Inflation of transcatheter aortic valve implantation with automatic adjustment for material and process variations

Abstract

In some embodiments, a method of delivering a medical device includes providing an artificial heart valve including a collapsible and expandable stent with struts, and a valve assembly coupled to the stent having a plurality of leaflets and a cuff; providing a delivery device including a catheter extending between proximal and distal ends, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal to the inflatable balloon; inflating the inflatable balloon in a first phase, measuring a first pressure using the at least one sensor, and calculating a fluid resistance factor during the first phase.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 615,316, filed December 28, 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 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 (“TAVR”), transcatheter aortic valve implantation (“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 in 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 valve annulus of the natural heart valve being replaced, 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 location relative to the natural valve annulus (e.g., via visualization under fluoroscopy), fluid (usually a liquid, but 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 inflating and expanding, thereby expanding the overlying artificial heart valve into the natural valve annulus.

[0005] Typically, a syringe is used to manually deploy a standard device to the nominal valve size, with little or no feedback from the system. Each nominal valve size is designed to cover a range of patient anatomy, and the amount of oversize or stretching of the natural tissue will vary depending on where the particular patient falls within that range. Further improvements to these methods are expected to yield better clinical outcomes. Summary of the Invention

[0006] In some embodiments, a method of delivering a medical device includes: providing an artificial heart valve including a collapsible and expandable stent with struts, and a valve assembly coupled to the stent having a plurality of leaflets and a cuff; providing a delivery device including a catheter extending between proximal and distal ends, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal to the inflatable balloon; inflating the inflatable balloon in a first phase, measuring a first pressure using the at least one sensor, and calculating a fluid resistance factor during the first phase.

[0007] In some embodiments, a method of delivering a medical device includes: providing an artificial heart valve including a collapsible and expandable stent with struts, and a valve assembly coupled to the stent having a plurality of leaflets and a cuff; providing a delivery device including a catheter extending between proximal and distal ends, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal to the inflatable balloon; inflating the inflatable balloon in a first phase; and analyzing the effect of a first parameter on the inflation of the inflatable balloon during the first phase. Attached Figure Description

[0008] Figure 1 This is a stereoscopic view of an example of an artificial heart valve.

[0009] Figure 2 yes Figure 1 A 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.

[0010] 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.

[0011] Figure 4 It is an example installed as part of the conveyor system. Figure 1 A top view of an artificial heart valve.

[0012] Figure 5 yes Figure 4 An enlarged view of the handle of the conveyor system shown.

[0013] Figure 6 yes Figure 4 An enlarged view of the far end of the conveyor system shown.

[0014] Figure 7 This is a top view of an example balloon catheter when the balloon is inflated.

[0015] Figure 8 It is used with Figure 4 The diagram shows a top view of an example of an inflatable system used in conjunction with a similar conveyor system.

[0016] Figure 9 yes Figure 8 Side view of the inflation system.

[0017] Figure 10 Is Figures 8 to 9 inflation system and Figure 4 A three-dimensional diagram of the connection between the handles of the conveying system.

[0018] 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.

[0019] Figure 12 This is a process diagram illustrating an inflation system according to some embodiments.

[0020] Figure 13 This is a top view of an example balloon catheter with sensors.

[0021] Figure 14 It is a curve of pressure versus volume.

[0022] Figure 15 This is a schematic diagram of the Hagen-Poiseuille variables in the pipeline.

[0023] Figure 16 This is a system boundary diagram illustrating an inflation system according to some embodiments. Detailed Implementation

[0024] 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. The desired position and orientation are used for ease of description of the valves disclosed herein. However, it should be noted that the use of the valve is not limited to the desired position and orientation, 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.

[0025] 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 an inflow end 12 and an outflow end 14. The artificial heart valve 10 may include a collapsible 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.

[0026] Figure 2 This is a front view of an example segment of the frame 20 of the artificial heart valve 10, as if it were cut longitudinally 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 (e.g., via a balloon within the frame), and the frame will substantially retain its modified shape when at rest.

[0027] 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.

