Patent Application
20230059371
Some applications of the present invention relate in general to cardiovascular medical procedures. Specifically, some applications of the present invention relate to use of a support to facilitate accessing native heart valves.
Transluminal delivery is used in a range of cardiac medical procedures. Targets of such procedures include native heart valves. Typically, transluminally accessing a native heart valve involves steering a tool within the confines of the heart.
Transluminally accessing the tricuspid valve presents clinical challenges, including catheter navigation within the right atrium.
Transseptal delivery typically involves accessing the right atrium through the vasculature, followed by puncture of the atrial septum from within the right atrium. The fossa ovalis is considered an optimal location for transseptal puncture, as tissue of the fossa ovalis is typically thinner than other tissue of the septum.
Strain placed upon the septum during transseptal puncture and/or manipulation of tools across the septum, may result in stretching or tearing of septal tissue, contributing to the risk of postoperative complications.
In accordance with some applications of the present invention, applying a supporting force to a portion of the delivery tool aids in navigation of a delivery tool while transluminally (e.g., transfemorally) navigating the delivery tool to an atrio-ventricular valve of the heart. For some applications, the supporting force is applied to support a supported portion of the delivery tool, which may serve as a pivot point with which the supporting force and a pushing force applied to the delivery tool can interact. Different intracatheter and extracatheter supports, and use of the supports in applying the supporting force to a delivery tool, are described herein.
For some applications, aspects of the present invention include implanting a prosthetic valve at a native valve of the heart. For some such applications, using the support to apply the supporting force to the delivery tool may facilitate coupling the prosthetic valve to ventricular tissue of the heart.
For some applications, a support is used to facilitate accessing a native heart valve from the right atrium. For example, a site of interest may be within the right side of the heart (e.g., the tricuspid valve), or may be within the left side of the heart (e.g., the mitral valve) but accessed transseptally from the right atrium. Typically for such applications, a catheter is advanced, via an inferior vena cava of the subject, to a right atrium of the heart, and a support is advanced, via a superior vena cava of the subject, to the right atrium.
For some applications, aspects of the present invention include engaging the delivery tool with the support within the right atrium of the heart, and steering a distal portion of the delivery tool toward a native valve, while using the support to support the delivery tool within the right atrium.
For some applications, aspects of the present invention include using an intracatheter support (e.g., comprising a stylet and/or a pull-wire) to apply the supporting force to the delivery tool. For example, the intracatheter support may be used to apply tension to a portion of the delivery tool.
For some applications, aspects of the present invention include engaging the catheter with a catheter-engaging element of an extracatheter support.
For some such applications, the catheter is mechanically engaged using the catheter-engaging element. For example, the distal portion may be advanced through a loop formed by the catheter-engaging element. Alternatively, a snare formed by the catheter-engaging element may be used to ensnare the catheter. For example, the catheter-engaging element may ensnare the catheter by transitioning the snare from a non-engaging state to an engaging state.
For some applications, the catheter is magnetically engaged with the catheter-engaging element. For example, an electromagnet may be activated to magnetically engage the catheter with the catheter-engaging element.
For some applications, the support is used to facilitate transseptally accessing a left atrium of a heart.
For some such applications, aspects of the present invention include advancing the catheter through an interatrial septum of the heart and into the left atrium. For example, the support may be used to support the catheter within the right atrium while the distal portion of the catheter is steered toward a mitral valve of the heart.
For example, the support may be used to support the catheter while implanting an implant (e.g., a prosthetic valve) at the native mitral valve.
For example, the support may be used to move the catheter by applying a force to the catheter. For some such applications, the force is applied to the catheter while the catheter is steered toward the mitral valve.
There is therefore provided, in accordance with an application of the present invention, an apparatus including a kit, the kit including:
a flexible catheter, the catheter being transfemorally advanceable to a heart of a subject; and
a support, the support being dimensioned for percutaneous access to the heart, the support defining:
In an application, the catheter and the support are configured such that, while the catheter-engaging element engages the catheter, pulling on the proximal end of the support applies a superiorly-directed force to the catheter.
In an application, the catheter-engaging element is shaped to form a loop, the loop being dimensioned to facilitate advancing the catheter through the loop.
In an application, the loop is tightenable around the catheter when the loop is engaged with the catheter.
In an application, the apparatus includes a tightening ring, the loop being threaded through the tightening ring, such that advancing the tightening ring, along the loop, tightens the loop around the catheter.
In an application, the catheter-engaging element is transitionable in shape from a non-engaging state into an engaging state.
In an application, the apparatus includes a pull-wire attached to the catheter-engaging element, and the catheter-engaging element is configured to be bent, using the pull-wire, from the non-engaging state into the engaging state.
In an application, the apparatus includes a constraint, and the catheter-engaging element includes a shape-memory material, such that:
the catheter-engaging element is constrainable in the non-engaging state by the constraint, and upon removal of the constraint, the catheter-engaging element automatically transitions into the engaging state.
In an application, the constraint includes a constraining overtube, and the catheter-engaging element is disposed within the constraining overtube.
In an application, the constraint includes a stiff internal rod disposed within the catheter-engaging element.
In an application, the catheter-engaging element includes a snare, the snare configured to engage the catheter through an opening of the snare.
In an application, the opening of the snare has a width that is greater than an external diameter of the catheter.
In an application: the catheter includes a support-engaging element coupled to an outer wall of the catheter, and the catheter-engaging element is configured to engage the support-engaging element.
In an application: the support-engaging element is shaped to define a rail extending along a portion of the catheter,
the catheter-engaging element is shaped to define a hook, and
the hook is configured to ensnare the rail.
In an application:
the support-engaging element includes a ferromagnetic material,
the catheter-engaging element includes a ferromagnetic material, and
the catheter-engaging element is configured to magnetically engage the support-engaging element.
In an application, the support-engaging element includes an electromagnet.
In an application, the catheter-engaging element includes an electromagnet.
