Percutaneous arterial access to position trans-myocardial implant devices and methods
Inventors
Van Bladel, Kevin • Nikolic, Serjan • Annest, Lon • Arcia, Rovil
Assignees
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Publication Number
US-11478353-B2
Publication Date
2022-10-25
Expiration Date
Abstract
A system for treating a heart includes a catheter that is advanceable into a chamber of the heart and that is repositionable within the chamber between a septal wall and an external wall to enable penetration of the septal and external walls via a needle that is disposed within a lumen of the catheter. A first guidewire is deliverable through the penetration of the septal wall so that a distal end of the first guidewire is disposed within another chamber of the heart. A second guidewire is deliverable through the penetration of the external wall so that a distal end of the second guidewire is disposed externally of the external wall. The first guidewire is connectable to the second guidewire to join or form a path within the chamber that extends between the septal wall and the external wall.
Core Innovation
The invention provides a minimally invasive percutaneous cardiac treatment system and method that positions catheters or elongate shafts to access a heart having first and second chambers separated by a septum, with the second chamber having an exterior wall. The distal end of an elongate shaft is positioned adjacent the septum, and the septum is penetrated to deliver a first guidewire from within a lumen so that the distal end of the first guidewire is positioned in the first chamber and is extractable therefrom. After penetrating the septum, the distal end of the elongate shaft is repositioned within the second chamber so that the distal end is adjacent the external wall.
The method then penetrates the external wall and delivers a second guidewire from within the lumen across the external wall so that the distal end of the second guidewire is positioned outside the external wall and is extractable therefrom. While a portion of the first guidewire and a portion of the second guidewire are positioned within the first chamber, the first guidewire is coupled to the second guidewire outside the body so that the first guidewire is locked relative to the second guidewire outside the body. The coupled end of the first guidewire and the second guidewire is delivered through the lumen of the elongate shaft to join a path within the second chamber between the penetration of the septum and the penetration of the external wall.
In additional aspects, the invention delivers an implant having first and second anchors connected by an elongate tension member to urge and engage heart walls. The disclosed system components include a septal anchor delivery and alignment device with a deployable and retractable anchor and a trans-septal needle, and an apical anchor device with a curved needle and a pivoting anchor. The disclosure further includes snare devices for in situ guidewire coupling, an axial force-application tool, and a tether cutter, and reports exemplary percutaneous delivery and anchor engagement in porcine and ovine models.
Claims Coverage
The provided content includes two independent method claims that share a common inventive approach: percutaneous advancement and repositioning of elongate shafts to penetrate a septum and an external wall, delivery and extraction of first and second guidewires, and coupling of the guidewires to form a joined path or a solitary or unitary guidewire through the septum and external wall. Dependent claim coverage further narrows or refines coupling and anchoring mechanisms via specific structural features such as snare devices, alignment devices, needle-based penetration, and pivoting or curved needle anchor delivery.
Joined intra-chamber path formed by coupled guidewires using septum and external wall penetrations
Positioning an elongate shaft adjacent the septum, penetrating the septum to deliver a first guidewire into the first chamber, repositioning the elongate shaft adjacent an external wall, penetrating the external wall to deliver a second guidewire outside the external wall, coupling the first guidewire to the second guidewire outside the body while a portion of each guidewire is positioned within the first chamber, and delivering a coupled end of the first and second guidewires through the lumen so that a joined path within the second chamber extends between the penetration of the septum and the penetration of the external wall.
Solitary or unitary guidewire through septum and external wall using two shafts with coupled guidewires
Advancing a first elongate shaft into the first chamber and advancing a second elongate shaft into the second chamber, positioning the second elongate shaft adjacent the septum, penetrating the septum and delivering a first guidewire across the septum, coupling within the first chamber the distal end of the first elongate shaft with the distal end of the first guidewire and extracting the first guidewire outside the patient body, repositioning the distal end of the second elongate shaft adjacent the external wall and delivering and extracting a second guidewire outside the external wall, coupling the first guidewire to the second guidewire to form a path that extends into and through the septum and external wall, delivering a coupled end through the lumen into the second chamber, and extracting the coupled end so that a solitary or unitary guidewire extends through the septum, through the second chamber, through the external wall.
Anchor and tension engagement urging septum and external wall into engagement
Advancing a first anchor into the first chamber against the septum via a tension member, slidably coupling and advancing a second anchor into engagement against the external wall, and applying tension through the tension member to urge the septum and external wall into engagement.
Guidewire coupling using a coupling member at proximal ends
Securing a coupling member to the proximal ends of a first and second guidewire to couple the two guidewires together.
Needle-based penetration through septum and external wall from within a second elongate shaft
Penetrating the septum and penetrating the external wall by advancing a needle through those structures from within the lumen of a second elongate shaft.
Penetration by advancing respective guidewires through septum and external wall
Penetrating a septum by advancing a first guidewire through the septum and penetrating an external wall by advancing a second guidewire through the external wall.
Across the independent claims, the inventive coverage centers on delivering and extracting first and second guidewires across a septum and an external wall, coupling the guidewires to create a joined intra-chamber path or a solitary or unitary guidewire through the septum and external wall. The provided dependent excerpts further cover anchor-and-tension engagement, proximal coupling of guidewires, and two alternative penetration mechanisms based on needle advancement or guidewire advancement.
Stated Advantages
Reduced invasiveness.
Reduced or avoided cardiopulmonary bypass.
Reduced or controlled wall penetration to limit trauma and bleeding.
Documented Applications
Minimally invasive percutaneous cardiac treatment in which catheters or elongate shafts position guides to penetrate a septum and an external wall for heart treatment, exemplified in porcine and ovine models.
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