Device for replacing mitral valve and method of use thereof

Abstract

Provided herein is a device and method for replacing a mitral valve. The device includes a controller, a cutting portion, and a guide wire, wherein the cutting portion can move between a folded position for delivering the device to the mitral valve and an expanded position for cutting the mitral valve leaflets. The size and dimensions of the device are just enough to enter the body of an individual through a first access point and pass through its circulatory system, and then leave the individual through a second access point, so that when the device is located in the individual's blood vessel, the distal end of the guide wire and the controller are both located outside the individual's body. The method includes percutaneously inserting the device from the first access point, gradually advancing the device in the individual's circulatory system to the second access point, cutting the mitral valve leaflets, and delivering the artificial valve from the second access point to the cut mitral valve leaflets in the blood vessel via the guide wire.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 632,198 filed on February 19, 2018, and U.S. Provisional Application No. 62 / 641,148 filed on March 9, 2018. The entire disclosure of the aforementioned provisional applications, including the specification, claims, abstract, and drawings, tables, and icons, etc., are hereby incorporated by reference. Technical Field

[0003] The present invention generally relates to devices for replacing heart valves and methods of use thereof. In particular, the present invention relates to devices for replacing mitral valves and methods of use thereof. Background Art

[0004] The mitral valve is the most complex and most commonly diseased part of the human heart. Conditions that can affect the function of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral valve stenosis. Mitral regurgitation is when the mitral valve leaflets fail to close completely during ventricular contraction, causing abnormal leakage of blood from the left ventricle into the left atrium. Mitral valve prolapse is when the mitral valve becomes abnormally thick and protrudes into the left atrium, causing the mitral valve to function abnormally. Mitral valve stenosis is when the mitral valve of the heart narrows, obstructing normal blood flow. There are many factors that can affect the normal function of the mitral valve.

[0005] Moderate levels of mitral valve impairment do not necessarily require treatment, but once the impairment becomes severe, symptoms (e.g., difficulty breathing, fatigue, inability to exercise) may occur and become life-threatening, necessitating invasive surgery to repair or replace the dysfunctional mitral valve.

[0006] Traditionally, repairing or replacing the mitral valve has required open-heart surgery. Open-heart surgery carries the risk of morbidity and mortality for the individual, and postoperative care often takes months. Open-heart surgery may also carry other adverse risks and may not be the best option for some patients, such as elderly patients and those with other heart problems. For these patients, an attractive treatment option would be to repair or replace the mitral valve without invasive open-heart surgery.

[0007] It is known that transcatheter mitral valve replacement (TMVR) devices can be used to treat mitral regurgitation in high-risk patients. Traditional TMVR technology uses anchoring to firmly fix the artificial mitral valve to the native mitral valve. Replacement of the artificial valve often leads to obstruction of the left ventricular outflow tract (LVOT). LVOT obstruction occurs when the replaced artificial valve squeezes the anterior leaflet of the mitral valve below the aortic valve and makes it closer to the ventricular septum. In addition, the success of the artificial valve transplantation also depends on the unique structure and function of the mitral valve itself. Figure 1 shows a heart 2 with LVOT phenomenon. The traditional TMVR device 4 compresses the mitral valve leaflet 6 below the aortic valve 8, thereby hindering blood flow.

[0008] Although some progress has been made in developing prosthetic valves that can be delivered percutaneously, there has been no significant success in applying this approach to mitral valve replacement. The success of mitral valve replacement is limited by the anatomy of the mitral valve itself, especially the anatomy of the mitral annulus where the mitral valve leaflets are located. The mitral annulus has an unpredictable asymmetry relative to the relatively symmetrical annulus of the aortic valve. The unpredictability of the anatomy of the mitral valve also complicates the safe, stable, and careful application of the prosthetic valve. It is known that mitral regurgitation can be treated by transcatheter implantation of the aortic valve with an appropriate anchoring device on the mitral valve (e.g., surgical replacement of the mitral annulus). However, transcatheter delivery and replacement of the aortic valve often results in complications similar to those of TMVR devices, including LVOT obstruction (when the replacement valve compresses the mitral valve leaflets below the aortic valve).

[0009] Some mitral valve replacement techniques require the native mitral valve to be divided or cut before positioning and implanting the prosthetic valve. This procedure is particularly challenging due to the potential for fatal complications if the prosthetic valve is not accurately positioned and / or implanted immediately after the native mitral valve is divided or cut.

[0010] The above-mentioned examples of related art and their related limitations are for illustration only and are not exhaustive. After reading the contents of the specification and related drawings of this application, those skilled in the art will be more able to understand other shortcomings and limitations of the related art. Summary of the invention

[0011] The following will illustrate the implementation and features of the present invention through exemplified systems, tools and methods, but the scope of the present invention is not limited thereto. In various implementations of the present invention, one or more of the aforementioned problems can be reduced or eliminated, while other implementations are related to improvements in other aspects.

[0012] In certain aspects, the present invention provides a device for replacing a mitral valve, comprising a controller, a cutting portion, and a guide wire, wherein the cutting portion is movable between a collapsed position for delivering the device to the mitral valve and an expanded position for cutting the mitral valve leaflets. The device is sized and dimensioned to enter a subject's body through a first access point and pass through the subject's circulatory system and then exit the subject through a second access point, such that when the device is located within the subject's blood vessel, the distal end of the guide wire and the controller are located outside the subject's circulatory system.

[0013] In certain embodiments, the proximal end of the guide wire extends longitudinally from the distal end of the cutting portion.

[0014] In certain embodiments, the proximal end of the cutting portion extends from the distal end of the controller along the length direction.

[0015] In certain embodiments, the cutting portion defines a cavity extending through the cutting portion along a length direction, and the wire extends through the cavity and is slidable in the cutting portion.

[0016] In certain embodiments, the cutting portion includes at least one blade that is configured to be radially outward away from a longitudinal axis defined by the device in the deployed position and radially retracted toward the longitudinal axis in the retracted position.

[0017] In certain embodiments, each blade is made of a memory material.

[0018] In some embodiments, the memory material comprises a memory metal alloy, which is composed of one or more substances selected from the group consisting of stainless steel, nickel, titanium and nitinol.

[0019] In some embodiments, the blade maintains a pre-deformed shape in the extended position and deforms into a deformed shape in the retracted position.

[0020] In certain embodiments, each blade comprises a cutting blade, and the proximal end of each blade is pivotally connected to the distal end of a lever arm, the distal end of each cutting blade is pivotally connected to the proximal end of the guide wire, and the proximal end of each lever arm is pivotally connected to the controller.

[0021] In some embodiments, the distance between the distal end of the cutter and the proximal end of the lever arm is greater in the retracted position than in the extended position.

[0022] In some embodiments, the cutting portion includes a rod and a runner slidable along the length of the rod.

[0023] In certain embodiments, each blade includes a distal end and a proximal end, the distal end being pivotally connected to the distal end of the rod, and the proximal end being pivotally connected to the slider.

[0024] In some embodiments, the distance between the proximal end and the distal end of each blade in the stowed position is greater than the distance between the proximal end and the distal end of each blade in the deployed position.

[0025] In certain embodiments, the slide is rotatable about the rod such that each blade is rotatable about the longitudinal axis.

[0026] In some embodiments, each blade is rotated about the long axis in a first direction to reduce the radial cross-sectional area of ​​the cutting portion.

[0027] In some embodiments, each blade is rotated about the long axis in a second direction opposite to the first direction so that the radial cross-sectional area of ​​the cutting portion becomes larger.

[0028] In certain embodiments, the cutting portion includes a rotor received in a housing and defining one or more slots for receiving at least one blade.

[0029] In certain embodiments, each blade extends radially from the rotor and concentrically surrounds the inner surface of the housing in the retracted position.

[0030] In certain embodiments, each blade can be deployed and retracted within the blade slot.

[0031] In certain embodiments, each blade extends radially from the rotor through the blade slot in the deployed position.

[0032] In some embodiments, the cutting portion can cut the mitral valve leaflet in a predetermined pattern.

[0033] In certain embodiments, the predetermined pattern is a T-shaped cut, a linear cut, or an X-shaped cut.

[0034] In certain embodiments, at least one blade is radially distal from a major axis defined by the device and has a configuration corresponding to the predetermined pattern.

[0035] In some embodiments, the controller is configured to move the cutting portion from the folded position to the extended position, or from the extended position to the folded position.

[0036] Another aspect of the present invention is to provide a method for replacing a mitral valve. The method includes percutaneously inserting the device from a first access point of a subject, and advancing the device in the circulatory system of the subject to a second access point of the subject. The device includes a controller, a cutting portion, and a guide wire, and the size and dimensions of the device are just enough to enter the subject's body from the first access point and pass through its circulatory system to the second access point, so that when the device is located in the subject's blood vessel, the distal end of the guide wire and the controller are both located outside the subject. The method further includes cutting the mitral valve leaflet with the cutting portion, and delivering the artificial valve from the second access point in the blood vessel via the guide wire to the cut mitral valve leaflet.

[0037] In some embodiments, the step of cutting the mitral valve leaflet includes expanding the cutting portion from a folded position to an expanded position, and advancing the cutting portion through the mitral valve leaflet in the expanded position.

[0038] In some embodiments, the method further comprises, after cutting the mitral valve leaflets, placing a prosthetic valve into the cut mitral valve leaflets.

[0039] In some embodiments, the method further comprises placing a prosthetic valve into the severed mitral valve leaflet immediately after the mitral valve leaflet is severed.

[0040] In certain embodiments, the method comprises placing a prosthetic valve into the severed mitral valve leaflet within about 5 seconds of severed mitral valve leaflet.

[0041] In certain embodiments, the method further comprises placing a prosthetic valve into the severed mitral valve leaflet within about 3 seconds after the severed mitral valve leaflet is severed.

[0042] In certain embodiments, the method further comprises placing a prosthetic valve into the severed mitral valve leaflet within about 1 second after the mitral valve leaflet is severed.

