Precision filling of indeflator for tavr

Abstract

An indeflator (1200) for a balloon inflation system, the indeflator having a moving member (1210) and a barrel (1250) having a fluidcontaining portion defining an internal space to receive a fluid. The indeflator is configured to receive a desired fill volume with high accuracy and precision. The filled indeflator can be used to accurately and precisely expand a medical device crimped on an inflatable.

Description

ABTSJM-0662PCT15979WOO1Precision Filling of Indeflator for TAVRCross-Reference to Related Applications

[0001] This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 739,738, filed December 30, 2024, the disclosure of which is hereby incorporated by reference herein.Background of the Disclosure

[0002] and specifically aortic and mitral valve disease, is a significant health issue in the United States. Valve replacement is one option for treating heart valve diseases. Prosthetic heart valves include surgical heart valves, as well as collapsible and expandable heart valves intended for transcatheter aortic valve replacement or implantation (“TAVR” or “TAVI”) or transcatheter mitral valve replacement (“TMVR”). Surgical or mechanical heart valves may be sutured into a native annulus of a patient during an open-heart surgical procedure, for example. Collapsible and expandable heart valves may be delivered into a patient via a delivery apparatus such as a catheter to avoid a more invasive procedure such as full open-chest, open-heart surgery. As used herein, reference to a “collapsible and expandable” heart valve includes heart valves that are formed with a small cross-section that enables them to be delivered into a patient through a catheter in a minimally invasive procedure, and then expanded to an operable state once in place, as well as heart valves that, after construction, are first collapsed to a small cross-section for delivery into a patient and then expanded to an operable size once in place in the valve annulus.

[0003] Collapsible and expandable prosthetic heart valves typically take the form of a one-way valve structure (often referred to as a valve assembly) mounted within an expandable frame (the terms “stent” and “frame” may be used interchangeably herein). In general, these collapsible and expandable heart valves include a self-expanding, mechanically-expandable, or balloonexpandable frame, often made of nitinol or another shape-memory metal or metal alloy (for selfexpanding frames) or steel or cobalt chromium (for balloon-expandable frames). The one-way valve assembly mounted to / within the stent includes one or more leaflets and may also include a cuff or skirt. The cuff may be disposed on the stent’s interior or luminal surface, its exterior orABTSJM-0662PCT15979WOO1abluminal surface, and / or on both surfaces. A cuff helps to ensure that blood does not just flow around the valve leaflets if the valve or valve assembly is not optimally seated in a valve annulus. A cuff, or a portion of a cuff disposed on the exterior of the stent, can help prevent leakage around the outside of the valve (the latter known as paravalvular or "PV" leakage).

[0004] Balloon expandable valves are typically delivered to the native annulus while collapsed (or “crimped”) onto a deflated balloon of a balloon catheter, with the collapsed valve being either covered or uncovered by an overlying sheath. Once the crimped prosthetic heart valve is positioned within the annulus of the native heart valve that is being replaced, the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped condition into an expanded or deployed condition, with the prosthetic heart valve tending to remain in the shape into which it is expanded by the balloon. Typically, when the position of the collapsed prosthetic heart valve is determined to be in the desired position relative to the native annulus (e.g. via visualization under fluoroscopy), a fluid (typically a liquid although gas could be used as well) such as saline is pushed via a syringe (manually, automatically, or semi-automatically) through the balloon catheter to cause the balloon to begin to fill and expand, and thus cause the overlying prosthetic heart valve to expand into the native annulus.Summary of the Disclosure

[0005] One aspect of the disclosure provides an indeflator for a balloon inflation system, the indeflator comprising: a moving member; and a barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the cylindrical portion, wherein the visual markings include one of: (i) graduation lines at intervals of 0.5mL or (ii) numerals at intervals of 0.5mL.

[0006] In one example, the fluid-containing portion has a length between 20-40cm.

[0007] In one example, the fluid-containing portion has a length of 30cm and a diameter of 1.34cm.

[0008] In one example, the visual markings include graduation lines having a thickness of approximately 0.5mm.ABTSJM-0662PCT15979WOO1

[0009] In one example, the indeflator further includes an optical element positioned over the fluidcontaining portion of the barrel, the optical element configured to magnify at least a subset of the visual markings.

[0010] In one example, the visual markings include numerals having a font size of 1mm or less.

[0011] Another aspect of the disclosure provides an indeflator for a balloon inflation system, the indeflator comprising: a moving member including a plunger and a seal, wherein the seal includes a seal visual marking; and a barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the fluid-containing portion.

[0012] In one example, the seal visual marking comprises a line having a color that is different from a color.

[0013] Another aspect of the disclosure provides an indeflator for a balloon inflation system, the indeflator comprising: a moving member including a plunger and a seal; and a barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the fluid-containing portion, wherein, when the fluid is received within the fluid-containing portion, the fluid is a different color than a color of the seal.

[0014] In one example, the fluid is received within the fluid-containing portion, the fluid is a contrasting color from the color of the seal.

[0015] Another aspect of the disclosure provides a balloon inflation system, comprising: an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; and a flow meter fluidically connected to the indeflator by a tubing, the flow meter configured to measure a rate of fluid flow to or from the indeflator, wherein a volume of fluid is determined based upon the rate of fluid flow.

[0016] In one example, the balloon inflation system further includes a stopcock fluidically coupled to the flow meter.

[0017] Another aspect of the disclosure provides a method of filling an indeflator for use in a balloon inflation system, the method comprising: measuring a volume of fluid with a secondary measurement device, wherein the secondary measurement device is a graduated cylinder; transferring the measured volume of fluid to the indeflator, wherein the indeflator is devoid ofABTSJM-0662PCT15979WOO1visual markings indicative of volume; and completely advancing a plunger of the moving member to pass an entirety of the measured volume of fluid to inflate a balloon of the balloon inflation system.

[0018] In one example, the indeflator is devoid of visual markings indicative of volume

[0019] Another aspect of the disclosure provides a balloon inflation system, comprising: an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a cylindrical portion defining an internal space to receive a fluid; and a scale configured to measure a weight of the fluid, wherein the balloon inflation system is configured to determine a volume of the fluid based upon the measured weight of the fluid and an identified density of the fluid.

[0020] In one example, (i) the identified density of the fluid is based upon a known constant density for an entirety of the fluid; or (ii) the identified density of the fluid is based on a real-time measurement by one of a hydrometer or a densimeter.

[0021] Another aspect of the disclosure provides a balloon inflation system, comprising: an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; and a pressure sensor configured to measure a differential pressure of the fluid, wherein the balloon inflation system is configured to determine a volume of the fluid inside the fluid-containing portion based upon the measured differential pressure.

[0022] Another aspect of the disclosure provides an indeflator for a balloon inflation system, comprising: a moving member including a plunger and a seal, wherein the plunger includes a plurality of plunger projections extending radially outward from the plunger, each adjacent pair of the plurality of plunger projections defining a recess therebetween; and a barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid and to receive a barrel flange, the barrel flange having at least one barrel flange projection configured to be received by the recess between any adjacent pair of the plurality of projections such that the indeflator defines a plurality of predetermined fill volumes.

[0023] In one example, the plurality of plunger projections includes a plurality of first plunger projections and a plurality of second plunger projections opposed to the plurality of first plunger projections.

[0024] In one example, the plurality of first plunger projections are axially aligned with each other.ABTSJM-0662PCT15979WOO1

[0025] In one example, the plunger is rotatable such that the plurality of first plunger projections are rotatable into and out of axial alignment with the at least one barrel flange projection such that, when the plurality of first plunger projections is axially aligned with the at least one barrel flange projection, axial movement of the plunger relative to the barrel is prevented.

[0026] Another aspect of the disclosure provides an indeflator for a balloon inflation system, comprising: a moving member including a plunger and a seal, wherein the plunger includes a plurality of plunger projections extending radially outward from the plunger; a barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid; a locking mechanism including a rotatable stopper, the rotatable stopper configured to confront at least one of the plurality of plunger projections to prevent axial movement of the plunger relative to the fluid-containing portion.

[0027] Another aspect of the disclosure provides a balloon inflation system, comprising: an indeflator including a moving member and a barrel, the moving member including a plunger, a handle, and a seal, the barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid; and at least one spacer positionable between the handle and the barrel flange and configured to prevent distal axial movement of the moving member relative to the barrel when the handle and the barrel flange both contact opposite ends of the at least one spacer, wherein the at least one spacer has a height corresponding a predetermined volume to be expelled from the fluid-containing portion.

[0028] Another aspect of the disclosure provides an indeflator for a balloon inflation system, comprising: a moving member including a plunger and a seal, wherein the plunger includes a plurality of detents extending radially outward from the plunger; and a barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid, the barrel flange having at least one recess configured to receive at least one of the plurality of detents.

[0029] Another aspect of the disclosure provides balloon inflation system, comprising: an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; and an indeflator pump configured to operate the moving member to fill the indeflator with a predetermined volume of fluid.Brief Description of the DrawingsABTSJM-0662PCT15979WOO1

[0030] Fig. 1 is a perspective view of an example of a prosthetic heart valve.

[0031] Fig. 2 is a front view of an example of a section of the frame of the prosthetic heart valve of Fig. 1, as if cut longitudinally and laid flat on a table.

[0032] Fig. 3 is a front view of an example of a prosthetic leaflet of the prosthetic heart valve of Fig. 1, as if laid flat on a table.

[0033] Fig. 4 is a top view of the prosthetic heart valve of Fig. 1 mounted on an example of a portion of a delivery system.

[0034] Fig. 5 is an enlarged view of the handle of the delivery system shown in Fig. 4.

[0035] Fig. 6 is an enlarged view of a distal end of the delivery system shown in Fig. 4.

[0036] Fig. 7 is a top view of an example of a balloon catheter when the balloon is inflated.

[0037] Fig. 8 is a top view of an example of an inflation system for use with a delivery system similar to that shown in Fig. 4.

[0038] Fig. 9 is a side view of the inflation system of Fig. 8.

[0039] Fig. 10 is a perspective view of a connection between the inflation system of Figs. 8-9 and the handle of the delivery system of Fig. 4.

[0040] Fig. 11 is a flowchart showing exemplary steps in a procedure to implant the prosthetic heart valve of Fig. 1 into a patient using the delivery system of Fig. 4.

[0041] Fig. 12 illustrates an indeflator for use in a balloon inflation system.

[0042] Fig. 13 illustrates an indeflator for use in a balloon inflation system.

[0043] Fig. 14 illustrates an indeflator for use in a balloon inflation system.

[0044] Fig. 15 illustrates an indeflator for use in a balloon inflation system.

[0045] Fig. 16 is a schematic diagram illustrating an indeflator for use in a balloon inflation system in connection with a flow meter.

[0046] Fig. 17 is a schematic diagram illustrating an indeflator for use in a balloon inflation system in connection with a secondary measurement device.

[0047] Fig. 18 is a schematic diagram illustrating an indeflator for use in a balloon inflation system in connection with a scale.

[0048] Fig. 19 is a schematic diagram illustrating an indeflator for use in a balloon inflation system in connection with a pressure sensor.

[0049] Fig. 20 illustrates an indeflator for use in a balloon inflation system.

[0050] Fig. 21 illustrates an indeflator for use in a balloon inflation system.ABTSJM-0662PCT15979WOO1

[0051] Fig. 22 illustrates an indeflator for use in a balloon inflation system.

[0052] Fig. 23 illustrates an indeflator for use in a balloon inflation system.

