The present invention is directed to a device for first grabbing, and then securing the native atrioventricular valve's leaflet to a prosthesis via transcatheter means.
Left ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). LVOT obstruction is the most frightening TMVR complication, which occurs in up to 40% of valves implanted in a native mitral annular calcification, 5% of valve-in-ring, and 2% of valve-in-valve cases (Yoon SH, Whisenant BK, Bleiziffer S, et al. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification. Eur Heart J 2019;40:441-51.), and leads to 62% in-hospital mortality (Guerrero M, Urena M, Himbert D, et al. 1-year outcomes of transcatheter mitral valve replacement in patients with severe mitral annular calcification. J Am Coll Cardiol 2018;71:1841-53.). Potential for LVOT obstruction is the most important cause for patient exclusion for TMVR, with 49% of the patients for valves implants in a native mitral annular calcification and 6% for valve-in-ring excluded for TMVR due to predicted risk of LVOT obstruction (Khan JM, et al. Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement, J Am Coll Cardiol. 2019 May 28; 73(20): 2521-2534.).
There are currently two mechanisms that lead to TMVR-induced LVOT obstruction. (1) static obstruction occurs when the native mitral valve's anterior leaflet is pushed toward the interventricular septum by the mitral valve prosthesis, creating a narrowed and elongated “neo-LVOT” (Blanke P, Naoum C, Dvir D, et al. Predicting LVOT obstruction in transcatheter mitral valve implantation: concept of the neo-LVOT. J Am Coll Cardiol Img 2017;10:482-5). (2) Dynamic obstruction occurs when the narrowed neo-LVOT generates Bernoulli forces that pull the anterior mitral leaflet toward the interventricular septum during systole (Khan JM, Trivedi U, Gomes A, Lederman RJ, Hildick-Smith D. ‘Rescue’ LAMPOON to treat transcatheter mitral valve replacement-associated left ventricular outflow tract obstruction. J Am Coll Cardiol Intv 2019. Feb. 7). A long anterior mitral leaflet with redundant chordae could be a risk factor (Khan JM, Lederman RJ, Devireddy CM, et al. LAMPOON to facilitate Tendyne transcatheter mitral valve replacement. J Am Coll Cardiol Intv 2018;11:2014-7.), which may also prolapse back into the transcatheterly-implanted mitral valve, interfering with valve closure and causing acute valve failure (Greenbaum AB, Condado JF, Eng M, et al. Long or redundant leaflet complicating transcatheter mitral valve replacement: case vignettes that advocate for removal or reduction of the anterior mitral leaflet. Catheter Cardiovasc Intery 2018;92: 627-32). A solution to avoid both static and dynamic TMVR-induced LVOT obstruction is first grabbing and then properly securing the native mitral valve's anterior leaflet to the implanted mitral prosthesis. The present invention comprises an assembly of components that work together as a device for first grabbing, and then securing the native mitral valve's leaflet to a mitral prosthesis via transcatheter means. The following shows step-by-step how a device mechanism through a catheter that transseptally (entering through the left atrium and then left ventricle through the interatrial septum) passes or directly enters the left atrium and then the left ventricle to grab the mitral anterior leaflet and then secure it to the mitral prosthesis.
It is an objective of the present invention to provide devices and methods that allow for first grabbing, and then securing the native atrioventricular valve's leaflet to a prosthesis via transcatheter means, as specified in the independent claims. Embodiments of the invention are given in the dependent claims. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive.
The present invention features a grasping device for securing a mitral leaflet component of a native mitral valve. The mitral leaflet component comprises a leaflet and chordae tendineae associated with said leaflet. In some embodiments, the device may comprise a first grasping component configured to grab chordae tendineae of said mitral leaflet component, and a second grasping component configured to anchor the mitral leaflet component to a prosthetic component. In some embodiments, the first grasping component may comprise at least one grasping arm configured to transition from a non-extended state to an extended state to a grasping state. In some embodiments, the second grasping component may comprise a hook disposed at a distal end of the device capable of anchoring to the prosthetic component. In some embodiments, the prosthetic component comprises a stent.
The present invention features a method for securing a mitral leaflet component of a native mitral valve. The mitral leaflet component comprises a leaflet and chordae tendineae associated with the leaflet. In some embodiments, the method may comprise providing a grasping device comprising a first grasping component configured to grab chordae tendineae of said mitral leaflet component, and a second grasping component configured to anchor the mitral leaflet component to a prosthetic component. The method may further comprise positioning the device to a side of chordae tendineae of the mitral leaflet component. Positioning the device to the side of chordae tendineae may comprise deploying the device into the mitral valve through a catheter. The method may further comprise actuating the first grasping component to grab chordae tendineae of the mitral leaflet component. The method may further comprise actuating the second grasping component to anchor the mitral leaflet component to the prosthetic component. In some embodiments, the method may further comprise removing the catheter from the mitral valve, leaving the device in place. In some embodiments, the first grasping component of the device may comprise at least a grasping arm configured to transition from a non-extended state to an extended state to a grasping state. In some embodiments, the second grasping component of the device may comprise a hook disposed at a distal end of the device. In some embodiments, the prosthetic component comprises a stent.
