Counterflexing steerable catheter for transcatheter heart valve therapy

Abstract

To provide a counterflexing steerable catheter for transcatheter heart valve therapy.SOLUTION: An implantable prosthetic device includes a flexible hollow tube extending from a proximal end to a distal end. A first flexible portion extends from the proximal end to a middle portion. A second flexible portion extends from the middle portion to the distal end. A first pull wire attaches to the middle portion such that applying tension to the first pull wire causes the first flexible portion to bend in a first bend direction. A second pull wire attaches to the distal end such that applying tension to the second pull wire causes the second flexible portion to bend in a second bend direction. The first bend direction is offset from the second bend direction by approximately 160 to 200 degrees.SELECTED DRAWING: Figure 40

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 808,200, entitled "Counterflexing Steerable Catheter for Transcatheter Heart Valve Therapy," filed February 20, 2019. The above-referenced application is incorporated by reference in its entirety for all purposes. [Background technology]

[0002] The native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring an adequate supply of blood in the forward flow through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can suffer from reduced efficiency. Such damage to these valves can result in significant cardiovascular deterioration or death. Such damaged valves can be surgically repaired or replaced under open-heart surgery. However, open-heart surgery can be highly invasive and can cause complications. Transvascular techniques are available for the introduction and implantation of prosthetic devices in a much less invasive manner than open-heart surgery. As an example, one transvascular technique available for accessing the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, advancing 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 may also be utilized for implantation of a prosthetic device into the tricuspid valve, which begins similarly to the transseptal technique but does not go as far as puncturing the septum, instead directing the delivery catheter into the right atrium to the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers to the inferior apex. The heart consists of four chambers, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a significantly different anatomical structure than other native heart valves. The mitral valve includes an annulus, which is a circular portion of native valve tissue that surrounds the mitral orifice, and a pair of leaflets or cusps that extend inferiorly from the annulus into the left ventricle. The mitral annulus may form a "D" shape, an ellipse, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet may be larger than the posterior leaflet, and when they close together, a generally "C" shaped boundary is formed between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets together function as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium and is instead pushed out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae anchor the leaflets to the papillary muscles of the left ventricle.

[0005] Valve regurgitation involves a valve allowing some of the blood to flow inappropriately in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle insufficiency, stretching of the mitral annulus as a result of left ventricular expansion, and two or more of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to the commissure of one of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, so the valve does not close and regurgitation exists. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 8,449,599 [Patent Document 2] International Patent Application No. PCT / US2019 / 055320 [Patent Document 3] US Patent Application Publication No. 2014 / 0222136 [Patent Document 4] US Patent Application Publication No. 2014 / 0067052 [Patent Document 5] US Patent Application Publication No. 2016 / 0331523 [Patent Document 6] U.S. Patent Application Serial No. 15 / 984661 [Patent Document 7] U.S. Patent Application Serial No. 62 / 770,071 [Patent Document 8] U.S. Patent Application Serial No. 15 / 815,385 Summary of the Invention [Means for solving the problem]

[0007] This summary is intended to present some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in an example of this summary are not required for a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined herein.

[0008] In some embodiments, a delivery system or device comprises a flexible hollow tube extending from a proximal end to a distal end. A first flexible portion extends from the proximal end to an intermediate portion. A second flexible portion extends from the intermediate portion to the distal end. A first pull wire is attached to the intermediate portion, and application of tension to the first pull wire causes the first flexible portion to bend in a first bending direction. A second pull wire is attached to the distal end, and application of tension to the second pull wire causes the second flexible portion to bend in a second bending direction. The first bending direction is offset from the second bending direction by about 160 degrees to about 200 degrees.

[0009] In one example method of manufacturing a device for delivering an implant to a native valve of a patient's heart, a flexible hollow tube is provided. The flexible hollow tube extends from a proximal end to a middle portion. The flexible hollow tube includes a middle portion disposed between the proximal end and the distal end. A plurality of first slots are cut into the flexible hollow tube between the proximal end and the middle portion to form a first flexible portion extending from the proximal end to the middle portion. A plurality of second slots are cut into the flexible hollow tube between the middle portion and the distal end to form a second flexible portion extending from the middle portion to the distal end. A first wire is attached to the middle portion. A first pull wire extends through the first flexible portion along a first side of the flexible hollow tube. A first bend is formed in the first flexible portion in a first direction by applying tension to the first pull wire in a proximal direction. A second pull wire is attached to the distal end. The second pull wire extends through the first and second flexible portions along a second side of the flexible hollow tube. A second bend is formed in the second flexible portion in a second direction by applying tension to the second pull wire in a proximal direction. The second side is offset from the first side by an offset angle that is the same as the offset angle by which the second direction of the second bend is offset from the first direction of the first bend. The offset angle is in the range of about 160 degrees to about 200 degrees.

[0010] In one example of a method of delivering a heart valve implant using a delivery catheter, the delivery catheter is advanced into an atrium (e.g., into the right atrium, across the septum into the left atrium, etc.). The delivery catheter comprises a distal end, a first flexible portion, a second flexible portion, and an intermediate portion connecting the first and second flexible portions. A first curve is formed in the first flexible portion by tensioning a first pull wire connected to the intermediate portion. By forming the first curve, the distal end of the delivery catheter is moved away from the native valve. A second curve in the proximal section is formed by tensioning a second pull wire connected to the distal end. By forming the second curve, the distal end is moved towards the native valve. This method can be performed on a live animal or on a simulation, such as on a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.), etc.

[0011] In one example embodiment, a device for delivering an implant to a native valve of a patient's heart includes a flexible hollow tube, a first pull wire, and a second pull wire. The flexible hollow tube has a proximal region and a distal region. The distal region of the flexible hollow tube includes a distal section and a proximal section. The first pull wire is fixed to a distal end of the distal section. The second pull wire is fixed to a distal end of the proximal section. The second pull wire is offset from the first pull wire. In some embodiments, the second pull wire is offset from the first pull wire by 180 degrees or about 180 degrees. Applying tension to the first pull wire in a proximal direction forms a first bend in the distal section in a first direction. Applying tension to the second pull wire in a proximal direction forms a second bend in the proximal section in a second direction different from the first direction. In some embodiments, the second direction is opposite or substantially opposite to the first direction.

[0012] A further understanding of the nature and advantages of the present invention will be provided in the following detailed description and claims, especially when considered in conjunction with the accompanying drawings, in which like parts bear like reference numerals.