[0028] 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 cells 30, 32 comprises twelve individual cells. However, it should be understood that each row may provide more or fewer than twelve cells. Further, the inflow section or annular section 22 may include more or fewer than two rows of cells. Further still, although cells 30, 32 are shown as hexagons, some or all of the cells in the inflow section 22 may have other shapes (e.g., rhombus, herringbone, or other suitable shapes). In the illustrated embodiment, each cell 30 in the first row is structurally similar to or identical to every other cell 30 in the first row, each cell 32 in the second row is structurally similar to or identical to every other cell 32 in the second row, and each cell 30 in the first row is structurally similar to or identical to every cell 32 in the second row (hole 26 is excluded). However, in other examples, the cells in each row are not identical to every other cell in the same row or in other rows.

[0029] The inflow vertex of each hexagonal unit 30 may include a hole 26 formed therein, which may receive 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.

[0030] 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. A 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. A 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.

[0031] CAF 40 can generally be used as an attachment site for joining blade joints (e.g., the location where two artificial blades are joined to each other) to frame 20. 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 the 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 the remainder 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.

[0032] In the above example, frame 20 includes two rows of hexagonal units 30, 32 and a single row of larger units 34. In an embodiment of a three-leaf artificial heart valve 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. The structures (e.g., struts) forming each row of individual units 30, 32 are also significantly more numerous than the structures forming the rows of larger units 34.

[0033] 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 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 CAF40s). Alternatively, after implantation, one or more coronary ostia can be positioned 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 stents) 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.

[0034] 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 contour of the units 30, 32 of the inlet section 22 of the frame 20. Preferably, the inner skirt 60 is sewn 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.

[0035] 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 the inlet edge of the outer skirt 80. 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.

[0036] 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, along the attachment edge 94 (or spaced apart therefrom) via a laser. 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.

[0037] 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, the delivery device housing or supporting the valve is inserted through the femoral artery and advanced against the flow of blood to 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.

[0038] 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.

[0039] 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.

[0040] A guidewire GW may be provided, which extends through the interior of all components of the delivery system 100, passing from the proximal end of the handle 110 through the atraumatic distal tip 138 of the delivery catheter 130. 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 patient's vascular system.

[0041] 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. A deflection indicator 118 may be included, indicating the degree of deflection of the distal end of delivery conduit 130. 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 used. Furthermore, in some examples (including...) Figures 6 to 7 (Those 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 in both conduits.

[0042] Still referencing Figures 4 to 5The delivery system 100 may include additional functionality to assist in positioning 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 may be rotatably coupled to an inner catheter 134 that supports the artificial heart valve 10 in a coiled state. With 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.

[0043] 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. Using this configuration, rotating the axial alignment knob 116 causes the tray to advance distally or retract proximally because the internal thread of the axial alignment knob 116 engages with the external thread of the tray, but the tray is prevented from rotating. As the tray 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 physically achieved by pushing 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 the axial alignment actuator 116 is included, it can be used to help ensure that, when the artificial heart valve 10 is deployed into the natural valve annulus, the inflow end of the artificial heart valve is axially aligned with the inflow aspect of the natural valve annulus (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 other than a knob, may be positioned in other suitable locations, and may be omitted entirely if desired.

[0044] 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 on the handle 110 at a distal end near the handle 110 and is provided in the form of a switch. The balloon actuator 120 can be actuated to cause the 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 covering the distal end of an inner catheter 134, and the balloon 136 receiving a coiled artificial heart valve 10 located thereon. 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 femoral artery 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), there is a relatively high probability that the inflow end of the artificial heart valve 10 (which is the anterior edge during femoral artery delivery) will contact the vessel wall (or a component of the delivery system), resulting in displacement of the artificial heart valve 10 relative to balloon 136. The distal occipital portion 136 may tend 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 coiled 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 Heart Valve Delivery and Trackability," the disclosure of which is incorporated herein by reference.

[0045] 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. For example, the balloon actuator 120 may be pressed forward or distally to allow fluid to travel through an inflation lumen located within the delivery catheter 130, thus 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 secured 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 secured 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 (which is operatively coupled to the delivery system 100).

[0046] 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 provided, for example, positioned at opposite ends of the mounting shaft 140. If the mounting shaft 140 is included, it can provide a position on which the artificial heart valve 10 can be coiled. If the proximal stop 142 and / or the distal stop 144 are provided, they can provide a physical barrier for 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 the proximal stop 142 and the distal stop 144 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.

