PERICARDIAL ANCHORING SYSTEM
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for cardiac device anchoring and more specifically to accessing and anchoring in the pericardial space.
This application claims priority to U.S Provisional Application No. 63/182,727, filed Apr. 30, 2021, and U.S. Provisional Application No. 63/179,490, filed Apr. 25, 2021, the entireties of each of these application are hereby incorporated by reference herein for all purposes.
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
FIELDThe present disclosure relates generally to cardiac device anchoring and more specifically to apparatuses, systems, and methods that include accessing and anchoring in the pericardial space.
BACKGROUNDThere is a need for anchoring medical devices in the chambers of the heart. Commonly, these devices may have an anchor that is imbedded in the myocardium. There remains a need for a more secure anchoring system for such devices.
SUMMARYDescribed embodiments are directed to apparatus, system, and methods for pericardial anchoring.
According to one example (“Example 1”), an anchoring system, comprises an anchor and a tether coupled to the anchor, the anchor operable to have a low profile in a first position and a larger profile in a second position. The anchor is operable to be advanced into a pericardial space from a heart chamber of a heart through a narrow access channel in a heart wall in the first position and expand to the second position in the pericardial space to a size greater than the narrow access channel.
According to another example (“Example 2”), a method of anchoring comprises advancing a guidewire into a heart up to and adjacent a heart wall; advancing a needle catheter over the guidewire and through an endocardium and into a myocardium of the heart wall; advancing the guidewire through the needle catheter through the myocardium and through the epicardium (visceral layer of serous pericardium) and into a pericardial space; withdrawing the needle catheter from the guidewire; advancing a catheter over the guidewire and into the pericardial space; separating the pericardium from the heart wall so as to enlarge the pericardial space; advancing an anchoring system either over the guidewire or through the catheter, an anchor portion of which placed into the pericardial space; deploying an anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium; and removing the guidewire and/or catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.
According to another example (“Example 3”), a method of anchoring comprises advancing a guidewire into a femoral vein; advancing the guidewire through the femoral vein and into the right atrium; advancing the guidewire through a septum and into a left atrium; advancing the guidewire through the mitral valve up to and adjacent a heart wall of a left ventricle; advancing a needle catheter over the guidewire and through an endocardium and into a myocardium of the heart wall; advancing the guidewire through the needle catheter through the myocardium and through an epicardium and into a pericardial space; withdrawing the needle catheter from the guidewire; advancing a catheter over the guidewire and into the pericardial space; inflating and separating the pericardium from the heart wall so as to enlarge the pericardial space; advancing an anchoring system either over the guidewire or through the catheter, an anchor portion of which placed into the pericardial space; deploying an anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium; and removing the guidewire and/or catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.
According to another example (“Example 4”), a method of anchoring comprises advancing a guidewire into a needle catheter such that a guidewire distal tip is adjacent to a needle catheter distal tip; advancing the needle catheter distal tip from a heart chamber through an endocardium and into a myocardium of a heart wall; advancing the guidewire distal tip through the myocardium and the epicardium and into a pericardial space; and advancing an anchor of an anchoring system over the guidewire and into the pericardial space.
In accordance with another example (“Example 5”), a method of anchoring comprises optionally advancing an optional support catheter into a heart up to and adjacent to or against a heart wall; advancing an anchoring catheter singularly or through the optional support catheter and placing in urging engagement against the heart wall, or in close proximity of the heart wall; advancing a guidewire through the anchor catheter through an endocardium through a myocardium and through an epicardium (visceral layer of serous pericardium) of the heart wall and into a pericardial space; advancing the anchor catheter over the guidewire and through the endocardium through the myocardium and through the epicardium (visceral layer of serous pericardium) of the heart wall and into the pericardial space; optionally withdrawing the guidewire from the pericardial space; optionally separating the pericardium from the epicardium so as to enlarge the pericardial space; advancing or exposing an anchor of an anchoring system through or at or near a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed into the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium; and removing the guidewire and/or anchor catheter and/or support catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.
In accordance with another example (“Example 6”), a method of anchoring comprises advancing an anchor catheter near or up to and against a heart wall in a heart chamber; advancing a guidewire through the anchoring catheter such that a guidewire distal tip advances through an endocardium and into a myocardium through the epicardium and into a pericardial space; and advancing a distal tip of the anchor catheter along or over the guidewire and into or adjacent to the pericardial space; advancing or exposing an anchor of an anchoring system through or at a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed in the pericardial space; deploying the anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium; and removing the guidewire and/or anchor catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber of an anchoring system over the guidewire and into the pericardial space.
In accordance with another example (“Example 7”), a mitral valve chord repair system, comprises a pericardial anchoring system, including an epicardial anchor comprising a skirt, a transmyocardial pledget, a pericardial anchoring suture coupled to the epicardial anchor and the transmyocardial pledget, a suture lock, and an anchor socket configured to constrain and dock the suture lock, wherein the epicardial anchor is configured to be transformable between a predeployed configuration and a deployed configuration, further including at least one leaflet anchor coupled to a leaflet anchor suture, wherein the suture lock is configured to secure the pericardial anchoring suture and the leaflet anchor suture.
In accordance with another example (“Example 8”), the mitral valve chord repair system of Example 7, wherein the epicardial anchor is configured to form a disc shape in the deployed configuration.
In accordance with another example (“Example 9”), the mitral valve chord repair system of Example 7, wherein the epicardial anchor is configured to form a curved shape, a compressed shape, a bunch, a wad, or a knot in the deployed configuration.
In accordance with another example (“Example 10”), the mitral valve chord repair system of Example 7, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a compressed configuration.
In accordance with another example (“Example 11”), the mitral valve chord repair system of Example 7, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a coiled configuration.
In accordance with another example (“Example 12”), the mitral valve chord repair system of Example 7, wherein the epicardial anchor has a free end in the predeployed configuration, wherein the epicardial anchor is configured to coil beginning from the free end of the epicardial anchor to form the deployed configuration.
In accordance with another example (“Example 13”), the mitral valve chord repair system of Example 7, wherein the epicardial anchor further comprises a wire frame, wherein the wire frame is covered with the skirt.
In accordance with another example (“Example 14”), the mitral valve chord repair system of Example 13, wherein the wire frame of the epicardial anchor has a shape memory property that is shape-set to the deployed configuration.
In accordance with another example (“Example 15”), the mitral valve chord repair system of Example 13, wherein the skirt is configured to slidingly receive the pericardial anchoring suture, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 16”), the mitral valve chord repair system of Example 13, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, wherein the skirt comprises a plurality of apertures along an edge of the skirt opposite the wire frame, wherein the pericardial anchoring suture is alternately weaved through the plurality of apertures, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 17”), the mitral valve chord repair system of Example 13, wherein the wire frame of the epicardial anchor further comprises a proximal leg, wherein the proximal leg is configured to remain straight and positioned in a center of the epicardial anchor in the deployed configuration.
In accordance with another example (“Example 18”), the mitral valve chord repair system of Example 17, wherein the transmyocardial pledget extends from the proximal leg of the epicardial anchor.
In accordance with another example (“Example 19”), the mitral valve chord repair system of Example 17, wherein the proximal leg includes two portions of the same wire that is doubled up, such that the two portions are parallel to each other.
In accordance with another example (“Example 20”), the mitral valve chord repair system of Example 7, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to proximal retraction of the pericardial anchoring suture.
