Coupling alignment torque response

Abstract

A delivery system for delivering a medical device may include a handle, a delivery catheter extending distally from the handle, and a balloon mounted to a distal end portion of the delivery catheter. An actuator on the handle may be operably coupled to the delivery catheter such that actuation of the actuator exerts a torque on the proximal end portion of the delivery catheter. The delivery catheter may have a proximal portion formed from a first material, and the delivery catheter may have a distal portion formed from a second material, the first material being more rigid than the second material, and the proximal portion being more rigid than the distal portion.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 592,251, filed October 23, 2023, the contents of which are incorporated herein by reference. Background Technology

[0002] Valvular heart disease (particularly aortic and mitral valve disease) is a major health concern in the United States. Valve replacement is one option for treating valvular heart disease. Artificial heart valves include surgical heart valves, as well as collapsible and expandable heart valves designed for use in transcatheter aortic valve replacement or implantation (“TAVR” or “TAVI”) or transcatheter mitral valve replacement (“TMVR”). For example, surgical or mechanical heart valves can be sutured into a patient’s natural valvular ring during open-heart surgery. Collapsible and expandable heart valves can be delivered to a patient via a delivery device (such as a catheter) to avoid more invasive procedures (such as open-heart surgery). As used herein, references to “collapseable and expandable” heart valves include heart valves that are formed with a small cross-section that allows them to be delivered to a patient via a catheter during minimally invasive surgery and then expand to an operable size once in place, as well as heart valves that, after being constructed, first collapse into a small cross-section for delivery to the patient and then expand to an operable size once in place within the valve annulus.

[0003] Collapsible and expandable artificial heart valves typically take the form of a unidirectional valve structure (often referred to as a valve assembly) fitted into an expandable frame (the terms "stent" and "frame" may be used interchangeably herein). These collapsible and expandable heart valves typically include self-expanding frames, mechanically expandable frames, or balloon-expandable frames, which are typically made of nitinol, or another shape memory metal, or a metal alloy (for self-expanding frames), or steel, or cobalt-chromium (for balloon-expandable frames). Unidirectional valve assemblies fitted to / within a stent include one or more leaflets and may also include a cuff or skirt. The cuff may be positioned on the inner or luminal surface of the stent, its outer or luminal surface, and / or both. The cuff helps ensure that blood does not flow solely around the valve leaflets if the valve or valve assembly is not optimally positioned within the valve annulus. The cuff or a portion of the cuff positioned on the outside of the stent helps prevent perivalvular leakage (the latter being referred to as perivalvular leakage or "PV" leakage).

[0004] A balloon-expandable valve is typically delivered to the natural valve annulus while the balloon collapses (or “rolls up”) onto the deflated balloon of the balloon catheter, with the collapsed valve covered or uncovered by an overlying sheath. Once the rolled-up artificial heart valve is positioned within the annulus of the replaced natural heart valve, the balloon is inflated to force the balloon-expandable valve from its collapsed or rolled-up state to an expanded or unfolded state, where the artificial heart valve tends to retain the shape formed by the balloon expansion. Typically, once the position of the collapsed artificial heart valve is determined to be in the desired position relative to the natural valve annulus (e.g., via visualization under fluoroscopy), fluid (usually a liquid, but a gas can also be used) (e.g., saline) is propelled through the balloon catheter via a syringe (manually, automatically, or semi-automatically) to cause the balloon to begin filling and expanding, thereby expanding the overlying artificial heart valve into the natural valve annulus. Summary of the Invention

[0005] According to one aspect of this disclosure, a delivery system for delivering a medical device includes: a handle, a delivery catheter extending distally from the handle, a balloon mounted to a distal portion of the delivery catheter, and an actuator on the handle operatively coupled to the delivery catheter such that actuation of the actuator applies torque to a proximal portion of the delivery catheter. The delivery catheter may have a proximal portion formed of a first material and a distal portion formed of a second material, the first material being more rigid than the second material, and the proximal portion being more rigid than the distal portion. The first material may be formed of a material having a Shore D hardness of about 63D or greater. The second material may have a Shore D hardness between about 35D and about 55D. The delivery catheter may have a total length extending distally from the handle, and the proximal portion may extend between about 70% and about 90% of the total length. The delivery catheter may include an intermediate transition section between the proximal and distal portions. The transition section may be formed of: (i) a first material whose amount decreases in the direction from the proximal side to the distal side, and (ii) a second material whose amount increases in the direction from the proximal side to the distal side. The transition section may be formed of a third material that is more rigid than the second material, and the first material that is more rigid than the second material.

[0006] When the proximal portion is substantially straight and the distal portion has a bend of approximately 180 degrees, actuation of the actuator can apply torque to the proximal portion of the delivery conduit to induce a first amount of angular rotation (Θi) at the proximal portion of the delivery conduit, which results in a second amount of angular rotation (Θo) at the distal portion of the delivery conduit. When the first amount of angular rotation (Θi) is between approximately 120 degrees and approximately 180 degrees, the torque response ratio (Θo:Θi) can be at least approximately 0.9. When the first amount of angular rotation (Θi) is between approximately 120 degrees and approximately 180 degrees, the torque response ratio can be substantially linear. When the first amount of angular rotation (Θi) is between approximately 120 degrees and approximately 360 degrees, the torque response ratio can be substantially linear.

[0007] According to another aspect of this disclosure, a method of implanting an artificial heart valve may include: advancing a delivery catheter through a patient's vascular system while the artificial heart valve is coiled on a balloon of the delivery catheter, the balloon being located at a distal portion of the delivery catheter having a proximal portion operatively coupled to a handle. The artificial heart valve may be positioned within the patient's natural aortic valve annulus while coiled on the balloon such that, when the artificial heart valve is positioned within the natural aortic valve annulus, the distal portion of the delivery catheter bends around the patient's aortic arch between the patient's descending aorta and the patient's ascending aorta. When the artificial heart valve is positioned within the natural aortic valve annulus, an actuator on the handle may be actuated to induce a first amount of angular rotation (Θi) at the proximal portion of the delivery catheter, resulting in a second amount of angular rotation (Θo) at the distal portion of the delivery catheter. When the first amount of angular rotation (Θi) is between about 120 degrees and about 180 degrees, the torque response ratio (Θo:Θi) may be at least about 0.9. When the first amount of angular rotation (Θi) is between approximately 120 degrees and approximately 180 degrees, the torque response ratio can be substantially linear. When the first amount of angular rotation (Θi) is between approximately 120 degrees and approximately 360 degrees, the torque response ratio can be substantially linear.

[0008] When the artificial heart valve is positioned within the natural aortic valve annulus, the delivery catheter may have a proximal portion that does not bend around the aortic arch, and the proximal portion may be formed of a first material, and the distal portion may be formed of a second material, the first material being more rigid than the second material, and the proximal portion being more rigid than the distal portion. The first material may have a Shore D hardness of about 63D or greater. The second material may have a Shore D hardness between about 35D and about 55D. The delivery catheter may have a total length extending distal to the handle, and the proximal portion may extend between about 70% and about 90% of the total length. The delivery catheter may include an intermediate transition section between the proximal and distal portions. The transition section may be formed of (i) a first material that decreases in amount in the direction from proximal to distal, and (ii) a second material that increases in amount in the direction from proximal to distal. The transition section may be formed of a third material that is more rigid than the second material, and the first material is more rigid than the second material. Attached Figure Description

[0009] Figure 1 This is a 3D diagram of an example of an artificial heart valve.

[0010] Figure 2 yes Figure 1 The front view of an example segment of the frame of an artificial heart valve, as if it were cut longitudinally and laid flat on a table.

[0011] Figure 3 yes Figure 1 The front view of an example of an artificial heart valve leaflet, as if it were lying flat on a table.

[0012] Figure 4 It is an example installed as part of the conveyor system. Figure 1 A top view of an artificial heart valve.

[0013] Figure 5 yes Figure 4 An enlarged view of the handle of the conveyor system shown.

[0014] Figure 6 yes Figure 4 An enlarged view of the far end of the conveyor system shown.

[0015] Figure 7 This is a top view of an example balloon catheter when the balloon is inflated.

[0016] Figure 8 Is with Figure 4 The shown conveyor system is an example of an inflatable system used in conjunction with a similar conveyor system.

[0017] Figure 9 yes Figure 8Side view of the inflation system.

