Deployment tools and methods for delivering a device to a native heart valve

Abstract

The present application relates to deployment tools and methods for delivering devices to native heart valves. A flexible delivery catheter can be used to deploy valve repair and replacement devices at implantation sites for repairing or replacing malfunctioning native heart valves. Such a catheter can include a flexible tube having a plurality of links. A control wire can be connected to the plurality of links such that applying tension to the control wire causes the flexible tube to bend.

Description

[0001] This application is a divisional application. The original application, with application number 201980086719.2 and filing date of November 19, 2019, is entitled "Deployment tool and method for delivering a device to a natural heart valve," the entire contents of which are incorporated herein by reference.

[0002] Related applications This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 770,071, filed November 20, 2018, entitled "Deployment Tool and Method for Delivering a Device to a Natural Heart Valve". The foregoing application is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This application relates to deployment tools and methods for delivering a device to a natural heart valve. Background Technology

[0004] Natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a crucial role in ensuring a proper flow of blood through the cardiovascular system. These valves can be damaged due to congenital malformations, inflammatory processes, infections, diseases, etc., thus reducing their effectiveness. Such damage to the valves can lead to serious cardiovascular injury or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can lead to complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner far less invasive than open-heart surgery. As an example, one transvascular technique that can be used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, ascending through the inferior vena cava, and into the right atrium). The septum is then punctured, and the catheter is advanced into the left atrium. A similar transvascular technique can be used to implant a prosthetic device into the tricuspid valve. It begins similarly to the transseptal technique, but stops without puncturing the septum and instead redirects the delivery catheter into the right atrium towards the tricuspid valve.

[0005] A healthy heart is generally conical in shape, tapering towards the lower apex. The heart is four-chambered, comprising the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally called the septum. The human heart's natural mitral valve connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other natural heart valves. It consists of an annular portion (the ring-shaped portion of natural valve tissue surrounding the mitral orifice) and a pair of leaflets or cusps extending downwards from the annulus into the left ventricle. The mitral annulus can form a "D," oval, or other out-of-round cross-sectional shape with long and short axes. The anterior leaflet can be larger than the posterior leaflet, forming an overall "C"-shaped boundary between the adjacent sides of the leaflets when they are closed.

[0006] When functioning properly, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also known as "ventricular diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular systole"), the increased blood pressure in the left ventricle forces the sides of the two leaflets together, thus closing the one-way mitral valve. This prevents blood from flowing back into the left atrium and instead drains it from the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding back into the left atrium through the mitral annulus, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0007] Valvular regurgitation involves a valve improperly allowing some blood to flow through it in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to close properly during the systolic phase of heart contraction, and blood flows from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have a variety of causes, such as leaflet prolapse, papillary muscle dysfunction, mitral annular stretching due to left ventricular dilation, or more than one of these. Mitral regurgitation located in the central portion of the leaflet is called central jet mitral regurgitation, while regurgitation closer to a commissure (i.e., the point where the leaflets meet) is called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, thus preventing valve closure and resulting in regurgitation. Summary of the Invention

[0008] The summary portion of this invention is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any feature included in the examples in the summary portion unless the claims expressly define that feature. Moreover, the features, components, steps, concepts, etc., described in the summary portion and in other locations of this disclosure can be combined in various ways. Various features and steps described in other locations of this disclosure may be included in the examples summarized herein.

[0009] Flexible delivery catheters can be used to deploy valve repair and replacement devices at the implantation site to repair or replace poorly functioning natural heart valves. Such catheters may include a flexible tube having multiple links. A control wire (e.g., a drawn wire) may be connected to the multiple links, such that applying tension to the control wire causes the flexible tube to bend.

[0010] In one embodiment, the delivery catheter includes a main lumen, a control wire lumen, a plurality of connectors, and a control wire. Each connector is aligned with or connected to at least one adjacent connector, and a groove is formed between each pair of adjacent connectors. When viewed from the side, the top portion of each connector is narrower than the bottom portion of each connector. Each connector includes an orifice at its bottom. Each connector includes at least one slit. Each slit originates and extends upward along at least a portion of the connector. The control wire is connected to the plurality of connectors. Applying tension to the control wire causes the distal region of the catheter to bend.

[0011] In one embodiment, the delivery catheter includes a flexible tube, a first ring, a second ring, a single control wire, a coil sleeve, and multiple connectors. The flexible tube includes a main lumen and a control wire lumen. The first ring is located in the distal region of the flexible tube. The second ring is located in the distal region of the flexible tube and spaced apart from the first ring. The single control wire is located in the control wire lumen and connected to the first ring. The multiple connectors are located between the first and second rings. The coil sleeve is located around the control wire in the control wire lumen. The portion of the single control wire extending from the second ring to the first ring is not covered by the coil sleeve. Applying tension to the single control wire causes bending in the distal region of the flexible tube.

[0012] The delivery catheter includes a flexible tube, a first ring, a second ring, a single control wire, multiple connectors, and a coil sleeve. The flexible tube has a main lumen and a control wire lumen. The first and second rings are spaced apart in the distal region of the flexible tube. The single control wire is located in the control wire lumen and connected to the first ring. The multiple connectors are arranged in the distal region of the flexible tube between the first and second rings. The connectors are cut from a single piece of material such that each connector is aligned and connected to at least one adjacent connector, having a groove formed between each pair of adjacent connectors, an orifice at the bottom of each connector, and at least one slit in each connector. The slit begins at the orifice and extends upward along at least a portion of the connector. The coil sleeve is arranged in the proximal region of the flexible tube around the control wire in the control wire lumen. The portion of the control wire extending from the second ring to the first ring is not covered by the coil sleeve. Applying tension to the control wire causes bending in the distal region of the flexible tube.

[0013] In one embodiment, a sheet is used to form a tube of a flexible conduit. The sheet has a plurality of spaced-aligned slits, each slit having a central portion between two end portions. The width of the central portion of each slit is wider than the width of the two end portions of the slit. The slits form a plurality of spaced-aligned strips, each strip having a central portion and two end portions. The width of the central portion of each strip is narrower than the width of the two end portions of the strip. Each spaced-aligned strip has a second slit along a first edge of the flat sheet. Each spaced-aligned strip has at least one slit that originates from the second slit and extends toward the center of the aligned strip. The sheet is configured to be rolled into a cylindrical shape (e.g., a substantially cylindrical shape) having a plurality of connectors, having a groove formed between each pair of adjacent connectors, a bottom orifice of each connector, and at least one slit extending upward from the bottom orifice. The top portion of the connector corresponds to the central portion of the strip. The bottom portion of the connector corresponds to the end portion of the strip. The bottom orifice corresponds to the second slit. The sides of the cylindrical shape (e.g., a substantially cylindrical shape) correspond to the ends of the slit.

[0014] In one embodiment, the delivery catheter includes a flexible tube, multiple connectors, a coiled tube, and a control wire. The flexible tube has a main lumen and a control wire lumen. Each connector has a slit along the bottom region of the flexible tube. In a first configuration, the distal region of the flexible tube is straight, and the top of each connector is spaced apart from adjacent connectors. In a second configuration, the distal region of the flexible tube is curved, the slits of the connectors are open, and the distance between the tops of the connectors is reduced, such that the top of the distal region of the flexible tube defines the curve.

[0015] In one embodiment, the delivery catheter has a first flexible portion, a second flexible portion, and a control wire. The first flexible portion has a first stiffness. The second flexible portion has a second stiffness, which is different from the first stiffness. The control wire extends along the first and second flexible portions to the distal end of the second flexible portion. Applying tension to the control wire causes the first and second flexible portions of the flexible tube to bend to different radii.

[0016] In one embodiment, the delivery catheter includes a first flexible portion, a second flexible portion, and a control wire. The first flexible portion has a first flexible frame having a first stiffness. The second flexible portion has a second flexible frame having a second stiffness different from the first stiffness. Applying tension to the control wire causes the first and second flexible portions of the flexible tube to bend to different radii.

[0017] In one embodiment, a delivery catheter for delivering a device to a natural valve of a patient's heart includes a flexible tube having a main lumen and a control wire lumen, and a plurality of connectors disposed in a distal region of the flexible tube. In some embodiments, each connector is aligned and connected to at least one adjacent connector, a groove being formed between each pair of adjacent connectors, wherein, when viewed from the side, the top portion of each connector is narrower than the bottom portion of each connector, and wherein each connector includes an orifice at the bottom of the connector. In some embodiments, each connector includes at least one slit, wherein the slit originates from the orifice and extends upward along at least a portion of the connector. The delivery catheter includes a control wire in the control wire lumen, which is connected to the plurality of connectors such that applying tension to the control wire causes the distal region of the flexible tube to bend.

[0018] In one embodiment, a delivery catheter for delivering a device to a natural valve of a patient's heart includes a flexible tube having a main lumen and a control wire lumen. The delivery catheter may also include a first ring in a distal region of the flexible tube and a second ring spaced apart from the first ring in the distal region of the flexible tube. In one embodiment, the delivery catheter includes a single control wire connected to the first ring in the control wire lumen. Multiple connectors may be arranged between the first and second rings in the distal region of the flexible tube. In some embodiments, a coil sleeve is at least partially arranged around the control wire in the control wire lumen. The coil sleeve may be configured to extend proximally from the distal region of the flexible tube such that a portion of the single control wire extending from the second ring to the first ring is not covered by the coil sleeve. The delivery catheter may be configured such that applying tension to the single control wire causes bending in the distal region of the flexible tube.

[0019] In one embodiment, a delivery catheter for delivering a device to a natural valve of a patient's heart includes a flexible tube having a central main lumen and a control wire lumen, and a first ring in a distal region of the flexible tube. In some embodiments, a second ring is located in the distal region of the flexible tube, spaced apart from the first ring. The delivery catheter includes a single control wire connected to the first ring in the control wire lumen. In some embodiments, the delivery catheter further includes a plurality of cylindrical connectors disposed between the first and second rings in the distal region of the flexible tube. The plurality of cylindrical connectors may be cut from a single piece of material such that each connector is aligned and connected to at least one adjacent connector, with a groove formed between each pair of adjacent connectors. An orifice may be located at the bottom of each connector, and at least one slit may be located in each connector. The slit may be configured to originate from the orifice and extend upward along at least a portion of the connector. The delivery catheter is configured such that applying tension to the control wire causes the distal region of the flexible tube to bend.

[0020] In some embodiments, the delivery catheter further includes a coil sleeve disposed in the proximal region of the flexible tube around the control wire within the control wire lumen. The coil sleeve may be configured to extend proximally from the distal region of the flexible tube such that the portion of the control wire extending from the second loop to the first loop is not covered by the coil sleeve.

[0021] In one embodiment, a sheet (e.g., a flat sheet) capable of forming a tube into a flexible conduit includes a plurality of spaced-aligned slits, each slit having a central portion between two end portions, wherein the width of the central portion of each slit is wider than the width of the two end portions of each slit. The slits may be configured to form corresponding plurality of spaced-aligned strips, each strip having a central portion and two end portions. The width of the central portion of each strip may be narrower than the width of the two end portions of each strip. In some embodiments, each spaced-aligned strip has a second slit along a first edge of the flat sheet. Each spaced-aligned strip may include at least one slit originating from the second slit and extending toward the center of the aligned strip. The sheet is configured to be rolled into a cylindrical shape (e.g., a substantially cylindrical shape) having a plurality of connectors, with a groove formed between each pair of adjacent connectors. The cylindrical shape (e.g., a substantially cylindrical shape) may also include a bottom opening of each connector and at least one slit extending upward from the bottom opening, wherein the top portion of the connector corresponds to the central portion of the strip, the bottom portion of the connector corresponds to the end portion of the strip, the bottom opening corresponds to the second cut, and the side of the cylindrical shape corresponds to the end of the slit.

[0022] In some embodiments, each spaced-aligned strip includes a third slit along a second edge of the flat sheet, and each spaced-apart flat strip includes another slit originating from the third slit. A bottom aperture may further correspond to the third slit aligned with the second slit.

[0023] In one embodiment, a method of fabricating the tube of a flexible catheter includes providing a flat sheet and / or a hypotube, and cutting a plurality of spaced-aligned slits in the sheet and / or hypotube. In some embodiments, each slit has a central portion between two end portions, wherein the width of the central portion of each slit is wider than the width of the two end portions of each slit, and wherein the slits form corresponding plurality of spaced-aligned strips, each strip having a central portion and two end portions. The width of the central portion of each strip may be configured to be narrower than the width of the two end portions of each strip. With respect to the flat sheet, the method may further include cutting a plurality of slits along a first edge of the flat sheet such that each edge of the aligned strips has a corresponding slit along the first edge of the sheet. The method may further include cutting a plurality of slits, wherein each slit originates from one of the slits along the first edge and extends toward the center of the aligned strips. The method may further include rolling the sheet into a cylindrical shape (e.g., a substantially cylindrical shape) having (and / or configuring the tube such that it includes) a plurality of connectors, having a groove formed between each pair of adjacent connectors, a bottom orifice of each connector, and at least one slit extending upward from the bottom orifice, wherein the top portion of the connector corresponds to the central portion of the strip, the bottom portion of the connector corresponds to the end portion of the strip, and the bottom orifice corresponds to a second cut. The sides of the cylindrical shape (e.g., a substantially cylindrical shape) may correspond to the ends of the slit.

