catheter stent guidance manipulation

Abstract

An apparatus comprising a set is described. The set includes a flexible catheter (22) and a stent (40). The catheter is advanceable via the femoral artery to the heart of a subject, and the stent is sized for percutaneous access to the heart. The stent has a proximal end, an elongated portion, and a distal portion (41) having a catheter engagement element (38). The catheter engagement element is configured to reversibly engage the catheter in a manner that does not impede longitudinal advance of the catheter. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] The claims of this patent application claim the benefit of U.S. Provisional Application No. 62 / 969,795, filed February 4, 2020, entitled “Stent-Guided Manipulation,” which is incorporated herein by reference. Technical Field

[0003] Some applications of this invention generally relate to cardiovascular medical procedures. Specifically, some applications of this invention relate to using a support to assist in accessing native heart valves. Background Technology

[0004] Transluminal delivery is used in a range of cardiac medical procedures. Such procedures target native heart valves. Typically, transluminal access to a native heart valve involves manipulating a tool within the limitations of the heart.

[0005] Access to the tricuspid valve via the endocardium presents clinical challenges, including catheter navigation within the right atrium.

[0006] Transseptal delivery typically involves accessing the right atrium via the vasculature, followed by puncture of the atrial septum within the right atrium. The fossa ovalis is considered the optimal location for transseptal puncture because the tissue there is generally thinner than the rest of the septum.

[0007] Tension applied to the septum during transseptal puncture and / or transseptal manipulation may cause stretching or tearing of the septal tissue, increasing the risk of postoperative complications. Summary of the Invention

[0008] According to some applications of the invention, applying a support force to a portion of the delivery tool facilitates navigation when navigating a delivery tool transluminally (e.g., transfemorally) to the atrioventricular valve of the heart. In some applications, the support force is applied to support a supported portion of the delivery tool, which can serve as a fulcrum, and the support force and a thrust applied to the delivery tool can interact with the fulcrum. Various intra- and extra-catheter stents are described herein, as well as their use in applying the support force to a delivery tool.

[0009] For some applications, several aspects of the invention include implanting an artificial valve at a native valve of the heart. For some such applications, using the stent to apply the supporting force to the delivery tool can help connect the artificial valve to the ventricular tissue of the heart.

[0010] In some applications, a stent is used to assist access from the right atrium to a native heart valve. For example, the site of interest may be in the right side of the heart (e.g., the tricuspid valve), or it may be in the left side of the heart (e.g., the mitral valve) but accessed from the right atrium via the septum. Typically for such applications, a catheter is advanced into the right atrium of the heart via the inferior vena cava of the subject, and a stent is advanced into the right atrium via the superior vena cava of the subject.

[0011] For some applications, several aspects of the invention include: engaging the delivery tool with the stent within the right atrium of the heart, and manipulating a distal portion of the delivery tool toward a native valve while using the stent to support the delivery tool within the right atrium.

[0012] For some applications, several aspects of the invention include using an endocervical stent (e.g., including a core and / or a drawwire) to apply the supporting force to the delivery tool. For example, the endocervical stent can be used to apply tension to a portion of the delivery tool.

[0013] For some applications, several aspects of the present invention include: engaging the catheter with a catheter engagement element of a catheter external support.

[0014] In some such applications, the catheter is mechanically engaged using the catheter engagement element. For example, the distal portion can be advanced through a loop formed by the catheter engagement element. Alternatively, a catch formed by the catheter engagement element can be used to catch the catheter. For example, the catheter engagement element can catch the catheter by changing the catch from a non-engaged state to an engaged state.

[0015] In some applications, the catheter is magnetically engaged with the catheter engagement element. For example, an electromagnet can be activated to magnetically engage the catheter with the catheter engagement element.

[0016] In some applications, the stent is used to assist in accessing a left atrium of a heart via the septum.

[0017] For some such applications, several aspects of the invention include: advancing the catheter through the atrial septum of the heart and into the left atrium. For example, the stent can be used to support the catheter in the right atrium when the distal portion of the catheter is manipulated toward the mitral valve of the heart.

[0018] For example, the stent can be used to support the catheter when an implant (e.g., an artificial valve) is placed at the native mitral valve.

[0019] For example, the stent can be used to move the catheter by applying a force to it. In some such applications, the force is applied to the catheter as it is manipulated toward the mitral valve.

[0020] Therefore, according to one application of the present invention, an apparatus is provided, comprising a set: the set comprising:

[0021] A flexible catheter, which can be advanced via the femoral artery to the heart of a subject; and

[0022] A stent, the stent being sized for percutaneous insertion into the heart, the stent defining:

[0023] One proximal end;

[0024] A long, narrow section; and

[0025] A distal portion has a catheter engagement element configured to reversibly engage the catheter in a manner that does not inhibit longitudinal advance of the catheter.

[0026] In one application, the catheter and the stent are configured such that when the catheter engagement element engages the catheter, the pulling force on the proximal end of the stent applies an upward force to the catheter.

[0027] In one application, the catheter engagement element is shaped to form a ring, the size of which is adapted to assist in advancing the catheter through the ring.

[0028] In one application, when the collar engages with the catheter, the collar can be tightened around the catheter.

[0029] In one application, the device includes: a tightening ring through which the collar passes, such that advancing the tightening ring along the collar tightens the collar around the conduit.

[0030] In one application, the shape of the catheter engagement element can be changed from a non-engaged state to an engaged state.

[0031] In one application, the device includes a pull wire connected to the catheter engagement element, and the catheter engagement element is configured to be bent from the non-engaged state to the engaged state using the pull wire.

[0032] In one application, the device includes: a constraint member, and the conduit engagement element includes a shape memory material, such that:

[0033] The catheter engagement element can be constrained in the non-engaged state by the constraint member; and

[0034] When the constraint is removed, the conduit engagement element automatically transitions to the engagement state.

[0035] In one application, the constraint includes a constraint outer tube, and the conduit engagement element is disposed within the constraint outer tube.

[0036] In one application, the constraint includes a rigid internal rod disposed within the conduit engagement element.

[0037] In one application, the catheter engagement element includes a catcher configured to engage the catheter via an opening in the catcher.

[0038] In one application, the opening of the catcher has a width greater than an outer diameter of the conduit.

[0039] In one application:

[0040] The catheter includes a support engagement element connected to an outer wall of the catheter; and

[0041] The catheter engagement element is configured to engage the stent engagement element.

[0042] In one application:

[0043] The shape of the stent engagement element is adapted to define a track extending along a portion of the catheter;

[0044] The shape of the catheter engagement element is adapted to define a hook; and

[0045] The hook is configured to capture the track.

[0046] In one application:

[0047] The bracket coupling element includes a ferromagnetic material;

[0048] The catheter connection element includes a ferromagnetic material; and

[0049] The catheter engagement element is configured to magnetically engage the stent engagement element.

[0050] In one application, the bracket engagement element includes an electromagnet.

[0051] In one application, the conduit engagement element includes an electromagnet.

[0052] According to one application of the present invention, a device is further provided, comprising a set, the set comprising:

[0053] A flexible catheter, wherein the catheter:

[0054] It can be advanced via the femoral artery to the heart of a subject; and

[0055] Define a primary lumen and a secondary lumen passing through the catheter;

[0056] An artificial valve, the artificial valve being sized to be delivered to the heart via the main lumen; and

[0057] A core, which is stiffer than the flexible conduit, can slide within the secondary lumen.

[0058] In one application, the die is rigid.

[0059] In one application, the kit includes a puncture device configured to puncture an atrial septum of the heart.

[0060] In one application, the kit includes: a dilator configured to dilate a punctured atrial septum of the heart.

[0061] According to one application of the present invention, a method for using the heart of a subject is further provided, the method comprising the steps of:

[0062] The distal end of a catheter is advanced through the femoral artery and through the atrium septum of the heart to the left side of the heart; and

[0063] When a distal end of a stylet is placed inside the catheter and in a right atrium of the heart, the distal end of the catheter is pulled proximally toward the atrial septum, causing the catheter to slide past the stylet.

[0064] In one application, the method includes the steps of: after advancing the distal end of the catheter and before 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 is placed in the right atrium of the heart, within the catheter.

[0065] In one application, the step of advancing the distal end of the catheter includes: advancing the distal end of the catheter through the femoral artery and through the atrial septum of the heart into the left side of the heart while the distal end of the core is inserted into the catheter.

[0066] In one application, the method includes the steps of: after withdrawing the distal end of the catheter proximally toward the atrial septum, withdrawing the distal end of the catheter from the heart.

[0067] In one application, an artificial valve is connected to the catheter, and the step of advancing the distal end of the catheter includes: advancing the distal end of the catheter via the femoral artery and through the atrial septum of the heart into the left side of the heart, thereby advancing the artificial valve via the femoral artery and through the atrial septum of the heart into the left side of the heart.

[0068] In one application, the method includes the step of implanting the artificial valve at the mitral valve of the heart.

[0069] According to one application of the present invention, a method for using the heart of a subject is further provided, the method comprising the steps of:

[0070] A distal portion of a catheter is advanced via the inferior vena cava of the subject into a right atrium of the heart, through an atrial septum of the heart, and into a left atrium of the heart;

[0071] A stent is advanced into the right atrium of the heart via a superior vena cava of the object;

[0072] The catheter is engaged with the stent within the right atrium of the heart; and

[0073] While using the stent to support the catheter in the right atrium, the distal end of the catheter is withdrawn proximally into the atrial septum.

[0074] According to one application of the present invention, a method for accessing a left atrium of a subject's heart via a septum is further provided, the method comprising the steps of:

[0075] A catheter is advanced into a right atrium of the heart via the inferior vena cava of the object;

[0076] A stent is advanced into the right atrium of the heart via a superior vena cava of the object;

[0077] The distal portion of the catheter is advanced through the atrium septum of the heart and into the left atrium;

[0078] The catheter is engaged with the stent within the right atrium of the heart; and

[0079] Subsequently, the distal portion of the catheter is manipulated toward the mitral valve of the heart, while the catheter is supported in the right atrium using the stent.

[0080] In one application, advancing the catheter into the right atrium includes advancing the catheter into the right atrium after advancing the stent into the right atrium.

[0081] In one application, advancing the catheter into the right atrium includes advancing the catheter into the right atrium before advancing the stent into the right atrium of the heart.

[0082] In one application, the stent includes a catheter engagement element, and engaging the catheter with the stent includes engaging the catheter with the catheter engagement element.

[0083] In one application, the catheter includes a stent engagement element, and engaging the catheter with the catheter engagement element includes engaging the stent engagement element to the catheter engagement element.

[0084] In one application, attaching the stent engagement element to the catheter engagement element includes: magnetically attaching the stent engagement element to the catheter engagement element.

[0085] In one application, the stent engagement element includes an electromagnet, and magnetically engaging the stent engagement element to the catheter engagement element includes activating the electromagnet.

[0086] In one application, the catheter connection element includes an electromagnet, and magnetically engaging the stent connection element to the catheter connection element includes activating the electromagnet.

[0087] In one application:

[0088] The bracket engagement element is a first bracket engagement element;

[0089] Magneticly attaching the stent engagement element to the catheter engagement element includes magnetically attaching the first stent engagement element to the catheter engagement element;

[0090] The catheter includes at least one second stent engagement element; and

[0091] The method includes the step of: after magnetically attaching the first stent engagement element to the catheter engagement element:

[0092] By deactivating the electromagnet, the magnetic engagement between the first stent engagement element and the catheter engagement element is stopped; and

[0093] Subsequently, by reactivating the electromagnet, the second stent engagement element is magnetically engaged to the catheter engagement element.

[0094] In one application, engaging the catheter with the catheter engagement element includes mechanically engaging the catheter with the catheter engagement element.