[0013] In order to further clarify various aspects of the embodiments of the present disclosure, a more particular description of some embodiments will be made with reference to various aspects of the accompanying drawings. It will be understood that these drawings merely illustrate typical embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, these drawings may be to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments of the present disclosure and other features and advantages will be described and explained with more specificity and detail through the use of the accompanying drawings. [Additional note 1] 1. A device for delivering an implant to a native valve of a patient's heart, comprising: a flexible hollow tube extending from a proximal end to a distal end, a first flexible portion extending from the proximal end to an intermediate portion; and a second flexible portion extending from the intermediate portion to the distal end. a flexible hollow tube comprising: a first pull wire extending through the first flexible portion to be attached to the intermediate portion, the first pull wire extending along a first side of the flexible hollow tube, and applying a proximal tension to the first pull wire forms a first bend in the first flexible portion in a first direction; a second pull wire extending through the first flexible portion and the second flexible portion to be attached to the distal end, the second pull wire extending along a second side of the flexible hollow tube, and applying tension to the second pull wire in a proximal direction to form a second bend in the second flexible portion in a second direction; Equipped with the second side is offset from the first side by the same offset angle as the second direction of the second bend is offset from the first direction of the first bend; The offset angle is within a range of about 160 degrees to about 200 degrees. [Additional note 2] 2. The device of claim 1, wherein the intermediate portion comprises a first pull ring and the distal end portion comprises a second pull ring. [Additional note 3] 3. The device of claim 2, wherein the first pull ring is integrally formed with the intermediate portion. [Additional note 4] 4. The device of claim 2 or 3, wherein the second pull ring is integrally formed with the distal end. [Additional note 5] a first conduit embedded within the flexible hollow tube and extending along the first side of the flexible hollow tube, the first conduit extending through the first flexible portion and at least a portion of the intermediate portion, and the first pull wire extending through the first conduit; a second conduit embedded within the flexible hollow tube and extending along the second side of the flexible hollow tube offset from the first conduit by the offset angle, the second conduit extending through the first flexible portion, the intermediate portion, and the second flexible portion, and the second pull wire extending through the second conduit; The device of any one of claims 1 to 4, further comprising: [Additional note 6] a proximal end of the first pull wire coupled to a first control mechanism for controlling tension on the first pull wire; 6. The device of any one of claims 1 to 5, wherein a proximal end of the second pull wire is coupled to a second control mechanism to control tension on the second pull wire. [Additional note 7] 7. The device of any one of claims 1 to 6, wherein the first bent portion forms an angle between 0 and 180 degrees, and the second bent portion forms an angle between 0 and 60 degrees. [Additional note 8] 7. The device of any one of claims 1 to 6, wherein the first bent portion forms an angle between 0 and 90 degrees, and the second bent portion forms an angle between 0 and 45 degrees. [Additional note 9] the first control mechanism comprises a first shaft, the first shaft being rotatable to wind up the first pull wire to apply tension to the first pull wire; 9. The device of any one of clauses 6 to 8, wherein the second control mechanism comprises a second shaft, the second shaft being rotatable to wind up the second pull wire to apply tension to the second pull wire. [Additional Note 10] 10. The device of any one of claims 1 to 9, wherein a proximal end of the first pull wire and a proximal end of the second pull wire are coupled to a shaft of a control mechanism. [Additional Note 11] the second pull wire has a slack portion when the flexible hollow tube is in a straight configuration; the slack is relieved when tension is initially applied to the second pull wire; 11. The device of any one of claims 1 to 10, wherein the slack portion is eliminated after the second bend is formed by continuing to apply tension to the second pull wire. [Additional Note 12] the shaft of the control mechanism has a first portion having a first diameter and a second portion having a second diameter, the first diameter being greater than the second diameter; the first pull wire is coupled to the first portion and the second pull wire is coupled to the second portion; 12. The device of claim 10 or 11, wherein rotation of the shaft increases tension on the first pull wire by a greater amount than the increase in tension on the second pull wire due to the rotation. [Additional Note 13] a shaft of the control mechanism having a first portion with a first thread pitch and a second portion with a second thread pitch, the first thread pitch being greater than the second thread pitch; the first pull wire is coupled to the first portion and the second pull wire is coupled to the second portion; 12. The device of claim 10 or 11, wherein rotation of the shaft increases tension on the first pull wire by a greater amount than the increase in tension on the second pull wire due to the rotation. [Additional Note 14] a proximal end of the first pull wire coupled to a first shaft of a control mechanism; a proximal end of the second pull wire coupled to a second shaft of the control mechanism; a clutch connecting the first shaft and the second shaft, the clutch having a disengaged position and an engaged position; Further equipped with when the clutch is in a disengaged position and the control mechanism is actuated, tension on the first pull wire increases; 9. The device of any one of claims 1 to 8, wherein when the clutch is in an engaged position and the control mechanism is actuated, the tension on the first pull wire and the tension on the second pull wire increase. [Additional Note 15] a first high stiffness region extending longitudinally along at least a portion of the first flexible portion; a second high stiffness region extending longitudinally along at least a portion of the second flexible portion; 15. The device of any one of claims 1 to 14, further comprising: [Additional Note 16] a center of longitudinal orientation of the first high stiffness region is circumferentially offset by 180 degrees from the first pullwire; 16. The device of claim 15, wherein a center of longitudinal orientation of the second high stiffness region is circumferentially offset by 180 degrees from the second pullwire. [Additional Note 17] the first high stiffness region extends about a first arc of a circumferential portion of the flexible hollow tube, the first arc having an angle between about 45 degrees and about 135 degrees; 17. The device of claim 15 or 16, wherein the second high stiffness region extends around a second arc of the circumferential portion of the flexible hollow tube, the second arc having an angle between about 45 degrees and about 135 degrees. [Additional Note 18] the angle of the first arc is between about 60 degrees and about 120 degrees; 18. The device of claim 17, wherein the angle of the second arc is between about 60 degrees and about 120 degrees. [Additional Note 19] the angle of the first arc is between about 85 degrees and about 95 degrees; 19. The device of claim 17 or 18, wherein the angle of the second arc is between about 85 degrees and about 95 degrees. [Additional Note 20] 20. The device of any one of claims 15 to 19, wherein a ratio of a first Shore D hardness of the first high stiffness region to a Shore D hardness of the flexible hollow tube is greater than a ratio of a second Shore D hardness of the second high stiffness region to the Shore D hardness of the flexible hollow tube. [Additional Note 21] 21. The device of claim 20, wherein the ratio of the Shore D hardness of the first high stiffness region to the Shore D hardness of the flexible hollow tube is between 1.5:1 and 5:1. [Additional Note 22] 22. The device of claim 20 or 21, wherein the ratio of the Shore D hardness of the first high stiffness region to the Shore D hardness of the flexible hollow tube is between 2.5:1 and 3.5:1. [Additional note 23] 23. The device of any one of the preceding clauses, wherein tension can be applied first to the first pull wire and then to the second pull wire. [Additional note 24] 23. The device of any one of claims 1 to 22, wherein tension can be applied to the first pull wire and the second pull wire simultaneously. [Additional note 25] 23. The device of any one of clauses 1 to 22, wherein tension can be applied first to the second pull wire and then to the first pull wire. [Additional note 26] 1. A method of manufacturing a device for delivering an implant to a native valve of a patient's heart, comprising: providing a flexible hollow tube extending from a proximal end to a distal end, the flexible hollow tube including an intermediate portion disposed between the proximal end and the distal end; cutting a plurality of first slots in the flexible hollow tube between the proximal end and the intermediate portion to form a first flexible portion extending from the proximal end to the intermediate portion; cutting a plurality of second slots in the flexible hollow tube between the intermediate portion and the distal end to form a second flexible portion extending from the intermediate portion to the distal end; attaching a first pull wire to the intermediate portion, the first pull wire extending through the first flexible portion along a first side of the flexible hollow tube, and applying a proximal tension to the first pull wire to form a first bend in the first flexible portion in a first direction; attaching a second pull wire to the distal end, the second pull wire extending through the first flexible portion and the second flexible portion along a second side of the flexible hollow tube, and applying tension to the second pull wire in a proximal direction to form a second bend in the second flexible portion in a second direction; Including, the second side is offset from the first side by the same offset angle as the second direction of the second bend is offset from the first direction of the first bend; The offset angle is within a range of about 160 degrees to about 200 degrees. [Additional note 27] 27. The method of claim 26, wherein the cutting step is performed using a laser cutter. [Additional note 28] The method of claim 26, wherein the device is a device described in any one of claims 1 to 25. [Additional note 29] 1. A method of delivering a heart valve implant using a delivery catheter, comprising: advancing a delivery catheter into the atrium, the delivery catheter comprising a distal end, a first flexible portion, a second flexible portion, and an intermediate portion connecting the first and second flexible portions; forming a first curve in the first flexible section by tensioning a first pull wire coupled to the intermediate section, the forming of the first curve moving the distal end of the delivery catheter away from a native valve; forming a second curve in the proximal section by tensioning a second pull wire coupled to the distal end, the forming of the second curve moving the distal end toward the native valve; A method comprising: [Additional note 30] 1. A device for delivering an implant to a native valve of a patient's heart, comprising: a flexible hollow tube having a proximal region and a distal region, the distal region of the flexible hollow tube comprising a distal section and a proximal section; a first pull wire fixed to a distal end of the distal section; a second pull wire secured to a distal end of the proximal section; Equipped with the second pull wire is offset from the first pull wire; applying tension to the first pull wire in a proximal direction to form a first bend in the distal section in a first direction; A device in which a second bend is formed in the proximal section in a second direction different from the first direction by applying tension to the second pull wire in a proximal direction. [Additional note 31] 31. The device of claim 30, wherein tension can be applied first to the first pull wire and then to the second pull wire. [Additional note 32] 32. The device of claim 30 or 31, wherein tension can be applied to the first pull wire and the second pull wire simultaneously. [Additional note 33] 33. The device of any one of clauses 30 to 32, wherein the distal end of the distal section comprises a first pull ring and the distal end of the proximal section comprises a second pull ring. [Additional note 34] 34. The device of any one of clauses 30-33, wherein the first pull wire extends through a first conduit located within the flexible hollow tube and extending through the distal section and the proximal section and along the top of the flexible hollow tube, and the second pull wire extends through a second conduit located within the flexible hollow tube and extending through the proximal section and along the bottom of the flexible hollow tube. [Additional note 35] 35. The device of any one of clauses 30 to 34, wherein a proximal end of the first pull wire is coupled to a first control mechanism and a proximal end of the second pull wire is coupled to a second control mechanism, the first control mechanism controlling the tension on the first pull wire and the second control mechanism controlling the tension on the second pull wire. [Additional note 36] 33. The device of any one of claims 30 to 32, wherein the first bend forms an angle between 0 and 180 degrees and the second bend forms an angle between 0 and 60 degrees. [Additional note 37] 37. The device of claim 36, wherein the first bend forms an angle between 0 and 90 degrees and the second bend forms an angle between 0 and 45 degrees. [Additional note 38] 38. The device of any one of clauses 30 to 37, wherein the proximal end of the first pull wire and the proximal end of the second control wire are coupled to a single control mechanism. [Additional note 39] 39. The device of claim 38, wherein the single control mechanism comprises a first shaft and a second shaft, the first shaft being rotatable to wind up the first pull wire to apply tension to the first pull wire, and the second shaft being rotatable to wind up the second pull wire to apply tension to the second pull wire. [Additional note 40] 40. The device of claim 38 or 39, wherein when the flexible hollow tube is in a straight configuration, the first and second control wires are slack, and an initial actuation of the single control mechanism applies tension to the first pull wire to form the first bend, the slack in the second control wire is relieved, and continued actuation of the single control mechanism applies tension to the second pull wire to form the second bend. [Additional note 41] 40. The device of claim 39, wherein the first shaft has a first diameter and the second shaft has a second diameter, the first diameter being larger than the second diameter. [Additional note 42] 42. The device of claim 41, wherein the first pull wire is coupled to the first shaft and the second pull wire is coupled to the second shaft, such that rotation of the first shaft and the second shaft together increases tension on the first pull wire by a greater amount than the increase in tension on the second pull wire due to the rotation. [Additional note 43] 40. The device of claim 39, wherein the first shaft has a first thread pitch and the second shaft has a second thread pitch, the first thread pitch being greater than the second thread pitch, the first pull wire is coupled to the first shaft, and the second pull wire is coupled to the second shaft. [Additional note 44] 44. The device of claim 43, wherein rotating the first shaft and the second shaft together increases tension on the first pull wire by a greater amount than the increase in tension on the second pull wire due to the rotation. [Additional note 45] 45. The device of any one of clauses 30-44, wherein a proximal end of the first pull wire is coupled to a first shaft of a control mechanism and a proximal end of the second pull wire is coupled to a second shaft of the control mechanism, the first shaft and the second shaft are coupled by a clutch, the clutch having a disengaged position and an engaged position, and when the clutch is in the disengaged position and the control mechanism is actuated, tension on the first pull wire increases, and when the clutch is in the engaged position and the control mechanism is actuated, the tension on the first pull wire and the tension on the second pull wire increase. [Additional note 46] 46. ​​The device of claim 45, wherein the distal section comprises a first region of high stiffness and the proximal section comprises a second region of high stiffness. [Additional note 47] a center of longitudinal orientation of the first high stiffness region is circumferentially offset by 180 degrees from the first pullwire; 47. The device of claim 46, wherein a center of longitudinal orientation of the second high stiffness region is circumferentially offset by 180 degrees from the second pullwire. [Additional note 48] 48. The device of claim 46 or 47, wherein the first high stiffness region extends around a first arc of a circumferential portion of the flexible hollow tube, the first arc being an angle between 45 degrees and 135 degrees, and the second high stiffness region extends around a second arc of the circumferential portion of the flexible hollow tube, the second arc being an angle between 45 degrees and 135 degrees. [Additional note 49] 49. The device of claim 48, wherein the first arc is between 60 degrees and 120 degrees, and the second arc is between 60 degrees and 120 degrees. [Additional Note 50] 49. The device of claim 48, wherein the first arc is between 85 degrees and 95 degrees and the second arc is between 85 degrees and 95 degrees. [Additional note 51] 48. The device of claim 47, wherein the ratio of Shore D hardness between the first high stiffness region and the flexible hollow tube is greater than the ratio of Shore D hardness between the second high stiffness region and the flexible hollow tube. [Additional note 52] 52. The device of claim 51, wherein the ratio of Shore D hardness of the first high stiffness region to the flexible hollow tube is between 1.5:1 and 5:1. [Additional note 53] 53. The device of claim 52, wherein the ratio of Shore D hardness of the first high stiffness region to the flexible hollow tube is between 2.5:1 and 3.5:1. [Additional note 54] 54. The device of any one of clauses 30-53, wherein the second pull wire is offset from the first pull wire by 180 degrees. [Additional note 55] 55. The device of any one of clauses 30 to 54, wherein the second direction is opposite to the first direction. [Additional note 56] 1. A device for delivering an implant to a native valve of a patient's heart, comprising: a flexible hollow tube having a proximal region and a distal region, the distal region of the flexible hollow tube comprising a distal section and a proximal section; a first pull wire fixed to a distal end of the distal section; a second pull wire secured to a distal end of the proximal section; Equipped with the second pull wire is offset from the first pull wire by approximately 180 degrees; applying tension to the first pullwire in a proximal direction to form a first bend in the distal section in a first direction; A device in which applying tension to the second pull wire in a proximal direction forms a second bend in the proximal section in a second direction substantially opposite to the first direction. [Additional note 57] 57. The device of claim 56, wherein the distal end of the distal section comprises a first pull ring and the distal end of the proximal section comprises a second pull ring. [Additional note 58] 58. The device of claim 56 or 57, wherein the first pull wire extends through a first conduit that is located within the flexible hollow tube and extends through the distal section and the proximal section along the top of the flexible hollow tube, and the second pull wire extends through a second conduit that is located within the flexible hollow tube and extends through the proximal section along the bottom of the flexible hollow tube. [Additional note 59] 59. The device of any one of clauses 56 to 58, wherein a proximal end of the first pull wire is coupled to a first control mechanism and a proximal end of the second pull wire is coupled to a second control mechanism, the first control mechanism controlling the tension on the first pull wire and the second control mechanism controlling the tension on the second pull wire. [Additional note 60] 60. The device of any one of claims 56 to 59, wherein the first bend forms an angle between 0 and 180 degrees and the second bend forms an angle between 0 and 60 degrees. [Additional note 61] The device of any one of clauses 56 to 60, wherein the proximal end of the first pull wire and the proximal end of the second control wire are coupled to a single control mechanism. [Additional note 62] 62. The device of claim 61, wherein the single control mechanism comprises a first shaft and a second shaft, the first shaft being rotatable to wind up the first pull wire to apply tension to the first pull wire, and the second shaft being rotatable to wind up the second pull wire to apply tension to the second pull wire. [Additional note 63] 63. The device of claim 61 or 62, wherein when the flexible hollow tube is in a straight configuration, the first control wire and the second control wire are slack, and an initial actuation of the single control mechanism applies tension to the first pull wire to form the first bend, the slack in the second control wire is relieved, and continued actuation of the single control mechanism applies tension to the second pull wire to form the second bend. [Additional note 64] 63. The device of claim 62, wherein the first shaft has a first thread pitch and the second shaft has a second thread pitch, the first thread pitch being greater than the second thread pitch, the first pull wire is coupled to the first shaft and the second pull wire is coupled to the second shaft. [Additional note 65] 65. The device of any one of clauses 56 to 64, wherein a proximal end of the first pull wire is coupled to a first shaft of a control mechanism and a proximal end of the second pull wire is coupled to a second shaft of the control mechanism, the first shaft and the second shaft are coupled by a clutch, the clutch having a disengaged position and an engaged position, and when the clutch is in the disengaged position and the control mechanism is actuated, tension on the first pull wire increases, and when the clutch is in the engaged position and the control mechanism is actuated, the tension on the first pull wire and the tension on the second pull wire increase. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a cut-away view of a human heart during diastole. [Diagram 2] FIG. 1 is a cut-away view of a human heart during systole. [Diagram 3] FIG. 1 is a cut-away view of a human heart in diastole illustrating the chordae tendineae attaching the mitral and tricuspid valve leaflets to the ventricular wall. [Figure 4]FIG. 1 illustrates a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Diagram 5] FIG. 1 illustrates a dysfunctional mitral valve with visible gaps between the leaflets viewed from the atrial side of the mitral valve. [Figure 6] FIG. 1 illustrates a mitral valve with a large gap between the posterior and anterior leaflets. [Figure 7] FIG. 2 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 9] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 10] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 11] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 11A] FIG. 12 shows an embodiment of an implantable prosthetic device similar to the device shown in FIG. 11, but with independently controllable paddles. [Figure 12] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 13] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 14] 1A-1D illustrate an example embodiment of an implantable prosthetic device at different stages of deployment. [Figure 15] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 16] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 17] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 17A]FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into the native mitral valve by an example reciprocal flexion delivery device. [Figure 18] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 18A] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into the native mitral valve by an example reciprocal flexion delivery device. [Figure 19] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 19A] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into the native mitral valve by an example reciprocal flexion delivery device. [Figure 20] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 21] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 22] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 23] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 24] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 24A] 33 illustrates the implantable prosthetic device of FIGS. 21-32 being delivered and implanted into the native mitral valve by a reciprocal flexion delivery device according to one example embodiment. FIG. [Diagram 25] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 25A]33 illustrates the implantable prosthetic device of FIGS. 21-32 being delivered and implanted into the native mitral valve by a reciprocal flexion delivery device according to one example embodiment. FIG. [Figure 26] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 27] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 28] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 29] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Diagram 30] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Diagram 31] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Diagram 32] 1A-1C illustrate an example embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 32A] 33 illustrates the implantable prosthetic device of FIGS. 21-32 being delivered and implanted into the native mitral valve by a reciprocal flexion delivery device according to one example embodiment. FIG. [Diagram 33] 1 is a perspective view of a distal section of an example delivery catheter used as part of an example delivery device for implanting an anchoring device. FIG. [Diagram 34] FIG. 34 is a cross-sectional view of multiple links of the distal section of FIG. 33. [Diagram 35] FIG. 2 is a perspective view of a distal section of a delivery catheter in a bent or curved configuration. [Diagram 36] FIG. 2 is a flattened view of an example laser cut sheet that may be used to form the distal section of a delivery catheter. [Figure 37]FIG. 13 is a flattened view of another example laser cut sheet that may be used to form the distal section of a delivery catheter. [Figure 38] FIG. 13 is a flattened view of another example laser cut sheet that may be used to form the distal section of a delivery catheter. [Figure 39] FIG. 13 is a perspective view showing a bent or curved configuration of a distal segment of a delivery catheter having two flexure sections that can be used to implant an anchoring device in a native valve, such as by using a transseptal technique. [Diagram 40] FIG. 1 is a schematic side view of the distal section of an example delivery catheter having an example two control wire or two pull wire system that may be used in various delivery catheters or delivery devices herein. [Diagram 41] FIG. 41 is a schematic perspective view of the delivery catheter of FIG. 40 in a partially actuated state. [Diagram 42] FIG. 41 is a schematic perspective view of the delivery catheter of FIG. 40 in a fully actuated state. [Figure 43A] FIG. 13 is an end view of another example embodiment of a delivery catheter. [Figure 43B] FIG. 43B is a cross-sectional view taken along the plane indicated by line BB in FIG. 43A. [Figure 43C] FIG. 43C is a cross-sectional view taken along the plane indicated by line DD in FIG. 43B. [Fig. 43D] FIG. 43C is a cross-sectional view taken along the plane indicated by line CC in FIG. 43B. [Figure 44A] FIG. 43D is a schematic perspective view of a distal section of the delivery catheter of FIGS. 43A-43D in a partially actuated state. [Figure 44B] FIG. 43B is a schematic perspective view of the distal section of the delivery catheter of FIGS. 43A-43D in a more actuated or curved actuated state. [Figure 45A] FIG. 43D is a partial view of the delivery catheter of FIGS. 43A-43D. [Figure 45B] 45B is a cross-sectional view of the delivery catheter shown in FIG. 45A in a plane perpendicular to the longitudinal axis of the delivery catheter. [Figure 45C]45B is a cross-sectional view of the delivery catheter shown in FIG. 45A in a plane perpendicular to the longitudinal axis of the delivery catheter. [Figure 45D] 45B is a cross-sectional view of the delivery catheter shown in FIG. 45A in a plane perpendicular to the longitudinal axis of the delivery catheter. [Diagram 46] FIG. 43C is a schematic diagram of an example two pull wire system for the delivery catheter shown in FIGS. 43A-43D. [Figure 47A] 1 is a plan view of a distal section of a delivery catheter used as part of a delivery device for implanting a valve repair or replacement device, according to one example embodiment. [Figure 47B] FIG. 47B is a side view of the distal section of the delivery catheter shown in FIG. 47A. [Figure 47C] FIG. 47B is a bottom view of the distal section of the delivery catheter shown in FIG. 47A. [Figure 47D] FIG. 47B is an end view of the distal section of the delivery catheter shown in FIG. 47A. [Figure 48A] FIG. 47B is a flattened view of a laser cut sheet for a distal section of a delivery catheter according to the example embodiment of FIG. 47A. [Figure 48B] FIG. 48B is an enlarged view of a portion of the laser cut sheet of FIG. 48A. [Figure 49A] FIG. 2 is a side view of a distal shaft of a catheter according to an example embodiment. [Figure 49B] FIG. 49B is an end view of a distal shaft of a steerable catheter according to the embodiment of FIG. 49A. [Figure 50A] FIG. 1 is a side view of a distal section of a delivery catheter with a control wire threaded therethrough according to an example embodiment. [Figure 50B] FIG. 50B is a side view of the distal section of the delivery catheter of FIG. 50A, showing operation when a control wire is pulled, according to one example embodiment. [Figure 51] FIG. 49B is a cross-sectional view of the steerable catheter of FIG. 49A taken along line BB-BB of FIG. 49A. [Figure 52A] 49A is a cross-sectional view of the steerable catheter of FIG. 49A taken along line CC-CC of FIG. 49A. [Figure 52B] FIG. 52B is an enlarged view of a portion of the cross-sectional view of FIG. 52A with a control wire. [Diagram 53] FIG. 49B is a cross-sectional view of the steerable catheter of FIG. 49A taken along line DD-DD of FIG. 49A. [Figure 54] FIG. 49B is a cross-sectional view of the steerable catheter of FIG. 49A taken along line EE-EE of FIG. 49A. [Figure 55A] FIG. 13 is a flattened view of a proximal anchoring ring for a distal portion of a delivery catheter according to one example embodiment. [Figure 55B] FIG. 55B is an enlarged view of a portion of the anchor ring shown in FIG. 55A with weld holes. [Figure 56A] FIG. 55B is a top view of the anchor ring of FIG. 55A having a hypotube anchor according to one example embodiment. [Figure 56B] FIG. 56B is a side view of the anchor ring of FIG. 56A. [Figure 56C] FIG. 56B is an end view of the anchor ring of FIG. 56A. [Figure 57A] FIG. 13 is a flattened view of a proximal coil stopper according to an example embodiment. [Figure 57B] FIG. 57B is a close-up view of the weld hole in the proximal coil stopper of FIG. 57A. [Figure 58A] FIG. 13 is a plan view of a portion of a proximal coil stopper and coil according to an example embodiment. [Figure 58B] FIG. 58B is a cross-sectional view of the proximal coil stopper and coil along line XX of FIG. 58A according to an example embodiment. [Figure 58C] FIG. 58B is an end view of the proximal coil stopper and proximal end of the coil of FIG. 58A. [Figure 59A] FIG. 1 is a schematic diagram of a reciprocal bending steerable catheter having two pull wire controls in a straight configuration according to an example embodiment. [Figure 59B] FIG. 59B is a schematic diagram of the reciprocally deflectable steerable catheter of FIG. 59A with a deflected distal segment in accordance with one example embodiment. [Figure 59C] FIG. 59B is a schematic diagram of the reciprocally deflectable steerable catheter of FIG. 59A with deflected distal and proximal segments in accordance with one example embodiment. [Figure 60A] FIG. 1 is a schematic diagram of a reciprocal deflection steerable catheter with a clutch-type pull wire control mechanism in a disengaged configuration, according to one example embodiment. [Figure 60B] FIG. 60B is a schematic diagram of the reciprocal bending steerable catheter of FIG. 60A with the clutch-type control mechanism in an engaged configuration. [Figure 61] FIG. 1 is a schematic diagram of a reciprocal bending steerable catheter having one pull wire control with slack to control when the proximal pull wire is tensioned, according to one example embodiment. [Figure 62A] FIG. 1 is a schematic diagram of a reciprocally deflectable steerable catheter having different stiffness characteristics along the length and circumference of the catheter to control deflection, according to one example embodiment. [Figure 62B] FIG. 1 is a schematic diagram of a reciprocally deflectable steerable catheter having different stiffness characteristics along the length and circumference of the catheter to control deflection, according to one example embodiment. [Figure 62C] FIG. 1 is a schematic diagram of a reciprocally deflectable steerable catheter having different stiffness characteristics along the length and circumference of the catheter to control deflection, according to one example embodiment. [Figure 63] FIG. 1 is a schematic diagram of a reciprocally flexing steerable catheter having different flex / wheel rotation ratios for each pull wire to pull the pull wires at different rates, according to one example embodiment. [Figure 64] FIG. 13 is a schematic diagram of a reciprocally flexing steerable catheter having different thread pitches for each pull wire to pull the pull wires at different rates, according to one example embodiment. [Figure 65] FIG. 1 is a schematic diagram of a reciprocal bending steerable catheter having two bending regions each having a single pull wire for bending in two different directions, according to an example embodiment. [Figure 66] 1 is a top view of a distal section of a delivery catheter used as part of a delivery device to implant a valve repair or replacement device, according to one example embodiment. [Figure 67]FIG. 67 is a side view of the distal section of the delivery catheter shown in FIG. [Figure 68] FIG. 67 is a bottom view of the distal section of the delivery catheter shown in FIG. [Figure 69] FIG. 67 is an end view of the distal section of the delivery catheter shown in FIG. [Figure 70] FIG. 1 is a side view of a distal section of a delivery catheter with a control wire threaded therethrough according to an example embodiment. [Figure 71] 71 is a side view of the distal section of the delivery catheter of FIG. 70, illustrating operation when a control wire is pulled, according to one example embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The following description refers to the accompanying drawings which illustrate specific embodiments of the present disclosure. Other embodiments having different structure and operation do not depart from the scope of the present disclosure.

[0016] Exemplary embodiments of the present disclosure relate to devices and methods for repairing heart valve defects. It should be noted that various embodiments of native valve repair devices and systems for delivery are disclosed herein, and any combination of these options is possible unless otherwise stated. In other words, each component of the devices and systems of the present disclosure can be combined unless they are mutually exclusive or physically impossible.

[0017] In the description herein, one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, although such interconnection may be direct between the components or may be indirect, such as through the use of one or more intermediate components. Also, in the description herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, in the description herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1% of a given value or condition).

[0018] The exemplary embodiment of the catheter can be flexed downward to target a native valve, such as the mitral valve, during the transseptal implantation procedure of the implant, and can also be elevated to place the implant higher above the native valve. The implant can take a wide variety of forms. In some embodiments, the implant can be configured as a valve repair device, such as the PASCAL system manufactured by Edwards Lifesciences Corporation. Various implementations and user interface controls are described herein. The system and method of use of the system can be used when the transseptal puncture is lower than the optimal or target location. The lower puncture reduces the space between the end of the catheter and the native annulus (e.g., mitral annulus, tricuspid annulus, etc.). The system and method can be used to provide more space between the end of the catheter where the implant is attached and the leaflets. By raising the height of the implant, it can be easier and / or more efficient to perform procedural steps such as clocking the implant, gripping the leaflets, disengaging the leaflets from the paddles, and repositioning the leaflets.

[0019] Exemplary embodiments described herein can include a steerable catheter having a distal region with a flex section at the distal-most end of the catheter, referred to herein as the distal flex section, and a flex section located within the distal region proximal to the distal flex section, referred to herein as the proximal flex section. The distal flex section can flex to form a 170 degree bend or about a 170 degree bend. The proximal flex section can flex to form a 60 degree bend or about a 60 degree bend. The distal flex section can have a pull wire (also referred to herein as a control wire) on the inferior side of the catheter, which directs the flex to bend inferiorly toward the valve. The proximal flex section has a pull wire on the superior side of the catheter, which directs the flex to bend away from the valve. When the distal and proximal flexure sections flex together, the proximal flexure section directs the distal region of the catheter superiorly and the distal flexure section directs the distal end of the catheter inferiorly, downward toward the heart valve. These two flexures ultimately result in an overall shape resembling a "question mark" pointing inferiorly, with the superior flexure gaining an elevated position above the valve. In this "question mark" configuration, the distal end is directed inferiorly by the flexion of the distal flexure section and elevated above the native valve by the flexion of the proximal flexure section.

[0020] The distal and proximal flex sections may be controlled by a single flex wheel or two independently controllable flex wheels. The flexing may be performed in any order, such as first the distal flex section and then the proximal flex section, or vice versa. The two flex sections may also be flexed simultaneously. In the exemplary embodiment described herein, simultaneous flexing of the proximal and distal flex sections may be utilized to maintain the pointed orientation of the distal end of the catheter while the distal end is elevated. Simultaneous flexing compensates for changes in the position and trajectory of the distal end by additional flexing of the distal flex section.

[0021] 1 and 2 are cutaway views of a human heart H in diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV, i.e., the atrioventricular valve. In addition, the aortic valve AV separates the left ventricle LV from the ascending vena cava AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 4 and 5) that extend inward beyond their respective ostia, and these leaflets meet or "coapt" together in flow to form a surface that blocks fluid in one direction. The native valve restoration system of the present application is described primarily in relation to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in detail. It should be understood that the devices described herein may be used for the repair of other native valves, for example, the devices may also be used to repair the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0022] The left atrium LA receives oxygen-rich blood from the lungs. During the diastolic phase (diastole) shown in FIG. 1, blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the systolic phase (systole) shown in FIG. 2, the left ventricle LV contracts, sending 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 left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In an example embodiment, the devices described herein are used to restore the function of a defective mitral valve MV. That is, these devices are configured to prevent blood from flowing back from the left ventricle LV into the left atrium LA by helping to close the leaflets of the mitral valve.

[0023] 1-7, the mitral valve MV comprises two leaflets, anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also comprises an annulus 24, which is a ring of fibrous tissue of variable density that circularly surrounds the leaflets 20, 22. Referring to FIG. 3, the mitral valve MV is tethered to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the 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. The papillary muscles 12 serve to limit the movement of the mitral valve MV and prevent it from retracting. 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. Rather, the papillary muscles reinforce the mitral valve MV against the high pressures required to circulate blood throughout the body. Together, the papillary muscles and chordae tendineae are known as the subvalvular apparatus, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA as the mitral valve closes.

[0024] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other cardiac diseases (e.g., cardiomyopathy) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as surgery on the mitral valve MV, suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0025] Generally, native valves can become dysfunctional in two distinct ways: (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis occurs due to the buildup of calcified material on the leaflets of the valve, which leads to thickening of the leaflets and impairs the ability of the valve to open sufficiently to allow forward flow of blood.

[0026] The second type of valve dysfunction, or valve regurgitation, occurs when the leaflets of the valve do not close completely, thereby allowing blood to leak back into the anterior chamber (e.g., blood leaks from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant or incompetent: Carpentier's Type I, Type II, and Type III dysfunction. Carpentier's Type I dysfunction involves distension of the valve annulus such that normally functioning leaflets deflect away from one another and are unable to form a tight seal (i.e., the leaflets do not coapt properly). Type I mechanical dysfunction includes leaflet perforation, as occurs in endocarditis. Carpentier's Type II dysfunction involves prolapse of one or more leaflets of the native valve above the coaptation plane. Carpentier's Type III dysfunction involves the motion of one or more leaflets of the native valve such that the leaflets are abnormally restrained below the plane of the annulus. Leaflet retention can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0027] With reference to Figure 4, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 are coapted, thereby preventing blood leakage from the left ventricle LV into the left atrium LA. With reference to Figure 5, regurgitation occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole. Such malcoaptation creates a gap 26 between the anterior leaflets 20 and posterior leaflets 22, thereby allowing blood to flow back from the left ventricle LV into the left atrium LA during systole. As indicated above, there are several different ways in which the leaflets (e.g., the leaflets 20, 22 of the mitral valve MV) can become dysfunctional, which can lead to regurgitation.

