US20180303488A1 - Stabilization of a transseptal delivery device - Google Patents

Abstract

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• 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.
BACKGROUND
• The 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.
SUMMARY
• One 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).
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross-sectional illustration of a procedure for transseptally delivering an apparatus (not visible) to a left atrium of a human heart with a delivery device.
• FIG. 2 is a partial, schematic illustration of a delivery device including a catheter and two stabilizers.
• FIG. 3A is a partial, schematic illustration of a delivery device in a delivery position.
• FIG. 3B is a partial, schematic illustration of the delivery device ofFIG. 3A in a deployed position.
• FIG. 4A is a partial, schematic illustration of an alternate delivery device in a delivery position.
• FIG. 4B is a partial, schematic illustration of the delivery device ofFIG. 4A in a deployed position.
• FIG. 5A is a partial, schematic illustration of another delivery device in a delivery position.
• FIG. 5B is a partial, schematic illustration of the delivery device ofFIG. 5A in a deployed position.
• FIG. 6 is a partial, schematic illustration of an alternate delivery device in an inflated, deployed position.
• FIG. 7 is a partial, schematic illustration of another delivery device in a deployed position, the delivery device including an anchor having at least one ablation element.
DETAILED DESCRIPTION
• 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 ahuman heart10 including aninferior vena cava12,right atrium14,septal wall16,left atrium18 and a plurality of valves, including amitral valve20, is generally depicted inFIG. 1. In this example, adelivery device30 including one or more coaxially arrangedcatheters32 carrying an apparatus (not visible) is maneuvered over aguide wire34, typically routed through thevena cava12 to theright atrium14 and to the patient'sseptal wall16. The delivery path can continue transseptally through the patient'sseptal wall16 to theleft atrium18 and resume, for example, by turning approximately 90° downward through the nativemitral valve20 or can travel topulmonary veins22 or a leftatrial appendage24, depending on the procedure. One of the difficulties in either positioning the prosthesis or other apparatus in theleft atrium18 or crossing themitral valve annulus20 with a transcatheter delivery device is stabilizing thedelivery device30 within theseptal wall16 during movement of thecatheter32. Although the point at which thecatheter32 passes through theseptal wall16 acts in some way as a stabilization point for thecatheter32, theseptal wall16 hole can be further damaged during the articulation of thecatheter tip36 into and through theleft atrium18. It is believed that the embodiments of the present disclosure will allow for atraumatic stabilization of a delivery device positioned within a septal wall causing less trauma to the septal wall as treatment is conducted. In addition, the disclosed stabilized delivery devices also provide for a more rigid backstop against which the distal tip of the delivery device can be steered. In further embodiments, the stabilizers disclosed herein can be configured to ablate pulmonary vein or left atrial appendage tissue. In addition, the stabilizers disclosed herein can also be configured to detach from the delivery device and occlude the left atrial appendage, as desired.
• Turning now also toFIG. 2, which schematically illustrates adelivery device50 having a catheter52 (shown as truncated) including a plurality oflumens54. Thecatheter52 is shown as having threelumens54, however, more orfewer lumens54 can be provided. In this embodiment, twolumens54 are provided forrespective stabilizers60. Eachstabilizer60 can include anactuating shaft62 and ananchor64 connected to a distal end66 of the actuatingshaft62. In some embodiments, theanchor64 is arranged and configured for engaging an inner surface of a respectivepulmonary vein22. In one example embodiment, eachanchor64 has an outer diameter in the range of about 9 mm to about 35 mm. Theanchors64 are shown as being cylindrical but can take other shapes. In addition, theanchor64 can be configured to allow blood to flow through the respectivepulmonary vein22. For example, theanchor64 can be generally tubular. Alternatively, the stabilizer can be arranged and configured for engaging an inner surface of a leftatrial appendage24. It may be desired to plug the leftatrial appendage24 after the delivery device is withdrawn from the patient and in this case, theanchor64 can be configured to disengage from both theshaft62 anddelivery device50 and theanchor64 can further be configured to occlude the leftatrial appendage24, as will be discussed in detail below. Thestabilizers60 of thedelivery device50 can be of the same configuration or can have different configurations.
• The disclosedstabilizers60 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 onepulmonary vein22 oratrial appendage24. A few illustrative examples of how thestabilizers60 can alternatively be configured are discussed below with respect to the remaining figures.
• In one embodiment schematically illustrated inFIGS. 3A-3B, astabilizer160 can include anactuator shaft162 attached to ananchor164 that can be a metal mesh cage made of nitinol or the like that has shape memory and is biased to a deployed position (FIG. 3B). In one example embodiment, theanchor164 has a greatest outer diameter in the range of about 9 mm to about 35 mm and can come in a multitude of sizes. Asheath168 is provided over theanchor164 in the delivery arrangement (FIG. 3A) to compress and retain theanchor164 against its natural bias. Once theanchor164 is positioned within the respective lumen of the anatomy, thesheath168 can be proximally retracted to allow theanchor164 to expand due to its natural bias. Theanchor164 is arranged and configured to expand and engage the anatomy, thus providing stability to the delivery device (see alsoFIGS. 1-2). Once the procedure is complete and the delivery device is to be withdrawn, thesheath168 can be distally advanced over theanchor164 to recapture and compress theanchor164 within thesheath168 for subsequent retraction and removal of thestabilizer160 from the patient. Thestabilizer160 can be used with thedelivery device50 and thecatheter52 ofFIG. 2 or an alternate delivery device.
