Multi-balloon inflation with separate pressure sensor

Abstract

A prosthetic heart valve delivery system may include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal portion of the outer catheter. A prosthetic heart valve may be configured to be received on a balloon, and a balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon portion and a distal balloon portion positioned distal to the proximal balloon portion. The interior volume of the proximal balloon portion may be fluidly isolated from the interior volume of the distal balloon portion such that the proximal balloon portion and the distal balloon portion may be inflated independently of each other.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 591,816, filed October 20, 2023, the contents of which are incorporated herein by reference. Background Technology

[0002] Valvular heart disease (particularly aortic and mitral valve disease) is a significant health problem 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, or total 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 construction, 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, an artificial heart valve delivery system includes a handle, an external catheter extending distally from the handle, a balloon attached to a distal portion of the external catheter, an artificial heart valve configured to be received on the balloon, and a balloon inflation system configured to inflate and deflate the balloon. The balloon may include a proximal balloon portion and a distal balloon portion positioned distal to the proximal balloon portion. The internal volume of the proximal balloon portion may be fluidly isolated from the internal volume of the distal balloon portion, such that the proximal and distal balloon portions can be inflated independently of each other. The balloon may include a central balloon portion positioned between the proximal and distal balloon portions. The internal volume of the central balloon portion may be fluidly isolated from the internal volumes of the proximal and distal balloon portions, such that the proximal, central, and distal balloon portions can be inflated independently of each other. A first sensor is operatively coupled to the proximal balloon portion, and a second sensor is operatively coupled to the distal balloon portion. The first sensor is configured to transmit data indicating the expansion state of the proximal balloon portion to the balloon inflation system, and the second sensor is configured to transmit data indicating the expansion state of the distal balloon portion to the balloon inflation system. The first sensor may be a first pressure sensor positioned in fluid communication with the internal volume of the proximal balloon portion, and the second sensor may be a second pressure sensor positioned in fluid communication with the internal volume of the distal balloon portion.

[0006] A first inflation lumen extends from the balloon inflation system to the proximal balloon portion, and a second inflation lumen extends from the balloon inflation system to the distal balloon portion. The balloon inflation system can be configured to allow the inflation medium to reach the proximal balloon portion through the first inflation lumen and to reach the distal balloon portion through the second inflation lumen, independently of allowing the inflation medium to reach the proximal balloon portion through the first inflation lumen. The second inflation lumen can be radially positioned inside the first inflation lumen. The first inflation lumen can be spaced apart from the second inflation lumen, and the first and second inflation lumen can extend parallel to each other. The proximal balloon portion can be annular when inflated, and the distal balloon portion can be annular when expanded. The proximal balloon portion can have a first shape when inflated, and the distal balloon portion can have a second shape when inflated, and the first and second shapes can be identical.

[0007] The distal balloon portion can be formed by multiple distal radial balloon portions. These distal radial balloon portions can be spaced apart from each other in a circumferential direction constraining a longitudinal axis passing through the center of the external catheter. The distal radial balloon portions can be fluidly isolated from each other, allowing each of the distal radial balloon portions to inflate independently. When each of the distal radial balloon portions is inflated, the distal balloon portion can have a circular outer circumference. The proximal balloon portion can be formed by multiple proximal radial balloon portions. The balloon may include a central balloon portion positioned between the proximal and distal balloon portions. The internal volume of the central balloon portion can be fluidly isolated from the internal volumes of the proximal and distal balloon portions, allowing the proximal, central, and distal balloon portions to inflate independently of each other; the central balloon portion is formed by multiple central radial balloon portions.

