Delivery system for a heart valve support device

Abstract

Devices for assisting heart tricuspid valve function include a shaft, a flow optimizer, and an anchoring mechanism. The tilting mechanism can be configured to tilt the shaft relative to a central axis of the anchoring mechanism. The leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and a rim, and the rim can have a higher stiffness than the membrane. A delivery system can be configured to deliver the device and adjust the position of the flow optimizer relative to the anchoring mechanism.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Provisional Application No. 63 / 142,853, entitled “Heart Valve Support Device,” filed January 28, 2021.

[0002] This application may relate to U.S. Application No. 16 / 882,226 (now patent number 10,842,628), filed May 22, 2020; U.S. Provisional Application No. 62 / 851,503, filed May 22, 2019, entitled “Heart Valve Support Device”; and U.S. Provisional Application No. 62 / 976,232, filed February 13, 2020, entitled “Heart Valve Support Device”, all of which are incorporated herein by reference.

[0003] By incorporating references All publications and patent applications mentioned in this specification are incorporated herein by reference to the same extent that each individual publication or patent application is specifically and individually indicated to be incorporated by reference.

[0004] background The tricuspid valve (TV) is an atrioventricular valve located on the right side of the human heart, between the right atrium (RA) and right ventricle (RV). The TV consists of three asymmetrical leaflets (septal, anterior, and posterior leaflets) supported by a complex subvalvular apparatus, including the chordae tendineae and papillary muscles. The TV is also located near the tendon of Todaro, where the heart's fragile atrioventricular node is located.

[0005] In tricuspid valve dysfunction, regurgitation occurs during the systolic phase of the cardiac cycle. This dysfunction is usually caused by a pathological enlargement of the valvular annulus that prevents the leaflets from fully engaging during cardiac systole (or the systolic phase of the cardiac cycle). This lack of engagement leads to the formation of a regurgitant orifice within the valve, through which blood can re-enter the right atrium instead of leaving the right ventricle via the pulmonary valve. This condition induces cardiac overload, followed by enlargement of the right ventricle and right atrium, decreased right ventricular stroke volume, increased systemic venous congestion, and other symptoms of congestive heart failure. Tricuspid regurgitation can be isolated from or associated with other valvular diseases and can lead to congestive heart failure, reduced functional cardiovascular volume, and an increased risk of premature death.

[0006] Surgical repair or replacement is the most common technique for treating tricuspid regurgitation, but clinical outcomes (such as mortality and recurrence rates) are not ideal. Furthermore, due to the high risks associated with these procedures, most patients are ineligible for surgical repair or replacement because of the common presence of several complications in patients affected by tricuspid regurgitation.

[0007] Transcatheter aspiration, which eliminates the need for open-heart surgery, may be a viable and safer alternative. However, the unique anatomy of the tricuspid valve presents a significant challenge for developing a safe and effective transcatheter implant. For example, anchoring the implant in the tricuspid valve may increase the burden on adjacent cardiac structures such as the superior or inferior vena cava, atrioventricular node, coronary sinus, right coronary artery, or ventricular myocardium. Furthermore, the lower pressure and output of the right tricuspid valve hemodynamic flow increase the risk of inducing atrioventricular pressure gradients and thrombosis. Therefore, a transcatheter tricuspid valve implant that overcomes some or all of these challenges is needed.

[0008] Overview of this disclosure In a first aspect, a delivery system for regulating a device for assisting heart valve function is provided. The system includes a manipulable catheter control section comprising a manipulable catheter configured to travel through the vascular system to the tricuspid valve; a controller configured to control the manipulable catheter's travel through the vascular system to the tricuspid valve; and an implant delivery catheter control section comprising a delivery catheter configured to travel through the manipulable catheter and configured to allow passage of a device including a device shaft; a flow optimizer fixedly connected to a distal end region of the device shaft; and a plurality of anchoring arms connected to a proximal region of the device shaft; a shaft located within the delivery catheter and configured to move relative to the delivery catheter, wherein translation of the shaft relative to the delivery catheter is configured to expose the device from within the delivery catheter; and a flexible member extending through the delivery catheter and configured to abut a proximal portion of the device shaft, wherein a distal portion of the flexible member is configured to interact with the proximal end of the device shaft, and wherein rotation and translation of the flexible member are configured to cause rotation and translation of the device shaft, thereby adjusting the position of the flow optimizer relative to the anchoring arms.

[0009] On the other hand, a delivery system for adjusting a device for assisting cardiac valve function is provided. The system includes a delivery catheter configured to travel through a vascular system and configured to allow passage of a device, the device including a device shaft; a flow optimizer fixedly connected to a distal end region of the device shaft; and a plurality of anchoring arms connected to a proximal region of the device shaft; a shaft located within the delivery catheter and configured to move relative to the delivery catheter, wherein translation of the shaft relative to the delivery catheter is configured to expose the device from within the delivery catheter; and a flexible member extending through the delivery catheter and configured to abut a proximal portion of the device shaft, wherein a distal portion of the flexible member is configured to interact with the proximal end of the device shaft, and wherein rotation and translation of the flexible member are configured to cause rotation and translation of the device shaft, thereby adjusting the position of the flow optimizer relative to the anchoring arms.

[0010] In some embodiments, the system includes an adjusting member extending through a delivery shaft and on a flexible member, the distal portion of which is biased to bend, the adjusting member being movable from a straighter configuration when positioned within the delivery shaft to a more bent configuration when at least a portion of the adjusting member is outside the shaft. The adjusting member can be configured to bend the flexible member when it is in its more bent configuration outside the shaft. In some embodiments, the flexible member, when bent, is configured to tilt the flow optimizer of the device relative to the device's anchoring mechanism. The adjusting member can be configured to rotate, wherein rotation of the adjusting member alters the orientation of the flexible member. In some embodiments, the system includes an adjusting member control section including a knob for controlling axial translation of the adjusting member. The system may include an adjusting member control section including a knob for controlling rotation of the adjusting member.

[0011] In some embodiments, the system includes a maneuverable catheter through which a delivery catheter extends. The system may include one or more drawstrings configured to control catheter deflection. The maneuverable catheter may include: a distal segment comprising a distal portion configured to deflect up to 180 degrees; a mid-section adjacent to the distal portion configured to deflect up to 60 degrees; and a proximal portion adjacent to the mid-section configured to deflect bilaterally up to 45 degrees. In some embodiments, the maneuverable catheter includes a damage-resistant distal end. The maneuverable catheter may include a distal surface that tapers toward the longitudinal axis of the maneuverable catheter. The end of the maneuverable catheter may include a distal surface that tapers toward the longitudinal axis of the maneuverable catheter.

[0012] The system may include a first controller for a distal portion, a second controller for a middle portion, and a third controller for a proximal portion. In some embodiments, the distal portion includes a first cutting pattern, the middle portion includes a second cutting pattern, and the proximal portion includes a third cutting pattern, wherein the first cutting pattern, the second cutting pattern, and the third cutting pattern are all different.

[0013] The system may include a hemostasis hub, which is configured to allow aspiration of the delivery catheter positioned within a maneuverable catheter without any fluid loss.

[0014] In some embodiments, the system includes one or more helical torsion tubes configured to screw fasteners into a joint to lock the device in position. The system may include one or more helical torsion tubes configured to screw fasteners into a ball joint to lock the position of the device's shaft relative to the device's anchoring mechanism. In some embodiments, the system includes one or more helical guide wires connected to the fasteners, and the helical torsion tube extends along the helical guide wires. The torsion tube may include a rigid tube near its proximal end. In some embodiments, the torsion tube includes a knob located at its proximal end.

[0015] The system may include a tension line extending through a handle and connected to the proximal end of a shaft of the device. The line may be looped through the shaft of the device. The system may include a spool around which the line can be tensioned.

[0016] In some embodiments, the system includes a flexible member control section that includes a knob for controlling axial translation of the flexible member. The system may also include a flexible member control section that includes a knob for controlling rotation of the flexible member.

[0017] The system may include a hemostatic valve located near the proximal end of the adjusting member. In some embodiments, the system includes a hemostatic valve located near the proximal end of the flexible member.

[0018] The system may include a sealing block comprising a plurality of cavities configured to correspond to a plurality of cavities on a delivery shaft, the sealing block including a seal and an injection port overlapping an adjustment member.

[0019] In some embodiments, the system includes a sliding platform configured to hold a handle. The system may include a first sliding platform for holding a portion of the handle secured to a delivery shaft, and a second sliding platform for holding a portion of the handle secured to a conduit through which the delivery shaft extends. Each sliding platform may be configured to lock in place. In some embodiments, each sliding platform includes a support with a notch configured to mate with a corresponding notch on the handle.

[0020] The system may include a guide rail on which various components of the handle are positioned. Each component includes a lead screw extending through it, wherein the lead screw is configured to translate the components along the guide rail. In some embodiments, the components include engagement devices configured to allow the components to engage or disengage with the lead screw. The components may include clamps configured to clamp or release the positioning of the components relative to the guide rail.

[0021] In some embodiments, the distal end of the delivery shaft includes one or more steps configured to offset the release of the arm of the device.

[0022] The system may include an arm loop extending through a shaft to a distal portion of a loop shaft located within the shaft. The distal portion of the loop shaft is configured to be positioned at approximately the same height as the device's anchor arm and the device's arm. The arm loop is loop-attached to the arm and returns to a loop control portion of the delivery system. The arm loop may be configured to control the extension and retraction of the arm. In some embodiments, the system further includes a knob connected to the arm loop and configured to control the tightening or loosening of the arm loop. The loop shaft may include a hole allowing the arm loop to exit. In some embodiments, the loop shaft includes a line extending along the loop shaft, and the loop is looped around the line. The system may include an enlarged diameter portion of the wire at its distal end, the enlarged diameter portion having a diameter larger than the diameter of the distal opening of the loop shaft. The enlarged diameter portion may include a coiled portion.

[0023] In some embodiments, the system includes a tilting member extending distally through a delivery axis to a rotating member connected to a proximal portion of the shaft. The tilting member surrounds one or more holes passing through the rotating member. The free end of the tilting member is connected to one or more controllers on the delivery system. Tensioning and releasing the tilting member causes the rotating member to tilt. The tilting member may include a line. In some embodiments, the shaft includes two tilting members surrounding the rotating member. The tilting member may pass through the rotating member such that it enters and exits the rotating member at least twice.

[0024] In another aspect, a method is provided for positioning a device for assisting heart valve function. The method includes advancing a flexible member through a delivery shaft until the flexible member abuts against the shaft of the device; axially translating the flexible member to adjust the height of a flow optimizer fixed to the shaft relative to an anchoring assembly of the device; and securing the shaft to the anchoring assembly, thereby fixing the position of the flow optimizer relative to the shaft.

[0025] In some embodiments, the method includes rotating the flexible member to adjust the rotational position of the flow optimizer relative to the anchoring assembly of the device. The method may also include tilting the flexible member to adjust the tilt of the flow optimizer relative to the anchoring assembly of the device.

[0026] In some embodiments, adjusting the tilt includes advancing the tilt adjusting member, which includes a curved portion near its distal end, over the flexible member and through the delivery shaft, such that at least a portion of the tilt adjusting member advances past the distal end of the delivery shaft, thereby moving that portion from a straight configuration to a curved configuration, and bending the flexible member and tilting the flow optimizer relative to the anchoring assembly. The method may include rotating the tilt adjusting member, thereby rotating the flow optimizer relative to the anchoring assembly. In some embodiments, the method includes adjusting the portion of the tilt adjusting member advancing past the distal end of the delivery shaft, thereby adjusting the degree of tilt of the flow optimizer.

[0027] Adjusting the tilt can include adjusting the tension on the tilting member of the rotating member that extends through and passes through the end of the delivery shaft, thereby causing the rotation of the rotating member and the tilting of the flexible member that extends through the cavity in the rotating member.

[0028] In some embodiments, securing the shaft to the anchoring assembly includes screwing a fastener into a ball joint that connects the anchoring assembly to the shaft. Screwing the fastener in may include advancing a torsion tube through the delivery shaft and to the fastener. In some embodiments, advancing the torsion tube is done on a guide wire. Methods may include locking the torsion tube to the fastener. In some embodiments, methods include engaging the torsion tube to the fastener using an interference fit. Methods may include locking the torsion tube to the fastener by advancing an external member over the engaged torsion tube and fastener. In some embodiments, methods include retracting the torsion tube and guide wire after screwing the fastener in.

[0029] The method may include removing the cable connecting the delivery system to the device after confirming that the device is correctly positioned. The method may also include removing the cable connecting the handle to the device after confirming that the device is correctly positioned. In some embodiments, removing the cable includes untying the cable from the device's shaft.

[0030] In some embodiments, propulsion and / or axial translation are performed using a lead screw. In some embodiments, propulsion and / or axial translation includes sliding one or more components along a guide rail.

[0031] The method may include retracting the delivery shaft to expose the arm of the device. In some embodiments, the delivery shaft includes a distal end, and the method further includes retracting the delivery shaft to expose the arm of the device in an interleaved manner.

[0032] The method may include extending the arm of the device by loosening an arm loop that extends through the handle into the device, loops around the arm, and returns to the handle. In some embodiments, the method includes retracting the arm of the device by tightening an arm loop that extends through the handle into the device, loops around the arm, and returns to the handle. Adjusting the arm loop may include rotating a knob on the handle. The method may include extending the arm of the device by loosening an arm loop that extends through the delivery shaft into the device, loops around the arm, and returns to a ring control portion of the handle. In some embodiments, the method includes retracting the arm of the device by tightening an arm loop that extends through the handle into the device, loops around the arm, and returns to a ring control portion of the handle. Adjusting the arm loop may include rotating a knob on the ring control portion of the handle.

[0033] The method may include traveling a maneuverable catheter through a catheter having a distal segment comprising a distal portion, a middle portion, and a proximal portion. In some embodiments, the method includes deflecting the distal portion by a first direction and amount, deflecting the middle portion by a second direction and amount, and deflecting the proximal portion by a third direction and amount, wherein the first direction and amount, the second direction and amount, and the third direction and amount are different from each other.

[0034] On the other hand, a device is provided for adjusting an anchoring arm of a device for supporting a heart valve. The device includes a base; a circular recess in the base, the circular recess including corner markers; and a plurality of sliders positioned within the recess and configured to slide within the recess, each slider including a slot configured to receive a portion of the anchoring arm.

[0035] In another aspect, a method is provided for adjusting the anchoring arm of a device for supporting a heart valve prior to surgery. The method includes placing the arm of the device within an opening in a slider aligned with the device; and sliding the slider around a circular groove in the device using markings on the device until the slider is aligned at a predetermined arm angle.

[0036] In another aspect, a delivery system for adjusting a device for assisting heart valve function is provided. The system includes a delivery shaft having multiple lumens; a tilting member extending through the delivery shaft to a rotating member positioned near a distal end of the delivery shaft; the tilting member surrounding and extending through one or more holes in the rotating member, the free end of the tilting member being connected to one or more controllers on a handle, wherein tensioning and loosening of the tilting member causes tilting of the rotating member.

[0037] In another aspect, a delivery system for adjusting a device for assisting heart valve function is provided. The system may include a delivery shaft; a tilting member extending through the delivery shaft to a rotating member positioned near a distal end of the delivery shaft; the tilting member extending around and through one or more holes in the rotating member, the free end of the tilting member being connected to one or more controllers on a tilt control portion of a handle, wherein tensioning and loosening of the tilting member causes tilting of the rotating member.

[0038] The tilting member may include a line. The shaft may include two tilting members that pass through the rotating member. In some embodiments, the tilting member passes through the rotating member such that it enters and exits the sphere at least twice. The tilting member may pass through the rotating member in such a way that friction fixes the relative position of the tilting member and the sphere. The rotating member may include an inner cavity that allows a flexible member to pass through it, wherein tilting of the rotating member causes tilting of the flexible member, which in turn causes tilting of the device shaft, when the device shaft interacts with the flexible member.