[0095] In one application, mechanically engaging the catheter with the catheter engagement element includes adapting a protrusion into a recess.

[0096] In one application:

[0097] The catheter includes a stent engagement element, the shape of which is adapted to define a track;

[0098] The shape of the catheter engagement element is adapted to define a hook; and

[0099] Engaging the catheter to the catheter engagement element includes: hooking the track with the hook.

[0100] In one application, the catheter engagement element is shaped to form a loop, and mechanically engaging the catheter with the catheter engagement element includes advancing the distal portion of the catheter through the loop of the catheter engagement element.

[0101] In one application, the catheter engagement element is shaped to define a catch, and mechanically engaging the catheter with the catheter engagement element includes supporting a supported portion of the catheter with the catch.

[0102] In one application, supporting the supported portion includes supporting the supported portion when the supported portion is placed in the right atrium.

[0103] In one application, the catheter engagement element is shaped to form a ring, and supporting the supported portion with the catheter engagement element includes tightening the ring around the catheter.

[0104] In one application, the catheter connection element has a non-connected state and a connected state, and advancing the stent into the right atrium includes advancing the stent when the catheter connection element is in the non-connected state.

[0105] In one application, engaging the catheter includes: changing the catheter engagement element from the non-engaged state to the engaged state.

[0106] In one application, supporting the catheter in the right atrium using the stent includes: after advancing the distal portion of the catheter through the atrial septum, moving the catheter by applying a force to the catheter using the stent.

[0107] In one application, applying the force to the catheter includes applying a supporting force to the catheter using the stent by applying tension to the stent.

[0108] In one application, using the support to move the catheter includes: using the support to change the orientation of the catheter.

[0109] In one application, supporting the catheter includes: continuing to apply the force to the catheter after moving the catheter by applying the force to the catheter.

[0110] In one application, the force applied to the stent assists in manipulating the distal portion of the catheter toward the mitral valve.

[0111] In one application, moving the catheter includes moving a supported portion of the catheter relative to the atrial septum.

[0112] In one application, moving the supported portion of the catheter relative to the atrial septum includes moving the supported portion of the catheter toward the superior vena cava.

[0113] In one application, the distal portion of the catheter includes a puncture device, and advancing the distal portion of the catheter through the atrial septum includes puncturing the septum with the puncture device.

[0114] In one application, the puncture device includes a needle, and puncturing the diaphragm includes mechanically puncturing the diaphragm with the needle.

[0115] In one application:

[0116] 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

[0117] The method includes the step of implanting the implant at the mitral valve.

[0118] In one application, the implant includes an artificial heart valve, and implanting the implant at the mitral valve includes: implanting the artificial heart valve at the mitral valve.

[0119] In one application, the implant includes an annulus reshaping device, and implanting the implant at the mitral valve includes implanting the annulus reshaping device at the mitral valve.

[0120] According to one application of the present invention, a method for implanting an artificial valve via the femoral artery at a native valve of a patient's heart is further provided, the method comprising the steps of:

[0121] A delivery device is advanced into the right atrium of the heart via the inferior vena cava of the object;

[0122] A stent is advanced into the right atrium of the heart via a superior vena cava of the object;

[0123] The delivery tool is engaged with the stent in the right atrium of the heart;

[0124] Manipulating a distal portion of the delivery tool toward the native valve while simultaneously using the stent to support the delivery tool in the right atrium; and

[0125] Subsequently, an artificial valve is deployed from the delivery tool at the original valve.

[0126] In one application, the stent includes a catheter engagement element having a non-engaged state and an engaged state, and engaging the delivery tool with the stent in the right atrium of the heart includes changing the catheter engagement element from the non-engaged state to the engaged state.

[0127] In one application:

[0128] Manipulating the distal portion of the delivery tool toward the native valve includes: manipulating the distal portion of the delivery tool toward the tricuspid valve of the heart; and

[0129] Deploying the artificial valve from the delivery tool includes: deploying the artificial valve from the delivery tool at the tricuspid valve.

[0130] In one application, the method includes the step of: after deploying the artificial valve from the delivery tool:

[0131] The stent was withdrawn from the right atrium via the superior vena cava; and

[0132] The delivery device is withdrawn from the right atrium via the inferior vena cava.

[0133] In one application:

[0134] The delivery tool includes a proximal housing and a distal housing;

[0135] Deploying the artificial valve from the delivery tool includes: increasing the distance between the proximal shell and the distal shell; and

[0136] The delivery tool is withdrawn proximally via the inferior vena cava, which includes retracting the distal outer shell through the artificial valve.

[0137] In one application, the method includes the step of disengaging the delivery tool from the stent after the artificial valve has been deployed from the delivery tool.

[0138] In one application, the stent includes a catheter engagement element having the non-engaged state and the engaged state, and disengaging the delivery tool from the stent includes changing the catheter engagement element from the engaged state to the non-engaged state.

[0139] In one application, using the stent to support the delivery tool in the right atrium includes: applying a force to the delivery tool using the stent.

[0140] In one application, applying the force to the delivery tool using the support includes moving the delivery tool using the support by applying the force.

[0141] In one application, moving the delivery tool includes changing the orientation of the distal portion of the delivery tool.

[0142] In one application, applying the force to the delivery tool using the stent includes applying the force to the delivery tool using the stent while the artificial valve is at least partially inserted into a right ventricle of the heart.

[0143] In one application, applying the force to the delivery tool using the stent includes applying the force to the delivery tool using the stent while the artificial valve is deployed at least partially from the delivery tool.

[0144] In one application, applying the force to the delivery tool using the stent includes connecting the artificial valve to a ventricular tissue of the heart.

[0145] In one application, applying the force to the delivery tool using the bracket includes applying an upward force to the delivery tool using the bracket.

[0146] In one application, applying the upward force to the delivery tool using the stent includes applying the upward force to the delivery tool using the stent while simultaneously deploying the artificial valve from the delivery tool.

[0147] In one application, applying the upward force to the delivery tool using the stent includes: after the artificial valve is deployed, applying the upward force to the delivery tool using the stent while simultaneously withdrawing at least a portion of the delivery tool back into the right atrium.

[0148] In one application, applying the upward force to the delivery tool using the stent while simultaneously withdrawing at least a portion of the delivery tool back into the right atrium includes: applying the upward force to the delivery tool using the stent while simultaneously withdrawing the distal outer shell back into the right atrium.

[0149] According to one application of the present invention, a method for accessing a left atrium of a subject's heart via a septum is further provided, the method comprising the steps of:

[0150] A delivery tool is positioned via the lumen, the delivery tool comprising: a catheter and a stylet, such that:

[0151] The catheter extends via the inferior vena cava of the object to a right atrium of the heart; and

[0152] The core extends within the catheter to the right atrium; and

[0153] When one distal end of the tubing remains in the right atrium:

[0154] Manipulating a distal portion of the catheter away from the distal end of the core and through the atrial septum of the heart into the left atrium; and

[0155] Subsequently, the distal portion of the catheter is manipulated toward the mitral valve of the heart.

[0156] In one 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 lacks the core.

[0157] In one 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 core is inserted into the catheter.

[0158] In one application, the catheter defines a primary lumen through the catheter, and extending the core within the catheter and into the right atrium includes extending the core through the secondary lumen.

[0159] In one application, the catheter accommodates an implant, and the method includes the steps of:

[0160] The implant is advanced into the right atrium via the inferior vena cava; and

[0161] After manipulating the distal portion of the catheter toward the mitral valve, the implant is deployed from within the catheter at the mitral valve.

[0162] In one application, the implant includes an artificial heart valve, and implanting the implant at the mitral valve includes implanting the artificial heart valve at the mitral valve.

[0163] In one application, the implant includes a valve annulus reshaping device, and implanting the implant at the mitral valve includes: implanting the valve annulus reshaping device at the mitral valve.

[0164] In one application, the delivery tool further includes: a puncture device extending distally from the distal end of the catheter, and manipulating the distal end of the catheter through the atrial septum includes: puncturing the septum with the puncture device.

[0165] In one application, the puncture device includes a needle, and puncturing the diaphragm includes mechanically puncturing the diaphragm with the needle.

[0166] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 1 and 70 mm.

[0167] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 1 and 70 mm comprises: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 1 and 10 mm.

[0168] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 10 and 20 mm.

[0169] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 10 and 70 mm.

[0170] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 10 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 20 and 70 mm.

[0171] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 20 and 70 mm comprises: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 20 and 30 mm.

[0172] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 30 and 60 mm.

[0173] In one application, manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the core and through the atrial septum when the core extends within the right atrium to an atrial height between 40 and 70 mm.

[0174] In one application, manipulating the distal portion of the catheter toward the mitral valve while the distal end of the stylet is held in the right atrium includes: manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 1 and 70 mm.

[0175] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 1 and 10 mm.

[0176] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 1 and 70 mm includes manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 10 and 20 mm.

[0177] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 10 and 70 mm.

[0178] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 10 and 70 mm includes manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 20 and 70 mm.

[0179] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 20 and 30 mm.

[0180] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 20 and 70 mm includes manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 30 and 60 mm.

[0181] In one application, manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 20 and 70 mm includes manipulating the distal portion of the catheter toward the mitral valve when the stylet extends within the right atrium to an atrial height between 40 and 70 mm.

[0182] According to one application of the present invention, a method for accessing a native valve of a heart of a subject via the femoral artery is further provided, the method comprising the steps of:

[0183] Positioning a delivery tool, the delivery tool comprising: a conduit and a core, such that:

[0184] The catheter extends via the inferior vena cava of the object to a right atrium of the heart, and

[0185] The core extends within the catheter to the right atrium; and

[0186] When one distal end of the tubing remains in the right atrium and within the catheter:

[0187] Manipulate a distal portion of the delivery tool away from the distal end of the core and toward the native valve.

[0188] In one application, the method includes the step of: after the manipulation step:

[0189] An artificial valve is deployed from the delivery tool at the site of the native valve.

[0190] In one application, the native valve is the tricuspid valve of the heart.

[0191] In one application:

[0192] The primary valve is the mitral valve of the heart, and

[0193] The manipulation steps include: advancing the distal portion of the delivery tool through the atrial septum of the heart into the left atrium of the heart.

[0194] In one application, the catheter defines a primary lumen through the catheter, and extending the core within the catheter and into the right atrium includes extending the core through the secondary lumen.

[0195] In one application, positioning the delivery tool includes: advancing the delivery tool through the lumen via the inferior vena cava.

[0196] In one application, positioning the delivery tool includes positioning the delivery tool such that the lumen extends within the catheter and through a primary lumen into the right atrium.

[0197] In one application, manipulating 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 across the stylet.

[0198] In one application, sliding the catheter distally across the stylet includes: maintaining the distal end of the stylet at a substantially constant atrial height while maneuvering the distal portion toward and through the native valve.

[0199] In one application, deploying the artificial valve from the distal portion of the delivery tool includes applying a proximal force to the delivery tool externally.

[0200] In one application, applying the proximal-directed force to the delivery tool in vitro includes applying the proximal-directed force to the delivery tool in vitro, causing the artificial valve to move proximally and engage with the tissue of the native valve.

[0201] In one application, the delivery tool includes a distal housing, and applying the proximal-directed force to the delivery tool externally includes increasing the distance between a distal opening of the catheter and the distal housing.

[0202] In one application, applying the proximal force to the delivery tool externally includes retracting the delivery tool through the artificial valve.

[0203] In one application, applying the proximal force to the delivery tool externally includes holding the distal end of the catheter in the right atrium by applying the proximal force to the catheter and a thrust to the catheter core, and maintaining a substantially constant atrial height within the catheter.