[0053] Fig. 24 illustrates an indeflator for use in a balloon inflation system in connection with an indeflator pump.Detailed Description of the Disclosure

[0054] As used herein, the term “inflow end” when used in connection with a prosthetic heart valve refers to the end of the prosthetic valve into which blood first enters when the prosthetic valve is implanted in an intended position and orientation, while the term “outflow end” refers to the end of the prosthetic valve where blood exits when the prosthetic valve is implanted in the intended position and orientation. Thus, for a prosthetic aortic valve, the inflow end is the end nearer the left ventricle while the outflow end is the end nearer the aorta. The intended position and orientation are used for the convenience of describing valves disclosed herein. However, it should be noted that the use of the valve is not limited to the intended position and orientation but may be deployed in any type of lumen or passageway. For example, although prosthetic heart valves are described herein as prosthetic aortic valves, those same or similar structures and features can be employed in other heart valves, such as the pulmonary valve, the mitral valve, or the tricuspid valve. Further, the term “proximal,” when used in connection with a delivery device or system, refers to a position relatively close to the user of that device or system when it is being used as intended, while the term “distal” refers to a position relatively far from the user of the device. In other words, the leading end of a delivery device or system is positioned distal to the trailing end of the delivery device or system, when the delivery device is being used as intended. As used herein, the terms “substantially,” “generally,” “approximately,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified. As used herein, the prosthetic heart valves may assume an “expanded state” and a “collapsed state,” which refer to the relative radial size of the stent.

[0055] Fig. l is a perspective view of one example of a prosthetic heart valve 10. Prosthetic heart valve 10 may be a balloon-expandable prosthetic aortic valve, although in other examples it may be a self-expandable or mechanically-expandable prosthetic heart valve, intended for replacing a native aortic valve or another native heart valve. Prosthetic heart valve 10 is shown in an expanded condition in Fig. 1. Prosthetic heart valve 10 may extend between an inflow end 12 and an outflowABTSJM-0662PCT15979WOO1end 14. Prosthetic heart valve 10 may include a collapsible and expandable frame 20, an inner cuff or skirt 60, an outer cuff or skirt 80, and a plurality of prosthetic leaflets 90. As should be clear below, prosthetic heart valve 10 is merely one example of a prosthetic heart valve, and other examples of prosthetic heart valves may be suitable for use with the concepts described below.

[0056] Fig. 2 is a front view of an example of a section of the frame 20 of prosthetic heart valve 10, as if cut longitudinally and laid flat on a table. The section of frame 20 in Fig. 2 may represent approximately one-third of a complete frame, particularly if frame 20 is used in conjunction with a three-leaflet prosthetic heart valve. In the illustrated example, frame 20 is a balloon-expandable stent and may be formed of stainless steel or cobalt-chromium, and which may include additional materials such as nickel and / or molybdenum. However, in some embodiments the stent may be formed of a shape memory material such as nitinol or the like. The frame 20, when provided as a balloon-expandable frame, is configured to collapse upon being crimped to a smaller diameter and / or expand upon being forced open, for example via a balloon within the frame expanding, and the frame will substantially maintain the shape to which it is modified when at rest.

[0057] Frame 20 may include an inflow section 22 and an outflow section 24. The inflow section 22 may also be referred to as the annulus section. In one example, the inflow section 22 includes a plurality of rows of generally hexagon-shaped cells. For example, the inflow section 22 may include an inflow-most row of hexagon-shaped cells 30 and an outflow-most row of hexagonshaped cells 32. The inflow-most row of hexagonal cells 30 may be formed of a first circumferential row of angled or zig-zag struts 21, a second circumferential row of angled or zigzag struts 25, and a plurality of axial struts 23 that connect the two rows. In other words, each inflow-most hexagonal cell 30 may be formed by two angled struts 21 that form an apex pointing in the inflow direction, two angled struts 25 that form an apex pointing in the outflow direction, and two axial struts that connect the two angled struts 21 to two corresponding angled struts 25. The outflow-most row of hexagonal cells 32 may be formed of the second circumferential row of angled or zig-zag struts 25, a third circumferential row of angled or zig-zag struts 29, and a plurality of axial struts 27 that connect the two rows. In other words, each outflow-most hexagonal cell 32 may be formed by two angled struts 25 that form an apex pointing in the inflow direction, two angled struts 29 that form an apex pointing in the outflow direction, and two axial struts that connect the two angled struts 27 to two corresponding angled struts 29. It should be understood that although the term “outflow-most” is used in connection with hexagonal cells 32, additionalABTSJM-0662PCT15979WOO1frame structure, described in more detail below, is still provided in the outflow direction relative to the outflow-most row of hexagonal cells 32.

[0058] In the illustrated embodiment, assuming that frame 20 is for use with a three-leaflet valve and thus the section shown in Fig. 2 represents about one-third of the frame 20, each row of cells 30, 32 includes twelve individual cells. However, it should be understood that more or fewer than twelve cells may be provided per row of cells. Further, the inflow or annulus section 22 may include more or fewer than two rows of cells. Still further, although cells 30, 32 are shown as being hexagonal, the some or all of the cells of the inflow section 22 may have other shapes, such as diamond-shaped, chevron-shaped, or other suitable shapes. In the illustrated embodiment, every cell 30 in the first row is structurally similar or identical to every other cell 30 in the first row, every cell 32 in the second row is structurally similar or identical to every other cell 32 in the second row, and every cell 30 in the first row is structurally similar or identical (excluding the aperture 26) to every cell 32 in the second row. However, in other examples, the cells in each row are not identical to every other cell in the same row or in other rows.

[0059] An inflow apex of each hexagonal cell 30 may include an aperture 26 formed therein, which may accept sutures or similar features which may help couple other elements, such as an inner cuff 60, outer cuff 80, and / or prosthetic leaflets 90, to the frame 20. However, in some examples, one or more or all of the apertures 26 may be omitted.

[0060] Still referring to Fig. 2, the outflow section 24 of the frame 20 may include larger cells 34 that have generally asymmetric shapes. For example, the lower or inflow part of the larger cells 34 may be defined by the two upper struts 29 of a cell 32, and one upper strut 29 of each of the two adjacent cells 32. In other words, the lower end of each larger cell 34 may be formed by a group of four consecutive upper struts 29 of three circumferentially adjacent cells 32. The tops of the larger cells 34 may each be defined by two linking struts 35a, 35b. The first linking strut 35a may couple to a top or outflow apex of a cell 32 and extend upwards at an angle toward a commissure attachment feature (“CAF”) 40. The second linking strut 35b may extend from an end of the first linking strut 35a back downwardly at an angle and connect directly to the CAF 40. To the extent that the larger cells 34 include sides, a first side is defined by a portion of the CAF 40, and a second side is defined by the connection between first linking strut 35a and the corresponding upper strutABTSJM-0662PCT15979WOO1

[0061] The CAF 40 may generally serve as an attachment site for leaflet commissures (e.g. where two prosthetic leaflets 90 join each other) to be coupled to the frame 20. In the illustrated example, the CAF 40 is generally rectangular and has a longer axial length than circumferential width. The CAF 40 may define an interior open rectangular space. The struts that form 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 one top (or outflow) strut that all include alternating projections and notches on their exterior facing surfaces. These projections and notches may help maintain the position of one or more sutures that wrap around these struts. These sutures may directly couple the prosthetic leaflets 90 to the frame 20, and / or may directly couple an intermediate sheet of material (e.g. fabric or tissue) to the CAF 40, with the prosthetic leaflets 90 being directly coupled to that intermediate sheet of material. In some embodiments, tabs or ends of the prosthetic leaflets 90 may be pulled through the opening of the CAF 40, but in other embodiments the prosthetic leaflets 90 may remain mostly or entirely within the inner diameter of the frame 20. It should be understood that balloon-expandable frames are typically formed of metal or metal alloys that are very stiff, particularly in comparison to selfexpanding frames. At least in part because of this stiffness, although the prosthetic leaflets 90 may be sutured or otherwise directly coupled to the frame at the CAFs 40, it may be preferable that most or all of the remaining portions of the prosthetic leaflets 90 are not attached directly to the frame 20, but are rather attached directly to an inner skirt 60, which in turn is directly connected to the frame 20. Further, it should be understood that other shapes and configurations of CAFs 40 may be appropriate. For example, various other suitable configurations of frames and CAFs are described in greater detail in U.S. Provisional Patent Application No. 63 / 579,378, filed August 29, 2023 and titled “TAVI Deployment Accuracy - Stent Frame Improvements,” the disclosure of which is hereby incorporated by reference herein.

[0062] With the example described above, frame 20 includes two rows of hexagon-shaped cells 30, 32, and a single row of larger cells 34. In a three-leaflet embodiment of a prosthetic heart valve that incorporates frame 20, each row of hexagon-shaped cells 30, 32 includes twelve cells, while the row of larger cells includes six larger cells 34. As should be understood, the area defined by each individual cell 30, 32 is significantly smaller than the area defined by each larger cell 34 whenABTSJM-0662PCT15979WOO1the frame 20 is expanded. There is also significantly more structure e.g. struts) that create each row of individual cells 30, 32 than structure that creates the row of larger cells 34.

[0063] One consequence of the above-described configuration is that the inflow section 22 has a higher cell density than the outflow section 24. In other words, the total numbers of cells, as well as the number of cells per row of cells, is greater in the inflow section 22 compared to the outflow section 24. The configuration of frame 20 described above may also result in the inflow section 22 being generally stiffer than the outflow section 24 and / or more radial force being required to expand the inflow section 22 compared to the outflow section 24, despite the fact that the frame 20 may be formed of the same metal or metal alloy throughout. This increased rigidity or stiffness of the inflow section 22 may assist with anchoring the frame 20, for example after balloon expansion, into the native heart valve annulus. The larger cells 34 in the outflow section 24 may assist in providing clearance to the coronary arteries after implantation of the prosthetic heart valve 10. For example, after implantation, one or more coronary ostia may be positioned above the frame 20, for example above the valley where two adjacent larger cells 34 meet (about halfway between a pair of circumferentially adjacent CAFs 40). Otherwise, one or more coronary ostia may be positioned in alignment with part of the large interior area of a larger cell 34 after implantation. Either way, blood flow to the coronary arteries is not obstructed, and a further procedure that utilizes the coronary arteries (e.g. coronary artery stenting) will not be obstructed by material of the frame 20. Still further, the lower rigidity of the frame 20 in the outflow section 24 may cause the outflow section 24 to preferentially foreshorten during expansion, with the inflow section 22 undergoing a relatively smaller amount of axial foreshortening. This may be desirable because, as the prosthetic heart valve 10 expands, the position of the inflow end of the frame 20 may remain substantially constant relative to the native valve annulus, which may make the deployment of the prosthetic heart valve 10 more precise. This may be, for example, because the inflow end of the frame 20 is typically used to gauge proper alignment with the native valve annulus prior to deployment, so axial movement of the inflow end of the frame 20 relative to the native valve annulus during deployment may make precise placement more difficult.

[0064] Referring back to Fig. 1, the prosthetic heart valve 10 may include an inner skirt 60 mounted to the interior surface of frame 20. The inner skirt 60 may be formed of tissue, such as pericardium, although other types of tissue may be suitable. In the illustrated example, the inner skirt 60 is formed of a woven synthetic fabric, such as polyethylene terephthalate (“PET”) orABTSJM-0662PCT15979WOO1polytetrafluoroethylene (“PTFE”), although other fabrics may be suitable, including fabrics other than woven fabrics. In some examples, the inner skirt 60 has straight or zig-zag shaped inflow and outflow ends that generally follow the contours of the cells 30, 32 of the inflow section 22 of frame 20. Preferably, inner skirt 60 is sutured to the frame 20 along the struts that form cells 30, 32. If apertures 26 are included, inner skirt 60 may also be coupled to frame 20 via sutures passing through apertures 26. Preferably, the inner skirt 60 does not cover (or does not cover significant portions of) the larger cells 34. The inner skirt 60 may be coupled to the frame 20 via mechanisms other than sutures, including for example ultrasonic welding or adhesives. Further, the inner skirt 60 may have shapes other than that shown, and need not have a zig-zag inflow or outflow end, and need not cover every cell in the inflow section 22. In fact, in some examples, the inner skirt 60 may be omitted entirely, with the outer skirt 80 (described in greater detail below) being the only skirt used with prosthetic heart valve 10. If the inner skirt 60 is provided, it may assist with sealing the prosthetic heart valve 10 within the heart, as well as serving as a mounting structure for the prosthetic leaflets 90 (described in greater detail below) within the frame 20.