[0039] On the other hand, a delivery system for adjusting a device for assisting heart valve function is provided. The system includes a delivery shaft; a plurality of rings extending distally along the delivery shaft and configured to be secured to an arm of the device, the proximal end of each ring being connected to a control knob on a handle, wherein actuation of the control knob is configured to cause tension or loosening of the rings, thereby causing expansion or contraction of the arm to which the rings are secured.

[0040] The ring may be configured to extend along an annular shaft positioned within a delivery shaft. The system may include a line extending along the annular shaft, and the rings looping around the line. In some embodiments, the system includes an enlarged diameter portion of the line at its distal end, the enlarged diameter portion having a diameter larger than the distal opening of the annular shaft. The enlarged diameter portion may include a coiled portion. In some embodiments, each ring exits a ring control portion of the handle through a ring port and is guided to its corresponding control knob. The ring control knobs may be arranged in a configuration that mimics the construction of their respective device arms.

[0041] On the other hand, a maneuverable catheter for delivering a cardiac valve support device is provided. The maneuverable catheter includes a distal segment comprising: a distal portion configured to deflect up to 180 degrees; a middle portion adjacent to the distal portion configured to deflect up to 90 degrees; and a proximal portion adjacent to the middle portion configured to deflect bilaterally up to 90 degrees.

[0042] In some embodiments, the intermediate portion is configured to deflect up to 60 degrees, and the proximal portion is configured to deflect bilaterally up to 45 degrees. The maneuverable catheter may include a damage-resistant distal end. In some embodiments, the damage-resistant end includes a distal surface that tapers toward the longitudinal axis of the maneuverable catheter. The maneuverable catheter may include a first controller for the distal portion, a second controller for the intermediate portion, and a third controller for the proximal portion. In some embodiments, the distal portion includes a first cutting pattern, the intermediate portion includes a second cutting pattern, and the proximal portion includes a third cutting pattern, wherein the first, second, and third cutting patterns are all distinct. The maneuverable catheter may include a hemostatic hub configured to allow aspiration of the delivery catheter positioned within the maneuverable catheter without any fluid loss. In some embodiments, the distal, intermediate, and proximal portions are configured such that the maneuverable catheter can travel to the patient's tricuspid valve. Brief description of the attached diagram In particular, the novel features of the invention are set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings, which illustrate illustrative embodiments utilizing the principles of the invention, in which: Figure 1A This is a side perspective view of the valve support device.

[0044] Figure 1B yes Figure 1A A top view of the valve support device.

[0045] Figure 2 This is a side view showing an exemplary size of a valve support device.

[0046] Figure 3 This is a side view of a valve support device with an exemplary defined angle.

[0047] Figure 4A yes Figure 1A-Figure 1B A perspective view of the valve support device, with one anchoring arm removed for clarity.

[0048] Figure 4B yes Figure 1A-Figure 1B A cross-sectional view of the valve support device.

[0049] Figure 4C yes Figure 1A-Figure 1B Another cross-sectional view of the valve support device.

[0050] Figure 5A yes Figure 1A-Figure 1B Another cross-sectional view of the valve support device.

[0051] Figure 5B yes Figure 1A-Figure 1BA perspective view of the valve support device; for clarity, the leaflets are not shown.

[0052] Figure 6 yes Figure 1A-Figure 1B Another perspective view of the valve support device, without leaflets for clarity.

[0053] Figure 7A This is a side perspective view of another valve support device.

[0054] Figure 7B yes Figure 7A A top view of the valve support device.

[0055] Figure 7C yes Figure 7A A cross-sectional view of the valve support device.

[0056] Figure 8A yes Figure 7A A cross-sectional view of the valve support device, in which the flow optimizer is tilted relative to the anchoring assembly.

[0057] Figure 8B yes Figure 8A A side perspective view of the valve support device.

[0058] Figure 8C yes Figure 8A A top-view perspective view of the valve support device.

[0059] Figure 9A This is a perspective view of a valve support device with a cover on the outer end of the anchoring arm.

[0060] Figure 9B yes Figure 9A A close-up view of the outer end of the anchoring arm of the device.

[0061] Figure 10A It is a perspective view of a flow optimizer with multi-layered lobes in an extended configuration.

[0062] Figure 10B It shows Figure 10A The top layer of the petals.

[0063] Figure 10C It shows Figure 10B The bottom layer of the petals.

[0064] Figure 11A yes Figure 10A A perspective view of the flow optimizer, where the top layer is compacted and the bottom layer is expanded.

[0065] Figure 11B yes Figure 11A A top view of the flow optimizer.

[0066] Figure 11C yes Figure 11A A top view of the flow optimizer.

[0067] Figure 12A It is a perspective view of the flow optimizer, in which the leaflets are stitched to the frame with a first suture pattern.

[0068] Figure 12B This is a perspective view of the flow optimizer, where the leaflets are stitched to the frame with a second suture pattern.

[0069] Figure 13A A pattern for cutting the top layer of the leaflet is shown.

[0070] Figure 13B The pattern used for cutting the bottom layer of the leaflets is shown.

[0071] Figure 14A This is a perspective view of a flow optimizer with a single-layer leaflet.

[0072] Figure 14B It shows Figure 14A The leaflets of the flow optimizer.

[0073] Figure 15A The distal end of the valve support device anchoring arm with padding is shown (the outer cannula has been removed for clarity).

[0074] Figure 15B It shows a sleeve on it. Figure 15A The distal end.

[0075] Figure 16A This is a cross-sectional view of the proximal end of the valve support device, with the ring lock in the proximal (unlocked) configuration.

[0076] Figure 16B yes Figure 16A A perspective view of the valve support device, in which the annular lock is in a proximal position and the flow optimizer is tilted relative to the anchoring mechanism.

[0077] Figure 16C yes Figure 16A A cross-sectional view of a valve support device, with the annular lock in the distal (locked) configuration.

[0078] Figure 16D yes Figure 16A A perspective view of the ring lock of the device.

[0079] Figure 17A This is a cross-sectional view of the proximal end of the valve support device, with the ring lock in the proximal (unlocked) configuration.

[0080] Figure 17B yes Figure 17AA perspective view of a valve support device, in which the annular lock is located in the proximal configuration.

[0081] Figure 17C yes Figure 17A A cross-sectional view of a valve support device, with the annular lock in the distal (locked) configuration.

[0082] Figure 17D yes Figure 17A A perspective view of the valve support device, with the annular lock in the distal configuration.

[0083] Figure 17E yes Figure 17A A perspective view of the ring lock of the device.

[0084] Figure 18A A side view of an embodiment of a valve support device delivered via a catheter is shown.

[0085] Figure 18B and Figure 18C A perspective view of a valve support device delivered via a catheter is shown.

[0086] Figure 19A A top view of an embodiment of a delivery system for delivering and adjusting valve support devices is shown.

[0087] Figure 19B It shows Figure 19A A side view of the delivery system.

[0088] Figure 19C and Figure 19D It shows Figure 19A and Figure 19B A cross-sectional side view of the delivery system.

[0089] Figure 19E It shows how to keep Figures 19A to 19C An embodiment of a sliding platform for a delivery system.

[0090] Figure 19F It shows the location Figure 19D On the sliding platform Figures 19A to 19C The delivery system.

[0091] Figure 20A It shows the direction from the catheter towards Figures 18A to 18B A perspective view of an embodiment of an extension adjustment member of a device.

[0092] Figure 20B A side view of the regulating member extending from the conduit toward the device is shown.

[0093] Figure 20C A side view of the adjusting member is shown, which is translated to the distal side to position it against the device.

[0094] Figure 21 It shows the direction from the catheter towards Figures 18A to 18B A perspective view of an embodiment of a tilt adjustment member extending from a device.

[0095] Figure 22A It shows the extension to Figure 18A and Figure 18B Detailed view of an embodiment of the spiral guide wire of the device.

[0096] Figure 22B A detailed view of the spiral guide wire extending to the device when the adjusting member is in a bent configuration is also shown.

[0097] Figure 22C It shows the direction from the catheter towards Figure 18A and Figure 18B A perspective view of the extended spiral guide wire of the device.

[0098] Figure 22D It shows in Figure 22B and Figure 22C A detailed view of an exemplary torsion tube extending on a helical guide wire.

[0099] Figure 22E A detailed view of an embodiment showing the interaction between the device shaft and the adjusting member is shown.

[0100] Figure 23A It shows Figure 18A and Figure 18B A top view of the equipment, showing the spiral guide wire and twist tube retracted.

[0101] Figure 23B It shows Figure 18A and Figure 18B Detailed view of the device's shafts and attachment lines.

[0102] Figure 23C It shows the removal Figure 23B The line after Figure 18A and Figure 18B A top view of the equipment.

[0103] Figure 24A A side view of another embodiment of the delivery system and platform is shown.

[0104] Figure 24B It shows Figure 24A A perspective view of the delivery system and platform.

[0105] Figure 25A It shows Figure 24A and Figure 24B A side view of an embodiment of the sheath control section of the delivery system.

[0106] Figure 25BIt shows Figure 25A A side sectional view of the sheath control section.

[0107] Figure 26A and Figure 26B A curved plane at the distal end of the sheath is shown in some embodiments.

[0108] Figure 27A It shows Figure 24A and Figure 24B A side view of an embodiment of the delivery system's conduit and tilt adjustment component control section.

[0109] Figure 27B It shows Figure 27A A side sectional view of the duct and tilt adjustment component control section.

[0110] Figure 28A It shows Figure 24A and Figure 24B A side view of an embodiment of the regulation control section of the delivery system.

[0111] Figure 28B It shows Figure 28A A side sectional view of the adjustment and control section of the delivery system.

[0112] Figure 29A It shows Figure 24A and Figure 24B An isometric view of the platform.

[0113] Figure 29B It shows Figure 29A The platform's rear isometric view.

[0114] Figure 30A and Figure 30B It shows the settings at different angles. Figure 29A and Figure 29B Side view of the platform.

[0115] Figure 31A It shows Figure 29A and Figure 29B An isometric view of the sliding platform on the platform.

[0116] Figure 31B It shows Figure 31A A cross-sectional view of the sliding platform.

[0117] Figure 31C It shows Figure 31A Front view of the sliding platform.

[0118] Figure 32 It shows in Figure 29A and Figure 29B An isometric view of the sliding platform on the platform.

[0119] Figure 33A An end view of an embodiment of a catheter with a stepped distal end is shown.

[0120] Figure 33B It shows Figure 33A Side view of the catheter.

[0121] Figure 33C It shows Figure 33A A perspective view of the duct.

[0122] Figures 34A to 34C It shows from Figures 33A to 33C An exemplary device for the deployment of conduits.

[0123] Figure 35A A perspective view of an embodiment of the alignment device is shown.

[0124] Figure 35B It shows Figure 35A A top view of the equipment.

[0125] Figure 35C A perspective view of an embodiment of the valve support device is shown, with its arm positioned at... Figure 35A and Figure 35B Inside the equipment.

[0126] Figure 36 A perspective view of an embodiment of a valve support device having a ring extending from the annular axis to the arm is shown.

[0127] Figures 37A to 37I Various embodiments of the distal end of the annular shaft are shown.

[0128] Figure 38A and Figure 38B An embodiment of a ring on the arm of a valve support device configured as a support ring is shown.

[0129] Figures 39A to 39C Various embodiments of the control section for the arm control ring are shown.

[0130] Figure 40 A cross-sectional view of an embodiment of a helical torsion member is shown.

[0131] Figures 41A to 41C An example of the interaction between the helical torsion member and the helical element is shown.

[0132] Figures 42A to 42C Various views of an embodiment of the torsion control section are shown.

[0133] Figure 43 A perspective view of an embodiment of a delivery system and platform for valve support devices is shown.

[0134] Figures 44A to 44CIt shows Figure 43 Various views of the delivery system.

[0135] Figures 45A to 45D Various views of an embodiment of the control section of the adjustment component are shown.

[0136] Figures 46A to 46C Various views of the platform slider embodiment are shown.

[0137] Figure 47A and Figure 47B It shows Figure 43 Various views of the platform.

[0138] Figures 48A to 48B Various views of embodiments of the tilting ball mechanism are shown.

[0139] Figure 48C It shows the use of Figure 48A and Figure 48B An embodiment of the control of the tilting ball mechanism.

[0140] Figures 49A to 49D Various views of embodiments of the maneuverable catheter are shown.

[0141] Figures 50A to 52D It shows Figures 49A to 49D The flexibility of various parts of the maneuverable catheter.

[0142] Figure 53 An exploded view of an embodiment of the hemostatic hub is shown.

[0143] Figures 54A to 54C Various views of an embodiment for a rotation control section of a valve support device are shown.

[0144] Detailed description This article describes intracardiac implants for catheter delivery to support and improve tricuspid valve function. Tricuspid valve implants (also known as tricuspid valve support devices) may include a flow optimizer and / or an anchor, one or both of which may be configured to adapt to anatomically and hemodynamically challenging locations within the tricuspid valve. For example, the flow optimizer may be configured such that during the diastolic phase of the cardiac cycle, the flow optimizer minimizes its cross-sectional area and allows hemodynamic flow around and across the implant, thus minimizing the potential risk of inducing atrioventricular pressure gradients and thrombosis. During the systolic phase of the cardiac cycle, the flow optimizer may expand to seal or minimize the regurgitation orifice and restore tricuspid valve efficacy. Furthermore, for example, the anchor may be configured to anchor the implant near the tricuspid valve without requiring invasive interactions with the tricuspid valve, right atrium, or right ventricle. The implant may allow for in-process adjustment of the position of the flow optimizer within the natural tricuspid valve under standard imaging techniques such as fluoroscopy and echocardiography, providing real-time optimization of hemodynamic flow across the tricuspid valve. The implants described in this article can advantageously increase the efficacy, safety, and success rate of transcatheter therapy for tricuspid regurgitation.

[0145] A flow optimizer can be placed within the lumen of the tricuspid valve and allows diastolic hemodynamic flow from the right atrium to the right ventricle, and reduces or prevents backflow of blood from the right ventricle to the right atrium during systole. The flow optimizer can be placed on the ventricular side (distal or basal) within the tricuspid valve. The flow optimizer can be directly attached to an anchor that engages the tricuspid valve annulus at the commissure of the natural leaflets. Anchoring can be achieved from the atrial side (proximal or superior). In some embodiments, the device can be anchored at the commissure within the right atrium. When implanted at the tricuspid valve, the device can seal the abutment gap between the natural leaflets during the systolic phase of the cardiac cycle and allow blood to flow from the right atrium to the right ventricle during the diastolic phase of the cardiac cycle.

[0146] The tricuspid valve support device described herein can be used to reduce or prevent tricuspid regurgitation. The device can be configured with a coiled structure for deployment using a standard intravascular catheter. Furthermore, the device can be configured to be deployed in the body.

[0147] Although illustrated and described with reference to the tricuspid valve, this device, flow optimizer, and / or anchoring mechanism can be adapted for use in any valve of the heart.

[0148] Figure 1A-Figure 1B A tricuspid valve support device 500 in its deployed configuration (with leaflets expanded) is shown. The device 500 is configured to be anchored to the tricuspid valve annulus. The device 500 includes an anchoring mechanism 510 and a flow optimizer 540 connected to a shaft 519.

