Cardiovascular access and device delivery system

[0001] This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2015/060726, filed on Nov. 13, 2015, which published in English as WO 2016/077783 A1 on May 19, 2016, and which claims priority benefit of U.S. Patent Application No. 62/079,811, filed on Nov. 14, 2014.

[0002] This application is directed to systems and methods for accessing heart chambers or major blood vessels to facilitate delivering and implanting devices or performing therapies therein.

[0003] Catheters are in widespread use for a wide number of procedures. In recent years, complex devices such as aortic valves have been delivered using catheters. These catheter based procedures provide benefits for patients, including reduced trauma compared to surgical techniques for accomplishing similar outcomes, e.g., aortic valve replacement.

[0004] Limitations of catheter based techniques have spurred efforts to develop a less invasive surgical technique that can be performed through cannulae inserted into the heart through the chest wall and through an apical puncture in the heart. These procedures have advantages, such as moving the proximal end of the tools used to perform the procedure closer to the surgical site.

[0005] These surgical approaches provide various disadvantages, however. For one, access to the heart through the chest wall is more complex than access to a superficial peripheral vessel, such as a femoral artery. For example, a surgical window must still be opened to advance the surgical cannulae through the skin and intervening tissue to the heart. To the extent large devices are delivered through this enlarged surgical window, trauma to the patient is increased and closure of the heart puncture is challenging.

[0006] The methods and systems herein provide low-profile access for creating a trans-cardiac rail with two externalized ends.

[0007] In one embodiment, a method of accessing a heart of a patient is provided. The method can be used to provide a treatment, which may involve implanting a prosthesis or other implant. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

[0008] In another embodiment, a method of accessing a heart is provided. Vascular access is provided at a peripheral vein. An access catheter is advanced through the peripheral vein, through the vena cava, and into the heart. A distal portion of the access catheter is advanced across the intra-atrial septum into the left atrium. A channel is established through a wall of the heart to provide direct access through the wall to the left ventricle. An elongate member is advanced through the channel into the left ventricle. The elongate member is drawn into the access catheter. The elongate member is tensioned between the distal portion of the access catheter and the channel.

[0009] In another embodiment, a method of accessing a heart is provided. Vascular access is provided at a peripheral artery. An access catheter is advanced into the aorta through the peripheral artery. In some embodiments, the access catheter passes through the brachial artery and the left subclavian artery. In some embodiments, the access catheter passes through a femoral artery and an iliac artery. In some embodiments, the elongate member advances antegrade from the ventricle into the aorta. In some embodiments, the elongate member advances into the subclavian artery or iliac artery. In at least one embodiment, the elongate member includes an atraumatic tip such as a floppy tip, a “J” tip, or a balloon tip.

[0010] In another embodiment, a method of placing a cardiovascular prosthesis is provided. A delivery system is advanced percutaneously from a peripheral blood vessel access site into the left atrium of a heart. The left ventricle is accessed from outside the heart through the wall of the heat at or adjacent to the apex of the heart by placing a sheath therethrough. An elongate member is advanced through the sheath across the aortic valve. The delivery system is linked with the elongate member to provide a venous-arterial rail for delivery of a prosthesis into the heart and/or the aorta. A condition in the heart and/or arterial vasculature is treated over the venous-arterial rail.

[0011] In another embodiment, a device for closing a cardiac access channel is provided. The device comprises an elongate body having a proximal end and a distal end. The proximal end has a first opening for delivering a closure medium and a second opening for delivering a pressurizing medium. The distal end has a first fillable member that comprises a distal face, an enclosure disposed at the distal face and extending proximally therefrom, and one or more pores disposed through the enclosure at the distal face thereof. The first fillable member is in fluid communication with the first opening such that the closure medium can be delivered to the first fillable member. The distal end has a second fillable member in fluid communication with the second opening such that the pressuring medium can be delivered to the second fillable member. The first and second fillable members are arranged such that when the first fillable member contains the closure medium and the second fillable member contains the pressurizing medium, the closure medium is disposed through the pore(s).

[0029] More detailed descriptions of various embodiments of catheter based and transapical delivery systems, components and methods useful to treat patients are set forth below.