[0028] 6, in some circumstances, the patient's mitral valve MV may have a large gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed position (i.e., during systole). For example, the gap 26 may have a width between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, about 10 mm, etc. In some circumstances, the gap 26 may have a width W greater than 15 mm. In any of the above circumstances, it is desirable for the valve repair device to be able to engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent blood backflow through the mitral valve MV.

[0029] Although stenosis or regurgitation can affect any valve, it has been found that stenosis primarily affects either the aortic valve AV or the pulmonary valve PV, and regurgitation primarily affects either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating blood throughout the body, dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, dysfunction of the mitral valve MV or the aortic valve AV is often more problematic due to the significantly higher pressures on the left side of the heart.

[0030] The dysfunctional native heart valve may be either repaired or replaced. Typically, repair involves preserving and correcting the patient's native valve. Typically, replacement involves replacing the patient's native valve with a biological or physical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage suffered by the leaflets is irreversible, some treatments for stenotic aortic or pulmonary valves are valve removal and replacement with a surgically implanted heart valve or with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to leaflet deformation, which prevents the mitral or tricuspid valve from closing properly as described above and allows blood to flow back from the ventricle into the atrium (e.g., a deformation of the mitral valve MV may allow blood to flow back from the left ventricle LV into the left atrium LA). Blood flow back from the ventricle into the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV can often be repaired. Additionally, regurgitation can occur due to incompetence of the chordae tendineae 10 (e.g., the chordae tendineae may stretch or break), causing the anterior and posterior leaflets 20 and 22 to evert, allowing blood to flow back into the left atrium LA. These problems caused by incompetence of the chordae tendineae 10 can be resolved by repairing the chordae tendineae or structure of the mitral valve (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0031] The devices and procedures disclosed herein often refer to the repair of the mitral valve for illustrative purposes. However, it should be understood that the devices and concepts presented herein can be used for the repair of any native valve and any component of the native valve. For example, referring to FIG. 7, any of the devices and concepts presented herein can be used for the repair of the tricuspid valve TV. For example, any of the devices and concepts presented herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent blood from flowing back from the right ventricle into the right atrium. Furthermore, any of the devices and concepts presented herein can be used simultaneously on all three leaflets 30, 32, 34 to prevent or block blood from flowing back from the right ventricle into the right atrium. That is, the valve repair device presented herein can be centered between the three leaflets 30, 32, 34.

[0032] An example of an implantable prosthetic device has one or more anchors and an optional coaptation element (e.g., spacer, coaptation element, etc.). The coaptation element may be configured to be positioned in the native heart valve orifice to fill the space between the native leaflets and help reduce or prevent the above-mentioned regurgitation by forming a more effective seal. The coaptation element may be impermeable or resistant to blood and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby preventing blood flow from the left or right ventricle into the left or right atrium, respectively. The prosthetic device may be configured to seal against two or three native leaflets, i.e., the device may be used in native mitral (bicuspid) and tricuspid valves. Because the coaptation element may fill the space between incompetent native mitral or tricuspid leaflets that do not close completely, the coaptation element is sometimes referred to herein as a spacer.

[0033] The coaptation elements (e.g., spacers, coaptation elements, etc.) may have a variety of shapes. In some embodiments, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some embodiments, the coaptation elements may have an elliptical cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The coaptation elements may have an atrial portion positioned in or adjacent to the left atrium, a ventricular or inferior portion positioned in or adjacent to the left ventricle, and a lateral surface extending between the native mitral valve leaflets. In embodiments configured for use in a tricuspid valve, the atrial or superior portion is positioned in or adjacent to the right atrium, the ventricular or inferior portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid valve leaflets.

[0034] The anchor may be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between those two native leaflets. In embodiments configured for use in a tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some embodiments, the anchor may be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some embodiments, the anchor may be attached to an actuating element, such as a shaft or actuation wire, to which the coaptation element is further attached. In some embodiments, the anchor and the coaptation element may be independently positioned relative to one another by individually moving each of the anchor and the coaptation element along the longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating wire, actuating tube, etc.). In some embodiments, the anchor and the coaptation element may be simultaneously positioned by moving the anchor and the coaptation element together along the longitudinal axis of the actuating element, such as a shaft or actuating wire. The anchor may be configured to be positioned behind the native leaflets when implanted such that the leaflets are gripped by the anchor.

[0035] The prosthetic device may be configured to be implanted via a delivery sheath or delivery catheter. The coaptation elements and anchors may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive force is released. The device may be configured to initially expand radially away from the coaptation elements, with the anchors still in a compressed state, to form a gap between the coaptation elements and the anchors. The native leaflets may then be positioned within the gap. The radial expansion of the coaptation elements may close the gap between the coaptation elements and the anchors, capturing the leaflets between the coaptation elements and the anchors. In some embodiments, the anchors and coaptation elements are optionally configured to self-expand. The implantation method may vary for various embodiments and is discussed in more detail in connection with each embodiment below. Further information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, International Patent Application PCT / US2019 / 055320, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, and U.S. Patent Application Publication No. 2016 / 0331523, each of which is incorporated by reference in its entirety for all purposes. These methods can be performed mutatis mutandis on live animals or on simulations, such as on cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.), etc.

[0036] The prosthetic device of the present disclosure may be configured to withstand high systolic pressures, with anchors coupled to the leaflets, utilizing tension from the natural chordae tendineae to urge the device into the left atrium. During diastole, the device may rely on compressive and retaining forces applied to the leaflets gripped by the anchors.

[0037] 8-14, a schematic diagram of an example implantable prosthetic device 100 (e.g., a prosthetic spacer device, etc.) is shown in various stages of deployment. The device 100 may include any of the other features for an implantable prosthetic device discussed herein and may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). Other implants and devices of other configurations and designs may also be used with the invention herein.

[0038] The device 100 is deployed from a delivery sheath or means 102 and comprises a mating portion, namely, a mating portion 104 and an anchor portion 106. In some embodiments, the mating portion 104 of the device 100 comprises a mating element or means 110 adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and slidably mounted to an actuating element 112 (e.g., an actuating wire, an actuating shaft, an actuating tube, etc.). The anchor portion 106 is actuable between an open state and a closed state and may take a variety of forms, such as, for example, a paddle or a gripping element. Actuation of the actuating element or means 112 causes the anchor portion 106 of the device 100 to open and close to grip the native leaflets during implantation. The actuating element or means 112 (as well as other actuating elements and means herein) may take a variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, combinations thereof, etc.). As an example, the actuating element can be threaded such that rotation of the actuating element moves the anchor portion 106 relative to the interface portion 104. Or, the actuating element can be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the interface portion 104.

[0039] The anchor portion 106 and / or anchor of the device 100 includes an outer paddle 120 and an inner paddle 122 that, in some embodiments, are connected between the cap 114 and the interface element or interface means 110 by portions 124, 126, 128. These connecting portions 124, 126, 128 may be joined and / or flexible to move between any of the positions described below. The outer paddle 120, inner paddle 122, interface element or interface means 110, and cap 114 are interconnected by portions 124, 126, and 128 to constrain the device to the positions and movements illustrated herein.

[0040] In some implementations, an actuation element or means 112 (e.g., actuation wire, actuation shaft, etc.) extends through the delivery sheath and the interface element or means 110 to a cap 114 located at the distal connection of the anchor portion 106. Extending and retracting the actuation element or means 112 increases and decreases the spacing between the interface element or means 110 and the cap 114, respectively. A collar or other attachment element releasably attaches the interface element or means 110 to the delivery sheath or delivery means 102, such that the actuation element or means 112 slides through the collar or other attachment element and the interface element or means 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0041] 11, the anchor portion 106 and / or the anchor comprises an attachment portion or gripping member. The illustrated gripping member comprises a clasp 130, which comprises a base or fixed arm 132, a movable arm 134, an optional barb or other fastening means 136, and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some embodiments, the fixed arm 132 is attached to the inner paddle 122 by a joint portion 138 disposed proximally of the joining element or joining means 110. The clasp or barb clasp has a flat surface and does not fit into a recess of the inner paddle. Rather, the flat portion of the clasp is disposed against a surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, or a pivot joint. In some embodiments, the joint portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary relative to the inner paddle 122 when the movable arm 134 is opened, thereby opening the clasp 130 and exposing the barb, friction enhancing element, or fastening means 136. In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, which causes the movable arm 134 to articulate, flex, or pivot relative to the joint portion 138. Other actuation mechanisms are also possible.

[0042] During implantation, the paddles 120, 122 can be opened and closed, for example, to grip a native leaflet (such as a native mitral leaflet) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element or coaptation means 110. The clasps 130 can be used to grip and / or further secure the native leaflet by engaging the leaflet with barbs, friction enhancing elements, or fixation means 136 and pinching the leaflet between the movable arm 134 and the fixation arm 132. These barbs, friction enhancing elements, or other fixation means 136 of the clasp or barb clasp 130 can increase friction with the leaflet or partially or completely pierce the leaflet. The actuation lines 116 can be individually actuated, such that each clasp 130 can be individually opened and closed. The separate movements allow one leaflet to be grasped at a time, or allow adjustment of the position of the clasp 130 for a poorly grasped leaflet without altering the normal grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), allowing the leaflets to be grasped in various positions as needed for a particular situation.

[0043] These clasps 130 may be individually opened by pulling on an attached actuation line 116 that extends through the delivery sheath or delivery means 102 and to the clasp 130. The actuation line 116 may take a variety of forms, such as a line, suture, wire, rod, or catheter. The clasps 130 may be spring loaded so that in the closed position, the clasp 130 continues to apply a pinching force against the grasped native leaflet. This pinching force remains constant regardless of the position of the inner paddle 122. The barbs or fixation means 136 of the barbed clasp 130 may pierce the native leaflet to further secure the native leaflet.

[0044] 8, the device 100 is shown in an extended or fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because it takes up the least amount of space, allowing for the use of the smallest catheter (or the largest device 100 for a given catheter size). In the extended state, the cap 114 is spaced away from the attachment element or attachment means 110, thereby allowing the paddles 120, 122 to be fully extended. In some embodiments, the interior angle formed between the outer paddle 120 and the inner paddle 122 is at or about 180 degrees. The clasp 130 is maintained in a closed state during deployment through the delivery sheath or delivery means 102 so that the barbs or fixation means 136 (FIG. 11) do not catch or damage the sheath or tissue within the sheath or the patient's heart.

[0045] 9, device 100 is shown in an extended unhooked state similar to FIG. 8, but with clasp 130 in a fully open position ranging from about 140 degrees to about 200 degrees, ranging from about 170 degrees to about 190 degrees, or at about 180 degrees between the fixed and movable portions of clasp 130. Fully opening paddles 120, 122 and clasp 130 has been found to improve ease of unhooking or removal of device 100 from patient anatomical structures, such as chordae tendineae, during implantation.

[0046] Referring now to FIG. 10, the device 100 is illustrated in a shortened or fully closed state. The compact size of the device 100 in the shortened state makes it easier to manipulate and place within the heart. To move the device 100 from the extended state to the shortened state, the actuation element or actuation means 112 is retracted, thereby pulling the cap 114 towards the attachment element or attachment means 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained to move such that the paddles or gripping elements 120, 122 are moved radially outward by the compressive force acting on the outer paddle 120 as the cap 114 is retracted towards the attachment element or attachment means 110. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuation element or actuation means 112. Optionally, the outer paddle 120 can be biased towards the closed position. During this operation, the inner paddle 122 moves through a much larger angle by being oriented away from the interface element or means 110 in the open state and contracting along the side of the interface element or means 110 in the closed state. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for greater movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 can be more flexible to allow for greater movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114, for example. In some embodiments, the inner paddle 122 may have the same width or substantially the same width as the outer paddle.

[0047] 11-13, the device 100 is illustrated in a partially open, graspable state. To move from the fully closed state to this partially open state, the actuation element or means 112 (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element or means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122 to partially open the anchor or anchor portion 106. The actuation line 116 is also retracted to open the clasp 130 so that the leaflets can be grasped. In the example shown in FIG. 11, the pair of inner and outer paddles 122 and 120 are moved together, rather than individually, by a single actuation element or means 112. The position of the clasp 130 also depends on the position of these paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp.

[0048] FIG 11A illustrates an example embodiment in which the paddles 120, 122 are individually controllable. The device 100A illustrated by FIG 11A is similar to the device illustrated by FIG 11, except that the device 100A illustrated by FIG 11A includes an actuation element configured as two independent actuation elements or wires 112A, 112B that are coupled to two independent caps 114A, 114B. To transition the first inner and first outer paddles from a fully closed state to a partially open state, the actuation element or means 112A is extended to push the cap 114A away from the mating element or means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially opening the first anchor portion 106. To transition the second inner and outer paddles from a fully closed state to a partially open state, the actuation element or means 112B is extended to push the cap 114B away from the mating element or means 110, thereby pulling the outer paddle 120 which in turn pulls the inner paddle 122 to partially open the first anchor portion 106. The independent paddle controls shown in FIG. 11A can be implemented for any of the devices disclosed herein.

[0049] 12, one of the actuation lines 116 is stretched to allow for closure of one of the clasps 130. Referring now to FIGURE 13, the other actuation line 116 is stretched to allow for closure of the other clasp 130. Either or both of these actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0050] 14, the device 100 is illustrated in a fully closed and deployed state. The delivery sheath or delivery means 102 and actuation element or actuation means 112 are retracted, and the paddles 120, 122 and clasp 130 remain in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position by a mechanical latch, or can be biased to remain closed by the use of spring materials such as steel, other metals, plastics, and composites, or shape memory alloys such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, 120, and / or additional biasing components (see component 524 in FIG. 28) can be formed from metals such as steel or shape memory alloys such as Nitinol manufactured as wires, sheets, tubes, or laser sintered powders and are biased to hold the outer paddle 120 closed around the coaptation element or means 110 and to hold the clasp 130 pinched around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to pinch the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, joint portion 138, and / or the inner and outer paddles 122, 120, and / or additional biasing components (see component 524 in FIG. 28) can be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device in a closed state after implantation.

[0051] 15-20, there is illustrated the implantable device 100 of FIGS. 8-14 being delivered and implanted into the native mitral valve MV of the heart H. The methods and steps shown and / or described may be performed on a live animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., a simulated body part, heart, tissue, etc.), etc.

[0052] 15, the delivery sheath 102, which may be positioned within a guide sheath 502, is inserted through the septum into the left atrium LA, and the device 100 is deployed from the delivery sheath in a fully open state. The guide sheath 502 is optional. The actuating element or means 112 is then retracted to move the device 100 to a fully closed state shown in FIG. 16. As can be seen in FIG. 17, the device 100 is moved into a position within the mitral valve MV toward the ventricle LV and partially opened to grasp the leaflets 20, 22. The actuating line 116 may be extended to close one or more of the clasps 130, thereby capturing one or more leaflets.

[0053] 17A, a diagram of a delivery sheath 102 is shown extending from a guide sheath 502 inserted through the septum into the left atrium LA at a position low enough in the septum that a single bend 67 in the distal flex section 115 positions the device 100 lower than the target or optimal deployment position in the left atrium relative to the mitral valve MV as shown in FIG. 17. In FIG. 17A, the delivery sheath 102 has a distal section bend 67 and also has a proximal section bend 66 in the proximal flex section 116 in the opposite direction to the distal section bend 67, thereby raising the overall height of the distal end of the delivery sheath upward in the atrium. As will be explained in more detail below, this allows for more freedom in positioning the delivery sheath 102 and device 100.

[0054] 18 and 18A, the actuating line 116 is extended, causing one of the clasps 130 to close and capture the leaflet 20. Figures 19 and 19A show that the other actuating line 112 is then extended, causing the other clasp 130 to close and capture the remaining leaflet 20. Finally, as seen in Figure 20, the delivery sheath or delivery means 102 and the actuating wire or actuating means 112 are then retracted and the device 100 is fully closed and deployed within the native mitral valve MV.

[0055] 21-32A, an example embodiment of an implantable device 500 is illustrated being delivered and implanted within a native mitral valve MV of a heart H. The device 500 may have a cover 540 covering a coaptation element 510, a clasp 530, an inner paddle 522, and / or an outer paddle 520. The device 500 is deployed from a guide sheath 502 and includes a coaptation portion 504 and an anchor portion 506 that includes a number of anchors 508 (i.e., two in the illustrated embodiment). The coaptation portion 504 includes a coaptation element 510 for implantation between the leaflets 20, 22 of the native mitral valve MV that is slidably mounted to an actuation wire or shaft 512. Actuation of the actuation wire or shaft 512 opens and closes the anchors 508 of the device 500 to grip the native leaflets 20, 22 during implantation.

[0056] The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly connected to the cap 514 and the joint element 510. The actuation element 512 extends through the capture mechanism 503 (see FIG. 27), the guide sheath 502, and the joint element 510 to the cap 514 that is connected to the anchor portion 506. Extending and retracting the actuation element 512 increases and decreases the spacing between the joint element 510 and the cap 514, respectively. In the example shown in FIGS. 21-37A, the pair of inner paddle 522 and outer paddle 520 are moved together, not individually, by a single actuation element 512. Also, the position of the clasp 530 depends on the positions of these paddles 522, 520. For example, referring to FIG. 31, closing the paddles 522, 520 also closes the clasp. In one example embodiment, device 500 can be made such that paddles 520, 522 are independently controllable in a manner similar to the embodiment of Figure 11A. Figure 32 shows the device with the paddles closed onto the leaflets of the mitral valve, and the delivery sheath 102 is separated from the device 500. Figure 32A shows the same deployed position of device 500, with the delivery sheath having a distal section bend 67 and a proximal section bend 66.

[0057] The fingers of the capture mechanism 503 removably mount the collar 511 to the guide sheath 502. The collar 511 and mating element 510 slide along the actuation element 512 during actuation, thereby opening and closing the anchors 508 of the anchor portion 506. In some implementations, the capture mechanism 503 is held closed around the collar 511 by the actuation element 512, such that removal of the actuation element 512 allows the fingers of the capture mechanism 503 to open, disengaging the collar 511 and therefore the mating element 510.

[0058] The joint elements 510 and paddles 520, 522 can be formed from a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or a laser cut or otherwise cut flexible material, which may be a fabric, a shape memory alloy wire such as Nitinol to provide shape fixation capabilities, or any other flexible material suitable for implantation in the human body.

[0059] Barb clasp 530 includes a base or fixed arm 532, a movable arm 534, a barb 536 (see FIG. 27), and a joint portion 538. Fixed arm 532 is attached to inner paddle 522 with joint portion 538 disposed proximal to joint element 510. A suture (not shown) attaches fixed arm 532 to inner paddle 522. Fixed arm 532 may be attached to inner paddle 522 using any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, or adhesive. Fixed arm 532 remains stationary or substantially stationary when movable arm 534 is opened, thereby opening barb clasp 530 and exposing barb 536. Barb clasp 530 is opened by applying tension to an actuation line 537 attached to movable arm 534 , which causes movable arm 534 to articulate, pivot, or flex relative to joint portion 538 .

[0060] During implantation, the anchor 508 is opened and closed to grip the native mitral leaflets between the paddles 520, 522 and the coaptation element 510. The outer paddle 520 has a wider curved shape that fits around the curved shape of the coaptation element 510 to more securely grip the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The barb clasp 530 further secures the native leaflets by engaging the leaflets with the barbs 536 and sandwiching them between the movable arm 534 and the fixed arm 532. The barbs 536 of the barb clasp 530 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines can be individually actuated so that each barb clasp 530 can be opened and closed individually. The separate movement allows one leaflet to be grasped at a time or allows adjustment of the position of the clasp 530 for a poorly grasped leaflet without altering the normal grip on the other leaflets. The barb clasp 530 can be fully opened and closed when the inner paddle 522 is not closed, allowing the leaflets to be grasped in various positions as needed for a particular situation.

[0061] The device 500 is loaded into the delivery sheath in the fully open position because it takes up the least space, allowing for the use of the smallest catheter (or the largest device 500 for a given catheter size). Referring now to Figure 21, the delivery sheath is inserted through the septum into the left atrium LA, and the device 500 is deployed in the fully open state from the guide sheath 502. The actuating element 512 is then retracted to move the device 500 to the fully closed state shown in Figures 22-23, and then steered towards the mitral valve MV as shown in Figure 24.

[0062] 24A shows the device 500 in the same position and in the same fully closed state as shown in FIG 24, whereby the device 500 is positioned by a guide sheath 502 having a distal flexure section 115 with a distal bend 67 and a proximal flexure section 116. As explained above with respect to FIG 17A, the proximal flexure section 116 raises the overall height of the delivery sheath's distal end 118 upwardly within the left atrium, thereby allowing positioning of this distal end 118 suitable for delivering the device 500 into the native valve when the delivery sheath is passed transseptally below the target position of the single distal section bend 67 to optimally position the device 500.