[0024] In some embodiments, each spaced-aligned strip includes a third cut along a second edge of the flat sheet, and each spaced-apart flat strip includes another slit beginning at the third cut, and a bottom opening further corresponds to the third cut aligned with the second cut.

[0025] In one embodiment, a delivery catheter for delivering a device to a natural valve of a patient's heart includes a flexible tube having a main lumen and a control wire lumen, and a plurality of connectors disposed in a distal region of the flexible tube, each connector having a slit along a bottom region of the flexible tube. The delivery catheter may also include a coil having a coiled lumen. A control wire may be positioned / arranged in the control wire lumen, fixedly connected to the distal ends of the plurality of connectors, and extends through the coiled lumen.

[0026] In some embodiments, in the first configuration: the distal region of the flexible tube is straight, a control wire of one length extends distally to the coil, a control wire of another length extends proximally to the coil, and the top of each connector is spaced apart from the adjacent connector by a distance.

[0027] In some embodiments, in the second configuration: the distal region of the flexible tube is curved, the slits of each connector are open, a shorter control wire extends distally to the coil compared to the first configuration, a longer control wire extends proximally to the coil compared to the first configuration, and the distance between the tops of each connector is reduced, such that the top of the distal region of the flexible tube defines the curve.

[0028] In some embodiments, the delivery catheter is configured such that applying tension to the control wire causes the distal region of the flexible tube to bend from a first configuration to a second configuration. In some embodiments, the delivery catheter is configured such that releasing tension from the control wire causes the distal region of the flexible tube to return to the first configuration.

[0029] In some embodiments, the delivery catheter for delivering a device to a natural valve of a patient's heart includes a flexible tube having a main lumen and a control wire lumen, and a first flexible portion in a distal region of the flexible tube including a first flexible frame, wherein the first flexible portion has a first stiffness. In some embodiments, the delivery catheter includes a second flexible portion in a distal region of the flexible tube including a second flexible frame, wherein the second flexible portion has a second stiffness different from the first stiffness. In some embodiments, the delivery catheter includes a control wire extending through the control wire lumen of the first and second flexible portions to a distal end of the second flexible portion, such that applying tension to the control wire causes the first and second flexible portions of the flexible tube to bend.

[0030] In some embodiments, the first and second flexible frames include a plurality of connectors, and each of the plurality of connectors is aligned and connected to at least one adjacent connector to form a slot between each pair of adjacent connectors.

[0031] In some embodiments, each of the plurality of connectors includes a top portion and a bottom portion, wherein the top portion is narrower than the bottom portion. In some embodiments, each of the plurality of connectors includes an opening at the bottom of the connector. In some embodiments, each of the plurality of connectors includes at least one slit, wherein the slit originates from the opening and extends upward along at least a portion of the connector.

[0032] In some embodiments, the second stiffness is less than the first stiffness, and the groove between the connectors of the first flexible portion is narrower than the groove between the connectors of the second flexible portion. In some embodiments, the second stiffness is less than the first stiffness, and the connector of the first flexible portion is wider than the connector of the second flexible portion. In some embodiments, the second stiffness is less than the first stiffness, and the connector of the first flexible portion is wider than the connector of the second flexible portion. In some embodiments, the first and second flexible portions can form a bend of approximately 90 degrees in a bent state.

[0033] In some embodiments, the first flexible portion has a first length that is approximately equal to the second length of the second flexible portion. In some embodiments, the first length of the first flexible portion is approximately half the length of the second flexible portion. In some embodiments, the first length of the first flexible portion is approximately one-third the length of the second flexible portion. In some embodiments, the first length of the first flexible portion is approximately twice the length of the second flexible portion. In some embodiments, the first length of the first flexible portion is approximately three times the length of the second flexible portion.

[0034] In some embodiments, the first flexible portion is formed of a first polymer material, and the second flexible portion is formed of a second polymer material. In some embodiments, the second polymer material has a second hardness (durometer), which is less than the first hardness of the first polymer material.

[0035] In one embodiment, the delivery catheter includes a flexible tube having a main lumen and a control wire lumen. A first flexible portion in the distal region of the flexible tube includes a first flexible frame, wherein the first flexible portion has a first stiffness. In some embodiments, a second flexible portion in the distal region of the flexible tube includes a second flexible frame, wherein the second flexible portion has a second stiffness, which is different from the first stiffness. In some embodiments, a third flexible portion in the distal region of the flexible tube includes a third flexible frame, wherein the third flexible portion has a third stiffness, which is different from the second stiffness. In some embodiments, the control wire extends through the control wire lumen of the first, second, and third flexible portions to the distal end of the third flexible portion, such that applying tension to the control wire causes the first, second, and third flexible portions of the flexible tube to bend.

[0036] In some implementations, the first, second, and third flexible frames include a plurality of connectors, and each of the plurality of connectors is aligned and connected to at least one adjacent connector to form a slot between each pair of adjacent connectors.

[0037] In some embodiments, each of the plurality of connectors includes a top portion and a bottom portion, wherein the top portion is narrower than the bottom portion. In some embodiments, each of the plurality of connectors includes an opening at the bottom of the connector. In some embodiments, each of the plurality of connectors includes at least one slit, wherein the slit originates from the opening and extends upward along at least a portion of the connector.

[0038] In some embodiments, the first stiffness and the third stiffness are less than the second stiffness, and the groove between the connectors of the second flexible portion is narrower than the groove between the connectors of the first and third flexible portions. In some embodiments, the first stiffness and the third stiffness are less than the second stiffness, and the connectors of the second flexible portion are wider than the connectors of the first and third flexible portions. In some embodiments, the first stiffness and the third stiffness are less than the second stiffness, the connectors of the second flexible portion are wider than the connectors of the first and third flexible portions, and the groove between the connectors of the second flexible portion is narrower than the groove between the connectors of the first and third flexible portions. In some embodiments, the first flexible portion, the second flexible portion, and the third flexible portion can form a bend of approximately 90 degrees in a bent state.

[0039] In some embodiments, the first flexible portion has a first length that is approximately equal to the second length of the second flexible portion and the third length of the third flexible portion. In some embodiments, the first flexible portion has a first length and the third flexible portion has a third length, and the first and third lengths are approximately half the second length of the second flexible portion. In some embodiments, the first flexible portion has a first length and the third flexible portion has a third length, and the first and third lengths are approximately one-third the second length of the second flexible portion. In some embodiments, the first flexible portion has a first length and the third flexible portion has a third length, and the first and third lengths are approximately twice the second length of the second flexible portion.

[0040] In some embodiments, the first flexible portion is formed of a first polymer material, the second flexible portion is formed of a second polymer material, and the third flexible portion is formed of a third polymer material.

[0041] A further understanding of the nature and advantages of the invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts have like reference numerals. Attached Figure Description

[0042] To further clarify various aspects of embodiments of this disclosure, certain embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only general embodiments of this disclosure and should not be considered as limiting the scope of this disclosure. Furthermore, while the drawings may be drawn to scale for some embodiments, they are not necessarily drawn to scale for all embodiments. Embodiments of this disclosure, along with other features and advantages, will be described and illustrated in more specific and detailed manner with reference to the accompanying drawings, in which: Figure 1 An example of a cross-sectional view of the human heart in diastole; Figure 2An example is a cross-sectional view of the human heart during systole; Figure 3 An example is a cross-sectional view of the human heart in diastole, showing the chordae tendineae attaching the leaflets of the mitral and tricuspid valves to the ventricular wall; Figure 4 An example of a healthy mitral valve with leaflet closure viewed from the atrial side; Figure 5 An example of a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side; Figure 6 An example of a mitral valve with a wide gap between the posterior and anterior leaflets; Figure 7 An example is shown of the tricuspid valve viewed from the atrial side; Figure 8A A perspective view of the distal segment of an example delivery catheter (or a delivery catheter that can be used as part of a delivery device or system for implanting valve repair or replacement devices) is shown. Figure 8B yes Figure 8A Cross-sectional views of several connecting bodies in the distal section; Figure 9 It is a perspective view of the distal segment of an instance of a delivery catheter (or a catheter that can be used for delivery), which is in a curved configuration; Figure 10 It can be used to prepare Figures 8A-8B A plan view of an example of laser-cut sheet material in the distal segment; Figure 11 It can be used to prepare Figure 9 A plan view of an example of laser-cut sheet material in the distal segment; Figure 12 This is a plan view of an example laser-cut sheet that can be used to prepare the distal segment of a delivery catheter; Figure 13 A perspective view shows a curved configuration of the distal segment of a delivery catheter (or a delivery catheter that can be used to implant a valve repair or replacement device at a natural valve) for use in transseptal techniques. Figure 14 A schematic side view of an example distal segment of a delivery catheter (or one that can be used with such a delivery catheter) with a dual control wire system is shown, which can be used for Figure 13 Delivery catheter; Figure 15 It shows Figure 13 and 14 A cross-sectional view of the multi-lumen extruded portion of the delivery catheter, the cross-section being cut in a plane perpendicular to the longitudinal axis of the delivery catheter; Figure 16It shows the partially actuated state. Figure 13-15 A schematic perspective view of the delivery catheter; Figure 17 The fully actuated state is shown. Figure 13-15 A schematic perspective view of the delivery catheter; Figure 18A A top view of a distal segment of an example of a delivery catheter (or a delivery device that can be used with the delivery catheter) as part of a delivery device or system for implanting valve repair or replacement devices; Figure 18B It shows Figure 18A The example in the middle is a side view of the far segment of the instance; Figure 18C It shows Figure 18A The bottom view of the far segment of the example in the middle; Figure 18D It shows Figure 18A The example in the middle is the end view of the far segment of the instance; Figure 19A It shows that it can be used to prepare Figure 18A A plan view of the laser-cut sheet in the distal segment of -D; Figure 19B It shows Figure 19A A close-up view of a portion of a laser-cut sheet; Figure 20A A top view of an example of a distal segment of a delivery catheter (or a delivery catheter that can be used with a control wire passing through it) is shown; Figure 20B It shows Figure 20A The example shown is a side view of the distal segment of a delivery catheter through which a control wire passes (or which can be used with the delivery catheter); Figure 20C It shows Figure 20B A side view of the distal segment of an example of a delivery catheter (or one that can be used with the delivery catheter) and how it moves when the control wire is pulled; Figure 21A A top view of an example distal pull ring attached to a control wire is shown; Figure 21B It shows Figure 21A A side view of the distal pull ring of an example attached to the control wire; Figure 21C It shows Figure 21A Bottom view of the distal pull ring of an example attached to the control wire; Figure 22A A side view of an example axis of a maneuverable catheter is shown; Figure 22B It shows Figure 22A An end view of the axis of an instance of a manipulable conduit; Figure 23A It shows along Figure 22B A cross-sectional view of the axis of an instance of a maneuverable conduit, taken by line AA. Figure 23B It shows Figure 23A A close-up view of a portion of the cross-sectional view of an instance of a maneuverable conduit; Figure 24 It shows along Figure 23A The line BB cut Figure 22A A cross-sectional view of an instance of a maneuverable conduit along its axis; Figure 25A It shows along Figure 23A The line CC cut Figure 22A A cross-sectional view of the axis of a maneuverable conduit instance; Figure 25B A control wire is shown. Figure 25A A close-up of a portion of a cross-sectional view; Figure 26 It shows along Figure 23A The line DD cut Figure 22A A cross-sectional view of an instance of a maneuverable conduit along its axis; Figure 27 It shows along Figure 22A The line EE cut Figure 22A A cross-sectional view of an instance of a maneuverable conduit along its axis; Figure 28A A plan view of an example anchoring ring for delivering the distal portion of a catheter is shown; Figure 28B It shows a hole with weld. Figure 28A A close-up view of a portion of the anchoring ring; Figure 29A An example embodiment of a device with a sodium hypochlorite tube is shown. Figure 28A A top view of an example anchoring ring; Figure 29B It shows Figure 29A A side view of an example anchoring ring; Figure 29C It shows Figure 29A An end view of an instance anchoring ring; Figure 30A A plan view of an example coil stopper is shown; Figure 30B It shows Figure 30A A close-up of the weld hole in an example coil stopper; Figure 31A A top view of an example coil stopper with a partial coil is shown; Figure 31B The example implementation shows the path along... Figure 31A The example of a coil stopper and a cross-sectional view of the coil cut off by line XX; Figure 31C It shows Figure 31A Example coil stopper and near-end view of the coil; Figure 32 This is a schematic side view of the distal end of an example of a delivery conduit in a curved configuration according to one embodiment. Figure 33 This is a schematic side view of the distal end of an example of a delivery conduit in a curved configuration according to one embodiment. Figure 34 –36 shows a schematic side view of the distal end of an example of a delivery catheter in a curved configuration for comparison of the three illustrated embodiments; Figure 37 A top view of an example distal segment of a delivery catheter (or a delivery catheter that can be used in the delivery catheter) as part of a delivery device or system for implanting a valve repair or replacement device, according to an exemplary embodiment; Figure 38 It shows Figure 37 Side view of the distal segment; Figure 39 It shows Figure 37 The bottom view of the distal section; Figure 40 It shows Figure 37 End view of the distal section; Figure 41 It shows that it can be used to form Figure 37 A plan view of the laser-cut sheet in the distal section of an example; Figure 42 It shows that a control wire passes through it. Figure 37 A top view of the distal segment of the example; Figure 43 It shows Figure 42 A side view of the distal segment of an instance with control wires; Figure 44 A top view of an example distal segment of a delivery catheter (or a delivery catheter that can be used in the delivery catheter) as part of a delivery device or system for implanting a valve repair or replacement device, according to an exemplary embodiment; Figure 45 It shows Figure 44 A side view of the distal segment of the instance; Figure 46 It shows Figure 44 The bottom view of the far side section of the instance; Figure 47 It shows Figure 44 The end view of the far segment of the instance; Figure 48 It shows that it can be used to prepare Figure 44 A plan view of the laser-cut sheet in the distal section; Figure 49 It shows that a control wire passes through it. Figure 44 A top view of the distal segment; and Figure 50 It shows Figure 49 The side view of the distal section with control wire shown. Detailed Implementation

[0043] The following description refers to the accompanying drawings illustrating specific embodiments of this disclosure. Other embodiments with different configurations, structures, and operations do not depart from the scope of this disclosure.