[0030] This application discloses various system and methods for providing a rail structure for guiding the advancement and deployment of cardiac prostheses or therapy devices. The rail structure preferably has two or more ends that are externalized. Externalized ends may include portions that are disposed outside the body, such as through percutaneous vascular access device or through direct cardiac access device. Intracorporeal lengths of the rail may be disposed between the externalized ends. FIGS. 1-5 illustrate systems and methods that provide a rail structure between a direct heart access and a peripheral blood vessel access site. FIG. 6 shows a variation where a rail structure is disposed between a direct heart access and a peripheral arterial access. FIGS. 7-14 illustrate systems and methods for closing a heart wall puncture. FIGS. 15-19 illustrate systems and methods that can be used to provide a rail between an externalized end at a peripheral venous site and an externalized end at a peripheral arterial site. The methods and systems of FIGS. 15-19 exploit the use of direct heart access to facilitate various techniques.

[0031] FIGS. 1-6 illustrate a method of accessing a heart. FIG. 1 illustrates a channel 2 established through a wall of the heart to provide direct access through the wall to the left ventricle 4. Prior to establishing the channel 2 through the heart, surgical access is provided to the outside of the heart. For example, a minimally invasive technique can be provided to expose the apex of the heart. The minimally invasive technique may involve spreading two or more ribs to provide for direct visualization of the heart. In some embodiments, the channel 2 is established with a small-profile needle 6. That is, the needle 6 may be inserted from the outside of the heart through the myocardium and into the left ventricle as shown. In at least one embodiment, the channel 2 is established using an 18-gauge, beveled needle. In some embodiments, the needle 6 includes a collapsible sheath to establish the channel 2 through the heart wall.

[0032] FIG. 2 shows an elongate member 10 advanced through the channel 2 into the left ventricle 4. For example, the elongate member 10 can be inserted such that a distal end thereof is advanced through the needle 6 into the ventricle as shown. The proximal end can remain outside the patient at this stage. The elongate member 10 can be similar to a stiff guidewire. In some embodiments, the elongate member 10 has a flow directed device such as a small balloon disposed at the distal end thereof.

[0033] FIG. 3 shows the needle 6 can be removed after the elongate member 10 is advanced into the left ventricle 4. In some embodiments, an introducer sheath or other spanning sheath 12 is fitted over the elongate member 10 and advanced over the elongate member 10 until the spanning sheath 12 spans across the heart wall. In some embodiments, the spanning sheath 12 is a low-profile sheath. In some embodiments, the spanning sheath is a 4 or a 5 French sheath. In some embodiments, the spanning sheath is 16-gauge or 18-gauge. Preferably the spanning sheath 12 is configured to limit or prevent backflow of blood out of the ventricle which is a high pressure chamber.

[0034] FIGS. 4-6 illustrate methods of vascular access, whereby an access catheter can be advanced from a peripheral venous site to the heart. FIG. 4 illustrates an access catheter 14 advanced through venous vascular path, e.g., from a femoral or other peripheral vein, through the inferior or superior vena cava, and into the heart.

[0035] FIG. 5 shows a distal portion 16 of the access catheter 14 is advanced across the intra-atrial septum into the left atrium 20. In one method, the elongate member 10 is drawn into the access catheter 14. In some embodiments, the distal portion 16 of the access catheter 14 may include a means for capturing the elongate member 10. In at least one embodiment, a snare 30 extends from the distal portion 16 of the access catheter 14 and entraps or captures the elongate member 10. The elongate member 10 is then drawn into the access catheter 14. The elongate member 10 can be tensioned between the distal portion 16 of the access catheter 14 and the channel 2. Alternatively, the access catheter 14 may be modified such as by being shortened and/or equipped with appropriate valves to be introduced through the left atrial wall using access methods discussed in U.S. Patent Application Publication Number US 2013/0041395, which is incorporated herein by reference. Further details of performing procedures using a taught platform between the access catheter 14 as illustrated or modified and a ventricle wall (e.g., with a base or footing deployed adjacent to an inner surface of the ventricle wall, with tines at least partially embedded in the wall, or with a trans-apical channel) are discussed in International Publication Number WO 2014/138284, which is incorporated herein by reference.