One of the unique and inventive technical features of the present invention is the use of a first grasping component for grasping chordae tendineae, and a second grasping component for anchoring to a prosthetic component in order to immobilize an anterior leaflet component AFTER grasping chordae tendineae. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention advantageously provides for the ability to prevent LVOT obstruction to a pre-deployed prosthetic component without risking damage to chordae tendineae even in the case of user error. None of the presently known prior references or work has the unique inventive technical feature of the present invention.
Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.
The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:
Following is a list of elements corresponding to a particular element referred to herein:
1 chordae tendineae
100 catheter
200 grasping device
210 first grasping component
215 memory wire
220 first slide lock
225 second slide lock
230 second grasping component
300 prosthetic component
410 chordae hook actuator
415 first detachment region
420 prosthesis hook actuator
425 second detachment region
Referring now to
The leaflet component may comprise a leaflet and a chordae tendineae (1) associated with said leaflet. In some embodiments, the leaflet component comprises a mitral leaflet component. In other embodiments, the leaflet component comprises a tricuspid leaflet component.
The mitral leaflet component comprises a leaflet (e.g., an anterior leaflet or a posterior leaflet) and chordae tendineae (1) associated with said leaflet. In some embodiments, the device (200) may comprise a first grasping component (210) configured to grab chordae tendineae (1) of said mitral leaflet component, and a second grasping component (230) configured to anchor the mitral leaflet component to a prosthetic component (300). In some embodiments, the prosthetic component (300) is a mitral prosthetic component (300) (e.g., a stent).
As shown in
Referring now to
In some embodiments, the memory wire (215) is disposed on an inner surface of a grasping arm. In other embodiments, the memory wire (215) is disposed on an exterior surface of a grasping arm. The surface of the grasping arm in which the memory wire (215) is disposed will fold inward. For example, if the memory wire (215) is disposed on the inner surface of the grasping arm the inner surface will fold inward (see
The arm may be configured to transition from a non-extended state to an extended state to a grasping state. In some embodiments, transitioning from the extended state to the grasping state comprises pulling the memory wire (215) to curl the arm (210) such that the first end meets or overlaps the second end of the arm (210). The memory wire (215) may extend from the surface of the arm to a point that allows a user to interact with the memory wire (215).
In some embodiments, the device (200) may further comprise a first slide lock (220) adapted to slide between a locked position and an unlocked position along the device (200). In other embodiments, the device (200) may further comprise a plurality of first slide locks (220) adapted to slide between a locked position and an unlocked position along the device (200). For example, a plurality of first slide locks (220) may be used with devices (200) described herein comprising a plurality of grasping arms.
The unlocked position of the first slide lock (220) may permit the arm (210) to transition from the non-extended state to the extended state. The locked position of the first slide lock (220) may keep the arm in the non-extended state or the grasping state, depending on which state the arm is currently in. An actuation method of the first slide lock (220) may be selected from a group comprising pulling a wire (e.g., an external wire) operatively coupled to the first slide lock (220) and twisting a wire coil operatively coupled to the first slide lock (220). A resting state of the memory wire (215) may be a straight line, and the arm may be transitioned from the non-extended state to the extended state by allowing the memory wire (215) to extend into the straight line.
In some embodiments, the memory wire (215) may be compressed in the non-extended (e.g., a folded) state and may remain compressed until exposed to body temperature. In some embodiments, once inside the body (i.e., once the memory wire (215) reaches body temperature) the memory wire (215) will want to extend into a straight line, thus extending the grasping arm; however, the first slide lock (220) prevents the grasping arm from extending into a straight line. Then where the first slide lock (220) is released, the grasping arm transitions into an extending state (e.g., a straight line). Once the grasping arm has captured the mitral leaflet component (e.g, chordae tendineae (1)), externally pulling the memory wire (215) will cause the grasping arm(s) to fold as a triangle (see
In some embodiments, the memory wire (215) comprises a nitinol wire. In other embodiments, the memory wire (215) comprises elastic nitinol. In further embodiments, the memory wire (215) comprises a memory shape alloy.
In some embodiments, the wire (e.g., a nitinol wire, an elastic nitinol wire, or a memory shape alloy) is operatively coupled to the memory wire (215). The external pulling of the memory wire will force the grasping arm to close (pulling force needs to overcome the force that keeps the memory wanting to keep the arm extended).
The arm may further comprise a set of teeth disposed at the first end for locking the arm in the grasping state. In some embodiments, the set of teeth prevents sliding of the grasping arm from the grasping state. For example, when the grasping arm is ready to be locked into the grasping state, there is nothing keeping the grasping arm from unfolding and sliding out of the gate. Therefore, the set of teeth prevents the grasping arm from unfolding into the extended state. In some embodiments, the set of teeth is taller/longer than the height of the gate hole. In some embodiments, the set of teeth comprises stiff biocompatible materials including but not limited to metal or plastic.
