STABILIZATION OF A TRANSSEPTAL DELIVERY DEVICE
A transcatheter delivery device including a catheter and at least one stabilizer useful for trasnsseptal procedures. The stabilizer includes a shaft connected to an anchor. The anchor has a delivery position in which the anchor is collapsed against the shaft and a deployed position in which the anchor expands to engage a pulmonary vein or atrial appendage to support the catheter within the septal wall as the catheter moves within a left atrium. Various disclosed delivery devices are also configured to ablate tissue proximate the anchor and/or can be disconnected from the delivery device after the procedure to occlude an atrial appendage. Methods of using the disclosed delivery devices and treating a heart are also disclosed.
This Non-Provisional Patent Application claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 62/487,836, filed Apr. 20, 2017, the entire teachings of which are incorporated herein by reference.
BACKGROUNDThe present disclosure relates to devices and methods for stabilizing a device positioned within a septal wall of a human heart. More particularly, it relates to devices and methods for transseptally accessing a left atrium of a heart for delivery of an apparatus, such as a prosthesis, ablation apparatus or other apparatus.
The heart is a four-chambered pump that moves blood efficiently through the vascular system. Blood enters the heart through the vena cava and flows into the right atrium. From the right atrium, blood flows through the tricuspid valve and into the right ventricle, which then contracts and forces blood through the pulmonic valve and into the lungs. Oxygenated blood returns from the lungs and enters the heart through the left atrium and passes through the mitral valve into the left ventricle. The left ventricle contracts and pumps blood through the aortic valve into the aorta and to the vascular system.
Diseased or otherwise deficient heart valves can be repaired or replaced with an implanted prosthetic heart valve. Conventionally, heart valve replacement surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. Traditional open-heart surgery inflicts significant patient trauma and discomfort, and exposes the patient to a number of potential risks, such as infection, stroke, renal failure, and adverse effects associated with the use of the heart-lung bypass machine, for example.
Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. With these percutaneous transcatheter (or transluminal) techniques, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example, through an opening in the femoral artery and through the patient's vasculature to the target site. A common approach for accessing the left side of the heart is a transseptal access from the right atrium through the intra-atrial septum and to the left atrium.
Other heart treatment procedures can be conducted via transseptal delivery of a transcatheter device. Such procedures can include heart tissue ablation for treatment of concomitant disease or delivery of an appendage plug for occluding a left atrial appendage, for example.
The disclosure addresses problems and limitations associated with related delivery devices for transseptally accessing a left atrium.
SUMMARYOne aspect of the present disclosure relates to a delivery device including a catheter and at least one stabilizer. In various embodiments, the catheter includes a plurality of lumens. One lumen optionally can serve as a passageway for a prosthesis or other apparatus to be delivered to the left atrium. Additional lumens can serve as a delivery conduit for respective stabilizers or other devices. During advancement of the delivery device through a septal wall, the stabilizers can be positioned within respective lumens. Once the delivery device is in position within the septal wall, an anchor of each stabilizer can be guided to and deployed to engage a pulmonary vein or a left atrial appendage to stabilize the delivery device, thus reducing the likelihood of damage to the septal wall as the catheter is navigated around the left atrium. In various embodiments, the stabilizer includes one or more ablation elements. In other embodiments, the stabilizer can be disconnected from the delivery device for implantation, for example, within the left atrial appendage to occlude the atrial appendage.
Another aspect of the present disclosure relates to methods of delivering an apparatus, such as a prosthesis, ablation or other apparatus, to the left atrium via transseptal delivery. The method includes providing a delivery system including a delivery device having a catheter and at least one stabilizer. After the delivery device is advanced through the septal wall, the stabilizer is deployed from the catheter to stabilize the delivery device with respect to the septal wall. In various embodiments, each stabilizer is deployed to engage one respective pulmonary vein. In other embodiments, one stabilizer is deployed to engage the left atrial appendage. In some embodiments, once the stabilizer is deployed, the prosthesis or other apparatus can be delivered through one respective lumen in the delivery device to the left atrium for treatment of the heart. In other embodiments, ablation is performed with the stabilizer, once deployed. Once a treatment procedure within the left atrium is complete, the stabilizer can optionally be disengaged from the respective anatomy, transitioned to the delivery position and then withdrawn from the patient along with the delivery device. Alternatively, the stabilizer can be disconnected from the delivery device and left within the patient (e.g., to occlude the left atrial appendage).
Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician.
By way of background, one example of a treatment procedure for a human heart 10 including an inferior vena cava 12, right atrium 14, septal wall 16, left atrium 18 and a plurality of valves, including a mitral valve 20, is generally depicted in
Turning now also to
The disclosed stabilizers 60 can take a variety of configurations transitioning from a compressed, delivery arrangement to an expanded, deployed arrangement for engagement within a bodily lumen, such as one pulmonary vein 22 or atrial appendage 24. A few illustrative examples of how the stabilizers 60 can alternatively be configured are discussed below with respect to the remaining figures.