[0036] In some embodiments, the venous-to-apex rail is used to deploy a prosthesis (not shown) to the mitral valve 25. A venous-to-apex rail is established as shown above in FIG. 5. Tension is applied through the elongate member 10 in the apical direction, e.g., by pulling on the proximal externalized end, to draw the prosthesis from the access catheter 14. In some embodiments, the prosthesis is delivered by a second catheter (not shown), which is threaded over the venous-to-apex rail. In at least one embodiment, the venous-to-apex rail passes through the lumen of the prosthesis and is used to assist in seating the prosthesis onto the mitral valve 25. In some embodiments, the prosthesis is deployed between the anterior and posterior mitral valve leaflets at the level of the mitral valve annulus. In at least one embodiment, the prosthesis is deployed by expanding a balloon within the lumen of the prosthesis to seat the prosthesis in the mitral valve annulus. In some embodiments, the prosthesis is deployed by retracting a sheath to expose the prosthesis and to permit the prosthesis to expand into secure engagement with the mitral valve annulus.

[0037] In some embodiments, the venous-to-apex rail is used to deploy an annuloplasty ring. Annuloplasty rings are discussed in U.S. Pat. No. 5,888,240, which is incorporated herein by reference. In some embodiments, an annuloplasty ring is deployed alternatively or in addition to seating a prosthesis onto the mitral valve 25.

[0038] FIG. 6 illustrates alternative embodiment, in which a rail with two externalized ends is provided between the apical access site discussed above and a peripheral artery. A path 14′ is shown, through which the elongate member 10 can travel to establish a rail that can be externalized at a peripheral artery. An arterial access catheter disposed at a peripheral location is advanced through the skin disposed over a peripheral artery and into the peripheral artery. In some embodiments, the arterial access catheter is introduced at a brachial artery and can be passed through the left subclavian artery 20, as illustrated in FIG. 6 by the solid line that extends through the left subclavian artery 20. In at least one embodiment, the arterial access catheter can be introduced at a femoral artery, and passed through the iliac artery 26, as illustrated in FIG. 6 by the dashed line that extends through the iliac artery 26. In some embodiments, the elongate member 10 is advanced antegrade into the aorta and/or into more distal arteries, to be drawn into the arterial access catheter. In some embodiments, the elongate member 10 is advanced antegrade into the subclavian artery 20, where a snare disposed through the arterial access catheter couples with elongate member 10. In at least one embodiment, the elongate member 10 is advanced antegrade into the iliac artery 26, where a snare disposed through the arterial access catheter couples with elongate member 10. After the snare or other capturing device disposed through the access catheter couples with the elongate member 10, the distal end of the elongate member 10 is drawn out of (e.g., externalized at) the arterial access site.

[0039] Thus, the path 14′ defines two example routes for an apex to arterial rail structure. The route to the subclavian artery 20 is advantageous in providing a straighter path and is more suitable for smaller and/or lower profile devices. The route to the iliac artery 26 is advantageous for larger and/or higher profile devices that, by virtue of the rail structure provided by the elongate member 10, can easily track the relatively more tortuous path to the heart. Other peripheral sites could be used to externalize the distal end of the elongate member 10.

[0040] FIGS. 7-14 show methods for closing the apical site through which the elongate member 10 entered the left ventricle 4. FIG. 7 shows that in one method the spanning sheath 12 is first removed from the apex of the left ventricle 4. If no bleeding results after removal of the spanning sheath 12, the elongate member 10 is then removed from the heart. In some embodiments, the myocardium is sutured at the site of apical access to compress the tissue and close the site of apical access.

[0041] FIGS. 8-14 show methods for reducing bleeding that follows removal of the spanning sheath 12. FIG. 8 illustrates an embodiment where a compression member 32 is advanced over the proximal portion of the elongate member 10 until the compression member 32 contacts the heart. In some embodiments the compression member 32 includes means to introduce biological glue onto the epicardial surface 34 of the left ventricle 4. In some embodiments, the compression member 32 is held against the epicardial surface 34 for 30 seconds to 5 minutes to reduce bleeding. After bleeding has been reduced, the compression member 32 is withdrawn from epicardial surface 34 and the elongate member 10 is removed from the heart.

[0042] FIG. 9 illustrates various configurations of the compression member 32. In some embodiments, the compression member 32 is blunt-tipped. In some embodiments, the compression member 32 is disc-shaped.