T In accordance with another example (“Example 21”), the mitral valve chord repair system of Example 13, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to a shape memory property of the wire frame that is shape-set to the deployed configuration.
In accordance with another example (“Example 22”), the mitral valve chord repair system of Example 7, wherein a first end of the wire frame and a second end of the wire frame each comprises a nontraumatic end.
In accordance with another example (“Example 23”), the mitral valve chord repair system of Example 7, wherein the transmyocardial pledget comprises a film with a tubular structure.
In accordance with another example (“Example 24”), the mitral valve chord repair system of Example 23, wherein the pericardial anchoring suture is weaved through a plurality of apertures through the film of the transmyocardial pledget.
In accordance with another example (“Example 25”), the mitral valve chord repair system of Example 7, wherein the anchor socket comprises a self-expanding frame covered with a film.
In accordance with another example (“Example 26”), a pericardial anchoring system, comprises an epicardial anchor comprising a skirt; a transmyocardial pledget extending from a proximal portion of the epicardial anchor; a pericardial anchoring suture coupled to the epicardial anchor and the transmyocardial pledget, a suture lock configured to secure the pericardial anchoring suture; and an anchor socket configured to constrain and dock the suture lock, wherein the epicardial anchor is configured to be transformable between a predeployed configuration and a deployed configuration.
In accordance with another example (“Example 27”), the pericardial anchoring system of Example 26, wherein the epicardial anchor is configured to form a disc shape in the deployed configuration.
In accordance with another example (“Example 28”), the pericardial anchoring system of Example 26, wherein the epicardial anchor is configured to form a curved shape, a compressed shape, a bunch, a wad, or a knot in the deployed configuration.
In accordance with another example (“Example 29”), the pericardial anchoring system of Example 26, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a compressed configuration.
In accordance with another example (“Example 30”), the pericardial anchoring system of Example 26, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a coiled configuration.
In accordance with another example (“Example 31”), the pericardial anchoring system of Example 26, wherein the epicardial anchor has a free end in the predeployed configuration, wherein the epicardial anchor is configured to coil beginning from the free end of the epicardial anchor to form the deployed configuration.
In accordance with another example (“Example 32”), the pericardial anchoring system of Example 26, wherein the epicardial anchor further comprises a wire frame, wherein the wire frame is covered with the skirt.
In accordance with another example (“Example 33”), the pericardial anchoring system of Example 32, wherein the wire frame of the epicardial anchor has a shape memory property that is shape-set to the deployed configuration.
In accordance with another example (“Example 34”), the pericardial anchoring system of Example 26, wherein the skirt is configured to slidingly receive the pericardial anchoring suture, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 35”), the pericardial anchoring system of Example 32, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, wherein the skirt comprises a plurality of apertures along an edge of the skirt opposite the wire frame, wherein the pericardial anchoring suture is alternately weaved through the plurality of apertures, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 36”), the pericardial anchoring system of Example 32, wherein the wire frame of the epicardial anchor further comprises a proximal leg, wherein the proximal leg is configured to remain straight and positioned in a center of the epicardial anchor in the deployed configuration.
In accordance with another example (“Example 37”), the pericardial anchoring system of Example 36, wherein the transmyocardial pledget extends from the proximal leg of the epicardial anchor.
In accordance with another example (“Example 38”), the pericardial anchoring system of Example 36, wherein the proximal leg includes two portions of the same wire that is doubled up, such that the two portions are parallel to each other.
In accordance with another example (“Example 39”), the pericardial anchoring system of Example 36, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to proximal retraction of the pericardial anchoring suture.
In accordance with another example (“Example 40”), the pericardial anchoring system of Example 32, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to a shape memory property of the wire frame that is shape-set to the deployed configuration.
In accordance with another example (“Example 41”), the pericardial anchoring system of Example 32, wherein a first end of the wire frame and a second end of the wire frame each comprises a nontraumatic end.
In accordance with another example (“Example 42”), the pericardial anchoring system of Example 41, wherein the nontraumatic end of each of the first end of the wire frame and the second end of the wire frame comprises an eyelet.
In accordance with another example (“Example 43”), the pericardial anchoring system of Example 26, wherein the transmyocardial pledget comprises a film with a tubular structure.
In accordance with another example (“Example 44”), the pericardial anchoring system of Example 43, wherein the pericardial anchoring suture is weaved through a plurality of apertures through the film of the transmyocardial pledget.
In accordance with another example (“Example 45”), an epicardial anchor, comprises: a skirt; and a pericardial anchoring suture coupled to the skirt, wherein the epicardial anchor is configured to be transformable between a predeployed configuration and a deployed configuration.
In accordance with another example (“Example 46”), the epicardial anchor of Example 45, wherein the epicardial anchor is configured to form a disc shape in the deployed configuration.
In accordance with another example (“Example 47”), the epicardial anchor of Example 45, wherein the epicardial anchor is configured to form a curved shape, a compressed shape, a bunch, a wad, or a knot in the deployed configuration.
In accordance with another example (“Example 48”), the epicardial anchor of Example 45, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a compressed configuration.
In accordance with another example (“Example 49”), the epicardial anchor of Example 45, wherein the predeployed configuration comprises an elongate configuration, and wherein the deployed configuration comprises a coiled configuration.
In accordance with another example (“Example 50”), the epicardial anchor of Example 45, wherein the epicardial anchor has a free end in the predeployed configuration, wherein the epicardial anchor is configured to coil beginning from the free end of the epicardial anchor to form the deployed configuration.
In accordance with another example (“Example 51”), the epicardial anchor of Example 45, wherein the epicardial anchor further comprises a wire frame, wherein the wire frame is covered with the skirt.
In accordance with another example (“Example 52”), the epicardial anchor of Example 45, wherein the wire frame of the epicardial anchor has a shape memory property that is shape-set to the deployed configuration.
In accordance with another example (“Example 53”), the epicardial anchor of Example 51, wherein the skirt is configured to slidingly receive the pericardial anchoring suture, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 54”), the epicardial anchor of Example 51, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, wherein the skirt comprises a plurality of apertures along an edge of the skirt opposite the wire frame, wherein the pericardial anchoring suture is alternately weaved through the plurality of apertures, and wherein the pericardial anchoring suture is operable to be tensioned so as to cinch the skirt into the deployed configuration.
In accordance with another example (“Example 55”), the epicardial anchor of Example 51, wherein the wire frame of the epicardial anchor further comprises a proximal leg, wherein the proximal leg is configured to remain straight and positioned in a center of the epicardial anchor in the deployed configuration.
In accordance with another example (“Example 56”), the epicardial anchor of Example 55, wherein the proximal leg includes two portions of the same wire that is doubled up, such that the two portions are parallel to each other.
In accordance with another example (“Example 57”), the epicardial anchor of Example 55, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to proximal retraction of the pericardial anchoring suture.
In accordance with another example (“Example 58”), the epicardial anchor of Example 51, wherein the epicardial anchor is transformable between the predeployed configuration to the deployed configuration at least partially due to a shape memory property of the wire frame that is shape-set to the deployed configuration.
In accordance with another example (“Example 59”), the epicardial anchor of Example 51, wherein a first end of the wire frame and a second end of the wire frame each comprises a nontraumatic end.
In accordance with another example (“Example 60”), the epicardial anchor of Example 64, wherein the nontraumatic end of each of the first end of the wire frame and the second end of the wire frame comprises an eyelet.