[0018] Figure 10 yes Figures 8 to 9 inflation system and Figure 4 A three-dimensional diagram of the connection between the handles of the conveying system.

[0019] Figure 11 It shows the use of Figure 4 The conveyor system will Figure 1 A flowchart illustrating exemplary steps in a surgical procedure for implanting an artificial heart valve into a patient.

[0020] Figure 12 It crosses around the patient's aortic arch. Figure 4 A schematic diagram of the distal portion of the conveying system.

[0021] Figure 13 It is a graph illustrating the torque response of an exemplary conduit constructed according to this disclosure compared to existing devices.

[0022] Figure 14 This is another graph illustrating the torque response of an exemplary conduit constructed according to this disclosure, which, compared to existing devices, is shown in this figure... Figure 13 Along a wider range of input angles. Detailed Implementation

[0023] As used herein, when used in conjunction with an artificial heart valve, the term "inflow end" refers to the end of the artificial valve from which blood first enters when the valve is implanted in the desired position and orientation, while the term "outflow end" refers to the end of the artificial valve from which blood exits when the valve is implanted in the desired position and orientation. Furthermore, for an artificial aortic valve, the inflow end is the end closer to the left ventricle, and the outflow end is the end closer to the aorta. For ease of description of the valves disclosed herein, desired positions and orientations are used. However, it should be noted that the use of the valve is not limited to desired positions and orientations, but can be deployed in any type of lumen or pathway. For example, although the artificial heart valve is described herein as an artificial aortic valve, these same or similar structures and features can be used for other heart valves (e.g., pulmonary valves, mitral valves, or tricuspid valves). Further, when used in conjunction with a delivery device or system, the term "proximal" refers to the position relatively close to the user when intended for use, while the term "distal" refers to the position relatively far from the device. In other words, when the delivery device is used as intended, the front end of the delivery device or system is positioned away from the rear end of the delivery device or system. As used herein, the terms “substantially,” “generally,” “approximately,” and “about” are intended to indicate that slight deviations from absolute values ​​are also included within the scope of terms modified in this way. As used herein, artificial heart valves may present as “expanded” and “collapsed,” referring to the relative radial dimensions of the stent.

[0024] Figure 1 This is a perspective view of an example of an artificial heart valve 10. The artificial heart valve 10 may be a balloon-expandable artificial aortic valve, but in other examples, it may be a self-expanding or mechanically expandable artificial heart valve designed to replace a natural aortic valve or other natural heart valves. The artificial heart valve 10 is... Figure 1 The artificial heart valve 10 is shown in an expanded state. It can extend between the inflow end 12 and the outflow end 14. The artificial heart valve 10 may include a foldable and expandable frame 20, an inner cuff or inner skirt 60, an outer cuff or outer skirt 80, and a plurality of artificial leaflets 90. As can be clearly seen below, the artificial heart valve 10 is merely one example of an artificial heart valve, and other examples of artificial heart valves may be suitable for use with the concepts described below.

[0025] Figure 2 This is a front view of an example segment of the frame 20 of the artificial heart valve 10, which appears to be longitudinally cut and laid flat on a table. Figure 2A segment of frame 20 may represent approximately one-third of a complete frame, particularly if frame 20 is used in conjunction with a three-leaflet artificial heart valve. In the illustrated example, frame 20 is a balloon-expandable stent and may be formed of stainless steel or cobalt-chromium, and may include additional materials such as nickel and / or molybdenum. However, in some embodiments, the stent may be formed of a shape memory material (e.g., nitinol or the like). When provided as a balloon-expandable frame, frame 20 is configured to collapse when rolled into a smaller diameter and / or expand when forcibly opened, for example via a balloon within the frame, and the frame will substantially retain its modified shape when at rest.

[0026] Frame 20 may include an inflow section 22 and an outflow section 24. The inflow section 22 may also be referred to as a ring section. In one example, the inflow section 22 includes multiple rows of generally hexagonal cells. For example, the inflow section 22 may include a row of hexagonal cells 30 closest to the inflow end and a row of hexagonal cells 32 closest to the outflow end. The row of hexagonal cells 30 closest to the inflow end may be formed by a first circular row of angled or zigzag supports 21, a second circular row of angled or zigzag supports 25, and a plurality of axial supports 23 connecting the two rows. In other words, each hexagonal cell 30 closest to the inflow end may be formed by: two angled supports 21 forming a vertex pointing in the inflow direction, two angled supports 25 forming a vertex pointing in the outflow direction, and two axial supports connecting the two angled supports 21 to the two corresponding angled supports 25. The row of hexagonal cells 32 closest to the outlet end can be formed by: a second circumferential row of angled or zigzag supports 25, a third circumferential row of angled or zigzag supports 29, and a plurality of axial supports 27 connecting the two rows. In other words, each hexagonal cell 32 closest to the outlet end can be formed by: two angled supports 25 forming a vertex pointing in the inflow direction, two angled supports 29 forming a vertex pointing in the outflow direction, and two axial supports connecting the two angled supports 27 to the two corresponding angled supports 29. It should be understood that although the term "closest to the outlet end" is used in conjunction with the hexagonal cell 32, additional frame structures, as described in more detail below, are still provided in the outflow direction relative to the row of hexagonal cells 32 closest to the outlet end.

[0027] In the illustrated embodiment, it is assumed that frame 20 is intended for use with a three-leaflet valve, and therefore Figure 2The section illustrated represents approximately one-third of frame 20, and each row of units 30, 32 comprises twelve individual units. However, it should be understood that each row of units may provide more or fewer than twelve units. Further, the inflow section or annular section 22 may include more or fewer rows of units. Further still, although units 30, 32 are shown as hexagons, some or all of the units in the inflow section 22 may have other shapes (e.g., rhombus, herringbone, or other suitable shapes). In the illustrated embodiment, each unit 30 in the first row is structurally similar to or identical to each other unit 30 in the first row, each unit 32 in the second row is structurally similar to or identical to each other unit 32 in the second row, and each unit 30 in the first row is structurally similar to or identical to each unit 32 in the second row (excluding holes 26). However, in other examples, the units in each row are not identical to each other unit in the same row or in other rows.

[0028] The inflow vertex of each hexagonal unit 30 may include a hole 26 formed therein, which can accept sutures or similar features that can help attach other elements (such as inner cuff 60, outer cuff 80, and / or artificial blade 90) to the frame 20. However, in some examples, one or more or all of the holes 26 may be omitted.

[0029] Still referencing Figure 2 The outflow section 24 of frame 20 may include larger units 34 with an generally asymmetrical shape. For example, the lower or inflow portion of a larger unit 34 may be defined by two upper pillars 29 of unit 32 and one upper pillar 29 of each of two adjacent units 32. In other words, the lower end of each larger unit 34 may be formed by a set of four consecutive upper pillars 29 of three circumferentially adjacent units 32. The top of each of the larger units 34 may be defined by two link pillars 35a, 35b. The first link pillar 35a may be attached to the top or outflow vertex of unit 32 and extends upward at an angle toward the joining attachment feature (“CAF”) 40. The second link pillar 35b may extend downward at an angle from one end of the first link pillar 35a and connect directly to the CAF 40. In the case where the larger unit 34 includes a side portion, the first side portion is defined by a portion of the CAF 40, and the second side portion is defined by the connection between the first link post 35a and the corresponding upper post 29 of the unit 32 attached to the first link post 35a.

[0030] CAF 40 can generally be used as an attachment site for joining the blade joint to frame 20 (e.g., where two artificial blades are joined to each other). In the illustrated example, CAF 40 is generally rectangular and has an axial length longer than its circumferential width. CAF 40 may also define an internal open rectangular space. The struts forming CAF 40 may be generally smooth on the surface defining the open rectangular space, but some or all of the struts may have one or more suture notches on opposite surfaces. For example, in the illustrated example, CAF 40 includes two side struts (on the longer side of the rectangle) and a top (or outflow) strut, all of which include alternating protrusions and notches on their outward-facing surfaces. These protrusions and notches help maintain the position of one or more sutures wrapped around these struts. These sutures can directly attach the artificial blade 90 to frame 20, and / or can directly attach an intermediate sheet of material (e.g., fabric or tissue) to CAF 40, where the artificial blade 90 is directly attached to the intermediate sheet of material. In some embodiments, the flaps or ends of the artificial blade 90 may be pulled through the opening of the CAF 40; however, in other embodiments, the artificial blade 90 may be largely or completely retained within the inner diameter of the frame 20. It should be understood that the balloon-expandable frame is typically formed of a very rigid metal or metal alloy, particularly compared to a self-expanding frame. At least in part due to this rigidity, although the artificial blade 90 may be sewn to the frame at the CAF 40 or otherwise directly attached to the frame, it is preferable that most or all of the remaining portion of the artificial blade 90 is not directly attached to the frame 20, but rather directly attached to the inner skirt 60, which in turn is directly connected to the frame 20. Furthermore, it should be understood that other shapes and configurations of the CAF 40 may be suitable. For example, various other suitable configurations of the frame and CAF are described in more detail in U.S. Provisional Patent Application No. 63 / 579,378, filed August 29, 2023, entitled “TAVI Deployment Accuracy - Stent Frame Improvements”, the disclosure of which is incorporated herein by reference.