[0008] 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 including a proximal balloon portion and a distal balloon portion positioned distal to the proximal balloon portion. The artificial heart valve may be positioned within the patient's natural valvular annulus while coiled on the balloon. Inflation media may be independently advanced into the proximal and distal balloon portions such that the proximal balloon portion expands independently of the distal balloon portion. When the proximal and distal balloon portions are inflated, the inflation status of the proximal balloon portion can be determined, and the inflation status of the distal balloon portion can be determined. The inflation status of the proximal balloon portion can be compared with the inflation status of the distal balloon portion to determine whether there is uneven balloon inflation. When uneven balloon inflation is detected, the inflation rate of one or both of the proximal and distal balloon portions can be adjusted to compensate for the uneven inflation. A first pressure sensor can be positioned in fluid communication with the internal volume of the proximal balloon portion, and a second pressure sensor can be positioned in fluid communication with the internal volume of the distal balloon portion. The first pressure sensor can transmit pressure information from the proximal balloon portion to a motorized balloon inflation system operatively coupled to the balloon, and the second pressure sensor can transmit pressure information from the distal balloon portion to the motorized balloon inflation system. The inflation status of the proximal balloon portion can be determined based on the pressure information transmitted from the first pressure sensor, and the inflation status of the distal balloon portion can be determined based on the pressure information transmitted from the second pressure sensor. The processor, operably coupled to the motorized balloon inflation system, can determine the existence of uneven balloon inflation, and when uneven balloon inflation is determined, the processor can cause the motorized balloon inflation system to adjust the inflation rate of one or both of the proximal balloon portion or the distal balloon portion. 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 8 Side 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 Is with Figure 4 The shown delivery system is a side view of an example of a multi-balloon configuration used in conjunction with similar delivery systems.

[0021] Figure 13 It is in the middle of expansion. Figure 12 A schematic side view of the multi-balloon configuration.

[0022] Figure 14 Is with Figure 13 Compared to the example shown, Figure 12 A schematic side view of the multi-balloon configuration during the subsequent expansion phase.

[0023] Figure 15 It shows Figure 12 The cross-section of the balloon illustrates an example of an isolated inflatable lumen.

[0024] Figure 16 This is a schematic diagram of an alternative configuration for a multipart balloon.

[0025] Figure 17 yes Figure 16 A cross-section of the view, showing the relationship with Figure 15Compared to the nested inflation lumen, the isolated inflation lumen extends in a parallel manner.

[0026] Figure 18 This is a schematic diagram of another alternative construction for a multipart balloon.

[0027] Figure 19 It is along Figure 18 The cross section is taken from section line 19-19. Detailed Implementation

[0028] 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.

[0029] 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 1The 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.

[0030] 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 2 A 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 balloon expansion within the frame, and the frame will substantially retain its modified shape when at rest.

[0031] 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.

[0032] In the illustrated embodiment, it is assumed that frame 20 is intended for use with a three-leaflet valve, and therefore Figure 2 The 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.

[0033] 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.

[0034] -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.

[0035] 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, with the artificial blade 90 directly attached to this 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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 (or at a distance spaced therefrom) the attachment edge 94. 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 CAF 40.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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, which covers the distal end of an inner catheter 134 and receives an 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 contacting 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.

[0049] 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.

[0050] 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.

[0051] 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 housing one or more components, such as a motor, one or more batteries, electronics for control and / or communication with other components, etc. The housing 172 may include one or more mounting brackets to receive a syringe 174. In the illustrated embodiment, the distal bracket 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 bracket 176. A proximal bracket 178 may also be provided, which may have a "C" or "U" shaped bottom hinged to the "C" or "U" shaped top. This configuration allows the proximal end of the outer body of the syringe 174 to engage in the bottom of the proximal bracket 178, and the top of the proximal bracket 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 housing 172 to help secure syringe 174 to housing 172 in any suitable manner.

[0052] 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.

[0053] 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 flow from syringe 174 to 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).

[0054] 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.

[0055] 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.

[0056] 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.