[0204] In one application, manipulating the distal portion of the delivery tool away from the distal end of the timepiece and toward the native valve while the timepiece is held in the right atrium and within the catheter comprises: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 1 and 70 mm.

[0205] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 1 and 10 mm.

[0206] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 10 and 20 mm.

[0207] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 1 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 10 and 70 mm.

[0208] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 10 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 20 and 70 mm.

[0209] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 20 and 30 mm.

[0210] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 30 and 60 mm.

[0211] In one application, manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 20 and 70 mm includes: manipulating the distal portion of the catheter away from the distal end of the timepiece and toward the native valve when the timepiece extends within the right atrium to an atrial height between 40 and 70 mm.

[0212] In one application, deploying the artificial valve from the delivery tool while the distal end of the lumen is held in the right atrium and within the catheter comprises: deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 1 and 70 mm.

[0213] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 1 and 70 mm includes: deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 1 and 10 mm.

[0214] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 1 and 70 mm includes deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 10 and 20 mm.

[0215] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 1 and 70 mm includes: deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 10 and 70 mm.

[0216] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 10 and 70 mm includes deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 20 and 70 mm.

[0217] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 20 and 70 mm comprises: deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 20 and 30 mm.

[0218] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 20 and 70 mm includes deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 30 and 60 mm.

[0219] In one application, deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 20 and 70 mm includes deploying the artificial valve from the delivery tool when the lumen extends within the right atrium to an atrial height between 40 and 70 mm.

[0220] According to one application of the present invention, a method for accessing the mitral valve of a subject's heart via the septum is further provided, the method comprising the steps of:

[0221] A catheter is positioned via the lumen, such that the catheter extends through the inferior vena cava of the subject to a right atrium of the heart;

[0222] The distal portion of the catheter is advanced through the atrium septum of the heart into the left atrium of the heart;

[0223] Subsequently, the distal portion of the catheter is tilted toward the mitral valve by extending a core through the lumen of the catheter into the right atrium.

[0224] In one application, extending the core through the lumen into the right atrium within the catheter includes: pushing a proximal portion of the core toward a superior vena cava of the heart externally.

[0225] In one 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.

[0226] In one application, the distal portion of the catheter is manipulated toward the mitral valve of the heart, while a distal end of the core is held in the right atrium.

[0227] In one application, the catheter accommodates an implant, and the method includes the step of: after tilting the distal portion of the catheter, deploying the implant from within the catheter at the mitral valve.

[0228] In one application, the implant includes an artificial heart valve, and implanting the implant at the mitral valve includes: implanting the artificial heart valve at the mitral valve.

[0229] In one application, the implant includes a valve annulus reshaping device, and implanting the implant at the mitral valve includes: implanting the valve annulus reshaping device at the mitral valve.

[0230] In one application, extending the core through the lumen into the right atrium within the catheter includes extending the core within the right atrium to an atrial height between 1 and 70 mm.

[0231] In one application, extending the wedge within the right atrium to an atrial height between 1 and 70 mm includes extending the wedge to an atrial height between 1 and 10 mm.

[0232] In one application, extending the core within the right atrium to an atrial height between 1 and 70 mm includes extending the core to an atrial height between 10 and 20 mm.

[0233] In one application, extending the wedge within the right atrium to an atrial height between 1 and 70 mm includes extending the wedge to an atrial height between 10 and 70 mm.

[0234] In one application, extending the wedge within the right atrium to an atrial height between 10 and 70 mm includes extending the wedge to an atrial height between 20 and 70 mm.

[0235] In one application, extending the die to an atrial height between 20 and 70 mm includes extending the die to an atrial height between 20 and 30 mm.

[0236] In one application, extending the die to an atrial height between 20 and 70 mm includes extending the die to an atrial height between 30 and 60 mm.

[0237] In one application, extending the die to an atrial height between 20 and 70 mm includes extending the die to an atrial height between 40 and 70 mm.

[0238] Other embodiments are also described.

[0239] The invention will be more fully understood from the following detailed description of several applications of the invention, which are considered together with the accompanying drawings: Attached Figure Description

[0240] Figures 1A to 1F and Figure 2 This is a schematic diagram illustrating some applications according to the present invention, using a multi-component system including a stent and a delivery tool to enter a left atrium of a subject's heart via the septum;

[0241] Figures 3A to 3B This is a schematic diagram illustrating the use of another multi-component system, including a stent and the delivery tool, for transseptal access to the left atrium according to some applications of the present invention.

[0242] Figures 4A to 4C This is a schematic diagram illustrating the use of another multi-component system, including a stent and the delivery tool, for transseptal access to the left atrium according to some applications of the present invention.

[0243] Figures 5A to 5C This is a schematic diagram illustrating the use of another multi-component system, including a stent and a delivery tool, for transseptal access to the left atrium according to some applications of the present invention.

[0244] Figures 6A to 6C This is a schematic diagram illustrating the use of another multi-component system, including a stent and a delivery tool, for transseptal access to the left atrium according to some applications of the present invention.

[0245] Figures 7A to 7C This is a schematic diagram illustrating the use of another multi-component system, including a stent and a delivery tool, for transseptal access to the left atrium according to some applications of the present invention.

[0246] Figures 8A to 8L and Figure 9 This is a schematic diagram illustrating some applications according to the present invention, the use of another multi-component system including a stent and a delivery tool for implanting an artificial valve via the femoral artery at a native valve of the heart;

[0247] Figures 10A to 10F and Figures 11A to 11B This is a schematic diagram illustrating some applications according to the present invention, for the use of a delivery tool, including a catheter and a stylet, for transseptal access to the left atrium;

[0248] Figures 12A to 12J This is a schematic diagram illustrating the use of another delivery tool, including a catheter and a core, for implanting an artificial valve into a native valve of the heart via the femoral artery, according to some applications of the invention.

[0249] Figures 13A to 13B and Figures 14A to 14D This is a schematic diagram illustrating some applications according to the invention, with or without the assistance of a core tube, accessing the left atrium of a subject via the femoral artery and septum; and

[0250] Figures 15 to 16 This is a schematic diagram illustrating the use of a delivery tool, including a catheter and a drawstring, for implanting an artificial valve into a native valve of the heart via the femoral artery, according to some applications of the present invention. Detailed Implementation

[0251] refer to Figures 1A to 1F and Figure 2 , Figures 1A to 1F and Figure 2 This is a schematic diagram illustrating some applications according to the present invention, using a multi-component system 10 including a stent 40 and a delivery tool 20 to enter a left atrium 80 of a heart 90 of a subject via the septum.

[0252] For some applications, several components of the system 10 (e.g., delivery tool 20 and support 40) are commercially packaged together, for example, in a set.

[0253] like Figure 1A As shown, a delivery tool 20, including a catheter 22, is shown via the inferior vena cava 72 (or, depending on the application, along a guidewire 92). Figure 1A In, but not shown Figures 1B to 1F and Figure 2 The catheter is advanced such that a distal portion 24 of the catheter reaches a right atrium 76 of the heart 90. Furthermore, a stent 40 (e.g., a distal portion 41 of the stent 40) is advanced via (e.g., via a jugular vein) a superior vena cava 74, such that a catheter engagement element 38 of the stent reaches the right atrium 76 of the heart. For some applications, and as shown, the catheter engagement element 38 is shaped to form a loop (e.g., a closed loop).

[0254] Other embodiments of the catheter connection element are described below.

[0255] For some applications, the distal portion 24 of the catheter 22 is advanced into the right atrium 76 before the catheter engagement element 38 of the stent 40 is advanced into the right atrium. For other applications, the distal portion 24 of the catheter 22 is advanced into the right atrium 76 after the catheter engagement element 38 of the stent 40 has been advanced into the right atrium. Alternatively, the distal portion 24 and the catheter engagement element 38 may be advanced into the right atrium 76 simultaneously.

[0256] Typically, and as shown, the catheter 22 engages with the catheter engagement element 38 when the catheter engagement element is placed within the right atrium 76. Figure 1B As shown, the catheter 22 is typically engaged with the catheter engagement element 38 when both the catheter engagement element and the distal portion 24 of the catheter are placed within the right atrium 76.

[0257] For some applications where the shape of the catheter engagement element 38 is adapted to form a set of loops, and as shown, the catheter engagement element is used to initially mechanically engage the catheter 22 by passing the distal portion 24 of the catheter through the catheter engagement element. Figure 1B Typically, the area of ​​the collar is at least equal to the cross-section of the conduit.

[0258] Typically for such applications, the distal portion 24 passes through the catheter engagement element 38 when both the distal portion and the catheter engagement element are positioned within the right atrium 76. In some applications where the shape of the catheter engagement element 38 is adapted to form a loop, the distal portion 24, for example, after the engagement element 38 has been pre-positioned anterior to an ovoid fossa 84, passes through the catheter engagement element 38 by advancing the distal portion of the catheter through the loop of the catheter engagement element. Alternatively or additionally, the catheter engagement element 38 may be longitudinally movable relative to the distal portion 24, such that the catheter 22 passes through the loop.

[0259] Passing the distal portion 24 through the collar can be assisted by one or more techniques for visualizing the tissues of the delivery tool 20, the stent 40, and / or the heart 90, including but not limited to fluoroscopy, transesophageal echocardiography (TEE), and tissue dyestaining.

[0260] like Figure 1C As shown, the distal portion 24 of the catheter 22 is advanced through an atrial septum 82 (e.g., a foramen ovale 84 of the atrial septum 82) of the heart 90 and into the left atrium 80. For some applications, the distal portion 24 of the catheter 22 includes a puncture device and / or a dilator (not shown). For some such applications, the distal portion 24 is advanced through the septum 82 by puncturing the septum (e.g., with the puncture device). For example, the puncture device may include a needle, and the needle is used to mechanically puncture the septum. Other methods of puncturing the septum 82 (e.g., radiofrequency ablation and / or ultrasound ablation) are also considered.

[0261] For some applications, the catheter engagement element 38 is used to support the catheter 22 (e.g., a supported portion 34 of the catheter) during further advancement and / or diversion of the catheter. The supported portion 34 is not necessarily a discrete part or feature of the catheter 22, but rather can be defined as a portion of the catheter currently engaged by the catheter engagement element 38. For some applications, the operator may not need to engage a precise target portion of the catheter 22 with the catheter engagement element 38. The inventors hypothesize that engaging a precise target portion of the catheter 22 is not required to assist in engaging the catheter using the support 40.

[0262] In some applications where the shape of the catheter engagement element 38 is adapted to form a loop, the catheter 22 is engaged by the catheter engagement element 38 by advancing the catheter through the loop. Figure 1B , 1C In such applications, the catheter 22 is typically supported by the stent 40. For example, as... Figure 1D As shown, moving the stent 40 42 closer to the superior vena cava 74 causes the stent to support the supported portion 34 of the catheter 22. For some such applications, and as described below, moving the stent 40 (e.g., moving it to the supported portion 34 of the stent 40) can result in moving the catheter.

[0263] Figures 1D to 1F It is shown that when the distal portion 24 is placed within the left atrium 80 (e.g., when the distal portion is manipulated toward the mitral valve 86), the supported portion 34 is supported by the catheter engagement element 38 of the stent 40.

[0264] For some applications, the catheter 22 is supported by the catheter engagement element 38, allowing a support force 50 (e.g., an upward-pointing force) to be applied from the support 40 to the catheter. Figure 1E Typically, the force is applied by an operator (e.g., by pulling on a proximal end of the support placed outside the body of the object) to apply tension (e.g., pulling). For some such applications, and as... Figure 1E As shown, the application of a force from the support 40 to the catheter 22 moves the catheter, for example, the supported portion 34 of the catheter, as indicated by arrow 44. In some applications, and as shown, the catheter 22 is then moved to advance the distal portion 24 of the catheter through the atrial septum 82 (e.g., when the distal portion is positioned within the left atrium 80). Alternatively, the catheter 22 is moved when the distal portion 24 is positioned within the right atrium 76.