In accordance with another example (“Example 61”), a method of anchoring a pericardial anchor system, comprises: advancing an epicardial anchor in a predeployed configuration constrained within an anchor catheter into a pericardial space of a heart; advancing the anchor catheter tangentially in the pericardial space a predetermined distance to allow for unsheathing of the epicardial anchor in the predeployed configuration; and retracting the anchor catheter to at least partially deploy the epicardial anchor in a deployed configuration in the pericardial space.
In accordance with another example (“Example 62”), the method of anchoring a pericardial anchor system of Example 61, wherein the predetermined distance comprises at least 10 cm.
In accordance with another example (“Example 63”), the method of anchoring a pericardial anchor system of Example 61, wherein the anchor catheter is configured to travel in a medial-lateral direction and/or in an inferior-superior direction in the pericardial space.
In accordance with another example (“Example 64”), the method of anchoring a pericardial anchor system of Example 61, further comprising positioning a proximal leg of the epicardial anchor between an epicardium and a distal tip of the anchor catheter to maintain a position of the epicardial anchor within the pericardial space.
In accordance with another example (“Example 65”), the method of anchoring a pericardial anchor system of Example 61, further comprising applying tension to a pericardial anchoring suture of the pericardial anchor system to at least partially transform the epicardial anchor to the deployed configuration.
In accordance with another example (“Example 66”), the method of anchoring a pericardial anchor system of Example 61, wherein the epicardial anchor is further transformed to the deployed configuration at least partially due to a shape memory property of a wire frame of the epicardial anchor that is shape-set to the deployed configuration.
In accordance with another example (“Example 67”), a method of anchoring a pericardial anchor system, comprises: advancing a support sheath up to and against a heart wall in a heart chamber; advancing a guidewire through the support sheath such that a guidewire distal tip advances through an endocardium, a myocardium, and an epicardium, and into a pericardial space; advancing an anchor sheath and a guidewire sheath together through the support sheath and over the guidewire and into the pericardial space to form a puncture through the endocardium, the myocardium, and the epicardium; maintaining a position of the guidewire sheath while retracting the anchor sheath and the support sheath together to deploy an epicardial anchor of a pericardial anchoring system in the pericardial space, wherein the epicardial anchor is in a predeployed configuration while positioned within the anchor sheath; maintaining a position of the anchor sheath while retracting the guidewire sheath to form a t-bar between a proximal leg of a wire frame of the epicardial anchor and a distal tip of the anchor sheath; retracting the support sheath, the anchor sheath, and the guidewire sheath together until the proximal leg is positioned against the puncture of the epicardium; maintain a position of the guidewire sheath and retract the anchor sheath and the support sheath together to deploy the epicardial anchor; and apply tension to a pericardial anchoring suture of the pericardial anchor system to at least partially transform the epicardial anchor to a deployed configuration.
In accordance with another example (“Example 68”), the method of anchoring a pericardial anchor system of Example 67, wherein the epicardial anchor is further transformed to the deployed configuration at least partially due to a shape memory property of the wire frame that is shape-set to the deployed configuration.
In accordance with another example (“Example 69”), the method of anchoring a pericardial anchor system of Example 67, further comprising maintaining a position of the guidewire sheath and retracting the support sheath and the anchor sheath to deploy a transmyocardial pledget and an anchor socket of the pericardial anchoring system, wherein a first portion of the transmyocardial pledget is positioned within the puncture of the epicardium, the myocardium, and the endocardium and a second portion of the transmyocardial pledget extends proximally from the puncture of the endocardium.
In accordance with another example (“Example 70”), the method of anchoring a pericardial anchor system of Example 67, further comprising folding the second portion of the transmyocardial pledget against the puncture of the endocardium.
In accordance with another example (“Example 71”), the method of anchoring a pericardial anchor system of Example 67, further comprising advancing a suture lock into the anchor socket and advancing the suture lock positioned within the anchor socket towards the endocardium to fold the second portion of the transmyocardial pledget.
In accordance with another example (“Example 72”), the method of anchoring a pericardial anchor system of Example 68, wherein the proximal leg of the epicardial anchor covered with a film is configured to seal the puncture of the epicardium, wherein the first portion of the transmyocardial pledget is configured to seal the puncture of the myocardium, and wherein the folded second portion of the transmyocardial pledget is configured to seal the puncture of the endocardium. In accordance with an embodiment, a pericardial access and fixation tool, referred herein as a tool, is provided operable for deployment into the myocardium and extending into the pericardial space from the ventricular side of the heart.
In accordance with another example (“Example 73”), a tool for placement in a heart wall and pericardial space operable to provide access to the pericardial space from a chamber of a heart and/or operable to be an anchor for devices coupled thereto, comprises a body defining a lumen operable to extend through the heart wall, a head at a distal end of the body operable to extend into the pericardial space, the head including movable elements operable to move from a low profile predeployed configuration to a high profile deployed configuration, the head defining an eyelet that is in fluid communication with the lumen so as to define and access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space, and the base further comprises a retention member operable to retain the base in the heart wall.
In accordance with another example (“Example 74”), the tool of Example 73, wherein the movable elements are operable to buttress a parietal pericardium when the movable members attain a high profile in the deployed configuration and wherein the retention member cooperates to engage the movable elements into abutment with the parietal pericardium.
In accordance with another example (“Example 75”), the tool of Examples 73 and 74, the tool of examples 1 and 2, wherein the movable elements include expander members operable to abut the pericardium so as to enlarge a pericardial space.
In accordance with another example (“Example 76”), the tool of Examples 73 and 74, wherein the eyelet is operable to expel or withdraw fluid or gas from a pericardial space using a device in communication with the lumen.
In accordance with another example (“Example 77”), the tool of Example 73, wherein the eyelet is operable to be a pressure port operable to measure pressure with a pressure sensing device.
In accordance with another example (“Example 78”), the tool of any of Examples 73-77, wherein the access channel is operable for receiving and allowing the passage of devices therethrough between a ventricular side of the heart to the pericardial space.
In accordance with another example (“Example 79”), the tool of any of Examples 73-77, wherein the eyelet is operable to resiliently deform between open and closed configurations, wherein in the closed configuration the access channel is occluded to prevent fluid passage through the access channel.
In accordance with another example (“Example 80”), the tool of any of Examples 73-77, wherein the head further includes an occluding element operable to resiliently move between open and closed positions, wherein in the closed position the access channel is occluded to prevent fluid passage through the access channel.
In accordance with another example (“Example 81”), the tool of any of Examples 73-77, further comprises an occluding plug operable to be placed in the access channel so as to occlude the access channel to prevent fluid passage through the access channel.
In accordance with another example (“Example 82”), the tool of any of Examples 73-77, wherein the tool is operable to couple with other devices or tissues of the heart.
In accordance with another example (“Example 83”), a method of implanting the tool of any one of examples 69-82, includes providing a delivery system operable for endovascular epicardial access, the delivery system including a steerable catheter and a delivery catheter, inserting the delivery system into the patient using a transvenous, transarterial, transseptal, transatrial, or transaortic approach, advancing the delivery catheter, onto which the tool is coupled, into the myocardium and extending the head of the tool into the pericardial space.
In accordance with another example (“Example 84”), the method of implanting the tool of Example 83, wherein the delivery system further includes a guidewire and/or needle, the method including advancing the guidewire or needle through the delivery catheter and extending through the tool into the myocardium and into the pericardial space and advancing the tool over the guidewire or needle.