[0063] 25, once the device 500 is aligned with the native valve, the actuation element 512 is extended to allow the paddles 520, 522 to open to a partially open position, and the actuation line 537 is retracted to open the barb clasp 530 in preparation for leaflet grasping. FIG. 25A shows the same position and condition of the device 500, with the delivery sheath 102 having both a distal section bend 67 and a proximal section bend 66. FIG. 25A also shows an optional guide sheath 502. The partially open device 500 is then inserted through the native valve until the leaflets 20, 22 are properly positioned in between the inner paddle 522 and the coaptation element 510 and within the open barb clasp 530, as shown in FIGS. 26-27.

[0064] FIG. 28 shows the device 500 with both clasps 530 closed, but with the barb 536 of one clasp 530 disengaged from one of the leaflets 22. As can be seen in FIGS. 28-30, the disengaged clasp 530 is again opened and closed to grasp the disengaged leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 512 is retracted to move the device 500 to the fully closed position shown in FIG. 31. With the device 500 fully implanted within the native valve, the actuating element 512 is withdrawn to disengage the capture mechanism 503 from the proximal collar 511. Once deployed, the device 500 can be maintained in the fully closed position using mechanical means such as a latch, or can be biased to remain closed by using a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the paddles 520, 522 can be formed from steel or Nitinol shape memory alloy manufactured as a wire, sheet, tube, or laser sintered powder and are biased to hold the outer paddle 520 closed around the inner paddle 522 and coaptation element 110 and to hold the barb clasp 530 clamped around the native leaflets 20, 22.

[0065] The device 500 may have a variety of different shapes and sizes. Referring to FIG. 21, in one embodiment, the coaptation element 510 functions as a gap filler in a valve regurgitant orifice, such as the gap 26 in the mitral valve MV shown by FIG. 6. The coaptation element 510 is deployed between two opposing leaflets 20, 22 such that the leaflets do not coapt against each other in the area of ​​the coaptation element 510, but instead coapt against the coaptation element 510. This reduces the distance that the leaflets 20, 22 must be approximated. The reduced leaflet approximation can result in multiple benefits. For example, the coaptation element and the resulting reduced approximation can facilitate repair of severe mitral valve anatomy, such as large gaps in functional valvular disease (see, e.g., FIG. 6). Because the coaptation element 510 reduces the distance that the native valves must be approximated, stresses on these native valves can be reduced or minimized. The closer proximity of the leaflets 20, 22 may often require less proximity force, which may result in less tension on the leaflets and less reduction in annular diameter. Less annular reduction (or no annular reduction required) may result in less reduction in valve orifice area when compared to devices that do not use a spacer. As a result, the coaptation element 510 may reduce the transvalvular gradient.

[0066] The various delivery catheters, delivery sheaths, and delivery means herein can be used with the exemplary implants and devices described herein and / or with other types of implants / devices (e.g., prosthetic heart valves, docking devices, stents, repair devices, replacement devices, etc.).

[0067] FIG. 33 illustrates an example flex segment 25 that can be used in a delivery catheter or delivery sheath 24. The flex segment 25 includes two opposing ends, two opposing sides 226 and 27, an apex 28, and a bottom 29 extending between the two ends. These are referred to as "top" and "bottom" for ease of explanation and understanding, and are not intended to limit the orientation of the distal flex segment 25. The orientation of the flex segment 25 can be set so that the apex 28 is aligned with a desired inward curvature of the catheter when in a flexed configuration. The flex segment 25 of FIG. 33 forms a generally cylindrical hollow tube that can include a number of links 38. Each link 38 has the shape of a cylindrical segment and is aligned with and connected to adjacent links 38 to form the cylindrical tube shape of the flex segment 25. In this embodiment, the distal flex segment 25 is cylindrical, although other shapes, such as an oval distal flex segment, are also possible. Each link 38 of flex segment 25 may have a greater width at the bottom 29 than at the top 28, so that the links 38 have an overall acute trapezoidal shape when viewed from the side, as best seen in Figure 34. The bottom of each link 38 may have slits 39, which may allow the links 38 to flex more relative to each other.

[0068] The flex segment 25 may include a double guide pattern forming a hybrid flex section incorporating bilateral teeth 31, 232 and upper teeth 33. To this effect, each link 38 may include two side teeth 31, 232 on either side of the link 38, and upper teeth 33. As best seen in FIG. 33, for this flex segment 25, the two rows of side teeth 31, 232 of the link 38 may be aligned along the length of the sides 226, 27 of the flex segment 25, respectively, and the upper teeth 33 may be aligned along the length of the flex segment 25 on the apex 28. The rows of side teeth 31, 232 and upper teeth 33 are shown in this exemplary embodiment as being linearly aligned along the length of the distal section 25, although other embodiments may have different configurations. For example, in some embodiments, the rows of side teeth 31, 232 and upper teeth 33 can spiral around the tube of the flex segment 25 to provide a particular bent shape to the flex segment 25 when the flex segment 25 is actuated. In some embodiments, the side teeth 31, 232 can be mirror images of each other to allow similar bending on both sides 226, 27 of the flex segment 25. In some embodiments, the side teeth 31, 232 can have different shapes and / or sizes. The teeth 31, 232, 33 can have any other shape and / or size suitable for allowing the distal region to move into a bent configuration during delivery of the anchoring device. The teeth 31, 232, 333 are all right-facing teeth in the illustrated embodiment (e.g., facing right in the view shown in FIG. 34), but in other embodiments can be left-facing teeth (see, e.g., FIG. 35), or the upper and side teeth can face in different directions, for example.

[0069] Adjacent each side tooth 31, 232 and each top tooth 33 is a corresponding side slot or groove 234, 35 and top slot or groove 36, respectively, in the adjacent link 38. Each slot 234, 35, 36 may be shape-complementary to the adjacent side tooth 31, 232 or top tooth 33. When the flex segment 25 is in a straight configuration, the side tooth 31, 232 is partially inserted into the side slot 234, 35, and the top tooth 33 is spaced from the adjacent top slot 36 by a gap. The partial location of the side tooth 31, 232 in the side slot 234, 35 in this straight configuration provides additional torque resistance to the flex segment 25 of the delivery catheter 1114 when the flex segment 25 is not fully flexed. However, in some embodiments, the side tooth 31, 232 may not be partially positioned in the side slot 234, 35 when the flex segment 25 is in a straight configuration.

[0070] As the flex segment 25 is bent, each side tooth 31, 232 moves further into the corresponding side slot 234, 35 and each top tooth 33 moves closer to and then into the corresponding top slot 36. The addition of the top teeth 33 and top slots 36 enhances the torque transmission and torque resistance of the distal section 25 when in a fully flexed configuration. Additionally, having both side teeth 31, 232 and top teeth 33 provides added guiding control and structural support when adjusting the flex segment 25 from a straight to a flexed configuration.

[0071] FIG. 34 is a detailed cross-sectional view of a number of links 38 of the flex segment 25 of FIG. 33. While FIG. 34 is a description in relation to the side teeth 232, the description is equally applicable to the side teeth 31 on the opposite side of the flex segment 25. The side teeth 232 are illustrated as being positioned along a tooth line 40 that is lower than the apex 28 of the flex segment 25. This positioning results in the side teeth 232 having a smaller amount of displacement, i.e., the distance the side teeth 232 move into the adjacent slot 35 is much less than or less than if the side teeth 232 were positioned closer to the apex 28 of the flex segment 25. For example, in the illustrated embodiment, the side teeth 31, 232 move a shorter distance during flexion than the upper teeth 33. In other words, the upper teeth 33 move a greater distance relative to the adjacent link 38 than the side teeth 31, 232 when the flex segment 25 is adjusted to a fully bent configuration. This configuration allows for shorter side teeth 31, 232 to be used (e.g., to have side teeth with a shorter longitudinal length), which can then be incorporated into a shorter bending section of the flex segment 25.

[0072] Additionally, the lower tooth line provides more space for the wider tooth slots 234, 35, e.g., to accommodate larger side teeth, etc., since the tooth slots 234, 35 are located at the lower, wider portion of the link 38. Having more space to accommodate larger and / or more suitable or robust tooth slots 234 for the side teeth 31, 232 may improve guidance of the teeth 31, 232 into the slots 234, 35, e.g., during bending. This lower tooth line also allows for the robust tooth slot design described above that still provides structural support while bending the links away from each other, i.e., in the opposite direction of the bent configuration. Thus, when the links are bent away from each other, the side teeth can still maintain interlocking with the adjacent side slots, and this maintained tooth-slot interlocking may provide greater structural support and torque transmission.

[0073] FIG. 35 is a perspective view of a flex segment 25' in a bent configuration according to a modification of the first embodiment. The flex segment 25' of FIG. 35 is similar to the flex segment 25 of FIG. 33, except that in FIG. 35, the row of upper teeth 33' and the row of side teeth 31', 232' are shifted laterally around the circumference of the tube-shaped flex segment 25', rather than extending in a straight line extending along the length of the flex segment. Such positioning of the rows of teeth 31', 232', 33', such as along a helical line, allows the flex segment 25' to bend in three dimensions as opposed to in a single plane as occurs in FIG. 33. As can be seen in FIG. 35, the flex segment 25' in this example has a three-dimensional curved shape. Various embodiments of the distal section can be laser cut (e.g., into a sheet or tube) such that the upper teeth and side teeth have a pattern that will form a desired shape during bending. For example, a pattern can be cut that forms a distal section having a curved shape such that the curved segment can be positioned at the mitral or other valve so that, for intraoperative use, the anchoring device can be advanced from the distal section and precisely positioned at the valve.

[0074] The flex segments 25, 25' may be manufactured, for example, by cutting a flat metal strip or sheet in the desired pattern, such as by laser cutting, and then rolling the patterned metal strip or sheet into a hypotube. Optionally, the desired pattern (e.g., the same or similar to those shown in the various figures herein) may be cut directly into the tube (e.g., hypotube) without the use of a sheet or the need to roll the material. As an example, FIG. 36 shows a flat view of an example laser cut file or sheet 230 that may be used for the flex segment 25 of FIG. 33. The laser cut sheet 230 includes both upper teeth 33 and associated slots 36, and side teeth 31, 232 and associated slots 234, 35, arranged in linear rows along the length of the flex segment 25. However, as noted above, the laser cutting file 230 may be modified such that the teeth 31, 232, 33 and their associated slots 234, 35, 36 are arranged in other different orientations or configurations, such as, for example, in a row of helical lines, to form a curved or spirally bent flex segment 25' similar to that shown in Figure 35. In some embodiments, various patterns may be cut to provide a bendable flex segment into other shapes or configurations that aid in precisely guiding and deploying the anchoring device to an implantation site location during surgery.

[0075] Many types of sheets that can be rolled into a tube can be used to create the cut flexure segments. Many types of tubes can also be cut into the desired pattern. 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 or tubes.

[0076] While the above embodiment includes both upper and side teeth such that each link 38 has a total of three teeth, other embodiments may include only upper teeth or only side teeth, or may include no teeth at all.

[0077] Figure 37 is a flattened view of another example laser cut sheet 230'' for a flex segment 25'' of a delivery catheter. The flex segment 25'' of Figure 37 is similar to the flex segment 25 of Figure 36, except that the link 38'' of the flex segment 25'' includes only two teeth 31, 232 and their associated slots 234, 35, and no upper teeth or corresponding slots.

[0078] Figure 38 is a flattened view of another example laser cut sheet 230''' for a flex segment 25''' of a delivery catheter. This flex segment 25''' is also similar to the flex segment 25 of Figure 36, except that each link 38''' of the flex segment 25''' includes only a single top tooth 33 and associated slot 36, and no side teeth or corresponding slots.

[0079] In some embodiments, each link can have more than three or less than two teeth in any combination. While Figures 36 and 37 show teeth arranged in linear rows along the length of flex segments 25", 25"', respectively, the laser cut sheets 230", 230'" can likewise be modified to have a variety of tooth patterns and tooth arrangements to enable the flex segments to bend in particular desired shapes, similar to those discussed above.

[0080] A variety of sheath and catheter designs are available for effectively deploying the anchoring device at the implantation site, and the deployment tools and methods, such as the sheath and catheter designs and actuated pull wire systems described in U.S. Patent Application Nos. 15 / 984,661 and 62 / 770,071, are incorporated herein by reference in their entireties.

[0081] 39, the delivery catheter may have two flex segments, a distal flex section 115 and a proximal flex section 116. The location of the distal flex section 115 on the delivery catheter is where the distal section bend 67 will be formed. The location of the proximal flex section 116 on the delivery catheter is where the proximal section bend 66 will be formed. The distal section bend 67 may be achieved by one of the embodiments described herein, such as by using a laser cut sheet as described above and shown in FIGS. 33-37. The slots 36 in the sheet, when rolled into a tubular shape, will be aligned along each of the distal and proximal flex sections 115, 116 and will curve towards themselves such that the space between the slots in each of these sections is reduced.

[0082] In embodiments with two flexure segments, there can be a second sheet with slots and teeth cut into it, which is rolled into a tube. The second sheet can be positioned and secured to the first sheet such that the distal end of the first sheet is secured to the proximal end of the first sheet. The slots are aligned such that the center of each slot of the second tube is offset by 180 degrees from the center of each slot of the first tube when the joined tubes are in a straight configuration. In some embodiments, the centers of the slots can be offset by 90 degrees or 45 degrees. In some embodiments, instead of having two sheets joined together, the tube can be made from one longer sheet, but laser cut so that the slots are offset from each other.

[0083] In one example embodiment, the distal section bend formed by the first tube is used to direct the distal end of the delivery catheter towards the mitral valve. The proximal section bend formed by the second tube is used in valve implant delivery scenarios where the delivery catheter punctures the septum at a lower target location than would be achieved if only the distal section bend were used to position the implant above the native valve. For example, the proximal flex section can pull the distal section of the delivery catheter up (with "up" being defined here as the upper left atrium).

[0084] In some embodiments, the catheter itself may also be positioned to pass below the plane of the native valve annulus or extend into the ventricle. The catheter may be positioned in any suitable manner that allows the device to be deployed at the implantation site, such as the mitral valve.

[0085] Referring again to FIG. 39, the delivery catheter 1114 is in a curved configuration. This illustrated configuration may be utilized to implant an anchoring device in a native valve (e.g., in a native mitral valve using a transseptal technique, etc.). In this configuration, a distal portion of the delivery catheter extending from the transseptal sheath 502 has a distal section bend 67, a proximal section bend 66, and a straight distal portion 69 located distal to the distal section bend 67. The straight distal portion 69 may be flexible. The shape of these subsections allows the delivery catheter to navigate to the location of the native valve (e.g., the native mitral valve) and precisely deploy the anchoring device at the native valve (e.g., at the mitral location). The catheter 1114 may take any suitable form, such as any of the forms described herein, that allows the distal region to take the above-mentioned curved configuration.

[0086] The guide sheath and / or distal section of the various delivery catheters herein may include one or more pull wires (e.g., 2-6 pull wires) to control or actuate the delivery catheter to a desired configuration. For example, the distal section of the various delivery catheters herein may have a two pull wire system (e.g., the two pull wire system described in Figs. 43A-46). For example, the configuration shown in Fig. 39 or any other configuration described herein may be achieved by using a flexible tube catheter configured with two pull rings positioned, for example, at or near actuation points 135a, 136a (Fig. 40). The pull rings may be engaged or coupled to each pull wire. The pull wires may be positioned circumferentially spaced 180° apart from each other around the delivery catheter. A first pull ring, such as positioned at the distal end 65 of the delivery catheter 64, may be actuated by the first pull wire to pull a distal region of the delivery catheter including the distal end portion. A second pull ring positioned proximally, such as between distal and proximal flex sections 115, 116, can be actuated by another pull wire to bend the catheter in a different direction. For example, second pull wire 136 can bend the catheter upward toward the apex of the left atrium. This upward bending of the catheter pulls the distal section higher within the left atrium, allowing the distal end, and therefore the valve implant, to be positioned directly above the native mitral valve.

[0087] In some embodiments, the two pull rings may be connected by a spine mounted on one of the diametrically opposed pull wires, e.g., on the opposite side of the pull wire for the most distal pull ring. Such an added spine limits the relative movement between the pull rings and allows for better directional control of the deflection caused by pulling the pull wire for the most distal pull ring, thereby preventing deflection of the flexible distal flexion segment perpendicular to the mitral plane or in other unintended directions. While the above-described embodiment may include three pull rings and two pull wires, it should be understood that any number of pull rings and / or pull wires may be used to form the various configurations described herein. Additionally, it should be understood that any suitable number of spines may be used to limit the relative movement between the pull rings.

[0088] In some embodiments, the distal flex section 115 can have one or more laser cut hypotubes (similar to the laser cut tubes described in Figures 34-37) arranged in a pattern such that when bent, the distal section forms any of the various configurations described herein. As also discussed, the laser cut distal section can have two or more actuation points that can be actuated independently of one another, such as by separate pull wires controlled by separate controls (e.g., knobs, tabs, inputs, buttons, levers, switches, etc.) or other mechanisms, to achieve a two-way deflection at the distal end in a fully bent configuration (e.g., one curve toward the mitral plane and the other curve is a circular section curved approximately around the mitral annulus). In some embodiments, these separate pull wires can be controlled by a single control, as described in more detail below. In some embodiments described below, both the distal section bend and the proximal section bend can be controlled by a single pull wire.

[0089] In some embodiments, the entire distal flex section 115 and / or the entire proximal flex section need not be configured as a laser cut hypotube. For example, the proximal flex section may be constructed of polyether block amide (PEBAX), such as having a hardness of 50D or about 50D, coated onto a coil or braided tube. This distal flex section 115 and its distal end portion 69 can also be constructed of PEBAX, such as having a hardness of 55D or about 55D, reflowed onto a coil or braided tube. By using this configuration, it is still possible to obtain a distal section 65 that can be shaped and operated substantially similarly to the laser cut hypotubes discussed above, without the need to form the entire distal section 65 as one or more laser cut hypotubes or any portion of a laser cut hypotube.

[0090] While the above-described embodiments have been used to describe a delivery catheter 64 having a distal flexure section 115, it should be understood that the above-described embodiments are by way of example only. The delivery catheter 1114 may take any suitable form capable of producing the configurations described herein. Additionally, the delivery catheter may be constructed of any suitable material capable of producing the configurations described herein.

[0091] FIG. 40 shows a perspective view of the distal region 117 of an example of a delivery catheter 1114 (which can be the same or similar to other delivery catheters described herein) for implanting a device in a native valve. In the case of the mitral valve, this can be performed using a transseptal technique. The delivery catheter is illustrated as having an example of a reciprocal flexion configuration. In this configuration, the guide sheath 502 extends through the fossa ovalis in a direction parallel to the plane of the native annulus (e.g., the mitral plane). In this embodiment, the distal region 117 then exits the guide sheath 502 and the distal flexion is flexed such that the distal end 118 points downward toward the native valve. The user can adjust the height of the distal end, such as by applying upward tension to a second flexion wire incorporated into or attached to the catheter. For example, a pull ring located between the distal and proximal sections can be pulled to flex the proximal section upward, thus shifting the entire distal section upward. Continuing adjustment by simultaneously applying more tension to the distal section can change the curvature of the distal section, allowing the distal end to remain pointing downward, thereby positioning the distal end above or just above the plane of the patient's native annulus.

[0092] In some embodiments, the distal region 117 can be one or more complete laser cut hypotubes (similar to the laser cut catheters described in Figures 34-37) with cuts arranged in a pattern such that when bent, the distal section forms a reciprocal flex configuration. In some embodiments, the reciprocal flex configuration of the laser cut hypotubes can be shape-fixed with a distally located lower flex portion and a proximally located upper flex portion that extends or stretches toward the native annulus plane (e.g., extends or stretches from the fossa ovalis to a position lower than the mitral plane). The distal tip of the catheter can be raised to lie along or just above the mitral plane, such as by bending or applying tension to the flex wires to cause the proximal flex section to flex upward as previously described. This feature allows the catheter tip to be adjusted to different heights to accommodate different patient anatomies.

[0093] In an embodiment using a delivery catheter 1114 having a reciprocal flexion configuration, the distal section may not be laser cut or may not be cut at all. For example, the distal flex section 115 of the delivery catheter 1114 may be formed by a flexible tube catheter configured with pull rings, pull wires, and / or spines configured to move the delivery catheter 1114 into the reciprocal flexion configuration.