[0149] The anchoring mechanism 510 includes multiple arms 515a-515c that surround and radially extend from the internal core 521 of the device 500. The profile of the end regions (or distal end regions) 526 of the arms 515a-515c can be matched to the tissue wall of the tricuspid valve annulus at the junction of the natural leaflets. The intermediate portions 517 of the arms 515a-515c can be shaped to conform to the inner superior annular wall of the right atrium to provide further support and / or stability. The arms 515a-515c can be made of, for example, a shape memory material (such as nitinol) to compress for delivery and to self-expand outward to conform to the anatomy of the tricuspid valve. When deployed in the tricuspid valve, the distal regions 526 of arms 515a-515c can mate with the tissue wall of the tricuspid annulus at the leaflet junction, and the intermediate portion 517 can rest against the inner superior annular wall of the right atrium to provide further retention and stabilization to the tricuspid flow optimizer 540. Figure 2 The diagram shows exemplary dimensions and angles of arm 515 (which can be any of arms 515a-515c). The specific shapes of arms 515a-515c are exemplary, and it should be understood that other shapes and corresponding dimensions and angles are also possible. For example, Figure 3 Arm 315 is shown, which extends at wider angles α and β relative to the longitudinal axis 333 of the device compared to arm 515.

[0150] refer to Figures 4A-4COne or more arms 515a-515c of the anchoring assembly 510 of device 500 can be configured to rotate about an inner core 521. In one embodiment, one arm (515a) can be held fixed relative to the inner core 521, while the other two arms (515b, 515c) can rotate independently clockwise or counterclockwise relative to the inner core 521. For example, the fixed arm 515a can have a cylindrical proximal portion 516a, which can be secured to the inner core 521, for example, via a snap-fit ​​mechanism. The second arm 515b can have a proximal portion 516b that slides circumferentially along a cam surface 532b on the inner core 521. Similarly, the third arm 515c can have a proximal portion 516c that slides circumferentially along a second cam surface 532c on the inner core 521. Once arms 515b and 515c have reached their desired circumferential positions, they can be individually locked in place via actuating screws 522b and 522c. For example, screw 522c can be configured to extend through a threaded hole 541c in the inner core 521. As screw 522c extends distally from hole 541c, it can engage with the wavy proximal edge 517c of the proximal portion 516c. In some embodiments, engagement with this wavy edge 517c prevents movement of arm 515c. In other embodiments, screw 522c can extend between the inner core 521 and the proximal portion 516c to force the proximal portion 516c against the cylindrical proximal portion 516a of the fixed arm 515a, thereby preventing movement of arm 515c due to friction. Screw 522b can similarly lock arm 515b in place.

[0151] By rotating arms 515b and 515c, the operator can advantageously position arms 515b-515c at different relative angles to arm 515a, thereby matching the angle of the commissure of the leaflets of the patient's natural tricuspid valve. As described in further detail below, the rotation and locking of arms 515b-515c can be performed before the procedure (e.g., before loading device 500 into the delivery catheter) and / or during the procedure.

[0152] refer to Figures 5A-5BThe shaft 519, fixed to the flow optimizer 540, can be configured to slide and / or rotate axially relative to the anchoring mechanism 510 to provide axial and rotational adjustment of the relative positions of the anchoring mechanism 510 and the flow optimizer 540 within the device 500. For example, the shaft 519 can slide or rotate within the central cavity 551 of the inner core 521. A lip 553 on the proximal end of the shaft 519 can be configured adjacent to the proximal end 555 of the inner core 521 to prevent the flow optimizer 540 from completely disengaging from the anchoring assembly 510. Furthermore, once the flow optimizer 540 and the anchoring assembly 510 are in the desired relative position, they can be locked in place relative to each other via an actuating screw 523. The screw 523 can engage (and rotate within) a threaded hole 557 in the inner core 521. The threaded hole 557 can extend at an angle (e.g., 30-45 degrees) relative to the longitudinal axis of the device. When the auger 523 moves to engage with the shaft 519, the auger 523 can push the shaft 519 against the inner core 521, thereby preventing the shaft 519 from moving relative to the inner core 521 through friction.

[0153] The axial and rotational positioning of the flow optimizer 540 relative to the anchoring assembly 510 can be performed before (e.g., before loading the device 400 into the delivery catheter) and / or during the process. Advantageously, when performed while the device 500 is properly positioned in the body, the axial position can be set without requiring rotation of the flow optimizer 540, thereby reducing unnecessary interactions with and / or entrapment of natural anatomical structures. Furthermore, the rotational position of the flow optimizer 540 relative to the anchoring assembly 510 can advantageously be specifically set via the rotation axis 510 (e.g., once the device 500 is properly positioned in the body), thereby allowing for precise positioning of the flow optimizer 540 relative to the natural tricuspid valve and optimization of its position relative to the regurgitation orifice. The positioning of the flow optimizer will be described in further detail below.

[0154] Return to reference Figure 1A The flow optimizer 540 may include a frame 545 supporting the leaflet 550, which expands radially during cardiac systole (e.g., Figure 1A As shown), and contracts radially toward the central axis during cardiac diastole. Frame 545 may include multiple convex arms extending from axis 519. The convex arms ensure that the flow optimizer 540 maintains the basic cup shape during expansion. This advantageously ensures that there is no blood pool between the anchoring assembly 510 and the flow optimizer 540 during cardiac systole. Furthermore, as... Figure 6As shown, the distal end 561 of shaft 519 may have a detent cut therein to prevent interaction with the constricted leaflet 550 during diastole.

[0155] During diastole, as blood flows from the right atrium through the tricuspid valve into the right ventricle under atrial contraction, the atrioventricular hemodynamic pressure gradient opens the tricuspid valve leaflets (similar to...). Figures 7A-8C (As shown). The atrioventricular hemodynamic pressure gradient can cause the leaflets 550 of the flow optimizer 540 to contract toward the central axis of the frame 545, thereby reducing the three-dimensional volume and cross-sectional area of ​​the flow optimizer 540, allowing blood to flow unrestricted around the flow optimizer 540 into the ventricles. During cardiac contraction (i.e., ventricular contraction), as the tricuspid leaflets converge around the flow optimizer 540, the ventricular hemodynamic pressure can cause the leaflets 550 to expand to all or part of their three-dimensional volume, sufficient to close the tricuspid regurgitation orifice and reduce or prevent blood flow into the right atrium.

[0156] Advantageously, the device 500 can ensure that the pressure gradient across the tricuspid valve remains low after implantation, such as less than 3 mmHg or less than 2 mmHg.

[0157] The device 500 can be loaded into, for example, an intravascular catheter and delivered to the right atrium and into the tricuspid valve via an IVC via the femoral artery or via the right internal jugular vein.

[0158] Another embodiment of the tricuspid valve support device 700 is... Figures 7A-8C The valve is shown in an expanded configuration (with the leaflets constricted). Support device 700 is similar to support device 500 and includes an anchoring mechanism 710 with multiple arms 715a-715c arranged radially around and from an inner core 721 (and can be locked with helices 722b, 722c). Furthermore, the shaft 719 fixed to the flow optimizer 740 can be configured to slide axially and rotate axially relative to the anchoring mechanism 710 (similar to device 500), and the leaflets of the flow optimizer can expand and constrict during cardiac systole and diastole, respectively.

[0159] However, unlike device 500, the shaft 719 and flow optimizer 740 of device 700 are also configured to be adjustablely off-axis positioned relative to anchoring mechanism 710 (i.e., can be configured to tilt). This tilt adjustment allows for precise angular positioning of the flow optimizer 740 relative to the natural tricuspid valve. To make the angular positioning of the flow optimizer 740 adjustable, device 700 (e.g., core 721) includes a spherical member 771 located within a socket 773. The spherical member 771 includes an inner cavity 775 through which the shaft 719 extends, and the shaft 719 can slide or rotate within the central inner cavity 775. Furthermore, the spherical member 771 can rotate within the socket 773, thereby allowing the flow optimizer 740 to be positioned off-axis relative to anchoring mechanism 710 (see [link to relevant documentation]). Figures 8A-8C The angled flange 779 on the inner cavity 751 of the core 721 can prevent the flow optimizer 740 from extending at an excessive angle relative to the anchoring mechanism 710. For example, the angle between the axis of the anchoring mechanism 710 and the axis of the flow optimizer 740 can be limited to less than 45 degrees, such as less than 35 degrees, such as less than 25 degrees. Adjusting the tilt of the flow optimizer will be described in more detail below.

[0160] Once the flow optimizer 740 and the anchoring assembly 710 are in the desired relative position, they can be locked in place relative to each other via actuating screws 777, 779. Screws 777, 779 can engage (and rotate within) threaded holes in the internal core 721. The threaded holes can extend at an angle (e.g., 5-45 degrees, such as 10-30 degrees) relative to the longitudinal axis of the device. Screws 777, 779 can be configured to extend through the orifice until they engage with a ball joint 771. Upon first engagement, the position of the ball joint 771 can be fixed, thereby fixing the angular position of the anchoring assembly 710 relative to the flow optimizer 740. Under this first engagement, the shaft 719 can still be allowed to move within the cavity 775 (e.g., axial sliding and axial rotation) (e.g., for axial or rotational positioning of the flow optimizer 740 relative to the anchoring assembly 710). When the auger 777 is tightened by the second additional amount, the ball 771 can be pushed against the shaft 719, thereby preventing the shaft 719 from moving within the cavity 775 and fixing the axial and rotational position of the flow optimizer 740 relative to the anchoring assembly 710.

[0161] Figures 16A-16DAnother embodiment of the tricuspid valve support device 1600 is shown. Similar to device 700, device 1600 includes a shaft 1619 and a flow optimizer 1640, which are configured to be positioned off-axis relative to the anchoring mechanism 1610 (i.e., can be configured to be tilted). Like device 700, device 1600 includes a ball 1671 positioned within a socket 1673. However, unlike device 700, device 1600 includes an annular lock 1662 configured to fit within an inner core 1621. The annular lock 1662 may include a threaded groove 1664 along its outer side, which is configured to engage with a threaded groove 1666 on the inner surface of the inner core 1621. In use, the annular lock 1662 can be positioned in a proximal configuration (e.g., Figures 16A-16B As shown), this allows the flow optimizer 1640 to tilt freely relative to the anchoring assembly 1610. Once the flow optimizer 1640 and the anchoring assembly 1610 are in the desired relative position, they can be locked in place relative to each other via the activation of the ring lock 1662. For this purpose, the ring lock 1662 can rotate within the inner core 1621, causing the ring lock 1662 to move distally toward the spherical member 1671 and into the distal configuration (e.g., Figure 16C (As shown). When engaged with the ball 1671 by the first amount, the position of the ball 1671 can be fixed, thereby fixing the angular position of the anchoring assembly 1610 relative to the flow optimizer 1640. Under this first amount, the shaft 1619 is still allowed to move within the cavity 1675 (e.g., axial sliding and axial rotation). When the annular lock 1662 rotates further distally, the ball 1671 can push against the shaft 1619, thereby preventing the shaft 1619 from moving within the cavity 1675 and fixing the axial and rotational position of the flow optimizer 1640 relative to the anchoring assembly 1610.

[0162] Figures 17A-17E Another embodiment of the proximal end of the tricuspid valve support device 1700 is shown. Similar to device 1600, device 1700 includes a ring lock 1762 to lock the flow optimizer in an inclined position relative to the anchor assembly. Unlike ring lock 1662, ring lock 1762 can be a snap-fit ​​lock (instead of a screw lock). Figures 17A-17B As shown, the ring lock 1762 can be positioned in a proximal configuration, wherein the lock 1762 does not engage with the ball 1761, and the shaft 1719 is free to tilt (and / or rotate or move axially). Figures 17C-17D As shown, the ring lock 1762 can be pushed (i.e., rather than rotated) to a distal configuration in which the lock 1762 engages with the ball 1761 to lock the position of the shaft 1719.

[0163] Advantageously, the adjustability of the arm of the anchoring mechanism described herein (e.g., shape and rotational position) combined with the adjustability of the position of the anchoring mechanism relative to the flow optimizer (e.g., rotation, angle, and / or axial alignment) provides precise alignment of the device relative to the natural tricuspid valve. The device can be fully integrated with the tricuspid valve and annulus, moving harmoniously and ergonomically during cardiac systole and diastole without obstructing the atria or ventricles. Furthermore, this adjustability can be performed by the operator in real time, allowing for immediate assessment and adjustment prior to permanent device implantation, thereby improving treatment outcomes. Similarly, the amount of seal (partial or complete) within the tricuspid valve provided by the flow optimizer described herein can be adjusted during the procedure (via tilt, rotation, and axial adjustment of the flow optimizer relative to the anchoring mechanism) and can be based on assessment or monitoring of the patient's RV function and pulmonary artery pressure.

[0164] refer to Figures 9A-9B In some embodiments, the anchoring arms 915a-915c (e.g., arms 515a-515c and 715a-715c) of any device described herein may include a cover 991 at their outer ends. The cover 991 may be made of, for example, polyethylene terephthalate fabric. In some embodiments, the cover 991 may extend only around the outer portion of the arms 915a-915c, such as 10%-40%, or 25%-35%, along the outer portion of the arms 915a-915c. The cover 991 may advantageously enhance endothelial growth and subsequent encapsulation of the outer ends of the arms 915a-915c (e.g., at a loop). The remaining portion of the arms 915a-915c may remain uncovered, thereby helping to prevent thrombosis during use.

[0165] refer to Figures 15A-15B In some embodiments, the cover 1591 (e.g., cover 991) may include a pad 1552 and a sleeve 1554. The pad 1552 may extend only at the distal end of each arm 1515, such as extending along the rearward hook portion of the arm 1515 (e.g., within the outer 10% of the arm 1515). The sleeve 1554 may be placed on the pad 1552 and the arm 1515 and may extend the full length of the cover 1591. The pad 1552 may advantageously contribute to making the ends of the arms 1515 atraumatic. In some embodiments, the pad 1552 may be made of multiple layers of fabric sealed together (e.g., 3-10 layers of fabric, 4-8 layers of fabric). For example, the pad 1552 may be made of polyethylene terephthalate (PET) fabric layers. In some embodiments, the pad 1552 may be made of a single sheet of foam.

[0166] Leaflets used in any of the devices described herein can be made of a material impermeable to blood cells and preferably impermeable to blood fluids (e.g., aqueous solutions). For example, leaflets can be formed from any suitable biocompatible material, including, for example, woven or nonwoven polymer fabrics or sheets and / or biological tissues harvested from animals (e.g., cattle, pigs, and horses) or humans. Suitable biological tissues include tissues obtained from the pericardial sac of donor animals and / or humans. In some embodiments, leaflets can be made of composite polymer materials. Composite materials can be made of two-dimensional woven (or braided or knitted) fabrics (e.g., PET fabric sheets) or three-dimensional thermoformed fabrics (e.g., PET fabric shapes). Fabric layers can advantageously bear the cyclic fatigue loads imposed on the leaflets by the hemodynamic flow during the cardiac cycle. The porosity of the fabric can be designed to allow it to be coated with a biocompatible and antithrombotic coating (such as polyurethane (PU) or polyurethane-silicone (PU-Sil)) without significantly affecting the flexibility of the fabric. In some embodiments, the coating can be applied to the fabric in liquid form using standard coating manufacturing processes (i.e., impregnation, spraying, electrospinning). The coating can completely cover the fabric and isolate it from blood flow. In some embodiments, the final composite material (e.g., PET+PU or PET+PU-Sil) can provide high fatigue resistance due to the woven fabric substrate and strong chemical stability due to the coating.

[0167] The leaflets can be sewn or attached to the arm of the frame (e.g., frame 545) using other standard fastening methods (e.g., adhesive). Additionally and / or alternatively, the leaflets can be molded into the desired three-dimensional shape as a single sub-component that can be mounted on the frame.