[0044] The exemplary embodiments of this disclosure relate to apparatuses and methods for repairing defective heart valves. It should be noted that various embodiments of the natural valve repair apparatus and systems for delivery are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed apparatus and systems may be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the treatment methods and procedures shown, discussed, and / or proposed herein can be performed on live animals or on simulants such as cadavers, cadaver hearts, simulators (e.g., in which body parts, hearts, tissues, etc., are simulated) etc.

[0045] As described herein, when describing one or more components being connected, joined, fixed, linked, attached, or otherwise interconnected, such interconnection may be direct between the components or indirect, such as through the use of one or more intermediate components. Also as described herein, references to “component,” “part,” or “section” should not be limited to individual structural components, parts, or elements, but may include assemblies of components, parts, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0046] This disclosure generally relates to deployment tools for delivering valve repair and replacement devices and methods of using them. More specifically, this disclosure relates to a flexible delivery catheter for deploying valve repair and replacement devices at an implantation site to repair or replace heart valves with malformations and / or dysfunctions, and a method of implanting such repair or replacement devices using the delivery catheter.

[0047] This document describes implementations of deployment tools and methods of use designed to facilitate implantation of prosthetic devices in one of the natural mitral, aortic, tricuspid, or pulmonary valve regions of the human heart. For example, the deployment tool can be used to deploy a valve repair or replacement device that acts as a docking site to position and secure a prosthetic heart valve in the natural valve region. Details of exemplary implementations of the deployment tool described herein can be used to deploy a wide variety of valve repair and / or replacement devices.

[0048] The valve repair and / or replacement devices and methods involved may take a wide variety of forms, including, but not limited to, those disclosed in U.S. Patent Application Serial No. 15 / 912,971 (published as US 2018 / 0193139), filed March 6, 2018; those disclosed in U.S. Patent Application Serial No. 15 / 902,956, filed February 22, 2019 and published as US 2018 / 0177594; and / or those disclosed in U.S. Patent Application Serial No. 62 / 908,402, filed September 30, 2019, all of which are incorporated herein by reference in their entirety. The valve repair or replacement device may be a transcatheter heart valve disposed in a docking station. The valve repair or replacement device may also be a heart valve sealing device as described below, and the systems and methods used may be the same as or similar to those described below: PCT patent application No. PCT / US2019 / 055320, filed October 9, 2019, and U.S. Patent Application Serial No. 62 / 744,031, filed October 10, 2018, the disclosures of which are incorporated herein by reference in their entirety. The deployment tools described herein can be used to more accurately position such a valve repair or replacement device so that the valve repair or replacement device and the prosthetic heart valve anchored thereto function properly after implantation. The methods and steps shown and / or discussed herein and / or in the incorporated references may be performed on live animals or on simulated objects (such as cadavers, cadaver hearts, simulators (e.g., body parts, hearts, tissues, etc. are simulated)).

[0049] Figure 1 and 2 These are cross-sectional views of the human heart (H) during diastole and systole, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA) by the tricuspid valve (TV) and mitral valve (MV), respectively (i.e., the atrioventricular valves). Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has a flexible leaflet extending inward across the corresponding orifice (e.g., Figure 4 and 5The leaflets 20 and 22 shown in the diagram meet or “oppose” in the flow to form a unidirectional fluid-blocking surface. The natural valve repair system of this application is primarily described with respect to the mitral valve (MV). Therefore, the anatomy of the left atrium (LA) and left ventricle (LV) will be described in more detail. It should be understood that the device described herein can also be used to repair other natural valves, for example, the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0050] The left atrium (LA) receives oxygenated blood from the lungs. During or after diastole, [the condition is described in the original text]. Figure 1 Blood collected in the left atrium (LA) during systole moves through the mitral valve (MV) and into the left ventricle (LV) via the dilation of the LV. During systole, or during contraction, blood is seen in… Figure 2 During systole, the left ventricle (LV) contracts to force blood through the aortic valve (AV) and the ascending aorta (AA) into the body. During systole, the leaflets of the mitral valve (MV) close to prevent blood from flowing back from the LV into the left atrium (LA), and blood is collected from the pulmonary veins in the left atrium. In one exemplary embodiment, the device described in this application is used to repair the function of a defective mitral valve (MV). That is, the device is configured to help close the leaflets of the mitral valve, thereby preventing blood from flowing back from the LV into the left atrium (LA).

[0051] Now for reference Figure 1 -7. The mitral valve MV consists of two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes a valve annulus 24, which is a ring of fibrous tissue of varying density surrounding the leaflets 20 and 22. (Reference) Figure 3 The mitral valve MV is anchored to the wall of the left ventricle (LV) via chordae tendineae 10. Chorda tendineae 10 are cord-like tendons that connect papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. Papillary muscles 12 restrict movement of the mitral valve MV and prevent mitral valve reverting. The mitral valve MV opens and closes in response to pressure changes in the left atrium (LA) and left ventricle (LV). The papillary muscles do not open or close the mitral valve MV. Instead, they support the mitral valve MV against the high pressure required for blood to circulate throughout the body. Together with the chordae tendineae, the papillary muscles form the subvalvular apparatus, which functions to prevent the mitral valve MV from prolapsed into the left atrium (LA) during mitral valve closure.

[0052] Various disease processes can impair the normal function of one or more of the heart's natural valves. These processes include degenerative processes (e.g., Barlow's disease, fibro-elasticity deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the left ventricle (LV) or right ventricle (RV) in pre-heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can deform the geometry of the natural valve, leading to its dysfunction. However, the vast majority of patients who undergo valve surgery (such as mitral valve MV surgery) suffer from degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0053] In general, natural valves can become dysfunctional in two different ways: (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when a natural valve does not open fully, thus causing obstruction of blood flow. Generally, valvular stenosis is caused by the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and weakens the valve's ability to open fully to allow positive blood flow.

[0054] The second type of valvular dysfunction, regurgitation, occurs when the leaflets of the valve fail to close completely, causing blood to leak back into the anterior chamber (e.g., causing blood to leak from the left ventricle into the left atrium). There are three main mechanisms by which a natural valve becomes regurgitant or dysfunctional, including Carpentier types I, II, and III. Carpentier type I dysfunction involves annular dilation causing the normally functioning leaflets to become separated from each other and unable to form a tight seal (e.g., improper leaflet occlusion). Type I mechanism dysfunction includes leaflet perforation, as present in endocarditis. Carpentier type II dysfunction involves the prolapse of one or more leaflets of the natural valve above the occlusion plane. Carpentier type III dysfunction involves the restriction of movement of one or more leaflets of the natural valve, causing the leaflets to be abnormally restricted below the annular plane. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0055] refer to Figure 4 When a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and posterior leaflet 22 align, preventing blood from leaking from the left ventricle (LV) into the left atrium (LA). (Reference) Figure 5Regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV displaces into the left atrium LA during systole. This failure to align results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle (LV) back into the left atrium LA during systole. As described above, leaflets (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction, leading to regurgitation in several different ways.

[0056] refer to Figure 6 In some cases, a patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in the closed position (i.e., during systole). For example, the gap 26 may have a width W, which may be between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some cases, the width W of the gap 26 may be greater than 15 mm. In any of the above cases, a valve repair device is desired that allows the anterior leaflet 20 and the posterior leaflet 22 to engage to close the gap 26 and prevent blood regurgitation through the mitral valve MV.

[0057] When mitral regurgitation occurs, blood flows from the left ventricle into the left atrium during systole. In a healthy heart, blood should flow into the left atrium only through the pulmonary veins, not through the left ventricle. However, when mitral regurgitation occurs, the pressure in the left atrium increases to a level higher than it should be throughout the cardiac cycle, and is most pronounced at the end of systole.

[0058] Although stenosis or regurgitation can affect any valve, stenosis is primarily found in the aortic valve (AV) or pulmonary valve (PV), and regurgitation is primarily found in the mitral valve (MV) or tricuspid valve (TV). Both valvular stenosis and regurgitation increase the workload of the heart (H) and can lead to very serious conditions if left untreated, such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for carrying blood through the systemic circulation, dysfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening. Therefore, due to the significantly higher pressure on the left side of the heart, dysfunction of the mitral valve (MV) or aortic valve (AV) is significantly more problematic.

[0059] Dysfunctional natural heart valves can be repaired or replaced. Repair generally involves preserving and correcting the patient's natural valve. Replacement generally involves replacing the patient's natural valve with a biological or mechanical substitute. Generally, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because the stenosis damage to the leaflets is irreversible, the most routine treatment for aortic or pulmonary valve stenosis is removal and replacement with a surgically implanted heart valve or a transcatheter heart valve. As mentioned above, various heart valves can be repaired using transvascular techniques, in which a catheter is delivered into the heart via, for example, the inferior vena cava (IVC) and then guided to the valve requiring repair. Reaching different valves requires different pathways through the heart. As an example, reaching the tricuspid valve (TV) from the inferior vena cava IVC requires the catheter to make a sharp turn or bend almost immediately after entering the right atrium (RA) from the inferior vena cava IVC (see [link to original text]). Figure 2 and 3 In contrast, reaching the mitral valve MV from the inferior vena cava (IVC) requires puncturing the septum so that the catheter can travel from the right atrium (RA) to the left atrium (LA) and then bend towards the mitral valve MV.

[0060] For reference Figure 8A –31C, Detailed examples and descriptions of exemplary implementations of delivery catheters having a maneuverable distal end and its components (e.g., a flexible tubular frame and one or more control wires (e.g., draw wires, etc.) to control the curvature of the distal region of the delivery catheter, etc.).

[0061] Figure 8A A delivery catheter 224 according to an exemplary embodiment is shown (see example). Figure 9A perspective view of the components of the distal segment 25 of the delivery catheter. The delivery device may have features such as those described in U.S. Patent Application Serial No. 15 / 984661, filed May 21, 2018 and published under U.S. 2018 / 0318079, the disclosure of which is incorporated herein by reference in its entirety. The distal segment includes two opposing ends and sides 226, 27, a top 28, and a bottom 29—extending between the two ends. These have been labeled for ease of understanding and are not intended to limit the orientation of the distal segment 25. The flexible tubular frame in the distal segment 25 of the delivery catheter forms a generally cylindrical hollow tube that includes a plurality of connectors 38. In a final configuration of the delivery catheter, the distal segment and / or the flexible tube may be covered, encased, and / or include additional elements. Each connector 38 has the shape of a cylindrical segment, and each connector 38 is aligned with and connected to adjacent connectors 38 to form the cylindrical tubular shape of the distal segment 25. Although the distal segment 25 is cylindrical in this embodiment, other shapes (such as an ovular distal segment) are also possible. The width of each connector 38 of the distal segment 25 at the bottom 29 is greater than that at the top 28, giving the connector 38 an overall acute trapezoidal shape when viewed from the side, as best seen in… Figure 8B Each connector 38 has a slit 39 at its bottom to allow the connector 38 to flex more relative to each other.

[0062] The distal segment 25 also includes an optional double guiding pattern, forming a mixed-curvature segment comprising side teeth 31, 32 and top teeth 33. To achieve this, each connector 38 includes two side teeth 31, 32 on opposite sides of the connector 38; and a top tooth 33. Regarding the distal segment 25, the two rows of side teeth 31, 32 of the connector 38 extend along the lengths of the sides 226, 27 of the distal segment 25, respectively, and the top teeth 33 extend along the length of the distal segment 25 on the top 28, as best seen in… Figure 8A Although the rows of side teeth 31, 32 and top teeth 33 are shown in this example embodiment as extending straight along the length of the distal section 25, other embodiments may have different configurations. For example, in some embodiments, the rows of side teeth 31, 32 and top teeth 33 may spiral around the tube of the distal section 25, such as... Figure 9As shown, a specific bending shape of the distal segment 25 is produced when the distal segment 25 is actuated. In some embodiments, the side teeth 31, 32 may be mirror images of each other to allow similar bending of the opposite sides 226, 27 of the distal segment 25. In some embodiments, the side teeth 31, 32 may have different shapes and / or sizes relative to each other. The teeth 31, 32, 33 may adopt any other suitable shape and / or size that allows the distal segment 25 to move to a flexural configuration during delivery of the valve repair or replacement device. Although the teeth 31, 32, 33 are all right-handed teeth in the example embodiment (e.g., Figure 8B (The view shown points to the right), but in other embodiments, for example, the teeth may be left-facing teeth (see example...). Figure 9 Alternatively, the top teeth and side teeth can face different directions.