[0057] When considering the design of balloon 136, there are various possible outputs and various inputs that may be incorporated into the design to achieve those outputs. However, certain inputs used to achieve one desired output may hinder the achievement of another desired output. For example, balloon 136 is generally expected to have a relatively high burst pressure to minimize or eliminate the possibility of balloon 136 rupturing during implantation. One way to increase the burst pressure is to form balloon 136 from a material with relatively low compliance. However, if balloon 136 is formed from a material with relatively low compliance, it may not be suitable for valves of various sizes, and balloons unsuitable for valves of various sizes are desirable in order to limit the number of delivery system options required to achieve the various sizes of valves offered by the implantation. Another output that can be considered is reducing the possibility of embolism of the artificial heart valve 10 during delivery and / or deployment. In this context, embolism of the artificial heart valve 10 refers to the unintentional displacement or disconnection of the artificial heart valve 10 from balloon 136 at any point before successful deployment within the natural aortic valve annulus. The likelihood of valvular embolism can be reduced by increasing the working length of balloon 136. However, as the working length of balloon 136 increases, the maneuverability of the delivery device becomes more difficult (especially at the distal end), and balloon 136 requires a larger volume to fill, which is generally not expected under all other conditions being equal. Furthermore, a longer balloon 136 may pose a risk of interfering with the anatomy of the sinus duct junction. A particular challenge when delivering and deploying the artificial heart valve 10, as well as other artificial valves with similar frame architectures, is the asymmetric force required to expand the artificial heart valve 10. As mentioned above, the outflow segment 24 of frame 20 (located proximally to balloon 136 during transfemoral delivery) requires less force to expand compared to the inflow segment 22 of frame 20 (located distal to balloon 136 during transfemoral delivery). As a result, if the balloon 136 is uniformly inflated and outward pressure is applied uniformly to the artificial heart valve 10, the expansion of the artificial heart valve 10 may occur unevenly (e.g., during deployment, the outflow end of the artificial heart valve 10 expands to a greater extent than the inflow end). Therefore, it is desirable to help prevent valvular embolism without excessively increasing the working length of the balloon 136. It is also desirable to increase the likelihood of uniform expansion of the artificial heart valve 10 (especially in the axial direction, but also radial expansion). Uniform expansion can also contribute to the accuracy of deployment depth. For example, if the balloon expands unevenly in the axial direction, there is a risk that the artificial heart valve may slip on the balloon during inflation, which could lead to poor or inaccurate placement relative to the natural valve ring in the depth direction.

[0058] Various balloon features and embodiments are described below. It should be understood that any of these features or embodiments can be used instead of balloon 136 having delivery system 100 or other balloon catheter delivery systems. Therefore, the following description focuses on balloon features, but it should be understood that other components related to the use of the balloon are not described in more detail below, and it should be understood that the features described in connection with delivery system 100 (other than specific balloon designs) can be used in conjunction with the balloon embodiments described below.

[0059] Figure 12 An example of balloon 336 is illustrated; balloon 336 can be used in place of balloon 136. (As shown) Figure 12 As shown, balloon 336 may have a proximal end coupled to external catheter 132 (in a manner similar to or the same as the connection between balloon 136 and external catheter 132) and a distal end coupled to anterior cone 138 and / or internal catheter 134 (in a manner similar to or the same as the connection between balloon 136 and anterior cone 138 and / or internal catheter 134). A key difference between balloon 336 and balloon 136 is that balloon 336 is disposed in multiple fluid-isolated portions. In the illustrated example, balloon 336 comprises three portions: a proximal portion 336a, a central portion 336b, and a distal portion 336c. However, it should be understood that in alternative examples, two portions may be provided, or more than three portions may be provided. It should be understood that although balloon 136 is described as having multiple portions, the multiple portions of balloon 136 are fluidly connected to each other, which differs from individual portions of balloon 336 being fluidly isolated from each other.

[0060] Each portion of balloon 336 includes an inflation lumen extending between the interior of the balloon portion and a handle (or another accessible component outside the patient's body), allowing the inflation medium to selectively enter any desired portion without requiring the inflation medium to enter any other portion. An example of the configuration of the inflation lumen is described in more detail below. In addition to being fluidly isolated from each other, each portion of balloon 336 includes a sensor (e.g., a pressure sensor) that provides an indication of the degree and / or size of inflation of the balloon portion. If the sensor is a pressure sensor, it can be placed anywhere along the fluid path of the corresponding balloon portion. For example, the pressure sensor can be located within the balloon portion itself or somewhere in the inflation lumen near the balloon portion. Each sensor can provide information to the user in any desired manner, including providing information via wired or wireless means to a computer or other system operatively connected to the sensor. Preferably, the sensor is wired to the balloon inflation system 170, which itself may be wired to an internal processor and / or an external processor capable of taking specific actions in response to data from the sensor, as described in more detail below.