[0031] In the above example, frame 20 includes three rows of hexagonal units 30, 32 and a single row of larger units 34. In an embodiment of an artificial heart valve with three leaflets incorporating frame 20, each row of hexagonal units 30, 32 includes twelve units, while a row of larger units includes six larger units 34. It should be understood that when frame 20 expands, the area defined by each individual unit 30, 32 is significantly smaller than the area defined by each larger unit 34. Furthermore, the structures (e.g., struts) forming each row of individual units 30, 32 are significantly more numerous than the structures forming the rows of larger units 34.

[0032] One result of the above configuration is that the inflow section 22 has a higher unit density than the outflow section 24. In other words, the total number of units in the inflow section 22, as well as the number of units per row, is greater than that in the outflow section 24. The configuration of the frame 20 also results in the inflow section 22 generally being more rigid and / or requiring greater radial force to expand compared to the outflow section 24, although the frame 20 can always be formed of the same metal or metal alloy. This increased stiffness or rigidity of the inflow section 22 can help, for example, anchor the frame 20 to the natural heart valve ring after balloon dilation. After implantation of the artificial heart valve 10, the larger units 34 in the outflow section 24 can help provide space to the coronary arteries. For example, after implantation, one or more coronary ostia can be positioned above the frame 20, for example, above the valley where two adjacent larger units 34 meet (approximately halfway between a pair of circumferentially adjacent CAFs 40). Alternatively, one or more coronary ostia can be positioned after implantation to align with a portion of the larger internal region of the larger unit 34. Either way, blood flow to the coronary arteries is not obstructed, and further procedures utilizing the coronary arteries (e.g., coronary stenting) are not hindered by the material of the frame 20. Furthermore, the lower stiffness of the frame 20 in the outflow segment 24 can cause the outflow segment 24 to shorten preferentially during expansion, while the inflow segment 22 experiences a relatively smaller amount of axial shortening. This is likely desirable because the position of the inflow end of the frame 20 can remain substantially constant relative to the natural valve ring as the artificial heart valve 10 expands, allowing for more precise deployment of the artificial heart valve 10. For example, this could be because the inflow end of the frame 20 is typically used to check proper alignment with the natural valve ring before deployment, and axial movement of the inflow end of the frame 20 relative to the natural valve ring during deployment could make precise placement more difficult.

[0033] Return to reference Figure 1The artificial heart valve 10 may include an inner skirt 60 mounted to the inner surface of the frame 20. The inner skirt 60 may be formed of tissue (e.g., pericardium), but other types of tissue are also suitable. In the illustrated example, the inner skirt 60 is formed of a woven synthetic fabric (e.g., polyethylene terephthalate (“PET”) or polytetrafluoroethylene (“PTFE”)), but other fabrics may also be suitable, including fabrics other than woven fabrics. In some examples, the inner skirt 60 has straight or zigzag inlet and outlet ends that generally follow the outline of the units 30, 32 of the inlet section 22 of the frame 20. Preferably, the inner skirt 60 is stitched to the frame 20 along the struts forming the units 30, 32. If a hole 26 is included, the inner skirt 60 may also be attached to the frame 20 via sutures passing through the hole 26. Preferably, the inner skirt 60 does not cover the larger unit 34 (or does not cover a significant portion thereof). The inner skirt 60 can be attached to the frame 20 via a means other than sutures, including, for example, ultrasonic welding or adhesive. Furthermore, the inner skirt 60 can have a shape different from the one shown and does not need to have a zigzag inlet or outlet end, nor does it need to cover each unit in the inlet section 22. In fact, in some examples, the inner skirt 60 can be omitted entirely, where the outer skirt 80 (described in more detail below) is the only skirt used with the artificial heart valve 10. If the inner skirt 60 is provided, it can help seal the artificial heart valve 10 within the heart and serve as a mounting structure for the artificial leaflet 90 (described in more detail below) within the frame 20.

[0034] Still referencing Figure 1The artificial heart valve 10 may include an outer skirt 60 mounted to the outer surface of the frame 20. The outer skirt 80 may be formed of tissue (e.g., pericardium), but other types of tissue may also be suitable. In the illustrated example, the outer skirt 80 is formed of woven synthetic fabric (e.g., PET or PTFE), but other fabrics may also be suitable, including fabrics other than woven fabrics. In some examples, the outer skirt 80 has a straight or zigzag inlet end. Preferably, the outer skirt 80 is sewn to the frame 20 and / or the inner skirt 60 along its inlet edge. If a hole 26 is included, the outer skirt 80 may also be attached to the frame 20 via sutures passing through the hole 26. The outer skirt 80 may include multiple folds or pleats (e.g., folds or pleats extending circumferentially). Folds or pleats can be formed in the outer skirt 80 via heat setting (e.g., by placing the outer skirt 80 within a folding mold that forces the outer skirt 80 to form pleats), and the outer skirt 80 can be heat-treated such that it tends to remain folded or pleated without applied force. The outflow edges of the outer skirt 80 can be attached to the frame 20 at selected spaced locations around the circumference of the frame 20. In some embodiments, the outflow edges of the outer skirt 80 can be attached to the inner skirt 60 along a substantially continuous suture. Some or all of the outer skirt 80 between its inflow and outflow edges can remain not directly attached to the frame 20 or the inner skirt 60. Preferably, the outer skirt 80 does not cover the larger unit 34 (or does not cover a significant portion thereof). In use, the outer skirt 80 can directly contact the inner surface of the natural heart valve annulus to aid in sealing, including sealing against PV leakage. If the outer skirt 80 includes folds or pleats, the additional material of the folds or pleats can help further mitigate PV leakage. However, it should be understood that folds or pleats can be omitted from the outer skirt 80, and the outer skirt 80 can have shapes other than those shown. In fact, in some examples, the outer skirt 80 can be omitted entirely, where the inner skirt 60 is the only skirt used with the artificial heart valve 10. If the inner skirt 60 is omitted, the artificial leaflet 90 can be directly attached to the frame 20 and / or directly attached to the outer skirt 80.

[0035] Figure 3This is a front view of the artificial leaflet 90, as if it were lying flat on a table. In the example of the artificial heart valve 10 shown, a total of three artificial leaflets 90 are provided; however, it should be understood that more or fewer than three artificial leaflets may be provided in other examples of artificial heart valves. The artificial leaflets 90 may be formed from synthetic materials (e.g., polymer sheets or fabrics) or biological materials (e.g., bovine or porcine pericardial tissue). However, other materials may be suitable. In one example, the artificial leaflet 90 is formed with a concave free edge 92 configured to coapt with the free edges of other leaflets to help provide unidirectional valve function. The artificial leaflet 90 may include an attachment edge 94 that is attached (e.g., by suturing) to other structures of the artificial heart valve 10. For example, the attachment edge 94 may be directly attached to the inner skirt 60, directly attached to the frame 20, and / or directly attached to the outer skirt 80. Preferably, the attachment edge 94 is directly attached only to the inner skirt 60, which helps reduce stress on the artificial blade 90 compared to if the attachment edge 94 were directly attached to the frame 20. In some embodiments, a plurality of holes 98 may be formed, for example, via a laser along the attachment edge 94 (or at a distance spaced therefrom). If holes 98 are included, they can be used to receive sutures passing through them, which makes it easier to attach the artificial blade 90 to the inner skirt 60 during manufacturing. For example, if the suturing is performed manually, the holes 98 can serve as guides, and if the position of the holes 98 is controlled by the use of layers, a plurality of holes 98 can be uniformly placed between different artificial blades 90 to reduce variability between different artificial blades 90. Blade tabs 96 may be provided at the junction between the free edge 92 and the attachment edge 94. Each blade tab 96 may be attached to the blade tab of an adjacent artificial blade to form an artificial blade junction, which may be attached to the frame 20 via the CAF 40.