• Yet another embodiment is illustrated inFIGS. 4A-4B, which shows astabilizer260 that can be used with thedelivery device50 and thecatheter52 ofFIG. 2 or alternate delivery device. Thestabilizer260 includes anexpandable anchor264 interconnected to anactuating shaft268, which are both positioned over arod262. In one example embodiment, theanchor264 has a greatest outer diameter in the range of about 9 mm to about 35 mm and has any of the properties of theanchors64,164 disclosed above. Adistal end266aof theanchor264 is fixedly secured to therod262 and aproximal end266bof theanchor264 is fixedly secured to theactuating shaft268. In this embodiment, proximal retraction of theactuating shaft268 correspondingly pulls theproximal end266bof theanchor264 proximally to correspondingly reduce the greatest outer diameter of theanchor264. This delivery position is illustrated inFIG. 4A. To transition theanchor264 into the deployed position ofFIG. 4B, theactuating shaft268 can be pushed distally to correspondingly push theproximal end266bof theanchor264 closer to thedistal end266aof theanchor264, thus expanding the greatest outer diameter of theanchor264 to engage theanchor264 with the vessel lumen and stabilize the delivery device. Another option would be to configure theshaft268 to be fixed and to use proximal and distal movement of therod262 as an actuator in a similar manner. For example, therod262 could be pushed distally with respect to theshaft268 to collapse theanchor264 and pulled proximally with respect to theshaft268 to expand the anchor264 (e.g., moving thedistal end266afarther or closer to theproximal end266b). Once the treatment procedure is complete, theactuating shaft268 can be proximally retracted to transition theanchor264 back into the delivery position for withdrawal within the respective catheter lumen (see, e.g.,catheter lumen54 ofFIG. 2).
• Referring also now toFIGS. 5A-5B, which illustrate analternate stabilizer360 that can be used with thedelivery device50 and thecatheter52 ofFIG. 2 or other delivery device. Thestabilizer360 includes ashaft362 interconnected to anexpandable anchor364. In one example embodiment, theanchor364 has a greatest outer diameter in the range of about 9 mm to about 35 mm and has any of the properties of theanchors64,164,264 disclosed above. A plurality ofelongate tension members368 extend along or through theshaft362 and circumscribe theexpandable anchor364. Eachtension member368 can be woven through theanchor364 to maintain thetension member368 in position around theanchor364. After wrapping around theanchor364, eachtension member368 extends proximally back through theshaft362. Thetension members368 are arranged and configured such that tension can be applied to thetension members368 to compress and restrain theanchor364 into the delivery position ofFIG. 5A. Thetension members368 can be, for example, sutures, filaments, cables, cords or the like. In one example embodiment, threetension members368 are provided. To deploy theanchor364 into the deployed position ofFIG. 5B, tension in thetension members368 can be lessened, thus allowing a greatest outer diameter of theanchor364 to expand, engage the vessel lumen and stabilize the delivery device. Once the treatment procedure is complete, thetension members368 can again be tensioned to compress theanchor364 back into the delivery position for withdrawal within the respective catheter lumen (see also,FIG. 2 and related disclosure).
• As shown, theanchor364 can optionally be housed within an outer,first balloon370 and an inner,second balloon372. Eachtension member368 is at least partially retained between the twoballoons370,372 and functions in a similar manner as above in the embodiment where theballoons370,372 are not provided. Thesecond balloon372 includes one ormore channels374 through which thetension members368 is routed to and from theanchor364. Theballoons370,372 are made of a compliant material so that they can expand along with theanchor364. Suitable materials forballoons370,372 include nylon, Pebax® thermoplastic elastomers, polyurethane, or the like and provide a particularlyatraumatic stabilizer360.
• Referring now also toFIG. 6, which illustrates analternate stabilizer460 that can be used with thedelivery device50 and thecatheter52 ofFIG. 2. Thestabilizer460 includes ashaft462 and aninflatable anchor464. Theinflatable anchor464 can, for example be a compliant balloon that is either elliptical or spherical upon inflation and made of nylon, Pebax® thermoplastic elastomers, polyurethane, or the like. In one example embodiment, theanchor464 has a greatest outer diameter in the range of about 9 mm to about 35 mm. To deploy theanchor464 from a delivery position in which theanchor464 is deflated (not shown) into the deployed position ofFIG. 6 in which a greatest diameter of theanchor464 is increased as compared to the delivery position, theanchor464 can be inflated via aninflation channel470 in theshaft462 or otherwise until theanchor464 engages a vessel lumen, such as a pulmonary vein or atrial appendage, to stabilize the delivery device. Once the treatment procedure is complete, theanchor464 can be deflated to transition theanchor464 back into the delivery position for withdrawal within the respective catheter lumen (see also,FIG. 2 and related disclosure).
• As schematically illustrated inFIG. 7, all of the stabilizers disclosed herein can also optionally be configured to ablate tissue of the anatomy proximate which the stabilizer is engaged. In one example embodiment, astabilizer560 can include one ormore ablation elements572 positioned on ananchor564 can be electrically connected to an ablation source via awire574 and configured to transfer ablation energy from the ablation source (not shown) to tissue (e.g., to thepulmonary vein22 oratrial appendage24 shown inFIG. 1). Ifmultiple ablation elements572 are positioned on eachstabilizer560, they may be configured to be individually energized so that deployment position of thestabilizer560 does not have to be very precise. Fewer ormore ablation elements572 can be utilized, as desired. Thestabilizer560 can otherwise take any of the forms and can be actuated similarly to any other of the stabilizers disclosed herein. As one illustrated example, theanchor564 can be positioned over arod562 and expansion and contraction of theanchor564 can be controlled with ashaft568 as also discussed above with respect toFIGS. 4A-4B.
• In one example, the ablation elements (e.g., ablation elements572) 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 elements572) 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 (20)