The foregoing Examples are just that and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure.
The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.
FIGS. 56A1 and 56A2 are top and side views, respectively, of a tool head with movable elements, in accordance with an embodiment.
FIG. 56A3 is a side view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56A4 is a side view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56B1 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56B2 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56B3 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56B4 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56C1 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56C2 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56C3 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56C4 is a top view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56D1 is a side view of a tool head with movable elements, in accordance with an embodiment.
FIG. 56D2 is a side view of a tool head with movable elements, in accordance with an embodiment.
Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.
Although the embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in connection with mitral valve leaflet prolapse prevention by way of an anchoring system that is contained within the pericardial space. However, embodiments within the scope of this disclosure can be applied toward any prosthesis or mechanism of similar structure and/or function that requires anchoring within the chambers of the heart.
Embodiments herein include various apparatuses, systems, and methods for a suture or other tether mechanism having an anchor that lies within the pericardial space, with the suture extending through the myocardium and endocardium for use to couple with a biological element, such as a mitral valve leaflet, or to a prosthesis, such as, but not limited to, a sensor or support structure. The anchor that lies within and adjacent to the epicardium (visceral layer of serous pericardium) may be of any suitable structure, such as, but not limited to, an umbrella-like element, a pledget, a multi-legged support structure, and the like. The anchor is operable to have a low profile so as to be able to pass through a narrow access channel in the heart wall and expand or deploy to a larger diameter or surface area within the pericardial space and not pass through the narrow access channel in the heart structure. The present disclosure relates to mitral valve repair or replacement and more generally to methods and devices for mitral valve reshaping, repair and/or replacement of mitral chords, also referred to as chordae tendineae, to restore proper functioning of the mitral valve from a state of malfunction, such as, but not limited mitral valve regurgitation.
The term “heart wall”, as used herein, is defined as the endocardium, myocardium and epicardium.
The terms “pericardial space” and “pericardial cavity”, as used herein, is that space defined by the heart wall and the pericardium, therebetween, or the space between the visceral pericardium and the parietal pericardium.
The term “coupled”, as used herein, means joined, connected, attached, adhered, affixed, or bonded, whether directly or indirectly, and whether permanently or temporarily.
In accordance with embodiments, and as provided in
Due to extremely small profile the risk of adverse events may be lowered, such as, unlikely to cause pericardial effusion/tamponade.
Crossing the epicardium with a guidewire instead of a needle catheter results in an increase in safety and also procedural ease-of-use by, for example, taking out guesswork/ambiguity of getting into the pericardial space for being not too short or too far, since imaging of this space and/or knowing placement in the pericardial space is challenging. The selection of guidewire stiffness, for example, is optimized, both at distal tip and along entire length, such that, but not limited to, the distal tip being stiff enough that it may cross the remainder of the heart wall and into the pericardial space, but soft enough so as to deflect and not puncture the pericardium (parietal layer of serous pericardium and fibrous pericardium). The guidewire is operable to coil up within the pericardial space and track within the pericardial space. Advancement of the guidewire distal end within the pericardial space and adjacent to the heart wall may provide the clinician evidence that the distal end of the guidewire is in the pericardial space.
Wherein the guidewire outer diameter is just slightly less than needle inner diameter, potential coring out of the heart wall is mitigated or minimize so as to reduce tissue trauma. The needle catheter and guidewire may be introduced together with the guidewire distal tip just slightly pulled back relative to needle catheter distal tip, i.e., nested or in tandem. Subsequent to the needle catheter puncturing the endocardium, the guidewire may be advanced beyond needle catheter distal tip with the needle catheter providing support for the guidewire.
It is appreciated that there are different ways to advance the small hollow needle catheter and subsequently the nested guidewire to a target location. In one embodiment, the needle catheter may be advanced over a previously placed guidewire, in an over-the-wire procedure, such as, but not limited to, from an access port in the femoral vein. In other embodiments, the needle catheter with or without a nested guidewire, may be advanced through a lumen of a previously-placed steerable or non-steerable sheath, support/guide catheters, and the like.
It is appreciated that subsequent to the guidewire crossing into the pericardial space, there may be some additional steps required to be performed prior to advancement of the anchoring system. By way of example, but not limited thereto, utilization of contrast agents, CO2, microcatheters, various guidewires, support/guide catheters, and other devices, agents, and therapeutics may be used for a particular purpose. Such devices, agents and therapeutics may be provided so as, but not limited to, creating physical space in the pericardial space at the target location, visualizing the pericardial space and/or heart/pericardium structures at the target location, ensuring adequate purchase of a suitability stiff and correct diameter guidewire in the pericardium to deliver the anchoring system.
In accordance with embodiments, diagnostic modalities may be employed so as to provide evidence of guidewire crossing the heart wall and into the pericardial space. By way of example, such diagnostic modalities may include, but not limited thereto, a guidewire attached to an ECG lead (such as a guidewire having a non-electrically conductive coating except for a proximal and distal tip), and a pressure-sensing guidewire with a sensing element at the distal tip. Data gathered from these modalities may provide evidence of guidewire crossing the heart wall and into the pericardial space.
It is anticipated that once the delivery system, that is, any guidewire 40 and/or catheter 44 is removed from the heart 2, the heart wall 41 will seal around the suture or tether 34 such that no additional material is needed to prevent bleeding from the access channel 12. It is anticipated that optionally, a sealing means 48 may be provided to reduce or eliminate potential bleeding. Such sealing means 48 may include, but not limited to, a surface texture on the tether 34 so as to induce a healing response between the tether 34 and the heart wall 41, a pledget along the tether 34 that may be used to plug the access channel 12, an expandable portion or element about the tether 34 and/or the anchor 32 that is operable to close the access channel 12 about the tether 34 and/or anchor,
In another embodiment, illustrated in
As provided before, the suture or tether 34 may be used for a particular purpose. In accordance with an embodiment, the suture or tether 34 is coupled to a mitral valve leaflet 9 so as to prevent the leaflet from prolapsing, illustrated in
In accordance with another embodiment, the suture or tether 34 may be coupled to a device, such as a prosthetic valve.
In accordance with another embodiment, the suture or tether 34 may be coupled to a device, such as a sensor.
In accordance with another embodiment, as provided in the flow diagram of
In accordance with another embodiment, a method of anchoring includes optionally advancing a support catheter into a heart near or up to and adjacent to or against a heart wall. An anchoring catheter is advanced singularly or through the optional support catheter and placed near or in urging engagement against the heart wall. A guidewire is advanced through the anchor catheter through an endocardium through a myocardium and through an epicardium (visceral layer of serous pericardium) of the heart wall and into a pericardial space. The anchor catheter is advanced over the guidewire and through the endocardium through the myocardium and through the epicardium (visceral layer of serous pericardium) of the heart wall and into the pericardial space. Optionally, the guidewire is withdrawn from the pericardial space. Optionally the pericardium is separated from the epicardium so as to enlarge the pericardial space. An anchor of an anchoring system is advanced or exposed through or at or near a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed into the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed so as to oppose the epicardium. The guidewire and/or anchor catheter and/or support catheter are removed from a patient leaving a tether that is coupled to the anchor in a heart chamber.