[0036] Artificial heart valves can be delivered via any suitable transvascular route (e.g., transapical or transfemoral). Typically, transapical delivery uses a relatively rigid catheter that punctures the apex of the left ventricle through the patient's chest, resulting in a relatively greater degree of trauma compared to transfemoral delivery. In transfemoral delivery, a delivery device housing or supporting the valve is inserted through the femoral artery and advanced against the flow of blood into the left ventricle. In either delivery method, the valve may first collapse on an inflatable balloon while the balloon deflates. The balloon may be attached to or located within a delivery system that transports the valve through the body and heart to the aortic valve, which is positioned on the balloon (and in some cases, below a covering sheath). Upon reaching the aortic valve or adjacent aortic valve, the surgeon or operator of the delivery system may align the artificial valve as desired within the natural valve ring while simultaneously collapsing the artificial valve on the balloon. When the desired alignment is achieved, the overlying sheath (if included) can be retracted (or advanced) so that the artificial valve is not covered, and the balloon can be inflated so that the artificial valve expands in the radial direction, wherein at least a portion of the artificial valve shortens in the axial direction.

[0037] Figure 4 An example of a delivery system 100 is illustrated, in which an artificial heart valve 10 is coiled on a balloon at the distal end of the delivery system 100. Although the delivery system 100 and its various components are described below, it should be understood that the delivery system 100 is merely one example of a balloon catheter that can be used to deliver and deploy an artificial heart valve 10.

[0038] In some examples, delivery system 100 includes a handle 110 and a delivery conduit 130 extending distally from the handle 110. An inlet 150 may be provided with delivery system 100. Inlet 150 may be an integrated or captive inlet, but in other embodiments, inlet 150 may be a non-integrated or non-captive inlet. In some examples, inlet 150 may be an expandable inlet, including, for example, an inlet that partially expands as a large-diameter component passes through it, wherein once the large-diameter component has passed through, the inlet returns to a smaller diameter. In other examples, inlet 150 is a non-expandable inlet.

[0039] A guidewire GW may be provided, which passes from the proximal end of the handle 110 through the atraumatic distal tip 138 of the delivery catheter 130 and extends through the interior of all components of the delivery system 100. The guidewire GW can be introduced into the patient to the desired location, and the delivery system 100 can be introduced through the guidewire GW to help guide the delivery catheter 130 through the guidewire GW across the patient's vascular system.

[0040] In some examples, the delivery catheter 130 is steerable. For example, one or more steerable lines may extend through the wall of the delivery catheter 130, with one end of the steerable line coupled to a steerable ring coupled to the delivery catheter 130, and the other end of the steerable line operably coupled to a steerable actuator on a handle 110. In such an example, when the steerable actuator is actuated, the steerable line is tensioned or relaxed to cause deflection or straightening of the delivery catheter 130 to help steer the delivery catheter 130 to a desired location within the patient's body. For example, Figure 5 This is an enlarged view of handle 110. Handle 110 may include a steering knob 112 that, when rotated, tensions or loosens the steering line to deflect the distal end of delivery conduit 130. Handle 110 may include a slot 118 having an indicator extending therethrough, which moves along the slot 118 as delivery conduit 130 deflects (e.g., the indicator moves proximally as deflection increases). If included, the indicator and slot 118 can provide the user with a simple reference to how much delivery conduit 130 has deflected at any given point. However, it should be understood that the steering function may be omitted in some examples, and in other examples, a steering actuator other than a knob may be utilized. Furthermore, in some examples, [the following is included] Figures 6 to 7 As shown, the delivery conduit 130 includes an outer conduit 132 and an inner conduit 134. A steering function may be provided in either the outer conduit 132 or the inner conduit 134, or both.

[0041] Still referencing Figures 4 to 5The delivery system 100 may include additional functionality to aid in the positioning of the artificial heart valve 10. For example, in the illustrated example, the handle 110 includes a merging alignment actuator 114, which can be positioned near the proximal end of the handle or at any other desired location. In the illustrated example, the merging alignment actuator 114 is in the form of a rotatable knob, but other forms may be suitable. The merging alignment knob 114 is rotatably coupled to a portion of the delivery catheter 130 that supports the artificial heart valve 10. For example, the merging alignment actuator 114 is rotatably coupled to an inner catheter 134 that supports the artificial heart valve 10 in a coiled position. In this configuration, rotating the merging alignment knob 114 rotates the inner catheter 134 about its longitudinal axis, and thus rotates the artificial heart valve 10 about its longitudinal axis. If the commissure alignment actuator 114 is included, it can be used to help ensure that, when the artificial heart valve 10 is deployed into the natural valve annulus, the commissure of the artificial heart valve is rotated to align with a corresponding one of the natural valve commissures (e.g., within a rotational alignment of + / -2.5 degrees, within a rotational alignment of + / -5 degrees, within a rotational alignment of + / -10 degrees, within a rotational alignment of + / -15 degrees, etc.). Although the commissure alignment actuator 114 is shown in this example as a knob positioned proximal to or near the handle 110, it should be understood that the actuator 114 may take the form of a knob or other suitable location, and may be omitted entirely if desired.

[0042] Still referencing Figures 4 to 5The delivery system 100 may include, or even further, functionality to aid in the positioning of the artificial heart valve 10. For example, in the illustrated example, the handle 110 includes an axial alignment actuator 116, which may be positioned near the proximal end of the handle, including distal to the merging alignment actuator 114, or at any other desired location. In the illustrated example, the axial alignment actuator 116 is in the form of a rotatable knob, but other forms may be suitable. The axial alignment knob 116 may be operatively coupled to a portion of the delivery catheter 130 that supports the artificial heart valve 10. For example, the axial alignment actuator 116 may include internal threads that engage with external threads of a bracket coupled to an inner catheter 134 that supports the artificial heart valve 10 in a coiled state. In such an example, the bracket may be rotatably secured to the handle 110. In this configuration, rotating the axial alignment knob 116 causes the bracket to advance distally or retract proximally because the internal thread of the axial alignment knob 116 engages with the external thread of the bracket, but the bracket is prevented from rotating. As the bracket advances distally or retracts proximally, the inner catheter 134 can correspondingly advance distally or retract proximally, and thus cause the artificial heart valve 10 to advance distally or retract proximally. It should be understood that if the axial alignment actuator 116 is included, it has a small total range of motion. In other words, a coarse or rough axial alignment between the artificial heart valve 10 and the natural valve ring can be achieved by physically advancing the entire delivery catheter 130 through the vascular system while holding the handle 110. However, for finer and more controlled adjustment of the axial position of the artificial heart valve 10 relative to the natural valve ring (which can be performed precisely before or during the deployment of the artificial heart valve 10), the axial alignment knob 116 can be used. If an axial alignment actuator 116 is included, it can be used to help ensure that the inflow end of the artificial heart valve 10 is axially aligned with the inflow aspect of the natural valve ring when the artificial heart valve 10 is deployed into the natural valve ring (e.g., within + / - 0.5 mm, within + / - 1.0 mm, within + / - 1.5 mm, within + / - 2.0 mm, etc.). Although the axial alignment actuator 116 is shown in this example as a knob positioned proximal to or near the handle 110, it should be understood that the actuator 116 may take the form of a knob or other suitable location, and may be omitted entirely if desired.