What is claimed is:

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 ofclaim 1, wherein catheter includes a second lumen in which a second stabilizer is positioned.

3. The delivery device ofclaim 1, wherein the stabilizer can be detached from the delivery device.

4. The delivery device ofclaim 1, wherein the stabilizer is configured to be non-occluding.

5. The delivery device ofclaim 1, wherein the stabilizer is a metal cage.

6. The delivery device ofclaim 1, wherein the stabilizer includes an ablation element.

7. The delivery device ofclaim 6, wherein the stabilizer includes a plurality of ablation elements spaced longitudinally along the stabilizer.

8. The delivery device ofclaim 1, wherein the stabilizer is inflatable.

9. The delivery device ofclaim 1, wherein the stabilizer includes an anchor secured to an actuator shaft that can vary a diameter of the anchor.

10. The delivery device ofclaim 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 ofclaim 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 ofclaim 11, wherein the method further includes the step of detaching the first anchor from the first shaft.

14. The method ofclaim 11, wherein the first stabilizer is configured to be non-occluding.

15. The method ofclaim 11, wherein the first stabilizer is a metal cage.

16. The method ofclaim 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 ofclaim 16, wherein the first anchor includes a plurality of ablation elements spaced longitudinally along the first anchor.

18. The method ofclaim 11, wherein the first anchor is inflated to engage one of the first pulmonary vein and the left atrial appendage.

19. The method ofclaim 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 ofclaim 11, wherein the delivery device includes a plurality of tension members that can vary a diameter of the first anchor.

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