[0168] refer to Figures 10A-10C In some embodiments, the leaflet 1050 of the device 1000 (which may be any leaflet described herein) may consist of two circumferential layers. That is, each leaflet may have a top layer 1011 (located toward the apex 1015 of the attrial end of the frame 1045) and a bottom layer 1013 (located toward the end or tip of the convex frame arm of the frame 1045). The top layer 1011 may be substantially triangular in shape, while the bottom layer 1013 may be substantially rectangular or quadrilateral in shape. Layers 1011 and 1013 may be radially overlapping, with the bottom layer 1013 located radially outward of the top layer 1011. During cardiac systole, the leaflet 1050 may be substantially convex (e.g., ...). Figure 10A (as shown), and layers 1011 and 1013 can abut against each other for sealing and / or contact.

[0169] like Figures 10B-10CAs shown, each individual leaflet layer 1011, 1013 may include an edge 1017 and a membrane 1019. The membrane 1019 may comprise a thin layer of a polymeric material, such as polyurethane-silicone. The edge 1017 of the top layer 1011 may extend along a first edge 1014a and a second edge 1014b (closest to the vertex 1015), while the third edge 1014c (the outermost edge of the ventricle) has no edge. Similarly, the edge 1017 of the bottom layer 1013 may extend along a first edge 1016a, a second edge 1016b, and a third edge 1016c, leaving a fourth edge 1016d (the outermost edge of the ventricle) without an edge. For example, the edge 1017 may be made of a fabric, such as polyethylene terephthalate fabric. In some embodiments, the edge 1017 may have a coating thereon, such as a polyurethane and / or silicone coating. Furthermore, the edge 1017 can be thicker and / or have greater stiffness than the membrane 1019.

[0170] refer to Figures 11A-11C During diastole, as blood flows from the right atrium into the right ventricle, the hemodynamic pressure gradient can cause the leaflets 1050 of device 1000 to constrict and / or become concave towards the central axis of frame 1045 (concave leaflets 1050 in...). Figure 11A (As shown in the image). Figures 11B-11C As shown, because the overlapping layers 1013, 1011 have varying stiffness (i.e., due to the position and size of the edge 1017), the top layer 1011 can contract first, thus leaving a gap 1018 between the top layer 1011 and the bottom layer 1013. In other words, the stiffness of the edge 1017 along the edges 1016a, 1016b, 1016c of the bottom layer 1013 can keep the bottom layer 1013 radially outward for a longer period compared to the edgeless overlapping bottom edge 1014c of the top layer 1011. Moving the layers 1011, 1013 sequentially (e.g., the top layer 1011 moving radially inward before the bottom layer 1013) allows blood to flow through the gap 1018, minimizing potential areas of blood stagnation and thus preventing thrombus formation around or within the leaflet 1050. Furthermore, sequential tightening can help minimize obstruction of atrial-ventricular flow during the diastolic phase of the heart by reducing the effective orifice area (e.g., it can help maintain a gradient of less than 3 mmHg, such as less than 2 mmHg after implantation). In other embodiments, the top layer 1011 and the bottom layer 1013 can be configured to tighten simultaneously.

[0171] refer to Figures 12A-12B Leaflet 1250 (which can be any leaflet described herein) can be along the edge (e.g., along) Figures 10A-10CThe edges 1014b, 1014c and 1016a, 1016b, 1016c (edges 1017, 1019) are sutured to the frame 1245. The sutures may be parallel to the edges, which can advantageously reduce the impact on blood flow and lower the risk of thrombosis. In some embodiments, the sutures may be positioned by pre-drilled (e.g., laser-cut) holes to ensure alignment of the components when sutured together. The sutures may wrap around the arms of the frame 1245 (e.g., ...). Figure 12A (as shown), or extends only in the direction parallel to the arm of frame 1245 (as shown). Figure 12B (As shown).

[0172] refer to Figures 13A-13B Exemplary methods for manufacturing leaflets include: 1) Obtain panel 1331, such as a polyethylene terephthalate fabric coated with polyurethane and silicone. Panel 1331 may be, for example, 40 micrometers thick.

[0173] 2) Place panel 1331 on a tray (such as a borosilicate glass tray).

[0174] 3) The pattern of the top petals (such as...) Figure 13A (As shown) Laser cutting is applied to panel 1331.

[0175] 4) Remove the central portion of the top leaflet from panel 1331, leaving only the edge 1317.

[0176] 5) Repeat steps 1-5 for the bottom petals (its patterned panel 1332 in Figure 13B (As shown in the image).

[0177] 6) Apply a coating (such as a polyurethane or silicone coating) to the entire surface of panels 1331 and 1332, including the cut-out portions. The coating may be, for example, 20 micrometers thick. The coating may form a film between the edges 1317.

[0178] 7) Repeat step 7 to apply additional coating as desired to achieve the required edge and film thickness.

[0179] 8) Cut the completed petals off panels 1331 and 1332.

[0180] refer to Figures 14A-14BIn some embodiments, leaflets 1450 (which can be used as part of any flow optimizer described herein) may consist of a single circumferential layer. Each leaflet 1450 may have a substantially triangular shape. Furthermore, each leaflet 1450 may have an edge 1417 and a membrane 1419 as described above with respect to leaflet 1050. Similar to the top layer 1011, edge 1417 may extend along the first edge 1414a and the second edge 1414b (towards the apex 1415), leaving the third edge 1414c (the outermost edge of the ventricle) without an edge. Except for step 5 (i.e., not fabricating the bottom leaflet), leaflets 1450 may be manufactured using the same process as described above with respect to the double circumferential layers of leaflets. In use, during diastole, as blood flows from the right atrium into the right ventricle, the hemodynamic pressure gradient causes leaflets 1450 to constrict toward the central axis of frame 1445. Because membrane 1419 is thinner than edge 1417 (e.g., the thickness of the membrane is less than 75% of the edge thickness, such as less than 60% of the edge thickness, such as less than 55% of the edge thickness, such as less than or equal to 50% of the edge thickness), membrane 1419 can advantageously contract rapidly during cardiac diastole (and similarly expand rapidly during cardiac systole).

[0181] In some embodiments, during diastole, the ratio of the device's cross-sectional area to the area of ​​the tricuspid annulus may be less than 0.4, such as less than 0.3, such as less than or equal to 0.26. A low cross-sectional area ratio relative to the tricuspid annulus can advantageously help ensure that the pressure gradient across the valve remains low (such as less than 3 mmHg or less than 2 mmHg).

[0182] In some embodiments, some or all of the devices described herein may be echo-generating and / or non-transmissive, allowing visualization during the process.

[0183] Advantageously, the device described herein can be placed even in the presence of pacemaker leads. Furthermore, the device described herein allows for the crossing of auxiliary devices from the right atrium to the right ventricle without interfering with device function.

[0184] In some embodiments, the cross-section of an extended flow optimizer as described herein may be substantially circular or elliptical (or convex triangular), while the cross-section of an unextended flow optimizer may be triangular (or concave triangular).

[0185] The device described herein may additionally or alternatively include any features described in PCT Publication WO2018 / 119192 entitled “Heart Valve Support Device and Methods for Making and Using the Same”, the entire contents of which are incorporated herein by reference.

[0186] Delivery system and control mechanism for heart valve support devices Examples of delivery systems for delivering and positioning the cardiac valve support devices described herein are provided.

[0187] Figure 18A An embodiment similar to the tricuspid valve support device 1800 described herein is shown. The valve support device 1800 is shown attached to a catheter 302. Prior to surgical procedures on the patient, the valve support device 1800 is compressed and positioned within the catheter 302. As described above, the arm 1804 of the device may comprise a shape memory alloy, which allows the arm to compress for placement and delivery within the catheter 302. The catheter travels through the vascular system to reach the tricuspid valve. The path between the insertion site (e.g., the femoral vein or jugular vein) and the tricuspid valve is tortuous. Therefore, the catheter needs to be articulated in such a manner to travel through this tortuous path.

[0188] Figures 19A to 19C Top, side, and side sectional views are shown of an embodiment of a delivery system 1900 that can be used to control the delivery and positioning of device 1800. A knob 342 of the delivery system can be used to deflect catheter 302 as it travels through the vascular system. In some embodiments, the threads within each knob can engage with external threads on an internal deflector element. The deflector element is configured to move forward and backward along guide rail 303. When the knob is turned, the guide rail prevents the deflector from rotating and restricts the forward or backward movement of the deflector element along the guide rail. The deflector element is attached to a drawstring passing through catheter 302 and can be used to bend the catheter by pulling or pushing the drawstring.

[0189] In some embodiments, catheter 302 does not include a pull cord for deflecting the catheter. In such embodiments, delivery system 1900 may not include knob 342.

[0190] like Figure 18C As shown, in some embodiments, a multi-lumen shaft 344 attached to the device 1800 is positioned within the catheter. The shaft 344 is used to extend the device 1800 out of the catheter. Turning the knob 314 on the handle pulls the catheter 302 back relative to the shaft 344 to expel the implant 1800.

[0191] Knob 314 controls the sheath-discharge screw 306, which can be used to pull the proximal end of the handle distally. As described further below, when the sheath-discharge screw 306 is in its distal position, such as Figure 19A and Figure 19B As shown, the catheter has advanced fully. The multi-lumen axis of the catheter engages with the implant, and the implant is slowly pushed out of the catheter.

[0192] To expose the device, the multi-lumen shaft can remain stationary when the catheter is retracted. Alternatively, the catheter can remain stationary when the multi-lumen shaft is advanced. The multi-lumen shaft is secured (e.g., attached, glued, etc.) to a portion of the delivery system near the sheathing screw knob 314. The catheter 302 is secured to a proximal portion of the delivery system. Figure 19D As shown, the delivery system rests on two sliding platforms, which help control which parts of the system and equipment remain stationary and which parts are allowed to move. If the distal sliding platform 1902 is locked in place using knob 1904, turning the sheathing screw 306 will cause the external catheter 302 to remain stationary and the multi-lumen shaft 344 to advance. Conversely, if the proximal sliding platform 1906 is locked in place using knob 1908, turning the sheathing screw 306 will cause the multi-lumen shaft to remain stationary and the external catheter to retract. Circular cutouts on the supports 1910 on the sliding platforms can be configured to mate with corresponding reciprocating cutouts in the handle, such as... Figure 19E As shown. This interaction allows the handle to rotate within the cut, but not translate forward or backward.

[0193] Unsheathing can be performed in a controlled manner, allowing the device's arm 1804 to be exposed slowly. This helps prevent the arm from opening too quickly and helps minimize trauma to surrounding tissues, while also allowing for control over the device's position.

[0194] In some embodiments, the device 1800 is exposed approximately at the center of the valve. The arm 1804 gradually contacts the suture site of the valve. Simultaneous imaging of the valve (e.g., using fluoroscopy or echocardiography) can be used to confirm proper implant placement. Rotation of the catheter can be used to rotate the valve and properly position the arm within the valve. In embodiments where the arms are pre-angled, only one arm needs to be aligned with the valve to ensure proper implant placement within the valve.

[0195] Refer again Figure 19B In some embodiments, a locking mechanism 334 surrounding the delivery system can be used to lock the rotation of the handle relative to the mounting platform once the clinician is satisfied with the rotational position of the device. Therefore, the lock 334 can be released when the clinician rotates the implant to ensure the anchoring arm is aligned. The lock can be reactivated once the rotational orientation is satisfactory.

[0196] In some embodiments, the device can be deployed in a manner that allows for individual control of the release or extension of each arm. Each arm can be connected to a material ring. Each ring can be individually controlled to allow it to extend radially outward (e.g., release the arm) or move radially inward (e.g., recapture the arm).

[0197] The ring material can be aligned with the arm (e.g., the distal end of the arm) or with hooks on the arm. The ring material can wrap around each arm and extend axially rearward through a multi-cavity ring control section of the delivery system.

[0198] The arm control ring advantageously allows for full deployment of the device without extending the arm. The arm ring can maintain the compressed form outside the sheath until the physician is satisfied with the placement. The physician can rotate the arm while it is compressed. Furthermore, because the ring allows control of the distal end, rather than attempting to control from the proximal end of the arm, it provides good control over arm movement (e.g., compared to attempting to control the arm from a more proximal position on the arm or catheter).

[0199] The arm loop allows the arm to open to any intermediate position between full compression and full extension (e.g., 1 / 2 open, 3 / 4 open, etc.).

[0200] Figure 36 An embodiment of device 3600 is shown. Unless otherwise described, device 3600 is similar to device 1800. A shaft 3602, as part of a delivery system, extends through the multi-cavity shaft of device 3600. Shaft 3602 includes at least one cavity to allow the passage of ring material (e.g., suture). Shaft 3602 may include one or more holes to allow each ring 3604 to exit the shaft and form a ring around each arm 3606.

[0201] Arm loops can also be used to recapture the arm during delivery. Pulling the arm with the loop brings it into a compressed position. Recapture the arm can be used for repositioning or retraction of the equipment.

[0202] Figures 37A to 37E An embodiment is shown that can be used to transport ring material from a handle to the distal end of an annular shaft of a device. The distal portion of the annular shaft may be integrally formed with the shaft. In some embodiments, the distal portion of the annular shaft includes a separate fitting that can be attached to the shaft 3602. For example, the distal portion may be press-fitted, bonded, or welded to the shaft 3602.

[0203] Figure 37AAn embodiment of a ring shaft 3702 or a distal fitting of a ring shaft is shown. The ring shaft 3702 includes a hollow cavity to allow ring material to pass through it. The ring shaft 3702 includes three holes 3704 to allow ring material to exit. Each hole includes a width that allows the three holes to be spaced apart, allowing the circumference of the ring shaft 3702 to pass through. For example, each hole 3704 may include approximately 10% to 30% of the width of the ring shaft circumference. Each hole may include a height sufficient to allow a ring to be freely inserted and translated within the hole.

[0204] Each hole 3704 includes a first segment 3706 and a second segment 3706, separated by a middle portion 3708 forming one side of the annular shaft 3702. For each ring, ring material may extend through the first segment 3706, around its corresponding arm, and return to the annular shaft 3702 through the second segment 3706. In some embodiments, each piece of material may include its own hole. In some embodiments, both strands of the ring may exit the shaft through the same portion of the hole. The edges of the hole 3704 may be rounded, which can advantageously reduce the risk of cutting the ring material.

[0205] Figure 37B Another embodiment of the distal end of an annular shaft 3710 or the distal fitting of an annular shaft is shown. The shaft includes three holes 3712 spaced apart around the annular shaft 3710. The holes 3712 are located near the distal portion 3714 of the shaft 3710. These holes include widths that allow the three holes to be spaced apart around the circumference of the annular shaft 3710. For example, each hole 3704 may include approximately 10% to 30% of the width of the annular shaft circumference. In some embodiments, the holes include a generally oval shape extending along the longitudinal axis of the shaft. The shaft includes an end portion where the sidewalls of the shaft transition to three forks 3716. The forks 3716 can be formed by removing material from the sidewalls of the shaft at the distal portion (e.g., laser cutting). In some embodiments, the forks 3716 are added to the shaft 3710 at the distal portion. Each fork may have a wide portion 3718 at its bottom and end. In some embodiments, each ring may surround the fork to hold the ring in place until it needs to be retracted.

[0206] Figure 37C Another embodiment of the distal end of the annular shaft 3730 or the distal fitting of the annular shaft is shown. The annular shaft 3730 includes a tapered and rounded, damage-resistant end 3732. The shaft includes three holes 3734 spaced apart around a portion of the shaft near the distal end. The holes 3734 include rounded edges to minimize friction between the ring and the shaft 3730.

[0207] Figure 37DAnother embodiment of the distal end of the annular shaft 3750 or the distal fitting of the annular shaft is shown. The annular shaft 3750 includes a distal end comprising three forked teeth 3752 having rounded, damage-resistant ends. The ring is configured to exit the shaft 3750 through an opening 3754 between the forked teeth 3752.