[0061] General Reference Figure 12 , Figure 13 and Figure 14 The above-described configuration of balloon 336 allows each balloon segment 336a, 336b, 336c to inflate at an independent inflation rate, and the inflation rate can be determined by a feedback loop in which data (e.g., pressure data) from each balloon segment is fed back to the user and / or balloon inflation system 170 in real time, wherein balloon inflation system 170 automatically adjusts the inflation rate of the individual segments so that these segments expand uniformly. Although an automatic feedback system is preferred, it should be understood that any amount of user input can be allowed to make the process more manual. For example, data (e.g., pressure data) related to the expansion of each individual balloon segment 336a, 336b, 336c can be displayed on a display device operatively coupled to balloon inflation system 170, and based on the displayed data, the user can manually adjust the inflation rate of the individual balloon segments to achieve uniform valve expansion.

[0062] Combination Figure 13 and Figure 14 An example illustrating and describing the usefulness of this feature is given. Figure 13An artificial heart valve 10 is shown in a partially deployed state as balloon 336 begins to inflate. In the illustrated example, as balloon 336 inflates, the distal portion of the artificial heart valve 10 expands faster than the proximal portion, resulting in uneven radial expansion. As the balloon partially inflates, data (e.g., pressure data) is fed back to the balloon inflation system 170 in real time, and this data is processed to determine if there is a difference or unevenness in the expansion of the balloon portions. In one example, in Figure 13 In the illustrated state, the proximal balloon portion 336a can have a lower pressure than the distal balloon portion 336c. Based on this information, the balloon inflation system 170 can increase the inflation rate of the proximal balloon portion 336a relative to the distal balloon portion 336c (e.g., by increasing the flow rate of the inflation medium). Utilizing this corrective action, such as... Figure 14 As shown, the proximal balloon portion 336a expands to a greater extent than the distal balloon portion 336c, which compensates for the earlier inflation difference, resulting in a more even or uniform expansion of the balloon 336 portions, and consequently, a more even or uniform expansion of the artificial heart valve 10 coiled on the balloon 336. Although the inflation rate compensation (which can also be considered as compensation for the balloon portion diameter) is described above as a single corrective action, it should be understood that compensation may occur frequently (e.g., every second or every fraction of a second) throughout the balloon inflation process as data is fed back to the balloon inflation system 170 for processing and corrective action. It should be understood that, although Figure 13 The illustration shows that the distal portion of the artificial heart valve 10 expands faster than the proximal portion, but in other embodiments the opposite may be true, and corrective inflation can be performed similarly to result in... Figure 14 The diagram shows corrected uniform expansion. It should be noted that the relationship between balloon pressure and balloon diameter typically includes a "filling" phase and a "stretching" phase, both of which are predictable for a given balloon 336. The stretching phase may include a relatively linear relationship between pressure and diameter. If the balloon deviates from the expected pressure-diameter curve, this may indicate that its diameter is too large or too small, and the pressure can be adjusted to achieve more uniform expansion.

[0063] Figure 15This is a cross-section of balloon 336 to illustrate an example of how the various parts of balloon 336 can be isolated from each other. This example shows that inflation lumens 337a, 337b, 337c (which correspond to balloon portions 336a, 336b, 336c, respectively) can be “telescopic” or nested. In other words, the inflation lumen 337c leading to balloon portion 336c can be radially positioned inside the inflation lumen 337b leading to balloon portion 336b, and balloon portion 336b can in turn be radially positioned inside the inflation lumen 337a leading to balloon portion 336a. In one example, each inflation lumen 337a, 337b, 337c can return to a corresponding inflation medium source. For example, although balloon inflation system 170 is shown and described as having a single syringe 174, it can alternatively have multiple syringes corresponding to the number of inflation lumens. In other examples, the balloon inflation system 170 may still consist of only a single syringe, but may provide valves that can selectively open or close to open or close each individual inflation lumen 337a, 337b, 337c. If a separate syringe 174 is provided for each inflation lumen 337a, 337b, 337c, the balloon inflation system 170 may simply adjust the inflation rate of each balloon section 336a, 336b, 336c by adjusting the rate at which the piston of each individual syringe is advanced, based on inflation data (e.g., pressure data) received from sensors within the balloon section. If a single syringe 174 is provided in total, the valves provided for each inflation lumen 337a, 337b, 337c can be opened or closed (by the user) or (by the balloon inflation system 170) automatically (in a binary or continuously adjustable manner) to adjust the proportion of inflation medium delivered from the single syringe 174 to the individual balloon portions 336a, 336b, 336c via the respective inflation lumen 337a, 337b, 337c.