There is further provided, in accordance with an application of the present invention, an apparatus including a kit, the kit including:
a flexible catheter, the catheter:
a prosthetic valve, the prosthetic valve being dimensioned to be passed to the heart through the primary lumen; and
a stylet that is stiffer than the flexible catheter, and is slidable through the secondary lumen.
In an application, the stylet is rigid.
In an application, the kit includes a piercing device, the piercing device being configured to pierce an interatrial septum of the heart.
In an application, the kit includes a dilator, the dilator being configured to dilate a pierced interatrial septum of the heart.
There is further provided, in accordance with an application of the present invention, a method for use at a heart of a subject, the method including:
advancing a distal end of a catheter transfemorally and through an interatrial septum of the heart into a left side of the heart; and
while a distal end of a stylet is disposed inside the catheter and within a right atrium of the heart, withdrawing the distal end of the catheter proximally toward the interatrial septum such that the catheter slides over the stylet.
In an application, the method includes, subsequently to the step of advancing the distal end of the catheter, and prior to the step of withdrawing the distal end of the catheter, advancing the distal end of the stylet through the catheter such that the distal end of the catheter becomes disposed within the right atrium of the heart, inside the catheter.
In an application, the step of advancing the distal end of the catheter includes advancing the distal end of the catheter transfemorally and through the interatrial septum of the heart into the left side of the heart while the distal end of the stylet is disposed inside the catheter.
In an application, the method includes, subsequently to withdrawing the distal end of the catheter proximally toward the interatrial septum, withdrawing the distal end of the catheter from the heart.
In an application, a prosthetic valve is coupled to the catheter, and the step of advancing the distal end of the catheter includes advancing the distal end of the catheter transfemorally and through the interatrial septum of the heart into the left side of the heart such that the prosthetic valve becomes advanced transfemorally and through the interatrial septum of the heart into the left side of the heart.
In an application, the method includes implanting the prosthetic valve at a mitral valve of the heart.
There is further provided, in accordance with an application of the present invention, a method for use at a heart of a subject, the method including:
advancing a distal portion of a catheter, via an inferior vena cava of the subject, to a right atrium of the heart, through an interatrial septum of the heart and into a left atrium of the heart;
advancing a support, via a superior vena cava of the subject, to the right atrium of the heart;
engaging the catheter with the support within the right atrium of the heart; and
while supporting the catheter in the right atrium using the support, withdrawing the distal end of the catheter proximally toward the interatrial septum.
There is further provided, in accordance with an application of the present invention, a method for transseptally accessing a left atrium of a heart of a subject, the method including:
advancing a catheter, via an inferior vena cava of the subject, to a right atrium of the heart;
advancing a support, via a superior vena cava of the subject, to the right atrium of the heart;
advancing a distal portion of the catheter through an interatrial septum of the heart and into the left atrium;
engaging the catheter with the support within the right atrium of the heart; and
subsequently, steering the distal portion of the catheter toward a mitral valve of the heart, while supporting the catheter in the right atrium using the support.
In an application, advancing the catheter to the right atrium includes advancing the catheter to the right atrium subsequently to advancing the support to the right atrium.
In an application, advancing the catheter to the right atrium includes advancing the catheter to the right atrium prior to advancing the support to the right atrium of the heart.
In an application, the support includes a catheter-engaging element, and engaging the catheter with the support includes engaging the catheter with the catheter-engaging element.
In an application, the catheter includes a support-engaging element, and engaging the catheter with the catheter-engaging element includes engaging the support-engaging element to the catheter-engaging element.
In an application, engaging the support-engaging element to the catheter-engaging element includes magnetically engaging the support-engaging element to the catheter-engaging element.
In an application, the support-engaging element includes an electromagnet, and magnetically engaging the support-engaging element to the catheter-engaging element includes activating the electromagnet.
In an application, the catheter-engaging element includes an electromagnet, and magnetically engaging the support-engaging element to the catheter-engaging element includes activating the electromagnet.
In an application:
the support-engaging element is a first support-engaging element,
magnetically engaging the support-engaging element to the catheter-engaging element includes magnetically engaging the first support-engaging element to the catheter-engaging element,
the catheter includes at least a second support-engaging element, and
the method includes, subsequently to magnetically engaging the first support-engaging element to the catheter-engaging element:
In an application, engaging the catheter with the catheter-engaging element includes mechanically engaging the catheter with the catheter-engaging element.
In an application, mechanically engaging the catheter with the catheter-engaging element includes fitting a protrusion into a recess.
In an application:
the catheter includes a support-engaging element shaped to define a rail,
the catheter-engaging element is shaped to define a hook, and
engaging the catheter with the catheter-engaging element includes hooking the rail with the hook.
In an application, the catheter-engaging element is shaped to form a loop, and mechanically engaging the catheter with the catheter-engaging element includes advancing the distal portion of the catheter through the loop of the catheter-engaging element.
In an application, the catheter-engaging element is shaped to define a snare, and mechanically engaging the catheter with the catheter-engaging element includes supporting a supported portion of the catheter with the snare.
In an application, supporting the supported portion includes supporting the supported portion while the supported portion is disposed within the right atrium.
In an application, the catheter-engaging element is shaped to form a loop, and supporting the supported portion with the catheter-engaging element includes tightening the loop around the catheter.
In an application, the catheter-engaging element has a non-engaging state and an engaging state, and advancing the support to the right atrium includes advancing the support while the catheter-engaging element is in the non-engaging state.
In an application, engaging the catheter includes transitioning the catheter-engaging element from the non-engaging state to the engaging state.
In an application, supporting the catheter in the right atrium using the support includes, subsequently to advancing the distal portion of the catheter through the interatrial septum, moving the catheter by applying a force to the catheter, using the support.
In an application, applying the force to the catheter includes applying a supporting force to the catheter using the support by applying tension to the support.
In an application, moving the catheter using the support includes using the support to change an orientation of the catheter.
In an application, supporting the catheter includes, subsequently to moving the catheter by applying the force to the catheter, continuing to apply the force to the catheter.
In an application, applying the force to the support facilitates steering the distal portion of the catheter toward the mitral valve.