[0094] While the above-described embodiments have been used to describe a delivery catheter 1114 having a distal flex section 115, it should be understood that the above-described embodiments are by way of example only. The delivery catheter 74 may take any suitable form capable of forming a reciprocal flexion configuration. Furthermore, the delivery catheter may be constructed of any suitable material capable of forming a reciprocal flexion configuration (e.g., the distal flex section 115 may take the form of the delivery catheter 1114 shown in Figures 43A-46).

[0095] While in the embodiments described above, the delivery device is typically or most often positioned above the native annulus plane (e.g., the mitral plane) and the anchoring device is extended away from the delivery device while still positioned on the atrial side and advanced into the ventricle, in some embodiments, at least a portion of the delivery device itself can be positioned within the ventricle.

[0096] 40-42, in one example embodiment, the distal region 117 of an example delivery catheter 1114 can be constructed from a hypotube having a first series of slots 125 and a second series of slots 326. This delivery catheter can also have a pull wire system (e.g., a two-pull wire system consisting of a first pull wire 135 and a second pull wire 136). FIG. 40 shows a schematic side view of the distal region 117 of one example embodiment of the delivery catheter 1114. FIGS. 41 and 42 show schematic perspective views of the delivery catheter 1114 of FIG. 40 in a partially actuated state and a fully actuated state, respectively. Other delivery catheters deployed and used in other ways, such as those shown in any of the embodiments discussed above, can also be constructed with a similar two-pull wire system.

[0097] In one embodiment, the delivery catheter 1114 has a distal region 117 with two bendable sections 115, 116. In the description provided herein, the term "first" can be applied to components associated with the distal flex section 115 and its flexure, and the term "second" can be applied to components associated with the proximal flex section 116 and its flexure. A first series of slots 125 can be arranged (e.g., linearly arranged or otherwise) along a first side of the distal region 117 that corresponds to and provides flexibility to the distal flex section 115, such that the distal flex section 115 can form a curved configuration when the delivery catheter is actuated. This configuration can be generally circular or semicircular to allow the distal end 118 to be pulled in a "down" direction (according to the orientation of FIG. 40, the distal flex section 115 curves upward) when positioned in the left atrium. The second series of slots 326 may be linearly positioned along a second side of the distal region 117 corresponding to and providing flexibility to the proximal flex section 116, such that the proximal flex section 116 may form a second bend when the delivery catheter 1114 is actuated. The second bend may be curved upward when positioned within the left atrium to pull the delivery catheter closer to the top of the left atrium, thereby pulling the distal end 118 further away from the bottom of the left atrium (according to the orientation of FIG. 40, the flexible section 116 curves downward). The second series of slots 326 may be positioned circumferentially around the delivery catheter such that it is positioned 180° apart from the first series of slots 125.

[0098] These slots 125, 326 can be laser cut or formed similarly to those discussed in the previous embodiment, or can be formed in a variety of other ways so long as the slots 125, 326 contribute to the desired shape setting of the delivery catheter 1114 upon actuation. The second series of slots 326 can be positioned slightly proximal to the first series of slots 125 corresponding to the bend locations of the sections 115, 116 and can be circumferentially offset, for example, by 180 degrees or about 180 degrees around the distal region 117, resulting in two bends in this region. In this case, the respective radii of curvature and articulation directions of the sections 115, 116 can be different from each other. In some embodiments, the sections 115, 116 can be circumferentially offset, for example, by between about 155 degrees and about 205 degrees, for example, between about 165 degrees and about 195 degrees, for example, between about 170 degrees and about 190 degrees, for example, between about 175 degrees and about 185 degrees, for example, about 180 degrees, etc.

[0099] In some embodiments, each of these sections 115, 116 may have an associated pull wire 135, 136 for controlling the bending of sections 115, 116, respectively. Pull wire 135 extends distally through slot 125 and may be attached to distal region 117, such as by welding or other attachment means at connection point 135a and / or a pull ring. Similarly, pull wire 136 extends distally through slot 326 and may be welded or otherwise attached to distal region 117 at connection point 136a and / or a pull ring.

[0100] Indeed, once the guide sheath 3 is positioned and positioned as desired (e.g., by crossing the septum in a mitral valve procedure as shown or described elsewhere herein), the distal region of the delivery catheter (e.g., the distal region 117 or any other distal region described herein), and in some embodiments a portion of the proximal section (e.g., the proximal section 116), is advanced out of the distal opening of the guide sheath 502. The portion of the delivery catheter 1114 extending from the guide sheath 502 can be positioned in the left atrium before the delivery catheter is adjusted to its working or final working configuration. In some cases, a portion of the delivery catheter can extend through the native mitral valve into the left ventricle before the delivery catheter is adjusted to its final working configuration. The pull wires 135, 136 can be tensioned to actuate the distal region 117 and to achieve articulation of two bends, such as sections 115, 116, located at the distal portion of the delivery catheter 1114.

[0101] In one sequence, as shown in Figure 41, a first pull wire 135 is first tensioned to bend section 115 into a circular or curved actuated state, which allows the curved section 115 to position distal end 118 perpendicular or substantially perpendicular to the native annulus of the native valve (e.g., the mitral plane). Then, as shown in Figure 42, a second pull wire 136 is tensioned to bend section 116 into an actuated or curved state, which moves the curved portion of section 115 upward to a higher position within the left atrium. Further tensioning of the first pull wire results in a further curve in section 115, which allows distal end 118 to remain or move to a position perpendicular or substantially perpendicular to the native annulus of the native valve.

[0102] In some embodiments, the second pull wire 136 may be tensioned first to bend section 116. The first pull wire 135 may then be tensioned to bend section 115 to a circular or curved state as shown in FIG. 42. In some embodiments, the first pull wire and the second pull wire may be tensioned simultaneously first. Section 115 may be bent until the bend is at an angle of about 0 degrees to about 200 degrees, or at an angle in the range of about 0 degrees to about 180 degrees, or at an angle in the range of about 0 degrees to about 90 degrees. Section 116 may be bent until the bend is at an angle of about 0 degrees to about 60 degrees.

[0103] 43A-43E, 45A-45D, and 46 illustrate one embodiment of a delivery catheter that may operate in the same or similar manner as the above-described delivery catheters 64, 1114. Any of the components, features, functions, elements, etc. of this embodiment (e.g., steering or actuation mechanisms or pull wire systems, pull wires, rings, spines, etc.) may be incorporated into other delivery catheters (and even guide sheaths) described herein.

[0104] In the examples shown in Figures 43A-43E, 45A-45D, and 46, the distal region 117 of the delivery catheter 1114 may be comprised of a flexible tube 2030. The delivery catheter has a steering / actuation mechanism or pull wire system that may be used to actuate and bend the distal region of the catheter. The steering / actuation mechanism or pull wire system herein can have one or more pull wires (e.g., 1-6 or more pull wires), one or more rings or pull rings (e.g., 1-7 or more rings), one or more spines, and / or other components.

[0105] In the illustrated embodiment, the delivery catheter has a two-pull wire system consisting of a first pull wire 1135, a second pull wire 1136, three rings that can be pull rings and / or anchor rings (i.e., first ring 2037, second ring 2038, third ring 2039), a first spine 2040, and a second spine 2041. In this case, the first pull wire refers to the pull wire that actuates the distal flexion section. FIG. 43A shows an end view of the distal region 117 of the delivery catheter 1114. FIG. 43B shows a cross-sectional view of the delivery catheter 1114 along the plane indicated by line BB. FIG. 43C shows a cross-sectional view of the delivery catheter 1114 along the plane indicated by line CC in FIG. 43B. FIG. 43D shows a cross-sectional view of the delivery catheter 1114 along the plane indicated by line DD in FIG. 43B. 44A and 44B are schematic perspective views of the delivery catheter 1114 in partially actuated and fully actuated states, respectively, similar to the views of FIGS. 41 and 42. FIG. 45A is a partial view of the delivery catheter 1114. FIGS. 45B-45D show cross-sectional views of the delivery catheter along the planes indicated by lines BB, CC, and DD, respectively, in FIG. 45A. FIG. 46 is a side view of a two-pull wire system for the delivery catheter 1114. Other delivery catheters or delivery sheaths deployed and used in various manners, such as those shown in any of the embodiments discussed above, can also be configured with a similar two-pull wire system. While the illustrated embodiment shows a delivery catheter 1114 having rings 2037, 2038, 2039 and spines 2040, 2041, it should be understood that the delivery catheter 1114 can be configured with any number of rings and / or spines, or no rings or spines.

[0106] In the illustrated embodiment, the delivery catheter 1114 has a distal region 117 with two flex sections 115, 116. With reference to FIG. 43B, the distal flex section 115 extends between a first ring 2037 and a second ring 2038. A first pull wire 1135 is attached to the first ring 2037 at connection point A, and actuation of the first pull wire 1135 causes the distal flex section 115 to form a curved configuration, such as that shown in FIG. 41. With reference to FIGS. 43B and 43C and 45A and 45B, an optional spine 2040 is coupled between the first ring 2037 and the second ring 2038. The spine 2040 is made of a material having a higher stiffness than the flexible tube 2030 and is therefore configured to resist movement, such as compression, between the rings 2037, 2038 when the first pullwire 1135 is actuated. The spine 2040 can be made of, for example, stainless steel, plastic, or any other suitable material that has a higher stiffness than the flexible tube. The flexible tube 2030 can be made of, for example, Nitinol, steel, and / or plastic, or any other suitable material or combination of materials that allows the delivery catheter 1114 to move into a bent configuration. In some embodiments, the ratio of the Shore D hardness of the spine 2040 to the Shore D hardness of the flexible tube 2030 is about 3:1. In some embodiments, the ratio of Shore D hardness of the spine 2040 to the flexible tube 2030 is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In some embodiments, the ratio of Shore D hardness of the spine 2040 to the flexible tube 2030 is greater than 5:1 or less than 1.5:1. The stiffness of the spine 2040 can be altered by changing the durometer of the spine. This stiffness can be determined by using a braid, by changing the coil, or by using a stent material. The stiffness can also be varied along the length of the spine by using one of these options.

[0107] In the illustrated embodiment, the spine 2040 is disposed on an opposing or substantially opposing side of the first pull wire 1135 such that the center of the spine 2040 is circumferentially offset from the first pull wire 1135 by 180 degrees or about 180 degrees. The center of the spine 2040 can be circumferentially offset from the first pull wire 1135 by between about 70 degrees and about 110 degrees, such as between about 80 degrees and about 100 degrees, such as between about 85 degrees and about 95 degrees. With reference to FIG. 45B, the width of the spine 2040 (defined by the angle θ) can be any suitable width that allows the delivery catheter 1114 to move into the bent configuration shown in FIGS. 41 and 42 (as well as FIGS. 44A and 44B). In some embodiments, the angle θ between the edges 2204, 2203 of the spine 2040 can be between about 45 degrees and about 135 degrees, such as between about 60 degrees and about 120 degrees, such as between about 75 degrees and about 105 degrees, such as between about 85 degrees and about 95 degrees, such as about 90 degrees. When the angle θ is greater, the spine 2040 may have more control in restricting the movement of the rings 2037, 2038 compared to when the angle θ is smaller. The spine 2041 can be made of, for example, Nitinol, steel, and / or plastic, or any other suitable material or combination of materials.

[0108] With reference to FIG. 43B, the proximal flex section 116 extends between the second ring 2038 and the third ring 2039. A second pull wire 1136 is attached to the second ring 2038 at connection point B, and actuation of the second pull wire 1136 causes the proximal flex section 116 to form the sharper bend shown in FIGS. 41 and 42. With reference to FIGS. 43B and 43D and 45A and 45C, an optional spine 2041 is connected between the second ring 2038 and the third ring 2039. The spine 2041 is made of a material that is more stiff than the flexible tube 2030 and is therefore configured to constrain movement between the rings 2038, 2039 when the second pull wire 1136 is actuated. The spine 2041 can be made of, for example, stainless steel, plastic, or any other suitable material that has a higher stiffness than the flexible tube. The flexible tube 2030 can be made of, for example, Nitinol, steel, and / or plastic, or any other suitable material or combination of materials that allows the delivery catheter 1114 to move into a bent configuration (e.g., the bent configuration shown in FIG. 42). In some embodiments, the ratio of the Shore D hardness of the spine 2041 to the Shore D hardness of the flexible tube 2030 is about 3:1. In some embodiments, the ratio of the Shore D hardness of the spine 2041 to the flexible tube 2030 is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In some embodiments, the ratio of the Shore D hardness of the spine 2041 to the flexible tube 2030 is greater than 5:1 or less than 1.5:1. The stiffness of the spine 2041 can be altered by changing the durometer of the spine. This stiffness can be determined by using a braid, by changing the coil, or by using a stent material. The stiffness can also be varied along the length of the spine by using one of these options.

[0109] In the illustrated embodiment, the spine 2041 is disposed on an opposing or substantially opposing side of the second pull wire 1136 such that the center of the spine 2041 is circumferentially offset from the second pull wire 1136 by 180 degrees or about 180 degrees. The center of the spine 2041 can be circumferentially offset from the second pull wire 1136 by between about 160 degrees and about 200 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees, such as about 180 degrees. With reference to FIG. 45C, the width of the spine 2041 (defined by angle β) can be any suitable width that allows the delivery catheter 1114 to move into a bent configuration having two curves that face away from one another as shown in FIGS. 17A and 39. In some embodiments, the angle β between the edges 2205, 2207 of the spine 2041 can be between about 45 degrees and about 135 degrees, such as between about 60 degrees and about 120 degrees, such as between about 75 degrees and about 105 degrees, such as between about 85 degrees and about 95 degrees, such as about 90 degrees. When the angle β is larger, the spine 2040 may have more control (provide more stiffness) in restricting the movement of the rings 2037, 2038 than when the angle β is smaller.

[0110] 43C and 43D, the delivery catheter 1114 includes a lumen 2032 that is sized sufficiently to deliver the valve repair device and / or valve repair device control components therethrough. The lumen 2602 remains sized sufficiently for the valve repair device and / or valve repair device control components when the first and second pullwires 1135, 1136 are actuated to move the delivery catheter 1114 to the bent configuration shown in FIG. 42. The lumen 2032 can have an oval or circular cross-section, for example, or any other suitable cross-section such that the valve repair device control components can move within the lumen to control the valve repair device.

[0111] A connection point B for attaching the second pull wire 1136 to the second ring 2038 is positioned proximally relative to a connection point A for attaching the first pull wire 1135 to the first ring 2037 and may be circumferentially offset, such as by 180 degrees or about 180 degrees, around the distal region 117. The 180 degree offset allows two bends to face in opposite directions relative to each other in this region, where the respective radii of curvature and articulation directions of sections 115, 116 may be different and independent of each other. In some embodiments, the bends of sections 115, 116 may be circumferentially offset, such as by between about 155 degrees and about 205 degrees, such as between about 165 degrees and about 195 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees, or about 180 degrees.

[0112] 43B and 43D, in some embodiments, the wires 2035, 2036 extend along the length L of the delivery catheter 1114 such that the wires are parallel or substantially parallel to an axis X that extends through the center of the delivery catheter. In this embodiment, the wires 2035, 2036 are circumferentially offset such that the angle α between the wires 2035, 2036 is 180 degrees. In some embodiments, the angle α is between about 155 degrees and about 205 degrees, such as between about 165 degrees and about 195 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees.

[0113] 43A-46, in practice, when the guide sheath 502 is positioned in the atrium, the distal region 117 of the delivery catheter 1114 is advanced out of the distal opening of the guide sheath 502. The portion of the delivery catheter 1114 extending from the guide sheath 502 can be positioned in the atrium (e.g., the left or right atrium), while in some cases, a portion of the delivery catheter 1114 can extend through a native valve (e.g., the native mitral valve) into a valve chamber (e.g., the left or right ventricle). The pull wires 1135, 1136 can be tensioned to actuate the distal region 117, i.e., to articulate two bends, e.g., of sections 115, 116, located at the distal portion of the delivery catheter 1114.

[0114] In one sequence, as shown in FIG. 44A, a first pull wire 1135 can be tensioned to bend section 115 to a curved actuated state where the distal end 118 faces the mitral valve opening. Then, as shown in FIG. 44B, a second pull wire 1136 can be tensioned to bend section 116 to a curved actuated state where the curvature of section 116 is in the opposite or substantially opposite direction to the curvature of section 115 when section 115 is in the actuated state. In some embodiments, the pull wires 1135, 1136 can be partially or fully tensioned in various amounts and / or sequences for proper and safe guidance around or against the patient's anatomy during actuation. In some embodiments, actuation of the pull wire or pull wire system in combination with torquing or rotating the delivery catheter within the sheath can direct the distal region and tip of the catheter to a desired position and / or orientation. That is, the catheter can be rotated to point the tip of the delivery catheter 1114 at the target location.

[0115] 45A-45D and 46, in some embodiments, the delivery catheter 1114 comprises a first conduit 2210 (e.g., a tube, sleeve, etc.) for housing the first pullwire 1135 and a second conduit 2212 for housing the second pullwire 1136. In the illustrated embodiment, the conduits 2210, 2212 are defined at least in part by a liner 2215 and an inner surface 2216 of a flexible tube 2030. In some embodiments, the conduits 2210, 2212 can take any other suitable form. In some embodiments, no conduits are used to house the pullwires 2035, 2036.

[0116] The design of the proximal section 140 and the configuration of the pull wires 2035, 2036 may provide an anti-jerk or anti-bend effect to the entire delivery catheter 1114 when the pull wires 2035 and 2036 are actuated. This may allow the delivery catheter 1114 to maintain full torqueability through the transseptal bend. This may also facilitate more effectively retaining or maintaining the actuated shape of the distal region 117 during torque application or rotation during delivery. In some embodiments, the delivery catheter 1114 includes a first coil sleeve 2211 that extends around the first pull wire 1135 until it reaches the distal flex section 115, and a second coil sleeve 2213 that extends around the second pull wire 1136 until it reaches the proximal flex section 116. The first pull wire 1135 and the first coil sleeve 2211 around it are positioned loosely within the first conduit 2210. The second pullwire 1136 and the surrounding second coil sleeve 2213 are freely positioned within the second conduit 2212. The coil sleeves 2211, 2213 are configured to provide an anti-jerk or anti-bend effect to the delivery catheter 1114 and allow it to maintain its full torqueability.

[0117] In one embodiment, a delivery catheter for delivering a device to a native valve of a patient's heart may have a flexible tube with a central main lumen and a pair of control wire lumens. Referring now to Figures 47A-47D, a flexible tube frame 1025 for use in a distal region of a flexible delivery catheter according to one example embodiment is illustrated. This flexible tube frame 1025 may have a cylindrical overall shape with both proximal and distal ends open, allowing for control of flexibility over the flexible tube located at the distal end of the delivery catheter. As with other example embodiments described herein, the flexible tube frame and the distal region of the delivery catheter are not limited to a circular cross section, but may also be elliptical or egg-shaped. In one example embodiment, each flex section may have its own flexible tube frame. For example, a delivery catheter may have two flexible tube frames, one for each of the two flex sections of the delivery catheter.

[0118] 47A, a plan view of a flexible tube frame of a delivery catheter is shown. The flexible tube frame 1025 can be made of links 1038 that are defined by slots or grooves 1036. The links 1038 can also have notches 1084 and slits 1039. Each of the multiple links 1038 can have a circular shape and be spaced from at least one other link by slots 1036 (or grooves) located on the top and sides of the link in a circular or other shaped configuration.

[0119] Referring now to FIG. 47B, a side view of the flexible tube frame is shown with the notches 1804 and slits 1039 positioned near the bottom of the frame. The notches 1804 can be curved in a shape such as a semicircular or semi-elliptical cut from the frame. There can be a corresponding cut out on each side of the frame 1025 (FIG. 48) for each of the links, so that when the frame is in the tube configuration, each pair of notches 1804 aligns to form a circular, elliptical, or cylindrical opening located along the bottom of the frame as shown in FIG. 47C. As shown in FIGS. 47B and 47C, the slits 1039 can be cut into the frame such that two slits are cut into each of the links that extend partially up from the frame bottom into the associated link. These slits create little or no space when the flexible tube frame is in a straight position, but when the frame is moved into a curved configuration, the frame links can each expand at the slits.

[0120] 47D, there is shown the distal end of the flexible tube frame 1025. Notches 1804 for connecting pull wires are located at the top of the distal end, and teeth 1807 for securing an anchor ring are located at the bottom of the distal end.