[0047] 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 example of the illustrated 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, which may include a motor, one or more batteries, electronics for control and / or communication with other components, etc. The housing 172 may include one or more fixed hangers for receiving a 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 be snapped into or out of the distal hanger 176. A proximal hanger 178 may also be provided, which may have a “C” or “U” bottom hingedly connected to the “C” or “U” top. This configuration allows the proximal end of the outer body of the syringe 174 to be snapped into the bottom of the proximal hanger 178, and the top of the proximal hanger 178 can be closed and connected 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, which together with housing 172 help to secure syringe 174 to housing 172 in any suitable manner.

[0048] 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 U-shaped beam shape, 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 advances further into or retracts further 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 forward movement of the movable member 180 forces fluid from the syringe 174 toward the balloon 136, while the retraction of the movable member 180 causes fluid to be withdrawn 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.

[0049] 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, which leads 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).

[0050] Despite Figure 8 , Figure 9 and Figure 10While not individually numbered, housing 172 may include one or more cables extending from it, for example, to allow the transmission of power (e.g., from an AC source or another component connected to the cable) and / or the transmission of data, information, control commands, etc. For instance, one 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 connections. Additional and related features of balloon inflation system 170, related systems, and their use are described in U.S. Patent Application No. 18 / 311,458, the disclosure of which is incorporated herein by reference.

[0051] 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 substantially or completely deflated after the rolling process. It should be understood that the rolling 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 rolling 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 require access to 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 this 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 is positioned just close 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 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 120 can be actuated in step 218, for example by pressing backward, to deflate balloon 136, and 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 an example of a single 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.

[0052] 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 system, features and / or methods of the invention described below.

[0053] Figure 12The diagram illustrates a parameter diagram of the inflation system process 1200, which details the various possible inputs and outputs of the system. For a TAVI system that deploys a valve to a precise size, certain factors referred to as "noise factors" 1210 can be considered. Noise factors 1210 may include component-to-component noise factors 1211, variations over time 1212, usage factors 1213, environmental factors 1214, and process variations 1215. The relative impact of each of these factors can vary. In some examples, component-to-component noise factors 1211 may include, but are not limited to: stent radial force and associated stent wall thickness and / or strut thickness, balloon compliance and associated balloon wall thickness, balloon length and / or balloon elastic modulus, valve tissue compliance and associated dimensions, tissue thickness and / or tissue tension from manual components, balloon length and / or catheter length. Furthermore, manufacturers may choose to vary some factors of the device (e.g., balloon resin, tissue type, nominal stent thickness, nominal balloon length and / or nominal balloon thickness). Noise factor 1210 may also include variations over time 1212 (e.g., tissue compliance and balloon material modulus). Noise factor 1210 may also include usage factors 1213 (e.g., air purge from the balloon and / or inflation lumen). Noise factor 1210 may also include environmental factors 1214 (e.g., anatomical differences, differences in calcification, and / or body temperature). Noise factor 1210 may also include process variations 1215 (e.g., balloon compliance (pressure versus volume), stent polishing, and / or curling forces).

[0054] These noise factors 1210 can all be introduced as inputs to the inflation system 1240 along with the input signal 1220 and the user control factors 1230. In some examples, the input signal 1220 may include the target valve diameter, valve area, and / or oversize criteria. In some examples, the user control factors 1230 may include valve selection, start / stop point, and deployment rate. When the noise factors 1210, input signal 1220, and user control factors 1230 are provided to the system together, the ideal response 1250 includes precise control of the diameter of the implanted valve and / or prediction of the pressure of the valve annulus. Alternatively, error conditions 1260 may include valve annulus rupture due to oversize, perivalvular leakage due to undersize, and valve migration due to undersize and / or balloon rupture.

[0055] Figure 12The interaction of various inputs with precise valve deployment, control, and error states is illustrated. It should be understood that the inflation system process 1200 can take into account any or all possible sources of variation. In some examples, the algorithm of the electronically controlled inflation system is capable of calculating the adjusted inflation parameters by regulating the inflation volume, inflation pressure, and / or inflation speed in response to certain inputs. In this example, noise factors can be considered when adjusting inflation parameters (e.g., inflation volume, inflation pressure, and / or inflation speed). Therefore, sources of variation that can be measured or characterized in the manufacture of the device or component can be identified, collected, documented, recorded, and used as inputs within the inflation system process to adjust inflation parameters. In some examples, the system includes the ability to store manufacturing data, and a programmable electronic memory storage is included in the transport system. The memory storage may include a small memory chip mounted in the handle of the transport system and connected to the electronically controlled inflation system. When connected during system preparation, the inflation system can read the memory chip and adjust, change, or refine the inflation parameters based on stored manufacturing data (e.g., factors 1211 between parts).