In accordance with another embodiment of a method of anchoring includes advancing an anchor catheter near or up to and against a heart wall in a heart chamber. A guidewire is advanced through the anchoring catheter such that a guidewire distal tip advances through an endocardium and into a myocardium through the epicardium and into a pericardial space. A distal tip of the anchor catheter is advanced along or over the guidewire and into or adjacent to the pericardial space. An anchor of an anchoring system is advanced or exposed through or at a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed in the pericardial space. The anchor of the anchoring system is deployed within the pericardial space and the anchor is placed so as to oppose the epicardium. The guidewire and/or anchor catheter are removed from a patient leaving a tether that is coupled to the anchor in a heart chamber of an anchoring system over the guidewire and into the pericardial space.
In accordance with an embodiment, an anchor system 100 includes an anchor 102.
The anchor 102 includes a wire 110 having a wire first end 112 and a wire second end114. The wire 110 has a shape memory property that is shape-set to a ring configuration wherein the wire first end 112 opposes the wire second end 114. A skirt 120 is coupled to the wire 110 along an edge defining a length. A plurality of apertures 126 are along an edge of the skirt 120 opposite the wire 110. The tether 130 is alternately weaved through the plurality of apertures 126, wherein the tether 130 defines a tether first end 132 and a tether second end 134. The tether first end 132 and the tether second end 134 are operable to be tensioned so as to cinch the skirt 120 into a disc-like shape when the wire 110 is in the ring configuration in a deployed configuration, and wherein the tether first end 132 and tether second end 134 may be tensioned so as to straighten the wire 110 into a straight configuration in a pre-deployment configuration.
The anchoring system 100, in accordance with another embodiment, is configured such that the wire first end 112 and the wire second end 114 are operable to fixedly couple together when in the ring configuration.
The anchoring system 100, in accordance with another embodiment, is configured such that the wire first end 112 and the wire second end 114 are operable to engage so as to prevent overlap of the wire first end 112 and the wire second end 114 beyond a complete loop of the wire 110 when in the ring configuration.
The anchoring system 100, in accordance with another embodiment, is configured such that the skirt 120 has tissue ingrowth properties on one side and tissue adhesion-prevention properties on the other side.
The anchoring system 100, in accordance with another embodiment, further includes a tether lock 140 slidingly coupled to the tether 130 being operable to slide along the tether 130 and lock in place so as to capture the heart wall between the tether lock 140 and the anchor 102.
A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a guidewire into a femoral vein, advancing the guidewire through the femoral vein and into a right atrium, advancing the guidewire through a septum and into a left atrium, advancing the guidewire through a mitral valve up to and adjacent a heart wall of a left ventricle, advancing a needle catheter over the guidewire and through an endocardium and into a myocardium of the heart wall, advancing the guidewire through the needle catheter through the myocardium and through an epicardium and into a pericardial space, withdrawing the needle catheter from the guidewire, advancing a catheter over the guidewire and into the pericardial space, inflating and separating a pericardium from the heart wall so as to enlarge the pericardial space, advancing the anchoring system either over the guidewire or through the catheter, the anchor of which is placed into the pericardial space, deploying an anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and/or catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.
A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a guidewire into a needle catheter such that a guidewire distal tip is adjacent to a needle catheter distal tip, advancing the needle catheter distal tip from a heart chamber through an endocardium and into a myocardium of a heart wall, advancing the guidewire distal tip through the myocardium and the epicardium and into a pericardial space, and advancing the anchor of the anchoring system over the guidewire and into the pericardial space, and deploying the anchor in the pericardial space, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end.
A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above, advancing a support catheter into a heart up to and adjacent to or against a heart wall, advancing an anchoring catheter singularly or through the support catheter and placing in urging engagement against the heart wall, advancing a guidewire along or through the anchor catheter through an endocardium through a myocardium and through an epicardium (visceral layer of serous pericardium) of the heart wall and into a pericardial space, advancing the anchor catheter along or over the guidewire and through the endocardium through the myocardium and through the epicardium (visceral layer of serous pericardium) of the heart wall and into the pericardial space, advancing or exposing the anchor of the anchoring system through or at a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed into the pericardial space, deploying the anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and anchor catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber.
A method of anchoring, in accordance with an embodiment, comprises providing the anchoring system as described above advancing an anchor catheter up to and against a heart wall in a heart chamber, advancing a guidewire through the anchoring catheter such that a guidewire distal tip advances through an endocardium and into a myocardium through the epicardium and into a pericardial space, advancing a distal tip of the anchor catheter along or over the guidewire and into or adjacent to the pericardial space, advancing or exposing the anchor of the anchoring system through or at a distal end of the anchor catheter which is in the pericardial space, wherein the anchor is placed in the pericardial space, deploying the anchor of the anchoring system within the pericardial space and placing the anchor so as to oppose the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration via tension on the tether first end and tether second end, and wherein the anchor is in a ring configuration in a deployed configuration via tension on the tether first end and tether second end, and removing the guidewire and anchor catheter from a patient leaving a tether that is coupled to the anchor in a heart chamber of an anchoring system over the guidewire and into the pericardial space.
In accordance with an embodiment, the pericardial anchoring system 200 includes an epicardial anchor 220, a transmyocardial pledget 240, an anchor socket 260, and a suture lock 270. The epicardial anchor 220 can be an anchor where at least a portion of the anchor is configured to be positioned in the pericardial space, such that the anchor can resist being pulled through a puncture in the heart wall. At least a portion of the epicardial anchor 220 can be embedded in or in contact with tissue of the heart, such as the epicardium of the heart wall. The epicardial anchor 220 can be an epicardial anchor 220, such that it can achieve a disc, ring, or annular configuration in a deployed configuration. The disc, ring, or annular configuration can be planar or nonplanar (such as a helix or biased shape). The epicardial anchor 220 can also take on a variety of other shapes in the deployed configuration, such as a curved shape, a compressed shape, a bunch, a wad, or a knot. As will be discussed further below, the epicardial anchor 220 can include a wire frame or can be wireless.
The epicardial anchor 220 can include a wire or wire frame 222 that is coupled to a skirt 230.
The proximal leg 228 can be reinforced, such as to resist a tensile or bearing force, compared the remainder of the wire frame 222. In accordance with an embodiment, the proximal leg 228 can include two portions of the same wire that is doubled up, such that they are parallel to each other and can be touching one another, and can be coupled together. In some embodiments, the proximal leg 228 can have a material property that is stiffer than a remainder of the wire. This advantageously allows the proximal leg 228 to resist bending and remain straight during deployment of the epicardial anchor 220, for example while bearing against a distal end of a delivery catheter, while the remainder of the wire frame 222 can be deployed to form a curved configuration. The proximal leg 228 is configured to remain straight and to seat the epicardial anchor 220 against the delivery catheter distal end 502 and the puncture in the epicardium to retain the epicardial anchor 220 in the pericardial space and to prevent the passage of the proximal leg 228 through the epicardium once in the pericardial space. The proximal leg 228 is operable to prevent the epicardial anchor 220 from being pulled proximally through the puncture in the epicardium.
In accordance with an embodiment, the proximal leg 228 is configured to maintain a straight configuration such that in combination with a curved bias of the remaining portion of the wire frame 222, presents an urging engagement with the delivery catheter so as to assist in deployment of the epicardial anchor 220. In accordance with another embodiment, the proximal leg 228 is configured to maintain a straight configuration such that in combination with the curved bias of the remaining portion of the wire frame 222, presents a profile operable to prevent the anchor from passing through the puncture in the epicardium once deployed.