[0121] 48A and 48B, a flattened view of a flexible tube frame in a flat configuration is shown. The flexible tube of the delivery catheter can have a flexible tube frame made of multiple links disposed at a distal region of the flexible tube, the multiple links being positioned between a first ring and a second ring. The multiple links can be cylindrically shaped and cut from a single piece of material such that each link is aligned with and connected to at least one adjacent link such that a slot is formed between each pair of adjacent links. In some embodiments, the tube is a hypotube (optionally capable of being formed from a flat sheet of material, from a preformed tubular material, from a mold, 3D printing, etc.) with laser cut slots 1036, notches 1804, and slits 1039 having similar or identical properties to the example embodiment described above and shown in FIG. FIG. 48A shows one embodiment of a flexible tube frame in a flat configuration, and FIG. 48B shows a close-up of a corner of the frame of FIG. 48A. The frame 1025 can have a rectangular or substantially rectangular shape when in the flat configuration, with a length L varying due to the cutouts 1804 and slits 1039. The slots 1036 can be cut out from a central region to form a number of links 1038. The slots can have an elongated and / or tapered shape, with the central region 1901 of each slot 1036 being longer in length L2 than the length L1 at each end of the slot. Additionally, the edges of the frame 1025 along each width W can be modified with the addition of cutouts. A first end of the frame can have one rectangular or substantially rectangular cutout with a further semicircular or substantially semicircular cutout aligned with the midpoint of the width W of the frame. The two end pieces 1902, 1903 formed by these notches in the first end form tooth 1807 attachment points for a pull ring 2037 that is positioned at the bottom of the frame when the frame is in the tube configuration.However, the teeth 1807 are not limited to being formed by two end pieces, but rather can be one end piece extending distally from the distal edge 1904 of the sheet. As with other example embodiments described herein, a frame such as that shown in FIG 48A can be used for each flexible section in the distal region of the delivery catheter.

[0122] The cutouts at the second end of the frame can be a number of elliptical or substantially elliptical windows 1808. The central window has an additional proximal cut that can be a proximal slot 1809, which opens the central window to the proximal edge 1905 of the frame. The proximal slot 1809 can be aligned with the anchor of the hypotube when the delivery catheter is fully assembled. These windows are used to provide openings for adhesive or polymeric materials to flow through and adhere to layers located below or within the windows, allowing embedding and thus fixing in place of a component (in this example the frame).

[0123] 50A and 50B, an example embodiment having two flexible tube frames is shown. In this embodiment, a distal section flexible tube frame 1025 is positioned at the distal end of the delivery sheath 1114 (see FIG. 49A) and a proximal section flexible tube frame 1026 is positioned proximal to the distal section flexible tube frame 1025. A first control wire 1135 may extend from the proximal end of the delivery catheter, pass through both the proximal section flexible tube frame 1026 and the distal section flexible tube frame 1025, and be coupled to a distal pull ring 2037. A second control wire 1136 may extend from the proximal end of the delivery catheter to the distal end of the proximal section flexible tube frame 1026 and be coupled to a pull ring 2038 at the distal end of the second flexible tube frame. The bending of the flexible tube frames may be controlled using these control wires. These components consist of a first optional ring added to the distal end of the distal section flex tube frame, a second optional ring added to the proximal end of the distal section flex tube frame, a third optional ring added to the distal end of the proximal section flex tube frame, and a fourth optional ring added to the proximal end of the proximal section flex tube frame.

[0124] The first ring located at the distal end of the distal section flex tube frame can be a pull ring 2037 coupled to a tooth 1807 located at the distal end of the frame. The pull ring is fixedly attached to the distal end and can be attached by welding between the pull ring and the tooth. Optionally, the pull ring and the distal end of the first frame can be attached by any other known technique typically used and capable of withstanding a tensile load of at least 25 pounds. The pull ring can have a notch 1804 that can overlap a notch in the flexible tube frame. A control wire 1135 can be fixedly attached to the pull ring. The third ring located at the distal end of the proximal section flex tube frame can be another pull ring 2038 coupled to a tooth 33 located at the distal end of the proximal frame. Similar to the pull ring attached to the distal section flex tube frame, the pull ring attached to the proximal section flex tube frame can be attached by any known technique typically used.

[0125] Referring again to FIG. 50A, there may be another ring located at the proximal end of the proximal flexible tube frame, such as an anchor ring 2039. This anchor ring 2039 is attached to the proximal end of the proximal section flexible tube frame 1026. The anchor ring 2039 may have a hypotube 2901 attached to its inner surface (see FIGS. 56A and 56B). The anchor ring 2039 may be positioned such that the hypotube 2901 is aligned with the pull wire 1136 that controls the proximal flex section 116. The pull wire 1135 that controls the distal flex section may pass through a central opening 2905 in the anchor ring 2039. The first control wire 1135 for the distal flexible tube passes through the hypotube. Additionally, there may be a second anchor ring (not shown) located at the proximal end of the distal flexible tube frame that may be in addition to or alternative to the hypotube attached pull ring 2038 for the second control wire 1136 that controls the proximal flex tube. In one such embodiment, the second anchor ring may be positioned such that the hypotube is aligned with the pull wire that controls the distal flex section 115.

[0126] 55A-56C, an anchor ring and hypotube assembly according to the example embodiment of FIGS. 50A and 50B is shown. FIG. 55A shows a flat view of an anchor ring 2039 for the proximal end of the proximal flexible tube 1036. When flat, the anchor ring can have a rectangular or substantially rectangular shape, with a width the same or nearly the same as the width of the flexible tube frame when in the flat configuration. The anchor ring 2039 can have a cutout 2803, which can have a rectangular shape. The anchor ring can also have a unique hole 2802. The holes 2802 and cutouts 2803 can be circular or substantially circular, rectangular, or any other shape that allows for stacking of materials in the assembly of the delivery catheter. The anchor ring can also have a weld hole 2801 for aligning and welding the hypotube 2901 to the top side in the anchor ring. FIG. 55B shows a close-up of the weld hole. FIG. 56A shows a top view of the anchor ring and hypotube 2901 welded together. The hypotube is an anchor for slidably passing control wires. FIG. 56B shows a side view of the anchor ring 2093 and the hypotube located on top of the anchor ring. The hypotube may be attached by welding or other known techniques. FIG. 56C shows an end view of the anchor ring. The hypotube may be positioned and welded to the inner surface on top of the anchor ring. The anchor ring may be curved into a cylindrical configuration to match the cylindrical configuration of the flexible tube frame, but the ends of the anchor ring do not have to be brought into contact with each other to form a perfect cylindrical shape or other substantially cylindrical shape. FIG. 56C shows a gap 2903 that may remain when the components are assembled. The weld between the anchor ring and the hypotube should be capable of withstanding a tensile load of at least 30 pounds applied coaxially to the hypotube.

[0127] 57A-58C, the coil sleeve 2211 and the proximal coil stopper 2005 will be described in further detail. Each control wire may have a coil sleeve and a coil stopper at the proximal region of the control wire. FIG. 57A shows a flat view of the coil stopper 2005. The coil stopper may have windows 3001 and weld holes 3002. The windows allow the assembly of components to be held together with the polymeric catheter material, and the weld holes allow the coil stopper to be secured to the coil sleeve. FIG. 57B is a close-up view of the weld holes 3002 that may be used to weld the coil stopper 2005 to the coil sleeve 2211. The second coil stopper 2010 for the second coil sleeve 2213 may be identical to the first coil stopper 2005 for the first coil sleeve 2211.

[0128] 58A-C show the proximal region of the coil sleeve 2211 when it is assembled with the first coil stopper 2005. In FIG. 58A, a plan view is shown. Here, the assembly windows are positioned such that there is a top proximal window and a top distal window. Each assembly window in FIG. 58A can be part of a pair with a corresponding bottom assembly window as shown in FIG. 58B. The coil stopper is not limited to this particular configuration of assembly windows and weld holes. FIG. 58B shows a cross-sectional view of the coil sleeve and stopper along line XX. The proximal end of the coil sleeve 2211 fits snugly into the proximal coil stopper. Weld holes are located on both the top and bottom sides of the coil stopper. These weld holes are located in the coil stopper so that the multiple turns of the coil in the coil sleeve can be fixed relative to the coil stopper. FIG. 58C shows the coil in the coil stopper and the channel 3101 through which the control wire slidably extends. The second coil sleeve 2213 and the second coil stopper 2010 may be identical to the first coil sleeve 2211 and the first coil stopper 2005 .

[0129] 49A and 49B, the distal portion of the delivery catheter 1114 is shown housing a flexible tube frame. FIG. 49A is a side view showing that the outer layer of the delivery catheter 1114 can be 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 in each section of the catheter. At a proximal location along the delivery catheter length, the catheter 1114 has a first opening 2201 for the exit of the first control wire 1135. The first control wire is connected to a control ring 2037 for the distal flex section. A first coil sleeve 2211 surrounds the first control wire until it passes through a first coil stopper 2005 that connects the coil to the ring 2038.

[0130] Referring again to FIG. 49B, at a proximal location along the length of the delivery catheter, the catheter 1114 has a second opening 2202 for the exit of a second control wire. This second control wire is coupled to a pull ring 2038 for the proximal flexure section. A second coil sleeve 2213 surrounds the second control wire until it passes through a second coil anchor 2010 that couples the coil 2213 to the ring 2038. FIG. 49B shows a distal end view of the delivery catheter.

[0131] The catheter components can extend for various lengths along the delivery catheter in various embodiments. With reference to Figs. 46 and 50A, the distal section flexible tube frame 1025 extends along the distal flex section 115 (see Fig. 42). The first coil sleeve 2211 extends through the proximal section flexible tube frame 1026 and is coupled to the ring 2038. The first coil sleeve 2211 extends from the proximal end of the proximal section tube frame 1026 inside the delivery catheter for a length, then exits the delivery catheter and extends proximally for another length. An optional first control wire lumen liner may extend along the entire length of the first control wire lumen.

[0132] 46 and 50A, a proximal section flexible tube frame 1026 extends along the proximal flex section 116 (see FIG. 42) of the distal region 117 of the delivery catheter. A second coil sleeve 2213 terminates in and is attached to a ring 2039. The second coil sleeve 2213 extends proximally within the delivery catheter for one length and then exits the delivery catheter and extends proximally for another length parallel to the first coil sleeve. A second control wire lumen liner can extend along the entire length of the second control wire lumen terminating in a control ring 2038.

[0133] 51-54, cross sections of the delivery catheter at various points along the length of the catheter shown in FIG. 49A are illustrated. FIG. 51-53 show a cross section of the distal region of the delivery catheter, comprising a distal section flexible tube frame 1025 and a proximal section flexible tube frame 1026. FIG. 54 shows a cross section along section line EE-EE at the proximal region of the delivery catheter, with control wires 1135, 1136 positioned external to the catheter.

[0134] Referring to FIG. 51, the cross section of the delivery catheter is shown along line BB-BB in FIG. 49A. The cross section is at the proximal portion of the distal region 117 having the proximal flex section 116. There is an outer layer 2301 of the catheter, which can be an outer polymer layer having any of the properties described above in connection with the polymer used for the delivery catheter. There is an inner layer, a primary lumen liner 2402, which can be made of etched PTFE and / or another material and can extend the entire length of the primary lumen of the delivery catheter. This liner can completely surround the inner surface of the catheter lumen. There can be a braid 2401, which provides additional support to the catheter without limiting the flexibility needed to guide the delivery catheter inside the heart. This optional braid 2401 is embedded within the outer polymer layer. The braid can be made from flat wire and can have an almond-shaped pattern or any other pattern known in the art that provides both strength to the delivery catheter and maintains its flexibility. There is a first control wire lumen 2503. Located within the control wire lumen 2503 is an optional control wire lumen liner 2502 that lines the control wire lumen and a coil sleeve 2211 that surrounds the first control wire 135. The first control wire lumen has the first control wire 1135 extending therethrough and terminates in a ring 2037 located at the distal end of the distal section flexible tube frame 1025.

[0135] 51, a second control wire lumen 2504 is provided that may have a control wire lumen liner 2505 lining it and a coil sleeve 2213 surrounding the second control wire 1136. A hollow primary lumen 2602 is disposed within the catheter within the primary catheter lumen liner 2402.

[0136] Referring to FIG. 52A, the cross section of the delivery catheter shown is taken along line CC-CC in FIG. 49A. The orientation of the catheter in FIG. 50A and FIG. 50B is rotated 180 degrees when compared to FIG. 46, FIG. 49A, FIG. 51, FIG. 52A, FIG. 52B, FIG. 53, and FIG. 54. This cross section is the middle portion of the distal region of the delivery catheter, located just proximal to the anchor ring 2039, which is connected to the second flexible tube frame. The first control wire 1135 and the second control wire 1136 are each present in this cross section. FIG. 52B shows a close-up view of the top of the catheter in the cross section shown in FIG. 52A, where the first control wire lumen is located. The hypotube 2901 is attached to the anchor ring 2039 (see FIG. 46). The coil 2213 is attached to the hypotube 2091, and the control wire 1136 extends through the hypotube 2901. The hypotube can be made from stainless steel, nitinol, polymers, and / or other biocompatible materials. Additionally, Figure 52A shows a control wire lumen 2503 along line CC-CC of Figure 49A with the control wire 1135 and coil 2211 located within lumen 2504.

[0137] There may also be an optional marker band 2501. This marker band may act as an indicator to the user of the location of the proximal end of the flexible tube frame in the distal region of the delivery catheter. This marker may be made of platinum iridium or other material that can be read by imaging techniques commonly used with valve implant delivery catheters. The liner 2402, which is the liner of the primary lumen 2602 of the catheter, may extend along the entire length of the lumen 2602, including the location of the line CC-CC portion in the distal region of the delivery catheter.

[0138] Referring to FIG. 53, a cross section of the delivery catheter is shown taken along line DD-DD in FIG. 49A. This cross section is located at the distal bend section of the delivery catheter. In this cross section, there is a distal section flexible tube frame 1025 embedded within the outer catheter 2301. This particular cross section is at a portion of the catheter having a cutout in the flexible tube frame as indicated by gap 1804. Optionally, the interior of the primary catheter lumen and the first control wire lumen are lined with a primary lumen liner 2402 and a control wire lumen liner 2502, respectively. The first control wire lumen has a first control wire 1135 located therein. In one example embodiment, the second control wire does not extend through the distal flexible tube frame. However, in some embodiments, a second empty lumen may be optionally disposed within this space. This outer catheter is made of a polymer as described above.

[0139] FIG. 54 shows a cross section of the proximal region of both flexible tube frames along line EE-EE of FIG. 49A. The primary catheter lumen 2602 has a liner 2402 that extends along the length of the delivery catheter. The control wire lumen originates at a more distal location in the catheter. At cross section EE-EE, the first control wire 1135 is external to the catheter so that it can be manipulated at its proximal end (not shown) by the operator. The first control wire 1135 is surrounded by a first coil sleeve 2211, which is partially covered by a first coil stopper 2005. At cross section EE-EE, the second control wire 1136 is external to the catheter so that it can be manipulated at its proximal end (not shown) by the operator. The second control wire 1136 is surrounded by a second coil sleeve 2213 , which is partially covered by a second coil stopper 2010 .

[0140] Referring again to FIGS. 50A, 50B, and 53, the delivery catheter may have a first control wire in a first control wire lumen 2502 (note again that FIGS. 50A and 50B are rotated 180 degrees when compared to FIGS. 46, 49A, 51, 52A, 52B, 53, and 54). The first control wire lumen 2502 may extend along the delivery catheter all the way to the first pull ring 2037. The control wire lumen 2502 may be disposed within and along (i.e., within) the first and second flexible tube frames. The hypotube and first coil sleeve 2211 of the anchor ring are disposed within this first control wire lumen 2502. The first coil sleeve 2211 is connected to the distal flexible tube frame 1025 by a hypotube 2901 which is connected to a pull ring 2038 .

[0141] The distal end of the second coil sleeve 2213 may be coupled to an anchor ring 2039. The coil surrounds the control wire to protect the coil wire and to prevent the plastic material around the coil sleeve from compressing, shortening, or buckling when the control wire is pulled. A first coil stopper 2005 may surround the proximal end of the first coil sleeve. The first coil sleeve 2211 has a distal region within the catheter within the first control wire lumen and exits the catheter at an opening 2201. A proximal region of the first coil sleeve is located outside the delivery catheter and extends a length. At least a portion of the first control wire 1135 that extends from the second ring to the first ring is not covered by the first coil sleeve (see FIG. 53). The first coil stopper 2005 maintains the integrity of the proximal end of the coil sleeve 2211 and provides a means for coupling the first coil sleeve 2211. The first coil sleeve 2211 prevents the control wire 1135 from compressing, shortening, or buckling the delivery catheter in the area of ​​the wire covered by the coil sleeve.

[0142] The second control wire lumen 2504 may extend to the second pull ring 2038. The second control wire lumen may extend into and along (i.e., within) the proximal flexible tube frame 1026. A second coil sleeve 2213 is disposed within the second control wire lumen. The coil is located proximal to the second flexible tube frame 1026 and is coupled to the anchor ring 2039. There may be a second hypotube to which the coil 2213 is coupled, or the coil 2213 may be directly coupled to the anchor ring 2039. The coil 2213 surrounds the control wire 1136 to protect the coil and to prevent the plastic material around the coil sleeve from compressing, shortening, or buckling when the control wire 1136 is pulled. A second coil stopper 2010 may surround the proximal end of the first coil sleeve. The coil sleeve 2211 has a distal region within the catheter within the control wire lumen and exits the catheter at an opening 2201. A proximal region of the second coil sleeve is external to the delivery catheter and extends a length. At least a portion of the second control wire 1136 that extends from anchor ring 2038 to anchor ring 2039 is not covered by the second coil sleeve 2213. This allows the catheter to flex in the area where the control wire 1136 is not covered. The second coil stopper 2010 maintains the integrity of the proximal end of the second coil sleeve 2213.

[0143] The delivery catheter 1114 includes a first control wire lumen 2502 for accommodating the first control wire 1135 and a second control wire lumen 2212 for accommodating the second control wire 1136. In the illustrated embodiment, these control wire lumens are each defined at least in part by an optional liner. In some embodiments, these control wire lumens can take any other suitable form.

[0144] In some embodiments, the delivery catheter 1114 includes a first coil sleeve 2211 that extends around the first control wire until it reaches the distal section flexible tube frame 1025. The delivery catheter may also include a second coil sleeve 2213 that extends around the second control wire until it reaches the proximal section flexible tube frame 1026. The design of the proximal section of the delivery catheter and the configuration of the first and second control wires 1135 and 1136 and the first and second coil sleeves 2211 and 2213 provide an anti-jerk or anti-bend effect on the entire delivery catheter 1114 when the control wires are actuated. This may allow the delivery catheter 1114 to maintain full torque transmission through the transseptal bend. Additionally, this may facilitate more effectively retaining or maintaining the actuated shape of the distal region 117 during torque application or rotation during delivery.

[0145] The control wires, control wire lumens, flexible tube frame, pull ring, anchor ring, and coil sleeve act in a manner similar to a cinch or drawstring if the control wires are strings, and the distal region of the catheter can be "cinched" by the flexible tube frame. FIG. 50B shows the movement of the components when tension is applied to the control wires. At the proximal end of the device, the operator can pull the first control wire 1135 in a proximal direction as shown by arrow 2006. This first control wire can be partially or fully tensioned in various amounts to properly and safely guide it around the patient's anatomy. When this tension is applied proximally to the first control wire 1135, the first control wire, which is coupled at its distal end to the first pull ring 2037, applies a force in a proximal direction against the top of the pull ring. This force moves the first pull ring 2037 upward and proximally as shown by arrow 2007. The distal section flexible tube frame 1025 bends and folds along the slots or grooves 1036 such that the slots 1036 positioned along the top curve of the frame become smaller as the tops of the frame links 1036 are pulled closer together as shown by arrow 2008. This causes the first flexible tube frame and corresponding section of the delivery catheter to flex such that the distal region of the catheter curves upward in the direction shown by arrow 2007, where upward is defined as the direction in which the tops of the frame 1025 face each other. As a result of applying tension to the first control wire 1135 by pulling the first control wire 1135 proximally, the distal flexible tube frame 1025 is curved into a configuration in which its proximal and distal ends are drawn closer together and have a curve as shown by curve 2009 in FIG. 50B. In this manner, the tension on the control wire determines the degree of curvature. Bending of the distal flexible tube frame 1025 can cause slits 1039 located along the bottom of the frame to expand and relieve forces applied to the distal flexible tube frame.