[0208] Figure 37E Another embodiment of the distal end of an annular shaft 3770 or the distal fitting of an annular shaft is shown. Shaft 3770 includes a flared portion 3772 toward its end. As flared portion 3772 moves distally, it extends from a smaller diameter to a larger diameter. Flared portion 3772 includes rounded edges. The flared portion can help reduce friction between the ring and shaft 3770. Knob 3774 extends from flared portion 3772 at the distal end of shaft 3770. Knob includes a damage-resistant end (e.g., a rounded distal end) 3776, which can help prevent tissue trauma. Knob includes three circumferentially spaced holes 3778 surrounding knob 3774. Holes 3778 may include generally straight sidewalls extending upwards to a rounded apex portion (e.g., U-shaped). The edges of holes 3778 may be rounded.

[0209] Figure 37F One embodiment is shown in which each ring uses a separate annular shaft 3780. Each shaft may include a groove 3782 and a hook feature 3784 located at the end of the shaft 3780. The groove feature 3782 can be used to guide the ring as it moves from the inner surface of the shaft 3780 toward the arm. The circular hook feature 3784 can help provide a damage-resistant end to reduce tissue trauma.

[0210] Figure 37G Another embodiment of the distal end of the annular shaft 3790 is shown. The annular shaft 3790 includes a pin 3791 configured to be received by a bore 3792 and moved distally for release from the bore 3792. The pin 3791 is configured to retain the ring when it is within the bore 3792.

[0211] Figure 37H Another embodiment of the distal end of the annular shaft 3793 is shown. The shaft includes a hole 3794. A line 3795 extending within the shaft 3793 is shown within the hole 3794. In some embodiments, the shaft 3793 may include more than one hole (e.g., two holes, three holes, etc.).

[0212] Optionally, line 3795 may have a thread at its distal end, which can ensure its position within shaft 3793 by engaging with a corresponding thread on the inner surface of shaft 3793.

[0213] These loops are constructed to form a loop around line 3795. To release the loops, line 3795 can be pulled proximally.

[0214] In some embodiments, such as Figure 37I As shown, the distal end 3796 of the wire is coiled, looped, bundled, or otherwise manipulated to have a diameter larger than the diameter of the opening of the shaft 3793 to prevent unintentional release of the loop. When sufficient force is applied, the larger diameter end of the wire can be pulled proximally into the shaft to release the loop.

[0215] Figure 38A and Figure 38B An embodiment is shown that includes an arm 3800 for stabilizing the ring material 3802. Figure 38A The loop positioned on arm 3800 at the hook-shaped portion of arm 3800 is shown. Figure 38B Another embodiment of a loop 3802 positioned on an arm is shown. In this embodiment, the loop is positioned on a cover 3804, which is located on the arm within the portion surrounding the loop. The cover helps to maintain the position of the loop.

[0216] In the ring control section of the delivery system, ring material can be formed into loops around a pulley rod. The pulley rod can be controlled by a knob, which allows each loop to be tightened or loosened. Figure 39A An embodiment of a ring control portion 3902 is shown, which includes a hole 3904 configured to receive each pulley bar. As shown herein, the pulleys may be arranged slightly vertically to minimize the amount of space occupied by the ring control portion 3902 on the handle.

[0217] Figure 39B Another embodiment of the ring control section 3920 of the delivery system is shown. The ring control section 3920 is configured with fins that increase in height as it moves proximally. Each knob 3922 and its corresponding pulley are arranged at a different height than the handle, thereby minimizing the space occupied by the ring control section 3920.

[0218] Figure 39C Another embodiment of the ring control section 3930 of the delivery system is shown. The ring control section 3930 includes a frame 3932 containing three control knobs 3934, each ring corresponding to one control knob. The knobs 3934 are generally concentrically positioned, their configuration intended to indicate the position of the arm controlled by each knob. The ring control frame 3932 may also include a label 3936 to indicate which knob controls the opening / closing of the corresponding arm of a device (e.g., device 700, 1600, 1700, etc.). This configuration provides an intuitive system for clinicians to use.

[0219] The ring control section 3930 includes a manifold 3937 and three ports 3938, which are configured to separate the ring and align it with their respective knobs 3934 when the ring leaves the ring shaft.

[0220] In some embodiments, the ring control section may include gears to provide more precise control over the ring. For example, a desired number of rotations of a knob may result in a desired movement of the arm.

[0221] In some embodiments, the knob can be removed from the delivery system.

[0222] Now for reference Figures 20A to 20C Once the device is locked in the valvular suture, catheter 302 is slightly retracted to allow adjustment of the flow optimizer shaft 2104, such as... Figure 20A As shown. The retracted conduit 302 exposes a flexible adjustment member 331 (e.g., a tube) extending from the conduit. The adjustment member 331 is responsible for adjusting the height and rotation of the flow optimizer.

[0223] like Figure 22E As shown, the distal end of shaft 2104 has a feature 2290 configured to interact with feature 2292 on the distal end of adjusting member 331.

[0224] A line (e.g., a braided line) can extend through the flexible member and help keep the adjusting member 331 under tension, thereby helping to keep the flexible member 331 and the flow optimizer abutting each other. The line hooks onto hook 2294 of shaft 2104. Shaft 2104 and adjusting member 331 can be advanced and retracted relative to anchoring assembly 2002, as... Figure 20B and Figure 20C As shown. This adjustment can adjust the height of the flow optimizer 336 relative to the anchoring assembly 2002. The rotating flexible member can control the rotational position of the flow optimizer relative to the anchoring assembly 2002.

[0225] Now refer to Figure 21 The tilt of the flow optimizer relative to the anchoring assembly 2002 is also adjusted. A tilt adjustment member 323 (e.g., a tube) overlaps with and is concentric with the adjustment member 331. The tube 323 has a bend towards its distal end. When the tilt adjustment member 323 is fully retracted and contained within the conduit 302, the tilt adjustment member 323 is generally straight. When the tilt adjustment member 323 is exposed, it is biased towards its bend shape, such as... Figure 21As shown. The bending of the tilt adjustment member 323 causes the adjustment member 331 to bend, thereby tilting the flow optimizer relative to the anchoring assembly 2002. The rotationally bent adjustment member 331 can adjust the orientation of the flow optimizer's tilt. In other words, the rotationally bent flexible member can adjust the direction of the flow optimizer of the anchoring assembly toward its tilted portion. Adjusting the length of the exposed portion of the tilt adjustment member 323 can adjust the degree of bending in the flexible member 331. Adjusting the degree of bending in the flexible member can adjust the degree of tilt of the flow optimizer.

[0226] It should be understood that other mechanisms can also be envisioned for using the flexible member 331 to control the tilt of the flow optimizer (e.g., see below). Figures 48A to 48C (Those mechanisms described). For example, a line may extend additionally or alternatively within or outside the adjusting member 331. Pulling the line will cause the flexible member to bend.

[0227] Therefore, using only the flexible component 331 and the adjusting tube 323 allows for adjustment of four degrees of freedom: rotation angle, height, tilt, and inclination.

[0228] Refer again Figures 19A to 19C Specifically, at the tilt adjustment member control section 1912, knob 328 controls tilt adjustment member 323. In some embodiments, clockwise rotation of knob 328 causes member 323 to retract, and counterclockwise rotation of knob 328 causes member to advance. Knob 337 located on path 329 (e.g., screw 329) controls the rotational placement of adjustment member 323. Knob 337 includes a clamp at its end that locks onto adjustment member 323 to allow rotation of knob 337 to cause rotation of adjustment member 323. The delivery system may include a hemostatic valve 1916 located at the end of tilt adjustment member 323, which allows saline injection to flush out the gap between tilt adjustment member 323 and adjustment member 331.

[0229] Referring now to the control section 1914 of the adjusting member 331, the knob 328 controls the axial translation of the adjusting member 331. In some embodiments, clockwise rotation of the knob 328 causes the member 331 to retract, and counterclockwise rotation of the knob 328 causes the member to advance. A knob 337 located on the path 329 (e.g., the screw 329) controls the rotational placement of the adjusting member 331. The knob 337 includes a clamp at its end that locks onto the adjusting member 331 to allow rotation of the knob 337 to cause rotation of the adjusting member 331. The delivery system may include a hemostatic valve 1918 located at the end of the adjusting member 331, which allows flushing of the volume inside the adjusting member 323.

[0230] Once the clinician is satisfied with the positioning and orientation of the flow optimizer, the flow optimizer can be locked relative to the anchoring assembly. In some embodiments, a ball joint is used to lock the flow optimizer in place (e.g., as described above with respect to device 700). (See also...) Figure 22A A detailed perspective view of the proximal end of the anchoring assembly 2002 and the device shaft 2104 is shown. Two (or more) helices 2012, similar to the helices 777, 779 described with respect to device 700, are screwed into a ball joint (not shown). Advancing the helices 2102 compresses the ball joint around the shaft 2104, preventing the shaft from moving relative to the anchoring assembly. Figure 22B A detailed perspective view of the proximal end of the anchoring assembly 2002, including the auger 2102, is shown when the adjusting member 331 bends. Figure 22A and Figure 22B As shown, guidewire 325 extends from helical element 2102 to catheter 302. Now refer to Figure 22C The helical torsion member 326 can extend from the multi-cavity shaft 344 onto the guidewire 325. When the clinician is ready to lock the flow optimizer, the helical torsion member 326 can advance along the guidewire, such as... Figure 22D As shown. Figure 22E The diagram illustrates how the distal end of the helical torsion member 326 engages with the head of the helical member 2102 in a manner that allows the torsion member 326 to apply rotational force to the helical member 2102. The guide wire 325 is also attached to the helical member 2102 using a helical member. Once the helical member 2102 has been screwed in to lock the flow optimizer in place, the helical torsion member can be retracted, and the guide wire 325 can be loosened and retracted, as shown. Figure 23A The figures shown and relative to Figure 23A As described.

[0231] In some embodiments, the helical torsion member includes additional features configured to prevent the helical torsion member from separating from the helical element. (See also...) Figure 40 The inner helical member 4002 can be used to screw the helical torsion member 4004 onto the helical member 4006. The smaller inner helical member 4002 can be tightened downwards onto the inner shoulder 4008 of the helical torsion member 4004, so that the helical torsion member 4004 and the helical member 4002 are no longer separable during this process. When the tightness of the helical member is confirmed and the clinician is ready to release, the inner helical member can be loosened (e.g., by rotating the guidewire helical tube in the handle), thereby separating the helical torsion member. This feature advantageously allows for a more secure engagement between the helical torsion member and the helical member.

[0232] Reference Figures 41A to 41C In some embodiments, an interference fit is used to lock the helical torsion member 4102 to the helical member 4104. For example... Figure 41AAs shown, the helical torsion member 4102 may include features 4106 (e.g., protrusions, holes, etc.) configured to mate with features 4108 (e.g., holes, protrusions, etc.) on the helical member 4104. The helical torsion member may include features 4110 (e.g., tabs, hooks, etc.) that engage the helical member 4104 when an intervening member (e.g., a sleeve, an outer submersible tube, etc.) is positioned between the engaged helical torsion member and the helical member. As long as the external member is positioned between the engaged helical torsion member and the helical member, the locking feature 4110 engages with the helical member 4104, and the two torsion members 4102 and the helical member 4104 are locked together. Figure 41B As shown, in order to disengage the helical torsion member from the helical member, the outer member can be retracted (e.g., retracted) and the two parts can be detached.

[0233] Figure 41C Various embodiments of helical members that can be used to connect to a helical torsion member using an interference fit lock are shown, such as those concerning... Figure 41A and Figure 41B As stated above.

[0234] The guidewire 325 and the torsion tube 326 are controlled manually from the outside of the handle. The clinician can hold the hemostatic valve 1920 attached to the proximal end of the torsion tube 326, as... Figure 19B As best shown, the guidewire 325 is advanced or retracted. The guidewire is also manually controlled at its proximal end. The guidewire 325 can be unscrewed from the helix 2102.

[0235] In some embodiments, the torsion tube may include one or more rigid tubes at its proximal end. For example... Figure 42A As shown, the rigid tube 4202 can be positioned near the proximal end of the torsion tube. The rigid tube 4202 can be fixed to the torsion tube, allowing torque to be easily converted between the two. The rigid tube 4202 can be fixed to the control knob 4206.

[0236] In some embodiments, the gear may be positioned between the tube and the knob. For example... Figure 42C As shown, the smaller tube gear 4208 can be configured to engage with the larger knob gear 4210 on the knob 4206. Each torsion tube may have one knob. In some embodiments, the knobs may be positioned adjacent to each other, with one closer to the other. In some embodiments, the knobs are configured to rotate in one direction (e.g., tightening a screw). Rotating the knob in the opposite direction would be more difficult.

[0237] The multi-cavity shaft 344 terminates at a handle, which contains various tubes and devices separated from the internal cavity, such as... Figure 19CAs best shown in the diagram. The spiral twist tube 326 and guide wire 325 exit the multi-cavity shaft 344 here and enter block 310, which has three separate cavities 1922 for separating various thiophanate tubes. More or fewer cavities may also be considered. Block 310 includes an injection port and a series of seals 1925 (in... Figure 19D (As shown in the detailed view), seal 1925 includes a seal overlapping with adjustment member 323, a seal overlapping with torsion tube 326 and seal 321, seal 321 may be an O-ring seal. Gaps within the conduit, between various tubes, lines and other equipment need to be flushed with saline to prevent air from escaping from the conduit and to prevent blood from accumulating and clotting within the conduit and draining out. Saline can be injected through injection port 1924 ( Figure 19A It can be injected and can flush the gaps inside the multi-cavity shaft and outside the tube.

[0238] Once the clinician retracts the guidewire 325 and the torsion tube 326, the wire 335 attached to the shaft 2104 is removed. (See reference...) Figure 19B The suture 335 extends posteriorly and proximally through the handle and loops around a spool 1930 located at the proximal end of the handle. The spool 1930 is used to adjust the tension in the suture 335. When the device is withdrawn from the catheter 302, the force exerted by the arm 1804 against the catheter end is counteracted to prevent the arm from ejecting outwards. The suture 335 can maintain a sufficiently high tension to keep the proximal end of the implant securely abutted against the multi-lumen shaft. Once the device is deployed and during adjustment of the device's position, the tension of the suture can be adjusted so that the shaft 2104 abuts against the adjustment member 331. To release the suture 335 at the end of the procedure, the clinician loosens the suture from the spool 1930 and pulls one end until the suture 335 is completely removed from the patient.

[0239] refer to Figure 24A and Figure 24B Additional embodiments of the delivery system 2400 for delivering and positioning the cardiac valve support device described herein are provided. The embodiments shown herein include a sheath through which a catheter extends. In some embodiments, instead of a catheter, the sheath can perform most of all bending and deflection functions. Transferring this function to the sheath allows the catheter to rotate within the sheath without affecting the sheath's deflection angle.

[0240] Figure 24A and Figure 24BSide views and isometric views of embodiments of delivery system 2400 and platform 2402 are shown, respectively. Unless otherwise stated, delivery system 2400 may include a similar structure and function to delivery system 1900. Delivery system 1900 may include a sheath control section 600, a catheter and tilt adjustment member control section 300, and an adjustment member control section 2404. Platform 2406 may include a guide rail 2408 along which the various control sections can translate.