[0064] Figure 16 The configuration of a multi-part balloon 436 is shown. Balloon 436 is functionally similar to balloon 336, but has a slightly different construction. For example... Figure 16As shown, balloon 436 may overly cover the external conduit 132 proximal to the anterior cone 138. Like balloon 336, balloon 436 includes multiple balloon portions 436a, 436b, 436c that are fluidly isolated from each other. Similar to balloon 336, although balloon 436 is shown as having three separate portions, in other embodiments it may include two or more portions. Like balloon portions 336a, 336b, 336c, balloon portions 436a, 436b, 436c may be structurally similar or identical to each other. For example, in the illustrated example, each balloon portion 436a, 436b, 436c is typically toroidal or donut-shaped when inflated. Although balloon portions 436a, 436b, and 436c can be provided as separate structures, in some embodiments they can be joined together (e.g., via adhesive), wherein the proximal end of the central portion 436b is joined to the distal end of the proximal portion 436a, and the distal end of the central portion 436b is joined to the proximal end of the distal portion 436c. However, in other embodiments, any portion may not be directly joined to any other portion. If portions 436a, 436b, and 436c have the illustrated torus shape, the external catheter 132 can extend through the center of each balloon portion to the anterior cone 138, wherein the inner surface of the balloon portion is secured (e.g., via adhesive) to the outer surface of the underlying external catheter 132.

[0065] refer to Figure 17 It shows Figure 16 In the cross-section of the embodiment, each balloon portion 436a, 436b, 436c may include a corresponding dedicated inflation lumen 437a, 437b, 437c. Functionally, these dedicated lumens can be combined with... Figure 15 The dedicated lumen shown and described is the same. However, although Figure 15 The multi-lumen configuration is either nested or telescopic, but Figure 17 The multi-lumen configuration provides separate inflatable lumens 437a, 437b, 437c that are parallel to each other and do not travel inside each other. For example, the wall of the external catheter 132 may include multiple inflatable lumens at different points along its circumference, and each inflatable lumen may have an outlet leading to the internal volume of the corresponding balloon portion.

[0066] Despite the combination Figures 16 to 17 The embodiments shown and described are structurally different from those in combination. Figures 12 to 15The embodiments shown and described are similar or identical in function and will not be described further herein. It will only be noted that each balloon segment may include associated sensors (e.g., pressure sensors) located within the balloon segment or otherwise along the inflation lumen associated with the balloon segment. As with the previous embodiments, inflation of balloon segments 436a, 436b, 436c can be monitored individually, and the balloon inflation system 170 may preferentially inflate any balloon segment or any group of balloon segments at different rates to compensate for uneven inflation that may occur, for example, due to external factors (one example of which is the varying rigidity of the artificial heart valve 10).

[0067] Combination Figures 12 to 17 The described balloon inflation control feedback loop may be beneficial for several reasons. It could be useful if the balloon is unevenly inflated while an artificial heart valve is deploying (similar to...). Figure 13 As shown in the configuration, continued uneven inflation can cause the artificial heart valve to slip completely off the balloon. For example, if balloon forces from the balloon are applied to the interior of the artificial heart valve 10 while it is being unevenly inflated, the forces from the balloon can cause the artificial heart valve to slide along the balloon, especially considering the anatomical environment and the smoothness of the balloon surface. Furthermore, correcting uneven expansion provides a more stable force distribution curve for expansion, reducing the likelihood of the artificial heart valve slipping off the balloon (also known as embolism), which can have catastrophic consequences. However, in addition to preventing embolism, the inflation feedback and control described herein can contribute to uniform expansion in the presence of irregular anatomical structures. For example, if the patient has an elliptical (or other non-circular) aortic valve annulus, or if the patient has localized calcium deposits forming an irregular annular shape, inflation feedback control can also help achieve uniform expansion of the artificial heart valve 10 despite the anatomical irregularities.