In an application, moving the catheter includes moving a supported portion of the catheter, relative to the interatrial septum.
In an application, moving the supported portion of the catheter relative to the interatrial septum includes moving the supported portion of the catheter towards the superior vena cava.
In an application, the distal portion of the catheter includes a piercing device, and advancing the distal portion of the catheter through the interatrial septum includes piercing the septum with the piercing device.
In an application, the piercing device includes a needle, and piercing the septum includes mechanically puncturing the septum with the needle.
In an application:
advancing the catheter, via the inferior vena cava, to the right atrium includes advancing an implant within the catheter, via the inferior vena cava, to the right atrium; and
the method includes implanting the implant at the mitral valve.
In an application, the implant includes a prosthetic heart valve, and implanting the implant at the mitral valve includes implanting the prosthetic heart valve at the mitral valve.
In an application, the implant includes an annuloplasty device, and implanting the implant at the mitral valve includes implanting the annuloplasty device at the mitral valve.
There is further provided, in accordance with an application of the present invention, a method for transfemorally implanting a prosthetic valve at a native valve of a heart of a subject, the method including:
advancing a delivery tool, via an inferior vena cava of the subject, to a right atrium of the heart;
advancing a support, via a superior vena cava of the subject, to the right atrium of the heart;
engaging the delivery tool with the support within the right atrium of the heart;
steering a distal portion of the delivery tool toward the native valve, while supporting the delivery tool in the right atrium using the support; and
subsequently, at the native valve, deploying a prosthetic valve from the delivery tool.
In an application, the support includes a catheter-engaging element having a non-engaging state and the engaging state, and engaging the delivery tool with the support within the right atrium of the heart includes transitioning the catheter-engaging element from the non-engaging state to the engaging state.
In an application:
steering the distal portion of the delivery tool toward the native valve includes steering the distal portion of the delivery tool toward a tricuspid valve of the heart; and
deploying the prosthetic valve from the delivery tool includes deploying the prosthetic valve from the delivery tool at the tricuspid valve.
In an application, the method includes subsequently to deploying the prosthetic valve from the delivery tool:
withdrawing the support from the right atrium, via the superior vena cava; and
withdrawing the delivery tool from the right atrium, via the inferior vena cava.
In an application:
the delivery tool includes a proximal housing and a distal housing,
deploying the prosthetic valve from the delivery tool includes increasing a distance between the proximal housing and the distal housing, and
withdrawing the delivery tool proximally via the inferior vena cava includes retracting the distal housing through the prosthetic valve.
In an application, the method includes, subsequently to deploying the prosthetic valve from the delivery tool, disengaging the delivery tool from the support.
In an application, the support includes a catheter-engaging element having a non-engaging state and the engaging state, and disengaging the delivery tool from the support includes transitioning the catheter-engaging element from the engaging state to the non-engaging state.
In an application, supporting the delivery tool in the right atrium using the support includes applying a force to the delivery tool using the support.
In an application, applying the force to the delivery tool using the support includes moving the delivery tool using the support, by applying the force.
In an application, moving the delivery tool includes changing an orientation of the distal portion of the delivery tool.
In an application, applying the force to the delivery tool using the support includes applying the force to the delivery tool using the support while the prosthetic valve is at least partially disposed within a right ventricle of the heart.
In an application, applying the force to the delivery tool using the support includes applying the force to the delivery tool using the support while the prosthetic valve is at least partially deployed from the delivery tool.
In an application, applying the force to the delivery tool using the support includes coupling the prosthetic valve to a ventricular tissue of the heart.
In an application, applying the force to the delivery tool using the support includes applying a superiorly-directed force to the delivery tool using the support.
In an application, applying the superiorly-directed force to the delivery tool using the support includes applying the superiorly-directed force to the delivery tool using the support, while deploying the prosthetic valve from the delivery tool.
In an application, applying the superiorly-directed force to the delivery tool using the support includes, subsequently to deploying the prosthetic valve, applying the superiorly-directed force to the delivery tool using the support while withdrawing at least a portion of the delivery tool into the right atrium.
In an application, applying the superiorly-directed force to the delivery tool using the support while withdrawing at least the portion of the delivery tool into the right atrium includes applying the superiorly-directed force to the delivery tool using the support while withdrawing the distal housing into the right atrium.
There is further provided, in accordance with an application of the present invention, a method for transseptally accessing a left atrium of a heart of a subject, the method including:
transluminally positioning a delivery tool including a catheter and a stylet such that:
In an application, extending the catheter, via the inferior vena cava, to the right atrium, includes extending the catheter, via the inferior vena cava, to the right atrium, while the catheter is empty of the stylet.
In an application, extending the catheter, via the inferior vena cava, to the right atrium, includes extending the catheter, via the inferior vena cava, to the right atrium, while the stylet is disposed within the catheter.
In an application, the catheter defines a secondary lumen therethrough, and extending the stylet within the catheter and to the right atrium includes extending the stylet through the secondary lumen.
In an application, the catheter houses an implant, and the method includes:
advancing the implant within the catheter, via the inferior vena cava, to the right atrium; and
subsequently to steering the distal portion of the catheter toward the mitral valve, deploying the implant from within catheter, at the mitral valve.
In an application, the implant includes a prosthetic heart valve, and implanting the implant at the mitral valve includes implanting the prosthetic heart valve at the mitral valve.
In an application, the implant includes an annuloplasty device, and implanting the implant at the mitral valve includes implanting the annuloplasty device at the mitral valve.
In an application, the delivery tool further includes a piercing device, the piercing device extending distally out of the distal end of catheter, and steering the distal end of the catheter through the interatrial septum includes piercing the septum with the piercing device.
In an application, the piercing device includes a needle, and piercing the septum includes mechanically puncturing the septum with the needle.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 1 and 10 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 10 and 20 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 20 and 30 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 30 and 60 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and through the interatrial septum while the stylet extends within the right atrium, to an atrial height that is between 40 and 70 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the distal end of the stylet remains in the right atrium, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 10 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 20 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 30 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 30 and 60 mm.