[0056] In some examples, the inflation system can also monitor and / or display the pressure applied to the patient's natural valve annulus during valve deployment. To accurately predict valve annulus pressure, certain factors (e.g., balloon compliance, stent radial force, and others) can be considered. Sometimes, these parameters cannot be kept under control due to variations between components or manufacturing processes. Therefore, a system or algorithm can be provided that acquires this information (e.g., from the device's memory) and considers noise factors (e.g., material component-to-component factors and / or manufacturing variations) to better predict valve deployment size and valve annulus pressure.

[0057] To achieve better clinical outcomes, there is a desire to further improve methods of inflation and / or sizing. Specifically, this disclosure describes improvements to methods and systems for automating the inflation of balloon catheters used in transcatheter valve implantation, with the aim of providing adjustable and / or precise valve sizing tailored to the individual patient's anatomy. As previously mentioned, conventional devices provide a nominal valve size designed to cover a range of anatomy. Furthermore, conventional devices are manually deployed using syringes with little or no feedback from the system. In contrast, this adjustable system will allow for customized sizing for each patient, which can improve clinical outcomes associated with permanent pacemaker implantation (PPI), paravalvular leakage (PVL), and / or valvular annular rupture.

[0058] To provide accurate, customized valve size, a strong relationship between the fluid delivered to the balloon and the final valve size can be analyzed or determined. Furthermore, pressure feedback during TAVI deployment can be a useful feature for physicians, and having a consistent pressure threshold (or maximum target pressure) for identifying high-risk scenarios would be helpful. Variations in the delivery system (e.g., noise factors mentioned above due to materials or other reasons) can cause the displayed pressure to be higher or lower than the predicted pressure, potentially leading to undesirable user responses. Therefore, the proposed system can help to better predict the final valve size and the displayed pressure.

[0059] In some examples, the systems and methods disclosed herein can account for variations in noise factors (e.g., balloon material properties, molded balloon size and / or shape, catheter positioning within the anatomy, contrast agent to saline ratio and viscosity of the resulting mixture, as well as fluid lumen diameter, length, and / or compliance), which can contribute to the pressure-volume relationship. For instance, the systems and methods disclosed herein can account for variations in contrast agent / saline concentration. Currently, balloon dilation of TAVI valves uses contrast agents in the balloon to allow visualization of the fluid in fluoroscopy. Contrast agents can be manually mixed to specific concentrations of saline and contrast agent solutions. If clinicians mix too little or too much contrast agent into the mixture, it will affect not only the quality of the fluoroscopic images but also the force required to press the syringe, inflation time, and / or pressure measurements obtainable from the balloon catheter. Therefore, the ability to observe, measure, and account for the viscosity of the contrast agent / saline solution mixture can be useful. Furthermore, the disclosed systems and methods can inform the user whether the mixture is outside the limits of a specified concentration or to account for variations in viscosity in the pressure / volume relationship. In some embodiments, a method is disclosed that takes into account material and process variations, in which an algorithm performs pressure and volume measurements during a short initial period of balloon inflation and adjusts the displayed pressure-volume curve accordingly.