[0146] At the proximal end of the device, the operator can pull the second control wire 1136 proximally as shown by arrow 2012. The second control wire can be partially or fully tensioned in various amounts to properly and safely navigate around the patient's anatomy. When this tension is applied proximally to the second control wire 1136, the second control wire coupled to the second pull ring 2038 applies a force in the proximal direction to the top of the second pull ring. This force causes the second pull ring 2038 to move upward and proximally as shown by arrow 2007. The proximal section flexible tube frame 1026 bends and folds along the slot or groove 1036, such that the slot 1036 positioned along the top curve of the frame becomes smaller as the tops of the frame links 1036 are pulled closer together as shown by arrow 2013. This causes the proximal section flexible tube frame and corresponding section of the delivery catheter to flex such that the distal region of the catheter curves downward in the direction indicated by arrow 2011, where downward is defined as the direction that the bottom of the proximal section flexible tube frame 1026 faces. As a result of applying tension to the second control wire 1136 by pulling it proximally, the proximal section flexible tube frame 1026 is curved into a configuration in which its proximal and distal ends are brought closer together and have a curve as indicated by curve 2011 in FIG. 50B. In this manner, the tension on the control wires determines the degree of bending. The bending of the proximal section flexible tube frame 1026 causes slits 1039 located along the bottom of the frame to expand, relieving the force applied to the proximal flexible tube frame.

[0147] 50B, the first control wire 1135 is fixedly coupled to the pull ring 2037 and slidably coupled to the anchor ring 2038 by passing through a hypotube 2901 coupled to the anchor ring 2038 (see FIG. 46). The first control wire 1135 is also slidably positioned within the first control wire lumen 2502 and the first coil sleeve 2211. The first coil sleeve 2211 prevents cinching and / or bunching of the delivery catheter in areas other than the area of ​​the flexible tube. The first coil sleeve provides additional stiffness to the delivery catheter so that the length of the delivery catheter having the coil sleeve does not flex excessively. When the first control wire 1135 is pulled in the direction of arrow 2006 to flex the distal region of the delivery catheter, a tensile load is applied to the distal end of the first control wire where it is coupled to the first pull ring 2037. The first flexible tube frame bends, but the first coil sleeve 2211 prevents bending of the first control wire 1135 at the proximal region of the delivery catheter. When tension in the first control wire is released, the tube frame returns to a straight configuration, the multiple links 1038 are again spaced apart along the slots and / or grooves 1036, and the slits 1039 close again.

[0148] The second control wire 1136 is fixedly coupled to the second pull ring 2038 and passes through an anchor ring 2039 at the proximal end of the proximal section flexible tube frame 1026. In some embodiments, the second control wire 1136 may be slidably coupled to the anchor ring 2039 and pass through a second hypotube within the anchor ring 2039. The second control wire 1136 is also slidably positioned within the second control wire lumen 2504 and the second coil sleeve 2213. The second coil sleeve 2213 prevents cinching and / or bunching of the delivery catheter in areas other than the area of ​​the flexible tube. The second coil sleeve provides additional stiffness to the delivery catheter so that the length of the delivery catheter having the coil sleeve does not flex excessively. When the second control wire 1136 is pulled in the direction of arrow 2012 to flex the distal region of the delivery catheter, a tensile load is applied to the distal end of the second control wire where it is coupled to the second pull ring. The proximal flexible tube frame bends, but the second coil sleeve 2213 prevents the second control wire 1136 from bending at the proximal region of the delivery catheter. When the tension in the second control wire is released, the tube frame returns to a straight configuration, the multiple links 1038 are again spaced apart along the slots and / or grooves 1036, and the slits 1039 close again.

[0149] 59A-59C, a schematic diagram of an example embodiment of a reciprocally flexing steerable catheter is shown. In these example embodiments described herein, the delivery catheter 1114 can be a steerable catheter, and the terms "delivery catheter" and "steerable catheter" can be used interchangeably. The steerable catheter has a distal region 117 having a distal flex section 115 and a proximal flex section 116. The steerable catheter also has two pull wires, each with its own control input, such as the knob shown. These control inputs for the wires 1135, 1136 can take a variety of different forms. Examples of control inputs include, but are not limited to, knobs, sliders, threaded connections, followers, threaded sliders, ball joints, and the like. Some examples of control inputs are disclosed by U.S. Patent Application No. 15 / 815,385, filed November 16, 2017, which is incorporated herein by reference. The control inputs are also generally shown herein as knobs 5901, 5902. In these figures, knobs 5901, 5902 are shown as having an axis of rotation that is perpendicular to the axis of the catheter. However, the axis of rotation of the knobs of any of the embodiments disclosed herein can be parallel and / or aligned with the axis of the catheter, and may optionally drive components that are coupled to wires along the length of the catheter.

[0150] 59A-59C, a first pull wire 1135 or control wire extends from a first control input 5901 to the distal end 118 of the steerable catheter 1114 and is anchored at a first actuation point 135a at the distal end 118. A second pull wire 1136 extends from a second control input 5902 to an intermediate location of the distal region at the distal end of the proximal flexion segment and is anchored at a second actuation point 136a at the intermediate location. The first pull wire can be coupled to a shaft 5903 coupled to the control input 5901, which can be a flexion wheel knob. The second pull wire can be coupled to a second shaft 5904 coupled to the control input 5902, which can be a flexion wheel. Each of these pull wires can be wound around the flexion wire when tensioned. However, in some embodiments, the pull wires may each be coupled to a coupler (or the same coupler in embodiments where there is only one flex wheel). For example, the couplers may be actuated along the length of the catheter by turning a knob. However, as noted above, the control inputs for the wires may take a variety of different forms.

[0151] FIG 59A shows the reciprocal flexure steerable catheter in a straight configuration. FIG 59B shows the reciprocal flexure steerable catheter of FIG 59A with the first control wire 1135 actuated using the first control input 5901. Actuating the first control wire applies tension to the first control wire and the distal flexure segment is bent as the steerable catheter is pulled by the tension in the first pull wire from the distal end where the steerable catheter is fixed. In FIG 59C, both pull wires have been actuated and actuation of the second pull wire 1136 by the second control input causes the applied tension to pull the proximal flexure section 116 in the opposite direction (e.g., 180 degrees, about 180 degrees) from the direction the distal flexure section is pulled by its pull wire.

[0152] 59A-59C show the distal flex section being actuated before the proximal flex section, the segments need not flex in that order. In some embodiments, the proximal flex segment may be actuated first, followed by the distal flex segment. It is also possible for the proximal and distal flex segments to flex simultaneously. In a scenario where the distal flex segment is flexed first, the proximal and distal flex segments may then be flexed simultaneously to raise the position of the distal end 118 of the steerable catheter and then adjust the curvature in the distal flex segment so that the distal end 118 faces the same direction as if only the distal flex segment was actuated.

[0153] 60A and 60B show schematic diagrams of a reciprocal flexure type steerable catheter with a single control wire actuator with a clutch type control wire actuation mechanism for controlling the control wire being actuated. In this example embodiment, the distal flexure section 115 is associated with a first pull wire 1135 and the proximal flexure section 116 is associated with a second pull wire. Both the first pull wire 1135 and the second pull wire 1136 are actuated by a single actuator 5901. FIG. 60A shows the clutch type mechanism in a disengaged position, where a first shaft 5903 attached to the flexure wheel (to actuate the first pull wire) is not coupled to a second shaft 5904 (to actuate the second pull wire). The actuator can be the flexure wheel 5901 and a shaft attached to the flexure wheel. In this embodiment, the first pull wire can be coupled to the flexure wheel. Rotating the flex wheel in a first direction applies tension to the first pull wire, causing the distal flex section 115 to flex, and rotating the flex wheel in a second direction may release tension on the first pull wire 1135, causing the distal flex section to relax and straighten. The second pull wire 1136 may be attached to a second shaft 5904 that is coupled to an external engagement mechanism 5905. This external engagement mechanism may be a button, as shown in FIGS. 60A and 60B, or may be a switch, lever, or other known clutch type mechanism. When the button is pressed, as shown in FIG. 60B, a second screw mechanism is engaged to the first shaft 5903, thereby coupling to the flex wheel 5901. When engaged, further rotation of the flex wheel in a first direction rotates the second pull wire, tensioning the second pull wire and bending the proximal flex segment, and rotation of the flex wheel in a second direction releases tension in the second pull wire and straightens the proximal flex section 116.

[0154] 61, a schematic diagram of a reciprocally flexing steerable catheter having one control input and two pull wires is shown, according to one example embodiment. In this embodiment, a first pull wire 1135, also referred to as the distal pull wire, extends longitudinally distally from the single control input to the distal end of the distal flex section 115. A second pull wire 1136, also referred to as the proximal pull wire, extends longitudinally distally from the single control input to the distal end of the proximal flex section 116. In a rest configuration, the second pull wire 1136 may have slack such that tension is initially applied to the first / distal pull wire by operating the single control input to apply tension to the wire. During initial tensioning of the first pull wire 1135, slack 5908 in the second pull wire will be relieved by the single control input. When this slack is removed, the second pull wire is also tensioned simultaneously with the first pull wire. When the tension in the pull wires is to be released to straighten the steerable catheter, the slack in the proximal pull wire will cause the proximal flexure section to complete straightening first, followed by the distal flexure section.

[0155] 62A-62C, schematic diagrams of a reciprocally flexing steerable catheter having various stiffness characteristics along the length and circumference of the catheter are shown. FIG. 62A shows an example embodiment with regions of different stiffness. There can be two or more regions, and FIG. 62A shows a schematic diagram with three regions. The distal flex section 115 has a first stiffness section or first spine 2040 having a first stiffness, the proximal flex section 116 has a second stiffness section or second spine 2041 having a second stiffness, and the intermediate region 6203 has a third stiffness. The first stiffness section can be located along all or a portion of the length of the distal flex section. The second stiffness section can be located along all or a portion of the length of the proximal flex section. These regions can change abruptly or gradually according to a gradient. This stiffness can be constant around the entire circumference of the steering catheter, or it can be limited to a portion of that circumference, such as in the embodiment described above having a spine that has a higher stiffness than other portions of the steering catheter.

[0156] The length of the flexible segment, including the overall circumference and thickness of the steerable catheter wall layer, the thickness of the flexible segment, and / or the durometer hardness all affect the extent to which the flexible segment can bend, the extent to which the flexible segment can bend upon actuation, and the rate at which the flexible segment can bend (i.e., time-dependent bending). The stiffer a region is, the less flexible it is. In one example embodiment, the proximal flex section 116 can have a higher stiffness than the distal flex section 115. This stiffness can vary based on the materials used, which can include any combination of metals, polymers, and / or other materials.

[0157] 62B, the stiffness differential is illustrated diagrammatically according to one embodiment. The distal flex section 115 has a steerable catheter segment or spine 2040 positioned on the opposite side of the distal pull wire that has a higher stiffness than the rest of the steerable catheter circumferential portion in the distal flex region. The proximal flex section 116 has a steerable catheter segment or another spine 2041 positioned on the opposite side of the proximal pull wire that has a higher stiffness than the rest of the steerable catheter circumferential portion in the proximal flex region. The first spine 2040 can extend over a portion or the entire length of the distal flex section 115. The spine 2040 can be made of a material having a higher stiffness than the rest of the steerable catheter tube and is therefore configured to limit motion, such as compression along the length of the distal flex segment, along the portion of the steerable catheter opposite the pullwire 1135 when the pullwire is actuated. The spine can be made of, for example, stainless steel, plastic, or any other suitable material that has a higher stiffness in the distal flex region than the rest of the steerable catheter. The steerable catheter can be made of, for example, nitinol, steel, and / or plastic, or any other suitable material or combination of materials that allows the delivery catheter to be moved into a flexed configuration.

[0158] In some embodiments, the ratio of the Shore D hardness of the first spine 2040 to the Shore D hardness of the steerable catheter is about 3:1. In some embodiments, the ratio of the Shore D hardness of the spine 2040 to the steerable catheter is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In some embodiments, the ratio of the Shore D hardness of the spine to the steerable catheter is greater than 5:1 or less than 1.5:1.

[0159] 62B, the first spine 2040 is disposed on an opposing or substantially opposing side of the first pull wire 1135 such that the center of the spine 2040 is circumferentially offset by 180 degrees or about 180 degrees from the first pull wire 1135. The center of the spine 2040 can be circumferentially offset from the first pull wire 1135 by between about 155 degrees and about 205 degrees, such as between about 165 degrees and about 195 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees.

[0160] In FIG. 62B, the second spine 2041 extends along at least a portion of the length of the proximal flex section 116. Just like the first spine 2040, the second spine 2041 is made of a material having a higher stiffness than the rest of the steerable catheter in the proximal flex section, and is therefore configured to limit the curvature of the proximal flex section when the second pull wire 1136 is actuated. The spine 2041 may be made of, for example, stainless steel, plastic, or any other suitable material that allows the steerable catheter to move into a flexed configuration. In some embodiments, the ratio of the Shore D hardness of the spine 2041 to the Shore D hardness of the steerable catheter is about 3:1. In some embodiments, the ratio of the Shore D hardness of the spine 2041 to the steerable catheter is between about 1.5:1 and about 5:1, such as between about 2:1 and about 4:1, such as between about 2.5:1 and about 3.5:1. In some embodiments, the ratio of Shore D hardness of the spine to the steerable catheter is greater than 5:1 or less than 1.5:1.

[0161] 62B, the second spine 2041 is disposed on an opposing or substantially opposing side of the second pullwire 1136 such that the center of the spine 2041 is circumferentially offset by 180 degrees or about 180 degrees from the second pullwire 1136. The center of the spine 2041 can be circumferentially offset from the first pullwire 1135 by between about 155 degrees and about 205 degrees, such as between about 165 degrees and about 195 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees.

[0162] When the flex wheel 5901 is rotated to apply tension to the pull wires, the stiffness of the distal pull wires and corresponding spines 2041 causes the distal flex segment to bend in a controlled manner, and the stiffness of the proximal pull wires and corresponding spines causes the proximal flex section to bend in a controlled manner. The second spine can have a higher stiffness than the first spine. The stiffness of the second spine 2041 can be higher than the first spine 2040, allowing the distal flex section to bend more easily and bend more strongly overall than the proximal flex section. In some embodiments, the stiffness of the distal spine can be higher than the stiffness of the proximal spine, resulting in a higher curvature and easier bending in the proximal flex section. It is also possible for the distal and proximal spines to have the same stiffness.

[0163] Referring now to Figure 62C, a schematic diagram of one embodiment is shown in which the spine characteristics remain the same as in the example embodiment shown by the schematic diagram of Figure 62B, except that a first spine is located on the same side of the steerable catheter as the first pull wire, and a second spine is located on the same side as the second pull wire.

[0164] 63, a reciprocally flexing steerable catheter is shown having a control input 5901 for controlling two pull wires 1135, 1136, according to one example embodiment. In this embodiment, a single control input pulls the two wires at two different speeds. In the example shown, the flex wheel shaft 5903 has two shaft regions, each with a shaft diameter, the first shaft region 6301 having a first diameter D1 and the second shaft region 6302 having a second diameter D2. The first pull wire is wound around the first shaft region when the flex wheel is rotated in a direction that applies tension to the pull wire. This tension in the first pull wire causes the distal flex section to bend in a direction toward the side where the first pull wire is located. The second pull wire is wound around the second shaft region when the flex wheel is rotated in a direction that applies tension to the pull wire. This tension in the second pull wire causes the proximal flex section to bend in a direction toward the side where the second pull wire is located. This second pull wire can be circumferentially offset 180 degrees from the first pull wire, causing the proximal flex section to bend in the opposite direction to the direction the distal flex section is bent. This is called a conterflex.

[0165] In the example shown by Fig. 63, diameter D1 can be greater than diameter D2. When D1 is greater than D2, distal flex section 115 flexes more quickly than proximal flex section 116 due to the larger diameter tensioning the first pull wire. In some embodiments, the rate at which each flex section is curved can be controlled by the difference in diameter between D1 and D2. A variety of different control inputs can be used to change the rate at which the flex sections bend.

[0166] Referring now to Fig. 64, a reciprocally flexing steerable catheter with different thread pitches for each pull wire is shown according to one example embodiment. As with some embodiments, such as those shown by Figs. 59A-64, the control input can be a knob with a rotation axis perpendicular to the length of the catheter and can have a variety of forms. For example, in the example of Fig. 64, the knob can drive a threaded shaft with a rotation axis along the length of the catheter, the threaded shaft having two different thread sections that drive two different wire couplers along the length of the shaft.

[0167] In the schematic diagram of FIG. 64, a first pull wire 1135 is associated with a first thread pitch P1 located at a first shaft region 6301 on a shaft 5903 mounted to a flex wheel 5901, and a second pull wire 1136 is associated with a second thread pitch P2 located at a second shaft region 6302 on the shaft 5903. Pitch P1 and pitch P2 can be the same if the pull wires are to be actuated at the same speed. If one pull wire is tensioned more aggressively than the other pull wire, i.e., the flex section associated with one pull wire curves faster or has a stronger overall curve, then the thread pitch associated with that wire will have a greater distance between threads, i.e., a greater thread pitch. In the embodiment of FIG. 64, the first pull wire 1135 has a greater thread pitch P1 than the thread pitch P2 of the second pull wire 1136. Thus, the first pull wire applies tension to the distal flex section 115 faster than the second pull wire 1136 applies tension to the proximal flex section 116 because the first pull wire is pulled more with each rotation of the flex wheels than the second pull wire. As a result, the distal flex section bends faster than the proximal flex section. In some embodiments, the thread pitches P1, P2 can be the same. In some embodiments, the thread pitch P2 of the second pull wire 1136 can be greater than the thread pitch P1 of the first pull wire, which can cause the proximal flex section to flex faster than the distal flex section.

[0168] FIG. 65 is a schematic diagram of a reciprocal flexure steerable catheter having a single pull wire to bend two flexure sections in two different directions, respectively, according to an example embodiment. In this embodiment, the pull wire 1135 is attached to the shaft 5903 of the flexure wheel 5901 and then extends to a location along the length of the proximal flexure section 116. The pull wire may be slidably positioned through the distal end of the proximal flexure section, for example through a hypotube positioned at the distal end of the proximal flexure section. The pull wire position along the length of the steerable catheter is rotated circumferentially to a new position where the pull wire extends along the length of the distal flexure section 115 to an anchor point 135a. This position of the pull wire along the distal flexure section may be rotated 180 degrees circumferentially from the pull wire position of the proximal flexure section. In some embodiments, the position of the pull wire can be rotated circumferentially by between about 155 degrees and about 205 degrees, such as between about 165 degrees and about 195 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees.

[0169] 65, the change in circumferential position of the pull wire can occur along the length of the steerable catheter in the intermediate region 6203 between the proximal flex section 116 and the distal flex section 115. The change in circumferential position of the pull wire can begin at the distal region of the proximal flex section 116 or at the end of the proximal flex section and terminate at or near the proximal end of the distal flex section. The circumferential position of the pull wire can also change more abruptly and rotate upward along a circumferential portion of the delivery catheter 1114 without extending the length of the delivery catheter. When the flex wheel 5901 is rotated and actuated to apply tension to the pull wire 1135, the proximal and distal flex sections can bend simultaneously. In some embodiments, the stiffness of these regions can vary, for example, various embodiments of the spine described herein can affect the degree to which each flex section bends and the speed at which the bending occurs.

[0170] 59A-65, the schematic diagram as shown shows a flex wheel knob 5901 extending upwardly out of the catheter sheath 1114, the flex wheel knob 5901 being positioned orthogonal to the direction that the control wires extend when in a straight configuration. In practice, however, the flex wheel knob 5901 may be oriented at a 90 degree angle from its position in the schematic diagram. The flex wheel knob may drive a coupler (not shown) attached to the end of a pull wire that is advanced and / or retracted based on rotation of the flex wheel knob.

[0171] Some embodiments of a delivery catheter for delivering a device to a native valve of a patient's heart may have a single flexible tube with two flexible portions. Referring now to Figures 66-71, an example of a flexible tube frame 600 at the distal end of a flexible delivery catheter according to an example embodiment having a first bent portion and a second bent portion is shown. The flexible tube frame 600 may have a cylindrical overall shape extending from a proximal end 601 to a distal end 602 and open at both the proximal end 601 and the distal end 602. The flexible tube frame 600 provides support and controlled flexibility for the first flexible tube portion 610 and the second flexible tube portion 620 at the distal end of the delivery catheter. In an example embodiment, the flexible tube frame 600 is formed from a single tube and includes two flexible portions, such that the delivery catheter may have one flexible tube frame and two flexible portions. Each flexible portion is for each of the two flexible sections of the delivery catheter. As with some embodiments described herein, the flexible tube frame 600 and the distal region of the delivery catheter are not limited to a cross-section having a circular shape (e.g., FIG. 69), i.e., the cross-section can be elliptical or egg-shaped.

