Transseptal Delivery System for Aortic Valve Therapeutic Devices
A system and method used to deliver an aortic valve therapeutic device, such as a delivery device for an aortic valve replacement, to an aortic valve site. The system includes a cable percutaneously introduced a cable into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The therapeutic device is passed over an end of the cable at the venous side and is secured to the cable. The therapeutic device is pushed in a distal direction while the second end of the cable is pulled in the proximal direction to advance the therapeutic device to the mitral valve site. A left ventricle redirector aids in orienting the therapeutic device and preventing migration of the cable towards delicate mitral valve structures and chordae tendoneae during advancement of the therapeutic device.
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This application is a continuation of U.S. application Ser. No. 16/365,601, filed Mar. 26, 2019, which claims the benefit of US Provisional Application U.S. 62/647,894, filed Mar. 26, 2018, and which is a continuation in part of PCT/US17/62913, filed Nov. 22, 2017. U.S. application Ser. No. 16/365,601 is also a continuation in part of PCT/US18/045445, filed 6 Aug. 2018, which claims the benefit of US Provisional Applications U.S. 62/541,761, filed Aug. 6, 2017, U.S. 62/541,771, filed Aug. 6, 2017, U.S. 62/567,736, filed Oct. 3, 2017, and U.S. 62/647,894, filed Mar. 26, 2018. Each of these applications is fully incorporated herein by reference.
BACKGROUNDA system that is used for transeptally driving mitral valve therapeutic devices into place is described in Applicant's co-pending PCT Application No. PCT/US17/62913 (Ref: ATR-820). A modified version of that system and method are described herein for use in implanting an aortic valve therapeutic device, such as an aortic valve replacement device or a device for repairing an aortic valve. The method described below and illustrated in the attached drawings differs from that described in PCT/US17/62913 primarily in that the aortic valve therapeutic device, once positioned in the left ventricle, is then advanced to the native aortic valve location.
A system and method are described herein for use in moving an aortic valve therapeutic device (“AVTD”) into position for treating an aortic valve. The presently disclosed system is designed to aid in the delivery of an AVTD to an aortic valve location. The terms “aortic valve therapeutic device” or “AVTD” used here refer to any device that may be delivered to the native aortic valve site for a therapeutic purpose. In the description that follows, the AVTD is shown as an aortic valve delivery system carrying a replacement aortic valve for a TAVR procedure, but it should be understood that the system and method described may be used to deliver other types of AVTD's such as those used to repair an aortic valve.
As will be appreciated from a review of the more detailed discussion that follows, the cable system functions to both push the proximal end of the AVTD while simultaneously pulling on the distal nose of it with equal and coordinated force to drive the AVTD across the interatrial septum. Pulling down further on the distal nose of the AVTD using the cable provides a steering force that serves to direct the stiff, bulky AVTD into position across the interatrial septum, and into the left atrium. The AVTD is further advanced through the center of the mitral valve at an angle that is perpendicular to the MV plane by use of a steering mechanism present in a unique device referred to as the LV redirector (described in detail below). From the left ventricle, the AVTD are moved, while remaining in contact with one another, towards the native aortic valve site until the AVTD is positioned at that site.
In the description of system and method below, the access points for the components of the system are described as the right femoral vein for the venous access and the left femoral artery for the arterial access. However, the system and method can just as readily be used with a different combination of venous and arterial access. For example, venous access may be gained via the right femoral vein and arterial access may be gained via the right femoral artery. Alternatively, both access points may be on the left side. In yet another embodiment, venous access is gained via the left femoral vein and arterial access is gained via the right femoral artery.
System
Referring to
The system further includes a tracker balloon catheter 16, shown extending through the RLC 10 in
In
A membrane 30 is positioned along a portion of the distal part of the shaft and along the external portion of the pullwire 26. When the pullwire is relaxed and the shaft is in the straight configuration, the panel and pull wire run along the distal part of the shaft. The membrane forms the D-shaped barrier shown in
Note that the term “pullwire” is not intended to mean that the pullwires must be formed of wire, as that term is used more broadly in this application to represent any sort of tendon, cable, or other elongate element the tension on which may be adjusted to change the shape of the LVR or other catheter in which the pullwire is used.