[0043] In certain embodiments, the method comprises implanting a prosthetic valve at a predetermined position determined by transesophageal echocardiography (TEE) and / or fluorescence microscopy after cutting the mitral valve leaflets.

[0044] In some embodiments, the predetermined position is selected to completely eliminate or minimize displacement of the anterior leaflet of the mitral valve.

[0045] In certain embodiments, the predetermined position is a position along the central axis of the anterior leaflet of the mitral valve and away from the anterior leaflet annulus, so that there is a sufficient amount of anterior leaflet tissue within the anchoring device for non-bleeding implantation of the prosthetic valve.

[0046] In certain embodiments, the predetermined position is selected to completely eliminate or minimize LVOT obstruction.

[0047] In certain embodiments, the step of inserting the device from the first access site and advancing the device through the individual's circulatory system comprises: using a retrograde transcatheter approach.

[0048] In certain embodiments, the step of inserting the device from the first access site and advancing the device through the individual's circulatory system comprises: using an antegrade transcatheter approach.

[0049] In some embodiments, the step of advancing the device through the second access site includes: percutaneously inserting a snaring guidewire and advancing it through the second access site, entrap the distal end of the device within the blood vessel, and allowing the distal end of the device to be withdrawn from the second access site.

[0050] Another aspect of the present invention is to provide a device for performing a method of replacing a mitral valve. The device includes a controller, a cutting portion, and a guide wire, wherein the cutting portion is movable between a folded position for delivering the device to the mitral valve and an expanded position for cutting the mitral valve leaflets. The device is sized and dimensioned to enter and pass through at least a portion of the circulatory system of a subject through a first access point and then exit the subject through a second access point, so that when the device is located in a blood vessel of the subject, the distal end of the guide wire and the controller are both located outside the circulatory system of the subject.

[0051] In some embodiments, the proximal end of the guide wire extends from the distal end of the cutting portion along the length direction.

[0052] In certain embodiments, the proximal end of the cutting portion extends from the distal end of the controller along the length direction.

[0053] In certain embodiments, the cutting portion defines a cavity extending through the cutting portion along a length direction, and the wire extends through the cavity and is slidable in the cutting portion.

[0054] In certain embodiments, the cutting portion includes at least one blade configured to extend radially outwardly away from a longitudinal axis defined by the device in the deployed position and to retract radially toward the longitudinal axis in the retracted position.

[0055] In certain embodiments, each blade is made of a memory material.

[0056] In certain embodiments, the memory material comprises a memory metal alloy, which is composed of one or more substances selected from the group consisting of stainless steel, nickel, titanium and nickel-titanium alloy.

[0057] In some embodiments, the blade maintains a pre-deformed shape in the extended position and deforms into a deformed shape in the retracted position.

[0058] In certain embodiments, each blade comprises a cutting blade, and the proximal end of each blade is pivotally connected to the distal end of a lever arm, the distal end of each cutting blade is pivotally connected to the proximal end of the guide wire, and the proximal end of each lever arm is pivotally connected to the controller.

[0059] In some embodiments, the distance between the distal end of the cutter and the proximal end of the lever arm is greater in the retracted position than in the extended position.

[0060] In some embodiments, the cutting portion includes a rod and a slider that can slide along the length of the rod.

[0061] In certain embodiments, each blade includes a distal end and a proximal end, the distal end being pivotally connected to the distal end of the rod, and the proximal end being pivotally connected to the slider.

[0062] In some embodiments, the distance between the proximal end and the distal end of each blade in the stowed position is greater than the distance between the proximal end and the distal end of each blade in the deployed position.

[0063] In certain embodiments, the slide is rotatable about the rod such that each blade is rotatable about the longitudinal axis.

[0064] In certain embodiments, the radial cross-sectional area of ​​the cutting portion is reduced by rotating each blade about the long axis in a first direction.

[0065] In certain embodiments, the radial cross-sectional area of ​​the cutting portion is enlarged by rotating each blade about the long axis in a second direction opposite to the first direction.

[0066] In certain embodiments, the cutting portion includes a rotor received in a housing and defining one or more slots for receiving at least one blade.

[0067] In certain embodiments, each blade extends radially from the rotor and concentrically surrounds an inner surface of the housing in the stowed position.

[0068] In certain embodiments, each blade can be expanded and retracted within the blade slot.

[0069] In certain embodiments, each blade extends radially from the rotor through the blade slot in the deployed position.

[0070] In some embodiments, the cutting portion can cut the mitral valve leaflet in a predetermined pattern.

[0071] In certain embodiments, the predetermined pattern is a T-shaped cut, a linear cut, or an X-shaped cut.

[0072] In certain embodiments, at least one blade is radially distal from a major axis defined by the device and is disposed in a configuration corresponding to the predetermined pattern.

[0073] In some embodiments, the controller is configured to move the cutting portion from the folded position to the extended position, or from the extended position to the folded position.

[0074] Another aspect of the present invention is to provide a system for replacing a mitral valve. The system includes a subaortic introducer and a device including a controller, a cutting portion, and a guide wire, wherein the cutting portion is movable between a folded position for delivering the device to the mitral valve and an expanded position for cutting the mitral valve leaflets. The device is sized and dimensioned to enter a subject through a first access point and pass through at least a portion of the subject's circulatory system and exit the subject through a second access point, such that when the device is located within a blood vessel of the subject, the distal end of the guide wire and the controller are located outside the subject's circulatory system.

[0075] In certain embodiments, the subaortic introducer includes a destructible tip that maintains the guidewire in a linear position as the device is advanced through a subject's circulatory system and allows the guidewire to deform into a J-shaped position as the device is destroyed and advanced past the tip.

[0076] In some embodiments, the proximal end of the guide wire extends from the distal end of the cutting portion along the length direction.

[0077] In certain embodiments, the proximal end of the cutting portion extends from the distal end of the controller along the length direction.

[0078] In certain embodiments, the cutting portion defines a cavity extending through the cutting portion along a length direction, and the wire extends through the cavity and is slidable in the cutting portion.

[0079] In certain embodiments, the cutting portion includes at least one blade configured to extend radially outwardly away from a longitudinal axis defined by the device in the deployed position and to retract radially toward the longitudinal axis in the retracted position.

[0080] In certain embodiments, each blade is made of a memory material.

[0081] In certain embodiments, the memory material comprises a memory metal alloy, which is composed of one or more substances selected from the group consisting of stainless steel, nickel, titanium and nickel-titanium alloy.

[0082] In some embodiments, the blade maintains a pre-deformed shape in the extended position and deforms into a deformed shape in the retracted position.

[0083] In certain embodiments, each blade comprises a cutting blade, and the proximal end of each blade is pivotally connected to the distal end of a lever arm, the distal end of each cutting blade is pivotally connected to the proximal end of the guide wire, and the proximal end of each lever arm is pivotally connected to the controller.

[0084] In some embodiments, the distance between the distal end of the cutter and the proximal end of the lever arm is greater in the retracted position than in the extended position.

[0085] In some embodiments, the cutting portion includes a rod and a slider that can slide along the length of the rod.

[0086] In certain embodiments, each blade includes a distal end and a proximal end, the distal end being pivotally connected to the distal end of the rod, and the proximal end being pivotally connected to the slider.

[0087] In some embodiments, the distance between the proximal end and the distal end of each blade in the stowed position is greater than the distance between the proximal end and the distal end of each blade in the deployed position.

[0088] In certain embodiments, the slide is rotatable about the rod such that each blade is rotatable about the longitudinal axis.

[0089] In certain embodiments, the radial cross-sectional area of ​​the cutting portion is reduced by rotating each blade about the long axis in a first direction.

[0090] In certain embodiments, the radial cross-sectional area of ​​the cutting portion is enlarged by rotating each blade about the long axis in a second direction opposite to the first direction.

[0091] In certain embodiments, the cutting portion includes a rotor received in a housing and defining one or more blade slots for receiving at least one blade.

[0092] In certain embodiments, each blade extends radially from the rotor and concentrically surrounds an inner surface of the housing in the stowed position.

[0093] In certain embodiments, each blade can be deployed and retracted within the blade slot.

[0094] In certain embodiments, each blade extends radially from the rotor through the blade slot in the deployed position.

[0095] In some embodiments, the cutting portion can cut the mitral valve leaflet in a predetermined pattern.

[0096] In certain embodiments, the predetermined pattern is a T-shaped cut, a linear cut, or an X-shaped cut.

[0097] In certain embodiments, at least one blade extends radially away from a major axis defined by the device and is arranged in a configuration corresponding to the predetermined pattern.

[0098] In some embodiments, the controller is configured to move the cutting portion from the folded position to the extended position, or from the extended position to the folded position.

[0099] In addition to the above-described exemplary aspects and embodiments, other features and advantages of the present invention will be more readily understood after referring to the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The exemplary embodiments of the present invention are described with reference to the accompanying drawings. The exemplary embodiments and drawings disclosed herein are merely examples, and the scope of the present invention is not limited thereto.