[0265] In some applications, alternatively or additionally, by moving the supported portion 34, a force 50 is applied to the supported portion 34 to change the orientation of the catheter, for example, the orientation of a right atrial portion 46 of the catheter, such as... Figure 1D and 1EThe transition between these is illustrated. The right atrial portion 46 is not typically defined by discrete features of the catheter 22. Rather, the right atrial portion 46 is typically defined by the fact that this portion of the catheter 22 is situated within the right atrium 76. That is, as the catheter is advanced through the right atrium, several consecutive portions of the catheter 22 may be referred to as the right atrial portion 46.

[0266] Typically, when the distal portion 24 is directed toward the mitral valve 86, the force is continuously applied to the supported portion 34, such as... Figure 1F As shown. For some applications, the currently supported portion 34 therefore changes during catheter advancement. In this way, the catheter engagement element 38 can support the progressively proximal supported portion 34 as the catheter is advanced and / or manipulated toward the mitral valve 86.

[0267] For some applications, while the upward force applied to the catheter using the support 40 allows for longitudinal advancement of the catheter (e.g., orthogonal to the plane of the septum 82), the force typically restricts the lateral movement of the supported portion 34 in at least one direction when the distal portion 24 of the catheter 22 is manipulated toward the mitral valve 86. The inventors hypothesize that restricting the lateral movement of the supported portion reduces the shear forces exerted by the catheter 22 on the tissue of the atrial septum 82 when the distal portion 24 of the catheter 22 is advanced and / or manipulated toward the mitral valve 86, thereby reducing the risk of stretching or tearing (e.g., “cheese wiring”) of the tissue of the septum 82. For some applications, the supported portion 34 can serve as a fulcrum around which several portions of the catheter 22 can pivot in response to forces applied to the catheter.

[0268] In some applications, the operator determines the intensity of the force applied by the stent 40 to the supported portion 34, thereby determining the extent to which the catheter (e.g., the supported portion of the catheter and / or the right atrial portion 46) is moved. For example, Figure 2 The diagram illustrates the effect of applying forces of varying intensities on the orientation of the catheter 22. The solid lines of the catheter 22 depict the force applied using the support 40 at different ratios. Figures 1E to 1F The direction of the conduit 22 when a stronger force is applied. As shown in the figure, the supported portion 34 is more oriented than the one in the middle. Figure 1D The catheter 22 is pulled more strongly towards the superior vena cava 74. This stronger force has a greater effect on the orientation of the catheter 22 compared to... Figure 2 The text is in dashed form. Figures 1E to 1FThe orientation of the catheter shown is illustrated. The inventors hypothesize that applying a force (e.g., applying a stronger force to more drastically change the orientation of the right atrial portion 46) helps, for example, to manipulate the distal portion 24 of the catheter 22 toward the mitral valve 86 by changing the angle at which the catheter passes through the fossa ovalis 84.

[0269] Typically, using the delivery tool 20 to enter the left atrium 80 of the heart 90 facilitates the 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.

[0270] Some embodiments of the present invention are used for implanting an implant via the septum into the mitral valve 86 of the heart 90. For example, the implant may be an artificial heart valve or a valve annuloplasty device. Typically for such an application, the implant is advanced within the catheter 22 via the inferior vena cava 72 into the right atrium 76. More typically, the stent 40 is used to support the catheter 22 in the right atrium 76 when the distal portion 24 of the catheter 22 is oriented toward the mitral valve 86, and when the implant is implanted at the mitral valve, as described above.

[0271] refer to Figures 3A to 3B , Figures 3A to 3B This is a schematic diagram illustrating the use of a multi-component system 120, comprising a stent 140 and the delivery tool 20, for transseptal access to the left atrium 80 of the heart 90 of a subject, according to some applications of the invention.

[0272] For some applications, several components of the system 120 (e.g., the delivery tool 20 and the support 140) are commercially packaged together, for example, in a set.

[0273] Unless otherwise stated, with necessary modifications, system 120 is generally identical to and similarly used to system 10 described above. Components with the same name across several systems often have similar characteristics and provide similar functionality. For example, system 120 includes the delivery tool 20, with necessary modifications, similar to the one referenced above. Figures 1A to 1FAs described. Therefore, the following description of the system 120 focuses on features specific to the system 120 (e.g., the use of a support 140).

[0274] Figure 3A A distal portion 141 of the stent 140 is shown, including the catheter engagement element 138, which has been advanced into the right atrium 76. Similar to the catheter engagement element 38 described above, the catheter engagement element 138 of the stent 140 is shaped to form a loop. Further similar to the catheter engagement element 38, the catheter 22 is advanced (e.g., through) the catheter engagement element 138 such that the catheter engagement element engages the catheter.

[0275] Compared to the catheter engagement element 38 described above, the collar formed by the catheter engagement element 138 can be tightened around the catheter 22 (e.g., the supported portion 34 of the catheter 22) so that the catheter engagement element supports the catheter. For some applications, such as in Figure 3A As shown in the illustration, the catheter engagement element 138 further includes a tightening ring 150 through which the catheter engagement element 138 passes. For some such applications, and as shown, the collar formed by the catheter engagement element 138 is tightened around the catheter 22 by pushing a tightening tube 152 toward the tightening collar 150. Figure 3B This reduces the circumference of the collar formed by the catheter engagement element. For some applications, tightening the collar formed by the catheter engagement element 138 around the catheter 22 can further limit non-orthogonal forces (e.g., lateral movement of the catheter) when manipulating the distal portion 24 of the catheter 22 toward the mitral valve 86, further reducing the risk of stretching or tearing the tissue of the septum 82.

[0276] refer to Figures 4A to 4C , Figures 4A to 4C This is a schematic diagram illustrating some applications according to the invention, including a multi-component system 210 comprising a stent 240 and the delivery tool 20, used in the left atrium 80 of the heart 90 of a subject via a septum.

[0277] For some applications, several components of the system 210 (e.g., the delivery tool 20 and the support 240) are commercially packaged together, for example, in a set.

[0278] Unless otherwise stated, with necessary modifications, system 210 is generally identical to and similarly used to system 10 described above. Components with the same name across several systems often have similar characteristics and provide similar functionality. For example, with necessary modifications, system 210 includes the delivery tool 20, similar to the one referenced above. Figures 1A to 1F As described. Therefore, the following description of system 210 focuses on features specific to system 210 (e.g., the use of a bracket 240).

[0279] Figure 4A A distal portion 241 of the stent 240 is shown, including a catheter engagement element 238, which has been advanced into the right atrium 76. Unlike other catheter engagement elements described above, the catheter engagement element 238 has both a non-engaged state and an engaged state. Typically for such an application, the stent 240 is advanced into the right atrium 76 while the catheter engagement element 238 is in the non-engaged state. Figure 4A ), and is subsequently transformed into the conjugate state within the right atrium ( Figure 4B ).

[0280] The catheter engagement element 238 can be configured to switch between its open and engaged states by including a shape memory material. For example, the catheter engagement element can be constrained in the non-engaged state (e.g., by a constraint such as a rigid inner rod or an outer tube) and can automatically transition to the engaged state when the constraint is removed.

[0281] The catheter engagement element 238 can be configured to switch between its non-engaged and engaged states by active bending, for example, by pulling one or more pull-wires connected to the catheter engagement element (e.g., pull-wires used in the field of maneuverable catheters, with necessary modifications).

[0282] For some applications, when the catheter engagement element 238 is in the non-engaged state, the catheter engagement element 238 engages (e.g., contacts) the catheter 22. For some applications, when the catheter engagement element 238 changes from the non-engaged state to the engaged state, the catheter engagement element 238 engages the catheter 22.

[0283] Figure 4BThe catheter engagement element 238 engages the catheter 22 (e.g., the supported portion 34 of the catheter 22) after the distal portion 24 of the catheter has been advanced through the atrial septum 82 and into the left atrium 80. Alternatively, the catheter engagement element 238 can be used to engage the catheter 22 when the distal portion 24 of the catheter 22 is positioned in the right atrium 76 (e.g., before the distal portion is advanced through the atrial septum 82). The inventors hypothesize that, in this way and for some applications, the catheter engagement element 238 advantageously allows the operator to decide at what stage during the procedure to engage the catheter 22.

[0284] With necessary modifications, as referenced above Figures 1C to 1D As shown in the stent 40, the stent 240 is used to support the catheter 22 (e.g., the supported portion 34 of the catheter 22) within the right atrium 76. Typically, the catheter engagement element 238 supports the catheter 22 when the catheter engagement element is in the engaged state. For some such applications, the stent 240 is used to apply a force to the supported portion 34 to change the orientation of the catheter (e.g., the orientation of the right atrial portion 46 of the catheter). Figure 4C Typically, the stent 240 is used to continuously apply the force to the supported portion 34, such that when the distal portion 24 is manipulated toward the mitral valve 86, the right atrial portion 46 remains in a tightly oriented position, with necessary modifications, such as... Figures 1E to 1F As shown.

[0285] refer to Figures 5A to 5C , Figures 5A to 5C This is a schematic diagram illustrating some applications of the invention, using a multi-component system 310 including a stent 340 and the delivery tool 20 to enter the left atrium 80 of a subject's heart 90 via the atrial septum.

[0286] For some applications, several components of the system 310 (e.g., the delivery tool 20 and the support 340) are commercially packaged together, for example, in a set.

[0287] Unless otherwise stated, with necessary modifications, system 310 is generally identical to and similarly used to system 10 described above. Components with the same name across several systems often have similar characteristics and provide similar functionality. For example, with necessary modifications, system 310 includes the delivery tool 20, similar to the one referenced above. Figures 1A to 1F As described. Therefore, the following description of the system 310 focuses on features specific to the system 310 (e.g., the use of the bracket 340).

[0288] Figure 5A A distal portion 341 of the stent 340 is shown, including a catheter engagement element 338, which has been advanced into the right atrium 76. The catheter engagement element 338 is used similarly to the catheter engagement element 238 described above, except that the catheter engagement element 338 cannot typically be transitioned from a non-engaged state to an engaged state. Instead, the catheter engagement element 338 is typically static (e.g., non-convertible) and shaped to form a catch. The catch formed by the catheter engagement element 338 typically defines an opening 354, the size of which is adapted to facilitate smooth engagement (e.g., catch) of the catheter 22 by being wider than an outer diameter of the catheter (e.g., the supported portion 34 of the catheter). Alternatively, the opening 354 may be slightly narrower than the outer diameter of the catheter and may be temporarily bent open in response to the catheter being moved through the opening, for example, to increase the stability of the catheter engagement. The remainder of the catheter engagement element 338 (the portion not defined by the opening 354) is generally shaped to assist in supporting the catheter 22 after the supported portion 34 passes through the opening and is captured.

[0289] Figure 5A The stent 340 is shown to be disposed within the right atrium 76 such that the opening 354 is positioned closer to the superior vena cava 74 than the remainder of the catheter engagement element 338, but further away from the superior vena cava than a target portion of the catheter 22 (e.g., the portion that will become the supported portion 34), and adjacent to the target portion of the catheter. In this manner, the catheter engagement element 338 is moved 42 closer to the superior vena cava 74. Figure 5B This causes the supported portion 34 of the catheter 22 to pass through the opening 354 of the catheter engagement element 338, supporting (e.g., capturing) the catheter. Typically, and as shown, the catheter engagement element 338 is used to capture the catheter 22 when the distal portion 24 of the catheter is positioned in the left atrium 80 (e.g., after the distal portion has been advanced through the atrial septum 82 and into the left atrium 80). Alternatively, the catheter engagement element 338 can be used to capture the catheter 22 when the distal portion 24 of the catheter 22 is positioned in the right atrium 76 (e.g., before the distal portion has been advanced through the atrial septum 82). The inventors hypothesize that, in this way and for some applications, the catheter engagement element 338 advantageously allows the operator to decide at which stage of the procedure to engage the catheter 22.