[0241] Now for reference Figure 25A and Figure 25B The diagram shows a side view and a side sectional view of the distal ends of the sheath control section 600 and the sheath 601, respectively. The sheath control section 600 includes a rotation locking clamp 609 configured to be positioned within a groove surrounding the control section 600. The clamp 609 can rotate relative to a handle but not relative to a corresponding slot on the platform. A rotation control knob 604 can be used to lock the clamp 609 in a rotational position relative to the sheath control section 600. For example, the knob 604 can be used to abut against the sheath control section 600 to tighten the clamp 609. An injection port 605 can be used to flush the space between the sheath 601 and the catheter. The distal end of the sheath may include one or more bends configured to achieve a desired bend radius and / or bend length. Different bend capabilities can be achieved, for example, by the number of slots / openings / notches, the repetition rate of the slots / openings / notches, the location of the slots / openings / notches, etc. For example, as Figure 25A and Figure 25B As shown, the distal end of the sheath includes a first curved portion 2502, a second curved portion 2504, and a third curved portion 2506. These curved sections allow for the bending or deflection necessary to advance the sheath into the right atrium. Figure 26A and Figure 26B The diagram illustrates two locations involved in advancing the sheath 601 into the right atrium. The first bend 2502, the second bend, and the third bend allow the sheath 601 to present... Figure 26A and Figure 26B The structure shown.

[0242] Now for reference Figure 27A and Figure 27B The diagram shows a side view and a side sectional view of the duct and tilt adjustment component control section 300.

[0243] The knob 342 of the handle can be used to deflect the catheter 302 as it travels through the vascular system. In some embodiments, the deflection of the catheter can be used to allow for fine-tuning of the implant after the catheter has exited the sheath and is coaxially positioned with the natural valve annulus. In some embodiments, the threads within each knob can engage with external threads on the internal deflector element. The deflector element is configured to move forward and backward along guide rail 303. When the knob is turned, the guide rail prevents the deflector from rotating and restricts the forward or backward movement of the deflector element along the guide rail. The deflector element is attached to a drawstring that passes through the catheter 302 and can be used to bend the catheter by pulling or pushing the drawstring.

[0244] The multi-lumen shaft 344 is located inside the catheter. Turning the knob 314 on the handle pulls the catheter 302 back relative to the shaft 344 to eject the implant 1800.

[0245] Knob 314 controls the sheath-discharge screw 306, which can be used to pull the proximal end of the handle distally. When the sheath-discharge screw 306 is in its distal position, such as Figure 27A and Figure 27B As shown, the catheter is fully retracted. The multi-lumen shaft of the catheter engages with the implant and slowly pushes the implant out of the catheter. The rod 353 helps stabilize the sheathing screw 306 as it moves back and forth. The rod may include a seal 356 (e.g., an O-ring) to allow sealing relative to the flow optimizer 336.

[0246] The tilt adjustment member 323 (e.g., a pipe) overlaps with and is concentric with the adjustment member 331. Figure 28A and Figure 28B The tube 323 has a bend toward its distal end. When the tilt adjustment member 323 is fully retracted and contained within the conduit 302, it is normally straight. When the tilt adjustment member 323 is exposed, it is biased toward its bend shape (e.g., as shown in the image). Figure 21 (As shown). Bending of the tilt adjustment member 323 causes bending of the adjustment member 331, thereby tilting the flow optimizer relative to the anchoring assembly. The rotationally bent adjustment member 331 can adjust the orientation of the flow optimizer's tilt. In other words, the rotationally bent flexible member can adjust the flow optimizer of the anchoring assembly toward its tilted portion. Adjusting the length of the exposed portion of the tilt adjustment member 323 can adjust the degree of bending in the flexible member 331. Adjusting the degree of bending in the flexible member can adjust the degree of tilt of the flow optimizer. It should be understood that other mechanisms for bending the flexible member 331 to control the tilt of the flow optimizer are also conceivable. For example, a line may additionally or alternatively extend within or outside the adjustment member 331. Pulling the line causes the flexible member to bend.

[0247] Knob 328 controls tilt adjustment member 323. In some embodiments, clockwise rotation of knob 328 causes member 323 to retract, and counterclockwise rotation of knob 328 causes member to advance. Knob 337 (e.g., screw 329) located on path 329 controls the rotational placement of adjustment member 323. Knob 337 includes a clamp at its end that locks onto adjustment member 323, allowing rotation of knob 337 to cause rotation of adjustment member 323. The delivery system may include a hemostatic valve 1916 located at the end of tilt adjustment member 323, which allows saline injection to flush out the gap between tilt adjustment member 323 and adjustment member 331.

[0248] Such as about Figure 19A and Figure 19B As described, the control of the guidewire 325 and the torsion tube 326 is performed manually from the outside of the handle. For example, a clinician can grasp the hemostatic valve 1920 attached to the proximal end of the torsion tube 326 and advance or retract the tube 326. The guidewire is also manually controlled at its proximal end. A torsion member (e.g., a chuck) can be secured to the guidewire 325 and can be used to provide the user with more surface area to grasp and manipulate the guidewire.

[0249] As described with respect to delivery system 1900, multi-lumen shaft 344 terminates at a handle, where various tubes and devices contained within the lumen are disassembled. A helical twist tube 326 and guidewire 325 exit from multi-lumen shaft 344 therein and enter flushing block 354. Flushing block 354 may include an injection port 1924. Saline solution can be injected through injection port 1924 for flushing the catheters. The flushing block includes three separate lumens for disassembling various thiophanate-methyl tubes. More or fewer lumens may also be considered.

[0250] Block 354 includes a series of seals 1925, 356 (e.g., O-rings), 357 (e.g., O-rings), and 352 (e.g., hemostatic valves). These seals include seals overlapping with adjusting member 323, seals overlapping with torsion tube 326, and seal 321, which may be an O-ring seal. Gaps within the catheter, between various tubes, wires, and other devices require saline flushing to prevent air from escaping from the catheter and to prevent blood from accumulating and clotting within the catheter and draining out. Saline can be injected through injection port 1924 and can flush gaps inside the multi-lumen shaft and outside the tubes.

[0251] The delivery system may include a multi-cavity shaft attachment 355. Attachment 355 may be secured (e.g., glued) to the proximal end of the multi-cavity shaft 344 to secure the multi-cavity shaft 344 relative to the handle. Attachment 355 may also facilitate easier guidance of the helical twist tube 326 into the cavity of the multi-cavity shaft.

[0252] Platforms (e.g., platforms 2903, 2904, Figure 29A The notch on the support can be configured to engage with the rotating clamp 334. This interaction allows the handle to rotate within the notch without translating forward or backward. The rotating locking knob 350, positioned on the clamp 334, can be tightened to lock the catheter and tilt adjustment control section relative to the slide, or loosened to allow rotation between the catheter and the tilt adjustment control section.

[0253] Go to Figure 28A and Figure 28B The figures show a side view and a side sectional view of the adjustment member control section 2404. The knob 337 includes a clamp at its end that locks onto the adjustment member 331, allowing rotation of the knob 337 to cause rotation of the adjustment member 331. The delivery system may include a hemostatic valve 1918 located at the end of the adjustment member 331, allowing flushing of the volume inside the adjustment member 331. Unlike the adjustment member control section 1914, the translation of the adjustment member control section 2404 is controlled by a lead screw, see reference... Figure 29A and Figure 29B To describe in more detail.

[0254] The delivery system 2400 is shown having a control section for the catheter and tilt adjustment member, and a separate control section for the adjustment member; however, in some embodiments, the controller for the adjustment member is integrated into the control section for the catheter and tilt adjustment member. Other combinations of controls are also under consideration.

[0255] Figure 29A and Figure 29B A front and rear isometric view of the platform used to hold and manipulate the positions of various components of the delivery system 2400 are shown, respectively. The platform includes a guide rail 2408 along which the various components can translate. In some embodiments, the guide rail 2408 includes a T-slot type guide rail (e.g., a T-slot aluminum extrusion). A distal lead screw block 2902 and a proximal lead screw block 2910 are located on the guide rail. The lead screw block 2902 may be configured to support the lead screw at or near each end of the lead screw. A lead screw crank 2911 may be positioned on the proximal lead screw block 2910, and the lead screw crank 2911 is configured to allow translational manipulation of the lead screw. Other control mechanisms (e.g., knobs) are also contemplated. Figure 29ATwo types of platforms are shown for traveling along guide rails and holding various components of the delivery system. Control platform 2903 includes a mechanism configured to engage or disengage with a lead screw. This mechanism may include a threaded portion (e.g., a portion of a nut) configured to engage with the lead screw's threads. The control platform may also include a locking mechanism configured to lock or unlock platform 2903 to guide rail 2408. Crank 2920 may be used to control the locking mechanism. Support platform 2904 may be configured to lock and unlock from guide rail 2408 (e.g., as shown with respect to platform 2903).

[0256] The control platform may include a support 2906, which includes a circular cutout shaped to mate with a corresponding cutout on the delivery system (e.g., on the clamp 334). The support platform may also include a support 2907, which includes a circular cutout shaped to mate with a corresponding cutout on the delivery system. Support 2907 may also include a cutout (e.g., a square cutout) for preventing rotation relative to the clamp 334. The clamp may include corresponding tabs configured (e.g., formed) to mate with the cutouts. Each component of the handle (e.g., the sheath control section, the catheter and tilt adjustment member control section, the adjustment member control section) may be supported and controlled by both control-type and support-type platforms. It should be understood that the various components of each type of platform can be combined and rearranged into different configurations to achieve the same function.

[0257] A spool support 2908 is shown positioned on the proximal platform. A spool 1930 is positioned on the spool support. (As shown) Figure 29B As shown, pin 2914 is operatively connected to spool 1930. Pin 2914 is configured to rotate spool 1930. In some embodiments, the spool may use a worm gear, preventing it from being driven back. In other words, the spool will not rotate under tension.

[0258] like Figure 29B As shown, connector 2912 extends between shaft control section 2404 and conduit and tilt adjustment member control section 300. Connector 2912 can be used to control the position of the two control sections relative to each other. Knob 2913 can be used to fix the position of one or both control sections.

[0259] Lead screw 2905 extends between distal lead screw block 2902 and proximal lead screw block 2910 and passes through platforms positioned along guide rail 2408. At least some of the various platforms through which the lead screw passes can be configured to engage or disengage with the lead screw, allowing the axial position of these platforms to be manipulated by the lead screw. Axial adjustment using the lead screw allows for precise operation of these components. Furthermore, axial translation and control using the lead screw allows a single operator to simultaneously control the position of multiple components.

[0260] In some embodiments, the user can unlock one or more platforms from the guide rails to advance components of the delivery system. For example, when advancing a sheath or catheter from the insertion site into the heart, the corresponding component can slide along the guide rails. Once the delivery tool is near the valve, a lead screw can be used for more precise translational positioning and / or adjustment.

[0261] The guide rail 2408 is at least partially supported by the tilting guide rail 2901. A first hinge 2913 is connected to a first end of the tilting guide rail 2901, where it is connected to the platform base. A second hinge 2912 is connected to a second end of the tilting guide rail 2901, where it is connected to the guide rail 2408.

[0262] Now for reference Figure 30A and Figure 30B Connector 3002 supports guide rail 2408 and connects it to base guide rail 3004. Translation of connector 3002 can adjust the angle of guide rail 2408 relative to base guide rail 3004 (e.g., relative to horizontal). Connector 3002 is attached to or integral with support member 3006. In some embodiments, support member 3006 can be secured (e.g., using a screw) to an insert that can slide along guide rail 2408. To adjust the position of connector 3002, insert can be released from its secured position (e.g., by loosening the screw on insert), and connector 3002 can slide along guide rail 2408 and base guide rail 3004 to a desired position, such as... Figure 30B As shown, connector 3002 is already relative to Figure 30A The position slides to the far side. Figure 30B The position of connector 3002 in the middle generates a ratio to guide rail 2408. Figure 30A Larger angles. Sliding the connector further distally increases the angle, and sliding it closer to the proximal side decreases the angle. Once in the desired position, the support 3006 can be secured to the guide rail 2408. Other mechanisms for securing the connector 3002 to the guide rail 2408 (e.g., spring-loaded connections, clamps, etc.) are also anticipated.

[0263] Adjusting the angle of the delivery system can facilitate achieving the optimal entry angle, regardless of the size of the patient and operator. For example, a patient's thighs may be larger or smaller relative to the average patient. Being able to adjust the entry angle makes performing the procedure easier in such situations. Adjusting the entry angle also helps to align everything as much as possible in a straight line, making it easier to advance the delivery and treatment equipment to the valve.

[0264] Now refer to each Figures 31A to 31CThe isometric, cross-sectional, and side views show detailed views of platform type 2903. The platform includes a mounting block 3130. Mounting block 3130 is positioned on a linear slider 7031, which is configured to slide along guide rail 2408. Crank 2920 is positioned on the slider and configured to lock the slider 7031 to the guide rail 2408 via bolts that fasten the linear slider 7031 to the guide rail. Knob 7033 can be used to engage or disengage the platform 2903 from the lead screw. Figure 31B As shown in the top cross-sectional view, the platform includes a lead screw connector 7035, which resembles a half-nut. A knob 7033 can engage or disengage the connector 7035 from the lead screw thread.

[0265] Now for reference Figure 32 An isometric view showing a detailed view of platform type 2904. Platform 2904 includes a mounting block 3240 positioned on a linear slider 3241.

[0266] Alternative catheter examples In some embodiments, the distal end of the catheter may be configured to deploy the arms of a valve support device (e.g., device 500, 700, 1800) one at a time. Figures 33A to 33C A front view, a side view, and an isometric view of the catheter configured to deploy its arm in this manner are shown. The distal end of the catheter 336 includes three end surfaces. Surface 3302 is the nearest side surface at the distal end. Surface 3304 is the farthest side surface at the distal end. Surface 3306 is located between surfaces 3304 and 3302.

[0267] Figures 34A to 34C It shows the use of Figures 33A to 33C The device for unfolding the catheter is 1800. (Example) Figure 34A As shown, the device arm positioned against a portion of the conduit near the nearest side surface 3302 will be the first arm exposed and begin to expand as the conduit retracts during device delivery. (Reference) Figure 34B The device arm positioned near a portion of surface 3306 along the conduit will be the next arm to be exposed and begin to expand during device delivery as the conduit retracts. Finally, as Figure 34C As shown, the device arm positioned against a portion of the conduit closest to the farthest side surface 3304 will be the last arm to be exposed and begin to expand as the conduit retracts during device delivery.

[0268] The configuration of the distal end of the catheter can be selected to suit the desired delivery. For example, in some embodiments, the configuration of the distal end can be adjusted to allow both arms to deploy simultaneously. The distal end can be adjusted such that the distance between various distal surfaces is longer or shorter, resulting in longer or shorter times between the deployment of the respective arms. The positions of the varying surfaces can be configured to correspond to an annular arrangement of the arms.

[0269] Surgical forearm alignment device In some embodiments, the anchoring arm of the valve support device (e.g., device 500, 700, 1800) can be positioned in an appropriate rotational orientation before surgery. Preoperative imaging (e.g., CT scan) can be used to determine how the arm should be positioned. (See reference...) Figure 35A and Figure 35B The image shows a top perspective view and a top view of an embodiment of the orientation device 3500. The device includes a base 3502. The device 3500 includes three sliders 3504 configured to slide around a circular track 3506 on the base 3502. Angle markings, similar to an indexer, are present around the circular track. Each slider 3504 includes a slot 3508. Figure 35C As shown, each slot 3508 can accommodate an arm of the valve support device. A slider can be adjusted to position the arm in the desired configuration.

[0270] refer to Figure 43 and Figures 44A to 44C This illustrates another embodiment of the delivery system 4300. Unless otherwise described, the system may include components, features, and functions similar to those described with respect to other systems (e.g., delivery systems 1900, 2400) herein. The delivery system includes a sheath control section 600 located on the distal portion of the delivery system. The handle includes an implant delivery control section 300 and a height and rotation adjustment member control section 2404.