In an application, steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm, includes steering the distal portion of the catheter toward the mitral valve, while the stylet extends within the right atrium, to an atrial height that is between 40 and 70 mm.
There is further provided, in accordance with an application of the present invention, a method for transfemorally accessing a native valve of a heart of a subj ect, the method including:
positioning a delivery tool including a catheter and a stylet, such that:
In an application, the method includes, subsequently to the step of steering:
deploying a prosthetic valve from the delivery tool, at the native valve.
In an application, the native valve is a tricuspid valve of the heart.
In an application:
the native valve is a mitral valve of the heart, and
the step of steering includes advancing the distal portion of the delivery tool through an interatrial septum of the heart into a left atrium of the heart.
In an application, the catheter defines a secondary lumen therethrough, and extending the stylet within the catheter and to the right atrium includes extending the stylet through the secondary lumen.
In an application, positioning the delivery tool includes advancing the delivery tool transluminally via the inferior vena cava.
In an application, positioning the delivery tool includes positioning the delivery tool such that the stylet extends, within the catheter and through a secondary lumen, to the right atrium.
In an application, steering the distal portion of the delivery tool away from the distal end of the stylet and toward the native valve includes sliding the catheter distally over the stylet.
In an application, sliding the catheter distally over the stylet includes holding the distal end of the stylet at a generally constant atrial height while steering the distal portion toward and through the native valve.
In an application, deploying the prosthetic valve from the distal portion of the delivery tool includes extracorporeally applying a proximally-directed force to the delivery tool.
In an application, extracorporeally applying the proximally-directed force to the delivery tool includes extracorporeally applying the proximally-directed force to the delivery tool such that the prosthetic valve moves proximally and engages tissue of the native valve.
In an application, the delivery tool includes a distal housing, and extracorporeally applying the proximally-directed force to the delivery tool includes increasing a distance between a distal opening of the catheter and the distal housing.
In an application, extracorporeally applying the proximally-directed force to the delivery tool includes retracting the delivery tool through the prosthetic valve.
In an application, extracorporeally applying the proximally-directed force to the delivery tool includes holding the distal end of the stylet in the right atrium, and within the catheter, a generally constant atrial height, by applying the proximally-directed force to catheter, and applying a pushing force to the stylet.
In an application, steering the distal portion of the delivery tool away from the distal end of the stylet and toward the native valve, while the distal end of the stylet remains in the right atrium, and within the catheter, includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 10 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 20 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 30 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 30 and 60 mm.
In an application, steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes steering the distal portion of the catheter away from the distal end of the stylet and toward the native valve, while the stylet extends within the right atrium, to an atrial height that is between 40 and 70 mm.
In an application, deploying the prosthetic valve from the delivery tool, while the distal end of the stylet remains in the right atrium, and within the catheter, includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm, includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 1 and 10 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm, includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 10 and 20 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 1 and 70 mm includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 10 and 70 mm includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 20 and 30 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 30 and 60 mm.
In an application, deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 20 and 70 mm includes deploying the prosthetic valve from the delivery tool while the stylet extends within the right atrium, to an atrial height that is between 40 and 70 mm.
There is further provided, in accordance with an application of the present invention, a method for transseptally accessing a mitral valve of a heart of a subject, the method including:
transluminally positioning a catheter such that the catheter extends, via an inferior vena cava of the subject, to a right atrium of the heart;
advancing a distal portion of the catheter through an interatrial septum of the heart into a left atrium of the heart;
subsequently, tilting the distal portion of the catheter toward the mitral valve by transluminally extending a stylet, within the catheter, to the right atrium.
In an application, transluminally extending the stylet, within the catheter, to the right atrium, includes extracorporeally pushing a proximal portion of the stylet towards a superior vena cava of the heart.
In an application, tilting the distal portion of the catheter includes tilting the distal portion of the catheter such that the distal opening of the catheter faces the mitral valve.
In an application, while a distal end of the stylet remains in the right atrium, steering the distal portion of the catheter toward a mitral valve of the heart.
In an application, the catheter houses an implant, and the method includes, subsequently to tilting the distal portion of the catheter, deploying the implant from within the catheter, at the mitral valve.
In an application, the implant includes a prosthetic heart valve, and implanting the implant at the mitral valve includes implanting the prosthetic heart valve at the mitral valve.
In an application, the implant includes an annuloplasty device, and implanting the implant at the mitral valve includes implanting the annuloplasty device at the mitral valve.
In an application, transluminally extending the stylet, within the catheter, to the right atrium, includes extending the stylet, within the right atrium, to an atrial height between 1 and 70 mm.
In an application, extending the stylet, within the right atrium, to an atrial height between 1 and 70 mm, includes extending the stylet to an atrial height between 1 and 10 mm.
In an application, extending the stylet, within the right atrium, to an atrial height between 1 and 70 mm, includes extending the stylet to an atrial height between 10 and 20 mm.
In an application, the stylet, within the right atrium, to an atrial height between 1 and 70 mm, includes extending the stylet to an atrial height between 10 and 70 mm.
In an application, extending the stylet, within the right atrium, to an atrial height between 10 and 70 mm, includes extending the stylet to an atrial height between 20 and 70 mm.
In an application, extending the stylet to an atrial height between 20 and 70 mm, includes extending the stylet to an atrial height between 20 and 30 mm.
In an application, extending the stylet to an atrial height between 20 and 70 mm, includes extending the stylet to an atrial height between 30 and 60 mm.
In an application, extending the stylet to an atrial height between 20 and 70 mm, includes extending the stylet to an atrial height between 40 and 70 mm.
Other embodiments are also described.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
For some applications, elements of system 10 (e.g., delivery tool 20 and support 40) are packaged together commercially, e.g., in a kit.
As shown in
Some other embodiments of catheter-engaging elements are described hereinbelow.