[0065] Still referring to Fig. 1, the prosthetic heart valve 10 may include an outer skirt 60 mounted to the exterior surface of frame 20. The outer skirt 80 may be formed of tissue, such as pericardium, although other types of tissue may be suitable. In the illustrated example, the outer skirt 80 is formed of a woven synthetic fabric, such as PET or PTFE, although other fabrics may be suitable, including fabrics other than woven fabrics. In some examples, the outer skirt 80 has straight or zig-zag inflow end. Preferably, outer skirt 80 is sutured to the frame 20 and / or inner skirt 60 along the inflow edge of the outer skirt 80. If apertures 26 are included, outer skirt 80 may also be coupled to frame 20 via sutures passing through apertures 26. The outer skirt 80 may include a plurality of folds or pleats, such a circumferentially extending folds or pleats. The folds or pleats may be formed in the outer skirt 80 via heat setting, for example by placing the outer skirt 80 within a mold that forces the outer skirt 80 to form folds of pleats, and the outer skirt 80 may be treated with heat so that the outer skirt 80 tends to maintain folds or pleats in the absence of applied forces. The outflow edge of outer skirt 80 may be coupled to the frame 20 at selected, spaced apart locations around the circumference of the frame 20. In some embodiments, the outflow edge of outer skirt 80 may be connected to the inner skirt 60 along a substantially continuous suture line. Some or all of the outer skirt 80 between its inflow and outflow edges may remain not directly couples to the frame 20 or inner skirt 60. Preferably, the outer skirt 80 does not cover (or does notABTSJM-0662PCT15979WOO1cover significant portions of) the larger cells 34. In use, the outer skirt 80 may directly contact the interior surface of the native heart valve annulus to assist with sealing, including sealing against PV leak. If folds or pleats are included with the outer skirt 80, the additional material of the folds or pleats may help further mitigate PV leak. However, it should be understood that the folds or pleats may be omitted from outer skirt 80, and the outer skirt 80 may have shapes other than that shown. In fact, in some examples, the outer skirt 80 may be omitted entirely, with the inner skirt 60 being the only skirt used with prosthetic heart valve 10. If the inner skirt 60 is omitted, the prosthetic leaflets 90 may be attached directly to the frame 20 and / or directly to the outer skirt 80.

[0066] Fig. 3 is a front view of a prosthetic leaflet 90, as if laid flat on a table. In the illustrated example of prosthetic heart valve 10, a total of three prosthetic leaflets 90 are provided, although it should be understood that more or fewer than three prosthetic leaflets may be provided in other example of prosthetic heart valves. The prosthetic leaflet 90 may be formed of a synthetic material, such a polymer sheet or woven fabric, or a biological material, such a bovine or porcine pericardial tissue. However, other materials may be suitable. In on example, the prosthetic leaflet 90 is formed to have a concave free edge 92 configured to coapt with the free edges of the other leaflets to help provide the one-way valve functionality. The prosthetic leaflet 90 may include an attached edge 94 which is attached (e.g. via suturing) to other structures of the prosthetic heart valve 10. For example, the attached edge 94 may be coupled directly to the inner skirt 60, directly to the frame 20, and / or directly to the outer skirt 80. It may be preferable that the attached edge 94 is coupled directly only to the inner skirt 60, which may help reduce stresses on the prosthetic leaflet 90 compared to if the attached edge 94 were coupled directly to the frame 20. In some embodiments, a plurality of holes 98 may be formed along the attached edge 94 (or a spaced distance therefrom), for example via lasers. If included, the holes 98 may be used to receive sutures therethrough, which may make it easier to couple the prosthetic leaflet 90 to the inner skirt 60 during manufacturing. For example, the holes 98 may serve as guides if suturing is performed manually, and if the positions of the holes 98 are controlled via the use of layers, the holes 98 may be consistently placed among different prosthetic leaflets 90 to reduce variability between different prosthetic leaflets 90. Leaflet tabs 96 may be provided at the junctions between the free edge 92 and the attached edge 94. Each leaflet tab 96 may be joined to a leaflet tab of an adjacent prosthetic leaflet to form prosthetic leaflet commissures, which may be coupled to the frame 20 via CAFs 40.ABTSJM-0662PCT15979WOO1

[0067] The prosthetic heart valve 10 may be delivered via any suitable transvascular route, for example transapically or transfem orally. Generally, transapical delivery utilizes a relatively stiff catheter that pierces the apex of the left ventricle through the chest of the patient, inflicting a relatively higher degree of trauma compared to transfemoral delivery. In a transfemoral delivery, a 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 method of delivery, the valve may first be collapsed over an expandable balloon while the expandable balloon is deflated. The balloon may be coupled to or disposed within a delivery system, which may transport the valve through the body and heart to reach the aortic valve, with the valve being disposed over the balloon (and, in some circumstances, under an overlying sheath). Upon arrival at or adjacent to the aortic valve, a surgeon or operator of the delivery system may align the prosthetic valve as desired within the native valve annulus while the prosthetic valve is collapsed over the balloon. When the desired alignment is achieved, the overlying sheath, if included, may be withdrawn (or advanced) to uncover the prosthetic valve, and the balloon may then be expanded causing the prosthetic valve to expand in the radial direction, with at least a portion of the prosthetic valve foreshortening in the axial direction.

[0068] Fig. 4 illustrates one example of a delivery system 100, with the prosthetic heart valve 10 crimped over a balloon on a distal end of the delivery system 100. Although delivery system 100 and various components thereof are described below, it should be understood that delivery system 100 is merely one example of a balloon catheter that may be appropriate for use in delivering and deploying prosthetic heart valve 10.

[0069] In some examples, delivery system 100 includes a handle 110 and a delivery catheter 130 extending distally from the handle 110. An introducer 150 may be provided with the delivery system 100. Introducer 150 may be an integrated or captive introducer, although in other embodiments introducer 150 may be a non-integrated or non-captive introducer. In some examples, the introducer 150 may be an expandable introducer, including for example an introducer that expands locally as a large diameter components passes through the introducer, with the introducer returning to a smaller diameter once the large diameter components passes through the introducer. In other examples, the introducer 150 is a non-expandable introducer.

[0070] A guidewire GW may be provided that extends through the interior of all components of the delivery system 100, from the proximal end of the handle 110 through the atraumatic distal tipABTSJM-0662PCT15979WOO1138 of the delivery catheter 130. The guidewire GW may be introduced into the patient to the desired location, and the delivery system 100 may be introduced over the guidewire GW to help guide the delivery catheter 130 through the patient’s vasculature over the guidewire GW.

[0071] In some examples, the delivery catheter 130 is steerable. For example, one or more steering wires may extend through a wall of the delivery catheter 130, with one end of the steering wire coupled to a steering ring coupled to the delivery catheter 130, and another end of the steering wire operable coupled to a steering actuator on the handle 110. In such examples, as the steering actuator is actuated, the steering wire is tensioned or relaxed to cause deflection or straightening of the delivery catheter 130 to assist with steering the delivery catheter 130 to the desired position within the patient. For example, Fig. 5 is an enlarged view of the handle 110. Handle 110 may include a steering knob 112 that, upon rotation, tensions or relaxes the steering wires to deflect the distal end of the delivery catheter 130. However, it should be understood that the steering functionality may be omitted in some examples, and in other examples steering actuators other than knobs may be utilized. Further, in some examples, including those shown in Figs. 6-7, the delivery catheter 130 includes an outer catheter 132, and an inner catheter 134. The inner catheter 134 may also be referred to as a guidewire catheter. The steering functionality may be provided in either the outer catheter 132, or the inner catheter 134, or in both catheters. However, in some examples, a separate steering catheter 135 may be provided. For example, as shown in Fig. 4, the steering catheter 135 may be positioned outside of the outer catheter 132 and may terminate just proximal to the balloon 136. With this configuration, deflection of the steering catheter 135 will also cause deflection of the outer catheter 132 and the inner catheter 134 which are both nested within the steering catheter 135. In some examples, the handle may include a window 118 that allows viewing of an indicator that corresponds to the amount of catheter deflection. For example, a carrier to which the indicator is attached may be attached to the steering wire. In some examples, when there is minimum (or zero) tension on the steering wire, the indicator is at the far distal position within window 118, but as deflection is actuated, for example by drawing a carrier proximally (and tensioning the steering wire as the carrier draws proximally), the indicator will move proximally along window 118, giving the user a readily-apparent indication of the amount of deflection applied to the catheter at any given moment.

[0072] Still referring to Figs. 4-5, the delivery system 100 may include additional functionality to assist with positioning the prosthetic heart valve 10. For example, in the illustrated example, handleABTSJM-0662PCT15979WOO1110 includes a commissure alignment actuator 114, which may be positioned near a proximal end of the handle or at any other desired location. In the illustrated example, the commissure alignment actuator 114 is in the form of a rotatable knob, although other forms may be suitable. The commissure alignment knob 114 may be rotationally coupled to a portion of the delivery catheter 130 supporting the prosthetic heart valve 10. For example, the commissure alignment actuator 114 may be rotationally coupled to an inner catheter 134 which supports the prosthetic heart valve 10 in the crimped condition. With this configuration, rotating the commissure alignment knob 114 may cause the inner catheter 134 to rotate about its longitudinal axis, and thus cause the prosthetic heart valve 10 to rotate about its longitudinal axis. If a commissure alignment actuator 114 is included, it may be used to help ensure that, upon deployment of the prosthetic heart valve 10 into the native valve annulus, the commissures of the prosthetic heart valve are in rotational alignment with respective ones of the native valve commissures (e.g. within + / - 2.5 degrees of rotational alignment, within + / - 5 degrees of rotational alignment, within + / - 10 degrees of rotational alignment, within + / - 15 degrees of rotational alignment, etc.). Although commissure alignment actuator 114 is shown in this example as a knob positioned at or near a proximal end of the handle 110, it should be understood that the actuator 114 may take forms other than a knob, may be positioned at other suitable locations, and may be omitted entirely if desired.

[0073] Still referring to Figs. 4-5, the delivery system 100 may include even further functionality to assist with positioning the prosthetic heart valve 10. For example, in the illustrated example, handle 110 includes an axial alignment actuator 116, which may be positioned near a proximal end of the handle, including distal to the commissure 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, although other forms may be suitable. The axial alignment knob 116 may be operably coupled to a portion of the delivery catheter 130 supporting the prosthetic heart valve 10. For example, the axial alignment actuator 116 may include internal threads that engage external threads (or another component, such as individual extensions, which may be cylindrical extensions that fit between internal threads of the actuator) of a carriage that is coupled to an inner catheter 134 which supports the prosthetic heart valve 10 in the crimped condition. In such an example, the carriage may be rotatably fixed to the handle 110. With this configuration, rotating the axial alignment knob 116 may cause the carriage to advance distally or retract proximally as the inner threads of the axial alignment knob 116 mesh with the external threads of the carriage, but theABTSJM-0662PCT15979WOO1carriage is prevented from rotating. As the carriage advances distally or retracts proximally, the inner catheter 134 may correspondingly advance distally or retract proximally, and thus cause the prosthetic heart valve 10 to advanced distally or retract proximally. It should be understood that, if axial alignment actuator 116 is included, it may have a small total range of motion, including for example between about 2mm and about 15mm of range of motion, including about 7.5mm range of motion. In other words, the rough or coarse axial alignment between the prosthetic heart valve 10 and native valve annulus may be achieved by physically advancing the entire delivery catheter 130 by pushing it through the vasculature while holding the handle 110. However, for fine and more controlled adjustment of the axial position of the prosthetic heart valve 10 relative to the native valve annulus, which may be performed just prior to or during deployment of the prosthetic heart valve 10, the axial alignment knob 116 may be used. If an axial alignment actuator 116 is included, it may be used to help ensure that, upon deployment of the prosthetic heart valve 10 into the native valve annulus, the inflow end of the of the prosthetic heart valve is in axial alignment with the inflow aspect of the native valve annulus (e.g. within + / - 0.5mm of axial alignment, within + / - 1.0mm of axial alignment, within + / - 1.5mm of axial alignment, within + / - 2.0 mm of axial alignment, etc.). Although axial alignment actuator 116 is shown in this example as a knob positioned at or near a proximal end of the handle 110, it should be understood that the actuator 116 may take forms other than a knob, may be positioned at other suitable locations, and may be omitted entirely if desired.