[0101] FIG1 is a side view of a cross-section of a heart showing LVOT obstruction due to a prosthetic mitral valve;

[0102] Figure 2A This is a top view of a cross section of the heart with the mitral valve adapted normally;

[0103] Figure 2B yes Figure 2A Side view of a cross section of the heart;

[0104] Figure 3 is a lateral view of a cross-section of the heart with posterior mitral leaflet prolapse;

[0105] Figure 4A is a top view of a device for replacing a mitral valve in a folded position according to an embodiment of the present invention;

[0106] Figure 4B yes Figure 4A a side view of the device in the retracted position;

[0107] Figure 4C yes Figure 4A a top view of the device in the deployed position;

[0108] Figure 4D yes Figure 4A a side view of the device in the deployed position;

[0109] Figure 4E yes Figure 4A A side perspective view of the device in the deployed position;

[0110] Figure 4F yes Figure 4A An exploded view of the device in the deployed position;

[0111] Figure 5 is a schematic diagram of a device for replacing a mitral valve of a subject via a vein through the subject's circulatory system according to one embodiment of the present invention;

[0112] Fig. 6A is a schematic diagram of cutting open the anterior leaflet of the mitral valve using a device for replacing the mitral valve according to one embodiment of the present invention;

[0113] Figure 6B is a schematic diagram of cutting open the anterior leaflet of the mitral valve using a device for replacing the mitral valve according to one embodiment of the present invention;

[0114] Figure 6C is a schematic diagram of cutting open the anterior leaflet of the mitral valve using a device for replacing the mitral valve according to one embodiment of the present invention;

[0115] Fig.6D is a schematic diagram of cutting open the anterior leaflet of the mitral valve using a device for replacing the mitral valve according to one embodiment of the present invention;

[0116] Fig. 6E is a schematic diagram of cutting open the anterior leaflet of the mitral valve using a device for replacing the mitral valve according to one embodiment of the present invention;

[0117] Figure 7 yes Figure 4A A partial schematic diagram of a device, wherein the blade is made of a memory material and has a pre-deformed shape;

[0118] Fig. 8A is a partial side view of a device for replacing a mitral valve in a folded position according to one embodiment of the present invention;

[0119] Figure 8B yes Fig. 8A Partial front, top and side perspective views of the device in the retracted position;

[0120] Figure 8C yes Fig. 8A A partial top view of the device in the folded position;

[0121] Fig.8D yes Fig. 8A a front view of the device in the folded position;

[0122] Fig. 8E yes Fig. 8A a partial side view of the device in the deployed position;

[0123] Fig.8F yes Fig. 8A Partial front, top and side perspective views of the device in the deployed position;

[0124] Figure 8G yes Fig. 8A a partial top view of the device in the deployed position;

[0125] Figure 8H yes Fig. 8A a front view of the device in the deployed position;

[0126] Fig.8I yes Fig. 8A A partial side view of the device in a collapsed position within a catheter;

[0127] Figure 8J yes Fig. 8A A partial side view of the device exiting the catheter from a deployed position;

[0128] Fig.9A is a partial side view of a device for replacing a mitral valve of a subject in a collapsed position according to an embodiment of the present invention;

[0129] Fig. 9B yes Fig.9A Partial front, top and side perspective views of the device in the retracted position;

[0130] Fig. 9C yes Fig.9A A partial top view of the device in the folded position;

[0131] Fig.9D yes Fig.9A a front view of the device in the folded position;

[0132] Fig.9E yes Fig.9A a partial side view of the device in the deployed position;

[0133] Fig.9F yes Fig.9A Partial front, top and side perspective views of the device in the deployed position;

[0134] Figure 9G yes Fig.9A a partial top view of the device in the deployed position;

[0135] Figure 9H yes Fig.9A a front view of the device in the deployed position;

[0136] Fig. 10A is a cross-sectional elevational view of a device for replacing a mitral valve in a folded position according to an embodiment of the present invention;

[0137] Fig. 10B yes Fig. 10Aa partial cross-sectional side view of the device in the retracted position;

[0138] Fig. 10C yes Fig. 10A a cross-sectional front view of the device in the deployed position;

[0139] Fig. 10D yes Fig. 10A a partial side view of the device in the deployed position;

[0140] Fig.11A is a cross-sectional side view of a heart with a first catheter advanced into the left atrium and a second catheter advanced into the left ventricle;

[0141] Fig. 11B According to one embodiment of the present invention, a device is used to replace Fig.11A a cross-sectional side view of the heart with a mitral valve of the heart and the device advanced to the ventricular surface of the anterior leaflet of the mitral valve;

[0142] Fig. 11C yes Fig. 11B a cross-sectional side view of a heart wherein a clasp has been advanced through a first catheter into the left atrium of the heart and a guide wire of the device has been advanced through the anterior leaflet of the mitral valve into the left atrium of the heart;

[0143] Fig.11D yes Fig. 11B A cross-sectional side view of the heart and device is shown, wherein the cutting portion of the device has been advanced to the ventricular surface of the anterior leaflet of the mitral valve of the heart;

[0144] Fig.11E yes Fig. 11B a cross-sectional side view of the heart and device shown wherein a cutting portion of the device has been advanced through the anterior leaflet of the mitral valve to the left atrium of the heart;

[0145] Fig.11F yes Fig. 11B A cross-sectional side view of the heart and device is shown, wherein the transcatheter heart valve prosthesis has been advanced through the device guide wire and delivered to an incision in the anterior leaflet of the mitral valve of the heart;

[0146] Fig.11G yes Fig.11F A cross-sectional side view of the heart, the device, and the transcatheter heart prosthesis, wherein the transcatheter heart prosthesis is placed in an incision on the anterior leaflet of the mitral valve of the heart to replace the function of the mitral valve;

[0147] Fig. 12A is a schematic diagram of a subject's body with a device for replacing a mitral valve according to an embodiment of the present invention, wherein a clasp has been advanced through a first catheter to the left atrium of the subject's heart and a guide wire of the device has been advanced through a second catheter to the left ventricle of the subject's heart;

[0148] Fig. 12B yes Fig. 12A a schematic diagram of a subject's body, heart, and device, wherein a lead of the device has been advanced over the anterior leaflet of the mitral valve into the left atrium of the subject's heart to engage with a clasp;

[0149] Fig. 12C yes Fig. 12A A schematic diagram of a body, heart, and device shown, wherein a cutting portion of the device is advanced into the left ventricle of the heart within a second catheter, and a transcatheter heart prosthesis is advanced along the device guide wire to a position in the left atrium above the anterior leaflet of the mitral valve;

[0150] Fig.12D yes Fig. 12C A schematic diagram of a body, heart, and device of the individual is shown, wherein a cutting portion of the device has been advanced from within a second catheter to a ventricular surface of an anterior leaflet of a mitral valve of the heart;

[0151] Fig.12E yes Fig. 12C A schematic diagram of a body, heart, and device of a subject is shown, wherein a cutout portion of the device is deployed within the left ventricle of the heart;

[0152] Fig.12F yes Fig.12E Schematic diagram of the cross section of the mitral valve leaflet along the BB line after puncture;

[0153] Figure 12G yes Fig. 12C A schematic diagram of a subject's body, heart, and device is shown, wherein a cutout portion of the device is advanced in an expanded form through the anterior leaflet of a mitral valve of the heart;

[0154] Fig.12H yes Figure 12G Schematic diagram of the cross section of the cut mitral valve leaflet along the AA line;

[0155] Fig.12I yes Fig. 12C A schematic diagram of a body, heart, and device of the individual shown, wherein the cutting portion of the device is in a collapsed state within the left atrium of the heart;

[0156] Fig.12J yes Fig. 12C A schematic diagram of a subject's body, heart, and device is shown, wherein a cutting portion of the device is retracted from the anterior leaflet of the mitral valve into a second catheter, and a transcatheter heart prosthesis is advanced to the cutting portion of the anterior leaflet of the mitral valve. DETAILED DESCRIPTION

[0157] The following detailed description is provided to enable those skilled in the art to better understand the present invention. However, to avoid obscuring the present invention, some well-known components are omitted or not described in detail. Therefore, the invention description and illustrations provided are only illustrative and not exhaustive.

[0158] Unless otherwise indicated, the term "anterior" (with respect to a subject's body or a part thereof) herein refers to a position closer to the front of a subject's body or a part thereof than to the back of a subject's body or a part thereof.

[0159] Unless otherwise indicated, the term "postterior" herein (with respect to a subject's body or a part thereof) refers to a position closer to the back of a subject's body or a part thereof than to the front of a subject's body or a part thereof.

[0160] Unless otherwise indicated, the term "proximal" as used herein (with respect to a device and parts thereof according to embodiments of the present invention) refers to a location closer to a controller or part thereof of the device.

[0161] Unless otherwise indicated, the term "distal" as used herein (with respect to a device and parts thereof according to embodiments of the present invention) refers to a location that is further away from a controller or part thereof of the device.

[0162] As used herein, unless otherwise indicated, "percutaneous," "percutaneously," and the like refer to a procedure that provides access to a subject's circulatory system and / or heart through the skin (eg, via a needle).

[0163] Unless otherwise indicated, the term "antegrade" herein refers to a percutaneous approach to the mitral valve via a single femoral vein, right atrium, right heart septal puncture, and left atrium.

[0164] Unless otherwise indicated, the term "retrograde" as used herein refers to a percutaneous approach to the mitral valve via a femoral vein, wherein the left ventricle enters and exits via the aortic valve.

[0165] Unless otherwise indicated, the term "intravascular" as used herein refers to being located or occurring within a subject's blood vessels or circulatory system.

[0166] As used herein, the term "external" (with respect to a subject's body or a portion thereof) means outside the subject's circulatory system or external to the body, unless otherwise indicated.

[0167] Unless otherwise indicated, the term "transcatheter" as used herein refers to a method performed through the lumen of a catheter.

[0168] Unless otherwise specified, the term "collapsed position" herein refers to a radially compressed state. Although the terms "radial" and "radially" and the like are often associated with annular objects or objects with annular features, it should be understood that the terms "radial" and "radially" and the like are to be interpreted in a broad sense herein and are not limited to absolutely annular objects, objects with annular features or annular cross-sections.

[0169] Unless otherwise indicated, the term "expanded position" as used herein refers to a radially enlarged, extended or expanded state.

[0170] Unless otherwise specified, the term "circulatory system" herein refers to a system that allows blood and / or lymph to circulate through a subject's body, consisting of one or more selected from the group consisting of heart, blood vessels, blood, lymph, lymphatic vessels and lymph glands.

[0171] Unless otherwise specified, the term "transcatheter heart valve prosthesis" in this document refers to an artificial valve that is used percutaneously to repair or replace a heart valve (such as a mitral valve, aortic valve, etc.) using a transcatheter heart valve prosthesis delivery system, including but not limited to a transcatheter mitral valve prosthesis.

[0172] Unless otherwise specified, the term "subject" as used herein refers to humans and / or animals (e.g., birds and / or mammals) and includes any subject that may benefit or may benefit from the present invention, for example, a subject having a condition that affects the normal function of a heart valve (including but not limited to the mitral valve) (e.g., mitral regurgitation, mitral valve prolapse, and mitral valve stenosis).