[0043] In addition to the steering actuator and the positioning actuator, the delivery system 100 may include a balloon actuator 120. In the illustrated example, the balloon actuator 120 is positioned near its distal end on the handle 110 and is provided in the form of a switch. The balloon actuator 120 can be actuated to cause inflation or deflation of the balloon 136, which is part of the delivery system 100. For example, briefly refer to... Figures 6 to 7 The delivery system 100 may include a balloon 136 that covers the distal end of the inner catheter 134 and receives the artificial heart valve 10 in a coiled state on the inner catheter 134. Figure 6 In the example shown, balloon 136 includes a proximal occipital portion 136a, a distal occipital portion 136b, and a central portion on which the artificial heart valve 10 is coiled. The proximal occipital portion 136a and distal occipital portion 136b can form shoulders on each side of the artificial heart valve 10, which helps ensure that the artificial heart valve 10 does not move axially relative to balloon 136 and / or inner catheter 134 during delivery. The shoulders formed by the distal occipital portion 136 also help protect the inflow edge of the artificial heart valve 10 from contact with anatomical structures during delivery. For example, during transfemoral delivery, when the distal end of the delivery catheter 130 crosses the sharp bend of the aortic arch (or during initial insertion into the patient), the inflow end of the artificial heart valve 10 (which is the anterior edge during transfemoral delivery) will contact the vessel wall (or components of the delivery system), resulting in a relatively high possibility of displacement of the artificial heart valve 10 relative to balloon 136. The distal occipital portion 136 may be inclined to have an outer diameter equal to or larger than the inflow end of the artificial heart valve 10 (when the artificial heart valve 10 is rolled up and the balloon 136 is deflated), which helps ensure that the inflow edge of the artificial heart valve 10 does not accidentally contact other structures during delivery. In some examples, the occipital portions 136a, 136b may be formed via heat setting. Additional relevant features for similar balloon catheter delivery systems are described in more detail in U.S. Provisional Patent Application No. 63 / 382,812, filed November 8, 2022, entitled "Prosthetic HeartValve Delivery and Trackability," the disclosure of which is incorporated herein by reference.

[0044] To deploy the artificial heart valve 10, the balloon 136 is inflated by actuating the balloon actuator 120 to force fluid (e.g., saline solution, but other fluids including liquids or gases may be used) into the balloon 136, thereby expanding the artificial heart valve 10 in the process. For example, the balloon actuator 120 may be pressed forward or distally to allow fluid to travel through the inflation lumen located within the delivery catheter 130, thereby inflating the balloon 136. Figure 7 An example of an inflated balloon 136 is illustrated; for clarity, the artificial heart valve 10 is omitted from the figure. In the illustrated example, the balloon 136 may be formed with a distal end that is attached to a portion of a non-invasive distal tip 138. The distal tip 138 may be tapered to help the delivery catheter 130 move more smoothly through the patient's vascular system. The proximal end of the balloon 136 may be attached to the distal end of the external catheter 132. The inflation lumen may be the space between the external catheter 132 and the internal catheter 134, or in other embodiments, the inflation lumen may be disposed within the wall of the internal catheter 134, or in any other location where the internal fluid of the balloon 136 is connected to a fluid source outside the patient's body, operatively coupled to the delivery system 100.

[0045] refer to Figure 7 In some examples, the mounting shaft 140 may be positioned on the inner catheter 134. A proximal stop 142 and / or a distal stop 144 may be positioned, for example, at opposite ends of the mounting shaft 140. Including the mounting shaft 140 provides a position on which the artificial heart valve 10 can be coiled. Proximal stops 142 and / or distal stops 144 provide a physical barrier to axial movement of the artificial heart valve 10 relative to the balloon 136. In one example, the proximal stop 142 may taper from a larger distal diameter to a smaller proximal diameter, and the distal stop may taper from a larger proximal diameter to a smaller distal diameter. If both the proximal stop 142 and the distal stop 144 are included, the spacing between them may be slightly greater than the length of the artificial heart valve 10 when it is coiled on the mounting shaft 140. However, it should be understood that one or both of the stops 142 and 144 may be omitted, and the mounting shaft 140 may also be omitted. If the mounting shaft 140 is included, it is preferably axially and rotatably fixed to the inner catheter 134, such that movement of the inner catheter 134 causes a corresponding movement of the mounting member 140, and consequently, when the artificial heart valve 10 is mounted on the mounting member 140, it causes a corresponding movement of the artificial heart valve 10.

[0046] Before describing the use of the balloon actuator 120 in more detail, it should be understood that in some embodiments, the balloon actuator 120 may be omitted, and alternatively, a manual device (such as a manual syringe) may be provided with the delivery system 100 to manually push fluid into the balloon 136 during the deployment of the artificial heart valve 10. However, in the illustrated example of the delivery system 100, the balloon actuator 120 provides motorized and / or automatic (or semi-automatic) balloon inflation functionality. For example, Figure 8 and Figure 9 An example of a balloon inflation system 170 is illustrated. The balloon inflation system 170 may include a housing 172 that accommodates one or more components, which may include a motor, one or more batteries, electronics for controlling other components and / or communicating with other components, etc. 。 The housing 172 may include one or more fixed hangers for receiving the syringe 174. In the illustrated embodiment, the distal hanger 176 is provided with an open “C” or “U” configuration, such that the distal end of the syringe 174 can engage or disengage from the distal hanger 176. A proximal hanger 178 may also be provided, which may have a “C” or “U” bottom hinged to the “C” or “U” top. This configuration allows the proximal end of the outer body of the syringe 174 to engage in the bottom of the proximal hanger 178, and the top of the proximal hanger 178 can close and connect to the bottom to fully circumscribe the outer body of the syringe 174 to lock the syringe 174 to the housing 172. It should be understood that more or fewer hangers of similar or different designs may be included with the housing 172 to help secure the syringe 174 to the housing 172 in any suitable manner.

[0047] The balloon inflation system 170 may include a movable member 180. In the illustrated embodiment, the movable member 180 includes a C-shaped or U-shaped bracket for receiving the plunger handle 182 of the syringe 174 therein, the bracket being attached to a bracket that extends at least partially into the housing 172. The bracket of the movable member 180 may be generally cylindrical and may include internal threads that engage with external threads of a screw mechanism (not shown) within the housing 172, which is operatively coupled to a motor. In some embodiments, the bracket may have a general shape of a U-beam, with the flat surface oriented towards the top. The movable member 180 may be rotatably secured to the housing 172 via any desired mechanism such that, when the screw mechanism is rotated by the motor, the movable member 180 may be further advanced into the housing 172 or retracted further away from the housing 172, depending on the direction of rotation of the screw mechanism. When the plunger handle 182 is engaged with the movable member 180, the advancement of the movable member 180 forces fluid from the syringe 174 toward the balloon 136, while the retraction of the movable member 180 withdraws fluid from the balloon 136 toward the syringe 174. It should be understood that a motor or other drive mechanism may be located within or outside the housing 172, and any other suitable mechanism may be used to operatively engage the motor or other drive mechanism with the movable member 180 to allow axial drive of the plunger handle 182.

[0048] like Figure 8 , Figure 9 and Figure 10 As shown in each of these, the distal end of syringe 174 may be coupled to conduit 184, which is in fluid communication with the inflation lumen of delivery conduit 130 leading to balloon 136 at or near the distal end of delivery system 100. Conduit 184 may allow fluid (e.g., saline) to pass from syringe 174 toward balloon 136, or allow fluid to be withdrawn from balloon 136 toward syringe 174 (e.g., depending on whether balloon actuator 120 is pressed forward or backward).

[0049] Despite Figure 8 , Figure 9 and Figure 10While no separate reference numerals are provided in the accompanying drawings, housing 172 may include one or more cables extending from housing, for example to allow the transmission of power (e.g., from AC mains power or another component connected to the cable) and / or the transmission of data, information, control commands, etc. For example, a cable may connect housing 172 to handle 110, allowing a controller on handle 110 (e.g., balloon actuator 120) to activate balloon inflation system 170 in a desired manner. Another cable may connect to a computer monitor or similar device to provide information about the inflation of balloon 136. However, it should be understood that any transmission of data or information may be provided wirelessly rather than via a wired connection, such as via Bluetooth or other suitable connection. Additional and related features of balloon inflation system 170, related systems, and uses thereof are described in U.S. Patent Application No. 18 / 311,458, the disclosure of which is incorporated herein by reference.