For some applications, distal portion 24 of catheter 22 is advanced to right atrium 76 prior to advancing catheter-engaging element 38 of support 40 to the right atrium. For other applications, distal portion 24 of catheter 22 is advanced to right atrium 76 subsequently to advancing catheter-engaging element 38 of support 40 to the right atrium. Alternatively, distal portion 24 and catheter-engaging element 38 may be advanced simultaneously to right atrium 76.
Typically, and as shown, catheter 22 is engaged with catheter-engaging element 38 while the catheter-engaging element is disposed within right atrium 76. As shown in
For some applications in which catheter-engaging element 38 is shaped to form a loop, and as shown, the catheter-engaging element is used to mechanically engage catheter 22 initially by threading distal portion 24 of the catheter through the catheter-engaging element (
Typically for such applications, distal portion 24 is threaded through catheter-engaging element 38 while the distal portion and the catheter-engaging element are both disposed within right atrium 76. For some applications wherein catheter-engaging element 38 is shaped to form a loop, distal portion 24 is threaded through catheter-engaging element 38 by advancing the distal portion of the catheter through the loop of the catheter-engaging element, e.g., after catheter-engaging element 38 is pre-positioned in front of fossa ovalis 84. Alternatively or in addition, catheter-engaging element 38 may be moved longitudinally with respect to distal portion 24, such that catheter 22 passes through the loop.
Threading distal portion 24 through the loop may be facilitated by one or more techniques for visualization of delivery tool 20, support 40 and/or tissue of heart 90, including but not limited to fluoroscopy, transesophageal echocardiography (TEE) and dye staining of tissue.
As shown in
For some such applications, catheter-engaging element 38 is used to support catheter 22 (e.g., a supported portion 34 of the catheter) during further advancement and/or steering of the catheter. Supported portion 34 is not necessarily a discrete part or feature of catheter 22, but rather the supported portion may be defined as a portion of the catheter currently being engaged by catheter-engaging element 38. For some applications, the operator may not need to engage a precise target on catheter 22 with catheter-engaging element 38. It is hypothesized by the inventors that obviating a need to engage a precise target portion of catheter 22 facilitates the use of support 40 to engage the catheter.
For some applications in which catheter-engaging element 38 is shaped to form a loop, the engagement of catheter 22 by catheter-engaging element 38 is achieved by advancing the catheter through the loop (
For some applications, catheter 22 being supported using catheter-engaging element 38 enables application of a supporting force 50 (e.g., a superiorly-directed force) from support 40 to the catheter (
For some applications, alternatively or in addition to moving supported portion 34, applying force 50 to supported portion 34 changes an orientation of the catheter, e.g., an orientation of a right atrial portion 46 thereof, e.g., as shown by the transition between
Typically, the force is continually applied to supported portion 34 while distal portion 24 is steered to mitral valve 86, as shown in
For some applications, although the superiorly-directed force applied to catheter using support 40 allows longitudinal advancement of the catheter (e.g., orthogonal to the plane of septum 82), the force typically nonetheless restricts lateral movement, in at least one direction, of supported portion 34 while distal portion 24 of catheter 22 is steered toward mitral valve 86. It is hypothesized by the inventors that restricting lateral movement of the supported portion reduces shearing forces applied by catheter 22 upon tissue of interatrial septum 82 while distal portion 24 of catheter 22 is advanced and/or steered toward mitral valve 86, thereby reducing a risk of stretching or tearing (e.g., “cheesewiring”) tissue of septum 82. For some applications, supported portion 34 may serve as a fulcrum about which portions of catheter 22 may pivot in response to forces applied to the catheter.
For some applications, the operator determines a strength of the force applied using support 40 to supported portion 34, thereby determining a degree to which the catheter (e.g., the supported portion and/or right atrial portion 46 thereof) is moved. For example,
Typically, accessing left atrium 80 of heart 90 using delivery tool 20 facilitates performance of one or more clinical interventions, including but not limited to mitral annuloplasty, mitral chord repair, mitral valve replacement, left atrial appendage occlusion, or ablation for atrial fibrillation.
Some embodiments of the current invention are used to transseptally implant an implant to mitral valve 86 of heart 90. For example, the implant may be a prosthetic heart valve or an annuloplasty device. Typically for such applications, the implant is advanced within catheter 22, via inferior vena cava 72, to right atrium 76. Further typically, support 40 is used to support catheter 22 in right atrium 76, as described hereinabove, while distal portion 24 of catheter 22 is steered toward mitral valve 86, and while the implant is implanted at the mitral valve.
Reference is made to
For some applications, elements of system 120 (e.g., delivery tool 20 and support 140) are packaged together commercially, e.g., in a kit.
Except where noted, system 120 is typically identical to system 10 described hereinabove, and is used similarly as system 10, mutatis mutandis. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, system 120 comprises delivery tool 20, similarly to as described hereinabove in reference to
In contrast to catheter-engaging element 38 described above, the loop formed by catheter-engaging element 138 may be tightened around catheter 22 (e.g., supported portion 34 thereof), such that the catheter-engaging element supports the catheter. For some applications, and as shown in inset of
Reference is made to
For some applications, elements of system 210 (e.g., delivery tool 20 and support 240) are packaged together commercially, e.g., in a kit.
Except where noted, system 210 is typically identical to system 10 described hereinabove, and is used similarly as system 10, mutatis mutandis. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, system 210 comprises delivery tool 20, similarly to as described hereinabove in reference to
Catheter-engaging element 238 may be configured to be transitioned between its open and engaging states by comprising a shape-memory material. For example, the catheter-engaging element may be constrained in the non-engaging state (e.g., by a constraint such as a stiff internal rod or an overtube) and may automatically transition into the engaging state upon removal of the constraint.
Catheter-engaging element 238 may be configured to be transitioned between its non-engaging and engaging states via active bending, such as by pulling one or more pull-wires (such as pull-wires that are used in the art of steerable catheters, mutatis mutandis) that are attached to the catheter-engaging element.
For some applications, catheter-engaging element 238 engages (e.g., contacts) catheter 22 while the catheter-engaging element 238 is in the non-engaging state. For some applications, catheter-engaging element 238 engages catheter 22 while the catheter-engaging element transitions from the non-engaging state to the engaging state.