[0290] In some applications, the stent 340 is used to apply a force to the catheter 22 (e.g., the supported portion 34 of the catheter 22) to support the catheter. In some such applications, as shown, applying the force to the supported portion 34 alters the catheter 22 (e.g., the right atrial portion 46 of the catheter 22). Figures 5B to 5C ) one direction.

[0291] refer to Figures 6A to 6C , Figures 6A to 6C This is a schematic diagram illustrating some applications according to the invention, using a multi-component system 410 including a stent 440 and a delivery tool 420 to enter the left atrium 80 of the heart 90 of a subject via the septum.

[0292] For some applications, several components of the system 410 (e.g., the delivery tool 20 and the support 440) are commercially packaged together, for example, in a set.

[0293] Unless otherwise stated, with necessary modifications, system 410 is generally identical to system 10 described above and is used similarly to system 10. Components with the same name in several systems generally have similar characteristics and provide similar functions. Components with the same reference numerals are generally interchangeable between delivery tool 20 and delivery tool 420. Therefore, the following description of system 410 focuses on features specific to system 410 (e.g., the use of the support 440 and the delivery tool 420).

[0294] The system 410 is generally different from the several systems described above in at least two ways: (i) the catheter 422 of the delivery tool 420 includes a stent engagement element 428, and (ii) a distal portion 441 of the stent 440 includes a catheter engagement element 438, the catheter engagement element 438 being sized to engage the stent engagement element 428. The stent engagement element 428 is generally a discrete element defined by and / or attached to the body of the catheter, for example, connected to an outer wall of the catheter engaged by the stent 440.

[0295] For some applications, and as shown in the figure, the shape of the catheter engagement element 438 is adapted to define a hook. For some applications, the shape of the stent engagement element 428 is adapted to define a track extending along a portion of the catheter 422. Typically for such applications, the catheter engagement element 438 is advanced into the right atrium 76 ( Figure 6A Afterwards, the hook is used to engage (e.g., capture) the track of the bracket engagement element 428. Figure 6B ).

[0296] Figure 6B The catheter engagement element 438 engages the stent engagement element 428 when a distal portion 424 of the catheter 422 is positioned in the left atrium 80 (e.g., after the distal portion has been advanced through the atrial septum 82 and into the left atrium 80). Alternatively, the catheter engagement element 438 can be used to engage the stent engagement element 428 when the distal portion 424 of the catheter 422 is positioned in the right atrium 76 (e.g., before the distal portion has been advanced through the atrial septum 82). The inventors hypothesize that providing the operator with the option to use the catheter engagement element 438 to engage the stent engagement element 428 at different stages of the advancement of the distal portion 424 into the mitral valve 86 facilitates operator responsiveness to specific cardiac anatomy and / or pathophysiology of the object.

[0297] For some applications, hooks formed by the catheter engagement element 438 are used to engage the track of the support engagement element 428, thereby defining a supported portion 434 of the catheter 422 by the presence of the track at that portion of the catheter.

[0298] For some applications, compared to the embodiments described above, where the catheter is typically supported at a discrete point defining the supported portion 34, an upward force applied from the catheter engagement element 438 to the stent engagement element can typically be distributed along a length of the catheter 422 (e.g., along the supported portion 434 where the stent engagement element is located) through the stent engagement element.

[0299] For some applications, the catheter engagement element 438 is used to move the catheter 422 (e.g., the supported portion 434 of the catheter 422) by applying an upward force 50 from the support 440 onto the catheter. For example, the force can change the orientation of the catheter 22 (e.g., the right atrial portion 46 of the catheter 22), such as... Figure 6C As shown.

[0300] refer to Figures 7A to 7C , Figures 7A to 7C This is a schematic diagram illustrating some applications according to the invention, using a multi-component system 510 comprising a stent 540 and a delivery tool 520 to access the left atrium 80 of a subject's heart 90 via the septum. Unless otherwise stated, the system 510 is generally identical to and similarly used to the system 10 described above, with necessary modifications.

[0301] For some applications, several components of the system 510 (e.g., the delivery tool 20 and the support 540) are commercially packaged together, for example, in a set.

[0302] In the systems described above, such as system 10, the catheter engagement element of the stent is mechanically engaged with the catheter 22. However, for some applications of the invention, the stent engages the catheter in a non-mechanical manner (e.g., magnetically). For example, in system 510, the catheter engagement element 538 of a distal portion 541 of the stent 540 magnetically engages the catheter 522. Apart from the different ways in which the catheter engagement element engages the catheter, components with the same name in several systems often have similar characteristics and provide similar functions. Therefore, the following description of system 510 focuses on features specific to system 510 (e.g., the use of the stent 540 and the delivery tool 520).

[0303] like Figure 7A As shown, and similar to the catheter 422 of system 410 described above, the catheter 522 of system 510 also includes a stent engagement element 528. However, instead of forming a track, the stent engagement element 528 includes a magnet. Similarly, instead of forming a hook, the catheter engagement element 538 of the stent 540 also includes a magnet. For some applications, the catheter engagement element 538 engages the catheter 522 (e.g., the stent engagement element 528 of the catheter 522) by magnetically engaging the catheter to the engagement element. For example, the catheter engagement element 538 may include an electromagnet. For some applications, the electromagnet is activated to magnetically engage the stent engagement element 528 to the catheter engagement element 538. For example, the catheter engagement element 538 may be an electromagnet that can be selectively activated and deactivated by an operator. Alternatively or additionally, the stent engagement element 528 may include an electromagnet.

[0304] For some applications where the catheter connection element 538 includes the electromagnet, the stent connection element 528 includes a ferromagnetic material. Similarly, for some applications where the stent connection element 528 includes the electromagnet, the catheter connection element 538 includes a ferromagnetic material.

[0305] For some applications, and such as Figures 7A to 7C As shown, the catheter 522 includes several of the stent engagement elements 528 (including those in the stent engagement elements 528). Figures 7A to 7B A first bracket engagement element marked 528a, and in Figure 7C(A second stent engagement element marked 528b). The inventors hypothesize that the plurality of stent engagement elements 528 assist in supporting the catheter using the catheter engagement element 538 by providing the operator with a selection of several targets (e.g., several stent engagement elements) that can be magnetically engaged with the catheter engagement element.

[0306] Apart from the differences between systems 410 and 510 described above, system 510 is substantially similar to system 410 described above when used. That is, the catheter engagement element 538 engages (e.g., magnetically engages) the stent engagement element 528, rather than using the catheter engagement element 438 to hook the stent engagement element 428. In this way, a supported portion 534 of the catheter 522 is defined by the adjacency of the supported portion 534 with the magnet 560, which is magnetically engaged to the catheter engagement element 538.

[0307] Figure 7B The catheter engagement element 538 engages the stent engagement element 528a when a distal portion 524 of the catheter 522 is positioned in the left atrium 80 (e.g., after the distal portion has been advanced through the atrial septum 82 and into the left atrium 80). Alternatively, the catheter engagement element 538 can be used to engage the stent engagement element 528 when the distal portion 524 of the catheter 522 is positioned in the right atrium 76 (e.g., before the distal portion has been advanced through the atrial septum 82). The inventors hypothesize that providing the operator with the option to engage the stent engagement element 528 using the catheter engagement element 538 at several different stages of the advancement of the distal portion 524 into the mitral valve 86 facilitates the operator's responsiveness to the specific cardiac anatomy and / or pathophysiology of the object.

[0308] In some applications, the catheter engagement element 538 is used to sequentially and magnetically engage several stent engagement elements 528 mounted along an outer wall of the catheter 522. Typically for such applications, the catheter engagement element 538 is an electromagnet, selectively activated, deactivated, and reactivated by an operator to: magnetically engage a first stent engagement element 528 (…). Figure 7B ), stop the magnetic engagement between the catheter engagement element and the first stent engagement element 528a, and then magnetically engage a second stent engagement element 528b. Figure 7CThis is typically accomplished when the distal portion 524 of the catheter 522 is maneuvered toward the mitral valve 86, thereby supporting the catheter 422 in the right atrium 76. The inventors hypothesize that by reducing resistance to the advancement of the catheter when maneuvering the distal portion 524 of the catheter 522 toward the mitral valve 86, the sequential magnetic engagement of the plurality of stent engagement elements 528 assists in supporting the catheter 522 using the stent 540.

[0309] In some applications, supporting the catheter 522 by using the catheter engagement element 538 to magnetically engage the stent engagement element 528 in turn can assist in the transmission of the upward force 50 from the stent 540 to the catheter. In some such applications, applying the force can change the orientation of the catheter 22 (e.g., the right atrial portion 46 of the catheter 22).

[0310] The embodiments of the catheter engagement element and the corresponding stent engagement element described above are not intended to be exclusive, and alternative methods of engaging the catheter engagement element to the stent engagement element (e.g., by adapting a protrusion into a recess) are also considered.

[0311] refer to Figures 8A to 8L and Figure 9 , Figures 8A to 8L and Figure 9 This is a schematic diagram illustrating some applications according to the invention, the use of a multi-component system 610 for implanting an artificial valve 668 via the femoral artery at a native valve of the heart 90, the multi-component system 610 including a stent 640 and a delivery tool 620. While the system 610 is described as being used for implanting the artificial valve 668 at the tricuspid valve 78, implantation of the artificial valve at other native valves of the heart using the system is also considered.

[0312] Figure 8A The delivery tool 620 is shown to have reached the femoral artery (along the femoral artery, depending on some applications). Figure 8A It is displayed in, but Figures 8B to 8L and Figure 9 A guidewire 650 (not shown) is advanced via the inferior vena cava 72 into the right atrium 76 of the heart 90. The delivery tool 620 includes a catheter 622, a proximal housing 662, and a distal housing 664. Typically, the delivery tool 620 includes a steerable distal portion 624, which... Figure 8B The middle part is shown as having extended from and been exposed from the catheter 622.

[0313] It should be noted that throughout this application (including the specification and claims), the terms "steer" and "steerable" refer to the active steerability of an element, such as a catheter, for example, by using an external controller operably and / or mechanically connected to a steerable portion of the element to achieve bending of the steerable portion of the element. (This contrasts with a flexible but unsteerable element that may bend in response to forces encountered during propulsion through the body of the object.) The steerability of the distal portion 624 facilitates the manipulation of the distal housing 664 and the proximal housing 662 toward the tricuspid valve 78. Figures 8B to 8C ). Usually, such as Figure 8C As shown, the distal portion 624 is further advanced such that at least a portion of the distal outer shell 664 is disposed within the right ventricle 66.

[0314] Figure 8D This shows a distal portion 641 of the stent 640 that has been advanced from the superior vena cava 74 into the right atrium 76. The stent 640 shown is in many respects similar to that described below. Figures 4A to 4C The stent 240 described herein. For example, the stent 640 includes a catheter engagement element 638 having a non-engaged state and an engaged state. However, with necessary modifications, the scope of the invention includes the use of other stents described herein.

[0315] Typically, the stent 640 is used to engage the delivery tool 620 within the right atrium 76. For some applications, and similar to the stent 240 described above, the stent 640 is advanced into the right atrium 76 when the catheter engagement element 638 is in the non-engaged state. Figure 8D Afterwards, the catheter engagement element 638 transitions to the engagement state. Figure 8E For some applications, the stent 640 engages the delivery tool 620 by changing the catheter engagement element 638 from the non-engaged state to the engaged state. Figure 8F Alternatively or additionally, a force (e.g., tension 642) may be applied to the stent 640 such that the catheter engagement element 638 engages the delivery tool 620 (e.g., the distal portion 624 of the delivery tool 620).