[0074] In addition to steering and positioning actuators, delivery system 100 may include a balloon actuator 120. In the illustrated example, balloon actuator 120 is positioned on the handle 110 near a distal end thereof, and is provided in the form of a switch. Balloon actuator 120 may be actuated to cause inflation or deflation of a balloon 136 that is part of the delivery system 100. For example, referring briefly to Figs. 6-7, the delivery system 100 may include a balloon 136 that overlies a distal end of inner catheter 134 and which receives the prosthetic heart valve 10 in a crimped condition thereon. In the example illustrated in Fig. 6, the balloon 136 includes a proximal pillowed portion 136a, a distal pillowed portion 136b, and a central portion over which the prosthetic heart valve 10 is crimped. The proximal pillow 136a and the distal pillow 136b may form shoulders on each side of the prosthetic heart valve 10, which may help ensure the prosthetic heart valve 10 does not move axially relative to the balloon 136 and / or inner catheter 134 during delivery. The shoulder formed by the distal pillow 136 may also help protect the inflow edge of the prostheticABTSJM-0662PCT15979WOO1heart valve 10 from contact with the anatomy during delivery. For example, during a transfemoral delivery, as the distal end of the delivery catheter 130 traverse the sharp bends of the aortic arch (or during initial introduction into the patient), there is a relatively high likelihood the inflow end of the prosthetic heart valve 10 (which is the leading edge during transfemoral delivery) will contact a vessel wall (or a components of an introduction system) causing dislodgment of the prosthetic heart valve 10 relative to the balloon 136. The distal pillow 136 may tend to have an equal or larger outer diameter than the inflow end of the prosthetic heart valve 10 (when the prosthetic heart valve 10 is crimped and the balloon 136 is deflated), which may help ensure the inflow edge of the prosthetic heart valve 10 does not inadvertently contact another structure during delivery. In some examples, the pillowed portions 136a, 136b may be formed via heat setting. Additional related features for use in similar balloon catheter delivery systems are described in greater detail in U.S. Provisional Patent Application No. 63 / 382,812, filed November 8, 2022 and titled “Prosthetic Heart Valve Delivery and Trackability,” the disclosure of which is hereby incorporated by reference herein.

[0075] In order to deploy the prosthetic heart valve 10, the balloon 136 is inflated, for example by actuating the balloon actuator 120 to force fluid (such as saline, although other fluids, including liquids or gases, could be used) into the balloon 136 to cause it to expand, causing the prosthetic heart valve 10 to expand in the process. For example, the balloon actuator 120 may be pressed forward or distally to cause fluid to travel through an inflation lumen within delivery catheter 130 to inflate the balloon 136. In some embodiments, the balloon actuator 120 may take the form of a “momentary switch” in which pushing the balloon actuator 120 forward engages inflation, pulling the balloon actuator 120 proximally engages deflation, and releasing the balloon actuator 120 pauses inflation. This particular example of functionality may allow the physician to precisely control the amount of fluid dispensed while reducing the occurrence of over- or under-inflation, for example because the system automatically pauses inflation when the switch is released. The physical form factor of the balloon actuator 120 may be any suitable desired form factor, including for example a rocker switch, a push button, etc. In some embodiments a second balloon actuator or button may be provided, either on the balloon actuator 120 or elsewhere on the handle 110, with the second balloon actuator allowing for a change (e.g. increase or decrease) in the rate of inflation, for example to a pre-programmed faster or slower rate of inflation. Fig. 7 illustrates an example of the balloon 136 after being inflated, with the prosthetic heart valve 10 omitted from the figureABTSJM-0662PCT15979WOO1for clarity. In the illustrated example, the balloon 136 may be formed to have a distal end that is fixed to a portion of an atraumatic distal tip 138. The distal tip 138 may be tapered to help the delivery catheter 130 move through the patient’s vasculature more smoothly. A proximal end of the balloon 136 may be fixed to a distal end of outer catheter 132. The inflation lumen may be the space between the outer catheter 132 and the inner catheter 134, or in other embodiments may be provided in a wall of the inner catheter 134, or in any other location that fluidly connects the interior of the balloon 136 to a fluid source outside of the patient that is operable coupled to the delivery system 100.

[0076] Referring to Fig. 7, in some examples, a mounting shaft 140 may be provided on the inner catheter 134. A proximal stop 142 and / or a distal stop 144 may be provided, for example at opposite ends of the mounting shaft 140. If the mounting shaft 140 is included, it may provide a location on which the prosthetic heart valve 10 may be crimped. If the proximal stop 142 and / or distal stop 144 is provided, they may provide physical barriers to the prosthetic heart valve 10 moving axially 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. The spacing between the proximal stop 142 and the distal stop 144, if both are included, may be slightly larger than the length of the prosthetic heart valve 10 when it is crimped over mounting shaft 140. However, it should be understood that one or both of the stops 142, 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 rotationally fixed to the inner catheter 134 so that movement of the inner catheter 134 causes corresponding movement of the mounting member 140, and thus the prosthetic heart valve 10 when mounted thereon.

[0077] Before describing the use of balloon actuator 120 in more detail, it should be understood that in some embodiments, the balloon actuator 120 may be omitted and instead a manual device, such as a manual syringe, may be provided along with delivery system 100 in order to manually push fluid into balloon 136 during deployment of the prosthetic heart valve 10. However, in the illustrated example of delivery system 100, the balloon actuator 120 provides for a motorized and / or automated (or semi-automated) balloon inflation functionality. For example, Fig. 8 and Fig.9 illustrate an example of a balloon inflation system 170. Balloon inflation system 170 may include a housing 172 that houses one or more components, which may include a motor, one or more batteries, electronics for control and / or communication with other components, etc. Housing 172ABTSJM-0662PCT15979WOO1may include one or more fixed cradles to receive a syringe 174. In the illustrated embodiment, a distal cradle 176 is provide with an open "C"- or "U"-shaped configuration so that the distal end of the syringe 174 may be snapped into or out of the distal cradle 176. A proximal cradle 178 may also be provided, which may have a "C"- or "U"-shaped bottom portion hingedly connected to a "C"- or "U"-shaped top portion. This configuration may allow for the proximal end of the outer body of the syringe 174 to be snapped into the bottom portion of proximal cradle 178, and the top portion of proximal cradle 178 may be closed and connected to the bottom portion 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 cradles, of similar or different designs, may be included with housing 172 to help secure the syringe 174 to the housing 172 in any suitable fashion.

[0078] The balloon inflation system 170 may include a moving member 180. In the illustrated embodiment, moving member 180 includes a "C"- or "U"-shaped cradle to receive a plunger handle 182 of the syringe 174 therein, the cradle being attached to a carriage that extends at least partially into the housing 172. The carriage of the moving member 180 may be generally cylindrical, and may include internal threading that mates with external threading of a screw mechanism (not shown) within the housing 172 that is operably coupled to a motor. In some embodiments, the carriage may have the general shape of a "U"-beam with the flat face oriented toward the top. The moving member 180 may be rotationally fixed to the housing 172 via any desirable mechanism, so that upon rotation of the screw mechanism by the motor, the moving member 180 advances farther into the housing 172, or retracts farther away from the housing 172, depending on the direction of rotation of the screw mechanism. While the plunger handle 182 is coupled to the moving member 180, advancement of the moving member 180 forces fluid from the syringe 174 toward the balloon 136, while retraction of the moving member 180 withdraws fluid from the balloon 136 toward the syringe 174. It should be understood that the motor, or other driving mechanism, may be located in or outside the housing 172, and any other suitable mechanism may be used to operably couple the motor or other driving mechanism to the moving member 180 to allow for axial driving of the plunger handle 182.

[0079] As shown in each of Fig. 8, Fig. 9, and Fig. 10, the distal end of syringe 174 may be coupled to tubing 184 that is in fluid communication with an inflation lumen of delivery catheter 130 that leads to the balloon 136 at or near the distal end of the delivery system 100. Tubing 184 may allow for the passage of the fluid (e.g., saline) from the syringe 174 toward the balloon 136, or forABTSJM-0662PCT15979WOO1withdrawal of fluid from the balloon 136 toward the syringe 174, for example based on whether the balloon actuator 120 is pressed forward or backward.

[0080] Although not separately numbered in Fig. 8, Fig. 9, and Fig. 10, the housing 172 may include one or more cables extending from the housing, for example to allow for transmission of power (e.g. from AC mains or another component with which the cable is coupled) and / or transmission of data, information, control commands, etc. For example, one cable may couple the housing 172 to handle 110 so that controls on the handle 110 (e.g. balloon actuator 120) may be used to activate the balloon inflation system 170 in the desired fashion. Another cable may couple to a computer display or similar device to provide information regarding the inflation of the balloon 136. However, it should be understood that any transmission of data or information may be provided wirelessly instead of via a wired connection, for example via a Bluetooth or other suitable connection. Additional and related features of balloon inflation system 170, related systems, and the uses thereof are described in U.S. Patent Application No. 18 / 311,458, the disclosure of which is hereby incorporated by reference herein.

[0081] Fig. 11 is a flowchart showing exemplary steps in an implantation procedure 200 to implant the prosthetic heart valve 10 of Fig. 1 into a patient using the delivery system 100 of Fig. 4. However, it should be understood that not all of the steps shown in connection with implantation procedure 200 need to be performed, and various steps not explicitly shown and described in connection with procedure 200 may be performed as part of the implantation procedure. At the beginning of the procedure 200 in step 202, the prosthetic heart valve 10 may be collapsed over or crimped onto balloon 136, with the balloon 136 being mostly or entirely deflated after the crimping procedure. It should be understood that crimping step 202 may be performed at any time prior to 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 crimping step 202 may be performed during a manufacturing stage of the delivery system 100 and / or prosthetic heart valve 10. During an early stage of the implantation procedure 200, a guidewire GW may be advanced into the patient in step 204, for example via the femoral artery, around the aortic arch, through the native aortic valve, and into the left ventricle. The guidewire GW may be used as a rail for other devices that need to access this pathway. For example, in step 206, the atraumatic distal tip 138 may be advanced over the proximal end of the guidewire GW, and the delivery catheter 130 may be advanced over guidewire GW toward the native aortic valve. During this initial advancement ofABTSJM-0662PCT15979WOO1the delivery catheter 130 into the patient, the introducer 150 (if included) may be positioned distally, for example so that it covers the prosthetic heart valve 10 or so that it is positioned just proximal to the prosthetic heart valve 10. Advancement of the delivery catheter 130 and introducer 150 may continue until a proximal hub of the introducer is in contact with the patient’s skin (or in contact with another device that enters the patient’s femoral artery. At this point, the introducer 150 may stop moving axially relative to the patient, with the delivery catheter 130 continuing to advance relative to the introducer 150. If steering capability is provided, the delivery catheter 130 may be steered or deflected at any point to assist with achieving the desired pathway of the delivery catheter 130. As on example, in step 208, the steering knob 112 may be actuated to deflect the distal end of the delivery catheter 130 as it traverses the sharp bends of the aortic arch. Advancement of the delivery catheter 130 may continue in step 210 until the prosthetic heart valve 10, while still crimped or collapsed, is positioned within the native aortic valve annulus. With the desired position achieved, the balloon 136 may be partially inflated, for example by pressing balloon actuator 120 forward, to partially expand the prosthetic heart valve 10 in step 212. In some examples, it is desirable to expand the prosthetic heart valve 10 only partially in step 212, because the position of the prosthetic heart valve 10 (including rotational and / or axial positioning) relative to the native aortic valve annulus may shift during this partial expansion. After the partial expansion of step 212, the user may examine the positioning of the prosthetic heart valve 10 relative to the native aortic valve annulus. If desired, in step 214, the axial positioning of the partially-expanded prosthetic heart valve 10 relative to the native aortic valve annulus may be finely adjusted (e.g. by actuating axial alignment actuator 116) and / or the rotational orientation of the prosthetic heart valve 10 relative to the native aortic valve may be finely adjust (e.g. by actuating commissure alignment actuator 114). When the desired axial alignment is achieved and the desired rotational alignment (e.g. rotational alignment between the prosthetic commissure and the native commissures) is achieved, the balloon 136 may be fully expanded in step 216 to fully expand the prosthetic heart valve 10 and to anchor the prosthetic heart valve 10 in the native aortic valve annulus in the desired position and orientation. After deployment is complete, the balloon 136 may be deflated in step 218, for example by pressing actuating balloon 120 backward, and the delivery catheter 130 and guidewire GW may be removed from the patient to complete the procedure. It should be understood that the nine steps shown in Fig. 11 as part of procedure 200 are merely exemplary of a single example of an implantation procedure, and steps shown may beABTSJM-0662PCT15979WOO1omitted, steps not shown may be included, and steps may be provided in any order deemed appropriate by the physician and / or medical personnel.