As described hereinabove in reference to support 40 shown in
Reference is made to
For some applications, elements of system 310 (e.g., delivery tool 20 and support 340) are packaged together commercially, e.g., in a kit.
Except where noted, system 310 is typically identical to system 10 described hereinabove, and is used similarly as system 10, mutatis mutandis. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, system 310 comprises delivery tool 20, similarly to as described hereinabove in reference to
For some applications, support 340 is used to apply a force to catheter 22 (e.g., supported portion 34 thereof), thereby supporting the catheter. For some such applications, and as shown, application of the force to supported portion 34, changes an orientation of catheter 22 (e.g., right atrial portion 46 thereof,
Reference is made to
For some applications, elements of system 410 (e.g., delivery tool 20 and support 440) are packaged together commercially, e.g., in a kit.
Except where noted, system 410 is typically identical to system 10 described hereinabove, and is used similarly as system 10, mutatis mutandis. Components that are identically named between the systems typically share similar features and serve similar functions as each other. Components bearing identical reference numerals are typically interchangeable between delivery tools 20 and 420. As such, the description below of system 410 focuses upon features that are particular to system 410 (e.g., the use of support 440 and delivery tool 420).
System 410 typically differs from the systems described hereinabove in at least two manners: (i) catheter 422 of delivery tool 420 comprises a support-engaging element 428, and (ii) a distal portion 441 of support 440 comprises a catheter-engaging element 438 dimensioned to engage support-engaging element 428. Support-engaging element 428 is typically a discrete element defined by and/or attached to the main body of the catheter, e.g., coupled to an outer wall of the catheter that is engaged by support 440.
For some applications, and as shown, catheter-engaging element 438 is shaped to define a hook. For some applications, support-engaging element 428 is shaped to define a rail extending along a portion of catheter 422. Typically for such applications, after catheter-engaging element 438 is advanced to right atrium 76 (
For some applications, hooking rail of support-engaging element 428, using the hook formed by catheter-engaging element 438, defines a supported portion 434 of catheter 422 by virtue of the presence of the rail at that portion of the catheter.
For some applications, in contrast to the embodiments described hereinabove, which typically support the catheter at a discrete point defining supported portion 34, a superiorly-directed force applied to the support-engaging element from catheter-engaging element 438 may be typically distributed, by the support-engaging element, along a length of catheter 422 (e.g., along supported portion 434 at which the support-engaging element is disposed).
For some applications, catheter-engaging element 438 is used to move catheter 422 (e.g., supported portion 434 thereof), by applying superiorly-directed force 50 from support 440 to the catheter. For example, the force may change an orientation of catheter 22 (e.g., of right atrial portion 46 thereof), as shown in
Reference is made to
For some applications, elements of system 510 (e.g., delivery tool 20 and support 540) are packaged together commercially, e.g., in a kit.
In systems described hereinabove, such as system 10, the catheter-engaging element of the support engages catheter 22 mechanically. However, for some applications of the invention, the support engages the catheter by non-mechanical means (e.g., magnetically). For example, in system 510, catheter-engaging element 538 of distal portion 541 of support 540 magnetically engages catheter 522. Besides the difference in the manner by which the catheter-engaging element engages the catheter, components that are identically named between the systems typically share similar features and serve similar functions as each other. As such, the description below of system 510 focuses upon features that are particular to system 510 (e.g., the use of support 540 and delivery tool 520).
As shown in
For some applications in which catheter-engaging element 538 comprises the electromagnet, support-engaging element 528 comprises a ferromagnetic material. Similarly, for some applications in which support-engaging element 528 comprises the electromagnet, catheter-engaging element 538 comprises a ferromagnetic material.
For some applications, and as shown in
With the exception of differences described hereinabove between system 410 and system 510, system 510 is used essentially similarly to system 410 described hereinabove. That is, catheter-engaging element 538 engages (e.g., magnetically engages) support-engaging element 528, instead of hooking support-engaging element 428 using catheter-engaging element 438. In this way, a supported portion 534 of catheter 522 is defined by virtue of the supported portion 534 being adjacent to magnet 560 which is magnetically engaged to catheter-engaging element 538.
For some applications, catheter-engaging element 538 is used to serially magnetically engage a plurality of support-engaging elements 528 disposed along an outer wall of catheter 522. Typically for such applications, catheter-engaging element 538 is an electromagnet, selectively activated, deactivated, and reactivated by the operator, in order to: magnetically engage a first support-engaging element 528 (
For some applications, supporting catheter 522 by using catheter-engaging element 538 to serially magnetically engage support-engaging elements 528 may facilitate transfer of superiorly-directed force 50 from support 540 to the catheter. For some such applications, applying the force may change an orientation of catheter 22 (e.g., right atrial portion 46 thereof).
The embodiments described hereinabove of catheter-engaging elements and respective support-engaging elements are not meant to be exclusive, and alternative means of engaging the catheter-engaging element to the support-engaging element (e.g., by fitting a protrusion into a recess) are also contemplated.
Reference is made to
It is to be noted that, throughout this application (including the specification and the claims), the terms “steer” and “steerable” refer to active steering of an element such as a catheter, e.g., by using an extracorporeal controller that is operatively and/or mechanically coupled to a steerable portion of the element to effect bending of the steerable portion of the element. (This is in contrast to a flexible but non-steerable element, which may bend in response to encountering forces during advancement through the body of the subject.) Steerability of distal portion 624 facilitates steering of distal housing 664 and proximal housing 662 toward tricuspid valve 78 (
Typically, support 640 is used to engage delivery tool 620 within right atrium 76. For some applications, and similarly to support 240 described hereinabove, support 640 is advanced to right atrium 76 while catheter-engaging element 638 is in a non-engaging state (
For some applications, support 640 is used to support distal portion 624 in right atrium 76 while delivery tool 620 is steered toward tricuspid valve 78. Typically for such applications, catheter-engaging element 638 is used to support catheter 22 while in the engaging state. It is hypothesized by the inventors that this facilitates steering distal portion 624 toward tricuspid valve 78, as described hereinabove in reference to
Typically, support 640 is used to support delivery tool 620 by applying a force (e.g., a superiorly-directed force) to the delivery tool (e.g., to distal portion 624 thereof). For some applications, applying the force causes support 640 (e.g., catheter-engaging element 638 thereof) to engage delivery tool (e.g., distal portion 624 thereof), defining an engaged portion 634.