In some embodiments, the second grasping component (230) may comprise a prosthesis grasping hook disposed at a distal end of the device (200) capable of anchoring to the prosthetic component. In some embodiments, the second grasping component (230) anchors the mitral leaflet component to the prosthetic component (300). Specifically, the second grasping component (230) may anchor a mitral valve leaflet (e.g., the anterior leaflet of the mitral valve). Without wishing to limit the present invention to any theory or mechanism it is believed that anchoring of the anterior leaflet of the mitral valve will prevent LVOT obstruction.
In some embodiments, the device (200) may further comprise a second slide lock (225) adapted to slide between a locked position and an unlocked position along the device (200), wherein the locked position closes the prosthesis grasping hook, and wherein the unlocked position allows the prosthesis grasping hook to anchor the mitral leaflet component to the prosthetic component (300). An actuation method of the second slide lock (225) may be selected from a group comprising pulling a wire operatively coupled to the second slide lock (225) and twisting a wire coil operatively coupled to the second slide lock (225). In some embodiments, the prosthetic component (300) comprises a stent.
Referring now to
In some embodiments, the delivery system (e.g., a catheter (100)) for deploying the device (200) may be able to rotate to move the grasping arms into an ideal location. An ideal position to start may be right before a leaflet of the mitral leaflet component (e.g., an anterior leaflet) so that the arm will grab chordae tendineae (1) through the sweep. In some embodiments, the device (200) may be rotated into an ideal location (e.g., a position in which the chordae tendineae (1) may be grabbed) regardless of the starting position.
The method may further comprise actuating the first grasping component (210) to grab chordae tendineae (1) of the mitral leaflet component (see
In some embodiments, the same delivery system is used to deploy the devices (200) described herein and the prosthetic component (300). In other embodiments, the same catheter (i.e., delivery catheter) is used to deploy the devices (200) described herein and the prosthetic component (300).
In some embodiments, the devices (200) described herein are permanent devices. In other embodiments, the device (200) described herein are semi-permanent devices.
In some embodiments, the first grasping component (210) of the device (200) may comprise at least one grasping arm comprising a memory wire (215) disposed lengthwise and attached to a surface of the arm. In some embodiments, the arm may be configured to transition from a non-extended state to an extended state to a grasping state. The method may further comprise pulling the memory wire (215) to curl the arm such that the first end meets or overlaps the second end of the arm in order to transition from the extended state to the grasping state.
In some embodiments, the device (200) may further comprise a first slide lock (220) adapted to slide between a locked position and an unlocked position along the device (200). The unlocked position of the first slide lock (220) may permit the arm to transition from the non-extended state to the extended state. The locked position of the first slide lock (220) may keep the arm in the non-extended state or the grasping state, depending on which state the arm is currently in. In some embodiments, the method may further comprise sliding the first slide lock (220) into the unlocked position to permit the arm to transition from the non-extended state to the extended state (see
In some embodiments, the second grasping component (230) of the device (200) may comprise a prosthesis grasping hook disposed at a distal end of the device (200). In some embodiments, the device (200) may further comprise a second slide lock (225) adapted to slide between a locked position and an unlocked position along the device (200). The locked position may close the prosthesis grasping hook, and the unlocked position may allow the prosthesis grasping hook to anchor the mitral leaflet component to the prosthetic component (300). In some embodiments, the method may further comprise sliding the second slide lock (225) into the unlocked position to allow the prosthesis grasping hook to anchor the mitral leaflet component to the prosthetic component (300) (see
In some embodiments, the prosthetic component (300) comprises a stent. In some embodiments, the stent further comprises a heart valve. In other embodiments, the prosthetic component (300) comprises a valve (e.g., a heart valve). In some embodiments, the prosthetic component (300) may comprise a landing base which aids in the deployment of the prosthetic component (300) (e.g., a prosthetic component (300) comprising a stent).
Referring now to
In some embodiments, the chordae grasping hooks or the prosthesis grasping hooks are detachable. In some embodiments, the first detachment region (415) and the second detachment region (425) may also act as locks (e.g., quarter-turn locks).
In some embodiments, the delivery system (e.g., a catheter (100)) may guide the chordae grasping hooks or the prosthesis grasping hooks to mechanically turn the catheter (100) thus, in turn, turning the chordae grasping hooks or the prosthesis grasping hook. This may include twisting, pulling, pushing, rotating the catheter to grab the mitral leaflet component (e.g., the leaflets/chords). Once the chordae grasping hooks loop chordae tendineae (1), the chordae hook actuator (410) at the first detachment region (415) may be pulled back, thus pulling back the chordae grasping hooks into a secure position in the device.
Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of” or “consisting of”, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of” or “consisting of” is met.
The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.
This application is a non-provisional and claims benefit of U.S. Provisional Application No. 63/154,080 filed Feb. 26, 2021, the specification of which is incorporated herein in their entirety by reference
Number | Date | Country | |
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63154080 | Feb 2021 | US |