[0173] Unless otherwise specified, the term "nitinol" herein refers to a nickel-titanium alloy having shape memory and / or superelastic properties. Nitinol can be deformed into a deformed shape and can return to its original, undeformed shape without heating.

[0174] Although the methods or devices of the present invention can be used to percutaneously repair any heart valve, the following description will only focus on mitral valve replacement. In addition, although the methods or devices of the present invention are preferably performed percutaneously and intravascularly, such methods and devices can also be used in open-heart surgery to access the heart through cardiac tissue, and / or in minimally invasive procedures to access the heart using thoracoscopy. In addition, although the methods or devices of the present invention are preferably used with traditional transcatheter heart valve prostheses, such methods or devices can also be implanted together with the prosthetic valve into the myocardial tissue of the heart, and / or the prosthetic valve can be implanted using a minimally invasive procedure (thoracoscopy).

[0175] like Figure 2A and Figure 2B The human heart 10 shown is a muscular pump that relies on heart valves to push blood forward. Under normal physiological function, oxygen-rich blood returning from the lungs is collected in the left atrium 20 and then enters the left ventricle 40 (i.e., the pumping chamber) through the mitral valve (inlet) 30. When the left ventricle 40 contracts, the mitral valve 30 closes due to the increase in left ventricular pressure, thereby preventing blood from flowing back into the left atrium 20. When the ventricular pressure exceeds the aortic pressure, the aortic (outlet) valve 50 will open, pumping blood forward into the aorta 60. When the left ventricle 40 relaxes, the ventricular pressure drops, and the mitral valve 30 will open again to allow blood to flow from the left atrium 20 to the left ventricle 40, and the whole process can be repeated continuously.

[0176] The mitral valve 30 separates the left atrium 20 from the left ventricle 40 and includes the mitral valve annulus 32, leaflets (anterior leaflet 34 and posterior leaflet 36), chordae tendineae 38, and papillary muscles 39. During ventricular systole, ventricular pressure increases. This forces the mitral valves 34, 36 to move toward the atrium 20 (i.e., what is commonly known as atrial diaphragmatic movement). The length and integrity of the chordae tendineae 38 determine the extent of atrial diaphragmatic movement. Under normal physiological function, the equidistant movement of the anterior leaflet 34 and the posterior leaflet 36 of the mitral valve brings the two leaflets into contact with each other and achieves the subsequent function of the mitral valve 30.

[0177] When the chordae tendineae 38 supporting the anterior and posterior leaflets 34 and 36 of the mitral valve become elongated or damaged, ventricular contraction can cause the mitral valve leaflets to move excessively, making the two leaflets unable to fit together ( Figure 3), which in turn causes mitral valve prolapse. In this case, the subsequent function of the mitral valve 30 is impaired and blood leakage occurs. Leakage through the mitral valve is called mitral regurgitation, and when it is caused by mitral valve prolapse, it is called degenerative mitral regurgitation. In other cases, the ventricular muscle itself may be impaired by disease, resulting in limited ventricular contraction and persistent ventricular dilatation. Because the mitral valve leaflets 34 and 36 are connected to the ventricular muscle via chordae tendineae 38, ventricular dilatation will limit the movement of the mitral valve leaflets toward the atrium 20 during contraction, resulting in poor coordination between the two leaflets and mitral regurgitation. This condition is also called functional mitral regurgitations.

[0178] The method and apparatus exemplified by the present invention use an existing transcatheter heart prosthesis to percutaneously replace the mitral valve. The method and apparatus exemplified by the present invention can percutaneously incise the mitral valve leaflet and precisely implant a transcatheter heart prosthesis at the incision. In this way, the incision and implantation can be performed in a controlled, deliberate and precise manner, and LVOT obstruction can be avoided or minimized. In certain embodiments, the size of the incision site can be controlled so that the implantation can be optimized. Certain embodiments of the present invention utilize percutaneous incision of the anterior leaflet of the mitral valve to allow the implantation of a transcatheter heart prosthesis after the anterior leaflet of the mitral valve has been incised, so as to reduce or eliminate the risk of hemodynamic instability.

[0179] Figures 4A-4F Device 100 is shown for replacing a heart valve (eg, a mitral valve). Other embodiments, device 500, device 600, and device 700 are shown in Figures 8A-8J , 9A-9H and Figures 10A-10D Many features and components of device 500, 600, 700 are similar to those of device 100, and therefore, in these similar embodiments, the same component symbols are used to represent similar features and components. In certain embodiments, device 100, 500, 600, 700 is used to percutaneously incise the mitral valve leaflets and precisely implant a transcatheter heart prosthesis at the incision. Device 100, 500, 600, 700 is sized to be able to percutaneously pass through the individual's circulatory system from a first access point to a second access point. In certain embodiments, the femoral artery or femoral vein of an individual is entered from the first access point. In certain embodiments, the femoral artery or femoral vein of an individual is entered from the second access point. When the femoral artery of an individual is entered from the first access point, the femoral vein of the individual is entered from the second access point, and vice versa. Figure 5 and Fig.11A -11J shows the device 100 from the first entry and exit point 106 ( Fig.11A -11J) through the individual's circulatory system 200 to the second entry and exit site 105 ( Fig.11A-11J), such that when the device 100 is located within a blood vessel and passes through the individual's circulatory system, the proximal end 102 and the distal end 104 of the device 100 are both located outside the individual's body. The devices 500, 600, and 700 are similarly located within the individual's circulatory system. Figure 5 In the illustrated embodiment, when the device 100 is located intravascularly and passes through the circulatory system of an individual, the proximal end 102 of the device 100 is outside the femoral artery and the distal end 104 is outside the femoral vein. However, this is not necessarily the case, and when the device 100 is located intravascularly and passes through the circulatory system of an individual, the proximal end 102 may be outside the femoral artery and the distal end 104 may be outside the femoral vein.

[0180] The device includes a controller, a cutting portion, and a guide wire. The device is operable from outside the body of an individual. For example, the controller can be operated from outside the body of an individual to advance the device within a blood vessel and from a first access point (e.g., access point 106, Fig.11A -11J) through the individual's circulatory system to a second access site (e.g., access site 108, Fig.11A -11J). In some embodiments, the controller is configured to operate the cutting portion and / or the guide wire within the blood vessel from outside the body.

[0181] A controller (e.g., controller 110) may be operable to move the device between a folded position and an expanded position. In the folded position, the device is radially collapsed so as to be able to pass through the individual's circulatory system. In the expanded position, the device is radially enlarged, extended, or expanded such that the radial cross-sectional area of ​​the device is greater than the radial cross-sectional area when it is in the folded position. In the expanded position, the device may be operable to cut the mitral valve leaflets. In some embodiments, the cutting portion (e.g., cutting portion 120, 520, 620, 720) may be operable to enable the device to be in the folded position ( Figure 4A ,4B,8A-8D,8I,9A-9D,10A-10B) and the expansion position ( Figures 4C-4F ,8E-8H,8J,9E-9H,10C-10D). In the folded position, the cutting portion is in a radially folded state to reduce its cross-sectional area. In the expanded position, the cutting portion is in a radially enlarged, extended or expanded state, so that the radial cross-sectional area of ​​the cutting portion in the expanded position is greater than the radial cross-sectional area of ​​the cutting portion in the folded position.

[0182] A guide wire (e.g., guide wire 130, 530, 630, 730) extends from the cutting portion in a length direction to guide and position the cutting portion to cut the mitral valve leaflets, and to place a transcatheter heart prosthesis (e.g., an artificial mitral valve) in the cut mitral valve leaflets. In this way, the transcatheter heart prosthesis can be accurately placed in the incision to reduce or eliminate the risk of hemodynamic instability. In some embodiments, the transcatheter heart prosthesis is placed at the incision position within 5 seconds after the incision. In some embodiments, the transcatheter heart prosthesis is placed at the incision position within 3 seconds after the incision. In some embodiments, the transcatheter heart prosthesis is placed at the incision position within 1 second after the incision. In some embodiments, the transcatheter heart prosthesis is placed at the incision position immediately after the incision. Accurate placement of the transcatheter heart prosthesis can avoid LVOT obstruction or minimize its occurrence. Immediate placement of a transcatheter heart valve prosthesis after incision can also minimize the risk of hemodynamic instability.

[0183] like Figures 4A-4F In the illustrated embodiment, the device 100 includes a cutting portion 120, a guide wire 130 (which extends from the distal end of the cutting portion 120), and a controller 110 (which extends from the proximal end in the opposite direction to the distal end of the cutting portion 120). Figures 4A-4F In the illustrated embodiment, the controller 110 includes a handle 116 and a knob 118. The handle 116 has a chamber (not shown) extending along its length. A rod 119 coupled to the knob 118 extends through the chamber and is slidable within the chamber to move the rod 119 and the knob 118 concentrically and / or longitudinally relative to the handle 116. The device is operated by sliding and / or rotating the knob 118 longitudinally relative to the handle 116. In some embodiments, the cutting portion 120 is rotatable relative to the controller 110. In some embodiments, the controller 110 and the cutting portion 120 are rotatably fixed so that the cutting portion 120 can be rotated by rotating the controller 110.

[0184] The guide wire 130 includes a proximal end 132 ( Figure 4F ), and a distal end 134 in the opposite direction of the proximal end. In some embodiments, the guide wire 130 can rotate relative to the controller 110 and / or the cutting portion 120. In some embodiments, the cutting portion 120 and the guide wire 130 are fixed in a rotatable manner, so that rotating the cutting portion 120 can rotate the guide wire 130, and vice versa. In the illustrated embodiment, the distal end 134 of the guide wire 130 has a hook 136 for hooking the clasp (engaging with the clasp). People skilled in the art should be able to understand and infer other ways of engaging with the clasp, which also fall within the scope of the present invention.