[0063] Adjacent to each side tooth 31, 32 and each top tooth 33 are corresponding side grooves or channels 34, 35 and top grooves or channels 36 on the adjacent connector 38, respectively. Each groove 34, 35, 36 may have a shape complementary to its adjacent side tooth 31, 32 or top tooth 33. When the distal section 25 is in a straightened configuration, the side teeth 31, 32 are partially inserted into the side grooves 34, 35, and the top tooth 33 is separated from its adjacent top groove 36 by a gap. In this straightened configuration, the side teeth 31, 32 are partially located within the side grooves 34, 35, providing additional torsional resistance to the distal section 25 of the delivery conduit 224 when it is not fully flexed. However, in some embodiments, the side teeth 31, 32 may not be partially positioned within the side grooves 34, 35 when the distal section 25 is in a straightened configuration.

[0064] When the distal segment 25 bends, the side teeth 31, 32 move further into their corresponding side grooves 34, 35, and the top teeth 33 move closer and then into their corresponding top grooves 36. The addition of the top teeth 33 and top grooves 36 provides enhanced torsional ability and torsional resistance to the distal segment 25 when it is in a fully flexed configuration. Furthermore, the side teeth 31, 32 and top teeth 33 provide additional guiding control and structural support when adjusting the distal segment 25 from its straightened configuration to its flexed configuration.

[0065] Figure 8B yes Figure 8A Detailed cross-sectional view of several connecting bodies 38 in the distal segment 25. Although Figure 8BThis description pertains to the side teeth 32, but it equally applies to the side teeth 31 on the opposite side of the distal section 25. The side teeth 32 are positioned along a tooth line 40 that is lower than the top 28 of the distal section 25. This positioning results in a smaller displacement of the side teeth 32; that is, the distance the side teeth 32 move into the adjacent slot 35 is much shorter or less than when the side teeth 32 are positioned closer to the top 28 of the distal section 25. For example, in the exemplary embodiment, the side teeth 31, 32 move a smaller distance during flexure than the top tooth 33 moves. In other words, the top tooth 33 moves a greater distance relative to the adjacent connector 38 when the distal section 25 is adjusted to a fully curved configuration compared to the side teeth 31, 32. This arrangement allows for the use of shorter side teeth 31, 32 (e.g., to give the side teeth a shorter longitudinal length), which can then be incorporated into a shorter curved section in the distal section 25.

[0066] Furthermore, the lower tooth line provides more space for the wider tooth recesses 34, 35 to accommodate, for example, even larger side teeth, since the tooth recesses 34, 35 are located in the wider lower portion of the connector 38. More space to accommodate larger and / or more suitable or robust tooth recesses 34, 35 for the side teeth 31, 32 can, for example, enhance the guidance of the teeth 31, 32 into the recesses 34, 35 during bending. The lower tooth line also allows for the implementation of the aforementioned robust tooth design, which provides structural support even when the connectors are bent away from each other (i.e., in the opposite direction of the bending configuration). Therefore, when the connectors are bent away from each other, the side teeth can still maintain their interface with the adjacent side recesses, and this maintained tooth-recess interface provides greater structural support and torsional flexibility.

[0067] Figure 9 This is a perspective view of the distal segment 25' of the curved configuration, according to a variation of the first embodiment. Figure 9 The distal segment 25' is similar to Figure 8A The distal segment 25, except in Figure 9 The central row of top teeth 33' and the rows of side teeth 31', 32' are laterally displaced in the distal section 25' of the tubular section, instead of extending in a straight line along the length of the distal section. This positioning of the rows of teeth 31', 32', 33' along, for example, a spiral allows the distal section 25' to bend in three dimensions, as with... Figure 8A The opposite of what will happen on a single plane. For example... Figure 9As shown, the distal segment 25' has a three-dimensional curved shape. Various embodiments of the distal segment can be laser-cut such that the top and side teeth follow a pattern that will form the desired shape during bending. For example, a pattern can be cut to create a distal segment with a curved shape that allows for positioning of the distal segment at the mitral valve or other valves during surgery, enabling the valve repair or replacement device to be advanced from the distal segment and accurately positioned at the valve.

[0068] The distal sections 25, 25' can be manufactured by cutting—for example, by laser-cutting a flat metal strip or sheet into a desired pattern and then rolling the patterned metal strip or sheet into a hyaluronic acid tube, or by cutting a pre-formed hyaluronic acid tube. As an example, Figure 10 It is used for Figure 8A A plan view of the laser-cut bound file or sheet 30 of the distal section 25. This laser-cut sheet 30 includes top teeth 33 and their associated grooves 36 arranged in a straight line along the length of the distal section 25, as well as side teeth 31, 32 and their associated grooves 34, 35. However, as described above, this laser-cut sheet 30 can be modified to have teeth 31, 32, 33 and their associated grooves 34, 35, 36 arranged in other different paths or configurations (e.g., in a spiral arrangement) to create a similar... Figure 9 The distal segment 25' shown is curved or spiral-shaped. In some embodiments, various patterns can be cut to provide a distal segment that can be bent in other shapes or configurations, which facilitate accurate navigation and deployment of the valve repair or replacement device to the implantation site during surgery. For example, Figure 11-12 Examples of implementations, such as 18A–19B, illustrate grooves and / or slots, slits, and cut-outs that facilitate accurate navigation and deployment of mitral valve implants. Various patterns can be cut into sheets to form tubes, or can be cut directly into pre-formed tubes (e.g., hypo tubes).

[0069] Various types of sheets that can be folded into tubes and / or various types of tubes can be used to prepare the distal sections. For example, nitinol and stainless steel, as well as various other suitable metals known in the art, can be used as materials for the sheets and / or tubes.

[0070] Although the above embodiments include top teeth and side teeth, so that each connector 38 has a total of three types of teeth, other embodiments may include only one of the top teeth or side teeth, or may not include any teeth at all.

[0071] Various sheath and catheter designs can be used to efficiently deploy valve repair or replacement devices at the implantation site. For example, for deployment at the mitral valve location, the delivery catheter can be shaped and / or positioned to point toward the commissure A3P3 and / or downward into the center of the mitral valve, between the leaflets. In a further embodiment, the catheter itself can also be positioned to pass through the mitral valve, below the mitral valve plane, and extend into the left ventricle (e.g., through one of the commissures). The catheter can be positioned in any suitable manner to allow the valve repair or replacement device to be deployed at the implantation site. In some embodiments, the catheter itself may have a non-invasive tip design to provide non-invasive access to the implantation site—e.g., by reducing or eliminating any damage that could potentially be caused by the advancement and / or shape manipulation of the catheter as it is positioned at the implantation site.

[0072] Figure 13 A perspective view of a curved, multi-curved, or "hockey stick" configuration of the distal segment 65 of the delivery catheter 64 is shown. This configuration can be used to implant a valve repair or replacement device at the natural mitral valve—using, for example, a transseptal technique. In the example configuration, the distal end 65 of the delivery catheter 64, extending from the guide sheath 220 (e.g., a transseptal sheath), has four main sub-segments: a shallowly curved portion 66, a circular planar portion 67, a bend 68, and a flexible distal portion 69. The shape of these sub-segments allows the distal segment 65 to navigate the delivery catheter 64 to the location at the natural valve (e.g., the natural mitral valve) and to accurately deploy a valve repair or replacement device at the natural valve. The distal segment 65 can take any suitable form that allows the distal segment to adopt the aforementioned flexural configuration, such as, for example, any form described in this application. While in the example embodiment the distal segment 65 of the delivery catheter 64 is curved in a clockwise direction, in other embodiments the distal segment 65 may instead be curved in the opposite counterclockwise direction. In embodiments where the delivery device is configured to deploy an implantable device in the tricuspid valve, as described above, different curvature profiles and radii may be selected to navigate the delivery catheter to a location at the natural tricuspid valve.

[0073] In some implementations, the flexible tubular frame can be a completely laser-cut hyaluronic acid tube (similar to the one described above). Figure 9The laser-cut catheter described in –12) has cuts arranged in a pattern such that, when bent, the distal segment forms a helical configuration. In some embodiments, the helical configuration of the laser-cut thiocarbide is shaped to extend from the FO position or to a position below the mitral valve plane. A corresponding gap between the apical tooth and its associated groove (e.g., where the groove is radially wider than the tooth to provide space for radial movement of the tooth as it is in its corresponding groove) allows vertical stretching of the catheter to occur. The distal segment can be shaped in this vertical stretching configuration. The distal tip of the catheter can then be pulled upwards when the helix is ​​within the mitral valve anatomy to position it along or just above the mitral valve plane—for example, by flexing or tensioning a flex wire in the distal segment of the catheter or otherwise attaching a soft wire to the distal segment, as previously described. This feature allows the helix to be adjusted to change its height to accommodate different patient anatomy.

[0074] refer to Figure 14 –17. In one exemplary embodiment, the distal region 117 of the delivery catheter 114 (which may be the same as or similar to the delivery catheter 64 and / or used to prepare the delivery catheter 64) may be formed of a thiopanthen tube with slits to provide controlled flexibility. The delivery catheter also has a dual control wire system, which includes a first control wire 135 and a second control wire 136. Figure 14 A schematic side view of the distal segment 117 of an exemplary embodiment of the delivery catheter 114 is shown. Figure 15 A cross-sectional view of the multi-lumen extrusion portion of the delivery catheter 114 is shown, the cross-section being taken in a plane perpendicular to the longitudinal axis of the delivery catheter. Figure 16 and 17 Schematic perspective views of the delivery catheter 114 in partially actuated and fully actuated states are shown respectively. In some embodiments, other similar and / or different dual control wire systems may be used. In some embodiments, only one control wire is used.

[0075] In some embodiments, each of segments 115, 116 may have associated control wires 135, 136 for controlling the bending of segments 115, 116, respectively. Control wire 135 may extend distally through groove 125 and may be attached to distal region 117 at connection point 135a—e.g., via welding or other attachment methods. Similarly, control wire 136 may extend distally through groove 126 and may be welded or otherwise attached to distal region 117 at connection point 136a. In one example embodiment, control wire 136 and the corresponding groove 126 are omitted, leaving only control wire 135 and groove 125.

[0076] Simultaneously, on the proximal side of the distal region 117, the delivery catheter 114 includes a proximal segment 140 that can be formed into a braided multi-lumen extruder. As in Figure 15 Best visible in cross-section, the proximal segment 140 of the delivery catheter 114 has one or more central lumens through which control wires 135, 136 extend to reach the distal region 117. The control wires 135, 136 may be arranged to extend side-by-side through the central region of the proximal segment 140, and then exit distally from the proximal segment 140 and attach to the sidewall of the distal region 117, as previously described. The central positioning of the control wires 135, 136 through the proximal segment 140 provides an anti-whipping or anti-bending effect when using the control wires 135, 136, allowing the delivery catheter 114 to maintain sufficient torsional flexibility.

[0077] Additionally, the proximal segment 140 has a main lumen 141 offset from the center of the extruded body. The main lumen 141 is sized sufficiently to allow a valve repair or replacement device to pass through or be delivered therein. The main lumen 141 may have, for example, an oval cross-section, a circular cross-section, or may have any other suitable cross-section shape, provided that the valve repair or replacement device can be effectively advanced through it. In addition to the main lumen, a plurality of optional parallel dummy cavities may also be formed in the proximal segment 140 and extend longitudinally through the proximal segment 140 to influence the symmetrical moment of inertia of the control wire passing through the proximal segment 140. In the illustrated embodiment, a first dummy cavity 142 is optionally diametrically positioned relative to the main delivery cavity 141 and formed in the same or substantially the same shape as the main lumen 141 (e.g., oval in the example embodiment). Additionally, two other optional dummy cavities 143 are diametrically positioned relative to each other and circumferentially positioned between cavities 141 and 142. This additional dummy cavity 143 is exemplified as being slightly smaller than cavities 141 and 142 and having a more circular shape. In practice, the size and shape of the dummy cavity 143 can vary in other ways and will generally be selected based on the corresponding dimensions of cavities 141 and 142 and the amount of remaining space in the extruded body. Additionally, depending on the specific application, the main cavity 141 and the first dummy cavity 142 can also have variable sizes and shapes. Furthermore, in some embodiments, a total number of more or fewer cavities may be formed in the proximal section 140 to influence the desired symmetry and moment of inertia, and equilibrium stiffness of the control wire extending through the central axis of the proximal section 140.

[0078] Return to reference Figure 13 and 14In practice, after the guide sheath 220 is positioned as needed (e.g., with its distal end in the desired chamber of the heart and / or close to the natural valve annulus), the distal region of the delivery catheters 64, 114 (including the distal terminal region 117, and in some embodiments, a portion of the proximal segment 140) is pushed out of the distal opening of the guide sheath 220. Here, the portion of the delivery catheters 64, 114 extending outside the guide sheath 220 can be positioned in the desired chamber of the heart (e.g., in the left atrium to access the mitral valve). In some cases, a portion of the delivery catheters 64, 114, or its distal end, may also extend into a second chamber (e.g., slightly into the left ventricle through the natural mitral valve, etc.). The central control wires 135, 136 can then be tensioned to actuate the distal region 117 and achieve articulation (joint connection, articulation) of one or both bends of segments 115, 116 at the distal portion of the delivery catheters 64, 114. The control wires 135 and 136 can be tensioned partially or completely in different amounts and / or sequences to navigate properly and safely around the patient's anatomy during actuation.