[0082] Although various components of a prosthetic heart valve 10 and delivery system 100 are described above, it should be understood that these components are merely intended to provide better context to the systems, features, and / or methods described below. Thus, various components of the systems described above may be modified or omitted as appropriate without affecting the systems, features, and / or methods described below. For example, prosthetic heart valves other than the specific configuration shown and described in connection with Figs. 1-3 may be used with delivery systems other than the specific configuration shown and described in connection with Figs. 4-10 as part of an implantation procedure that uses steps other than the specific configuration shown and described in connection with Fig. 11, without affecting the inventive systems, features, and / or methods described below.

[0083] A balloon inflation system, such as balloon inflation system 170, can be used during TAVR procedures. An indeflator, also referred to as a syringe (such as, for example, syringe 174 described above), of the balloon inflation system is used to inject a fluid, such as a saline-contrast solution, into a balloon to expand a valve that is collapsed or crimped onto the balloon. In most existing systems, this process is performed manually, similar to manual operation of an indeflator.

[0084] During delivery of a prosthetic heart valve, it may be important to precisely and accurately fdl the indeflator with a desired volume of fluid to deploy the valve to an accurate size. For example, in most existing systems, the indeflator is fully depressed to force all fluid out of the indeflator, instead of for example only forcing a portion of the fluid from the indeflator to finetune the level of balloon expansion. Thus, increasing the precision with which the indeflator is initially filled may allow for full depletion of the indeflator during balloon inflation to achieve precision in the inflation of the balloon, and corresponding precision in expansion and deployment of the prosthetic heart valve crimped thereon. Increased accuracy in deployed valve size within the patient advantageously reduces paravalvular leakage (PVL) and poor valve gradient that may result from underfilling the indeflator with fluid (and underinflating the balloon upon expelling all fluid from the indeflator). Increased accuracy in valve size also advantageously reduces the chance of conduction disturbances and annulus rupture from overfilling the indeflator with fluid (and overinflating the balloon upon expelling all fluid from the indeflator).ABTSJM-0662PCT15979WOO1

[0085] Certain existing indeflators have volume graduations in 1ml increments with thick graduation lines that make it difficult to accurately and precisely fill the indeflator with fluid. Further, fill volumes between the graduations may be difficult or impossible to achieve accurately, as there may be no visual indicator to correspond to the desired fill volume.

[0086] It is therefore desirable to provide balloon inflation systems including an indeflator that allows for more possible fill volumes, including fill volumes between visual markings, as well as increased accuracy and precision in filling.

[0087] Fig. 12 illustrates a indeflator 1200 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1200 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1200 is intended to be fully depressed to fully expel fluid within the indeflator 1200 toward the balloon. However, in some examples, indeflator 1200 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 1200 is intended to be fully depleted of fluid during balloon expansion. The indeflator 1200 caninclude amoving member 1210 and abarrel 1250. The moving member 1210 can include a plunger handle 1215 (also referred to as a plunger flange), a plunger 1220 connected to the plunger handle 1215 and positioned distally relative to the plunger handle 1215, and a seal 1230 connected to the plunger 1220 and positioned distally relative to plunger 1220. The seal 1230 may be configured to contact the interior surface of the barrel 1250 so that, when the plunger 1220 is pushed distally, fluid within the barrel 1250 is forced out of the distal end of the barrel 1250, for example through hub 1280 and tubing 1290 (described in greater detail below).

[0088] The barrel 1250 can include a fluid-containing portion 1255 and a barrel flange 1260 connected to the fluid-containing portion 2255 and positioned proximally relative to the fluidcontaining portion 1255. As shown in Fig. 12, the fluid-containing portion 1255 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 1255 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 1255 can include one or more visual markings indicative of a volume of fluid within theABTSJM-0662PCT15979WOO1fluid-containing portion 1255. The visual markings can include graduation lines 1255a and / or numerals 1255b. The visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 1250.

[0089] At a distal end of the barrel 1250, an adapter or hub 1280 can be coupled to the barrel 1250, allowing tubing 1290 to be in fluid communication with the fluid-containing portion 1255 of barrel 1250. The tubing 1290 can be fluidically connected downstream to a stopcock (not shown) and / or one or more components configured to increase accuracy and / or precision of fluid volume. The tubing 1290 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.

[0090] The fluid-containing portion 1255 of the barrel 1250 (or the barrel 1250 itself) can have a diameter d and a length I. The fluid-containing portion 1255 of the barrel 1250 can have a diameter d that is less than a diameter do of certain existing indeflator barrels. This can advantageously allow for more accurate filling of the fluid-containing portion 1255 of barrel 1250 with fluid. In order to deliver the same or substantially the same amount of fluid as certain existing indeflator barrels, a length I of the barrel 1250 will be greater than a length lo of certain existing indeflator barrels. In one example, the length / of the barrel 1250 can be calculated according to the following equation:

[0091] For inflation of a balloon, such as balloon 136 described above, it may be desirable to fill the barrel with up to 40mL of fluid or more. In this regard, the numerals 1255b can range from OmL to up to 40mL or more at regular intervals, and in one example can range from OmL to 42mL.

[0092] In one example, the fluid-containing portion 1255 can have a diameter of 1.9cm and have a length of 15cm, having graduation lines 1255a and / or numerals 1255b which can be provided at regular ImL intervals. For increased precision, the graduation lines 1255a and / or numerals 1255b can be provided at regular 0.5mL intervals. In this example, the length of the fluid-containing portion 1255 can be in the range of 20-40cm, and in one particular example is 30cm in length and 1.34cm in diameter. A thickness of graduation lines 1255a can be 0.5mm, which may still provide for adequate readability to the user while allowing for a relatively large number of graduation lines 1255a to be provided.

[0093] Fig. 13 illustrates a indeflator 1300 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1300 may beABTSJM-0662PCT15979WOO1particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1300 is intended to be fully depressed to fully expel fluid within the indeflator 1300 toward the balloon. However, in some examples, indeflator 1300 may be useful in an automated or semi -automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 1300 is intended to be fully depleted of fluid during balloon expansion. Similar to indeflator 1200 described above, indeflator 1300 can include a moving member 1310 and a barrel 1350. The moving member 1310 can include a plunger handle 1315 (also referred to as a plunger flange), a plunger 1320 connected to the plunger handle 1315 and positioned distally relative to the plunger handle 1315, and a seal 1330 connected to the plunger 1330 and positioned distally relative to plunger 1320. The seal 1330 may be configured to contact the interior surface of the barrel 1350 so that, when the plunger 1320 is pushed distally, fluid within the barrel 1350 is forced out of the distal end of the barrel 1350, for example through hub 1380 and tubing 1390 (described in greater detail below).

[0094] The barrel 1350 can include a fluid-containing portion 1355 and a barrel flange 1360 connected to the fluid-containing portion 1355 and positioned proximally relative to the fluidcontaining portion 1355. As shown in Fig. 13, the fluid-containing portion 1355 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 1355 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 1355 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 1355. The visual markings can include graduation lines 1355a and / or numerals 1355b. The visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 1350.

[0095] At a distal end of the barrel 1350, an adapter or hub 1380 can be coupled to the barrel 1350, allowing tubing 1390 to be in fluid communication with the fluid-containing portion 1355 of barrel 1350. The tubing 1390 can be fluidically connected downstream to a stopcock (not shown) and / or one or more components configured to increase accuracy and / or precision of fluid volume. The tubing 1390 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.ABTSJM-0662PCT15979WOO1

[0096] As shown in Fig. 13, an optical element 1370 can be positioned relative to the fluidcontaining portion 1355 so that the optical element magnifies the visual markings, including either or both of the graduation lines 1355a and / or numerals 1355b. The optical element 1370 can be any type of lens capable of magnification, and in one example is a biconvex lens. The optical element 1370 can have a magnification value of greater than 1.0, including a magnification value of at least 2.0.

[0097] The optical element 1370 can have an internal diameter that is greater or equal to an outer diameter of fluid-containing portion 1355 such that the optical element 1370 can be positioned radially outward of the fluid-containing portion 1355 of barrel 1350. In another example, the optical element 1370 is integral with the fluid-containing portion 1355 and / or barrel 1350 itself.

[0098] The optical element 1370 can extend along a portion or an entire length of the fluidcontaining portion 1355 of barrel 1350. In the example of Fig. 13, a distal edge 1370a of the optical element 1370 is positioned between a first or distal-most visual marking (e.g., the visual marking indicating the lowest volume) and the adapter or hub 1380. In the example of Fig. 13, a proximal edge 1370b of the optical element 1370 is positioned between a last or proximal-most visual marking (e g., the visual marking indicating the highest volume) and the barrel flange 1360. In another example, the optical element 1370 can extend along a portion of the length of the fluidcontaining portion 1355 and can be adjusted to magnify a subset of the visual markings. In this regard, the optical element 1370 can be slid proximally or distally to allow a desired visual marking to be magnified.

[0099] Since at least some or all of the of the visual markings can be magnified by the optical element 1370, a font size of at least some or all of the numerals 1355b can be reduced. For example, a font size (vertical character height) of the numerals 1355b can be 5 mm or less, and in one example is equal to or less than approximately 1mm. Advantageously, reducing the font size allows for a decrease in interval value of visual markings, allowing for greater precision and accuracy of volume. It should be understood that, although the optical element 1370 may not be strictly needed for other embodiments with larger sized markings, the optical element 1370 may nonetheless be applied to other indeflator embodiments described herein in which visual markings are positioned on the indeflator.

[0100] Fig. 14 illustrates a indeflator 1400 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1400 may beABTSJM-0662PCT15979WOO1particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1400 is intended to be fully depressed to fully expel fluid within the indeflator 1400 toward the balloon. However, in some examples, indeflator 1400 may be useful in an automated or semi -automated balloon inflation system, such as balloon inflation system 170 described above or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 1400 is intended to be fully depleted of fluid during balloon expansion. Similar to indeflators 1200 and / or 1300, indeflator 1400 can include amoving member 1410 and a barrel 1450. The moving member 1410 can include a plunger handle 1415 (also referred to as a plunger flange), a plunger 1420 connected to the plunger handle 1415 and positioned distally relative to the plunger handle 1415, and a seal 1430 connected to the plunger 1420 and positioned distally relative to plunger 1420. The seal 1430 may be configured to contact the interior surface of the barrel 1450 so that, when the plunger 1420 is pushed distally, fluid within the barrel 1450 is forced out of the distal end of the barrel 1450, for example through hub 1480 and tubing 1490 (described in greater detail below).

[0101] The barrel 1450 can include a fluid-containing portion 1455 and a barrel flange 1460 connected to the fluid-containing portion 1455 and positioned proximally relative to the fluidcontaining portion 1455. As shown in Fig. 14, the fluid-containing portion can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 1455 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 1455 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 1455. The visual markings can include graduation lines 1455a and / or numerals 1455b. The visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 1450.