[0316] For some applications, the stent 640 is used to support the distal portion 624 in the right atrium 76 when the delivery tool 620 is manipulated toward the tricuspid valve 78. Typically for such applications, the catheter engagement element 638 is used to support the catheter 22 when in the engaged state. The inventors hypothesize that this facilitates manipulating the distal portion 624 toward the tricuspid valve 78, with necessary modifications, as referenced above. Figure 2 As described in B to 2C, the supported portion 634 can serve as a pivot point, and one or more forces (e.g., an upward force applied by the support 640 and a thrust applied to the delivery tool 620) can interact with the pivot point.

[0317] Typically, the stent 640 is used to support the delivery tool 620 by applying a force (e.g., an upward force) to the delivery tool (e.g., to the distal portion 624 of the delivery tool). In some applications, applying the force causes the stent 640 (e.g., the catheter engagement element 638 of the stent 640) to engage the delivery tool (e.g., the distal portion 624 of the delivery tool), defining an engaged portion 634.

[0318] Subsequently, the artificial valve 668 is deployed from the delivery tool 620 onto the native valve (e.g., the tricuspid valve 78). For some applications, such as... Figure 8G As shown, the artificial valve 668 is deployed by increasing a distance d672 between the proximal housing 662 and the distal housing 664. For example, the distal housing 664 may be moved distally relative to the proximal housing 662, and / or the proximal housing may be moved proximally relative to the distal housing. In this way, the movement of the proximal housing 662 and the distal housing 664 assists in exposing the artificial valve 668 from the plurality of housings.

[0319] For some applications, the artificial valve 668 is composed of a shape-memory superelastic material (e.g., nitinol), such that exposure of the artificial valve from the plurality of housings causes it to expand automatically. Alternatively, with necessary modifications, the artificial valve 668 may require an expansion element (e.g., an inflatable balloon, not shown) to expand after deployment from the plurality of housings.

[0320] Figure 8HThe image shows the application of an upward force 642b to the supported portion 634 of the distal portion 624 using the stent 640. In some applications, this force is applied when the artificial valve 668 is at least partially inserted into the right ventricle 66 of the heart 90. For example, as shown, the force is applied simultaneously with the partial deployment of the artificial valve 668 from the delivery tool 620.

[0321] In some applications, applying the upward force causes the distal portion 624 to move. In some applications, as shown in the figure, the application of the upward force moves the prosthetic valve 668, the proximal housing 662, and the distal housing 664 in an upstream direction (indicated by arrow 644). For example, the prosthetic valve 668 moves proximally when the prosthetic valve portion is deployed. For example, the upstream movement of the prosthetic valve 668 assists in connecting the prosthetic valve to the tricuspid valve tissue 70 (e.g., several leaflets) when the ventricular catchers of the prosthetic valve are in an expanded state. Figure 8H The inventors hypothesize that this upstream movement of the artificial valve 668 is assisted by the stent 640, for example, compared to using the delivery tool 620 alone. The inventors further hypothesize that such assistance is particularly useful where the orientation of the artificial valve during its upstream movement and the vector of that upstream movement are important for successful implantation.

[0322] Figure 8I The artificial valve 668 is shown to be further deployed as the upward-pointing force 642b is applied using the stent 640 to the distal portion 624. (As shown) Figure 8J As shown, the artificial valve 668 is fully deployed at the tricuspid valve 78. The inventors hypothesize that when the deployment of the artificial valve 668 is complete, the upward force 642b applied to the delivery tool 620 by the stent 640 assists in the connection of the artificial valve to the ventricular tissue 70.

[0323] Usually, and such Figure 8K As shown, after the deployment of the artificial valve 668 (e.g., after full deployment), a disengaging force (e.g., thrust 642c) is applied to the stent 640. In this way, the stent 640 disengages from the delivery tool 620, so that force is no longer transmitted from the stent 640 to the delivery tool 620. For some such applications, the stent 640 disengages from the delivery tool 620 by changing the catheter engagement element 638 from the engaged state to the unengaged state. Figure 8LAfter disengagement of the stent 640 from the delivery tool 620, the stent is typically withdrawn (e.g., via the superior vena cava 74). More typically, after disengagement of the stent 640 from the delivery tool 620, the distal housing 664 retracts proximally through the artificial valve to facilitate proximal withdrawal of the delivery tool 620 via the inferior vena cava 72.

[0324] In some applications, after implantation of the artificial valve 668, the stent 640 assists by reapplying the upward force to withdraw a portion of the delivery tool 620 (e.g., the housing 664) into the right ventricle before the stent disengages from the delivery tool, for example, as... Figure 9 As shown.

[0325] refer to Figures 10A to 10F and Figures 11A to 11B , Figures 10A to 10F and Figures 11A to 11B This is a schematic diagram illustrating the use of a delivery tool 720, comprising a catheter 722 and a stylet 725, for transseptal access into the left atrium 80 according to some applications of the invention.

[0326] For some applications, several components of the delivery tool 720 (e.g., the conduit 722 and the core 725) are commercially packaged together, for example, in a set.

[0327] Unless otherwise stated, the delivery tool 720 is used similarly to the delivery tool 20 with necessary modifications. Components with the same name across several systems often have similar characteristics and provide similar functions. For example, the delivery tool 720 includes the conduit 722, modified as necessary, similar to the referenced above. Figures 1A to 1F The catheter 22 is described. A notable difference that distinguishes the delivery tool 720 from the delivery tool 20 is the presence and use of the stylet 725, which at least partially avoids the use of the stent 40. Therefore, the following description of the delivery tool 720 focuses on the features specific to the delivery tool 720 (e.g., the use of the stylet 725).

[0328] The presence of a portion of the mandrel within the conduit 722 increases the rigidity of that portion of the conduit. That is, the mandrel 725 increases the ability of the conduit 722 (or portions thereof) to withstand bending forces. For some applications, when the mandrel 725 is extended within the conduit 722, the stiffness of the conduit becomes at least 10 percent greater than the stiffness of the conduit alone.

[0329] Typically, the mandrel 725 is inherently stiffer than the conduit 722, for example, having a flexural stiffness, measured in N / m, that is at least 10% greater than that of the conduit. Alternatively, the mandrel 725 may assist in increasing the stiffness of the conduit 722 without itself being stiffer than the conduit. The mandrel 725 may be a monolithic rod, for example, comprising a metal or a rigid polymer.

[0330] For some applications, the delivery tool 720 is used to deliver an implant to the left atrium 80 (e.g., to the mitral valve 86). Typically for such applications, the implant is advanced within the catheter 722 via the inferior vena cava 72 to the right atrium 76. For example, the implant may be positioned within the catheter 722, for instance, until the implant is deployed to the mitral valve. For some such applications, the implant may be an artificial heart valve or a valve repair device, such as an annulus repair device.

[0331] As shown in the figure, the delivery tool 720 is typically positioned (e.g., advanced through the lumen along a guide wire 750, such as...). Figure 12A As shown, but not displayed. Figures 12B to 12J (in the middle), such that the catheter 722 extends via the inferior vena cava 72 to the right atrium 76 of the heart 90 (in the middle), so that the catheter 722 extends via the inferior vena cava 72 to the right atrium 76 of the heart 90 (in the middle). Figure 10A More typically, the conduit 722 extends along a conduit advancement axis d721. The conduit 722 typically defines a primary lumen 727 within which the core 725 can slide. For some applications, and as shown, the lumen 727 extends from a proximal region of the conduit 722 but terminates before the distal end of the conduit. Figure 10A As shown in the illustration, the secondary lumen 727 extends parallel to the primary lumen 723 defined by one wall of the catheter 722. For some applications, and as shown, the guidewire 750 passes through the primary lumen 723. Alternatively, with necessary modifications, a guidewire 850 can pass through a tertiary lumen (not shown) defined by one wall of the catheter 722.

[0332] As shown in the figure, the catheter 722 is advanced into the right atrium 76, reaching an atrial height d731 within the right atrium 76. The height d731 thus represents the distance the core 725 extends into the right atrium 76. For some applications, the atrial height d731 can be between 1 and 70 mm (e.g., between 1 and 10 mm, or between 10 and 70 mm).

[0333] like Figure 10AAs shown, the catheter 722 can be advanced into the right atrium 76 when the catheter 722 (e.g., the secondary lumen 727 of the catheter 722) lacks the stylet 725, after which the stylet (e.g., the support portion 728 of the stylet) extends within the secondary lumen. Figure 10B In this manner, the catheter 722 has a dynamically variable longitudinal stiffness (i.e., the stiffness of the catheter is variable when the catheter is within the heart 90, by adjusting the position of the core 725 within the catheter 722). The inventors hypothesize that: (i) the catheter 722 has less stiffness as it is advanced into the heart, which aids in navigation through the vascular system, and (ii) at least a portion of the catheter has greater stiffness to assist (e.g., support) in using the catheter to enter the left atrium 80, as described below. Alternatively, the catheter 722 may be advanced into the right atrium 76 when the core 725 has already been positioned within the catheter (e.g., within the secondary lumen 727).

[0334] like Figures 10C to 10D As shown, a steerable distal portion 724 of the catheter 722 is steered away from the axis d721 and through the atrial septum 82. Typically, and as shown, the distal portion 724 is steered while a distal end 730 of the stylet 725 is held in the right atrium 76 within the catheter 722. That is, advancement of the catheter 722 toward and through the septum 82 gradually causes the catheter to slide distally away from the stylet 725. For some such applications, the distal end 730 of the stylet 725 is held at a substantially constant atrial height d731 as the distal portion 724 is steered through the atrial septum 82. The stylet 725, and the portion of the catheter 722 in which the stylet is held, is bent away from the axis 721 in response to steer of the distal portion 724 of the catheter.

[0335] Figure 10D This illustrates that a distal end of the catheter 722 has been advanced through the atrial septum 82 (e.g., the fossa ovalis 84 of the atrial septum 82) and into the left atrium 80. For some applications, a puncture device and / or a dilator 734 extends distally from the distal end of the catheter 722, for example, to assist in puncturing and / or dilating the septum 82. For instance, the puncture device may include a needle used to mechanically puncture the septum. Other methods of puncturing the septum 82 (e.g., radiofrequency ablation and / or ultrasound ablation) are also considered.

[0336] Figures 10E to 10FThe distal portion 724 of the catheter 722, positioned within the left atrium 80, is manipulated toward the mitral valve 86. Typically, and as shown, the catheter is manipulated while the distal end 730 of the stylet 725 is held in the right atrium 76. For some such applications, when the distal portion 724 is manipulated toward the mitral valve 86, the distal end 730 of the stylet 725 is held at a substantially constant atrial height d731.

[0337] For some applications, and such as Figure 11A As shown, the catheter 722 (e.g., the steerable distal portion 724 of the catheter 722) is advanced through the atrial septum 82 before the core 725 is advanced into the right atrium 76. For some such applications, and such as... Figure 11B As shown, when the distal portion 724 is within the left atrium 80, the cuticle 725 (e.g., the support portion 728 of the cuticle 725) is extended within the catheter 722 (e.g., through the secondary lumen 727) to the atrial height d731. For example, the support portion 728 can (e.g., by externally pushing a proximal portion of the cuticle) extend the cuticle 725 into the right atrium 76 by pushing (arrow 744).

