein the additional heart implant procedure is the LAA occlusion procedure, and the LAA occlusion procedure is performed prior to the TEER procedure.

14. The method of claim 11, wherein the additional heart implant procedure is the LAA occlusion procedure, and the LAA occlusion procedure is performed after the TEER procedure.

15. The method of claim 13 or 14, further comprising: deflecting the distal end of the first catheter, using the first steering actuator on the first handle of the MDSGC, to be substantially parallel to a central longitudinal axis of an ostium of the LAA of the patient.

16. The method of any of claims 11-15, further comprising: prior to performing the additional heart implant procedure, coupling a first attachment assembly of the MDSGC to a distal attachment site of a stabilizer.

17. The method of claim 16, wherein advancing the additional implant delivery device through the first catheter is performed after the first attachment assembly of the MDSGC is coupled to the distal attachment site of the stabilizer.ABTEVA-0076PCT 15897WOO118. The method of claim 17, further comprising: prior to deploying the additional medical device from the additional catheter, coupling a second attachment assembly of the additional implant delivery device to a proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site.

19. The method of claim 18, further comprising translating the additional implant delivery device into the first catheter while the additional implant delivery device is coupled to the stabilizer at the proximal attachment site.

20. The method of claim 18 or 19, further comprising: prior to deploying the fixation device from the second catheter, coupling an attachment assembly of the TEER implant delivery device to the proximal attachment site of the stabilizer while the MDSGC is coupled to the stabilizer at the distal attachment site.

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