[0102] At a distal end of the barrel 1450, an adapter or hub 1480 can be coupled to the barrel 1450, allowing tubing 1490 to be in fluid communication with the fluid-containing portion 1455 of barrel 1450. The tubing 1490 can be fluidically connected downstream to a stopcock (not shown) and / or one or more components configured to increase accuracy and / or precision of fluid volume. The tubing 1490 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.ABTSJM-0662PCT15979WOO1

[0103] In operation, a thickness of the seal 1430 can be greater than a thickness of the visual markings on the fluid-containing portion 1455, e.g., graduation lines 1455a and / or numerals 1455b, and a user may be confused regarding how to align the seal 1430 and markings to achieve accurate and precise volumes. To allow for better visual alignment of seal 1430 and visual markings, the seal 1430 can include a visual marking 1435 to allow a user to align the seal 1430 with a desired graduation line 1455a and / or numeral 1455b. A color of the visual marking 1435 may be different from one or both of a color of the seal 1430 and / or fluid so as to provide visual contrast among the visual marking 1435 and one or both of the seal 1430 and / or fluid. In this regard, the color of the visual marking 1435 can be a visually contrasting from the color of the seal 1430 and / or the fluid, and in one example the seal 1430 is black, the visual marking 1435 is red, and the fluid is clear, while in other examples the color of visual marking 1435 can be any color that creates visual contrast. The visual marking 1435 can be a color or dye applied to the seal 1430 or can be integrally molded with the seal 1430. In another example, the visual marking 1435 can be affixed, such as adhered, to the seal 1430.

[0104] In the example of Fig. 14, the visual marking 1435 is positioned distally on the seal 1430, but in other examples the visual marking can be positioned centrally or proximally on the seal 1430. It should be understood that visual marking 1435 may be incorporated into any other embodiment described herein in which a visual marking on the indeflator is configured to be compared to a position of the seal connected to the plunger.

[0105] Fig. 15 illustrates a indeflator 1500 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1500 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1500 is intended to be fully depressed to fully expel fluid within the indeflator 1500 toward the balloon. However, in some examples, indeflator 1500 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 1500 is intended to be fully depleted of fluid during balloon expansion. Similar to indeflator 1200, 1300, and / or 1400, indeflator 1500 can include a moving member 1510 and a barrel 1550. The moving member 1510 can include a plunger handle 1515 (also referred to as a plunger flange), a plunger 1520 connected to the plunger handle 1515 and positioned distally relative to the plunger handle 1515, and a seal 1530 connected to the plungerABTSJM-0662PCT15979WOO11520 and positioned distally relative to plunger 1 20. The seal 1530 may be configured to contact the interior surface of the barrel 1550 so that, when the plunger 1520 is pushed distally, fluid within the barrel 1550 is forced out of the distal end of the barrel 1550, for example through hub 1580 and tubing 1590 (described in greater detail below).

[0106] The barrel 1550 can include a fluid-containing portion 1555 and a barrel flange 1560 connected to the fluid-containing portion 1555 and positioned proximally relative to the fluidcontaining portion 1555. As shown in Fig. 15, the fluid-containing portion can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 1555 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 1555 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 1555. The visual markings can include graduation lines 1555a and / or numerals 1555b. The visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 1550.

[0107] At a distal end of the barrel 1550, an adapter or hub 1580 can be coupled to the barrel 1550, allowing tubing 1590 to be in fluid communication with the fluid-containing portion 1555 of barrel 1550. The tubing 1590 can be fluidically connected downstream to a stopcock (not shown) and / or one or more components configured to increase accuracy and / or precision of fluid volume. The tubing 1590 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.

[0108] As shown in Fig. 15, the fluid F is dyed or colored to increase a color contrast between fluid F, seal 1530, and / or visual markings (e.g. graduation lines 1555a and / or numerals 1555b) in order to enhance visibility of the visual markings and / or seal relative to the fluid F and to increase precision and accuracy of filling volume of fluid F within the barrel 1550. As shown in Fig. 15, the fluid F can be dyed to be a color that is different from a color of the seal 1530 so as to provide visual contrast among the seal 1530 and the fluid F. In this regard, the color of the fluid F can be a visually contrasting color from the color of the seal 1530, and in one example, the seal 1530 can be black, the fluid F can be red, and / or the visual markings (graduation lines 1555a and / or numerals 1555b) can be black, while in other examples the color of fluid F can be any color that creates visual contrast. It should be understood that, although a dyed or colored fluid F is described inABTSJM-0662PCT15979WOO1connection with indeflator 1500, the fluid filling the indeflator of any other embodiment herein may be colored or dyed, particularly for embodiments in which a visual marking on the indeflator is configured to be viewed against the backdrop of the fluid within the indeflator.

[0109] Fig. 16 is a schematic diagram illustrating a indeflator 1600 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system, in connection with a flow meter 1692. Indeflator 1600 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1600 is intended to be fully depressed to fully expel fluid within the indeflator 1600 toward the balloon. However, in some examples, indeflator 1600 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semi-automated) in which the indeflator 1600 is intended to be fully depleted of fluid during balloon expansion.

[0110] The indeflator 1600 can be similar to any one of indeflators 1200, 1300, 1400, and / or 1500 described above and can include a moving member 1610 and a barrel 1650, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, and / or 1500.

[0111] At a distal end of the barrel 1650, an adapter or hub (not shown, but which may be similar or identical to the adapters or hubs described elsewhere herein) can be coupled to the barrel 1650, allowing tubing 1690 to be in fluid communication with the fluid-containing portion of barrel 1650. The tubing 1690 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.

[0112] The tubing 1690 can also be fluidically connected to a flow meter 1692, which can be fluidically connected to a stopcock 1696 or other valve by tubing 1694, which may be considered part of tubing 1690.

[0113] The stopcock 1696 can be a three-way stopcock having a first port 1696a for fluidically connecting to flow meter 1692 (e.g., via tubing 1694), a second port 1696b for receiving a volume of fluid to be transmitted to the fluid-containing portion of barrel 1650, and a third port 1696c for transmitting the volume of fluid to a downstream balloon. The flow meter 1692 can be positioned between and fluidically connect the tubing 1690 and the tubing 1694 and can be positioned between the indeflator 1600 and a balloon of the balloon inflation system 170. In the example of Fig. 16, the flow meter 1692 is fluidically coupled to tubing 1690. In other examples, the flowABTSJM-0662PCT15979WOO1meter 1692 can be incorporated directly into the indeflator 1600 such that only a single tubing is required.

[0114] The stopcock 1696 can be incorporated to de-air the fluid delivered from indeflator 1600 to balloon, which is described in further detail in US 63 / 614,719, filed December 16, 2023, the entirety of which is herein incorporated by reference.

[0115] The flow meter 1692 can be any type of flow meter capable of measuring a flow rate of a fluid, such as one or more of an electromagnetic flow meter, differential pressure flow meter, mechanical or propeller flow meter, ultrasonic flow meter, and / or vortex flow meter. The flow meter 1692 can include one or more components typically present in a general -purpose computer, such as a processor, memory, and / or display. Additionally, or alternatively, the flow meter 1692 can be connected to an external computing device including a processor, memory, and / or display.

[0116] In operation, an amount of fluid to be delivered from the indeflator 1600 can be transmitted to the indeflator 1600 via port 1696b. In this regard, the fluid can pass into port 1696b, out of port 1696a, optionally through a tubing 1694, through flow meter 1692, optionally through a tubing 1690, and into the indeflator 1600. The flow meter 1692 can measure a rate of fluid flow passing from tubing 1694 to 1690. Based upon the measured flow rate, the flow meter 1692 (or an external computing device) can determine a total volume of fluid passing into the indeflator 1600, for example by integrating the flow rate over time. Alternatively or additionally, the flow meter 1692 can measure a flow rate, and subsequently volume, of fluid that leaves the indeflator to be transmitted to balloon. In one example, prior to filling the indeflator 1600, (i) the moving member 1610 may be fully depressed 1610, (ii) the stopcock 1696 may be in a condition in which the third port 1696c is closed and the first port 1696a and second port 1696b are open, (iii) third port 1696c may be flui dically coupled to a reservoir that includes the desired filling fluid (e.g. saline), and (iv) all tubing between the indeflator 1600 and the reservoir may be filled with fluid (e.g. saline). At this point, the moving member 1610 may be withdrawn to draw fluid from into the indeflator 1600, with the flow meter 1692 precisely tracking the volume of fluid passing through the flow meter 1692, and thus the volume of fluid passing into the indeflator 1600. Because the flow meter 1692 provides for highly precise tracking of fill volume, in some example the indeflator 1600 may exclude any sort of volume markings. However, in other embodiments, the indeflator 1600 may include volume markings, and in some examples any of the features described in connection Figs.ABTSJM-0662PCT15979WOO112-15 may be combined with a flow meter, for example to provide both automatic tracking of fdl volume and visual confirmation of fill volume.

[0117] Fig. 17 is a schematic diagram illustrating a indeflator 1700 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1700 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1700 is intended to be fully depressed to fully expel fluid within the indeflator 1700 toward the balloon. However, in some examples, indeflator 1700 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semi-automated) in which the indeflator 1700 is intended to be fully depleted of fluid during balloon expansion. Indeflator 1700 is shown in Fig. 17 in connection with a secondary measurement device 1792.

[0118] The indeflator 1700 can be similar to any one of indeflators 1200, 1300, 1400, 1500 and / or 1600 described above and can include a moving member 1710 and a barrel 1750, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500 and / or 1600. As shown, an external surface of the fluid-containing portion 1755 can include one or more visual markings indicative of a volume of fluid within the fluidcontaining portion 1755. The visual markings can include graduation lines 1755a and / or numerals 1755b. The visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 1750.

[0119] At a distal end of the barrel 1750, an adapter or hub 1780 can be coupled to the barrel 1750, allowing tubing 1790 to be in fluid communication with the fluid-containing portion 1755 of barrel 1750. The tubing 1790 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.

[0120] In this example, a secondary measurement device 1792 can be incorporated to measure a fluid volume prior to fdling the indeflator 1700. The secondary measurement device 1792 can be any type of measurement device capable of accurate fluid measurement, such as a graduated cylinder. In the example of Fig. 17, the secondary measurement device 1792 is a graduated cylinder having a volume of 25mL with graduation increments of 0.2mL. In other examples, the secondary measurement device can be a graduated cylinder having a volume of up to 60mL with graduation increments of 0.5mL and an accuracy of + / - 0.5mL.ABTSJM-0662PCT15979WOO1

[0121] In operation, secondary measurement device 1792 can be filled with a predetermined volume of fluid using graduation lines and / or numerals on the secondary measurement device. The predetermined volume of fluid can be transferred to the indeflator 1700, for example by a stopcock and tubing arrangement. Since the volume of fluid has already been measured, it is not necessary to confirm the volume with visual markings, e.g., graduation lines 1755a and / or numerals 1755b. In this regard, the indeflator 1700 may be devoid of such visual markings. Once the predetermined volume of fluid is transferred to indeflator 1700, as with all other examples of indeflators described herein, the inflation process can begin (including either via manual, automated, or semi-automated actuation of the indeflator 1700) once the prosthetic heart valve and balloon are in the desired position as described above. In this regard, a plunger of the moving member 1710 can be completely advanced to expel all of the fluid from the indeflator 1700 in order to inflate the balloon.

[0122] Fig. 18 is a schematic diagram illustrating a indeflator 1800 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1800 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1800 is intended to be fully depressed to fully expel fluid within the indeflator 1800 toward the balloon. However, in some examples, indeflator 1800 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semi-automated) in which the indeflator 1800 is intended to be fully depleted of fluid during balloon expansion. Indeflator 1800 is shown in Fig. 19 in connection with a scale 1892.

[0123] The indeflator 1800 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, and / or 1700 described above and can include a moving member 1810 and a barrel 1850, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600 and / or 1700.

[0124] At a distal end of the barrel 1850, an adapter or hub (not shown, but which me similar or identical to the other adapters or hubs described herein) can be coupled to the barrel 1850, allowing tubing 1890 to be in fluid communication with the fluid-containing portion of barrel 1850. The tubing 1890 can be fluidically connected to a three-way stopcock 1896. The tubing 1890 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter.ABTSJM-0662PCT15979WOO1

[0125] A scale 1892 can be incorporated to measure a weight of the fluid. The scale 1892 can include one or more components typically present in a general-purpose computer, such as a processor, memory, and / or display. Additionally, or alternatively, the scale 1892 can be connected to an external computing device including a processor, memory, and / or display. The measured weight can be converted to a volume, either by the scale 1892 or an external computing device, based upon a density of the fluid.