[0079] The design of the proximal section 140 and the central arrangement of the control wires 135, 136 provide anti-swaying or anti-bending effects through the delivery catheters 64, 114 when operating the control wires (one or more) 135, 136, allowing the delivery catheters 64, 114 to maintain sufficient torsional flexibility through the septal bend, and promoting more effective retention and maintenance of the actuated shape of the distal region 117.

[0080] In some embodiments, the delivery catheter for delivering the device to a natural valve of a patient's heart has a flexible tube with a centrally located main lumen and a control wire lumen. Reference is now made to... Figure 18A –18D illustrates a flexible tubing frame 1025 at the distal end of a flexible delivery catheter according to an exemplary embodiment. This flexible tubing frame 1025 may have a generally cylindrical shape, opening at both the proximal and distal ends, and providing controlled flexibility for the flexible tubing at the distal end of the delivery catheter. As with the various exemplary embodiments described herein, the flexible tubing frame and the distal region of the delivery catheter are not limited to a circular cross-section; the cross-sectional shape may also be elliptical or oval.

[0081] refer to Figure 18A The diagram illustrates a top view of a flexible tubing frame for catheter delivery. The flexible tubing frame 1025 may be made of connectors 1038, which are defined by slots or grooves 1036. Connectors 1038 may also have cutouts 1804 and slits 1039. Each of the plurality of connectors 1038 may have a circular shape, and in a circular configuration, each connector may be spaced apart from at least one other connector at its top and sides by slots 1036 (or grooves). Reference is now made to... Figure 18BThe diagram illustrates a side view of a flexible tubular frame, where cutout 1804 and slit 1039 are located near the bottom of the frame. Cutout 1804 can be curved, such as a semi-circular or semi-oval cutout on the frame. Cutouts corresponding to each of the plurality of connectors may be present on each side of the frame 1025 (see [reference]). Figure 19A and 19B This allows each pair of cuts 1804 to align when the frame is in a tubular configuration, forming a circular, oval, or cylindrical opening positioned along the bottom of the frame, such as... Figure 18C Example from the text. Figure 18B and 18C The slit 1039 in the example can be cut into the frame such that each of the plurality of connectors has two slits cut into it, the slits extending partially upward from the bottom of the frame into the associated connector. When the flexible tubular frame is straight, there is almost no space for the slits to be created, but when the frame moves to a curved configuration, the frame connectors can each expand at the slits.

[0082] For reference Figure 18D The example illustrates the distal end of the flexible tubular frame 1025. A notch 1804 for connecting the control wire is located at the top of the distal end, and a tooth 1807 for securing the anchoring ring is located at the bottom of the distal end.

[0083] For reference Figure 19A and 19B The diagram illustrates a planar view of a flexible tubular frame in a planar configuration. The flexible tubing for delivering the conduit may have a flexible tubular frame made of multiple connectors arranged in a distal region of the flexible tubing, the connectors being positioned between a first ring and a second ring. The connectors may be cylindrical and cut from a single piece of material such that each connector is aligned and connected to at least one adjacent connector, with a groove formed between each pair of adjacent connectors. The flat sheet may be a thiabend tube, having the same characteristics as described above. Figure 9 The example implementations are similar or identical in nature, having a groove 1036, a cut 1804, and a slit 1039 formed by laser cutting. Figure 19A An example implementation of a flexible tubular frame in a planar configuration is illustrated, and Figure 19B Example Figure 19AA close-up view of the corner of the frame. When in a planar configuration, the frame 1025 can be rectangular or substantially rectangular, with its length L varying via cuts 1804 and slits 1039. Grooves 1036 can be formed by cutting from a central region to create multiple connectors 1038. Grooves can have an elongated and / or tapering shape, such that the length L2 of the central region 1901 of each groove 1036 is greater than the length L3 of the end of each groove. The frame 1025 can also be varied along its width W via additional cuts. A first end of the frame can have a rectangular or substantially rectangular cut, and another semi-circular or substantially semi-circular cut aligned with the midpoint of the width W of the frame. These cuts in the first end create two end pieces 1902, 1903, which, when the frame is in a tubular configuration, provide toothed attachment points 1807 for a pull ring 2001 positioned at the bottom of the frame. However, the tooth 1807 is not limited to being formed by these two end pieces; instead, it can be a single end piece extending distally from the distal edge 1904 of the sheet. The semi-circular notch 1804 is positioned at the top of the first end of the frame when the frame is in a tubular configuration and can be clocked by a control wire when the distal end of the delivery catheter is assembled. In this example embodiment, a single control wire (e.g., a drawing wire) is used to control the curvature of the distal region of the delivery catheter, but the device is not limited to this in other examples where the delivery catheter may have more than one control wire.

[0084] The cut at the second end of the frame can be multiple oval or substantially oval windows 1808. A central window may have an additional proximal cut, which can be a proximal groove 1809, such that the central window opens against the proximal edge 1905 of the frame. When the delivery conduit is fully assembled, the proximal groove 1809 can be aligned with the submersible anchor. Windows can be used to provide openings through which adhesive or polymeric materials flow and adhere to layers below or inside the window, allowing the component (in this case, the frame) to be inserted and thus secured in place.

[0085] For reference Figure 20A and 20B The control wire 1135 and other components are assembled with the flexible tubular frame to control the bending of the flexible tubular frame by utilizing the control wire. The components include an optional first ring added at the distal end of the flexible tubular frame and an optional second ring added at the proximal end of the flexible tubular frame.

[0086] The first ring at the distal end of the flexible tubular frame may be a pull ring 2001, which is connected to a tooth 1807 at the distal end of the frame. This pull ring is securely attached to the distal end and can be attached by welding between the pull ring and the tooth. The pull ring and the distal end of the frame can be attached, or by any other known technique commonly used and capable of withstanding a tensile load of at least 25 pounds. The pull ring may have a cutout 1804 that overlaps with a cutout in the flexible tubular frame. A control wire 1135 may be securely attached to the pull ring.

[0087] For reference Figure 21A -21C, an example of a pull ring 2001 attached to control wire 1135, as shown in Figure 20A and 20B The kind used in the example implementation. Figure 21A A top view of the pull ring and control wire assembly is shown. The pull ring 2001 has an opening 2101. Figure 21B A side view of the pull tab and control wire assembly is shown in the example. The pull tab may have additional cutouts, such as 1804. Figure 21B and 21C Those on the proximal end of the pull ring. The additional cuts facilitate positioning of the pull ring on the distal end of the flexible tubular frame. For example, cut 1804 is positioned on the bottom of the pull ring and aligned with the teeth 1807 of the flexible tubular frame during assembly.

[0088] Figure 21C It is a bottom view of the pull ring and control wire, with the bottom cutout 1804 having a certain size and shape to align with the teeth, and also revealing a view of the distal end of the control wire 1135.

[0089] Figure 20A A top view of the assembly is shown, and the control wire 1135 extends along the length of the flexible tube frame 1025 and is visible at each groove 1036. Figure 20B A side view of the assembly is shown, and control wire 1135 is visible extending along the top interior of the flexible tubular frame.

[0090] A second ring, namely anchoring ring 2002, may be present in the distal region of the flexible tube. This second ring, located in the distal region of the flexible tube, is spaced apart from the first ring. Anchoring ring 2002 is attached to the proximal end of the flexible tube frame. The inner top surface of anchoring ring 2002 may be attached to hyaluronic acid tube 2901 (see [reference]). Figure 29A and 29B Furthermore, the control wire passing through the flexible tubular frame is slidably positioned within the hysteresis tube 2901.

[0091] refer to Figure 28A -29C, an example based on Figure 20A and 20B An anchoring ring and hysteresis tube assembly of example implementation. Figure 28AAn example plan view of anchoring ring 2002 is shown. When flat, the anchoring ring may have a rectangular or substantially rectangular shape, with a width approximately the same as the width of the flexible tubing frame in a planar configuration. Anchoring ring 2002 may have a cutout 2803, which may be rectangular in shape. The anchoring ring may also have its own hole 2802. Hole 2802 and cutout 2803 may be circular or substantially circular, and may also be rectangular, or any other shape that allows for layering of material in the assembly of the delivery conduit. The anchoring ring may also have a weld hole 2801 for aligning and welding the submersible tube 2901 to the top inner side of the anchoring ring. Figure 28A A close-up view of the weld hole is shown as an example. Figure 29A The example shows a top view of the anchoring ring and the hyaluronic acid tube 2901 welded together. The hyaluronic acid tube is the anchoring element through which the control wire can slide. Figure 29B This is a side view of the anchoring ring 2002 and the wave tube 2901. Figure 29C An end view of the anchoring ring is shown in the example. The thallium tube can be positioned and welded to the inner surface of the top of the anchoring ring. The anchoring ring can be curved into a cylindrical configuration to fit the flexible tubular frame; however, the ends of the anchoring rings do not need to contact each other to form a complete cylinder or other substantially cylindrical shape. Figure 29C Example 2903 shows the clearance that can be maintained after component assembly. The weld between the anchor ring and the hyaluronic acid tube should be able to withstand a tensile load of at least 30 pounds, where the load is applied to the hyaluronic acid tube in a coaxial direction.

[0092] For reference Figure 30A –31C describes the coil sleeve 2004 and the proximal coil stopper 2005 in more detail. Figure 30A A plan view of a proximal coil stop 2005 is shown. The proximal coil stop may have a window 3001 and a weld hole 3002. The window allows the assembly of the component to be secured to the polymer conduit material, and the weld hole allows the proximal coil stop to be secured to the coil sleeve. Figure 30B A close-up of weld hole 3002 is shown, which can be used to weld the near-side coil stop 2005 to the coil sleeve 2004.

[0093] Figure 31A –31C illustrates the proximal region of the coil sleeve 2004 when assembled with the proximal coil stopper 2005. Figure 31A The image shows a top view. The assembly window is positioned here, resulting in a top near-side window and a top far-side window. Figure 31A Each of the assembly windows in the middle can be part of a pair, with a corresponding bottom assembly window, such as Figure 31B As shown. The near-side coil stop is not limited to this specific configuration of assembly window and weld hole. Figure 31BThe diagram illustrates a cross-section of a coil sleeve and a proximal coil stop taken along line X–X. The proximal end of the coil sleeve 2004 is snugly fitted within the proximal coil stop. Solder holes are located at the top and bottom of the proximal coil stop. These solder holes, situated within the proximal coil stop, allow for the securing of a plurality of rotations of the coil within the coil sleeve to the proximal coil stop. Figure 31C An example is shown of a coil within a proximal coil stop and a channel 3101 through which the control wire can slide. The weld between the proximal coil stop and the coil sleeve should be able to withstand a compressive load of at least 35 pounds.

[0094] For reference Figure 22A and 22B The example illustrates the distal portion of a delivery catheter 1114 comprising a flexible tubular frame. Figure 22A A side view is shown, illustrating the outer layer as a polymer coating. The polymer coating can be a thermoplastic elastomer (TPE), which can be a polyether block amide (PEBA). The properties of the polyether block amide can vary along the length of the distal end of the catheter and can be selected based on the desired flexibility and number of components for each section of the catheter. At a proximal position along the length of the delivery catheter, the catheter 1114 has an opening 2201 for the control wire 1135 to exit. A coil sleeve 2004 surrounds the control wire until the control wire passes through the proximal coil anchor. Figure 22B An example view of the distal end of the delivery catheter is shown.

[0095] For reference Figure 23A and 23B Examples along Figure 22B The line A–A is a cross-section of the distal end of the delivery catheter. Figure 23B yes Figure 23A A close-up view of a portion of the cross-section.

[0096] exist Figures 22A-23A The components exemplified in the various cross-sections may extend for different lengths along the delivery catheter in some exemplary embodiments. For example, the flexible tubing frame 1025 extends along the distal region of the delivery catheter. The coil sleeve 2004 is located proximal to the flexible tubing frame and extends a length within the control wire lumen before exiting the delivery catheter and extending another length in the proximal direction. The braid 2401 extends along the central region of the delivery catheter. The dominant lumen liner may extend along the entire length of the delivery catheter. The control wire lumen liner may extend along the entire length of the control wire lumen.

[0097] Figure 23A The example illustrates the position of control wire 1135 from its distal end, fixed to the pull ring, to the portion of the control wire surrounded by the coil sleeve. The coil sleeve 2004 covers the portion of the control wire near the anchor ring. (As shown...) Figure 23A and 23B As shown, the delivery catheter can be configured such that a flexible tubing frame contacts the polymer outer layer 2301 of the delivery catheter. Grooves or channels 1036 of the flexible tubing frame are positioned at the top and sides of the frame, and slits and cutouts are located at the bottom of the frame.

[0098] For reference Figure 24-27 Examples show cross-sections of the delivery catheter taken at different points along the catheter length. Figure 24-26 An example is shown of a cross-section from the distal region of the delivery catheter and includes a flexible tubular frame 1025. Figure 27 An example is shown of a cross-section from the proximal region of the delivery catheter, where the control wire is positioned outside the catheter.