[0185] The cutting portion 120 includes one or more blades 126 that can be radially expanded to cut the mitral valve. The controller 110 can be used to expand or collapse each blade 126. Figures 4A-4F In the illustrated embodiment, the cutting portion 120 includes three blades 126 that can be radially expanded to cut the mitral valve in a T-shaped manner. The number and arrangement of the blades of the device 100 can be selected according to the desired cutting shape. For example, the number and arrangement of the blades of the device 100 can be selected so that the mitral valve has a "T-shaped", "straight-shaped", or "X-shaped" incision ( Figures 6A-6E ). Other shapes of incisions are commonly used in the field of cardiac surgery. In some embodiments, the expansion or folding of each blade 126 is located within a predetermined area of ​​the cutting portion.

[0186] exist Figures 4A-4F In the illustrated embodiment, each blade 126 includes a cutter 126a pivotally connected to a lever arm 126b via a hinge 126c. The hinge 126c includes a pin, a screw or other known mechanical fastener. To expand or retract the blades 126, the cutting portion 120 includes a rod 129 coupled to the rod 119 via its proximal end 129a and coupled to the lever arm 126b via its distal end 129b ( Figure 4F ). In some embodiments, the rod 129 is coupled to the rod 119. In other embodiments, the rod 129 and the rod 119 are formed together as a single rod (not shown). In some embodiments, the lever arm 126b is pivotally connected to the distal end 129b by a hinge (e.g., a pin, screw, or other well-known mechanical fastener). The cutter 126a is coupled to the proximal end 132 of the guide wire 130. In some embodiments, the cutter 126a is pivotally connected to the guide wire 130 by a hinge (not shown, e.g., a pin, screw, or other well-known mechanical fastener).

[0187] In the folded position ( Figures 4A-4B ), the cutting blade 126a and the lever arm 126b are folded together with the hinge 126c into a radially collapsed state to reduce the cross-sectional area of ​​the cutting portion 120, so that the device 100 can be percutaneously inserted and pass through a blood vessel. Figures 4C-4F ), pull the knob 118 coupled to the rod 119 out along the A axis to move it away from the handle 116 ( Figure 4A). Thus, the rod 129 coupled to the rod 119 can slide in the length direction in the chamber (not shown) defined by the handle 116 to pull the distal end 129b of the rod 129 away from the proximal end 132 of the guide wire 130. As the distal end 129b is pulled away from the guide wire 130 along the A axis, the cutter 126a and the lever arm 126b can move radially away from the A axis as the hinge 126c is unfolded. Thus, the cutter 126a can cut the mitral valve. To collapse the cutting portion 120, the knob 118 is pushed toward the handle 116 along the A axis, so that the distal end 129b of the rod 129 approaches the proximal end 132 of the guide wire 130, and the cutter 126a and the lever arm 126b can be folded and collapsed together with the hinge 126c. The cutter 126a and the lever arm 126b are in a radially collapsed state toward the A axis. In the collapsed state, device 100 may be inserted into a catheter (eg, catheter 12).

[0188] In the illustrated embodiment, the device 100 includes a blade tube (or blade sheath) 121 (although it is not required). The blade tube 121 defines a chamber (not shown) extending in the length direction and one or more blade slots 121c, each blade slot 121c being configured to allow the blade 126 to pass therethrough. The distal end 129b of the rod 129 and the proximal end 132 of the guide wire 130 extend through the chamber. Thus, when the device 100 is in the deployed position, the blade tube 121 can span the gap between the distal end 129b of the rod 129 and the proximal end 132 of the guide wire 130. Therefore, the blade tube 121 can couple the cutting portion 120 and the guide wire 130 together along the A axis. When the device 100 is in the deployed position, the blade tube 121 can prevent the material between the cutting portion 120 and the guide wire 130 from being loosened. The blade tube 121 can improve the accuracy of the device 100 when cutting the mitral valve and implanting a transcatheter heart valve prosthesis.

[0189] In the illustrated embodiment, the device 100 includes a connecting tube 123 (although it is not necessary). The connecting tube 123 defines a chamber (not shown) extending along the length direction. The distal end 121b of the blade tube 121 and the proximal end 132 of the guide wire 130 can extend through the chamber. Thereby, the connecting tube 123 can rigidly couple the cutting portion 120 and the guide wire 130 together along the A axis. The connecting tube 121 can improve the accuracy of the device 100 when cutting the mitral valve and implanting the transcatheter heart prosthesis.

[0190] In the illustrated embodiment, the device 100 includes a rod tube 125 (although it is not required). The rod tube 125 defines a chamber (not shown) extending in a length direction. The distal end 121b of the blade tube 121 and the rod 129 can extend through the chamber and slide in the length direction within the chamber. The rod tube 125 can increase the rigidity of the device 100. For example, the rod tube 125 can rigidly couple the controller 110 and the cutting portion 120 along the A axis. The rod 119 and / or the rod 129 can slide in the chamber of the rod tube 125 along the A axis.

[0191] In the illustrated embodiment, the device 100 includes a sleeve 127 (although it is not required). The sleeve 127 defines a chamber (not shown) extending in the length direction. The proximal end 121a of the blade tube 121 and the rod tube 125 (and / or the rod 129) can extend through the chamber and slide in the length direction in the chamber. The sleeve 127 can increase the rigidity of the device 100.

[0192] In some embodiments, the device 100 and / or portions thereof comprise sterile or sterilizable materials. In some embodiments, the device 100 and / or portions thereof comprise one or more medical grade materials, including plastics, thermoplastics, stainless steel, metal alloys (e.g., nitinol or other types of nickel / titanium alloys), and titanium. Those skilled in the art will appreciate that other sterile or sterilizable materials known or commonly used in the field of cardiac surgery can be used to manufacture the device 100 and / or portions thereof.

[0193] In some embodiments, each blade 126 is made of a sterile or sterilizable memory material, such as a memory metal alloy, including but not limited to stainless steel and / or nickel and / or titanium and / or nitinol. For example, Figure 7 The blade 126d shown is made of a single piece of sterile or sterilizable memory material (e.g., memory metal alloy, including but not limited to, stainless steel and / or nickel and / or titanium and / or nitinol). Figure 7 As shown, the blades 126d can maintain a pre-deformed shape when in the extended position. Each blade 126d can be deformed to a retracted position (not shown).

[0194] To expand and collapse the blade 126d, the proximal end 126e of the blade 126d is coupled to the distal end 129b of the rod 129. In some embodiments, the proximal end 126e is pivotally connected to the rod 129 via a hinge (not shown, such as a pin, screw, or other well-known mechanical fastener). The distal end 126f of the blade 126d is coupled to the proximal end 132 of the guide wire 130. In some embodiments, the distal end 126f is coupled to the guide wire 130 via a hinge (not shown, such as a pin, screw, or other well-known mechanical fastener).

[0195] In the retracted position (not shown), the blade 126d is deformed into a radially retracted state to reduce the cross-sectional area of ​​the cutting portion 120 so that the device 100 can be percutaneously inserted and cross a blood vessel. To deploy the cutting portion 120, the knob 118 coupled to the rod 119 is pushed toward the handle 116 ( Figure 7 ). Thus, the rod 129 coupled to the rod 119 can slide in the length direction in the chamber (not shown) defined by the handle 116 to push the distal end 129b of the rod 129 toward the proximal end 132 of the guide wire 130. As the distal end 129b advances along the B-axis toward the guide wire 130, the distance between the two ends 126e, 126f of the blade 126d is reduced and the blade 126d is radially expanded away from the B-axis to a pre-deformed shape. Thus, the blade 126d is positioned to cut the mitral valve. To collapse the cutting portion 120, the knob 118 is pulled away from the handle 116 along the B-axis so that the distal end 129b of the rod 129 is away from the proximal end 132 of the guide wire 130. As the distal end 129b is pulled away from the proximal end 132 of the guide wire 130 along the B-axis, the distance between the two ends 126e, 126f of the blade 126d is increased and the blade 126d is collapsed radially toward the B-axis into a deformed state. In the collapsed state, device 100 may be inserted into a catheter (eg, catheter 12).

[0196] exist Figures 8A-8J In the illustrated embodiment, the device 500 includes a cutting portion 520, a guide wire 530 (which extends away from the distal end of the cutting portion 520), and a controller 510 (not shown, which extends away from the proximal end in the opposite direction of the distal end of the cutting portion 520). Many features and components of the controller 510 are similar to the controller 110 described previously. In some embodiments, the controller includes a handle (not shown) and a knob (not shown). The handle has a cavity (not shown) extending along its length. A rod coupled to the knob extends through the cavity and can slide within the cavity to move the rod and knob concentrically and / or longitudinally relative to the handle. The device is operated by sliding and / or rotating the knob longitudinally relative to the handle.

[0197] The cutting portion 520 includes one or more blades 526 that can be radially expanded to cut the mitral valve. Each blade 526 can be expanded or retracted using a controller. Figures 8A-8J In the illustrated embodiment, the cutting portion 520 includes three blades 526 that can be radially expanded to cut the mitral valve in a T-shaped manner. The number and arrangement of the blades of the device 500 can be selected according to the desired cutting shape. Each blade 526 is constructed as a single piece of sterile or sterilizable material (e.g., memory metal alloy, including but not limited to stainless steel and / or nickel and / or titanium and / or nickel-titanium alloy (nitinol)). Figures 8E-8H As shown in FIGS. 8J and 8J , each blade 526 can maintain a pre-deformed shape when in the deployed position. Figures 8A-8D As shown in Figures 8I, each blade 526 can be deformed into a closed position. In other embodiments, each blade 526 includes a cutter that is pivotally connected to a lever arm via a hinge. The structure and function of these cutters are similar to the blade 126 of the device 100.