[0060] Figure 13 It shows something similar to Figure 7The balloon catheter 1300 includes an inflatable balloon 136. The balloon 136 is shown inflating; for clarity, the artificial heart valve 10 is omitted from the figure. In the example shown, the balloon 136 may be formed with a distal end secured 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 secured to the distal end of the external catheter 132. The inflation lumen may be located in 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 (operably coupled to the delivery system 100). A mounting shaft 140 is disposed on the internal catheter 134. The balloon catheter 1300 may include a proximal stop 142 and / or a distal stop 144 at opposite ends of the mounting shaft 140. In some examples, pressure measurements may be performed using one or more integrated sensors (e.g., pressure sensors) disposed in the balloon fluid lumen and / or the balloon itself, and such sensors may be used in conjunction with an electronically controlled inflation device. Figure 13 A first sensor 1350a is shown positioned within the inflation lumen (e.g., in the space between the outer catheter 132 and the inner catheter 134, or in the wall of the inner catheter 134, or in any other location where the internal fluid of the balloon 136 is fluidly connected to a fluid source outside the patient (operably coupled to the delivery system). The sensor may also be positioned within the handle. In some examples, only a single sensor is required to perform proper calibration, as will be described in more detail below. Pressure sensing and measurement can occur anywhere within the balloon or the fluid lumen. In some examples, pressure measurements can be performed before or during implantation of the artificial heart valve, and before the valve is deployed within the patient. Alternatively, pressure measurements can be performed by first inflating the balloon in an unconstrained state (e.g., in air or another medium without placing the valve on it), or by placing the valve on the balloon before surgery and allowing the valve to deploy in air or another medium, and then re-wrapping or re-rolling the valve after measurement.

[0061] In some examples, if measurements are taken during valve deployment, the process can be defined as a two-stage inflation, where the first stage occurs during the initial inflation of the balloon to obtain data; and the second stage is used for subsequent (partial or complete) inflation. Figure 14Characteristic pressure / volume curves 1400 from the deployed valve are shown. In this figure, the vertical axis represents pressure, while the horizontal axis represents volume. For each volume of the balloon, the curve shows the pressure measured proximally to the balloon (e.g., adjacent to the first sensor 1350a). In the first stage, the initial filling stage 1420 represents the first 10%, 15%, or 20% of the filling process. During the initial filling of the balloon 1420, the pressure in the balloon is zero or close to zero as the balloon rapidly expands. Furthermore, the pressure is higher proximally to the balloon (e.g., adjacent to the first sensor 1350a) because it fills this region first and forms the head pressure. Known hydrodynamic relationships can be used to measure fluid resistance caused by material or process variations. Specifically, the Hagen-Poiseuille equation can be used, which provides the principle that the pressure drop of an incompressible Newtonian fluid in laminar flow through a long cylindrical tube of constant cross-section follows: , in Δ p It is the pressure difference between the two ends; μ It is dynamic viscosity; L It is the length of the pipe; Q It is the volumetric flow rate; π has its known value; and and R Where is the pipe radius.

[0062] Figure 15 The diagram illustrates a simplified flow at a volumetric flow rate of Q in pipe 1500. It shows the pressure difference Δ between two points P1 and P2 spaced apart by a distance L in a pipe or conduit with radius R. p This equation can be used when the fluid flow is laminar, and it can be assumed to apply to catheters with a uniform cross-section and a large length-to-diameter ratio. In the current case, the pressure can be measured at a distance proximal to the balloon ( P sensor And the calculation is performed assuming the balloon pressure is zero, as shown below:

[0063] Additionally, the fluid resistance factor can be defined by combining viscosity, conduit length, and diameter as a single factor. As shown below:

[0064] Finally, using an electronically controlled inflation device, it is possible to inflate at a known flow rate ( QThe programming is performed. During the initial inflation of the balloon, the fluid drag factor is determined by rewriting the Hagen-Poiseuille equation as follows:

[0065] Using this equation, once the fluid drag factor is calculated... Therefore, it can be assumed to be a constant and used to calculate the remainder of the inflation (e.g., any portion of curve 1400 beyond the initial filling stage 1420). P Balloon In some examples, the relevant phase of inflation is when the valve contacts or begins to push against the aorta as it expands. This relevant phase can be approximately the last 40% of the inflation curve 1420, and the following equation can be applied at this phase or at any point after the initial balloon inflatation.

[0066]

[0067] Therefore, by taking viscosity, catheter length, and catheter diameter into account in the algorithm described above, doctors can access more accurate data (e.g., pressure at the balloon during inflation) despite inherent variations in materials and manufacturing processes. P Balloon This system and method can account for variations in the process (e.g., variations in the saline-contrast agent mixture) or noise factors. Furthermore, these systems and methods can be used to observe and set target or maximum balloon pressure to improve clinical outcomes.