[0099] refer to Figure 24 The cross-section of the example delivery catheter along Figure 23A The BB section is cut from the distal region. An outer layer 2301 is present, which can be any polymer outer layer having the properties described above regarding the polymer used for the delivery catheter. An inner layer, namely the main lumen liner 2402, is present, which may be made of etched PTFE and extends the full length of the main lumen of the delivery catheter. The liner completely surrounds the inner surface of the catheter lumen to provide a smooth surface, allowing the valve implantation device to be passed through without getting stuck on the inner surface and delivered to the heart valve. A braid 2401 may be present, providing additional support to the catheter without limiting the flexibility required for navigating the delivery catheter within the heart. The braid 2401 is embedded in the polymer outer layer. The braid may be made of flat filaments (one or more) and / or rounded filaments (one or more) and may have an almond-shaped pattern or any other pattern known in the art to provide strength to the delivery catheter while maintaining its flexibility. There is a control wire cavity 2502 located at the top of the tube, and within this cavity, at cross-section BB, there is a control wire cavity liner 2502 that liners the control wire cavity; and a coil sleeve 2004 surrounding the control wire 1135. In the conduit, inside the main lumen liner 2402, there is a hollow main lumen 2602.

[0100] refer to Figure 25A The cross-section of the example delivery catheter along Figure 23A The line CC is cut off. This cross-section is located in the middle part of the distal region of the delivery catheter, just near the flexible tubular frame, where the anchoring ring is located. Figure 25B The top of the catheter is shown in the example. Figure 25A The diagram shows a close-up view of the control wire cavity at its cross-section. The hypotube 2901 is attached to the anchoring ring 2002, and the control wire 1135 extends through the hypotube 2901. The hypotube may be made of stainless steel, polymer, or other biocompatible materials.

[0101] A marking strip 2501 may also be present. The marking strip provides the user with an indication of the proximal position of the flexible tubular frame in the distal region of the delivery catheter. The marking strip may be made of platinum-iridium or other materials readable by imaging techniques commonly used with mitral valve implantation delivery catheters. A liner 2401, i.e., a liner of the main lumen 2602 of the catheter, may extend along the entire length of lumen 2602, including a portion of the distal region of the delivery catheter at the line CC.

[0102] refer to Figure 26 The cross-section of the example delivery catheter along Figure 23A The cross-section is taken from the line DD. This cross-section is located on the distal side of the delivery catheter's distal region. At this cross-section, a flexible tubular frame 1025 is embedded within the outer catheter 2301. This specific cross-section is taken at the catheter portion with a cutout 1804 at the bottom of the flexible tubular frame, as shown in the gap 2601. The interiors of the main lumen and the control wire lumen are respectively lined with a main lumen liner 2402 and a control wire lumen liner 2502. The control wire lumen is occupied by the control wire. The outer catheter is made of the aforementioned polymer.

[0103] Figure 27 Examples along Figure 22A The control wire EE is a cross-section taken in the proximal region. The main lumen 2602 has a liner 2402 that extends along the length of the delivery catheter. The control wire lumen begins at a more distal position in the catheter. At the cross-section EE, the control wire has exited the catheter, allowing it to be manipulated by an operator at its proximal end (not shown). The control wire 1135 is surrounded by a coil sleeve 2004, and the coil sleeve is partially covered by a proximal coil stop 2005.

[0104] Refer again Figure 20A and 20B The delivery catheter may have a control wire in the control wire lumen 2502 (see...). Figure 26 The control wire cavity 2502 can be connected to a pull ring and extends at least along the delivery conduit, at an internal location, along the flexible tubing frame (i.e., inside the flexible tubing frame). The anchoring ring's thiopanel and coil sleeve 2004 are arranged within the control wire cavity. The coil is located proximal to the flexible tubing frame and is connected to the proximal end of the thiopanel 2901. The coil surrounds the control wire to protect it and to prevent the plastic material around the coil sleeve from compressing, shortening, or bending when the control wire is pulled. A proximal coil stop 2005 may surround the proximal end of the coil sleeve. The distal region of the coil sleeve 2004 is within the conduit, within the control wire cavity, and exits the conduit at opening 2201. The proximal region of the coil sleeve is outside the delivery conduit and extends for a certain length. At least the portion of the control wire extending from the second ring to the first ring is not covered by the coil sleeve (see...). Figure 26The coil stop 2005 maintains the integrity of the proximal end of the coil sleeve 2004 and provides means for connecting the coil sleeve to other components of the catheter, such as a pull ring. The coil sleeve acts as a stop for the control wire to prevent it from compressing, shortening, or bending the proximal region of the delivery catheter. The coil stop and coil sleeve can be configured in a variety of different ways and can be omitted in some embodiments.

[0105] The delivery catheter 114 includes a control wire lumen 2502 for receiving the control wire 1135. In the example embodiment, the control wire conduit is at least partially defined by a gasket. In some embodiments, the control wire conduit 2502 may take any other suitable form.

[0106] In some embodiments, the delivery catheter 114 includes a coil sleeve 2004 that extends around the control wire until it reaches the flexible tubular frame 1025. The design of the proximal section of the delivery catheter, along with the arrangement of the control wire 1135 and the coil sleeve 2004, achieves an anti-swaying or anti-bending effect through the delivery catheter 114 when the control wire is operated. This allows sufficient torsional flexibility to be maintained through the septal bend of the delivery catheter 114. This also facilitates more effective retention and maintenance of the actuated shape of the distal region 25 during delivery, during twisting or rotation. The coil sleeve 2004 is configured to provide anti-swaying or anti-bending effects and maintain sufficient torsional flexibility of the delivery catheter 114.

[0107] The control wire 1135, control wire conduit 2502, flexible tubing frame 1035, pull ring 2001, anchoring ring 2002, and coil sleeve 2004 operate in a manner similar to a cinch or drawstring, wherein the control wire is a string, and the flexible tubing frame allows the distal region of the catheter to be “cinched” (like a cinch). Figure 20CThe movement of components is illustrated when tension is applied to the control wire. At the proximal end of the device, the operator can pull the control wire 1135 in a proximal direction, as indicated by arrow 2006. The control wire can be partially or fully tensioned in varying amounts to navigate properly and safely around the patient's anatomy. After this tension is applied to the control wire 1135 in a proximal direction, the control wire distally connected to the pull ring 2001 applies a proximal force to the top of the pull ring. This force causes the pull ring 2001 to move upward and in a proximal direction, as indicated by arrow 2007. The flexible tubular frame 1025 bends and buckles along the groove or channel 1036, such that the groove 1036, positioned along the top curve of the frame, becomes smaller as the top of the frame connector 1036 is pulled closer together, as indicated by arrow 2008. This causes the flexible tubing frame, and therefore the distal segment of the delivery catheter, to flex, resulting in an upward curve in the direction illustrated by arrow 2007, where this upward direction is defined as the direction facing the top of the tubing frame 1025. The result of applying tension to the control wire 1135 by pulling it proximally is that the flexible tubing frame 1025 curves into a configuration where its proximal and distal ends converge and become more curved, as... Figure 20C The curve 2009 in the figure provides the type. In this way, the tension of the control wire determines the degree of curvature. When the flexible tubular frame 1025 bends, the slit 1039 at the bottom of the frame can expand to reduce the force applied to the flexible tubular frame.

[0108] Refer again Figure 20C The control wire 1135 is fixedly connected to the pull ring 2001 and slidably connected to the anchoring ring 2002 at the proximal end of the flexible tubing frame 1025 by passing through the thiouret tube 2901. The control wire 1135 is also slidably positioned within the control wire lumen 2502 and the coil sleeve 2004. The coil sleeve 2004 prevents circumduction and / or wrinkling of the delivery catheter in areas outside the flexible tubing. The coil sleeve provides additional stiffness to the delivery catheter, preventing excessive deflection of the length of the delivery catheter with the coil sleeve. When the control wire 1135 is pulled in the direction of arrow 2006 to deflect the distal region of the delivery catheter, a tensile load is applied to the distal end of the control wire, where it is connected to the pull ring. The flexible tubing frame bends, but the coil sleeve 2004 prevents the control wire 1135 from bending in the proximal region of the delivery catheter. When the tension in the control wire is released, the tube frame returns to its straight configuration, the plurality of connectors 1038 are once again separated along the groove and / or channel 1036, and the slit 1039 closes again.

[0109] To deliver some implantable prosthetic devices, the distal end of the delivery device may need to be bent / curved at approximately 90 degrees to properly align the implantable prosthetic device within the mitral valve. One technique for reaching the mitral valve is the transseptal technique mentioned above. In some transseptal techniques, the delivery device extends through the inferior vena cava (IVC) (see [link to original text]). Figure 2 and 3 The mitral valve then passes through a puncture in the septum (although in some implementations the septum may be accessed via the superior vena cava SVC). The distal height at which the mitral valve bends / curves to its maximum bend (e.g., 90 degrees) determines the minimum distance between the mitral valve and the puncture made during implantation through the septum, i.e., the septal puncture height. If the puncture making the puncture through the septum is too close to the mitral valve—below the minimum septal puncture height—the distal end will not be able to bend / curve to 90 degrees without contacting cardiac tissue, thus hindering proper alignment and implantation of the implantable prosthesis within the mitral valve, as in... Figure 32 As can be seen in the image. The delivery device can also be configured to reach the tricuspid valve TV after extending through the inferior vena cava IVC, which may require additional bending of more than 90 degrees, where the bending height and distance also affect the alignment of the implantable prosthesis within the tricuspid valve TV.

[0110] For reference Figure 32 A schematic side view of the distal end 200 of an example delivery catheter is shown, protruding through a septal perforation or opening 201 in the septum of the heart and curving toward the mitral valve MV. Guide sheath 220 (see...) Figure 13 This can also be used to guide a delivery catheter and / or traverse the septum, such as via a septal sheath. A septal perforation 201 is created at a vertical distance above the mitral valve MV or at a septal perforation height 202. The center of the mitral valve MV is laterally separated from the septum by a lateral distance 204. The distal end 200 has a curved portion 210 with a bending radius 212 that allows the distal end 200 of the delivery device to bend toward the mitral valve MV to deliver an implantable prosthetic device within the valve for implantation. Similarly, in embodiments where the delivery catheter is configured to reach the tricuspid valve TV, the delivery catheter enters the right atrium RA from the inferior vena cava (IVC) (and / or the superior vena cava SVC) and bends toward the tricuspid valve TV to deliver an implantable prosthetic device within the valve for implantation.

[0111] As mentioned above and in Figure 32As can be seen, the bending height 206 of the curved portion 210 is greater than the minimum septal perforation height 202. Therefore, the fully extended curved portion 210', shown in dashed lines, will interfere with the natural tissue of the mitral valve MV, preventing the implantable prosthesis from being implanted in the middle of the mitral valve MV using the septal perforation 201. A similar situation can occur when delivering an implantable prosthesis to the tricuspid valve TV if the bending radius of the delivery catheter is not small enough to bend from the inferior vena cava IVC to the middle of the tricuspid valve TV.

[0112] For reference Figure 33 A schematic side view of an example delivery catheter (e.g., a multi-curved / bent delivery catheter) is shown, with the distal end 300 protruding through a septum perforation 201. The distal end 300 has a first curved or bendable portion 310 and a second curved or bendable portion 320. The first curved portion 310 bends / curves with a first bending radius 312, and the second curved portion 320 bends / curves with a second bending radius 322. The first bending radius 312 is larger than the second bending radius 322, such that the first curved portion 310 bends more gently than the second curved portion 320. The smaller bending radius of the second curved portion 320, combined with the larger bending radius of the first curved portion 310, allows the distal end 300 to bend / curve a full 90 degrees, and the bending height 306 is less than the septum perforation height 202. The bending height 306 can be changed by altering the first bending radius 312 and the second bending radius 322 of the first curved portion 310 and the second curved portion 320 (e.g., by altering the stiffness of the first curved portion 310 and the second curved portion 320). The various ways of changing the stiffness of the first bending portion 310 and the second bending portion 320 are discussed in more detail below. The bending height 306 can also be changed by altering the relative lengths of the two bending portions 310, 320. For example, the first bending portion 310 may be approximately one-quarter, one-third, one-half, two-thirds, or three-quarters of the length of the distal end 300, wherein the second bending portion 320 constitutes the remaining length of the distal end 300.

[0113] For reference Figure 34 –36, shows a schematic side view of the distal end of the instance delivery catheter in a 90-degree bent / curved state. Figure 34 The distal end 200 is shown to be bent / curved to 90 degrees (or curved so that the distal end is oriented at 90 degrees to the direction of the duct portion before the bend or at the septum crossing area), with a bend height 206 and a lateral bend distance 208. Figure 35The diagram illustrates the bending / curved bending of the distal end 300 to 90 degrees, reaching a bending height 306 and a lateral bending distance 308. Both the bending height 306 and bending distance 308 of the distal end 300 are smaller than the bending height 206 and bending distance 208 of the distal end 200 because the distal end 300 includes a first bending portion 310 and a second bending portion 320 having a first bending radius 312 and a second bending radius 322, compared to the single bending radius 212 of the bending portion 210 of the distal end 200.