[0068] Figure 18 The configuration of a multi-part balloon 536 is shown, which is functionally similar to balloon 336 but has a slightly different construction. For example... Figure 18 As shown, balloon 536 may have a proximal end coupled to external catheter 132 and a distal end coupled to anterior cone 138. Like balloon 336, balloon 536 includes a plurality of balloon portions 536a, 536b, 536c that are fluidly isolated from each other. Although balloon 536 is shown as having three separate portions, like balloon 336, in other embodiments, balloon 536 may include two or more portions. Like balloon portions 336a, 336b, 336c, balloon portions 536a, 536b, 536c may be structurally similar or identical to each other.

[0069] The main difference between balloon 536 and balloon 336 is that each individual balloon segment 536a, 536b, 536c can be further radially subdivided. For example, Figure 19 The diagram illustrates the following: along Figure 18 The cross-section of the distal balloon portion 536c is taken by section line 19-19. The distal balloon portion 536c may be divided into a plurality of radial portions that are fluidly isolated from each other. For example, in the illustrated example, the distal balloon portion 536c is divided or segmented into six separate radial balloon portions 536c1 to 536c6. Although six radial balloon portions are shown, it should be understood that two to five or more radial portions may be provided for each balloon portion 536a, 536b, 536c. Preferably, each radial portion 536c1 to 536c6 is structurally substantially similar to or identical to each of the other radial portions, and when all radial portions are inflated, they preferably exhibit a substantially smooth and circular outer circumference.

[0070] Still referencing Figure 19 Each individual radial portion can be fluidly isolated from each other radial portion (e.g., via a separate inflation lumen). Further, each individual radial portion may include a sensor (e.g., a pressure sensor) located within the portion or otherwise along the inflation path leading to it. Thus, portions of balloons 336 and 436 can be individually inflated based on feedback (e.g., pressure feedback) transmitted to the balloon inflation system 170 to ensure uniform expansion at different axial positions of the artificial heart valve 10, while balloon 536 includes the same function, further adding the ability to control equal radial expansion. In other words, if any one or more of the radial portions 536c1 to 536c6 are under-inflated compared to the other radial portions, data transmitted to the balloon inflation system 170 (e.g., pressure data) can be processed, causing additional inflation medium to be sent to the under-inflated radial portions 536c1 to 536c6 to achieve uniform radial expansion. Although Figure 19 The inflation lumen of each radial portion is not illustrated, but the inflation lumen may be similar to the telescopic inflation lumen of balloon 336 or the parallel inflation lumen of balloon 436.

[0071] 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. An artificial heart valve delivery system, comprising: handle; An external catheter extending distally from the handle; A balloon, which is installed on the distal portion of the external catheter; An artificial heart valve, the artificial heart valve being configured to be received on the balloon; A balloon inflation system configured to inflate and deflate the balloon; as well as The balloon includes a proximal balloon portion and a distal balloon portion, the distal balloon portion being positioned distal to the proximal balloon portion, and the internal volume of the proximal balloon portion being fluidly isolated from the internal volume of the distal balloon portion, such that the proximal balloon portion and the distal balloon portion can be inflated independently of each other.

2. The artificial heart valve delivery system of claim 1, wherein the balloon includes a central balloon portion positioned between the proximal balloon portion and the distal balloon portion, the internal volume of the central balloon portion being fluidly isolated from the internal volumes of the proximal balloon portion and the distal balloon portion, such that the proximal balloon portion, the central balloon portion, and the distal balloon portion can be inflated independently of each other.

3. The artificial heart valve delivery system of claim 1, further comprising a first sensor and a second sensor, the first sensor being operatively coupled to the proximal balloon portion and the second sensor being operatively coupled to the distal balloon portion, the first sensor being configured to transmit data indicating the expansion state of the proximal balloon portion to the balloon inflation system, and the second sensor being configured to transmit data indicating the expansion state of the distal balloon portion to the balloon inflation system.

4. The artificial heart valve delivery system of claim 3, wherein the first sensor is a first pressure sensor positioned in fluid communication with the internal volume of the proximal balloon portion, and the second sensor is a second pressure sensor positioned in fluid communication with the internal volume of the distal balloon portion.