[0172] The proximal end 601 of the flexible tube frame 600 includes a plurality of round, elliptical, and / or substantially elliptical windows or cutouts 603 and a central notch or proximal slot 605 (FIG. 68) that opens into the proximal end 601 of the flexible tube frame 600. The proximal slot 605 may be aligned with a hypotube anchor when the delivery catheter is fully assembled. The plurality of cutouts 603 are used to provide openings for adhesive or polymeric materials to flow through the flexible tube frame 600 to bond to other materials, such as layers below or within the cutouts 603, thereby embedding and securing the flexible tube frame 600 in a desired location.

[0173] The distal end 602 of the flexible tube frame 600 includes a tooth-shaped mounting portion 604 protruding from a bottom side of the distal end 602 for mounting the flexible tube frame 600 to a distal pull ring 632 (FIGS. 70-71). The mounting portion 604 may be formed from a single protrusion. Optionally, the mounting portion 604 can be formed from two protrusions that are joined together if the flexible tube frame 600 is formed from a flat sheet of material. The distal end 602 also includes a semicircular distal notch 606 (FIG. 66) positioned on the top side of the distal end 602. The distal notch 606 is mounted to a second control wire 650 (FIGS. 70-71). The distal end 602 of the flexible tube frame 600 is illustrated in FIG. 69 to show the circular cross-sectional shape of the flexible tube frame 600 and the relative positions of the mounting portion 604 and the notch 606.

[0174] 66, a plan view of a flexible tube frame 600 is shown. The flexible tube frame 600 has a first bent portion 610 and a second bent portion 620 having lengths 611, 621, respectively. The first bent portion 610 and the second bent portion 620 are formed from a plurality of links 612, 622 defined by slots or grooves 614, 624. The links 612, 622 may also include notches 616, 626 and slits 618, 628. Each of the plurality of links 612, 622 may have a circular shape and be spaced from at least one other link in the circular configuration by the slots or grooves 614, 624. The slots 614, 624 are wider than the slits 618, 628 so that the flexible tube frame 600 bends toward the slots 614, 624 when tension is applied to the control wires that extend through the flexible tube frame 600 and are attached to a portion of the flexible tube frame 600.

[0175] The cutouts 616, 626 may have a rounded shape, such as a semicircular or semi-elliptical shape. Each cutout 616, 626 corresponds to one of the multiple links 612, 622. The slits 618, 628 are formed in the flexible tube frame 600 such that two slits 618, 628 are cut into each of the multiple links 612, 622. The slits 618, 628 extend into a particular link 612, 622 partially away from the bottom or top of the flexible tube frame 600, respectively. The slits 618, 628 operate similarly to relief cuts in that the slits 618, 628 are closed or substantially closed when the flexible tube frame 600 is in a straight configuration and may open or expand as the frame links 612, 622 move apart as the flexible tube frame 600 transitions to a bent configuration.

[0176] 66-68, the slot 614 is positioned near the top of the first flexible portion 610, and the notch 616 and the slit 618 are positioned near the bottom of the first flexible portion 610. The slot 624 is positioned near the bottom of the second flexible portion 620, and the notch 626 and the slit 628 are positioned near the bottom of the second flexible portion 620. That is, the first flexible portion 610 is configured to bend toward the top of the flexible tube frame 600, and the second flexible portion 620 is configured to bend toward the bottom of the flexible tube frame 600.

[0177] The links 612, 622 of the flexible tube frame 600 are formed by laser cutting various shapes into the tube material. Specifically, the shapes of the links 612, 622 are defined by slots 614, 624, notches 616, 626, and slits 618, 628. The slots 614, 624 may have an elongated and / or tapered shape such that the central region of each slot 614, 624 is wider than the ends of the slot 614, 624. The slits 618, 628 extend from the notches 616, 626 toward the center of the slot 614, 624. The proximal end 601 of the tube is cut to form the notches 603 and the distal end 602 of the tube is cut to form the mounting protrusions 604.

[0178] 70 and 71, the flexible tube frame 600 is shown assembled to other components of the distal end of the delivery catheter. The distal end assembly includes the flexible tube frame 600, an optional distal pull ring or movable ring 632, and an optional proximal stationary, fixed, or anchor ring 634. A first control wire 640 extends through the first flexible portion 610 to the intermediate portion 630. A second control wire 650 extends through the first flexible portion 610 and the second flexible portion 620 and is attached to the distal pull ring 632. Both the first control wire 640 and the second control wire 650 extend through a first coil sleeve 642 and a second coil sleeve 652, which are similar to the coil sleeves described above. The intermediate portion 630 is integrally formed with the first flexible portion 610 and the second flexible portion 620 and operates similarly to a pull ring 632 .

[0179] The first flexible portion 610 and the second flexible portion 620 have different bending directions due to the different orientations of the links 612, 622 in the first flexible portion 610 and the second flexible portion 620. That is, the link 612 of the first flexible portion is oriented toward the bottom of the flexible tube frame 600, causing the first flexible portion 610 to bend toward the bottom of the flexible tube frame 600, while the link 622 of the second flexible portion is oriented toward the top of the flexible tube frame 600, causing the second flexible portion 620 to bend toward the top of the flexible tube frame 600.

[0180] The difference in bending direction of the first flexible portion 610 and the second flexible portion 620 can be described by an offset angle measured between the first flexible portion 610 and the second flexible portion 620 in a bent state. This offset angle can be, for example, an angle between about 160 degrees and about 200 degrees, such as between about 170 degrees and about 190 degrees, such as between about 175 degrees and about 185 degrees, or about 180 degrees.

[0181] The position of the distal end 602 relative to the proximal end 601 of the flexible tube frame 600 when the first and second flexible portions 610, 620 are in a fully bent state is determined by the lengths 611, 621 of the first and second flexible portions 610, 620 and their respective bend radii. Increasing the length 611, 621 of one of the flexible portions 610, 620 increases the angle of the arc formed by the flexible portions 610, 620 when they are fully bent. Increasing the bend radius of the flexible portions 610, 620 without changing the lengths 611, 621 has the opposite effect, i.e., the arc angle decreases as the bend radius increases for a given length 611, 621.

[0182] In some embodiments, the first flexible section 610 and the second flexible section 620 may be constructed using a flexible material, such as a polymer. The durometer or hardness of the flexible material may be the same along the length of the flexible tube frame 600, or may have different durometers along the length of the flexible tube frame 600. When assembled, the bending characteristics of the first flexible section 610 and the second flexible section 620 depend on the stiffness or resistance to bending of the flexible material. That is, when a material with a higher stiffness is used, more force is required to bend, which creates a larger bend radius in the section with the higher stiffness. Similarly, a material with a lower durometer will be softer and bend more easily, which results in a smaller bend radius compared to the relatively stiffer section. By using different combinations of soft and hard polymer materials for the first flexible portion 610 and the second flexible portion 620, the bending radii of the first bending portion 610 and the second bending portion 620 can be varied.

[0183] 70 and 71, the bending of the flexible tube frame can be controlled through the use of control wires 640, 650. Each control wire, flexible tube frame, pull ring, anchor ring, and coil sleeve act in a manner similar to a cinch or pull string if the control wire is a string, and the flexible tube frame can "cinch" the distal region of the catheter. That is, tension is applied to one or both of the control wires 640, 650, shortening the length of the control wires 640, 650 disposed within the flexible tube frame 600, thereby moving portions of the flexible tube frame 600 closer together. Because the slots 614, 624 are wider than the notches 616, 626 and the slits 618, 628, as well as the control wires 640, 650, the flexible tube frame 600 tends to bend toward the slots 614, 624 when tension is applied to one of the first control wire 640 and the second control wire 650.

[0184] 71 , the operation of the components of the flexible tube frame 600 is illustrated when tension is applied to each of the control wires 640, 650. At the proximal end 601 of the flexible tube frame 600, an operator may pull the first control wire 640 in a proximal direction 660. Because the first control wire 640 is attached to the midsection 630, applying tension in the proximal direction 660 on the first control wire 640 applies a force in the proximal direction 660 on the midsection 630, which in turn applies a compressive force on the first flexible section 610. As a result, the links 612 are compressed together as indicated by opposing arrows 662, reducing the gap between the links formed by the slots 614. Because the widest portion of the slot 614 is configured along one side of the first flexible portion 610, the first flexible portion 610 is bent toward the side where the slot 614 is formed, as indicated by arrow 664. In this manner, tension applied to the first control wire 640 determines the degree of curvature of the first flexible portion 610. By locating the first control wire 640 along the side of the flexible tube frame 600 closest to the widest portion of the slot 614, the first flexible portion 610 can be bent to a state closest to a fully bent or maximum bent state where adjacent links 612 contact each other and the slot 614 is closed. As the first flexible portion 610 bends and the slot 614 closes in response to the compressive force applied by the first control wire 640, the slit 618 can expand to relieve the resulting tension on the opposing side of the first flexible portion 610. When the tension in the first control wire 640 is released, the first flexible portion 610 of the flexible tube frame 600 returns to a straight configuration, the links 612 once again move apart along the slots 614, and the slits 618 once again close.

[0185] At the proximal end 601 of the flexible tube frame 600, an operator can pull the second control wire 650 in a proximal direction 670. Because the second control wire 650 is attached to the distal pull ring 632, applying tension in the proximal direction 670 on the second control wire 650 applies a force in the proximal direction 670 on the distal pull ring 632, which in turn applies a compressive force on the second flexible portion 620. The compressive force is not applied to the first flexible portion 610 due to the sleeve 652 around the wire 650 within the first flexible portion 610. As a result, the links 622 are compressed together as indicated by opposing arrows 672, and the gap between the links formed by the slots 624 is reduced. Because the widest portion of the slot 624 is configured along one side of the second flexible portion 620, the second flexible portion 620 is bent toward the side where the slot 624 is formed, as indicated by arrow 674. In this manner, tension applied to the second control wire 650 determines the degree of curvature of the second flexible portion 620. By positioning the second control wire 650 along the side of the flexible tube frame 600 closest to the widest portion of the slot 624, the second flexible portion 620 can be bent to a state closest to a fully bent or maximum bent state where adjacent links 622 contact each other and the slot 624 is closed. As the second flexible portion 620 bends and the slot 624 closes in response to the compressive force applied by the second control wire 650, the slit 628 can expand to relieve the resulting tension on the opposing side of the second flexible portion 620. When the tension in the second control wire 650 is released, the second flexible portion 620 of the flexible tube frame 600 returns to a straight configuration, the links 622 once again move apart along the slots 624, and the slits 628 once again close.

[0186] Various features of each of the embodiments described herein, including those associated with the schematic diagrams above, can be used together in various combinations to achieve desired differences in pull rates and curvatures between the distal and proximal flexures, both in terms of timing and relative curvature.

[0187] In some embodiments, the "rest configuration" of the distal region of the reciprocally flexing steerable catheter can be one in which the proximal and distal flex segments are curved together, for example as shown in FIG. 59C. This can be achieved by using a shape-setting material to shape-set the flex regions to have a curved rest state. A first pull wire can be tensioned to straighten the curve in the distal flex section. A second pull wire can be tensioned to straighten the curve in the proximal flex section. In use, the pull wires are relaxed when the user determines the amount of bending to bend each flex region.

[0188] Various controls and controls of the systems and devices described herein may be automated and / or motorized. For example, the controls or knobs mentioned above can be buttons or electrical inputs that cause the actions described in connection with the controls / knobs above. This may be accomplished by coupling some or all of the operating parts (directly or indirectly) to a motor (e.g., electric motor, pneumatic motor, hydraulic motor, etc.) that is actuated by the button or electrical input. For example, the motor may be configured to move a distal region of the catheter by tensioning or relaxing a control wire or pull wire described herein when actuated. Additionally or alternatively, the motor may be configured to move an anchoring or docking device in and / or out of the catheter by moving a pusher translationally or axially relative to the catheter when actuated. Automatic stops or prevention means may be built in to prevent damage to the system / device and / or the patient, such as to prevent movement of a component beyond a certain point.

[0189] It should be noted that the devices and apparatus described herein may be used with other surgical procedures and access sites (e.g., transapical, open heart, etc.) It should also be noted that the devices described herein (e.g., deployment tools) may also be used in combination with various other types of valve repair or replacement devices and / or prosthetic valves that differ from the examples described herein.

[0190] In this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. These disclosed methods, devices, and systems should not be construed as limiting in any respect. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations. These methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments are not required to have any one or more particular advantages or to solve any problem.

[0191] Although some operations of the disclosed embodiments have been described in a particular sequential order for convenience of presentation, it should be understood that this description style encompasses reordering unless a particular order is required by a particular expression. For example, operations described in a sequential order may be reordered or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be utilized in combination with other methods. Furthermore, the description sometimes uses terms such as "provide" or "enable" to describe the disclosed methods. These terms are highly abstract expressions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation, and are readily recognized by those skilled in the art.

[0192] Although various inventive aspects, concepts, and features of the present disclosure have been described and illustrated herein as embodied in combination in example embodiments, these various aspects, concepts, and features may be used in numerous alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be included within the scope of the present application. Furthermore, although various alternative embodiments of various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, structures, configurations, methods, devices, and components, as well as alternatives in terms of form, compatibility, and function, etc., such descriptions are not intended as a complete or comprehensive list of available alternative embodiments, whether currently known or later developed. Those skilled in the art may readily utilize one or more of these inventive aspects, concepts, or features for additional embodiments and uses within the scope of the present application, even if not expressly disclosed herein.

[0193] Furthermore, although certain features, concepts, or aspects of the present disclosure may be described herein as preferred configurations or methods, such description is not intended to imply that such features are required or essential, unless expressly stated. Furthermore, while example or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended as critical values ​​or ranges only when expressly stated.

[0194] Furthermore, although various aspects, features, and concepts may be expressly identified herein as being in accordance with the present invention or as forming part of the present disclosure, such identification is not intended to be exhaustive; rather, there may be aspects, concepts, and features of the present invention that are fully described herein but not expressly identified as such or as part of a particular disclosure, and instead the present disclosure is set forth in the appended claims. The description of exemplary methods and processes is not limited to including every step as required in every instance, nor should the order in which steps are presented be construed as essential unless expressly stated. Furthermore, the treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed on live animals or on non-living simulations, such as on cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.), etc. The terms used in the claims have their ordinary meanings and are not limited in any way by the description of the embodiments herein.

[0195] In view of the numerous possible embodiments to which the principles of the present disclosure may be applied, it should be understood that these illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the present disclosure, which is rather defined by the appended claims. [Explanation of symbols]

[0196] 10 Chordae tendineae 12 Papillary muscles 20 Leaflets, valve tissue, anterior leaflet 22 Leaflets, valve tissue, posterior leaflet 24 Valve annulus, delivery sheath 25 Flexion segment, distal flexion segment, distal section 26 Gap 28 Top 29 Bottom 30 Anterior leaflet 31 Lateral tooth 32 septal cusp 33 Upper teeth 34 Posterior apex 35 Side slot, side groove 36 Upper slot, upper groove 38 Links 39 Slit 40 Tooth Line 64 Delivery Catheter 65 Distal end, distal section 66 Proximal section bend 67 Single bend, distal section bend, distal bend, single distal section bend 69 Straight distal portion, distal end portion 74 Delivery Catheter 100 Implantable artificial devices 100A Device 102 Delivery sheath, delivery means 104 Joint part 106 anchor portion, first anchor portion 110 Joining elements, joining means 112 Actuating elements, actuating means, actuating lines 112A Actuating wires, actuating elements, actuating means 112B Actuation wire, actuation means, actuation means 114 Cap 114A Cap 114B Cap 115 Distal Flexion Section 116 working line, proximal flexion section, proximal section, flexible section 117 Distal Region 118 Distal end 120 Outer paddle, gripping element 122 Inner paddle, gripping element 124 parts, connected parts 125 Slots 126 parts, connected parts 128 parts, connected parts 130 Clasp, Barb Clasp 132 Fixed Arm 134 Movable Arm 135 first pull wire, first control wire 135a operating point, connection point, first operating point, anchor point 136 Barb, fixing means, second pull wire 136a Operating point, connecting point, second operating point 138 Joint part 140 Proximal Section 226 Side 230 Laser cutting file, laser cutting sheet 232 Lateral tooth 234 Side slots, side grooves, tooth slots 326 Slots 500 Implantable Devices 502 Guide sheath, transseptal sheath, 503 Capture mechanism 504 Joint part 506 Anchor part 508 Anchor 510 Joint elements 511 Collar, Proximal Collar 512 Actuation wires, actuation shafts, actuation elements 514 Cap 520 Outer Paddle 522 Inner Paddle 524 Components 530 clasp, barb clasp 532 Fixed Arm 534 Movable Arm 536 Barb 537 Operating Line 538 Joint part 540 Cover 600 flexible tube frame 601 Proximal end 602 Distal end 603 Notch 604 Tooth-shaped mounting part, mounting protrusion 605 Proximal Slot 606 Semicircular upper distal notch 610 First flexible tube section, first flexible section, first bent section 612 Link, Frame Link 614 Slot, groove 616 Notch 618 Slit 620 second flexible tube section, second flexible section, second bent section 622 Link, Frame Link 624 Slot, groove 626 Notch 628 Slit 630 Middle part 632 Distal pull ring, distal movable ring 634 Proximal positioning ring, proximal fixation ring, proximal anchor ring 640 First control wire 642 First coil sleeve 650 Second control wire 652 Second coil sleeve 1025 flexible tube frame, distal section flexible tube frame, distal flexible tube frame 1026 Proximal section flexible tube frame, second flexible tube frame 1036 Slot, groove, frame link, proximal flexible tube 1038 Link 1039 Slit 1084 Notch 1114 Delivery catheter, delivery sheath, catheter sheath, steerable catheter 1135 First pull wire, first control wire 1136 Second pull wire, second control wire 1804 Notch, gap 1807 Teeth 1808 Window 1809 Proximal Slot 1901 Central area 1902 End piece 1903 End Piece 1904 Distal Edge 1905 Proximal Edge 2005 Proximal coil stopper, first coil stopper 2009 curve 2010 Second coil stopper, second coil anchor 2011 curve 2030 Flexible Tube 2032 lumens 2035 Pull Wire 2036 Pull Wire 2037 First ring, first pull ring, control ring, distal pull ring 2038 2nd ring, 2nd pull ring, control ring, anchor ring 2039 3rd Ring, Anchor Ring 2040 First Spine 2041 Second Spine 2091 Hypotube 2093 Anchor Ring 2201 First opening 2202 Second Opening 2204 Edge 2205 Edge 2210 First Conduit 2211 First coil sleeve, coil 2212 Second conduit, second control wire lumen 2213 Second coil sleeve, coil 2215 Lina 2216 Inner surface 2301 Outer catheter, outer layer of catheter 2401 Braided body 2402 Primary lumen liner, primary catheter lumen liner 2501 Marker Band 2502 Control wire lumen liner, first control wire lumen 2503 First control wire lumen 2504 Second control wire lumen 2505 Control Wire Lumen Liner 2602 Lumen, hollow primary lumen, primary lumen, primary catheter lumen 2801 Welding hole 2802 Hole 2803 Notch 2901 Hypotube 2903 Gap 2905 Central opening 3001 Window 3002 Welding hole 3101 Channel 5901 Knob, first control input, actuator, flex wheel, flex wheel knob 5902 Knob, second control input 5903 Shaft, 1st shaft 5904 Second Shaft 5905 External engagement mechanism 5908 Slack 6203 Intermediate area 6301 First shaft area 6302 Second Shaft Area

Claims

[Claim 1] 1. A device for delivering an implant to a native valve of a patient's heart, comprising: a flexible hollow tube extending from a proximal end to a distal end, a first flexible portion extending from the proximal end to an intermediate portion; and a second flexible portion extending from the intermediate portion to the distal end. a flexible hollow tube comprising: a first pull wire extending through the first flexible portion to be attached to the intermediate section, the first pull wire extending along a first side of the flexible hollow tube, and applying a proximal tension to the first pull wire forms a first bend in the first flexible portion in a first direction; a second pull wire extending through the first flexible portion and the second flexible portion to be attached to the distal end, the second pull wire extending along a second side of the flexible hollow tube, and applying tension to the second pull wire in a proximal direction to form a second bend in the second flexible portion in a second direction; Equipped with the second side is offset from the first side by the same offset angle as the second direction of the second bend is offset from the first direction of the first bend; The offset angle is within a range of about 160 degrees to about 200 degrees.

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