[0114] Figure 36 An example distal end 400 is shown, which has an additional curved / curved portion, such that the distal end 400 is formed by first, second, and third curved portions 410, 420, and 430. The first, second, and third curved portions 410, 420, and 430 have first, second, and third bending radii 412, 422, and 432, respectively. The bending radii 412 and 432 of the first and third curved portions 410 and 430 are smaller than those of the second curved portion 420. Therefore, the bending height 406 of the distal end 400 is greater than the bending height 306 and less than the bending height 206. Although the bending height 406 is greater than the bending height 306, the bending distance 408 of the distal end 400 is less than the bending distance 308 due to the addition of the first curved portion 410 with a smaller bending radius 412.

[0115] In some implementations, the distal end (as described herein) may have any number of curved or flexural portions with various lengths and radii of curvature to allow customization of the distal end's curvature height, curvature distance, and shape when bent to approximately 90 degrees or at other angles desired for application. The curvature properties of the distal end can be modified to achieve specific curvature heights or radii (which achieve specific curvature profiles or paths). For example, different curvature profiles may be configured depending on whether the implantable prosthesis is intended to be delivered to the tricuspid valve TV or the mitral valve MV via a transseptal procedure.

[0116] As described above, an exemplary embodiment of a delivery catheter for delivering a device to a patient's natural heart valve may have a centrally located main lumen and a control wire lumen. Reference is now made to... Figure 37 –43, illustrates an example flexible tubular frame 500 at the distal end of a flexible delivery catheter according to an exemplary embodiment, having a first bend 510 and a second bend 520. The flexible frame 500 extends from a proximal end 501 to a distal end 502 and may have a generally cylindrical shape, opening at both the proximal end 501 and the distal end 502. The flexible frame 500 at the distal end of the delivery catheter comprises a first polymer layer 530 and a second polymer layer 540 (…). Figure 42 –43) provides supported and controlled flexibility. As with other exemplary embodiments described herein, the flexible tubular frame 500 and the distal region of the delivery conduit are not limited to a circular cross-section (e.g., Figure 40 That is, the shape of the cross-section can also be elliptical or oval. In addition, the first polymer layer 530 and the second polymer layer 540 can be used with any frame described herein (such as a frame having a single uniform flexural segment to form a curved portion with a different bending radius).

[0117] The proximal end 501 of the flexible tubular frame 500 includes a plurality of rounded, oval, or generally oval windows or cutouts 503, and a central cutout or proximal groove 505 opening into the proximal end 501 of the flexible tubular frame 500. The proximal groove 505 can be aligned with the submersible anchor when the delivery catheter is fully assembled. The plurality of cutouts 503 are used to provide openings for the adhesive material or polymer material of the first polymer layer 530 and the second polymer layer 540 to flow through the flexible tubular frame 500 to adhere to other materials (such as layers below or inside the cutouts 503), thereby embedding and securing the flexible tubular frame 500 in the desired location.

[0118] The distal end 502 of the flexible tubular frame 500 includes a toothed attachment portion 504 projecting from the underside of the distal end 502 for attaching the flexible tubular frame 500 to a distal pull ring 560. Figure 42 –43) or other pull rings (such as pull ring 2001 described above). The attachment portion 504 may be formed by a single protrusion or two protrusions, which in the flexible tubular frame 500 are made of a flat sheet of material (see, for example...). Figure 41 The flat sheets shown are joined together during formation.

[0119] The distal end 502 may also include an optional semi-circular distal cutout 506, which is positioned on the top side of the distal end 502 when the flexible tubular frame 500 forms a tubular configuration. The distal cutout 506 is attached to the control wire 570. Figure 42 –43) or other control wires, such as control wire 1135 mentioned above. Figure 40 The image shows the distal end 502 of the flexible tubular frame 500, the circular cross-sectional shape of the flexible tubular frame 500, and the relative positions of the attachment portion 504 and the cutout 506.

[0120] refer to Figure 37The image shows a top view of a flexible tubular frame 500. The flexible tubular frame 500 has a first curved portion 510 and a second curved portion 520. Each of the first curved portion 510 and the second curved portion 520 is formed by a plurality of connectors 512, 522 defined by slots or grooves 514, 524. The connectors 512, 522 may also include cutouts 516, 526 and slits 518, 528. Each of the plurality of connectors 512, 522 may have a circular shape and, in a circular configuration, be spaced apart from at least one other connector at the top and sides of the connectors 512, 522 by slots or grooves 514, 524.

[0121] For reference Figure 38 The diagram shows a side view of a flexible tubular frame 500, wherein cutouts 516, 526 and slits 518, 528 are located at and / or near the bottom of the flexible tubular frame 500. Cutouts 516, 526 may optionally have rounded shapes, such as semi-circular or semi-oval. Each cutout 516, 526 corresponds to one of the plurality of connectors 512, 522. When the flexible tubular frame 500 is cut from a flat sheet of material (… Figure 41 When cut, cuts 516 and 526 are formed on either side of the flexible tubular frame 500, such that when the flexible tubular frame 500 is rolled into a tubular configuration, each pair of cuts 516 and 526 aligns to form a circular, oval, or other rounded opening, thus forming a row of openings along the bottom of the flexible tubular frame 500, such as... Figure 39 As can be seen in the text.

[0122] Slits 518 and 528 are formed in the flexible tubular frame 500 such that two slits 518 and 528 are cut into each of the plurality of connectors 512 and 522. Slits 518 and 528 extend partially upward from the bottom of the flexible tubular frame 500 and into the specific connectors 512 and 522. Slits 518 and 528 operate similarly to relief cuts because they close or are substantially closed when the flexible tubular frame 500 is in a straight configuration and can open or expand when the frame connectors 512 and 522 move toward each other (when the flexible tubular frame 500 changes to a curved configuration).

[0123] For reference Figure 41 The diagram shows a plan view of a flexible tubular frame 500 in a planar configuration. The flexible tubular frame 500 is rectangular or substantially rectangular in shape when in planar configuration, and can be rolled along its longitudinal axis to form a cylindrical or other tubular shape with a cross-section. Optionally, Figure 41The planar pattern shown can be used to instruct a laser cutter to cut through the formed or pre-formed hyaluronic acid tube, thus eliminating the need for a curling step. The hyaluronic acid tube may have properties similar to or the same as those described in the example embodiments above. The connectors 512, 522 of the flexible tube frame 500 are formed by laser cutting various shapes in a flat sheet of material. Specifically, the shapes of the connectors 512, 522 are defined by grooves 514, 524, cuts 516, 526, and slits 518, 528. That is, the grooves 514, 524 can be cut from the central region to form the plurality of connectors 512, 522. The grooves 514, 524 may have an elongated and / or tapered shape, such that the central region of each groove 514, 524 is wider than the ends of the grooves 514, 524 near the sides of the rectangular sheet. The edges of the flat material sheet are shaped by cuts 516 and 526, which form a rounded oval shape when the material sheet is rolled into a flexible tubular frame 500. Slits 518 and 528 extend from the cuts 516 and 526 toward the center of the sheet. Cuts in the distal end 502 of the sheet form two attachment protrusions 504, which form a single attachment portion 504 when the material sheet is rolled into a tubular shape.

[0124] For reference Figure 42 and 43 This illustrates a flexible tubing frame 500 assembled with other components at the distal end of a delivery catheter. The distal assembly includes the flexible tubing frame 500, an optional proximal stationary or fixed ring 550, an optional distal pull loop or movable ring 560, and a control wire 570, and operates similarly to the distal assembly described above. The control wire 570 extends through the proximal ring 550, through the flexible tubing frame 500, and is attached to the distal ring 560. Similar to... Figure 20C The flexible tubular frame shown, when tension is applied to the control wire 570, causes the connectors 512, 522 to move toward each other and the width of the grooves 514, 524 to decrease, thereby causing the flexible tubular frame 500 to bend toward its top or the inner radius of the bend. Applying bending tension to the control wire 570 also causes the cuts 516, 526 and slits 518, 528 on the bottom or outer radius of the bend to expand. In this exemplary embodiment, a single control wire is used to control the curvature of the distal region of the delivery catheter; however, the device is not limited to this in other exemplary embodiments, where the delivery catheter may have more than one control wire.

[0125] The connector 512 of the first curved portion 510 is more convergent than the connector 522 of the second curved portion 520, such as... Figure 37See –39 and 41–43. Therefore, the groove 514 of the first curved portion 510 is narrower than the groove 524 of the second curved portion. The different spacing of the connectors 512, 522 in the first curved portion 510 and the second curved portion 520 contributes to the different bending characteristics of the first curved portion 510 and the second curved portion 520. That is, the closer spacing of the connectors 512 in the first curved portion 510 strengthens the first curved portion 510 relative to the second curved portion 520, such that the bending radius of the first curved portion 510 is larger than that of the second curved portion 520. Optionally, the spacing of the connectors 512, 522—and therefore the width of the grooves 514, 524—can be the same between the first curved portion 510 and the second curved portion 520, and the width and / or thickness of the connectors 512, 522 can be varied to change the bending characteristics of the first curved portion 510 and the second curved portion 520. That is, thicker and / or wider connectors 512, 522 can be used to reinforce the bent portions 510, 520, thereby increasing the bending radius when exposed to bending forces. Due to the relative stiffness difference between the first bent portion 510 and the second bent portion 520, applying a bending force to the flexible tubular frame 500 via the control wire 570 to bend the flexible tubular frame 500 to a bending state of approximately 90 degrees results in the more flexible second bent portion 520 bending before the more rigid first bent portion 510. In an example instance, a single control wire 570 controls the bending of both the first bent portion 510 and the second bent portion 520.

[0126] Connectors of varying widths and / or thicknesses can be combined with varying spacing between connectors to further customize the bending characteristics, thereby modifying the bending radius obtained when bending from a straight state to approximately 90 degrees at the distal end. Variations in the spacing, width, and / or thickness of the connectors can be between defined bending portions at the distal end—for example, between the first bending portion 510 and the second bending portion 520—or can be varied per connector to form elliptical and other forms of curved bends at the distal end. That is, the distal end of the example can be designed for any bending profile or path based on the needs of a specific implantation procedure—such as implantation in the mitral or tricuspid valve—or for specific patients whose hearts may have small or large characteristics requiring different bending profiles to reach the target valve.

[0127] Refer again Figure 42 and 43The first curved portion 510 and the second curved portion 520 are indicated by dashed lines, showing the locations of the first polymer outer layer 530 and the second polymer outer layer 540, which may be made of a flexible material (such as a polymer). The first polymer layer 530 and the second polymer layer 540 may be the same as or substantially the same as the polymer layer 230 described above, but may have two different stiffnesses and / or be used on a frame 500 with multiple different curved portions (e.g., 510, 520) to provide different bending radii using a single filament 570. The polymer layers 530 and 540 may have the same stiffness or hardness, or may have different stiffnesses. Similar to the effect of the size and spacing of the connectors 512 and 522 on bending described above, the bending characteristics of the first polymer layer 530 and the second polymer layer 540 depend on the stiffness or bending resistance of the material used to form the first and second polymer layers. That is, using a stiffer material will require greater force to bend, resulting in a larger bending radius in the stiffer section. Similarly, a lower stiffness material will be softer and more easily bent, resulting in a smaller bending radius relative to the relatively stiffer portion. Therefore, similar to the thickness and spacing of connectors 512 and 522, the material properties of polymer layers 530 and 540 can be modified to alter the bending characteristics of the flexible tubular frame 500. Various combinations of soft and hard polymer materials and / or connector dimensions used for the first polymer layer 530 and the second polymer layer 540 can be used together to provide a wide variety of bending radii for the first bending portion 510 and the second bending portion 520.

[0128] For reference Figure 44 –50, showing an example flexible tubing frame 600 at the distal end of a flexible delivery catheter according to an exemplary embodiment, having first and second curved portions. The flexible tubing frame 600 extends from a proximal end 601 to a distal end 602 and may have an overall cylindrical shape opening at both the proximal and distal ends 602. The flexible tubing frame 600 has first, second, and third polymer layers 640, 650, 660 at the distal end of the delivery catheter. Figure 49 –50) provides supported and controlled flexibility. As with other exemplary embodiments described herein, the flexible tubular frame 600 and the distal region of the delivery conduit are not limited to a circular cross-section (e.g., Figure 47 That is, the shape of the cross-section can also be elliptical or oval.

[0129] The proximal end 601 of the flexible tubular frame 600 includes a plurality of rounded, oval, or substantially oval windows or cutouts 603, and a central cutout or proximal groove 605 opening into the proximal end 601 of the flexible tubular frame 600. When the delivery catheter is fully assembled, the proximal groove 605 can be aligned with the submersible anchor. The plurality of cutouts 603 provide openings for adhesive or polymeric materials to flow through the flexible tubular frame 600 to adhere to other materials, such as layers below or within the cutouts 603, thereby allowing the flexible tubular frame 600 to be embedded and secured in the desired location.

[0130] The distal end 602 of the flexible tubular frame 600 includes a toothed attachment portion 604 projecting from the underside of the distal end 602 for attaching the flexible tubular frame 600 to a distal pull ring 660. Figure 49 –50) or other pull rings, such as pull ring 2001 described above. The attachment portion 604 may be formed by a single protrusion or two protrusions, which in the flexible tubular frame 600 are made of a flat sheet of material (see, for example...). Figure 48 The flat sheet shown is joined together during formation. The distal end 602 also includes a semi-circular distal cutout 606, which is positioned on the top side of the distal end 602 during the formation of the tubular configuration of the flexible tubular frame 600. The distal cutout 606 is attached to the control wire 670 (…). Figure 49 –50) or other control wires, such as control wire 1135 mentioned above. Figure 47 The image shows the distal end 602 of the flexible tubular frame 600, the circular cross-sectional shape of the flexible tubular frame 600, and the relative positions of the attachment portion 604 and the cutout 606.