The skirt 230 can be coupled to the wire frame 222 along an edge defining a length. The wire frame 222 can be positioned on one end or edge of the skirt 230. In one embodiment, a tether or pericardial anchor suture 280 is coupled to an opposite edge of the skirt 230. In accordance with another embodiment, a plurality of anchor apertures 232 are positioned along an edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is alternately weaved through the plurality of anchor apertures 232 and slidably received therethrough. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to a first end of the skirt 230 at a suture attachment 234. The suture attachment 234 can be a reinforced portion of the skirt 230 wherein the reinforced portion is reinforced with additional material or a secondary material added to facilitate and strength the coupling, in accordance with an embodiment. In another embodiment, the reinforced portion may have a different material property, such as, but not limited to, pressure and/or heat densification, such as with a porous material. The suture attachment 234 can be at a distal end or portion of the skirt 230. This can advantageously improve deployment of the epicardial anchor 220 and in retaining tension of the pericardial anchor suture 280. In accordance with an embodiment the suture attachment 234 at a distal end or portion of the skirt 230 in cooperative engagement with the anchor apertures 232 in the skirt 230 results in a predetermined amount of force distribution along the skirt 230 as compared with a more concentrated load at the attachment point located at a more proximal location on the skirt 230,
The entire wire frame 222 may be coupled to the skirt 230. In an embodiment, the skirt 230 covers the entire wire frame 222, such as, for example, by being within a fold or hem of the film or embedded within layers of the film, which can improve stability of the epicardial anchor 220 in the event of a fracture or damage of the wire frame 222. The skirt 230 covering the wire frame 222 can additionally prevent the pericardial anchor suture 280 from being misrouted or becoming entangled with the wire frame 222, in particular during transition between the predeployed configuration (such as the elongate configuration) to the deployed configuration (such as a curved configuration) of the epicardial anchor 220.
In other embodiments, instead of weaving the pericardial anchor suture 280 through a plurality of anchor apertures 232, the pericardial anchor suture 280 can be incorporated into the skirt 230 in other ways, such as by being integrated into the skirt 230 itself or by being fixedly attached or slidingly received within a portion of the skirt 230. In some examples, the skirt 230 can include a tunnel or channel that slidingly receives the pericardial anchor suture 280.
In other embodiments, instead of a wire frame 222, a biasing element can be integrated or incorporated into the skirt 230. The biasing element is operable to bias the skirt 230 into a curved configuration. In accordance with an embodiment, the biasing element can be a densified, embossed, or treated portion of the skirt 230 that is operable to have a bias so as to transform the epicardial anchor 220 from a predeployed configuration to a deployed configuration, such as from an elongate configuration to a curved configuration.
The epicardial anchor 220 can be maintained in the straightened configuration against the bias of the wire frame 222 in the predeployed configuration by applying tension to a suture distal end 315 of the pericardial anchor suture 280 and/or a suture proximal end 317 of the pericardial anchor suture 280 that extends through the skirt 230, as shown in
Whether the skirt 240 has a biasing member, such as a wire frame 222, or not, the deployed configuration may attain a coiled, wadded, bunched, ring, annular, knotted, among other configurations. The deployed configurations are operable to provide one or more functions, such as, but not limited to, prevent pull-through the puncture in the heart wall. And/or to distribute loading caused by tension on the suture to a broader area of the vessel wall. And/or to provide a suitable surface for tissue ingrowth and/or overgrowth in a healing response.
In some examples, the suture proximal end 317 of the pericardial anchor suture 280 is tensioned, such as in a proximal direction, to cinch the skirt 230 into a deployed configuration (such as a compressed, coiled, curved, curled, ring, annular, knotted, bunched, or wadded shape) when the epicardial anchor 220 is in the deployed configuration. The biasing force of the biasing member, which is biased to pull the skirt into a curved configuration. Tension on the pericardial anchor suture 280 may assist in the curvature of the biasing member and/or assist in ensuring a complete deployed configuration (such as a curved or ring configuration). The epicardial anchor 220 can be transitioned between the predeployed configuration (such as an elongate configuration), such as shown in
In accordance with an embodiment, the wire frame 222 has a shape memory property that is shape-set to a curved or a ring or annular configuration, as shown in
In some configurations, the wire frame 222 can be biased to form a helix when in the curved configuration in the deployed configuration. This bias towards a helix can advantageously prevent the wire frame 222 from becoming entangled with itself, other components of the anchor system or the area of implantation. The helix configuration can assist in allowing the epicardial anchor 220 to transform to a coiled configuration. In some configurations, the wire frame 222 has a bias to conform the epicardial anchor 220 so as to define a substantially planar disk when in the deployed configuration.
In other embodiments, instead of a coiled configuration as shown in
In some embodiments, the epicardial anchor 220 can be bunched or wadded to achieve a deployed configuration. For example, the epicardial anchor 220 in the elongate configuration can be folded, compressed, bunched, curled, or wadded to form a deployed configuration.
As described above, the pericardial anchoring system 200 can also include a pericardial anchor suture 280. The pericardial anchor suture 280 can extend through each of the epicardial anchor 220 and a transmyocardial pledget 240. The pericardial anchor suture 280 can be coupled to the skirt 230, such as, but not limited, by weaving through or integrated with the skirt 230 of the epicardial anchor 220. As shown in
The pericardial anchoring system 200 can include a pledget as disclosed in International Application No. PCT/US2020/032054 or International Application No. PCT/US2020/032168 (the entireties of which are incorporated by reference herein) and the various embodiments of pledgets disclosed therein. The transmyocardial pledget 240 can include a film. The film can be a fluoropolymer, which can have tissue ingrowth properties. The film of the transmyocardial pledget 240 can have a tubular structure. The transmyocardial pledget 240 can include a plurality of pledget apertures 262 positioned along the length of the transmyocardial pledget 240. The pericardial anchor suture 280 can be weaved through or integrated in the film of the transmyocardial pledget 240. As shown in
As shown in
The transmyocardial pledget 240 is configured to extend from the epicardial anchor 220 and through punctures of the epicardium, myocardium, and endocardium, also referred to as the heart wall channel 5, as shown in
The pericardial anchoring system 200 can further include an anchor socket 260 which can hold a suture lock 270. The pericardial anchoring system 200 can include a suture lock as disclosed in U.S. Pat. No. 9,877,833. The pericardial anchoring system 200 can include a suture lock and socket as disclosed in International Application No. PCT/US2021/035423 or U.S. application Ser. No. 16,711,321 (the entireties of which are incorporated by reference herein) and the various embodiments of suture locks or sockets disclosed therein. The pericardial anchoring system 200 can include a socket as disclosed in U.S. application Ser. No. 16/710,637 (the entirety of which is incorporated by reference herein) and the various embodiments of suture locks or sockets disclosed therein. The suture lock 270 can be used to secure each of the pericardial anchor suture 280 and the leaflet anchor sutures 310. The suture lock 270 can also be used to tension and adjust the length of each of the pericardial anchor suture 280 and the leaflet anchor sutures 310. Once the lengths have been optimized to achieve adequate tension for the mitral chord repair, the suture lock 270 can be locked to fix the length of each of the pericardial anchor suture 280 and the leaflet anchor sutures 310.