Subsequently, prosthetic valve 668 is deployed from delivery tool 620 at the native valve (e.g., tricuspid valve 78). For some applications, and as shown in
For some applications, prosthetic valve 668 is comprised of a shape-memory superelastic material (e.g., Nitinol), such that exposure of the prosthetic valve from the housings causes the prosthetic valve to automatically expand. Alternatively, prosthetic valve 668 may require an expansion element (e.g., an inflatable balloon, not shown) in order to expand following deployment from the housings, mutatis mutandis.
For some applications, applying the superiorly-directed force causes distal portion 624 to move. For some applications and as shown, application of the superiorly-directed force moves prosthetic valve 668, proximal housing 662 and distal housing 664 in an upstream direction (indicated by arrow 644). For example, prosthetic valve 668 is moved proximally while the prosthetic valve is partially deployed. For example, movement of prosthetic valve 668 in an upstream direction while ventricular snares of the prosthetic valve are in an expanded state facilitates coupling the prosthetic valve to tissue 70 (e.g., leaflets) of the tricuspid valve (
Typically, and as shown in
For some applications, after implantation of prosthetic valve 668, support 640 is used to facilitate withdrawal of a portion of delivery tool 620 (e.g., of housing 664) into the right atrium, by again applying the superiorly-directed force, prior to disengagement of the support from the delivery tool, e.g., as shown in
Reference is made to
For some applications, elements of delivery tool 720 (e.g., catheter 722 and stylet 725) are packaged together commercially, e.g., in a kit.
Except where noted, delivery tool 720 is used similarly as delivery tool 20, mutatis mutandis. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, delivery tool 720 comprises catheter 722, similarly to catheter 22 described hereinabove in reference to
The presence of the stylet within a portion of catheter 722 increases rigidity of that portion of the catheter. That is, stylet 725 increases the ability of catheter 722 (or portions thereof) to withstand bending forces. For some applications, upon extending stylet 725 within catheter 722, a stiffness of the catheter becomes at least ten percent greater than the stiffness of the catheter alone.
Typically, stylet 725 is itself stiffer than catheter 722, e.g., having a bending stiffness, measured in N/m, that is at least 10% greater than the stiffness of the catheter. Alternatively, stylet 725 may contribute to increased rigidity of catheter 722 without being, itself, stiffer than the catheter. Stylet 725 may be a monolithic rod, e.g., comprising a metal or rigid polymer.
For some applications, delivery tool 720 is used to deliver an implant to left atrium 80 (e.g., to mitral valve 86). Typically for such applications, the implant is advanced within catheter 722, via inferior vena cava 72, to right atrium 76. For example, the implant may be disposed within catheter 722, e.g., until the implant is deployed at mitral valve. For some such applications, the implant may be a prosthetic heart valve or a valve repair device, such as an annuloplasty device.
As shown, delivery tool 720 is typically positioned (e.g., advanced transluminally along a guidewire 750, shown in
As shown, catheter 722 is advanced into right atrium 76, to an atrial height d731 in right atrium 76. Height d731 thereby represents the distance by which stylet 725 is extended into right atrium 76. For some applications, atrial height d731 may be between 1 and 70 mm (e.g., between 1 and 10 mm, or between 10 and 70 mm).
As shown in
As shown in
For some applications, and as shown in
For some applications, and as shown, extending stylet 725 within catheter 722 and into right atrium 76 applies a supporting force to distal portion 724 of the catheter, thereby changing an orientation of the distal portion. In this way, distal opening 726 of the catheter advantageously tilts towards mitral valve 86. For some such applications, extending stylet 725 within catheter 722 and into right atrium 76 changes the orientation of distal portion 724 of the catheter, such that such that distal opening 726 advantageously faces mitral valve 86. It is hypothesized by the inventors that, for some applications, such tilting further facilitates access to the mitral valve, in addition to steering of distal portion 724.
It is hypothesized by the inventors that the use of stylet 725 as described, provides similar advantages to those described hereinabove as being provided by the use of a support, mutatis mutandis. In fact, for some applications, stylet 725 may be considered to be an intracatheter support, while the supports described with reference to
As described hereinabove in reference to delivery tool 20, accessing left atrium 80 of heart 90 using delivery tool 720 may facilitate performance of one or more clinical interventions, including but not limited to mitral annuloplasty, mitral chord repair, mitral valve replacement, left atrial appendage occlusion, or ablation for atrial fibrillation. Typically for such applications, stylet 725 (e.g., supporting portion 728 thereof) remains in right atrium 76 (e.g., within secondary lumen 727), while the clinical intervention is performed. It is hypothesized by the inventors that tilting distal opening 726 of catheter 722 towards mitral valve 86, e.g., such that the distal opening faces the mitral valve, facilitates performance of the clinical interventions.
Reference is made to
Delivery tool 820 is similar in certain aspects to delivery tool 720. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, delivery tool 820 comprises catheter 822 and stylet 825, similarly to catheter 722 and stylet 725, mutatis mutandis. As such, the description below of delivery tool 820 focuses upon features that are particular to delivery tool 820.
For some applications, elements of delivery tool 820 (e.g., catheter 822 and stylet 825) are packaged together commercially, e.g., in a kit.
As shown in the inset of
Typically, catheter 822 comprises a steerable distal portion 824, which is shown in
Stylet 825 is typically stiffer than catheter 822, as discussed hereinabove in reference to stylet 725, such that the presence of the stylet within catheter 822 increases rigidity of the portion of the catheter in which the stylet is disposed. Therefore, stylet 825, and portions of catheter 822 within which the stylet remains disposed, resist being bent away from axis d821 in response to steering of distal portion 824 of the catheter.