[0198] To expand and retract the blades 526, the cutting section 520 includes a slider 570. The proximal end 526a of each blade 526 is coupled to the slider 570. The distal end 526b of each blade 526 is coupled to the guide wire 530. The slider 570 defines a chamber (not shown) extending in the length direction. The slider 570 is slidably mounted on the rod 528. The rod 528 extends from the controller through the chamber of the slider 570 so that the slider 570 can slide longitudinally along the rod 528. The slider 570 is coupled to the distal end 529a of the sleeve 529 so that the cutting section 520 can be manipulated. The sleeve 529 is coupled to the handle 116 of the controller so that the slider 570 can be slid along the rod 528 by pulling or pushing the knob 118. The sleeve 529 defines a chamber (not shown) extending in the length direction. The rod 528 extends through the chamber of the sleeve 529.

[0199] In some embodiments, the device 500 includes a joint 540 that is fixedly coupled to the proximal end 532 of the guide wire 530; and the distal end 526b of each cutter 526 is coupled to the joint 540. The slider 570 can slide longitudinally over the rod 528 relative to the joint 540. Figure 8C ) pushes the sleeve 529 toward the joint 540, so that each blade 526 can be moved from the closed position ( Figures 8A-8D ) into radially expanded position ( Figures 8E-8Hand 8J). Thereby, the slide 570 can slide along the rod 528 toward the joint 540. As the slide 570 is pushed toward the joint 540 along the C-axis, the distance between the two ends 526a, 526b of the blade will be reduced so that each blade 526 can be radially expanded and away from the C-axis. Thereby, the blade 526 is arranged to cut the mitral valve. To close the blade 526, the slide 570 is pulled along the C-axis in a direction away from the joint 540, so that the slide 570 is away from the joint 540. As the slide 570 is pulled away from the joint 540 along the C-axis, the increase in the two ends 526a, 526b of the blade will be reduced so that each blade 526 can be radially closed toward the C-axis. When in the closed position, the device 500 can be inserted into a catheter (e.g., catheter 12).

[0200] In some embodiments, the device 500 and / or portions thereof comprise sterile or sterilizable materials. In some embodiments, the device 500 and / or portions thereof comprise one or more medical grade materials, including plastics, thermoplastics, stainless steel, metal alloys (e.g., nitinol or other types of nickel / titanium alloys), and titanium. Those skilled in the art will appreciate that other sterile or sterilizable materials known or commonly used in the field of cardiac surgery can be used to manufacture the device 500 and / or portions thereof.

[0201] In some embodiments, the cutting portion includes one or more rotatably deformable blades. For example, Figures 9A-9H The device 600 shown includes three rotatably deformable blades 626. Figures 9A-9H In the illustrated embodiment, the device 600 includes a cutting portion 620, a guide wire 630 (which extends away from the distal end of the cutting portion 620), and a controller (not shown) which extends away from the proximal end (i.e., the other end opposite the distal end) of the cutting portion 620. Many features and components of the controller are similar to the controller 110 described previously. In some embodiments, the controller includes a handle (not shown) and a knob (not shown). The handle has a cavity (not shown) extending along its length. A rod coupled to the knob extends through the cavity and can slide within the cavity to move the rod and knob concentrically and / or longitudinally relative to the handle. The device 500 is operated by sliding and / or rotating the knob longitudinally relative to the handle.

[0202] The cutting portion 620 includes one or more blades 626 that can be radially expanded to cut the mitral valve. A controller can be used to expand or retract each blade 626. Figures 9A-9HIn the illustrated embodiment, the cutting portion 620 includes three blades 626 that can be radially expanded to cut the mitral valve in a T-shaped manner. The number and arrangement of the blades of the device 600 can be selected according to the desired cutting shape. Each blade 626 is constructed as a single piece of sterile or sterilizable material (e.g., memory metal alloy, including but not limited to stainless steel and / or nickel and / or titanium and / or nickel-titanium alloy (nitinol)). Figures 9E-9H As shown, each blade 626 can maintain a pre-deformed shape when in the deployed position. Figures 9A-9D As shown, each blade 626 can be deformed into a stowed position.

[0203] To expand and retract the blades 626, the cutting portion 620 includes a slider 670. The proximal end 626a of each blade 626 is coupled to the slider 670. The distal end 626b of each blade 626 is coupled to the guide wire 630. The slider 670 defines a chamber (not shown) extending in the length direction. The slider 670 is mounted on the rod 628 in a rotatable manner around the rod 628. In some embodiments, the slider 670 is mounted on the rod 628 in a manner that it can rotate and slide around the rod 628. The rod 528 extends from the controller through the chamber of the slider 670, so that the slider 670 can rotate concentrically around 628 or slide longitudinally along the rod 628. The slider 670 is coupled to the distal end 629a of the sleeve 629 so that the cutting portion 620 can be controlled. The sleeve 629 is coupled to the handle 116 of the controller so that the slider 670 can be slid along the rod 628 by pulling or pushing the knob 118. The sleeve 569 defines a cavity (not shown) extending in the longitudinal direction. The rod 628 extends through the cavity of the sleeve 629.

[0204] In some embodiments, the device 600 includes a joint 640 that is fixedly coupled to the proximal end 632 of the guide wire 630; and the distal end 626b of each cutter 626 is coupled to the joint 640. In some embodiments, the slider 670 can slide longitudinally over the rod 628 relative to the joint 640. Fig. 9C ) by rotating the slide 670 concentrically relative to the joint 640 in a first direction, each blade 626 can be moved from the closed position ( Figures 9A-9D ) into radially expanded position ( Figures 9E-9H ). As the sleeve 629 is rotated in the first direction, each blade 626 can be deformed rotationally about the rod 621, thereby reducing the radial joint area of ​​the cutting portion. In the collapsed position, the device 600 can be inserted into a catheter (e.g., catheter 12).

[0205] Each blade 626 is returned to its pre-deformed state in the deployed position by rotating the sleeve 628 concentrically about the D-axis relative to the joint 640 in a second direction opposite to the first direction, so that the cross-sectional area of ​​the cutting portion in the deployed position is much larger than the cross-sectional area in the collapsed position. In this position, the blades 626 are positioned to cut the mitral valve. In some embodiments, pulling the sleeve 628 away from the joint 640 along the D-axis (with or without rotation in the first direction) increases the distance between the ends 626a, 626b of the blades and allows each blade 626 to collapse radially toward the D-axis. Pushing the sleeve 628 toward the joint 640 along the D-axis (with or without rotation in the second direction) thereby moving the slider 670 toward the joint 640 can deploy the blades 626. As the slider 670 is pushed toward the joint 640 along the D-axis, the distance between the ends 626a, 626b of the blades decreases and causes the blades 626 to expand radially away from the D-axis.

[0206] In some embodiments, the device 600 and / or portions thereof comprise sterile or sterilizable materials. In some embodiments, the device 600 and / or portions thereof comprise one or more medical grade materials, including plastics, thermoplastics, stainless steel, metal alloys (e.g., nitinol or other types of nickel / titanium alloys), and titanium. Those skilled in the art will appreciate that other sterile or sterilizable materials known or commonly used in the field of cardiac surgery can be used to manufacture the device 600 and / or portions thereof.

[0207] exist Figures 10A-10D In the illustrated embodiment, the device 700 includes a cutting portion 720, a guide wire 730 (which extends away from the distal end of the cutting portion 720), and a controller (not shown, which extends away from the proximal end in the opposite direction of the distal end of the cutting portion 720). Many features and components of the controller are similar to the controller 110 described previously. In some embodiments, the controller includes a handle (not shown) and a knob (not shown). The handle has a cavity (not shown) extending along its length. A rod coupled to the knob extends through the cavity and can slide within the cavity to move the rod and knob concentrically and / or longitudinally relative to the handle. The device is operated by sliding and / or rotating the knob longitudinally relative to the handle.

[0208] The cutting portion 720 includes one or more blades 726 that can be radially expanded to cut the mitral valve. Each blade 726 can be expanded or retracted using a controller. To expand or retract the blades 726, the cutting portion 720 includes a rotor 760 housed in a housing 780. The housing 780 includes at least one blade slot 782, each blade slot 782 being configured to receive and allow a corresponding blade 726 to pass therethrough. Each blade 726 can be expanded or retracted in a corresponding blade slot 782 defined by the housing 780. In some embodiments, the rotor 760 is coupled to the rod 129 and can be activated by rotating the rod 129. In some embodiments, the rotor 760 extends longitudinally through the controller so that the cutting portion 720 can be activated by rotating the rotor 760.

[0209] exist Figures 10A-10D In the illustrated embodiment, the cutting portion 720 includes three blades 726a, 726d, and 726g (which can be radially expanded to cut the mitral valve in a T-shaped manner). Fig. 10C The number and arrangement of the blades of the device 700 can be selected according to the desired shape of cutting. Each blade 726 is constructed as a single piece of sterile or sterilizable material (e.g., memory metal alloy, including but not limited to stainless steel and / or nickel and / or titanium and / or nitinol). Figures 10C-10D As shown, each blade 726 can maintain a pre-deformed shape when in the deployed position. Figures 10A-10B As shown, the rotor 760 can be operated so that each blade 726 can be deformed into a closed position. In some embodiments, one or more blades 726 include one or more openings (not shown) to allow it to be deformed in the housing 780 while maintaining a desired shape to cut the mitral valve of the heart.

[0210] To provide a T-shaped cutting pattern, a first end 726b of blade 726a is secured to an arm 762 that is coupled to and extends radially away from rotor 760. A first end 726e of blade 726d is secured to arm 762 such that ends 726b, 726e are coupled to opposite sides of arm 762. A first end 726h of blade 726g is coupled to rotor 760. In certain embodiments, first end 726h is coupled to rotor 760 at a location substantially opposite arm 762 (approximately the diameter of rotor 760). Blades 726a, 726d extend outwardly from arm 762 and extend radially away from rotor 760 in a first direction (i.e., Fig. 10AThe blade 726g extends outward from the rotor 760 and concentrically surrounds the inner surface 781 in the first direction. By having the blades 726a, 726d, 726g concentrically surround the inner surface 781, the cutting portion 720 of the device 700 is in a retracted state (or position) (FIGS. 10A-10B).