As used herein, the term “socket” is inclusive of and may be used interchangeably with any of the following terms: covers, receptacles, shrouds, couplers, constrainers, retaining members and the like. In accordance with an embodiment, the anchor socket 260 can have a tubular structure that can receive and at least partially cover the suture lock 270. The anchor socket 260 can include a self-expanding frame that can minimize the profile of the anchor socket 260 when in the predeployed configuration on the delivery system. The self-expanding frame can be a stent frame made of nitinol. The self-expanding frame can be tapered to facilitate docking of the suture lock 270 within the anchor socket 260 and more tightly constrain the anchor socket 260 around the sutures 280, 310. The anchor socket 260 can further include gold marker bands around the circumference of the anchor socket 260 which can provide visual guidance. The self-expanding frame can be covered with fluoropolymer film. In some configurations, the inner surface of the stent frame can be covered with the fluoropolymer film. This film can extend proximally from the film of the transmyocardial pledget 240. The anchor socket 260 can have a length that exceeds the length of the suture lock 270 to ensure full coverage of the suture lock 270 by the anchor socket 260. The anchor socket 260 can be a retaining member to constrain motion of the suture lock relative to the remainder of the pericardial anchoring system 200, as well as motion of the sutures relative to the suture lock 270. The anchor socket 260 can also be called a suture lock guide, socket, or sleeve. The anchor socket 260 can reduce wear on each of the pericardial anchor suture 280 and the leaflet anchor sutures 310 which can ensure the tension in the sutures. The anchor socket 260 can couple the pericardial anchoring system 200 and the suture lock.
As shown in
As shown in
Instead of the epicardial disc anchor, various types of ventricular anchors or epicardial anchors can assume various shapes besides a disc or annular shape. The ventricular or epicardial anchor can be a pull-string anchor in which a suture can be tensioned or retracted to convert the anchor from a predeployed configuration to a deployed configuration. The predeployed configuration can be an elongate configuration. The deployed configuration can take a variety of shapes, such as a as described above, including a disc, annular, curved, compressed, bunched, wadded, or knotted shape.
The wireless skirt 230 can function similarly to the skirt 230 of the epicardial anchor 220. The pericardial anchor suture 280 can be integrated or weaved through the wireless skirt 230. The pericardial anchor suture 280 can be tensioned to cinch the wireless skirt 230 into a disc, ring, curved, or bunched wad configuration in a deployed configuration, such as shown in
The delivery subsystem 400 can be delivered through a delivery catheter. The delivery subsystem 400 can include three catheters or sheaths, including a support sheath 460, an anchor sheath 440, and a guidewire sheath 420. The delivery subsystem can further include a guidewire 410 configured to be delivered through the guidewire sheath 420. The sheaths 420, 440, 460 can be configured to fit within each other or nested within one another. The support sheath 460 can be an outer sheath that receives the anchor sheath 440. The anchor sheath 440 can be an intermediate sheath that is received by the support sheath 460 and receives the guidewire sheath 420. The guidewire sheath 420 can be received be received by the anchor sheath 440 and receives the guidewire 410.
The support sheath 460 can provide control to direct the delivery subsystem 400 to a target location, such as to the left ventricle or the ventricle wall of the left ventricle. The support sheath 460 can provide support, while the pericardial anchoring system is advanced through the ventricle wall, such as advancement of the guidewire 410 or the anchor sheath 440. The support sheath 460 can have at least a distal portion that is compliant. The distal portion of the anchor sheath 440 is operable to advance through the heart wall 41, including the endocardium, the myocardium, and epicardium of the heart wall 41. The anchor sheath 440 can have at least a proximal portion that is more rigid relative to the compliant distal portion, which can provide more control during delivery. The anchor sheath 440 can include a radiopaque marker at the distal end or tip of the anchor sheath 440.
The guidewire sheath 420 can be a thin-walled catheter. The guidewire sheath 420 can include a dilator tip 422 at a distal end of the guidewire sheath 420. The dilator tip 422 can be smooth and tapered to minimize trauma when crossing the heart wall 41. The proximal end of the dilator tip 422 can be tapered to allow the dilator tip 422 to be withdrawn smoothly and minimize trauma during withdrawal of the dilator tip 422 through the heart wall 41.
The epicardial anchor 220 can be constrained in the pre-deployment configuration during delivery, such as by the anchor sheath 440 as shown in
In accordance with an embodiment, the pericardial anchoring system 200 may be used to control the motion of a mitral valve leaflet by coupling the pericardial anchor suture 280 to one or more leaflet anchor sutures 310, also referred to as tethers, that are themselves coupled to the mitral valve leaflet 9. After the epicardial anchor 220 is delivered to the target location, the pericardial anchor suture 280 may be coupled to the mitral valve leaflet 9, as shown in
Once the leaflet anchoring system 312 is deployed to the target location in the leaflet 9, a suture lock 270 can be provided to lock the leaflet anchor suture 310 from the pericardial anchor system 200 and the leaflet anchor suture 310 from the one or more leaflet anchors 524 provided in the leaflet 9.
The transmyocardial anchor is accordioned in the process of bringing the lock down to the heart wall. The sutures are locked together after a predetermined tension has been applied to the leaflet anchor to correct the valve leaflet function. In accordance with another embodiment, the anchor suture is tensioned, the transmyocardial anchor pledget is cinched, the leaflet anchors are tensioned and then the sutures are coupled together.
Once the suture lock 270 is delivered to the target location in the anchor socket 260, a suture cutter 542 can be provided to cut the suture tails of the one or more leaflet anchor sutures 310 and the suture tail of the pericardial anchor suture 280.
In accordance with other embodiments, the present disclosure relates to apparatus, systems and methods for placing hardware, devices, or therapies into the pericardial space from the ventricular side of the heart. Although the present disclosure discusses the embodiments herein with respect to a patient's endovascular location and ventricles, the embodiments are applicable to placement into the pericardial space from many approaches, including improvements on current methods performed percutaneously from outside the chest or abdomen.
The tool, when used for placement of a device or therapy into the pericardial space, the present disclosure may be performed with echocardiography and/or fluoroscopy, and deployment of the tool and its use may be permanent or reversible.
In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, it will be understood by persons of ordinary skill in the art that some embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, units and/or circuits have not been described in detail so as not to obscure the discussion.
The present disclosure relates to systems and methods for placing hardware, devices, or therapies into the pericardial space from the heart's ventricles using an endovascular approach. This placement may be necessary when therapies for the treatment of valve disease, ventricular dilatation, ischemic heart disease, congenital lesions, heart failure, or structural heart disease are needed. In accordance with an embodiment, a pericardial access and fixation tool, referred herein as a tool, is provided operable for deployment into the myocardium and extending into the pericardial space from the ventricular side of the heart. These embodiments enable traversing of the myocardium with minimization of risk or degree of myocardial injury, bleeding, or placement in untoward places.
In accordance with an embodiment, the access channel 176 may include an occluding element 175 operable to occlude or stop the fluid communication through the access channel 176. In accordance with an embodiment, the eyelet 174 comprises a resilient material operable to open under an abutment force of an object passing through the lumen 172 or fluid or gas pressure, and operable to close the fluid communication with the lumen 172 when the object or fluid or gas pressure is not present at the eyelet 174. In another embodiment, the eyelet 174 further includes a flap operable to open under an abutment force of an object or fluid or gas pressure, and operable to close the fluid communication with the lumen 172 when the object or fluid or gas pressure is not present at the eyelet 174.
In accordance with embodiments, the movable members 161 may be anchor expander members 162 and/or anchor apposition members 164.
The anchor expander members 162 are operable to provide a graduated crossing profile in a predeployed configuration and buttress the parietal pericardium when the anchor expander members 162 are expanded or moved to a deployed configuration.