For some applications, and as shown, distal housing 864 is used to house an implant (e.g., prosthetic valve 868) until deployment at the native valve (e.g., tricuspid valve 78). For some applications, and as shown, deployment of prosthetic valve 868 from distal housing 864 is facilitated by distal advancement (840,
Typically and as shown, prosthetic valve 868 is deployed from delivery tool 820 at the native valve (e.g., tricuspid valve 78) while stylet 825 remains within catheter 822, such that supporting portion 828 of the stylet is within right atrium 76. For example and as shown, distal end 830 of stylet 825 may generally remain disposed at atrial height d831 while prosthetic valve 868 is deployed.
For some applications, while proximally-directed force 842 is applied, a pull-wire (e.g., that passes through shaft 870, from the proximal portion of delivery tool 820 to prosthetic valve 868) is pulled, in order to adjust an angle at which the prosthetic valve approaches tissue of the native valve. For example, movement of prosthetic valve 868 in an upstream direction, and at a desirable angle, while the ventricular snares of prosthetic valve 868 are in an expanded state facilitates coupling the prosthetic valve to tissue (e.g., leaflets) of tricuspid valve 78 (
It is hypothesized by the inventors that the upstream movement of prosthetic valve 868 is facilitated by an interaction between proximally-directed force 842 and rigidity that stylet 825 (e.g., supporting portion 828 thereof) provides to catheter 822. It is further hypothesized by the inventors that such facilitation is particularly useful in instances in which the orientation of the prosthetic valve during its upstream movement, and the vector of the upstream movement, are important for successful implantation.
As prosthetic valve 868 is further deployed from distal housing 864, upstream skirt 866 is exposed from distal opening 826 and expands on an atrial side of tricuspid valve 78. In some cases, and as shown in
Typically for such cases, a pulling force 842b (
For some applications, pulling force 842b continues to be applied to shaft 870 while prosthetic valve 868 is fully deployed at tricuspid valve 78 (
Typically, following deployment of prosthetic valve 868 at the native valve, delivery tool 820 is withdrawn by retracting distal housing 864 through the prosthetic valve (
Typically, after retracting distal housing 864 through prosthetic valve 868, delivery tool 820 is withdrawn proximally from right atrium 76, via inferior vena cava 72.
Reference is now made to
One or more undesirable results may occur as a result of this behavior. For example, rather than prosthetic valve 968 moving in a predominantly upstream direction (e.g., along an atrioventricular axis), the upstream portion of the prosthetic valve may tilt toward fossa ovalis 84, thereby placing the prosthetic valve in a suboptimal orientation with respect to the mitral valve (e.g., as shown in
For some applications, elements of delivery tool 920′ (e.g., catheter 922′ and stylet 925) are packaged together commercially, e.g., in a kit.
For some applications, stylet 925 is similar to other stylets described hereinabove, mutatis mutandis.
Catheter 922′ is subsequently pulled proximally in order to engage snares 970 with tissue of the mitral valve (
As shown in
For some applications, and as shown, secondary lumen 927 does not reach the distal end of catheter 922′. Similarly to catheter 922, catheter 922′ comprises a steerable distal portion 924. For some applications, and as shown, secondary lumen 927 does not reach steerable distal portion 924, such that stylet 925 is advanceable, within the secondary lumen, to a point proximal of the steerable distal portion. It is hypothesized by the inventors that stylet 925 being advanceable only as far as a point proximal of steerable distal portion 924 may have a desirable effect of maintaining steerability of catheter 922′ (e.g., of steerable distal portion 924 thereof) while stylet 925 is advanced within the catheter. For example, the limited length of secondary lumen 927 may prevent the operator from inadvertently advancing stylet 925 into steerable distal portion 924 and thereby inadvertently inhibiting steerability.
Alternatively, secondary lumen 927 may reach the steerable distal portion 924 and/or the distal end of catheter 922′. It is hypothesized by the inventors that this may facilitate withdrawal, to a greater degree, of catheter 922′ out of left atrium 80 while retaining stylet 925 in place.
It is to be noted that the techniques described with reference to
Reference is made to
For some applications, elements of delivery tool 1020 (e.g., catheter 1022 and pull-wire 1082) are packaged together commercially, e.g., in a kit.
Delivery tool 1020 is similar in certain aspects to delivery tool 820. Components that are identically named between the systems typically share similar features and serve similar functions as each other. For example, delivery tool 1020 comprises catheter 1022 that defines a primary lumen 1023 through which a shaft 1070 passes, similarly to shaft 870 that passes through primary lumen 823 of catheter 822. Further similarly to delivery tool 820, guidewire 1050 passes through a shaft-lumen 1072 defined by shaft 1070, and a secondary lumen 1080 is defined by catheter 1022.
Typically, and in contrast to delivery tool 820, delivery tool 1020 comprises a pull-wire 1082 that passes through a pull-wire lumen 1080 that is defined by catheter 1022 (similarly to secondary lumen 827 of catheter 822, mutatis mutandis). As shown in the respective insets of
In
It is hypothesized by the inventors that so using pull-wire 1082 to tension portion 1084 of catheter 1022 may reduce shear forces being applied to fossa ovalis 84, reducing the risk of cheesewiring described hereinabove.
In
For some applications, in addition to pull-wire lumen 1080, catheter 1022 further defines a secondary lumen through which a stylet may be advanced, as described hereinabove in reference to
The apparatus and techniques described in the present patent application may be applied to those described in one or more of the following patent application publications. For example, the delivery tools, catheters, and prosthetic valves described in the present application may represent, or may be substituted with, one or more of the delivery tools, catheters, and prosthetic valves described in one or more of the following patent application publications, each of which is incorporated herein by reference in its entirety:
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
This patent application claims benefit of U.S. Provisional application 62/969,795, filed Feb. 4, 2020, and entitled “SUPPORT-GUIDED STEERING,” which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2021/050132 | 2/4/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62969795 | Feb 2020 | US |