[0211] By rotating the rotor 760 in the first direction, the cutting portion 720 is moved from the closed position ( Figures 10A-10B ) into radially expanded position ( Figures 10C-10D ). The ends 726c, 726f, 726i of the blades 726a, 726d, 726g may move concentrically around the inner surface 781 in a first direction and advance through the knife groove 782. In certain embodiments, in order to provide a T-shaped cutting pattern, the blade 726 may include a wedge 729 coupled adjacent to the end 726f. As the blade 726d moves concentrically within the housing 780, the wedge 729 may contact the inner surface 781. When the rotor 760 rotates in the first direction, the wedge 729 may prevent the blade 726d from advancing through the knife groove 782a, but will not prevent the blade 726d from advancing through the knife groove 782d. Thereby, the blade 726a advances through the knife groove 782a, the blade 726d advances through the knife groove 782d, and the blade 726g advances through the knife groove 782g ( Fig. 10C To retract the blade 726 into the blade slot 782, in the second direction (ie, Fig. 10A The rotor 760 is rotated in a clockwise direction so that each blade 726 is concentrically disposed around the inner surface 781 ( Fig. 10A ).

[0212] In some embodiments, the device 700 and / or portions thereof comprise sterile or sterilizable materials. In some embodiments, the device 700 and / or portions thereof comprise one or more medical grade materials, including plastics, thermoplastics, stainless steel, metal alloys (e.g., nitinol or other types of nickel / titanium alloys), and titanium. Those skilled in the art will appreciate that other sterile or sterilizable materials known or commonly used in the field of cardiac surgery can be used to manufacture the device 700 and / or portions thereof.

[0213] Figures 11A-11G 12A-12J provide a method for replacing a mitral valve of a heart. The features of the illustrated heart are similar to those of the above-described heart 10, and thus the same reference numerals are used to represent similar features. Figures 12A-12J The method shown is implemented with the apparatus 100. The apparatuses 500, 600, 700 described above may also be used in the same manner.

[0214] To replace the mitral valve, the device 100, 500, 600, 700 is inserted into the subject through the first access site 106 and advanced into the subject using known transcatheter methods. The device 100, 500, 600, 700 may be inserted into the subject using a subaortic introducer. As previously described, the guide wire 130, 530, 630, 730 may have a hook 136 on its distal end 134. The distal end 134 may have a "J-shaped" shape to avoid damaging the heart while maintaining a sharp tip for piercing the heart valve leaflets. The subaortic introducer must be capable of maintaining the linear state of the guide wire 130, 530, 630, 730 as the device 100, 500, 600, 700 is advanced within the individual's circulatory system and allowing the distal end 134 of the guide wire 130, 530, 630, 730 to deform into a "J-shaped" hook 136 when the guide wire 130, 530, 630, 730 exits the subaortic introducer. To this end, the subaortic introducer must include a tip that is made of a stretchable material and / or can be broken by applying force to the distal end 134 of the guide wire 130, 530, 630, 730. In some embodiments, the tip is made of a rigid material that defines one or more weak points that allow the guide wire 130, 530, 630, 730 to be advanced from these locations. In some embodiments, a conventional subaortic introducer (e.g., Fig.11A and 12A The device 100, 500, 600, 700 is inserted into the body of the individual using a subaortic introducer 12) or other devices known to those skilled in the art.

[0215] In some embodiments, the device 100, 500, 600, 700 is advanced through the introducer 14 using an antegrade transcatheter approach. In certain other embodiments, the device 100, 500, 600, 700 is advanced through the introducer 12 using a retrograde transcatheter approach. When the device 100, 500, 600, 700 is introduced into the femoral artery of the individual, the guide wire 130, 530, 630, 730 is advanced intravascularly through the artery and through the aortic valve by the introducer 12 so as to be inverted toward the ventricular surface of the anterior leaflet 34 of the mitral valve 30 ( Fig. 11B and 12A ). Use conventional TEE and / or fluorescence techniques to determine where the guidewire 130, 530, 630, 730 can puncture and pass through the anterior lobe ( Fig. 11C and 12B). As mentioned above, the position where the guidewire punctures the anterior leaflet of the mitral valve can define the position where the cutting portion 120, 520, 620, 720 will advance, so the guidewire 130, 530, 630, 730 can be used to define the position where the transcatheter heart prosthesis will eventually be implanted. In some embodiments, the selected guidewire puncture position is a position that minimizes the risk of anterior leaflet displacement when the transcatheter heart prosthesis is finally implanted. Thereby, LVOT obstruction can be avoided or the probability of its occurrence can be minimized. In certain other embodiments, the guidewire puncture position is a position along the central axis of the anterior leaflet away from the anterior leaflet annulus, so that when the transcatheter heart prosthesis is implanted, a sufficient amount of anterior leaflet tissue is available at the anchoring device (not shown), while avoiding LVOT obstruction or minimizing its probability of occurrence.

[0216] In the left atrium, the lead 130, 530, 630, 730 is captured by a known clamp-type lead 300 and exits the subject's circulatory system through the subject's femoral vein at the second access site 108 ( Fig. 11C and 12B ). The clasp-type guidewire 300 is introduced into the femoral vein of the individual through the second access point 108 using the well-known antegrade catheterization method. For example, the clasp-type guidewire 300 can be inserted into the body of the individual using a well-known transseptal introducer (e.g., transseptal introducer 14) or other devices known to those skilled in the art. The clasp-type guidewire 300 enters from the femoral vein, passes through the atrial septum, and reaches the left atrium of the individual. The clasp-type guidewire 300 is placed to face the atrial surface of the anterior leaflet 34 of the mitral valve. The clasp-type guidewire 300 can clamp the distal end 134 of the guidewire 130, 530, 630, 730, so that the guidewire 130, 530, 630, 730 exits the atrial septum of the individual. The guidewire 130, 530, 630, 730 and the clasp-type guidewire 300 leave the individual's circulatory system through the femoral vein from the second access point 108. As the guide wire 130, 530, 630, 730 exits the second access site 108 via the femoral vein, the cutting portion 120, 520, 620, 720 is advanced through the individual femoral artery in a collapsed state and can be placed adjacent to the ventricular surface of the anterior mitral leaflet 34 ( Fig.11D and 12D For the device 100, 500, 600, 700, the guide wire 130, 530, 630, 730 is coupled to the corresponding cutting portion 120, 520, 620, 720, so that when the guide wire 130, 530, 630, 730 is withdrawn from the second access point 108, the corresponding cutting portion 120, 520, 620, 720 will be advanced through the individual femoral artery in a collapsed state and placed adjacent to the ventricular surface of the anterior leaflet 34 of the mitral valve.

[0217] Before cutting the anterior leaflet of the mitral valve, the folded transcatheter heart prosthesis 400 (known) and its delivery system 16 can be placed in the individual's heart via the guide wire 130, 530, 630, 730 from the second access point 108 into the femoral vein ( Fig. 12C and 12D ). Thus, the artificial valve 400 can be immediately placed in an accurate implantation position after the cutting portion 120, 520, 620, 720 cuts the anterior leaflet.

[0218] like Figures 12C-12D As shown, as the guide wire 130,530,630,730 extends through the anterior leaflet 34 of the mitral valve, the folded cutting portion 120,520,620,720 advances to the ventricular surface of the anterior leaflet of the mitral valve. The artificial valve 400 is delivered to the left atrium by the guide wire 130,530,630,730. After the incision, the artificial valve 400 is delivered to the incision position along the guide wire 130,530,630,730. To incise the anterior leaflet, the cutting portion 120,520,620,720 is expanded and advanced through the anterior leaflet to incise the leaflet ( Figures 11D-11E and 12E-12H).

[0219] Once the anterior mitral valve leaflet 34 is cut, the cutting portion 120, 520, 620, 720 returns to the folded state and withdraws from the cut portion to the left ventricle ( Fig.12I ). Afterwards, the artificial valve 400 is advanced by the guide wire 130, 530, 630, 730 and placed at the incision ( Fig.11F and 12J ).like Figures 11E-11F As shown in Figures 12I-12J, after the incision and after the cutting portion 120, 520, 620, 720 is withdrawn into the left ventricle, the artificial valve 400 can be delivered and implanted at the incision by the guide wire 130, 530, 630, 730. The implanted artificial valve is well known. With the artificial valve 400 implanted, the device 100, 500, 600, 700 (the cutting portion 120, 520, 620, 720 is in the folded state) can be withdrawn from the first access point via the femoral artery. The artificial valve 400 can replace the function of the original mitral valve.

[0220] The position where the guidewire pierces the anterior leaflet defines the incision position (i.e., the position where the cutting portion 120, 520, 620, 720 advances to the incision of the anterior leaflet) and the artificial valve implantation position (i.e., the position where the artificial valve is delivered and implanted). In this way, the risk of anterior leaflet displacement when the artificial valve is implanted can be minimized, while avoiding or minimizing the chance of LVOT obstruction.

[0221] Those skilled in the art will appreciate that the method of the present invention can be modified to utilize an antegrade transcatheter approach to insert the device 100, 500, 600, 700 through a first access site and advance it through the femoral vein of the individual. When the device 100, 500, 600, 700 is introduced into the femoral vein of the individual, the guide wire 130, 530, 630, 730 is advanced through the femoral vein into the left atrium of the heart of the individual. Thereafter, the guide wire 130, 530, 630, 730 is pierced at a precise location and advanced through the anterior leaflet. Within the left ventricle, the guide wire 130, 530, 630, 730 is captured by the clasp guide wire 300 and traverses the femoral artery to exit the circulatory system of the individual at a second location.

[0222] Using a retrograde transcatheter approach, the clamp-type guidewire 300 is introduced into the femoral artery from the second access point. The clamp-type guidewire 300 is advanced through the femoral artery, through the aortic valve, and faces the ventricular surface of the anterior leaflet of the mitral valve. The clamp-type guidewire 300 can clamp the distal end 134 of the guidewire 130, 530, 630, 730 and exit the guidewire 130, 530, 630, 730 through the aortic valve of the individual. The guidewire 130, 530, 630, 730 and the clamp-type guidewire 300 leave the individual's circulatory system through the second access point via the femoral artery.