The anchor apposition members 164 are operable to provide a graduated crossing profile in a predeployed configuration and buttress against the visceral pericardium 19 when the anchor apposition members 164 and expanded or moved to a deployed configuration in the pericardial space 10. In accordance with an embodiment, the movable members 161 are operable to function as both an anchor expander member 162 and anchor apposition member 164, that is, they are one of the same.
The body 170 is operable to occupy the traversing segment 28 after crossing of the myocardium so as to maintain hemostasis. As will be discussed below, the heart wall 4 is pierced by a needle 56 and/or the tool 150 from the ventricle side to the pericardial space 10 side so as to deploy the tool 150 therebetween. That pierced or formed heart wall channel in the heart wall 4 is referred herein as the traversing segment 28.
The tool 150 further includes a retention element 180 that is operable to retain the tool 150 within the heart wall 4 and/or as a means for coupling to other therapeutic devices. In accordance with an embodiment, the retention element 180 is a biocompatible cord or similar member to which a therapeutic device (e.g., valve repair, heart failure repair, or replacement prosthesis) may be coupled.
The delivery catheter system 50 is operable to deliver the tool to the desired location. The delivery catheter system 50, in accordance with an embodiment, includes a steerable catheter(s) 51, 53 that may accept a delivery catheter(s) 55 that are operable to place and deploy the tool 150 with the body 170 in the heart wall 4 and the head 160 extending therefrom and in the pericardial space 10.
In accordance with embodiments, the delivery catheter system 50 includes a guidewire 54 and a needle 56, singularly or in combination, operable to provide support for traversing the myocardium and piercing the visceral pericardium 19. The needle 56 may be coupled to or integrated with a guidewire 54 that can be advanced into the pericardial space 10 after the visceral pericardium 19 is pierced, in order to facilitate subsequent catheter exchanges, as shown in
The tool 150 is then advanced through the myocardium 13.
In some embodiments, the eyelet 174 facilitates confirmation of placement in the pericardial space 10, as well as passage of wires, catheters, or devices into the pericardial space 10. The eyelet 174 can be used to transduce hydraulic or mural pressure as well as deliver contrast or visualizing agents. The eyelet 174 can also be used to inject material into and expand the pericardial space 10 (e.g., a gas, fluid, or mechanical expander) to facilitate subsequent device placement. In at least one embodiment, the eyelet 174 is at the distal end of the tool 150, facing towards the pericardial space 10 in either an orthogonal, perpendicular, or oblique orientation relative to the pericardial planes. In at least one embodiment, the eyelet 174 may be positioned more proximal or along a length of the head 160 of the tool 150. In other embodiments, the eyelet 174 may be oval, circular, square, rectangular or another geometric shape and size. In other embodiments, the eyelet 174 may be multiple in number, some or all of which are in fluid communication with one or more lumens 172 in the body 170.
In some embodiments, the tool 150 contains movable elements that help expand the pericardial space 10 as the tool 150 is being advanced. In at least one embodiment, the head 160 defines these movable elements to reside at or near the distal end of the tool 150 and are controlled by cables or push/pull rods. In at least one embodiment, the movable elements contribute to expansion of the pericardial space 10 as well as anchoring.
Once a satisfactory position is obtained, the epicardial anchoring tool 150tool 150 is decoupled from the delivery catheter system 50. The tool 150 is retained by the engagement of the retention element 180 in cooperative engagement with the head 160 of the tool 150, leaving the tool 150 within the myocardium and extending into the pericardial space 10 for use. In accordance with an embodiment, the eyelet 174 may be closed so as to prevent fluid communication between the ventricle 22 and the pericardial space 10 with an occluding element 175.
FIGS. 56A1-56D2 show different configurations of the anchor expander members 162 and anchor apposition members 164. They may be symmetrical, asymmetric, have different lengths, be concave or convex, have different pads and sizes, and be offset or perpendicular.
In some embodiments, similar methods described herein for the use of the tool 150 to access the pericardial space 10 can also be used to place devices, anchors, or therapies on the surface of the parietal pericardium.
Inventive features of this disclosure have been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.
Claims
1. A tool for placement in a heart wall and pericardial space operable to provide access to the pericardial space from a chamber of a heart and/or operable to be an anchor for devices coupled thereto, comprising:
- a body defining a lumen operable to extend through the heart wall;
- a head at a distal end of the body operable to extend into the pericardial space, the head including movable elements operable to move from a low profile predeployed configuration to a high profile deployed configuration, the head defining an eyelet that is in fluid communication with the lumen so as to define an access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space; and
- the base further comprising a retention member operable to retain the base in the heart wall.
2. The tool of claim 1, wherein the movable elements are operable to buttress a parietal pericardium when the movable members attain a high profile in the deployed configuration and wherein the retention member cooperates to engage the movable elements into abutment with the parietal pericardium.
3. The tool of claim 1, wherein the movable elements include expander members operable to abut the pericardium so as to enlarge a pericardial space.
4. The tool of claim 2, wherein the movable elements include expander members operable to abut the pericardium so as to enlarge a pericardial space.
5. The tool of claim 1, wherein the eyelet is operable to expel or withdraw fluid or gas from a pericardial space using a device in communication with the lumen.
6. The tool of claim 1, wherein the eyelet is operable to be a pressure port operable to measure pressure with a pressure sensing device.
7. The tool of claim 1, wherein the access channel is operable for receiving and allowing the passage of devices therethrough between a ventricular side of the heart to the pericardial space.
8. The tool of claim 1, wherein the eyelet is operable to resiliently deform between open and closed configurations, wherein in the closed configuration the access channel is occluded to prevent fluid passage through the access channel.
9. The tool of claim 1, wherein the head further includes an occluding element operable to resiliently move between open and closed positions, wherein in the closed position the access channel is occluded to prevent fluid passage through the access channel.
10. The tool of claim 1, further comprises an occluding plug operable to be placed in the access channel so as to occlude the access channel to prevent fluid passage through the access channel.
11. The tool of claim 1, wherein the tool is operable to couple with other devices or tissues of the heart.
12. A method of implanting a tool for placement in a heart wall and pericardial space operable to provide access to the pericardial space from a chamber of a heart and/or operable to be an anchor for devices coupled thereto, comprising: providing the tool, comprising:
- a body defining a lumen operable to extend through the heart wall;
- a head at a distal end of the body operable to extend into the pericardial space, the head including movable elements operable to move from a low profile predeployed configuration to a high profile deployed configuration, the head defining an eyelet that is in fluid communication with the lumen so as to define an access channel operable to provide a fluid passage between the chamber of the heart and the pericardial space; and
- the base further comprising a retention member operable to retain the base in the heart wall providing a delivery system operable for endovascular epicardial access, the delivery system including a steerable catheter and a delivery catheter;
- inserting the delivery system into the patient using a transvenous, transarterial, transseptal, transatrial, or transaortic approach;
- advancing the delivery catheter onto which the tool is coupled into the myocardium and extending the head of the tool into the pericardial space.
13. The method of claim 12, wherein the delivery system further includes a guidewire and/or needle, the method including:
- advancing the guidewire or needle through the delivery catheter and extending through the tool into the myocardium and into the pericardial space; and advancing the tool over the guidewire or needle.
Type: Application
Filed: Apr 25, 2022
Publication Date: Oct 27, 2022
Inventor: Paul Sorajja (Minneapolis, MN)
Application Number: 17/728,814