[0338] In some applications, as shown in the figure, extending the stylet 725 within the catheter 722 and into the right atrium 76 applies a supporting force to the distal portion 724 of the catheter, thereby changing the orientation of the distal portion. In this way, a distal opening 726 of the catheter is advantageously tilted towards the mitral valve 86. In some such applications, extending the stylet 725 within the catheter 722 and into the right atrium 76 changes the orientation of the distal portion 724 of the catheter, such that the distal opening 726 advantageously faces the mitral valve 86. The inventors hypothesize that, for some applications, in addition to the manipulation of the distal portion 724, this tilting further assists in accessing the mitral valve.

[0339] The inventors hypothesize that, with necessary modifications, the use of the described core 725 provides similar advantages to those provided by the use of a stent as described above. Indeed, for some applications, the core 725 can be considered an intra-catheter stent, while referring to… Figures 1A to 9 The described stents can be considered as several external catheter stents.

[0340] As described above with reference to the delivery tool 20, using the delivery tool 720 to enter the left atrium 80 of the heart 90 can assist in the execution of one or more clinical interventions, including but not limited to mitral annuloplasty, mitral valve repair, mitral valve replacement, left atrial appendage occlusion, or ablation for atrial fibrillation. Typically for such applications, when the clinical intervention is performed, the stylet 725 (e.g., the support portion 728 of the stylet 725) remains in the right atrium 76 (e.g., within the secondary lumen 727). The inventors hypothesize that tilting the distal opening 726 of the catheter 722 toward the mitral valve 86, for example, such that the distal opening faces the mitral valve, assists in the execution of the clinical intervention.

[0341] refer to Figures 12A to 12J , Figures 12A to 12J This is a schematic diagram illustrating the use of a delivery tool 820, comprising a catheter 822 and a stylet 825, for implanting an artificial valve 868 into the native valve site of the heart via the femoral artery, according to some applications of the invention. While the delivery tool 820 is described as being used for implanting the artificial valve 868 into the tricuspid valve 78, the use of this system for implanting the artificial valve into other native valve sites of the heart is also considered.

[0342] The delivery tool 820 is similar to the delivery tool 720 in several specific aspects. Components with the same name across several systems often have similar characteristics and provide similar functions. For example, the delivery tool 820 includes the catheter 822 and the stylet 825, which, with necessary modifications, are similar to the catheter 722 and the stylet 725. Therefore, the following description of the delivery tool 820 focuses on the features unique to the delivery tool 820.

[0343] For some applications, several components of the delivery tool 820 (such as the conduit 822 and the core 825) are commercially packaged together, for example, in a set.

[0344] Figure 12A The delivery tool 820 has been advanced along a guidewire 850 via the inferior vena cava 72 and the femoral artery into the right atrium 76 of the heart 90. Similar to the description above with reference to the catheter 722 of the delivery tool 720, the catheter 822 of the delivery tool 820 generally defines a primary lumen 827 within which the stylet 825 can slide. Further similarly, and as shown, the lumen 827 extends from a proximal region of the catheter 822 but terminates before the distal end of the catheter.

[0345] like Figure 12AAs shown in the illustration, the secondary lumen 827 is generally thinner than the primary lumen 823 defined by the conduit 822. Figure 12A The illustration also shows an axis 870 passing through the main lumen 823 of the catheter 822. For some applications, the axis 870 defines an axis lumen 872 extending from a proximal portion of the delivery tool 820 through the catheter 822 to the artificial valve 868. For some such applications, as shown, the guidewire 850 passes through the axis lumen 872 from the proximal portion of the delivery tool 820 to a distal end of the catheter 822. Alternatively, with necessary modifications, the guidewire 850 may pass through a tertiary lumen (not shown) defined by one wall of the catheter 822.

[0346] Figure 12B A support portion 828 of the mandrel 825 extends within the secondary lumen 827 of the catheter 822 into the right atrium 76, for example, up to an atrial height d831. The height d831 thus represents the distance the mandrel 725 extends into the right atrium 76. For some applications, the atrial height d831 may be between 1 and 70 mm (e.g., between 1 and 10 mm or between 10 and 70 mm).

[0347] Typically, the catheter 822 includes a steerable distal portion 824, the distal portion 824 being in Figure 12C The image shows that it extends from the spool 825 toward the tricuspid valve 78. Figure 12D In this configuration, the distal portion 824 is shown to have been further advanced, such that at least a portion of a distal outer shell 864 is manipulated through the tricuspid valve 78 and into the right ventricle 66. As described with reference to the delivery tool 720, the catheter 822 is manipulated toward and through the tricuspid valve 78, gradually sliding distally away from the stylet 825. For some such applications, as the distal portion 824 is manipulated through the tricuspid valve 78, a distal end 830 of the stylet 825 remains at a substantially constant atrial height d831.

[0348] As discussed above with reference to the mandrel 725, the mandrel 825 is generally stiffer than the conduit 822, such that the presence of the mandrel within the conduit 822 increases the rigidity of the portion of the conduit in which the mandrel is disposed. Therefore, the mandrel 825 and the portion of the conduit 822 in which the mandrel is disposed resist bending away from the axis d821 in response to manipulation of the distal portion 824 of the conduit.

[0349] For some applications, as shown in the figure, the distal housing 864 is used to receive an implant (e.g., the artificial valve 868) until deployment at the native valve (e.g., the tricuspid valve 78). For some applications, as shown in the figure, deployment of the artificial valve 868 from the distal housing 864 is assisted by distal advancement of the distal housing relative to a distal opening 826 of the catheter 822 (840, Figure 12E For example, as shown in the figure, the artificial valve 868 may include a shape memory material that automatically expands when exposed from within the distal housing 864.

[0350] Typically, and as shown, when the stylet 825 is held within the catheter 822 such that the support portion 828 of the stylet is within the right atrium 76, the artificial valve 868 is deployed from the delivery tool 820 at the native valve (e.g., the tricuspid valve 78). For example, and as shown, when the artificial valve 868 is deployed, the distal end 830 of the stylet 825 can be maintained approximately at the atrial height d831.

[0351] Figure 12F A proximal force 842 is shown applied to the catheter 822. Typically for such applications, the proximal force 842 is applied while the stylet 825 (e.g., the support portion 828 and the distal end 830 of the stylet 825) is held within the catheter 822 and within the right atrium 76, causing the catheter (e.g., portion 824 of the catheter) to slide proximally on the stylet. For some applications, the stylet 825 remains stationary relative to the anatomy when the proximal force 842 is applied. More typically and as shown, the proximal force 842 is applied when the prosthetic valve 868 is partially deployed from the distal housing 864. Similar to what was described above regarding the application of the upward force 642b to the delivery tool 620, the proximal force 842 causes the prosthetic valve 868 and the distal housing 864 to move in an upstream direction as the prosthetic valve 868 is partially deployed. For some applications, when the proximal force 842 is applied, a drawstring (e.g., a drawstring passing through the shaft 870 from the proximal portion of the delivery tool 820 to the artificial valve 868) is pulled to adjust the angle at which the artificial valve approaches the tissue of the native valve. For example, when the ventricular capture element of the artificial valve 868 is in an expanded state, the upstream movement of the artificial valve 868 at a desired angle assists in connecting the artificial valve to the tissue (e.g., leaflet) of the tricuspid valve 78. Figure 12F ).

[0352] The inventors hypothesize that the upstream movement of the artificial valve 868 is assisted by an interaction between the proximal force 842 and the stiffness provided to the catheter 822 by the stylet 825 (e.g., the support portion 828 of the stylet 825). The inventors further hypothesize that such assistance is particularly useful where the orientation of the artificial valve during its upstream movement and the vector of that upstream movement are important for successful implantation.

[0353] Figure 12G The artificial valve 868 is shown to be further deployed from the distal housing 864, exposing the shaft 870. Typically, the shaft 870 (e.g., at the distal portion of the shaft) is reversibly connected to the artificial valve 868 and to the distal housing 864.

[0354] As the artificial valve 868 is further deployed from the distal shell 864, an upstream skirt 866 is exposed from the distal opening 826 and dilates on the atrial side of the tricuspid valve 78. In some cases, and such as Figure 12G As shown, the expansion of the upstream skirt 866 on the atrial side applies a distal force to the artificial valve 868, causing the artificial valve to be unnecessarily positioned deep within the right ventricle 66. In some such cases, the unnecessarily positioned artificial valve deep within the right ventricle 66 results in tissue tightening or stretching of the native valve.

[0355] Typically, in this situation, a tensile force of 842b ( Figure 12H The material is then applied to the shaft 870 (e.g., to a proximal portion of the shaft 870), which pulls the artificial valve 868 toward the right atrium 76, thereby relieving the tension or stretching of the tissue.

[0356] For some applications, when the artificial valve 868 is fully deployed at the tricuspid valve 78, the tension 842b continues to be applied to the axis 870. Figure 12I For some such applications, the shaft 870 separates from the distal housing 864 and / or the artificial valve 868 to assist in the complete deployment of the artificial valve. The inventors hypothesize that applying the tension 842b to the artificial valve 868 upon completion of deployment further assists in connecting the artificial valve to the tricuspid valve 78.

[0357] Typically, after the artificial valve 868 is deployed at the native valve, the delivery tool 820 is withdrawn by retracting the distal housing 864 through the artificial valve. Figure 12JIn some applications, as shown, a thrust 844 is applied (e.g., externally) to the stylet 825, for example, when a proximal force 842 is applied to the catheter 822. As shown, pushing the stylet 825 causes the catheter 822 to move upward within the right atrium 76. In some applications, the stylet 825 (e.g., the support portion 828 and the distal end 830 of the stylet 825) also moves upward, such that the atrial height 831b is greater than... Figure 12B The atrial height d831 is shown in the figure. The inventors hypothesize that the thrust 844 assists in retracting the distal shell 864 through the artificial valve 868.

[0358] Typically, after the distal housing 864 is retracted through the artificial valve 868, the delivery tool 820 is withdrawn proximally from the right atrium 76 via the inferior vena cava 72.

[0359] Now for reference Figures 13A to 13B and 14A to 14D, Figures 13A to 13B Figures 14A to 14D are schematic diagrams illustrating some applications according to the invention, with or without the assistance of a core 925, via the femoral artery-septum into the left atrium of the subject. Figures 13A to 13B The illustration depicts some undesirable outcomes that may occur during transfemoral-septal implantation of artificial mitral valves, and... Figures 14A to 14D The illustration shows how the use of the die 925 in some applications according to the present invention can reduce this undesirable effect.

[0360] Figure 13A A delivery tool 920 is shown, comprising a maneuverable catheter 922 for transfemoral-septal delivery of an artificial valve 968 within a housing of the delivery tool (e.g., comprising a proximal housing 962 and a distal housing 964), and at least comprising several ventricular captures 970 of the artificial valve already deployed from the delivery tool (e.g., from the distal housing 964) within the left ventricle 68 of the heart. For some applications, with necessary modifications, the delivery tool 920 is similar to other delivery tools described above. For some applications, with necessary modifications, the artificial valve 968 is similar to other artificial valves described above.

[0361] Figure 13BThe prosthetic valve 968 is shown moved proximally, for example, by pulling one or more components of the tool 920 (e.g., the catheter 922) proximally to engage the capture element 970 with the tissue of the mitral valve. Due to the curvature of the transfemoral-transseptal path to the mitral valve, and therefore the curvature of the tool 920, the proximal pull for moving the prosthetic valve 968 proximally (represented by arrow 901) causes the tool to reposition and / or reshape to take a shorter path to the mitral valve 86 (represented by arrow 902). Figure 13A The position of tool 920 described in the text is in Figure 13B (Shown in dashed lines.) One or more adverse outcomes may occur as a result of this action. For example, instead of the artificial valve 968 moving in a predominantly upstream direction (e.g., along an atrioventricular axis), the upstream portion of the artificial valve may tilt toward the fossa 84, thereby placing the artificial valve in a preferred orientation relative to the mitral valve (e.g., as shown in dashed lines). Figure 13B (As shown). Furthermore, as the portion of the catheter 922 positioned within the heart moves toward the apex of the heart, this portion may exert an undesirable force (e.g., shear force) on the fossa ovum 84, which may stretch or tear the fossa ovum (e.g., as shown). Figure 13B (As shown).