[0271] The delivery system is positioned on platform 4700, which includes guide rail 2408 along which various control sections of the handle can be translated. Platform 4700 is described in more detail below.

[0272] Now for reference Figures 44A to 44C The following figures show a top view, a side view, and a top sectional view of the delivery system 4300. The annular delivery shaft 3602 is shown extending from the distal portion of the handle. The distal segment 336 of the catheter is also shown.

[0273] A knob 314 is shown at the proximal end of the sheath-exit screw 306. Knob 314 can be used to control the distal pull of the sheath-exit screw 306 on the proximal end of the handle. When the sheath-exit screw 306 is in its most distal position, the catheter is fully retracted. The multi-lumen shaft of the catheter engages with the implant and slowly pushes the implant out of the catheter. A lever 353 helps stabilize the sheath-exit screw 306 as it moves back and forth. The lever may include a seal 356 (e.g., an O-ring) to allow sealing relative to the flow optimizer 336.

[0274] The handle includes a proximal handle housing 311 and a distal handle housing 338.

[0275] The ring control system 3930, including the knob 3934, is located in the middle part of the handle. The ring port 3938 is located near the knob 3934.

[0276] Flushing block 354 is located near port 3934. Flushing block 354 may include injection port 1924. As described above, block 354 includes a series of seals 1925, 352 (e.g., hemostatic valves). These seals include a seal overlapping with regulating member 323, a seal overlapping with torsion tube 326, and seal 321, which may be an O-ring seal. Gaps within the catheter, between various tubes, wires, and other devices require flushing with saline to prevent air from escaping from the catheter and to prevent blood from accumulating and clotting within the catheter and draining out. Saline can be injected through injection port 1924 and can flush gaps inside the multi-lumen shaft and outside the tubes.

[0277] The torsion tube control knob 4206 is located near the flush block 354.

[0278] The torsion guidewire 325 and the torsion tube 326 extend proximally to the hemostatic valve 352. The rigid tube 351 is located at the proximal end of the torsion tube 326 to allow for manipulation thereon.

[0279] The tilt adjustment control section 4003 is positioned towards the proximal end of the system. The knob 4004 allows manipulation of the implant's tilt ball, as described in more detail below.

[0280] The delivery system includes a hemostatic valve located at the end of the regulating member 331, which allows flushing of the volume inside the regulating member 331.

[0281] Figures 45A to 45D Top view, side view, side sectional view, and rear view of another embodiment of the adjustment member control section 2404 are shown. Unless otherwise stated, the adjustment member control section includes features similar to those described above. Figure 28A and Figure 28BThe features described. Knob 337 includes a collet 4504 at its end, which locks onto adjusting member 331, allowing rotation of knob 337 to cause rotation of adjusting member 331. The adjusting member control section may include a stop 4502 configured to limit the amount of rotation allowed by knob 337. In some embodiments, a washer may be used to limit clockwise rotation, and another washer may be used to limit counterclockwise rotation.

[0282] Reference Figures 46A to 46C The diagram shows a perspective view, a top sectional view, and a side view of another embodiment of the platform slider 4600. The platform includes a mounting block 3130. The mounting block 3130 is positioned on a linear slider 7031, which is configured to slide along a platform guide rail. A crank 2920 is positioned on the slider and configured to lock the slider 7031 to the guide rail via bolts, which secure the linear slider 7031 to the platform guide rail. A knob 7033 can be used to engage or disengage the platform 4600 from the lead screw. Figure 46B As shown in the top cross-sectional view, the platform includes a lead screw connector 7035, resembling a half-nut. A knob 7033 can engage or disengage the connector 7035 from the lead screw thread. A spring 4606 is located below the knob 7033 and biases the knob 7033 to the disengaged position. Clinicians must overcome this spring force to engage the connector with the lead screw. This helps minimize the risk of the slider inadvertently remaining engaged with the lead screw and helps ensure that the slider is truly disengaged when the knob is in the disengaged (e.g., vertical) position.

[0283] Now for reference Figure 47A and Figure 47B The diagram shows a front perspective view and a rear perspective view of another embodiment of platform 4700. Unless otherwise described, platform 4700 may include... Figure 29A and Figure 29B The platform 2402 shown has similar features, components, and functions. Platform 4700 includes a guide rail 2408, and a slider 4600 is configured to translate along the guide rail 2408. In some embodiments, the guide rail 2408 includes a T-slot guide rail (e.g., a T-slot aluminum extrusion). A distal lead screw block 2902 and a proximal lead screw block 2910 are located on the guide rail. The lead screw block 2902 may be configured to support the lead screw at or near each end of the lead screw. A lead screw crank 2911 may be positioned on the proximal lead screw block 2910, and the lead screw crank 2911 is configured to allow translational manipulation of the lead screw. Other control mechanisms (e.g., knobs) are also contemplated.

[0284] Figure 47A and Figure 47BTwo types of platforms are shown, comprising various components for traveling along guide rails and holding the handle. The control platform 4600 includes mechanisms configured to engage or disengage with a lead screw, as described above. Figures 46A to 46C This allows for precise control of its translation along guide rail 2408. The control platform may also include a locking mechanism configured to lock or unlock platform 4600 to guide rail 2408. Crank 2920 may be used to control the locking mechanism. Support platform 2904 may be configured to lock and unlock from guide rail 2408 (e.g., as shown with respect to platform 4600).

[0285] One or more control platforms may include a support 2906, which includes a circular cutout shaped to mate with a corresponding cutout on the handle (e.g., on the clamp 334). The support platform may also include a support 2907, which includes a circular cutout shaped to mate with a corresponding cutout on the handle. Support 2907 may also include a cutout (e.g., a square cutout) for preventing rotation relative to the clamp 334. The clamp may include corresponding tabs configured (e.g., formed) to mate with the cutouts. Each component of the handle (e.g., the sheath control section, the catheter and tilt adjustment member control section, the adjustment member control section) may be supported and controlled by both control-type and support-type platforms. It should be understood that the various components of each type of platform can be combined and rearranged into different configurations to achieve the same function.

[0286] A spool support 2908 is shown positioned on the proximal platform. A spool 1930 is positioned on the spool support. (As shown) Figure 47B As shown, pin 2914 is operatively connected to spool 1930. Pin 2914 is configured to rotate spool 1930. In some embodiments, the spool may use a worm gear, preventing it from being driven back. In other words, the spool will not rotate under tension.

[0287] like Figure 47B As shown, connector 2912 extends between shaft control section 2404 and conduit and tilt adjustment member control section 300. Connector 2912 can be used to control the position of the two control sections relative to each other. Knob 2913 can be used to fix the position of one or both control sections.

[0288] Guide rail 2408 is supported by distal beam 4710 and proximal beam 4712. The beams are supported by legs 4714. Connector 4716, configured to slide or translate along legs 4714, connects beams 4710 and 4712 to legs 4714. Crank 2920 can be used to unlock the beams from the legs and allow translation. Once the clinician is satisfied with the position, crank 2920 can be used to lock the beams onto the legs.

[0289] While beams can typically be maneuvered evenly up and down on the legs, each connector can be individually controllable, allowing for precise control over the position of the delivery system.

[0290] Figures 48A to 48C A perspective view of the distal end, a front view of the distal end, and a proximal control section are shown, respectively, of another embodiment of the tilting mechanism for a tilting flow optimizer. Figure 48A and Figure 48B As shown, the spherical component of the device (e.g., similar to spherical components 771, 1671) includes multiple holes. One or more wires can pass through the holes in a manner that allows the spherical component to tilt, thereby tilting the device.

[0291] The spherical member can be positioned toward the distal end of the multi-cavity shaft. The spherical member includes an inner cavity through which a flexible member (e.g., flexible member 331) extends. Therefore, tilting of the spherical member causes tilting of the flexible member, which can lead to tilting of the device shaft.

[0292] It should be understood that the spherical component does not have to be an actual sphere, but can be any rotating component that can be tilted using the tilting ring described herein.

[0293] Figure 48A and Figure 48B A first top hole 4802 and a second top hole 4802, as well as a first bottom hole 4804 and a second bottom hole 4804, are shown. These holes are positioned approximately equidistantly on the surface of the ball-shaped member 4806 about the longitudinal axis of the delivery conduit. These holes may be positioned within the distal half or a portion of the ball-shaped member.

[0294] The top outlet port 4822 and the bottom outlet port 4832 can also be positioned approximately equidistantly on the spherical member around the longitudinal axis of the conduit. The ports can be positioned in such a way that they are located within the proximal half or portion of the spherical member.

[0295] The top loop 4808 extends distally along the delivery system toward the spherical member 4806, along the outer portion of the spherical member, and enters the first top hole 4802. From there, the loop 4808 extends proximally along the top spherical member channel 4820 to the proximal portion of the spherical member and exits the spherical member through the top exit hole 4822. The loop 4808 extends to the second top exit hole 4822 and is reinserted into the spherical member. The loop 4808 extends along the second top spherical member channel 4820 and exits the spherical member at the second top hole 4802. From there, the loop 4808 extends proximally toward the tilt control portion of the handle.

[0296] A bottom loop 4810 extends distally from the tilt control portion of the handle toward the ball 4806, extends along the outer portion of the ball, and enters the first bottom hole 4804. From there, a loop 4808 extends proximally along the bottom ball channel 4830 to the proximal portion of the ball and exits the ball through the bottom exit hole 4832. The loop 4810 extends to the second bottom exit hole 4832 and is reinserted into the ball. The loop 4810 extends along the second bottom ball channel 4830 and exits the ball at the second bottom hole 4804. From there, the loop 4808 extends proximally toward the tilt control portion of the handle.

[0297] Each end of the coil extends back to the knobs 4812, 4814 shown on the tilt control manifold 4003. The top coil 4808 extends proximally, one end connected to the top knob 4812, and the other end connected to a corresponding top knob on the other side of the handle (not shown). The bottom coil 4810 extends proximally, one end connected to the bottom knob 4004, and the other end connected to a corresponding bottom knob on the other side of the handle (not shown). The tension on each end of the coils 4808, 4810 is controlled to allow the ball to tilt, thereby tilting the device shaft from 0 to 90° in each direction.

[0298] Reference Figures 49A to 52D This provides various aspects of another embodiment of the maneuverable catheter 4900. Figure 49A A maneuverable catheter extending from the handle is shown. A portion of the handle, including a maneuverable catheter controller 600, is also shown. A stop valve extends from the handle.

[0299] The steerable catheter includes a distal deflector section 4902 and a steerable shaft 4904.

[0300] Go to Figure 49B The handle controller 600 is shown in more detail. A controllable shaft 4904 is shown extending through the handle. A pull cable 4908 exits the controllable shaft at the distal end of the handle and extends proximally toward the control knobs. A guide rail 4906 extends along the handle, surrounding the interior of the controllable shaft. Various deflection screws 4922 are positioned along the guide rail. Various control knobs are positioned along the guide rail. Translation of the control knobs causes tension or relaxation of the corresponding pull cable.

[0301] The distal deflection knob 4910 is positioned toward the distal portion of the guide rail and is configured to control the deflection of the distal portion 4912 of the distal segment of the manipulable catheter. The height deflection knob 4914 is located proximal to the distal deflection knob 4910 and is configured to control the deflection of the intermediate portion 4916 of the distal segment of the manipulable catheter. The lateral deflection knob 4918 is located proximal to the height deflection knob 4914 and is configured to control the deflection of the proximal portion 4920 of the distal segment of the manipulable catheter.

[0302] The handle also includes the handle housing portion 4910.

[0303] The hemostatic hub 4930 is positioned toward the proximal end of the maneuverable catheter. The hemostatic hub 4930 includes a valve 4932 (e.g., a double-layer cross valve), an irrigation tube 4934, and a backup valve 4936. Further details of the hemostatic hub are provided below.

[0304] Figure 49C An embodiment of the distal segment 4902 of the maneuverable catheter is shown. The distal portion 4912 is located at the distal end of the distal segment. (As shown) Figure 50A and Figure 50B As shown, the distal portion 4912 can be configured to deflect to an angle A ranging from approximately 0 to 200°.

[0305] In some embodiments, the distal portion 4912 includes a length of about 40 mm to 70 mm (or about 50 mm to 60 mm, 45 mm to 65 mm, 55 mm, less than 40 mm, greater than 70 mm, etc.).

[0306] Return and refer to Figure 49C The middle portion 4916 of the distal segment 4902 of the maneuverable catheter is located proximal to the distal portion 4912. For example... Figure 51A and Figure 51B As shown, the middle portion 4916 can be configured to deflect to an angle B ranging from approximately 0 to 90°.

[0307] In some embodiments, the intermediate portion 4916 includes a length of about 15 mm to 30 mm (or about 20 mm to 25 mm, 21 mm to 24 mm, less than 15 mm, greater than 30 mm, etc.).

[0308] Return and refer to Figure 49C The proximal portion 4920 of the distal segment 4902 of the maneuverable catheter is located proximal to the intermediate portion 4916. For example... Figures 52A to 52D As shown, the proximal portion 4920 can be configured to allow lateral deflection (e.g., in either direction) to an angle C of approximately 0 to 90°.

[0309] In some embodiments, the length of the proximal portion 4920 is about 15 mm to 40 mm (or about 20 mm to 35 mm, or about 25 mm to 30 mm, greater than 40 mm, less than 15 mm, etc.).

[0310] The construction of the distal, intermediate, and proximal portions allows the maneuverable catheter to travel to the patient's tricuspid valve.

[0311] Return and refer to Figure 49C The far-side section 4902 includes guy wire fixing point 4940.

[0312] The distal section 4902 includes the laminated connection pattern portion 4942.

[0313] The distal section 4902 includes the compressive strain relief portion 4944.

[0314] Figure 49D The distal end of the distal segment 4902 is shown, which includes a damage-resistant end 4950 on the maneuverable catheter tip. This damage-resistant end includes a tapered surface 4952 that tapers towards the distal end of the catheter. This configuration can be designed to maintain the coaxiality of the delivery catheter within the maneuverable catheter even during maneuverable catheter deflection (e.g., at maximum bending of the maneuverable deflector). This ensures and helps to position the implant coaxially with the tricuspid valve annulus during the procedure and reduces risks in the system.

[0315] In some embodiments, the tamperable tip is radiopaque and visible under fluorescence fluoroscopy to help identify the position and orientation of the catheter relative to anatomical structures and other components of the delivery system.

[0316] Figure 53 It shows something similar to about Figure 49B An exploded view of an embodiment of the described hemostatic hub 4930. The hemostatic hub allows clinicians to maintain hemostasis during catheter insertion and removal.

[0317] The hemostatic hub includes a hemostatic hub housing 5302. The hub housing includes a flushing tube 4934. The housing contains seals 5312 (e.g., a duckbill valve), 5306, and 5304, and provides the ability to aspirate any air contained within the operable conduit shaft via the flushing tube 4934 without introducing external air.

[0318] The hub includes a cross-slit valve 5304. The cross-slit valve can help provide a hemostatic seal after the clinician removes the dilator from the catheter. A valve 5306 (e.g., a cross-slit valve) may be located adjacent to the cross-slit valve 5304 and is configured to engage an auxiliary valve.

[0319] The intermediate plate 5308 houses a spare seal and an additional valve 5310 (e.g., a silicone seal with an opening for shaft passage). This section helps prevent air ingress and blood leakage.

[0320] A hemostatic hub may include one or more O-rings 5314 to ensure proper sealing.

[0321] Now for reference Figures 54A to 54CThe diagram provides a side view, a side sectional view, and a perspective view of an embodiment of the rotation control section 5400. A releasable knob 5402 can separate the multilumen shaft from the outer surface of the delivery catheter. This separation allows the device to be rotated by rotating only the multilumen shaft, rather than the entire delivery catheter. A rotation clamp 5404 allows this rotation of both the multilumen shaft and the device. This separation of the components reduces frictional forces applied during rotation and allows for more precise rotational control.