[0223] Before the anterior leaflet of the mitral valve is cut, the artificial valve 400 and its delivery system can be introduced into the femoral artery through the guide wire 130, 530, 630, 730 from the second access point 108 and placed in the individual's heart. The cutting portion 120, 520, 620, 720 is advanced to the left atrial surface of the anterior leaflet of the mitral valve in a collapsed state. The artificial valve 400 is placed in the left ventricle by the guide wire 130, 530, 630, 730, and the artificial valve 400 is delivered to the incision along the guide wire 130, 530, 630, 730 immediately after the incision. To cut the anterior leaflet, the cutting portion 120, 520, 620, 720 in the expanded state is advanced through the anterior leaflet to cut the anterior leaflet. As the cutting portion 120, 520, 620, 720 is withdrawn, the artificial valve 400 is delivered and placed in the incision by the guide wire 130, 530, 630, 730. Afterwards, the device 100, 500, 600, 700 (with the cutting portion 120, 520, 620, 720 in a retracted state) can be withdrawn from the individual's body through the femoral vein from the first entry and exit point.

[0224] The length of each cutting portion 120, 520, 620, 720 and guide wire 130, 530, 630, 730 between its respective proximal and distal ends is not particularly limited. The length of the device 100, 500, 600, 700 is sufficient to enable it to traverse from the first access point through the individual's circulatory system to the second access point. In certain embodiments, the length of the device 100, 500, 600, 700 is sufficient to enable access from the first access point, through the femoral artery, through the aortic valve to the left ventricle, through the mitral valve to the left atrium, through the femoral vein to the second access point, so that the controller (e.g., controller 110) and the distal end 134 of the guide wire 130, 530, 630, 730 are located outside the individual's body. The relative lengths of the cutting portion 120, 520, 620, 720 and the guide wire 130, 530, 630, 730 can be selected depending on where the first and second locations are located. For example, when the device 100, 500, 600, 700 is introduced into the circulatory system of a subject via the femoral artery, the length of the guide wire 130, 530, 630, 730 is sufficient to enable it to cross the circulatory system of the subject from the anterior leaflet to the femoral vein puncture site (i.e., the second access site), and deliver a known transcatheter heart prosthesis through the guide wire distal end 134 outside the subject's body using a known transcatheter valve delivery system. The length of the cutting portion 120, 520, 620, 720 is sufficient to enable it to cross the circulatory system of the subject from the femoral artery puncture site (i.e., the first access site) to the anterior leaflet. When the device 100, 500, 600, 700 is introduced into the circulatory system of a subject via the femoral artery, the length of the guide wire 130, 530, 630, 730 is sufficient to enable it to traverse the circulatory system of the subject from the femoral artery puncture site (i.e., the second access site) to the anterior leaflet, and deliver a known transcatheter heart prosthesis through the distal end of the guide wire 134 outside the subject's body using a known transcatheter valve delivery system. The length of the cutting portion 120, 520, 620, 720 is sufficient to enable it to traverse the circulatory system of the subject from the anterior leaflet to the femoral vein puncture site (i.e., the second access site). In some embodiments, the length of the guide wire 130, 530, 630, 730 is at least twice the length of a known transcatheter valve delivery system. In some embodiments, the femoral artery is preferred as the first access site due to one or more factors such as size, ease of insertion, and minimal trauma to the heart.

[0225] In certain embodiments, the methods and devices of the present invention may include one or more catheters (e.g., catheters 12 and / or 14, Figures 11A-12J) is used to advance the device 100, 500, 600, 700 through the individual's circulatory system. The size of the catheter is to accommodate the device 100, 500, 600, 700 and / or its portion, and / or the clasp-type guide wire 300, and / or the transcatheter heart valve prosthesis 400 in a collapsed state and / or its intravascular delivery system. In certain embodiments, the methods and devices of the present invention may include one or more transcatheter heart valve delivery systems (e.g., transcatheter heart valve delivery system 16, Figures 12C-12D , 12E and 12G-12J), to deliver the transcatheter heart valve prosthesis 400 through the individual's circulatory system. The transcatheter heart valve delivery system is sized to accommodate the prosthesis 400 and / or portions thereof within a blood vessel.

[0226] Transcatheter mitral valve prostheses and aortic valve prostheses that can be used with the methods or devices of the present invention are well known, including, but not limited to, apical tethers, annular winglets, native leaflet engagement devices, radial force devices, mitral annulus fixation devices, external anchoring devices, and annular anchoring devices. Other transcatheter mitral valve prostheses and aortic valve prostheses that can be used with the methods or devices of the present invention are within the common knowledge of those skilled in the art.

[0227] Glossary

[0228] Unless otherwise indicated, in this specification and claims:

[0229] ˙“comprises, comprising” and similar terms should be interpreted as including the stated (as opposed to excluding the stated), in other words, should be interpreted as including but not limited to the stated;

[0230] ˙“connected” or “coupled” and similar terms herein shall mean any direct or indirect connection or coupling between two or more components. The connection or coupling between components may be physical connection, logical connection, or a combination thereof; components formed in one piece may be considered to be directly connected or coupled;

[0231] ˙When using nouns such as "herein", "above", and "below" in this article, they should be considered as a description of the article as a whole, rather than a description of part of the content;

[0232] ˙When the word "or" is used in a list containing two or more options, it means all of the following interpretations: any one of the options in the list, all of the options in the list, and any combination of the options in the list;

[0233] ˙The singular form (a, an, the) in this article also includes the plural form.

[0234] Nouns used to indicate orientation, such as "vertical," "transverse," "horizontal," "upward," "downward," "forward," "backward," "inward," "outward," "left," "right," "front," "back," "bottom," "above," "under," and the like, when used to describe any of the accompanying claims, will be determined by the specific orientation of the device. It should be assumed that the orientation of the objects described herein is not limited to a specific orientation. Therefore, the interpretation of the orientation should not be limited to a specific range.

[0235] The specific embodiments of the systems, methods and devices disclosed in the above embodiments are all for the purpose of illustrating the present invention, and therefore are only illustrative and not exhaustive. The disclosed technology can be applied to systems other than the exemplified embodiments. When implementing the present invention, various changes, modifications, additions, or omissions may be made to the content of the present invention. The scope of the present invention also covers changes that are obvious to those with ordinary knowledge in the technical field to which the present invention belongs, including replacing the features, components, and / or actions by equivalent features, components, and / or actions; mixing and matching the features, components, and / or actions by different embodiments; combining the features, components, and / or actions of the embodiments with other technologies; and / or omitting the features, components, and / or actions of the embodiments.

[0236] The following appended claims should be interpreted to cover all obvious changes, modifications, additions, omissions, and sub-groups that can be easily derived. The scope of the claims should not be limited to the exemplary embodiments, but should be interpreted in the broadest sense consistent with the entire specification.

[0237] Various exemplary features and implementations are discussed herein, and those skilled in the art will readily appreciate various possible changes, modifications, additions, omissions, and readily induced sub-combinations of these implementations.

[0238] Various exemplary features and embodiments are discussed herein, and those skilled in the art will readily recognize various possible changes, modifications, additions, omissions, and sub-combinations of these embodiments. The following claims should be interpreted as covering all obvious changes, modifications, additions, omissions, and sub-combinations of the above, which fall within the spirit and scope of the present invention.

Claims

1. A device for replacing a mitral valve, comprising: a controller including a handle and a knob; A cutting portion, comprising: a sleeve coupled to the handle of the controller, the sleeve defining a chamber extending in a length direction; a rod extending from a distal end of the controller and passing through the chamber of the sleeve; a slider fixedly connected to a distal end of the sleeve and mounted on the rod in a rotatable and slidable manner, wherein the slider defines a chamber extending along the length direction and the rod extends through the chamber; at least one blade radially deployable about a long axis of the device between a folded position for delivering the device to the mitral valve and an expanded position for cutting the mitral valve leaflets, wherein a proximal end of each blade is coupled to the slider and a distal end of each blade is coupled to a guide wire; a joint fixedly connected to the proximal end of the guide wire and the distal end of each blade; wherein the sleeve and / or slide are rotatable about a longitudinal axis defined by the device, wherein rotation of the sleeve and / or rotation of the slide about a longitudinal axis of the device can move the at least one blade between a retracted position and an extended position; and The distance between the proximal end and the distal end of the at least one blade when in the folded position is greater than the distance between the proximal end and the distal end when in the extended position.

2. The device of claim 1, wherein each blade is made of a memory material.

3. The device of claim 2, wherein the memory material comprises a memory metal alloy, which is composed of one or more substances selected from the following group: stainless steel, nickel, titanium and nickel-titanium alloy (nitinol).

4. The device of any one of claims 1 to 3, wherein the blade maintains a pre-deformed shape in the extended position and deforms into a deformed shape in the retracted position.

5. The device according to any one of claims 1 to 3, wherein each blade is pivotally connected to a distal end of a lever arm via a hinge, and the lever arm and the blade are foldable together with the hinge.

6. The device according to any one of claims 1 to 3, wherein the radial cross-sectional area of ​​the cutting portion can be reduced by rotating the at least one blade about the long axis in a first direction.

7. The device of claim 6, wherein the radial cross-sectional area of ​​the cutting portion can be enlarged by rotating the at least one blade about the long axis in a second direction opposite to the first direction.

8. A device as claimed in any one of claims 1 to 3, wherein each of said at least one blades is positioned radially away from a major axis of said device in a manner corresponding to a predetermined pattern.

9. The device of any one of claims 1 to 3, wherein the cutting portion comprises three blades, and the three blades are configured to cut the mitral valve leaflet in a predetermined pattern.

10. The device of claim 8, wherein the predetermined pattern is a T-shaped cut, a linear cut, or an X-shaped cut.

11. The device of claim 9, wherein the predetermined pattern is a T-shaped cut, a linear cut, or an X-shaped cut.

12. The device of any one of claims 1 to 3, wherein the at least one blade is constructed in an integrally formed single piece form.

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