[0131] refer to Figure 44 The image shows a top view of a flexible tubular frame 600. The flexible tubular frame 600 has first, second, and third curved portions 610, 620, and 630. Each of the first, second, and third curved portions 610, 620, and 630 is formed by a plurality of connectors 612, 622, and 632 defined by slots or grooves 614, 624, and 634. Connectors 612, 622, and 632 may also include cuts 616, 626, and 636, and slits 618, 628, and 638. Each of the plurality of connectors 612, 622, and 632 may have a circular shape, and in a circular configuration, is spaced apart from at least one other connector by slots or grooves 614, 624, and 634 at the top and sides of the connectors 612, 622, and 632.

[0132] For reference Figure 45The diagram shows a side view of a flexible tubular frame 600, where cutouts 616, 626, 636 and slits 618, 628, 638 are located near the bottom of the flexible tubular frame 600. Cutouts 616, 626, 636 may have rounded shapes, such as semi-circular or semi-oval. Each cutout 616, 626, 636 corresponds to one of the plurality of connectors 612, 622, 632. When the flexible tubular frame 600 is made of a flat sheet of material (… Figure 48 When cut, cuts 616, 626, and 636 are formed on either side of the flexible tubular frame 600, such that when the flexible tubular frame 600 is rolled into a tubular configuration, each pair of cuts 616, 626, and 636 aligns to form circular, oval, or other rounded openings, creating a row of openings along the bottom of the flexible tubular frame 600, as shown below. Figure 46 As can be seen, slits 618, 628, and 638 are formed in the flexible tubular frame 600 such that two slits 618, 628, and 638 cut into each of the plurality of connectors 612, 622, and 632. Slits 618, 628, and 638 extend partially upward from the bottom of the flexible tubular frame 600 and into the specific connectors 612, 622, and 632. Slits 618, 628, and 638 operate similarly to pressure relief cuts because they close or are substantially closed when the flexible tubular frame 600 is in a straight configuration and can open or expand when the frame connectors 612, 622, and 632 move toward each other (when the flexible tubular frame 600 changes to a curved configuration).

[0133] For reference Figure 48 The diagram shows a plan view of a flexible tubular frame 600 in a planar configuration. The flexible tubular frame 600 is rectangular or substantially rectangular in shape when in planar configuration and can be rolled along its longitudinal axis to form a cylindrical tubular shape. Optionally, Figure 48The planar pattern shown can be used to instruct a laser cutter to cut through the formed hyaluronic acid tube, thus eliminating the need for a curling step. The hyaluronic acid tube may have properties similar to or the same as those described in the example embodiments above. The connectors 612, 622, and 632 of the flexible tube frame 600 are formed by laser cutting various shapes in a flat sheet of material. Specifically, the shapes of the connectors 612, 622, and 632 are defined by grooves 614, 624, and 634, cuts 616, 626, and 636, and slits 618, 628, and 638. That is, the grooves 614, 624, and 634 can be cut from the central region to form the plurality of connectors 612, 622, and 632. The grooves 614, 624, and 634 may have an elongated and / or tapered shape, such that the central region of each groove 614, 624, and 634 is wider than the ends of the grooves 614, 624, and 634 near the sides of the rectangular sheet. The edges of the flat material sheet are shaped by cuts 616, 626, and 636, which form a rounded oval shape when the material sheet is rolled into a flexible tubular frame 600. Slits 618, 628, and 638 extend from the cuts 616, 626, and 636 toward the center of the sheet. Cuts in the distal end 602 of the sheet form two attachment protrusions 604, which form a single attachment portion 604 when the material sheet is rolled into a tubular shape.

[0134] For reference Figure 49 and 50 This illustrates a flexible tubing frame 600 assembled with other components at the distal end of a delivery catheter. The distal assembly includes the flexible tubing frame 600, an optional proximal stationary or fixed ring 670, an optional distal pull loop or movable ring 680, and a control wire 690, and operates similarly to the distal assembly described above. The control wire 690 extends through the proximal ring 670, through the flexible tubing frame 600, and is attached to the distal ring 680. Similar to... Figure 20C The flexible tubular frame shown, when tension is applied to the control wire 690, causes the connectors 612, 622, 632 to move toward each other and the widths of the grooves 614, 624, 634 to decrease, thereby causing the flexible tubular frame 600 to bend toward its top or the inner radius of the bend. Applying bending tension to the control wire 690 also causes the cuts 616, 626, 636 and slits 618, 628, 638 on the bottom or outer radius of the bend to expand. In this exemplary embodiment, a single control wire is used to control the curvature of the distal region of the delivery catheter, but the device is not limited to this in other exemplary embodiments, where the delivery catheter may have more than one control wire.

[0135] The connectors 612 and 632 of the first and third curved / curved portions 610 and 630 are further apart than the connector 622 of the second curved portion 620, such as... Figure 44See in –46 and 49–50. Therefore, the grooves 614 and 634 of the first and third curved portions 610 and 630 are wider than the groove 624 of the second curved portion. The different spacing of the connectors 612, 622, and 632 in the first, second, and third curved portions 610, 620, and 630 contributes to the different bending characteristics of the first, second, and third curved portions 610, 620, and 630. That is, the closer spacing of the connectors 622 in the second curved portion 620 strengthens the second curved portion 620 relative to the first and third curved portions 610 and 630, resulting in a larger bending radius for the second curved portion 620 than that for the first and third curved portions 610 and 630. Optionally, the spacing of the connectors 612, 622, 632—and therefore the width of the grooves 614, 624, 634—may be the same between the first, second, and third curved portions 610, 620, 630, and the width and / or thickness of the connectors 612, 622, 632 may vary to alter the bending characteristics of the first, second, and third curved / curved portions 610, 620, 630. That is, thicker or wider connectors 612, 622, 632 may be used to reinforce one or more of the curved portions 610, 620, 630, thereby increasing the bending radius relative to one or more more flexible curved portions when exposed to bending forces. Due to the relative stiffness differences of the first, second, and third bending portions 610, 620, and 630, a bending force is applied to the flexible tubular frame 600 via control wire 690 to bend the flexible tubular frame 600 to an approximately 90-degree bending state, causing the more flexible first and third bending portions 610 and 630 to bend before the more rigid second bending portion 620. In an example instance, a single control wire 690 controls the bending of the first bending portion 610, the second bending portion 620, and the third bending portion.

[0136] Connectors of varying widths and / or thicknesses can be combined with varying spacing between connectors to further customize the bending characteristics, thereby modifying the bending radius obtained when bending from a straight state (or from an adjacent straightened portion) to a bending state of approximately 90 degrees at the distal end. Variations in the spacing, width, and / or thickness of the connectors can be between defined bending portions at the distal end—for example, between the first, second, and third bending portions 610, 620, 630—or can be varied per connector to form elliptical and other forms of curved bends at the distal end. That is, the distal end of the example can be designed for any bending profile or path based on the needs of a specific implantation procedure—such as implantation in the mitral or tricuspid valve—or for specific patients whose hearts may have characteristics requiring different bending profiles to reach the target valve, whether small or large.

[0137] Refer again Figure 49 and 50The first, second, and third bent portions 610, 620, and 630 are indicated by dashed lines, showing the locations of the first, second, and third polymer layers 640, 650, and 660, which may be made of a flexible material such as a polymer. The polymer layers 640, 650, and 660 may have the same or different stiffness. Similar to the effect of the dimensions and spacing of the connectors 612, 622, and 632 on bending described above, the bending characteristics of the first, second, and third polymer layers 640, 650, and 660 depend on the stiffness or bending resistance of the material used to form the first and second polymer layers. That is, using a stiffer material will require greater force to bend, resulting in a larger bending radius in the stiffer sections. Similarly, a less stiff material will be softer and more easily bent, resulting in a smaller bending radius relative to the stiffer portions. Therefore, similar to the thickness and spacing of the connectors 612, 622, and 632, the material properties of the polymer layers 640, 650, and 660 can be modified to change the bending characteristics of the flexible tubular frame 600. Various combinations of soft and rigid polymer materials and connector dimensions used for the first, second, and third polymer layers 640, 650, 660 can be used together to provide a wide variety of bending radii for the first, second, and third curved portions 610, 620, 630. Additionally, the first, second, and third polymer layers 640, 650, 660 (or any number of different polymer layers) can be used in conjunction with any frame described herein, such as a frame having a single uniformly flexed segment to form curved portions with different bending radii.

[0138] It should be noted that the devices and equipment described herein can be used in conjunction with other surgical procedures and access points (e.g., transapical, open cardiac visualization, etc.). It should also be noted that the devices described herein (e.g., deployment tools) can also be used in combination with various other types of valve repair or replacement devices and / or prosthetic valves, different from the examples described herein.

[0139] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, this disclosure relates to all novel, non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the presence of any one or more specific advantages or the resolution of any problem.

[0140] Although some embodiments of this disclosure are described in a specific ordered order for ease of presentation, it should be understood that this descriptive style encompasses rearrangement unless a specific order is required by particular language. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for brevity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, the description sometimes uses terms such as “provide” or “implement” to describe the disclosed methods. These terms are highly abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art. Moreover, examples or representative numerical values ​​and ranges may be included to aid in understanding this application; however, such numerical values ​​and ranges should not be interpreted in any limiting sense and are intended to be critical values ​​or ranges only where explicitly stated.

[0141] Given that the principles of this disclosure apply to a variety of possible implementations, it should be understood that the exemplified embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of this disclosure. The scope of this disclosure is defined by the claims.

[0142] While various inventive aspects, ideas, and features of this disclosure may be described and exemplified herein as being implemented in combination in exemplary embodiments, these various aspects, ideas, and features may be applied individually or in various combinations and sub-combinations in a variety of alternative embodiments. Unless expressly excluded herein, all such combinations and sub-combinations are intended to fall within the scope of this application. Furthermore, while various alternative embodiments of various aspects, ideas, and features of this disclosure may be described herein—such as alternative materials, structures, configurations, methods, apparatuses, and components, alternative forms in terms of form, fit, and function, etc.—such description is not intended to be a complete or exhaustive enumeration of available alternative embodiments, whether currently known or developed hereafter. Those skilled in the art will readily apply one or more inventive aspects, ideas, or features to other embodiments and applications within the scope of this application, even if such embodiments are not expressly disclosed herein.

[0143] Furthermore, while various aspects, features, and ideas may be explicitly identified herein as part of the inventiveness or constituent part of this disclosure, such identification is not intended to be exclusive. Rather, there may be inventive aspects, ideas, and features that are fully described herein but not explicitly identified as inventive aspects, ideas, and features or as part of a specific disclosure, which is instead set forth in the claims. Descriptions of exemplary methods or processes are not limited to including all steps in all cases, and the order in which steps are shown is not construed as required or mandatory unless explicitly stated otherwise. Furthermore, the treatment techniques, methods, operations, steps, etc., described or proposed herein or in the incorporated references may be applied to living animals or non-living simulants (such as cadavers, cadaver hearts, simulants (e.g., simulated body sites, tissues, etc.)). The terms used in the claims have their full ordinary meaning and are not in any way limited to the description of the embodiments in the specification.

Claims

1. A delivery catheter for delivering a device to a natural valve of a patient's heart, comprising: A flexible tube having a main cavity and a control wire cavity; Multiple connectors are arranged in the distal region of the flexible tube; Each connector is aligned and connected to at least one adjacent connector, and a groove is formed between each pair of adjacent connectors. When viewed from the side, the top portion of each connector is narrower than the bottom portion of each connector. Each connector includes an opening at the bottom of the connector; Each connector includes at least one slit, wherein the slit originates from the orifice and extends upward along at least a portion of the connector; as well as A control wire, located in the control wire cavity, is connected to the plurality of connectors, wherein applying tension to the control wire causes the distal region of the flexible tube to bend.

2. The delivery catheter of claim 1, wherein each connector is connected to at least one adjacent connector only at the bottom portion of the connector.

3. The delivery catheter of any of the preceding claims, wherein when tension is applied to the control wire to bend the distal region, the top portion of the connector is pulled closer together.

4. The delivery catheter of claim 3, wherein a coil sleeve surrounding a portion of the control wire prevents the proximal region of the delivery catheter from bending.

5. The delivery catheter of claim 3, wherein the plurality of connectors are in a straight configuration when tension is removed from the control wire.

6. The delivery catheter of any of the preceding claims, wherein the flexible tube further comprises a polymer coating.

7. The delivery catheter of any of the preceding claims, wherein the flexible tube further comprises a polyether block amide coating.

8. The delivery catheter of any of the preceding claims, wherein the plurality of connectors are made of at least one of shape memory material, stainless steel or polymer.

9. The delivery catheter of any of the preceding claims, wherein the flexible tube includes a ring distal to the plurality of connectors, and the control wire is securely attached to the ring.

10. The delivery catheter of claim 9, wherein the ring is connected to the distal connector of the plurality of connectors.

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