[0322] The hoop 5404 includes a stop 5406, which is configured to interact with a stop 5408 on the rod 5410, and the stop 5408 restricts rotation (e.g., up to + / - 180°).

[0323] When a feature or element is referred to herein as being “on” another feature or element, it may be directly on the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is referred to as being “directly on” another feature or element, no intermediate features or elements are present. It will also be understood that when a feature or element is referred to as being “connected,” “attached,” or “joined” to another feature or element, it may be directly connected, attached, or joined to the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is referred to as being “directly connected,” “directly attached,” or “directly joined” to another feature or element, no intermediate features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements thus described or illustrated may be applied to other embodiments. Those skilled in the art will also recognize that a structure or feature positioned with reference to “adjacent” to another feature may have portions overlapping with or below the adjacent feature.

[0324] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context otherwise clearly indicates otherwise. It should be further understood that the terms “comprises” and / or “comprising”, when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0325] For ease of description, spatially related terms such as “under,” “below,” “lower,” “over,” and “upper” are used herein to describe the relationship of an element or feature as illustrated in the accompanying drawings to other elements or features. It should be understood that spatially related terms are intended to encompass different orientations of the device in use or operation beyond those depicted in the drawings. For example, if the device in the drawings were inverted, an element described as “below” or “below” other elements or features would then be oriented “over” other elements or features. Thus, the exemplary term “under” can encompass both “above” and “below” orientations. The device may be otherwise oriented (rotated 90 degrees or otherwise), and the spatially related descriptive terms used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms “upwardly,” “downwardly,” “vertical,” and “horizontal,” etc., are used herein for illustrative purposes.

[0326] While the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise requires. These terms may be used to distinguish one feature / element from another. Therefore, without departing from the teachings of the invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0327] In this specification and the appended claims, unless the context otherwise requires, the term "comprise" and its variations such as "comprises" and "comprising" mean that various components may be used together in methods and articles of manufacture (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any of the stated elements or steps, but does not exclude any other elements or steps.

[0328] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all figures may be treated as being preceded by the words “about” or “approximately”, even if the term is not explicitly stated. The phrase “about” or “approximately” may be used when describing magnitude and / or location to indicate that the described value and / or location is within a reasonably expected range of value and / or location. For example, numerical values ​​may have values ​​of + / -0.1% of a set value (or range of values), + / -1% of a set value (or range of values), + / -2% of a set value (or range of values), + / -5% of a set value (or range of values), + / -10% of a set value (or range of values), etc. Any numerical range stated herein is intended to include all subranges contained therein.

[0329] While various illustrative embodiments have been described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may typically be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of the various apparatus and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0330] The examples and illustrations included herein are shown by way of illustration, not limitation, of specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, allowing for structural and logical substitutions and changes without departing from the scope of this disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention," and if actually more than one is disclosed, it is not intended to actively limit the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement considered to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. After reading the above description, those skilled in the art will understand the combinations of the above embodiments and other embodiments not specifically described herein.

Claims

1. A delivery system for adjusting a device for assisting heart valve function, comprising: A steerable catheter control section, the steerable catheter control section comprising: - A maneuverable catheter, configured to travel through the vascular system to the tricuspid valve; and - A controller configured to control the movement of the operative catheter through the vascular system to the tricuspid valve; An implant delivery catheter control section, the implant delivery catheter control section comprising: - A delivery conduit configured to travel through the steerable conduit and configured to allow the device to pass through, the device including a device shaft; a flow optimizer fixedly connected to a distal end region of the device shaft; and a plurality of anchoring arms connected to a proximal region of the device shaft; - An axis located within the delivery catheter and configured to move relative to the delivery catheter, wherein the translation of the axis relative to the delivery catheter is configured to expose the device from within the delivery catheter; - A flexible member extending through the delivery conduit and configured to abut the proximal portion of the device shaft; and A tilting member extends through the distal side of the axial direction to a rotating member connected to the proximal portion of the shaft. The tilting member surrounds one or more holes passing through the rotating member. The free end of the tilting member is connected to one or more controllers on the delivery system. Tensioning and releasing the tilting member causes the rotating member to tilt. The distal portion of the flexible member is configured to interact with the proximal end of the device shaft, and rotation and translation of the flexible member are configured to cause rotation and translation of the device shaft, thereby adjusting the position of the flow optimizer relative to the anchoring arm.

2. A delivery system for adjusting a device for assisting heart valve function, comprising: A delivery catheter configured to travel through a vascular system and configured to allow passage of the device, the device including a device shaft; flow An optimizer, which is fixedly connected to the distal end region of the device shaft; And multiple anchoring arms that are connected to the proximal region of the device shaft; An axis located within the delivery catheter and configured to move relative to the delivery catheter, wherein translation of the axis relative to the delivery catheter is configured to expose the device from within the delivery catheter; A flexible member extending through the delivery conduit and configured to abut the proximal portion of the device shaft; and A tilting member extends through the distal side of the axial direction to a rotating member connected to the proximal portion of the shaft. The tilting member surrounds one or more holes passing through the rotating member. The free end of the tilting member is connected to one or more controllers on the delivery system. Tensioning and releasing the tilting member causes the rotating member to tilt. The distal portion of the flexible member is configured to interact with the proximal end of the device shaft, and rotation and translation of the flexible member are configured to cause rotation and translation of the device shaft, thereby adjusting the position of the flow optimizer relative to the anchoring arm.

3. The delivery system of claim 1 or claim 2 further includes an adjustment member extending through the shaft and on the flexible member, the distal portion of the adjustment member being biased to bend, the adjustment member being movable from a straighter configuration when positioned in the shaft to a more bent configuration when at least a portion of the adjustment member is outside the shaft.

4. The delivery system according to claim 3, wherein, The adjusting member is configured to bend the flexible member when the adjusting member is in a more curved configuration outside the axis.

5. The delivery system according to claim 4, wherein, The flexible member is configured to tilt the flow optimizer of the device relative to the device's anchoring mechanism when it bends.

6. The delivery system according to any one of claims 3-5, wherein, The adjusting member is configured to rotate, wherein the rotation of the adjusting member changes the orientation of the flexible member.

7. The delivery system according to any one of claims 3-6, comprising an adjustment member control section, the adjustment member control section including a knob for controlling the axial translation of the adjustment member.

8. The delivery system according to any one of claims 3-7, comprising an adjustment member control section, the adjustment member control section including a knob for controlling the rotation of the adjustment member.

9. The delivery system according to any one of claims 2-8, further comprising a steerable catheter extending through the steerable catheter.

10. The delivery system of claim 9 further includes one or more pull wires configured to control the deflection of the conduit.

11. The delivery system according to any one of claims 9 and 10, wherein, The steerable catheter includes a distal segment, the distal segment including a distal portion configured to deflect up to 180 degrees; and an intermediate portion adjacent to the distal portion of the distal segment, the intermediate portion configured to deflect up to 60 degrees. And the proximal portion, the proximal portion of the distal segment being close to the middle portion, the proximal portion of the distal segment being configured to be bilaterally deflected by a maximum of 45 degrees.

12. The delivery system according to claim 11, wherein, The steerable catheter includes a distal end designed to prevent damage.

13. The delivery system according to claim 11, wherein, The distal end of the steerable catheter includes a distal surface that tapers toward the longitudinal axis of the steerable catheter.

14. The delivery system according to any one of claims 11-13, comprising a first controller for the distal portion of the distal segment, a second controller for the intermediate portion, and a third controller for the proximal portion of the distal segment.

15. The delivery system according to any one of claims 11-14, wherein, The distal portion of the distal segment includes a first cutting pattern, the intermediate portion includes a second cutting pattern, and the proximal portion of the distal segment includes a third cutting pattern, wherein the first cutting pattern, the second cutting pattern, and the third cutting pattern are all different.

16. The delivery system according to any one of claims 1 and 9-15, further comprising a hemostatic hub configured to allow aspiration of the delivery catheter positioned within the steerable catheter without any fluid loss.

17. The delivery system according to any one of claims 1-16, further comprising one or more helical torsion tubes configured to screw fasteners into the joint to lock the position of the device.

18. The delivery system according to any one of claims 1-17, further comprising one or more helical torsion tubes configured to screw fasteners into ball joints to lock the position of the device's shaft relative to the device's anchoring mechanism.

19. The delivery system of claim 18, further comprising one or more helical guide wires connected to the fastener, and the helical torsion tube extending on the helical guide wires.

20. The delivery system according to any one of claims 18-19, wherein, The torsion tube includes a rigid tube near the proximal end of the torsion tube.

21. The delivery system according to any one of claims 18-20, wherein, The torsion tube includes a knob located at the proximal end of the torsion tube.

22. The delivery system according to any one of claims 1-21, further comprising a tension line extending through the delivery system and connected to the proximal end of the shaft of the device.

23. The delivery system according to claim 22, wherein, The tensioning wire is looped through the shaft of the device.

24. The delivery system according to any one of claims 22 and 23, further comprising a spool, the tension line being tensionable around the spool.

25. The delivery system according to any one of claims 1-24, comprising a flexible member control section, the flexible member control section including a knob for controlling the axial translation of the flexible member.

26. The delivery system according to any one of claims 1-25, comprising a flexible member control section, the flexible member control section including a knob for controlling rotation of the flexible member.

27. The delivery system according to any one of claims 3-8, comprising a hemostatic valve near the proximal end of the adjusting member.

28. The delivery system according to any one of claims 1-27, comprising a hemostatic valve near the proximal end of the flexible member.

29. The delivery system according to any one of claims 3-8, further comprising a sealing block including a plurality of cavities configured to correspond to a plurality of cavities of the shaft, the sealing block including a seal and an injection port overlapping the adjusting member.

30. The delivery system according to any one of claims 1-29 further includes a sliding platform configured to hold the handle.

31. The delivery system according to any one of claims 1-30, further comprising a first sliding platform and a second sliding platform, the first sliding platform for holding a portion of a handle fixed to the shaft, and the second sliding platform for holding a portion of the handle fixed to a conduit through which the shaft extends.

32. The delivery system according to claim 31, wherein, Each sliding platform is configured to lock in place.

33. The delivery system according to any one of claims 31 or 32, wherein, Each sliding platform includes a support, the support including a cut configured to mate with a corresponding cut on the handle.

34. The delivery system according to any one of claims 1-33, further comprising a guide rail, on which various components of the handle are positioned, said various components including a lead screw extending through said various components, wherein, The lead screw is configured to translate the various components along the guide rail.

35. The delivery system according to claim 34, wherein, The various components include a coupling configured to allow the components to engage or disengage with the lead screw.

36. The delivery system according to any one of claims 34 or 35, wherein, The various components include clamps configured to clamp or release the positioning of the components relative to the guide rail.

37. The delivery system according to any one of claims 1-36, wherein, The distal end of the shaft includes one or more steps configured to offset the release of the arm of the device.

38. The delivery system according to any one of claims 1-37, further comprising an arm loop extending through the shaft to a distal portion of an annular shaft located within the shaft, the distal portion of the annular shaft being configured to be positioned at approximately the same height as the anchoring arm of the device and the arm of the device, the arm loop being circumferentially secured to the arm and returning to a ring control portion of the delivery system.

39. The delivery system according to claim 38, wherein, The arm ring is configured to control the expansion and contraction of the arm.

40. The delivery system according to any one of claims 38 and 39, further comprising a knob connected to the arm ring and configured to control the tightening or loosening of the arm ring.

41. The delivery system according to any one of claims 38-40, wherein the annular shaft includes a hole allowing the arm ring to exit.

42. The delivery system according to claim 41, wherein, The annular shaft includes a line extending along the annular shaft, and the arm loops loop around the line.

43. The delivery system of claim 42, further comprising an enlarged diameter portion of the line located at a distal end of the delivery system, the enlarged diameter portion having a diameter greater than that of the distal opening of the annular shaft.

44. The delivery system according to claim 43, wherein, The enlarged diameter portion includes a coiled portion.

45. The delivery system according to any one of claims 1-44, wherein, The inclined member includes a line.

46. ​​The delivery system according to any one of claims 1-45, wherein, The shaft includes two inclined members that surround the rotating member.

47. The delivery system according to any one of claims 1-46, wherein, The tilting member passes through the rotating member such that the tilting member enters and exits the rotating member at least twice.

48. The delivery system according to any one of claims 1-47, further comprising means for adjusting an anchoring arm of a device for supporting a heart valve, said means for adjusting the anchoring arm comprising: Base; The base has a circular groove, the circular groove including corner marks; as well as A plurality of sliders are positioned within the groove and configured to slide within the groove, each slider including a slot configured to receive a portion of an anchoring arm.

49. The delivery system according to any one of claims 1-48, wherein, The inclined member passes through the rotating member in such a way that the relative positions of the inclined member and the spherical member are fixed by friction.

50. The delivery system according to any one of claims 1-49, wherein, The rotating member includes an inner cavity that allows a flexible member to pass through it, wherein when the device shaft interacts with the flexible member, tilting of the rotating member causes tilting of the flexible member, which in turn causes tilting of the device shaft.

51. The delivery system according to any one of claims 1-37, further comprising: Multiple rings extend distally along the axial direction and are configured to be fixed to an arm of the device. The proximal end of each ring is connected to a control knob on a handle, wherein actuation of the control knob is configured to cause tension or loosening of the ring, thereby causing expansion or contraction of the arm to which the ring is fixed.

52. The delivery system according to claim 51, wherein, The ring is configured to extend along an annular axis positioned within the shaft.

53. The delivery system of claim 52 further includes a line extending along the annular axis, and the ring is looped around the line.

54. The delivery system of claim 53, further comprising an enlarged diameter portion of the line located at a distal end of the delivery system, the enlarged diameter portion having a diameter larger than the distal opening of the annular shaft.

55. The delivery system according to claim 54, wherein, The enlarged diameter portion includes a coiled portion.

56. The delivery system according to any one of claims 51-55, wherein, Each ring exits the ring control section of the handle through the ring port and is guided to its corresponding control knob.

57. The delivery system according to any one of claims 51-56, wherein, The control knobs are arranged to mimic the construction of their respective equipment arms.

58. The delivery system according to claim 1, wherein, The tunable catheter includes: The distal segment of the steerable catheter, the distal segment of the steerable catheter comprising: The distal portion is configured to deflect up to 180 degrees. The middle portion, which is closer to the distal portion, is configured to deflect at a maximum of 90 degrees; and The proximal portion, which is close to the middle portion, is configured to be bilaterally deflected by a maximum of 90 degrees in the distal segment.

59. The delivery system according to claim 58, wherein, The middle portion is configured to deflect up to 60 degrees, and the proximal portion of the distal segment is configured to deflect up to 45 degrees on both sides.

60. The delivery system of claim 58 or claim 59 further includes a damage-resistant distal end.

61. The delivery system according to claim 60, wherein, The damage-resistant distal end includes a distal surface that tapers toward the longitudinal axis of the steerable catheter.

62. The delivery system according to any one of claims 58-61, comprising a first controller for the distal portion of the distal segment, a second controller for the intermediate portion, and a third controller for the proximal portion of the distal segment.

63. The delivery system according to any one of claims 58-62, wherein, The distal portion of the distal segment includes a first cutting pattern, the intermediate portion includes a second cutting pattern, and the proximal portion of the distal segment includes a third cutting pattern, wherein the first cutting pattern, the second cutting pattern, and the third cutting pattern are all different.

64. The delivery system according to any one of claims 58-63, wherein, The distal portion, the intermediate portion, and the proximal portion of the distal segment are configured such that the steerable catheter can travel to the patient's tricuspid valve.

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