[0050] Figure 11 It shows the use of Figure 4 The conveyor system 100 will Figure 1The flowchart illustrates exemplary steps in an implantation procedure 200 for implanting an artificial heart valve 10 into a patient. However, it should be understood that not all steps shown in the implantation procedure 200 need to be performed, and various steps not explicitly shown and described in the procedure 200 may be performed as part of the implantation procedure. In step 202 at the beginning of the procedure 200, the artificial heart valve 10 may collapse or roll onto a balloon 136, wherein the balloon 136 is mostly or completely deflated after the rollover procedure. It should be understood that the rollover step 202 may be performed at any time before the procedure (including at the beginning of the procedure) or at an earlier stage before the delivery system 100 is provided to the end user. In other words, the rollover step 202 may be performed during the manufacturing phase of the delivery system 100 and / or the artificial heart valve 10. During the early stages of the implantation procedure 200, the guidewire GW may be advanced into the patient in step 204 (e.g., via the femoral artery, around the aortic arch, through the natural aortic valve, and into the left ventricle). The guidewire GW can be used as a track for other devices that need to enter the pathway. For example, in step 206, the atraumatic distal tip 138 can be advanced through the proximal end of the guidewire GW, and the delivery catheter 130 can be advanced through the guidewire GW toward the natural aortic valve. During the initial advancement of the delivery catheter 130 into the patient, the inserter 150 (if included) can be positioned distally, for example, such that it covers the artificial heart valve 10, or such that it is positioned just proximal to the artificial heart valve 10. Advancement of the delivery catheter 130 and the inserter 150 can continue until the proximal hub of the inserter contacts the patient's skin (or contacts another device entering the patient's femoral artery). At this point, the inserter 150 can stop axial movement relative to the patient, while the delivery catheter 130 continues to advance relative to the inserter 150. If steering capability is provided, the delivery catheter 130 can be steered or deflected at any point to help achieve the desired path of the delivery catheter 130. In one example, in step 208, as the delivery catheter 130 traverses the sharp bend of the aortic arch, the steering knob 112 can be actuated to deflect the distal end of the delivery catheter 130. Advancement of the delivery catheter 130 can continue in step 210 until the artificial heart valve 10 is positioned within the natural aortic valve annulus while still curled or collapsed. Upon reaching the desired position, the balloon 136 can be partially inflated, for example, by pressing forward on the balloon actuator 120, to partially dilate the artificial heart valve 10 in step 212. In some examples, it is desirable to dilate the artificial heart valve 10 only partially in step 212 because the position of the artificial heart valve 10 relative to the natural aortic valve annulus (including rotational and / or axial positioning) may shift during this partial dilation.After partial dilation in step 212, the user can check the positioning of the artificial heart valve 10 relative to the natural aortic valve annulus. If necessary, in step 214, fine adjustment can be made to the axial positioning of the partially dilated artificial heart valve 10 relative to the natural aortic valve annulus (e.g., by actuating the axial alignment actuator 116) and / or fine adjustment can be made to the rotational orientation of the artificial heart valve 10 relative to the natural aortic valve (e.g., by actuating the commissure alignment actuator 114). When the desired axial alignment and desired rotational alignment (e.g., rotational alignment between the artificial and natural commissures) are achieved, the balloon 136 can be fully dilated in step 216 to fully dilate the artificial heart valve 10 and anchor the artificial heart valve 10 in the natural aortic valve annulus in the desired position and orientation. After deployment is complete, balloon 136 can be deflated in step 218, for example, by pressing the actuating balloon 120 backward, and the delivery catheter 130 and guidewire GW can be removed from the patient to complete the procedure. It should be understood that... Figure 11 The nine steps shown as part of surgery 200 are merely a single exemplary example of implantation surgery, and the steps shown may be omitted, steps not shown may be included, and the steps may be provided in any order that the doctor and / or medical personnel deem appropriate.

[0051] Although various components of the artificial heart valve 10 and delivery system 100 have been described above, it should be understood that these components are intended only to provide a better background for the systems, features, and / or methods described below. Therefore, various components of the above-described systems may be appropriately modified or omitted without affecting the systems, features, and / or methods described below. For example, in addition to combining... Figures 1 to 3 Artificial heart valves, other than those shown and described in the specific configurations, can be combined with other types of valves. Figures 4 to 10 The conveying system is used in conjunction with the specific configuration shown and described, in addition to the combination Figure 11 The steps are part of the implantation procedure other than those shown and described in the specific configuration, without affecting the inventive systems, features and / or methods described below.

[0052] As described above, it may be desirable that, when the artificial heart valve 10 is implanted into the natural aortic valve, the commissure of the artificial heart valve is rotated to align with the commissure of the natural aortic valve. One way to achieve this alignment is to actively rotate the artificial heart valve 10 while it is coiled on the balloon 136 and radially positioned within the natural aortic valve just before deployment. The rotational orientation of the artificial heart valve 10 can be examined at one or more points, just before deployment and after the balloon 136 has begun to inflate. This examination can be performed, for example, under visualization such as fluoroscopy and / or transesophageal echocardiography (“TEE”). If it is determined that the commissure of the artificial heart valve 10 fails to rotate and align with the commissure of the natural aortic valve at any point before deployment has begun, or after deployment has begun but before the artificial heart valve is anchored within the aortic valve annulus, the rotational orientation of the artificial heart valve 10 can be adjusted, for example, by rotating the commissure alignment actuator 114 in the desired rotational direction to induce a corresponding rotation of the artificial heart valve 10 until the desired rotational alignment is achieved.

[0053] During transfemoral aortic valve replacement surgery, when the artificial heart valve 10 is positioned within the natural aortic valve AV, as... Figure 12 As shown, the delivery catheter extends upwards in a retrograde direction through the descending aorta A. D It surrounds the aortic arch AA and descends back to the ascending aorta A. A For this particular delivery route (and potentially for other highly tortuous delivery routes), competing design factors of the delivery catheter 130 may come into play. For example, it is generally desirable for the delivery catheter 130 to have significant flexibility so that it can smoothly “follow” around the aortic arch AA, which can have 180-degree turns. As used herein, the term “follow” refers to the ability of the delivery catheter to follow the contours of the tortuous vascular system as it is advanced through it. However, in order to be able to rotate the artificial heart valve 10 by aligning the actuator 114 via the coupling on the manipulator 110, torque must be able to be transmitted from the manipulator 110 (located at or near the very proximal end of the delivery system 100) to the artificial heart valve 10 and the underlying catheter (located at or near the very distal end of the delivery system 100). Similar to Figure 12In the position shown, torque transmission can be particularly difficult when the artificial heart valve 10 is positioned within the natural aortic valve AV and the delivery catheter 130 is highly deflected around the aortic arch AA. Furthermore, while simple torque transmission from the handle 110 to the artificial heart valve 10 is important for achieving synergistic alignment, other functionalities may be desired for the ease of use and predictability of this alignment. For example, a 1:1 torque response between the synergistic alignment actuator 114 and the artificial heart valve 10 is generally desirable. In other words, if the synergistic alignment actuator 114 rotates 30 degrees, preferably, the artificial heart valve also rotates 30 degrees. While a perfect 1:1 torque response is not required, a near-1:1 torque response is preferred because the use of the synergistic alignment actuator 114 will have highly predictable results in terms of reorienting the rotational position of the artificial heart valve 10. Two items related to this torque response that are to be avoided include hysteresis and jitter. As used herein, the term "hysteresis" refers to the buildup of rotational energy. For example, if the syndesm alignment actuator 114 rotates 30 degrees, but the artificial heart valve 10 only rotates 15 degrees because some rotational energy applied by the syndesm alignment actuator 114 is stored within the delivery conduit 130, then hysteresis has already occurred. Jitter refers to the release of this stored energy. For example, assuming hysteresis has already occurred as described above, the stored energy can be released as the procedure continues, and this release of stored energy can cause the artificial heart valve 10 to rotate another 15 degrees even if the syndesm alignment actuator 114 remains stationary, as the stored energy is released. The occurrence of hysteresis and jitter is undesirable because they create unpredictability regarding the desired rotational position of the artificial heart valve 10, and they can occur to some extent spontaneously, which further increases the unpredictability of the syndesm alignment process. Therefore, it is desirable to maximize torque response (e.g., close to or achieving a 1:1 torque response ratio) while the delivery catheter 130 is shaped around the aortic arch AA, while still maximizing the ability of the delivery catheter 130 to track around the aortic arch AA during delivery (e.g., by maintaining a relatively low tracking force).

[0054] Still referencing Figure 12 The diagram illustrates a delivery catheter 130 after the coiled artificial heart valve 10 has been delivered to the natural aortic valve AV but before dilation. As described above, when the delivery catheter 130 has the illustrated configuration, it is desirable to maximize the torque response. In one example, the torque response can be defined as the amount of angular rotation Θo generated in the delivery catheter 130 at the location of the coiled artificial heart valve 10, plus the angular rotation Θ applied to the proximal portion of the delivery catheter 130. i The ratio between quantities. Figure 12 In the diagram, the applied or input angle rotation Θi Its relevant location is in the abdominal aorta, near (in the direction of blood flow) the descending aorta A. D Somewhere near the end. However, applying or inputting an angular rotation Θ i The relevant location can be further defined proximally along the delivery conduit 130, including until the connection point between the actuator 114 and the delivery conduit 130 is aligned with the joint. Therefore, in some embodiments, it is desirable to achieve a torque response ratio Θ. o :Θ i Equal to or close to 1.