[0068] Figure 16 The diagram illustrates a system boundary diagram of system 1600 for delivering an artificial heart valve 1602 via a delivery device having a deflection catheter 1610, a balloon catheter 1611, and a loader sheath 1612. In this example, a semi-automatic inflation device 1620 can actuate an syringe 1622 to inflate the balloon of the balloon catheter 1611 via fluid, and the balloon catheter 1611 may include one or more sensors 1660. As shown, a handle 1630 may include actuators (e.g., a deflection knob 1631, a coupling alignment knob 1632, and a fine-tuning knob 1633). The handle 1630 may also include a printed circuit board 1640 configured to receive power and / or communicate with the semi-automatic inflation device 1620. In some examples, a memory chip 1650 (e.g., an electrically erasable programmable read-only memory (EEPROM)) may be integrated into a component of system 1600 (e.g., the handle 1630 of the delivery device).

[0069] 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 method for delivering a medical device, the method comprising: An artificial heart valve is provided, the artificial heart valve comprising a collapsible and expandable stent with struts, and a valve assembly coupled to the stent, the valve assembly having multiple leaflets and a cuff; A delivery device is provided, the delivery device comprising a catheter extending between a proximal end and a distal end, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximally to the inflatable balloon. In the first stage, the inflatable balloon is inflated; The first pressure is measured using the at least one sensor; as well as The fluid resistance factor is calculated during the first stage.

2. The method of claim 1, wherein inflating the inflatable balloon in the first phase comprises: The inflatable balloon is inflated to approximately 15% of its total volume.

3. The method of claim 2, wherein measuring a first pressure with the at least one sensor comprises: The first pressure is measured during the first stage.

4. The method of claim 1, further comprising: In the second stage, the inflatable balloon is inflated.

5. The method of claim 4, wherein inflating the inflatable balloon in the second stage is performed after the first stage.

6. The method of claim 4, wherein inflating the inflatable balloon in the second phase comprises: The inflatable balloon is inflated at least until it comes into contact with the natural valve annulus.

7. The method of claim 6, further comprising the step of using the fluid resistance factor to calculate the balloon pressure during the second phase.

8. The method of claim 1, wherein inflating the inflatable balloon in the first phase comprises: The inflatable balloon is expanded in an unrestrained state before implantation.

9. The method of claim 8, further comprising the step of re-rolling the artificial heart valve after the first stage.

10. A method for delivering a medical device, the method comprising: An artificial heart valve is provided, the artificial heart valve comprising a collapsible and expandable stent with struts, and a valve assembly coupled to the stent, the valve assembly having multiple leaflets and a cuff; A delivery device is provided, the delivery device comprising a catheter extending between a proximal end and a distal end, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximally to the inflatable balloon. In the first stage, the inflatable balloon is inflated; and During the first phase, the effect of the first parameter on the inflation of the inflatable balloon is analyzed.

11. The method of claim 10, wherein analyzing the effect of the first parameter on inflation of the inflatable balloon during the first phase comprises: The effect of fluid viscosity on the inflation of the inflatable balloon was analyzed.

12. The method of claim 10, wherein analyzing the effect of the first parameter on inflation of the inflatable balloon during the first phase comprises: The effect of the inflation medium on the inflation of the inflatable balloon was analyzed.

13. The method of claim 12, wherein the aeration medium comprises a mixture of physiological saline and contrast agent solution.

14. The method of claim 10, wherein analyzing the effect of the first parameter on inflation of the inflatable balloon during the first phase comprises: The effect of catheter length on the inflation of the inflatable balloon was analyzed.

15. The method of claim 10, wherein analyzing the effect of the first parameter on inflation of the inflatable balloon during the first phase comprises: The effect of catheter diameter on the inflation of the inflatable balloon was analyzed.

16. The method of claim 10, wherein inflating the inflatable balloon in the first stage comprises: The inflatable balloon is inflated to approximately 15% of its total volume.

17. The method of claim 10, further comprising: In the second stage, the inflatable balloon is inflated.

18. The method of claim 17, wherein inflating the inflatable balloon in the second stage is performed after the first stage.

19. The method of claim 17, wherein inflating the inflatable balloon in the second phase comprises: The inflatable balloon is inflated at least until it comes into contact with the natural valve annulus.

20. The method of claim 10, wherein inflating the inflatable balloon in the first stage comprises: The inflatable balloon is inflated in air before implantation.

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