5. The artificial heart valve delivery system of claim 1, further comprising a first inflation lumen and a second inflation lumen, the first inflation lumen extending from the balloon inflation system to the proximal balloon portion, the second inflation lumen extending from the balloon inflation system to the distal balloon portion, the balloon inflation system being configured to allow an inflation medium to reach the proximal balloon portion through the first inflation lumen, and to allow an inflation medium to reach the distal balloon portion through the second inflation lumen independently of allowing an inflation medium to reach the proximal balloon portion through the first inflation lumen.

6. The artificial heart valve delivery system according to claim 5, wherein the second inflation lumen is radially positioned inside the first inflation lumen.

7. The artificial heart valve delivery system according to claim 5, wherein the first inflation lumen is spaced apart from the second inflation lumen, and the first inflation lumen and the second inflation lumen extend parallel to each other.

8. The artificial heart valve delivery system of claim 7, wherein the proximal balloon portion is annular when inflated, and the distal balloon portion is annular when expanded.

9. The artificial heart valve delivery system of claim 1, wherein the proximal balloon portion has a first shape when inflated, and the distal balloon portion has a second shape when inflated, the first shape and the second shape being identical.

10. The artificial heart valve delivery system of claim 1, wherein the distal balloon portion is formed by a plurality of distal radial balloon portions.

11. The artificial heart valve delivery system of claim 10, wherein the plurality of distal radial balloon portions are spaced apart from each other in a circumferential direction, the circumferential direction constraining a longitudinal axis passing through the center of the external catheter.

12. The artificial heart valve delivery system of claim 11, wherein the plurality of distal radial balloon portions are fluidly isolated from each other, such that each of the plurality of distal radial balloon portions can be inflated independently.

13. The artificial heart valve delivery system of claim 12, wherein when each of the plurality of distal radial balloon portions is inflated, the distal balloon portion has a circular outer circumference.

14. The artificial heart valve delivery system of claim 10, wherein the proximal balloon portion is formed by a plurality of proximal radial balloon portions.

15. The artificial heart valve delivery system of claim 14, wherein the balloon includes a central balloon portion positioned between the proximal balloon portion and the distal balloon portion, the internal volume of the central balloon portion being fluidly isolated from the internal volumes of the proximal balloon portion and the distal balloon portion, such that the proximal balloon portion, the central balloon portion, and the distal balloon portion can be inflated independently of each other, the central balloon portion being formed by a plurality of central radial balloon portions.

16. 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 around the balloon of the delivery catheter, the balloon comprising a proximal balloon portion and a distal balloon portion, the distal balloon portion being positioned distal to the proximal balloon portion; The artificial heart valve is positioned within the patient's natural valvular annulus, while the artificial heart valve is rolled up on the balloon. The inflation medium is independently propelled into the proximal balloon portion and into the distal balloon portion, such that the proximal balloon portion expands independently of the distal balloon portion; While the proximal balloon portion and the distal balloon portion are being inflated, determine the inflation status of the proximal balloon portion and the inflation status of the distal balloon portion. The inflation state of the proximal balloon portion is compared with that of the distal balloon portion to determine whether there is uneven balloon inflation. as well as When uneven balloon inflation is detected, the inflation rate of one or both of the proximal balloon portion or the distal balloon portion is adjusted to compensate for the uneven balloon inflation.

17. The method of claim 16, wherein the first pressure sensor is positioned in fluid communication with the internal volume of the proximal balloon portion, and the second pressure sensor is positioned in fluid communication with the internal volume of the distal balloon portion.

18. The method of claim 17, wherein the first pressure sensor transmits pressure information of the proximal balloon portion to a motorized balloon inflation system operatively coupled to the balloon, and the second pressure sensor transmits pressure information of the distal balloon portion to the motorized balloon inflation system.

19. The method of claim 18, wherein the inflation state of the proximal balloon portion is determined based on pressure information transmitted from the first pressure sensor, and the inflation state of the distal balloon portion is determined based on pressure information transmitted from the second pressure sensor.

20. The method of claim 19, wherein a processor operatively coupled to the motorized balloon inflation system performs a determination that there is uneven balloon inflation, and upon determination that there is uneven balloon inflation, the processor causes the motorized balloon inflation system to adjust the inflation rate of one or both of the proximal balloon portion and the distal balloon portion.

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