[0043] FIGS. 10-14 illustrate a device 40 for closing a cardiac access channel 2. The device 40 provides for controlled dispensing of a closure medium in the pericardium or onto the epicardium. Referring to FIGS. 11 and 12, the device 40 comprises an elongate body 42 having a proximal end 44 and a distal end 46. The proximal end 44 has a first opening 50 for delivering a closure medium and a second opening 52 for delivering a pressurizing medium. The distal end 46 has a first fillable member 54 that comprises a distal face 56, an enclosure 58 disposed at the distal face 56 and extending proximally therefrom, and one or more pores 60 disposed through the enclosure 58 at the distal face 56 thereof. In some embodiments, the distal face 56 has first and second traverse dimensions 53, 55 that are larger than cardiac access channel to be closed. In at least one embodiment, the first and second traverse dimensions 53, 55 are at least four times the size of the cardiac access channel to be closed. In at least one embodiment the first and second traverse dimensions 53, 55 are at least 12 mm.

[0044] The first fillable member 54 is in fluid communication with the first opening 50 such that the closure medium can be delivered to the first fillable member 54. The distal end 46 has a second fillable member 62 in fluid communication with the second opening 52 such that the pressuring medium can be delivered to the second fillable member 62. The first and second fillable members 54, 62 are arranged such that when the first fillable member 54 contains the closure medium and the second fillable member 62 contains the pressurizing medium, the closure medium is disposed through the pore(s) 60.

[0045] FIGS. 15-19 illustrate a method of placing a cardiovascular prosthesis that can be used for cardiac devices and also for deploying devices in the aorta and other large vessels close to the heart. A delivery system 70 is advanced percutaneously from a peripheral blood vessel access site into the left atrium of a heart. The left ventricle is accessed from outside the heart through the wall of the heart at or adjacent to the apex of the heart by placing a spanning sheath 12 therethrough. An elongate member 10 is advanced through the spanning sheath 12. An arterial access catheter is introduced into or through a peripheral artery. The elongate member 10 is advanced antegrade, and is captured by or through the access catheter, for example by a snare that couples with the elongate member 10, as described above. The elongate member 10 is drawn into the arterial access catheter after traversing one branch of the path 14′ (e.g., into the subclavian or into the iliac). FIG. 16 shows that the elongate member 10 is also captured by a snare or loop 72 or similar structure that is extended from the distal portion 16 of the access catheter 14. FIG. 16 shows the delivery system 70 is linked with the elongate member 10 to provide a venous-arterial rail for delivery of a prosthesis into the heart and/or the aorta.

[0046] In some embodiments, the delivery system 70 accesses the left atrium through the left atrial wall using methods discussed in U.S. Patent Application Publication Number US 2013/0041395, which is incorporated herein by reference. In some embodiments, a delivery system 70 that accesses the left atrium through the left atrial wall is used to deploy a taught ventricular platform extending to a position adjacent an inner wall of the ventricle, extending to a position at least partially embedded in a wall about a ventricle, or extending completely through a ventricle wall as in a transapical channel as discussed in International Publication Number WO 2014/138284, which is incorporated herein by reference.

[0047] FIGS. 17-19 illustrate treating a condition in the heart and/or arterial vasculature over the venous-arterial rail. The loop 72 of delivery system 70 links to the elongate member 10. In some embodiments, the delivery system 70 links to the elongate member 10 subsequent to the elongate member 10 coupling with the arterial access catheter. In some embodiments, the delivery system 70 links to the elongate member 10 before the elongate member 10 has coupled to the arterial access catheter. In some embodiments, tension in the proximal end of the feed wire 74 is reduced to allow the wire 74 to extend from the delivery system 70 and to track along the elongate member 10 into the arterial vasculature. In the arterial vasculature, the feed wire 74 follows and may in some cases couple with the elongate member 10 along the path 14′, as described above. Tension can be applied from outside the cardiac access site to the elongate member 10 to draw the feed wire 74 from the delivery system 70 and into the ventricle 4. Further tension on the elongate member 10 can cause the prosthesis 80 (discussed below) to be drawn out of the delivery system 70. Tension on the elongate member 10 applied at a distal arterial site (e.g., on an externalized distal end of the elongate member 10 after the elongate member 10 has traversed one of the branches of the path 14′) can draw the feed wire 74 and/or the prosthesis 80 through the aortic valve 24 and/or to the peripheral artery.