[0126] In one example, the weight of the fluid can be measured prior to filling the indeflator, for example in a container of known weight. In another example, the indeflator 1800 can be filled with fluid and the combination of the indeflator and fluid can be weighed. In this regard, the indeflator 1800 can have a known weight and the weight of the fluid will be the total weight less the weight of the indeflator.

[0127] Once the weight of the fluid is determined, the volume can be determined based upon an identified density of the fluid (e.g., a saline and contrast solution). The determined volume can be displayed to a user, for example, by an onboard display of the scale 1892 or by a display of an external computing device operably connected to the scale 1892. This calculation may be based upon the identified density, e.g., a known density that is relatively consistent for the entirety of the fluid. In some cases, the fluid may not have a consistent density. In this example, a hydrometer 1894 can be fluidically coupled to the stopcock 1896. The identified density can be measured by a hydrometer that can measure a real-time relative density (e.g. relative to water at 4 degrees Celsius) of the fluid, as the fluid is being provided to the indeflator 1800, which value can be provided to the scale 1892 to determine the volume based upon the measured weight and the measured real-time density. In another example, a densimeter can be incorporated instead of or in addition to a hydrometer 1894. The identified density can be measured by a densimeter that can measure a real-time absolute density of the liquid, which can be similarly used to calculate volume.

[0128] Fig. 19 is a schematic diagram illustrating a indeflator 1900 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 1800 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 1800 is intended to be fully depressed to fully expel fluid within the indeflator 1800 toward the balloon. However, in some examples, indeflator 1800 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated,ABTSJM-0662PCT15979WOO1or semi -automated) in which the indeflator 1800 is intended to be fully depleted of fluid during balloon expansion. Indeflator 1800 is shown in Fig. 19 in connection with a pressure sensor 1992.

[0129] The indeflator 1900 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, and / or 1800 described above and can include a moving member 1910 and a barrel 1950, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, and / or 1800.

[0130] At a distal end of the barrel 1950, an adapter or hub (not shown, but which can be similar or identical to any of the other adapters or hubs described herein) can be coupled to the barrel 1950, allowing tubing 1990 to be in fluid communication with the fluid-containing portion of barrel 1950. The tubing 1990 may also be fluidically connected, either directly or indirectly, to the interior space of a balloon of a balloon catheter. The tubing 1990 can be fluidically connected to a three-way stopcock 1996. The stopcock 1996 can be a three-way stopcock having a first port 1996a for fluidically connecting to indeflator 1900, a second port 1996b for receiving a volume of fluid to be transmitted to the fluid-containing portion of barrel 1950, and a third port 1996c for transmitting the volume of fluid to a downstream balloon. The stopcock 1996 can be incorporated to de-air the fluid delivered from indeflator 1900 to balloon, which is described in further detail in US Patent Application No. 18 / 955,260, filed November 21, 2024, the entirety of which is herein incorporated by reference. Generally, the de-airing may include ensuring that all fluidically connected volume between the indeflator 1900 and the balloon of the delivery device contains fluid (e.g. saline contrast solution) while having little or no air.

[0131] A pressure sensor 1992 can be incorporated to measure a pressure of the fluid passed from a second indeflator 1994 (or other secondary fluid reservoir) to indeflator 1900 or a pressure of fluid ejected from the indeflator 1900. The pressure sensor 1992 can be any type of pressure sensor, such as a strain gauge pressure sensor, capacitive pressure sensor, piezoelectric pressure sensor, optical pressure sensor, and / or resonant pressure sensor. The pressure sensor 1992 can include one or more components typically present in a general-purpose computer, such as a processor, memory, and / or display. Additionally, or alternatively, the pressure sensor 1992 can be connected to an external computing device including a processor, memory, and / or display.

[0132] The pressure sensor 1992 can measure a differential pressure of the fluid, and the pressure data can be provided to the processor and / or memory. The processor can then convert the differential pressure to a volume, and the volume can be displayed to a user via the display.ABTSJM-0662PCT15979WOO1

[0133] In Fig. 19, the sensor 1992 is depicted at a distal end of indeflator 1900, near the adapter or hub. In other examples, the sensor 1992 can be positioned anywhere on the indeflator 1900 or along tubing 1990.

[0134] In operation, the plunger 1930 can be fully retracted, as shown in Fig. 19, and locked in the fully retracted position. The indeflator 1900 can then be de-aired through the first port 1996a and the second part 1996b of the stopcock 1996. After de-airing is complete, the moving member 1910 would be substantially fully depressed. A second indeflator 1994 (or other secondary fluid reservoir) can be attached to the second port 1996b of the stopcock 1996, with the second indeflator 1994 having at least as much fluid as will be needed for balloon inflation, e.g., equal to or exceeding the desire fluid volume. The sensor 1992 can then take a first pressure measurement Pi at a first volume Vi of fluid inside the indeflator 1900. Since the indeflator is empty (or substantially empty), the first volume Vi=0. Then, the user opens the second port 1996b and allows the fluid to pass from the second indeflator 1994, through the first port 1996a, through the tubing 1990, and into the indeflator 1900. Third port 1996c is preferably closed during this process. After the first pressure measurement is taken, the pressure sensor 1992 can take continuous (or substantially continuous) pressure measurements.

[0135] As mentioned above, a processor that receives the pressure measurements can convert the differential pressures to volumes. This volume represents the volume of fluid inside the indeflator 1900 and can be calculated using Boyle’s law PiVi=P2V2, where Pi and Vi are the first measurement values and P2 and V2 represent the subsequent measurement values, with V2 being calculated based upon the measured values of P2. Since the plunger 1930 is initially fully retracted and locked, the indeflator 1900 represents a closed system in which Boyle’s law can be used to determine volume of fluid. Optionally, the processor can subtract the volume of fluid in tubing 1990 if the tubing has known parameters, such as length and internal diameter. The volume of fluid in the indeflator V2 can be displayed in real time for the user, and the user can cease injecting fluid into fluid port 1996b when the displayed volume value reaches the desired value. When the indeflator 1900 has been filled with the desired volume, the port 1996b may be closed and the second indeflator 1994 may be removed. A pressure sensor can be selected with an accuracy of at least 1 psi or better so that the pressure difference between the starting vacuum and the filled indeflator (whether completely filled or partially filled to the desired volume) can accurately and precisely reflect the volume of fluid of the filled indeflator.ABTSJM-0662PCT15979WOO1

[0136] Fig. 20 illustrates a indeflator 2000 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 2000 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 2000 is intended to be fully depressed to fully expel fluid within the indeflator 2000 toward the balloon. However, in some examples, indeflator 2000 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 2000 is intended to be fully depleted of fluid during balloon expansion.

[0137] The indeflator 2000 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800 and / or 1900 described above and can include a moving member 2010 and a barrel 2050, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800 and / or 1900.

[0138] The moving member 2010 can include a plunger handle 2015 (also referred to as a plunger flange), a plunger 2020 connected to the plunger handle 2015 and positioned distally relative to the plunger handle 2015, and a seal 2030 connected to the plunger 2020 and positioned distally relative to plunger 2020. The seal 2030 may be configured to contact the interior surface of the barrel 2050 so that, when the plunger 2020 is pushed distally, fluid within the barrel 2050 is forced out of the distal end of the barrel 2050, for example through a hub and / or tubing at a distal end of the barrel 2050.

[0139] The barrel 2050 can include a fluid-containing portion 2055 and a barrel flange 2060 connected to the fluid-containing portion 2055 and positioned proximally relative to the fluidcontaining portion 2055. As shown in Fig. 20, the fluid-containing portion 2055 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 2055 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 2055 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 2055, such as graduation lines and / or numerals. If included, the visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 2050.ABTSJM-0662PCT15979WOO1

[0140] The plunger 2020 can include one or more projections 2025a-b that extend radially outward from the plunger 2020. As shown in Fig. 20, the plunger 2020 includes a first plurality of projections 2025a that extend radially outward from the plunger 2020. The first plurality of projections 2025a can have any axial height (e.g. the dimension extending along a longitudinal axis of plunger 2020) and have a width (e.g. the dimension extending radially outward from the plunger 2020 toward the wall of the barrel 2050) that is less than a radius of fluid-containing portion 2055. The outer edge of projections 2025a can be curved and form an arc of a circle defining a first diameter.

[0141] Since the first plurality of projections 2025a are axially arranged (e.g. at regular or irregular axially-spaced intervals) and extend radially outward, recesses 2027a can be at least partially defined between pairs of axially-adjacent projections 2025a and an exterior surface of the plunger 2020. The first plurality of projections 2025a are axially aligned and can be axially spaced such that each of the first plurality of projections 2025a, or the recesses 2027a defined between adjacent of the first plurality of projections 2025a, correspond to a predetermined volume of fluid in the barrel 2050 when the projections 2065a-b are received within recesses 2027a-b, described in more detail below. In the example shown in Fig. 20, the plunger 2020 includes five projections 2025a and defines four recesses 2027a therebetween, but any number of projections 2025a and corresponding recesses 2027a can be implemented according to the parameters of the indeflator 2000.

[0142] The plunger 2020 can include a second plurality of projections 2025b that extend radially outward from the plunger 2020. As shown in Fig. 20, the plunger 2020 includes a second plurality of projections 2025b that extend radially outward from the plunger 2020 and are radially opposed to the first plurality of projections 2025a. The second plurality of projections 2025b can any axial height (e.g. the dimension extending along a longitudinal axis of plunger 2020) and have a width (e.g. the dimension extending radially outward from the plunger 2020 toward the wall of the barrel 2050) that is less than a radius of fluid-containing portion 2055, and in one example can have an axial height and a width that is identical to the first plurality of projections 2025a. The outer edge of projections 2025b can be curved and form an arc of a circle having the same first diameter as projections 2025a.

[0143] Since the second plurality of projections 2025b are axially arranged (e.g. at regular or irregular axially-spaced intervals) and extend radially outward, recesses 2027b can be at leastABTSJM-0662PCT15979WOO1partially defined between pairs of axi ally-adjacent projections 2025b and an exterior surface of the plunger 2020. The second plurality of projections 2025b are axially aligned and can be axially spaced such that each of the second plurality of projections 2025b, or the recesses 2027b defined between adjacent of the second plurality of projections 2025b, correspond to a predetermined volume of fluid in the barrel 2050 when the projections 2065a-b are received within recesses 2027a-b, described in more detail below. In the example shown in Fig. 20, the plunger 2020 includes five projections 2025b and defines four recesses 2027b therebetween, but any number of projections 2025b and corresponding recesses 2027b can be implemented according to the parameters of the indeflator 2000. Also in the example shown in Fig. 20, the number of projections 2025a is equal to the number of projections 2025b and the number of recesses 2027a is equal to the number of recesses 2027b.

[0144] The barrel flange 2060 can include a plurality of projections 2065a-b that extend radially inward from the barrel flange 2060. The first projection 2065a can have any axial height (e.g. the dimension extending along a longitudinal axis of plunger 2020) and have a width (e.g. the dimension extending radially inward from the barrel flange 2060 toward the plunger 2020) that is less than a radius of fluid-containing portion 2055. The inner edge of first projection 2065a can be curved and form an arc of a circle. In one example, the projection 2065a is sized and shaped to be received in recess 2027a defined by projections 2025a.

[0145] The second projection 2065b can have any axial height (e.g. the dimension extending along a longitudinal axis of plunger 2020) and have a width (e.g. the dimension extending radially inward from the barrel flange 2060 toward the plunger 2020) that is less than a radius of fluid-containing portion 2055 and is radially opposed to the first projection 2065a. In one example, the second projection 2065b is identical to first projection 2065a. The inner edge of second projection 2065b can be curved and form an arc of a circle. In one example, the second projection 2065b is sized and shaped to be received in recess 2027b defined by projections 2025b.