[0055] Typically, to achieve a torque response ratio Θ o :Θ i One way to achieve a torque response ratio equal to or close to 1 is to make the delivery catheter 130 rigid. However, instead of simply making the delivery catheter 130 rigid, different material properties can be provided at specially selected locations of the delivery catheter 130 to maximize the torque response ratio without excessively increasing the tracking force around the aortic arch AA. For example, in Figure 12 In the example shown, the delivery catheter 130 includes a proximal portion 130a, a distal portion 130b, and a transition point 130c. When the delivery catheter 130 is inserted into a patient so that the coiled artificial heart valve 10 is positioned axially aligned with the natural aortic valve AV, the entire portion of the catheter that bends around the aortic arch AA is preferably located within the distal portion 130b, while the proximal portion 130a has little or no bend around the aortic arch AA. To maximize traceability and torque response ratio, the distal portion 130b of the delivery catheter 130 may be formed of a material that is more flexible or softer (e.g., a lower stiffness or rigidity value) than the material used to form the proximal portion 130a. In some examples, the delivery catheter 130 (and / or portions thereof) is formed with an internal tubular liner (e.g., an etched PTFE liner) from which a braided tube extends radially outward, and then a polymer sheath flows back as the outermost layer of the catheter stack. As a non-limiting example, the distal portion 130b can be formed as a reflux axis where the reflux material is a relatively soft or flexible polymer, such as a block copolymer variant of polyether block amide (e.g., provided by Arkema under the Pebax® trademark) (e.g., 45D Pebax). As another non-limiting example, the proximal portion 130a can be formed as a reflux axis where the reflux material is a relatively rigid or relatively hard polymer (e.g., 63D Pebax or nylon (e.g., nylon 11)). In the above examples, when the delivery catheter 130 is advanced retrogradely through the femur, the relatively soft or flexible distal catheter portion 130b is able to follow around the aortic arch AA with relatively low force, but when... Figure 12In the configuration shown, when torque is applied to the delivery conduit 130a, the long, relatively straight, relatively rigid, or relatively stiff proximal conduit portion 130b is able to transmit torque very well at a ratio of 1:1 or close to 1:1, but the torque ratio may be at least about 0.90 or at least 0.95.

[0056] While specific examples of polymers for forming the distal portion 130b and the proximal portion 130a have been provided above, it should be understood that other materials may also be suitable. For example, for the relatively soft distal portion 130b, a range of soft polymers having a Shore D hardness between about 35D and about 55D may be suitable, while for the relatively hard proximal portion 130a, a range of more rigid polymers having a Shore D hardness of about 63D or greater may be suitable.

[0057] It should be understood that although various materials are generally described herein in conjunction with delivery conduit 130, in some embodiments, the material is specifically related to the formation of outer conduit 132. In delivery conduit 130, inner conduit 134 is very small compared to outer conduit 132, and therefore the material forming inner conduit 134 has a significantly smaller impact on the problems described herein. However, in some embodiments, inner conduit 134 may include the same or similar hardness / rigidity / flexibility differences described in conjunction with outer conduit 132. Therefore, although the material properties described herein generally relate to outer conduit 132, they can be used in either or both of inner conduit 134 and outer conduit 132.

[0058] It should be understood that the aforementioned transition point 130c is preferably located at, near, or close to the curvature of the aortic arch AA. Because patient anatomy varies, there may not be a location for the transition point 130c that is ideal for all patients. However, in some embodiments, the length of the delivery catheter 130 extending distal to the handle 110 can be between approximately 90 cm (approximately 35.5 in.) and approximately 110 cm (approximately 43.5 in.), including approximately 95 cm (approximately 37.5 in.), approximately 100 cm (approximately 39.5 in.), and approximately 105 cm (approximately 41.5 in.). In one particular example, the length is approximately 41 inches (approximately 104 cm). In this particular example, the proximal portion 130a may have a length of approximately 32 inches (approximately 81 cm) distal to the handle 110, and the distal portion may have a length of approximately 9 inches (approximately 23 cm). Therefore, in this embodiment, the transition point 130c can be located at approximately 78% of the length of the delivery conduit 130 in the distal direction from the distal end of the handle 110. However, it should be understood that these figures are merely exemplary. In other embodiments, the specific length of the entire delivery conduit 130, as well as both the proximal portion 130a and the distal portion 130b, may differ from the example provided above. In some embodiments, the transition point 130c can be located between approximately 70% and approximately 90% of the length of the delivery conduit in the proximal-to-distal direction from the handle 110, including approximately 75%, approximately 80%, and approximately 85%.

[0059] In some embodiments, transition point 130c is an abrupt transition where the material forming the proximal portion 130a suddenly transitions to the material forming the distal portion 130b. In some embodiments, a tapered transition may be present. For example, assuming the proximal conduit portion 130a is formed of nylon 11 and the distal conduit portion 130b is formed of 45D Pebax, then at a location spaced proximally from transition point 130c, 45D Pebax forming the delivery conduit 130 may be absent, and at a location spaced distally from transition point 130c, nylon 11 forming the delivery conduit 130 may be absent. However, instead of an abrupt transition from nylon 11 to 45D Pebax, the amount of nylon 11 forming the delivery conduit 130 may gradually decrease in the direction toward and beyond transition point 130c, while the amount of 45D Pebax forming the delivery conduit 130 may gradually increase, resulting in a gradient of hard / rigid and soft / flexible materials at and around transition point 130c. It should be understood that, in addition to Nylon 11 and 45D Pebax, other materials can also achieve a gradual transition in stiffness (e.g., a continuously variable hardness transition). For example, polyether block amides can be used to manufacture sheaths or sleeves with varying hardness or extrusion properties throughout the extrusion length. An exemplary benefit of a continuously variable hardness transition compared to a more abrupt hardness transition includes providing a greater amount of strain relief between segments of different hardness, which can help reduce springback (described in more detail below).

[0060] In some embodiments, a third material may be provided at and around the transition point 130c to provide enhanced functionality. For example, a moderately rigid or moderately hard material (e.g., more flexible or softer than the proximal conduit portion 130a, but more rigid or harder than the distal conduit portion 130b) may be provided between the proximal portion 130a and the distal portion 130b (e.g., at an elongated version of the transition point 130c). In one example, the material forming this elongated transition segment 130c may be 63D Pebax. This moderately rigid or hard transition segment 130c can serve as a strain relief segment, which can reduce the occurrence of springback. If the transition point 130c is an abrupt transition between the more rigid / harder polymer of the proximal conduit portion 130a and the more flexible / softer polymer of the distal conduit portion 130b, then when the delivery conduit 130 has Figure 12 In the configuration shown (or a similar profile configuration), the delivery conduit 130 can spring back proximally when the soft / flexible polymer is hinged just distal to the transition point 130c. This springback can be reduced or eliminated by introducing a medium-hardness / medium-rigidity section at and around the transition point 130c.

[0061] In the above description, it is generally stated that the material forming the distal portion 130b is softer or more flexible than the material forming the proximal portion 130a. However, it should be understood that, for example, forming a conduit portion from a softer polymer generally results in the conduit portion itself being more flexible. Therefore, although the material forming the conduit is described as more rigid or more flexible, it can also be said, or alternatively, that the distal portion 130b itself is softer or more flexible than the proximal portion 130a. Other components of the proximal portion 130a and / or the distal portion 130b, in addition to the recirculated polymer material itself, can be selected or modified to help create a desired relative softness and rigidity between the proximal portion 130a and the distal portion 130b. For example, in addition to changing the polymer hardness, the rigidity can also be changed by: changing the weave density of any braided material forming a portion of the proximal portion 130a and / or the distal portion 130b; adjusting the pattern density of any laser cut used in forming the proximal portion 130a and / or the distal portion 130b; changing the wall thickness of the proximal portion 130a and / or the distal portion 130b, etc.