[0362] Figures 14A to 14D The use of a delivery tool 920' is shown, which includes a catheter 922' to perform similar steps, but is assisted by the use of the tool 925. The delivery tool 920' is generally the same as the delivery tool 920, except that the catheter 922' defines a primary lumen 927 through which the tool 925 can be advanced.

[0363] For some applications, several components of the delivery tool 920' (e.g., the conduit 922' and the mandrel 925) are commercially packaged together, for example, in a set.

[0364] For some applications, with necessary modifications, the die 925 is similar to the other dies described above.

[0365] Figure 14A Showing with Figure 13A The same implantation state. The stylet 925 is then advanced distally within the secondary lumen 927 of the catheter 922', at least distal to the right atrium 76, and typically until the stylet 925 reaches the vicinity of the fossa ovalis 84 (e.g., within 1 cm, for example within 0.5 cm). Figure 14BAlternatively, the mandrel 925 may have been positioned within the conduit 922' prior to the advancement of the conduit. As described above, with the necessary modifications, the presence of the mandrel 925 increases the rigidity of the portion of the conduit 922' in which the mandrel 925 is positioned. Therefore, this typically straightens that portion of the conduit 922, for example, as... Figure 14A and 14B The transition between them is illustrated. For some applications and / or in some objects (e.g., due to anatomy), this results in the duct being positioned higher within the fossa 84 (i.e., further from the apex of the heart), for example, as in Figure 14A and 14B The transformation between them is illustrated.

[0366] The catheter 922' is then pulled proximally to engage the capture element 970 with the tissue of the mitral valve. Figure 14C For some applications, such as... Figure 14C As shown, when the catheter 922' (and the secondary lumen 927 of the catheter 922') is pulled proximally, the catheter 922' may slip past the stylet 925, which, as shown, can remain stationary relative to the heart. The stylet 925 can be used to apply a supporting force to the catheter 922, thereby preventing the catheter 922' from being repositioned and / or reshaped by pull 901, and thus reducing the likelihood of the adverse outcomes described above. For example, as Figure 14C As shown, compared to the placement of the delivery tool 920 without the stylet 925, the artificial valve 968 tilts less towards the fossa 84, and the fossa is less likely to be stretched or torn (or the stretching or tearing is reduced). To further illustrate this, the catheter 922 in Figure 13B The dashed line image in the middle position Figure 14C The text is displayed for comparison.

[0367] like Figure 14D As shown, after the artificial valve 968 is fully deployed, the stylet 925 can also assist in the retraction of the delivery tool 920' (e.g., the distal housing 964). For example, and as... Figure 14D As shown, the presence of the core 925 allows the outer casing 964 to be withdrawn axially through the center of the artificial valve 968 with little or no tilt.

[0368] In some applications, as shown in the figure, the secondary lumen 927 does not reach the distal end of the catheter 922'. Similar to catheter 922, catheter 922' includes a steerable distal portion 924. In some applications, as shown in the figure, the secondary lumen 927 does not reach the steerable distal portion 924, allowing the die 925 to be advanced within the secondary lumen to a point proximal to the steerable distal portion. The inventors hypothesize that allowing the die 925 to be advanced only to a point proximal to the steerable distal portion 924 can have the desired effect of maintaining the steerability of catheter 922' (e.g., the steerable distal portion 924 of catheter 922') as the die 925 is advanced within the catheter. For example, the limited length of the secondary lumen 927 can prevent the operator from inadvertently advancing the die 925 into the steerable distal portion 924, thereby unintentionally inhibiting steerability.

[0369] Alternatively, the secondary lumen 927 may reach the distal end of the steerable distal portion 924 and / or the distal end of the catheter 922'. The inventors hypothesize that this can assist more effectively in withdrawing the catheter 922' from the left atrium 80 while holding the stylet 925 in place.

[0370] It should be noted that, after necessary modifications and references Figures 14A to 14D The described technique can alternatively be performed using a stent other than a core, such as stent 40, stent 140, stent 240, stent 340, stent 440, or stent 540 as described above.

[0371] refer to Figures 15 to 16 , Figures 15 to 16 The illustration shows the use of a delivery tool 1020, including a catheter 1022 and a drawwire 1082, for implanting an artificial valve 1086 into a native valve 86 of the heart via the femoral artery, according to some applications of the present invention.

[0372] For some applications, several components of the delivery tool 1020 (e.g., the conduit 1022 and the draw wire 1082) are commercially packaged together, for example, in a set.

[0373] The delivery tool 1020 is similar to the delivery tool 820 in certain respects. Components with the same name across several systems often have similar characteristics and provide similar functions. For example, the delivery tool 1020 includes the catheter 1022, which defines a main lumen 1023, through which a shaft 1070 passes, similar to the shaft 870 passing through the main lumen 823 of the catheter 822. Further similar to the delivery tool 820, a guidewire 1050 passes through a axial lumen 1072 defined by the shaft 1070, and a primary lumen 1080 is defined by the catheter 1022.

[0374] Typically, and relative to the delivery tool 820, the delivery tool 1020 includes a drawstring 1082 that passes through a drawstring lumen 1080 defined by the catheter 1022 (with necessary modifications, similar to a secondary lumen 827 of the catheter 822). Figures 15 to 16 As shown in the corresponding illustration, the delivery tool 1020 further includes a pull ring 1090, which is fastened (e.g., welded) to the pull cord 1082. For some applications, as shown, the pull ring 1090 is embedded in a wall of the catheter 1022. Typically for such applications, the pull cord 1082 extends proximally from the pull ring 1090 to a proximal portion (e.g., in a proximal portion of the delivery tool 1020) such that when a pulling force is applied to the proximal portion of the pull cord, it is transferred via the pull ring 1090 to a portion of the catheter 1022, as described below.

[0375] Figures 15 to 16 This shows that the catheter 1022 has been advanced as described above. Figure 14C The described stage involves the delivery of the artificial valve 1068 from the outer shells 1062 and 1064. Pulling the proximal portion of the pull wire 1082 alters the arc of the catheter 1022 within the right atrium 76, as described above. Figure 13B The dashed image of the catheter 922 in the image is shown for comparison.

[0376] exist Figure 15 In this configuration, the pull ring 1090 is embedded in a portion of the conduit 1022 adjacent to the fossa 84, such that a tight portion 1084 located distal to the pull ring and adjacent to the fossa 84 is raised (arrow 1092).

[0377] The inventors hypothesize that using the drawstring 1082 to tension the portion 1084 of the conduit 1022 in this way can reduce the shear force applied to the fossa 84 and reduce the risk of the aforementioned opening.

[0378] exist Figure 16 In this configuration, the pull ring 1090 is embedded within a portion of the catheter 1022, the portion being more than the portion within the catheter. Figure 15 In the middle, further from the oval fossa 84 towards the proximal end. Therefore, pulling the pull line 1082 raises the relative [the height of the line]. Figure 15 The longer tensioning portion 1084 is shown. For some applications, and as shown, the portion of the conduit 1022 that is desired to be the tensioning portion 1084 (i.e., the portion of the conduit distal to the pull ring 1090 but proximal to the steerable distal portion 1024) is more elastic (e.g., thinner) than the portion of the conduit proximal to the pull ring. The inventors hypothesize that (i) the tensioning portion 1084 comprises a material that is more elastic than the material comprising the proximal portion of the conduit, and / or (ii) the pull ring 1090 is positioned at a greater distance from the fossa 84 to assist in increasing the elevation of the tensioning portion 1084 when the pull line 1082 is pulled. Figure 16 ).

[0379] For some applications, necessary modifications are made, as shown in the reference above. Figures 14A to 14D As described, in addition to the draw tube lumen 1080, the conduit 1022 further defines a primary lumen through which a core can be advanced.

[0380] The apparatus and technology described in this patent application may be applied to the apparatus and technology described in one or more of the following patent application disclosures. For example, the delivery tool, catheter, and artificial valve described in this application may represent one or more delivery tools, catheters, and artificial valves described in one or more of the following patent application disclosures, or may be replaced by one or more delivery tools, catheters, and artificial valves described in one or more of the following patent application disclosures, each of which is incorporated herein by reference in its entirety:

[0381] HaCohen's U.S. Patent No. 2015 / 0157457,

[0382] U.S. Patent No. 2013 / 0172992 to Gross et al.

[0383] U.S. Patent No. 2014 / 0324164 to Gross et al.

[0384] U.S. Patent No. 2014 / 0257475 to Gross et al.

[0385] U.S. Patent No. 2014 / 0207231 to HaCohen et al.

[0386] U.S. Patent No. 2015 / 0351906 to Hammer et al.

[0387] U.S. Patent No. 2017 / 0266003 to Hammer et al.

[0388] U.S. Patent No. 2018 / 0014930 to Hariton et al.

[0389] U.S. Patent No. 2018 / 0280136 to Hariton et al.

[0390] U.S. Patent No. 2017 / 0231766 to Hariton et al.

[0391] U.S. Patent No. 2019 / 0231525 to Hariton et al.

[0392] U.S. Patent No. 2019 / 0167423 to Hariton et al.

[0393] Hariton et al., WO 2019 / 030753,

[0394] Hariton et al., WO 2019 / 026059

[0395] Hariton et al., WO 2019 / 116369.

[0396] Those skilled in the art will understand that this invention is not limited to the content specifically shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications of the invention that would arise to those skilled in the art upon reading the above description.

Claims

1. An apparatus comprising a delivery tool (1020), characterized in that: The delivery tool (1020) includes: A catheter (1022) for implanting an artificial valve (1068) via the femoral artery into a native valve (86) of the heart, the catheter (1022) defining a primary lumen (1023) and a secondary lumen (1080), the catheter (1022) comprising: A pull ring (1090) is embedded in one wall of the conduit (1022) at a portion of the conduit (1022) that is configured to be disposed adjacent to the fossa ovalis (84); The remote control portion (1024) can be manipulated; and The tensioning portion (1084) of the catheter (1022) is located distal to the pull ring (1090) and proximal to the steerable distal portion (1024). The tensioning portion (1084) is configured to adjoin the fossa ovalis (84). The tensioning portion (1084) is more elastic than the portion of the catheter (1022) proximal to the pull ring (1090). A drawstring (1082), which is secured to the pull ring (1090) and passes through the secondary lumen (1080), extends proximally from the pull ring (1090) to a proximal portion of the delivery tool (1020), such that when a pulling force is applied to the proximal portion of the drawstring (1082), the pulling force is transferred via the pull ring (1090) to the tensioned portion (1084) of the catheter (1022) to elevate the tensioned portion (1084); and A shaft (1070) passes through the main lumen (1023) and defines a shaft cavity (1072) to facilitate the passage of a guidewire (1050) through the shaft cavity (1072).

2. The apparatus as described in claim 1, characterized in that: The tensioning portion (1084) is thinner than the portion of the conduit (1022) proximal to the pull ring (1090).

3. The apparatus as described in claim 1 or 2, characterized in that: The steerable distal portion (1024) of the catheter (1022) is configured to maintain contact between the artificial valve and the native valve during the pulling of the proximal portion of the pull wire (1082).

4. The apparatus as described in claim 1 or 2, characterized in that: The device is configured such that pulling the proximal portion of the pull wire (1082) alters the curvature of the catheter (1022) within the right atrium.

5. The apparatus as described in claim 3, characterized in that: The device is configured such that pulling the proximal portion of the pull wire (1082) alters the curvature of the catheter (1022) within the right atrium.

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