[0048] In some embodiments, a prosthesis 80 is delivered to the heart through the delivery system 70. In at least one embodiment, tension is applied through the elongate member 10 from a proximal externalized end of the elongate member 10 in the apical direction to draw the prosthesis 80 from the delivery system 70. After the prosthesis 80 enters the left ventricle 4, tension is applied to the elongate member 10 from a distal externalized end of the elongate member 10 that has been externalized after following a branch of the path 14′ to draw the prosthesis 80 into or through the aortic valve 24. Thereafter, the prostheses 80 can be deployed in the aortic valve space or in the vasculature, e.g., in the ascending aorta. In some embodiments, the prosthesis 80 is deployed in the aortic valve annulus. In FIG. 19, the feed wire 74 extends through the lumen of the prosthesis 80, while the elongate member 10 is outside the lumen of the prosthesis 80. In some embodiments, the prosthesis 80 is positioned at the aortic valve 24 and held in place while the elongate member 10 is withdrawn from the aortic valve 24. In some embodiments, the prosthesis 80 is held in place by partially deploying the prosthesis 80. The prosthesis 80 can be self-expandable such that withdrawal of a sheath permits a portion or all of the prosthesis 80 to expand. The prosthesis 80 can be secured to the elongate member 10 while a sheath retaining the prosthesis 80 in a low-profile configuration is withdrawn. As the sheath is withdrawn, the prosthesis 80 is permitted to expand and does expand by virtue of an elastic or shape memory material or member forming a part thereof. The prosthesis 80 could be mounted on a balloon or other expandable member capable of deploying the prostheses 80. In some embodiments, the elongate member 10 is withdrawn from the aortic valve 24 by drawing the elongate member 10 toward the peripheral arterial access site along one of the branches of the path 14′ e.g., by pulling on the distal externalized end. In some embodiments, the elongate member 10 is withdrawn from the aortic valve 24 by disengaging the elongate member 10 from the feed wire 74 and pulling on the proximal externalized end of the elongate member 10 and in the apical direction.

[0049] In some embodiments, an over-the-wire catheter is used to move the prosthesis 80 along the venous-to-apex rail, along the apex-to-arterial rail, or along the venous-to-arterial rail. The rail can be pulled tight to straighten the rail in certain segments, e.g., from the heart apex through the aortic valve or through the mitral valve. In some embodiments, the prosthesis 80 is coupled to the feed wire 74 and pulled along with the rail. The prosthesis 80 may be coupled to the feed wire 74 by a variety of methods including releasably attaching or crimping onto the feed wire 74 a retaining platform (not shown) that temporarily holds the prosthesis 80 in an undeployed configuration. In other words, systems and method disclosed herein can have a first configuration or mode where a rail can be held stationary, while permitting a catheter or other device that may carry the prosthesis 80 to move relative to the rail such that the catheter, device or prosthesis can be advanced or retracted over the rail. The systems and method herein can have a second configuration or mode where the rail can be coupled to a catheter, device or prosthesis for no relative movement between the rail and the catheter, device or prosthesis such that the rail can be moved through the patient carrying the catheter, component and/or prosthesis. The first configuration can provide a direct push-pull mode. The second configuration can provide an indirect push-pull mode. The second configuration also enable the catheter, device or prosthesis to be pulled from distal a target site or proximal of a target site.

[0050] The prosthesis 80 may also be introduced to the heart using methods such as those described in International Application Number PCT/US2014/041366, which is incorporated herein by reference.

[0051] Although the present invention has been disclosed with reference to certain specific embodiments of devices and methods, the inventors contemplate that the invention more broadly relates to methods disclosed above, such as those useful for orienting a catheter with respect to an anatomical structure, as well as performing diagnostic and/or therapeutic procedures in the heart or adjacent the heart. For instance, one could place a treatment device, including a stent-graft, in the ascending aorta, the aortic root, the descending aorta, or the abdominal aorta. Accordingly, the present invention is not intended to be limited to the specific structures and steps disclosed herein, but rather by the full scope of the attached claims.