In one embodiment schematically illustrated in
Yet another embodiment is illustrated in
Referring also now to
As shown, the anchor 364 can optionally be housed within an outer, first balloon 370 and an inner, second balloon 372. Each tension member 368 is at least partially retained between the two balloons 370, 372 and functions in a similar manner as above in the embodiment where the balloons 370, 372 are not provided. The second balloon 372 includes one or more channels 374 through which the tension members 368 is routed to and from the anchor 364. The balloons 370, 372 are made of a compliant material so that they can expand along with the anchor 364. Suitable materials for balloons 370, 372 include nylon, Pebax® thermoplastic elastomers, polyurethane, or the like and provide a particularly atraumatic stabilizer 360.
Referring now also to
As schematically illustrated in
In one example, the ablation elements (e.g., ablation elements 572) are placed at the ostium of the pulmonary veins or the ostium of the left atrial appendage. In yet another example, a multitude of electrodes (e.g., ablation elements 572) are provided on the anchor that are capable of delivering radio frequency (RF) energy or high voltage pulses to deliver irreversible electroporation.
All of the above embodiments can optionally be configured to release the anchor from the stabilizer and delivery device. Release from the delivery device could be done mechanically. For example, a ball in socket mechanism could be used to attach the stabilizer to the actuating shaft (e.g., 62) and released by use of an actuator in a user handle of the delivery device (not shown) or the socket itself could be retractable into the catheter and made of a memory shape material such as Nitinol where retraction would cause the socket to change shape and release from the stabilizer. Alternatively, release of the anchor could be accomplished by looping a suture or the like through the anchor material (e.g. metal mesh cage) and threaded back through the catheter. The suture could be cut and removed at a proximal end of the catheter, exterior to the patient, by the clinician to selectively release the anchor. In yet another embodiment, the delivery device could provide an electromagnetic connection between the anchor and the shaft that could be modulated via current injected into the shaft to selectively release the anchor.
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
Claims
1. A delivery device for transseptal delivery of an apparatus to a human heart from a right atrium, through a septal wall and into a left atrium of the human heart; the delivery device comprising:
- a catheter including a first lumen in which a stabilizer is positioned; wherein the stabilizer has a delivery position in which the stabilizer is contained within the first lumen and a deployed position in which the stabilizer interconnects a portion of the human heart and the catheter; wherein the stabilizer is configured to engage a portion of a human heart selected from the group consisting of a pulmonary vein and a left atrium appendage.
2. The delivery device of claim 1, wherein catheter includes a second lumen in which a second stabilizer is positioned.
3. The delivery device of claim 1, wherein the stabilizer can be detached from the delivery device.
4. The delivery device of claim 1, wherein the stabilizer is configured to be non-occluding.
5. The delivery device of claim 1, wherein the stabilizer is a metal cage.
6. The delivery device of claim 1, wherein the stabilizer includes an ablation element.
7. The delivery device of claim 6, wherein the stabilizer includes a plurality of ablation elements spaced longitudinally along the stabilizer.
8. The delivery device of claim 1, wherein the stabilizer is inflatable.
9. The delivery device of claim 1, wherein the stabilizer includes an anchor secured to an actuator shaft that can vary a diameter of the anchor.
10. The delivery device of claim 1, wherein the delivery device includes a plurality of tension members that can vary a diameter of the stabilizer.
11. A method of stabilizing a catheter during transseptal access of a left atrium of a heart of a patient; the method comprising the steps of:
- providing a first delivery device including:
- a catheter and a first stabilizer positioned within the catheter; the stabilizer including a first anchor secured to a first shaft, the first anchor having a delivery position and a deployed position; wherein a diameter of the first stabilizer is greater in the deployed position than in the delivery position;
- with the first stabilizer in the delivery position, directing the delivery device through a vascular system of the patient to position the delivery device within a septal wall; and
- deploying the first stabilizer so that the first anchor engages one of a first pulmonary vein and a left atrial appendage.
12. The method of claim 11, wherein catheter includes a second lumen in which a second stabilizer is positioned and the method further includes the step of deploying a second anchor of the second stabilizer to engage one of a second pulmonary vein and the left atrial appendage.
13. The method of claim 11, wherein the method further includes the step of detaching the first anchor from the first shaft.
14. The method of claim 11, wherein the first stabilizer is configured to be non-occluding.
15. The method of claim 11, wherein the first stabilizer is a metal cage.
16. The method of claim 11, wherein the first anchor includes an ablation element, the method further comprising the step of ablating tissue adjacent the first anchor.
17. The method of claim 16, wherein the first anchor includes a plurality of ablation elements spaced longitudinally along the first anchor.
18. The method of claim 11, wherein the first anchor is inflated to engage one of the first pulmonary vein and the left atrial appendage.
19. The method of claim 11, wherein the first anchor is secured to an actuator shaft; the method further comprising the step of adjusting the position of the actuator shaft to vary a diameter of the first anchor.
20. The method of claim 11, wherein the delivery device includes a plurality of tension members that can vary a diameter of the first anchor.
Type: Application
Filed: Apr 20, 2018
Publication Date: Oct 25, 2018
Inventor: Alexander Hill (Blaine, MN)
Application Number: 15/958,545