[0062] While a 1:1 torque response ratio is desirable as described above, it should be understood that even a lower torque response can be significantly better than the torque response offered by current equipment. For example, Figure 13 The figure illustrates the torque response of different catheters, with those catheters having similar characteristics to... Figure 12 The bend shown in the image. Figure 13 The diagram illustrates a dashed line representing a perfectly consistent 1:1 torque response ratio. For example, the four lines at the bottom illustrate when having a similar... Figure 12 The torque response ratio of the existing device shown in the diagram illustrates a relatively consistent but poor torque response ratio, where an input angle of 60 degrees achieves only about 5-10 degrees of output angle, and an input angle of 120 degrees achieves only about 15 degrees of output angle. Other lines (besides the 1:1 response line) show three tests of a first example of a delivery conduit 130 formed according to this disclosure (where 63DPebax is used as the refluxing polymer on the proximal portion 130a), and three tests of a second example of a delivery conduit 130 formed according to this disclosure (where nylon 11 is used as the refluxing polymer on the proximal portion 130a). Figure 13Both Examples 1 and 2 shown in the diagrams can include a distal portion 130b formed by a Pebax 45D. As can be seen from the diagrams, the catheter examples formed based on the disclosure provided herein exhibit significantly better torque response when bending around the aortic arch AA compared to existing known devices. For example, at an input angle of approximately 30 degrees, Examples 1 and 2 have a torque response greater than approximately 40%. At an input angle of approximately 60 degrees, Examples 1 and 2 have a torque response greater than approximately 60%. At an input torque of approximately 90 degrees, Examples 1 and 2 have a torque response greater than approximately 80%. At input torques of approximately 120 degrees, approximately 150 degrees, and approximately 180 degrees, Examples 1 and 2 may have torque ratios between approximately 90% and approximately 120%. Therefore, while a 1:1 torque ratio may be preferred, a torque response between approximately 50% and 100%, approximately 60% and 100%, approximately 70% and 100%, approximately 80% and 100%, or approximately 90% and 100% may still be a significant achievement, especially (but not necessarily exclusively) at input angles of 60 degrees and above, including approximately 90 degrees, approximately 120 degrees, approximately 150 degrees, and approximately 180 degrees.

[0063] To explain the torque response in different terms, although a 1:1 torque response when the delivery catheter 130 bends around the aortic arch AA might be desirable, achieving it may be unrealistic, at least because of some inefficiencies associated with friction and the bending or curvature around the aortic arch AA. Therefore, although according to this disclosure... Figure 13 The two examples did not provide the expected perfect torque response, and while there was a slight hysteresis, the torque response was highly linear, especially between input angles of approximately 60 degrees and approximately 180 degrees. This linear response means that the rotation of the artificial heart valve is highly predictable for the user as the delivery catheter bends around the aortic arch, even if it is not a perfect 1:1 response.

[0064] Figure 14 It better illustrates the comparison with existing equipment. Figure 13The range of linear torque response of the catheter in Example 1. As can be seen from existing devices, the torque response is extremely nonlinear, especially when the user increases the input angle from approximately 210 degrees to approximately 330 degrees. While 210 to 330 degrees represents a total input of approximately 120 degrees of rotation, the output increases over a range of approximately 30 degrees to approximately 270 degrees or greater. In other words, existing devices are highly unpredictable in terms of how the input rotation translates into output rotation as the input rotation increases. On the other hand, the device of Example 1 constructed according to this disclosure has an extremely linear (and therefore predictable) response over a very large range of input angles. Therefore, even in the absence of a perfect 1:1 torque ratio, the example constructed according to this disclosure offers significant benefits in terms of both the overall torque ratio (closer to 1:1) and the linearity and predictability of the torque response over a wide range of input angles, while the delivery catheter 130 is shaped around the aortic arch AA.

[0065] While the invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely exemplary illustrations of the principles and applications of the invention. Therefore, it should be understood that many modifications can be made to the exemplary embodiments, and other arrangements can be designed, without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A delivery system for transporting medical equipment, the delivery system comprising: handle; A delivery conduit that extends distally from the handle; A balloon, which is attached to the distal portion of the delivery catheter; as well as An actuator located on the handle, the actuator being operatively coupled to the delivery conduit, such that actuation of the actuator applies torque on the proximal portion of the delivery conduit; The delivery conduit has a proximal portion formed of a first material and a distal portion formed of a second material, the first material being more rigid than the second material and the proximal portion being more rigid than the distal portion.

2. The conveying system according to claim 1, wherein the first material is formed of a material having a Shore D hardness of about 63D or greater.

3. The conveying system according to claim 2, wherein the second material has a Shore D hardness between about 35D and about 55D.

4. The delivery system of claim 1, wherein the delivery conduit has a total length extending from the distal end of the handle, and the proximal portion extends between about 70% and about 90% of the total length.

5. The delivery system of claim 1, wherein the delivery conduit includes an intermediate transition section located between the proximal portion and the distal portion.

6. The conveying system of claim 5, wherein the transition section is formed by: (i) a first material whose amount decreases in the direction from the proximal side to the distal side, and (ii) a second material whose amount increases in the direction from the proximal side to the distal side.

7. The conveying system of claim 5, wherein the transition section is formed of a third material, the third material being more rigid than the second material, and the first material being more rigid than the second material.

8. The delivery system of claim 1, wherein when the proximal portion is substantially straight and the distal portion has a bend of approximately 180 degrees, actuation of the actuator applies the torque to the proximal portion of the delivery conduit to cause a first amount of angular rotation (Θ) at the proximal portion of the delivery conduit. i This results in a second amount of angular rotation (Θ) at the distal portion of the delivery conduit. o When the angle rotation (Θi) of the first quantity is between approximately 120 degrees and approximately 180 degrees, the torque response ratio (Θi) o :Θ i The value is at least approximately 0.

9.

9. The conveying system according to claim 8, wherein when the first amount of angular rotation (Θ) i The torque response ratio is substantially linear between approximately 120 degrees and approximately 180 degrees.

10. The conveying system according to claim 8, wherein when the first amount of angular rotation (Θ) i The torque response ratio is substantially linear between approximately 120 degrees and approximately 360 degrees.

11. A method for implanting an artificial heart valve, the method comprising: The delivery catheter is advanced through the patient's vascular system while the artificial heart valve is coiled on the balloon of the delivery catheter, the balloon being located at the distal portion of the delivery catheter, the delivery catheter having a proximal portion operatively connected to a handle; The artificial heart valve is positioned within the patient's natural aortic valve annulus, while the artificial heart valve is rolled up on the balloon such that when the artificial heart valve is positioned within the natural aortic valve annulus, the distal portion of the delivery catheter bends around the patient's aortic arch between the patient's descending aorta and the patient's ascending aorta. When the artificial heart valve is positioned within the natural aortic valve annulus, the actuator on the handle is actuated to cause a first amount of angular rotation (Θ) at the proximal portion of the delivery catheter. i This results in a second amount of angular rotation (Θ) at the distal portion of the delivery conduit. o ), such that: when the angle of the first quantity rotates (Θ) i The torque response ratio (Θ) is between approximately 120 degrees and approximately 180 degrees. o :Θ i The value is at least approximately 0.

9.

12. The method of claim 11, wherein the torque response ratio is substantially linear when the angular rotation (Θi) of the first amount is between about 120 degrees and about 180 degrees.

13. The method of claim 11, wherein the torque response ratio is substantially linear when the angular rotation (Θi) of the first amount is between about 120 degrees and about 360 degrees.

14. The method of claim 11, wherein when the artificial heart valve is positioned within the natural aortic valve annulus, the delivery catheter has a proximal portion that does not bend around the aortic arch, the proximal portion being formed of a first material and the distal portion being formed of a second material, the first material being more rigid than the second material, and the proximal portion being more rigid than the distal portion.

15. The method of claim 14, wherein the first material has a Shore D hardness of about 63D or greater.

16. The method of claim 15, wherein the second material has a Shore D hardness between about 35D and about 55D.

17. The method of claim 14, wherein the delivery conduit has a total length extending from the distal end of the handle, and the proximal portion extends between about 70% and about 90% of the total length.

18. The method of claim 14, wherein the delivery conduit includes an intermediate transition section located between the proximal portion and the distal portion.

19. The method of claim 18, wherein the transition section is formed by: (i) a first material whose amount decreases in the direction from the proximal side to the distal side, and (ii) a second material whose amount increases in the direction from the proximal side to the distal side.

20. The method of claim 18, wherein the transition section is formed of a third material that is more rigid than the second material, and the first material is more rigid than the second material.

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