The conveyor cable 18, shown in
Segmental tensioner 22, shown in
Method
As an initial step, the Right-Left Catheter (RLC) 10 is introduced using the well-known technique of transseptal catheterization from the right atrium (RA) into the left atrium (LA), such as by using a Brockenbrough needle assembly 12 through the RLC, which is positioned in the right femoral vein (RFV) as shown in
The tracker balloon catheter 16 is deflated (
The left ventricle redirector (LVR) is introduced over the cable (
Alternatively, as shown in
A cable lock may be used to lock the proximal end of the LVR onto the conveyor cable outside the access point to the femoral artery so that the LVR and cable will move together. The user pulls on the cable on the patient's venous side (the patient's right which is the left side of the drawings). On the patient's arterial side (the right side of the drawings), the user pushes the LVR.
Once within the heart, the LVR is pushed strongly into the apex of the left ventricle by a pushing force applied to its proximal end.
The RLC is next withdrawn from the venous side. The cable is still in place as shown. The AVTD is connected to the cable.
Once the AVTD has entered the venous circulation it is advanced toward the right atrium (
At this point, a significant pulling force is applied to the AVTD/tensioner assembly by the cable. This force is slightly more than the “push force” force on the AVTD so as to pull the distal nose of the AVTD down and to the patient's left through the interatrial septum.
The pullwire of the LVR is activated, placing its protective panel in the deployed position in the left ventricle.
All patents and patent applications referred to herein, including for purposes of priority, are fully incorporated herein by reference.
Claims
1. A system for of delivering an aortic valve therapeutic device to an aortic valve site, comprising:
- a cable proportioned for introduction into a vasculature of a patient and for positioning in the vasculature to run from a femoral vein, through a heart via a transseptal puncture, and to a femoral artery such that the positioned cable has a first end external to the patient at the femoral vein and a second end external to the patient at the femoral artery;
- an aortic valve delivery device with an aortic valve replacement device thereon, the aortic valve delivery device removably attachable to the first end of the cable and including a distal nose;
- a left ventricle redirector (LVR) having a tubular lumen, the lumen at the distal end advanceable over the second end of the cable at the femoral artery and advanceable though an aorta and aortic valve to a left ventricle,
- wherein the distal nose of the aortic valve delivery device is engageable with the distal end of the LVR, and wherein the distal end of the LVR is actively steerable within the heart when engaged with the aortic valve therapeutic device to actively change an orientation of the aortic valve delivery system within the heart.
2. The system of claim 1, further including a tubular connector having a distal end and a proximal end, wherein the distal nose of the aortic valve delivery device is engageable with the proximal end of the tubular connector and the distal end of the tubular connector is engageable with the distal end of the LVR.
3. The system of claim 1, further including a right-to-left conduit (RLC) insertable from the femoral vein into an inferior vena cava into a right atrium, through an interatrial septum into a left atrium, through a mitral valve to a left ventricle, and through an aortic valve into an aorta, wherein the second end of the cable is insertable into the RLC at the femoral vein and advanceable through the RLC and out a distal end of the RLC.
4. The system of claim 3, further including:
- a balloon catheter having an expandable balloon, the balloon catheter introducible into in the right atrium, insertable through the interatrial septum into the left atrium, and inflatable within the left atrium such that the balloon catheter is carried by blood flow into and through the aorta to the femoral artery, wherein the RLC is introduceable over a proximal end of the balloon catheter and advanceable to position a distal end of the RLC in the left femoral artery, wherein the second end of the cable is introduceable into the RLC at the femoral vein and advanceable to the distal end of the RLC; and
- a snare for capturing the second end of the cable via the femoral artery and positioning the second end external to the body.
Type: Application
Filed: Aug 25, 2021
Publication Date: Mar 17, 2022
Applicant: Synecor LLC (Durham, NC)
Inventors: Richard S Stack (Chapel Hill, NC), William L. Athas (Chapel Hill, NC), Kevin W. Johnson (Durham, NC)
Application Number: 17/411,489