[0146] In operation, and beginning from a state in which the plunger 2020 and seal 2030 are completely retracted, the plunger 2020 can be advanced such that the projections 2025a-b approach projections 2065a-b. Where the projections 2025a-b are already out of axial alignment with the projections 2065a-b and the projections 2025a-b are axially aligned with radial spacings defined between projections 2065a-b, the plunger 2020 can continue to be advanced, unrestricted by projections 2065a-b.ABTSJM-0662PCT15979WOO1

[0147] Where the projections 2025a-b are axially aligned with the projections 2065a-b, the plunger 2020 can be advanced until the projections 2025a-b are stopped by the projections 2065a-b, since the outer edge of projections 2025a-b extend radially outward from the plunger 2020 relative to the outer edge of projections 2065a-b such that the plunger 2020 is prevented from further advancement.

[0148] The user may then rotate the plunger 2020 so that the projections 2025a-b are out of axial alignment with the projections 2065a-b and the projections 2025a-b are axially aligned with radial spacings defined between projections 2065a-b. In this regard, the external surface of the plunger 2020 can freely move axially relative to the projections 2065a-b. The plunger 2020 can be advanced until all of the projections 2025a-b are positioned distally relative to the projections 2065a-b, as shown in the state depicted in Fig. 20, and further advanced to the fully advanced state at which seal 2030 reaches the distal end of barrel 2050. In some examples, the indeflator 2000 can be provided to the user already in the fully advanced state.

[0149] With the plunger 2020 in the fully advanced state, a fluid port of the stopcock can be opened to allow for the indeflator 2000 to be filled with fluid from a secondary fluid reservoir (e.g. second indeflator 1994 described above).

[0150] To withdraw the plunger 2020, for example from the fully advanced state, and fill the indeflator 2000 with fluid, the user may begin to retract the plunger 2020. Where the projections 2025a-b are already out of axial alignment with the projections 2065a-b and the projections 2025a-b are axially aligned with radial spacings defined between projections 2065a-b, the plunger 2020 can continue to be retracted, unrestricted by projections 2065a-b.

[0151] Where the projections 2025a-b are axially aligned with the projections 2065a-b, the plunger 2020 may be retracted until the projections 2025a-b are stopped by projections 2065a-b. The user may then rotate the plunger 2020 so that the projections 2025a-b are out of axial alignment with the projections 2065a-b and the projections 2025a-b are axially aligned with radial spacings defined between projections 2065a-b.

[0152] The plunger 2020 can be retracted, drawing fluid into the indeflator 2000, until the projections 2025a-b (or recesses 2027a-b therebetween) corresponding to the desired fill volume are radially aligned with the projections 2065a-b. Once radially aligned and the desired fill volume is achieved, the plunger 2020 can be rotated so that the projections 2025a-b are axially aligned with the projections 2065a-b and the projections 2065a-b are received by the desired recessesABTSJM-0662PCT15979WOO12027a-b. Tn this state, axial movement of the plunger 2020, either distally or proximally, is prevented and the indeflator 2000 is in a locked state where fluid cannot be expelled.

[0153] To unlock the indeflator 2000 and allow for expelling of the fluid, the plunger 2020 can be rotated so that the projections 2025a-b are out of axial alignment with the projections 2065a-b and the projections 2025a-b are axially aligned with radial spacings defined between projections 2065a-b, allowing the plunger 2020 to be advanced, unrestricted by projections 2065a-b. The plunger 2020 can be completely advanced to expel all of the fluid from the indeflator 2000.

[0154] Advantageously, the indeflator 2000 can have a plurality of pre-set positions with predetermined volumes, with the pre-set positions being defined by engagement of the projections 2065a-b and the different recesses 2027a-b. In this regard, visual (or otherwise) measurement is not necessary to achieve accurate and precise filling of the indeflator 2000.While visual measurement is not necessary, the indeflator 2000 can nonetheless include one or more visual markings (such as graduation lines and / or numerals described above) for secondary confirmation that the desired fill volume is achieved.

[0155] Fig. 21 illustrates a indeflator 2100 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 2100 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 2100 is intended to be fully depressed to fully expel fluid within the indeflator 2100 toward the balloon. However, in some examples, indeflator 2100 may be useful in an automated or semi -automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 2000 is intended to be fully depleted of fluid during balloon expansion.

[0156] The indeflator 2100 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900 and / or 2000 described above and can include a moving member 2110 and a barrel 2150, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900 and / or 2000.

[0157] The moving member 2110 can include a plunger handle 2115 (also referred to as a plunger flange), a plunger 2120 connected to the plunger handle 2115 and positioned distally relative to the plunger handle 2115, and a seal 2130 connected to the plunger 2120 and positioned distally relative to plunger 2120. The seal 2130 may be configured to contact the interior surface of theABTSJM-0662PCT15979WOO1barrel 2150 so that, when the plunger 2120 is pushed distally, fluid within the barrel 2150 is forced out of the distal end of the barrel 2150, for example through a hub and / or tubing at a distal end of the barrel 2050.

[0158] The barrel 2150 can include a fluid-containing portion 2155 and a barrel flange 2160 connected to the fluid-containing portion 2155 and positioned proximally relative to the fluidcontaining portion 2155. As shown in Fig. 21, the fluid-containing portion 2155 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 2155 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 2155 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 2155, such as graduation lines and / or numerals. If included, the visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 2150.

[0159] The plunger 2120 can include one or more projections 2125 that extend radially outward from the plunger 2120. The projections 2125 can have any axial height (e.g. the dimension extending along a longitudinal axis of plunger 2020) and have a width (e.g. the dimension extending radially outward from the plunger 2020 toward the wall of the barrel 2050) that is less than a radius of plunger 2120. The outer edge of projections 2125 can be curved and form an arc of a circle defining a diameter.

[0160] As shown in Fig. 21, the projections 2125 may be arranged in a spiral or helical configuration relative to longitudinal extent of plunger 2120. In this regard, the projections 2125 can be axially spaced such that the projections 2125 can be positioned at spaced intervals along the longitudinal axis of the plunger 2120 and the projections 2125 correspond to a volume of fluid in the barrel 2150 when the particular projection 2125 engages with stopper 2165a, described in more detail below. The projections 2125 can also be radially spaced such that each of the projections 2125 is positioned at different circumferential positions relative to the plunger 2120. As shown in Fig. 21, since each of the projections is radially spaced, no two projections 2125 axially overlap, e.g. no two projections occupy the same arc of the circle corresponding to the cross-section of plunger 2120.ABTSJM-0662PCT15979WOO1

[0161] The barrel flange 2160 can include a locking mechanism 2165. The locking mechanism 2165 can have a stopper 2165a that is rotatable about the axial direction. An outer edge of the stopper 2165a can be curved and form an arc of a circle, and can be positioned so that the stopper 2165a axially overlaps with only one projection 2125 at a time. The locking mechanism 2165 can have a visual indicator, such as a dial, that associates rotational positions of the stopper 2165a and desired volumes of fluid within the barrel 2160.

[0162] In operation, the indeflator 2100 can be empty and prepared to receive the fluid. The user can then operate the locking mechanism 2165 to set a desired volume of fluid to be received into the indeflator 2100 (and eventually delivered from the indeflator 2100 during balloon inflation). This can be done by rotation of a dial, thus rotating the stopper 2165a relative to plunger 2120. The plunger 2120 may be restricted or from rotating. The user can then withdraw the plunger 2120 until the stopper 2165a confronts and / or contacts the projection 2125 and stops the plunger 2120 at a position corresponding to the desired volume. The desired volume can then be delivered as described above. Advantageously, the locking mechanism 2165 can be set once, prior to filling the indeflator 2100 with fluid, and there is no need for subsequent adjustment of the locking mechanism to ensure accurate volume delivery.

[0163] Fig. 22 illustrates a indeflator 2200 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 2200 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 2200 is intended to be fully depressed to fully expel fluid within the indeflator 2200 toward the balloon. However, in some examples, indeflator 2200 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semi-automated) in which the indeflator 2200 is intended to be fully depleted of fluid during balloon expansion.

[0164] The indeflator 2200 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000 and / or 2100 described above and can include a moving member 2210 and a barrel 2250, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000 and / or 2100.

[0165] The moving member 2210 can include a plunger handle 2215 (also referred to as a plunger flange), a plunger 2220 connected to the plunger handle 2215 and positioned distally relative toABTSJM-0662PCT15979WOO1the plunger handle 2215, and a seal 2230 connected to the plunger 2220 and positioned distally relative to plunger 2220. The seal 2230 may be configured to contact the interior surface of the barrel 2250 so that, when the plunger 2220 is pushed distally, fluid within the barrel 2250 is forced out of the distal end of the barrel 2250, for example through a hub and / or tubing at a distal end of the barrel 2250.

[0166] The barrel 2250 can include a fluid-containing portion 2255 and a barrel flange 2260 connected to the fluid-containing portion 2255 and positioned proximally relative to the fluidcontaining portion 2255. As shown in Fig. 22, the fluid-containing portion 2255 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 2255 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 2255 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 2255, such as graduation lines and / or numerals. If included, the visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 2250.

[0167] In operation, the indeflator 2200 can be filled with an amount of fluid equal to or greater than the desired amount. With the plunger 2220 at least partially or completely withdrawn, a spacer 2270 can be inserted between the plunger handle 2215 and the barrel flange 2260.

[0168] The spacer 2270 can be generally cylindrical shaped, having a length and a diameter. The spacer 2270 can define a central bore 2270a with a diameter that is at least equal to or greater than a diameter of plunger 2220 such that the plunger 2220 can pass through the central bore 2270a. The spacer 2270 can have a C-shaped cross section, defined by a proxi m al -to-distal recess (not shown), that allows the spacer 2270 to be placed and removed relative to plunger 2220.

[0169] In operation, a user may withdraw the plunger 2220, allowing the indeflator 2200 to be completely filled with fluid. A spacer 2270 can mounted to the indeflator 2200 such that the plunger 2220 is advanced until the spacer 2270 is flush with both barrel flange 2260 and plunger handle 2215, thus preventing further advancement of plunger 2220. A plurality of spacers 2270 can be provided, each spacer having a different length and a visual indicator corresponding to a desired amount of volume to be delivered, as will be explained below.ABTSJM-0662PCT15979WOO1

[0170] In operation, a user may fully retract the plunger 2220, allowing the indeflator 2200 to be completely filled with fluid. A spacer 2270 is selected such that, upon advancing the plunger 2220 from the fully retracted position to a position where the plunger 2220 is halted by the spacer 2270, a volume of fluid remains in the indeflator. In this way, an excess volume of fluid can be expelled from the indeflator 2200 such that the desired volume remains in the indeflator 2200. A length of the spacer 2270 is selected such that the plunger 2220 is halted when the excess volume is expelled and the desired volume remains in indeflator 2200. A plurality of spacers 2270 can be provided, each spacer having a different height and a visual indicator corresponding to a desired amount of volume to be delivered. With the desired volume of fluid in the indeflator 2200, the indeflator 2200 can be completely expelled of fluid after removing the spacer 2270 to deliver an accurate and precise volume of fluid during inflation.

[0171] Fig. 23 illustrates a indeflator 2300 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 2300 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 2300 is intended to be fully depressed to fully expel fluid within the indeflator 2300 toward the balloon. However, in some examples, indeflator 2300 may be useful in an automated or semi -automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semiautomated) in which the indeflator 2300 is intended to be fully depleted of fluid during balloon expansion.

[0172] The indeflator 2300 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and / or 2200 described above and can include a moving member 2310 and a barrel 2350, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900,2000, 2100 and / or 2200.

[0173] The moving member 2310 can include a plunger handle 2315 (also referred to as a plunger flange), a plunger 2320 connected to the plunger handle 2315 and positioned distally relative to the plunger handle 2315, and a seal 2330 connected to the plunger 2320 and positioned distally relative to plunger 2320. The seal 2330 may be configured to contact the interior surface of the barrel 2350 so that, when the plunger 2320 is pushed distally, fluid within the barrel 2350 is forcedABTSJM-0662PCT15979WOO1out of the distal end of the barrel 2350, for example through a hub and / or tubing at a distal end of the barrel 2350.

[0174] The barrel 2350 can include a fluid-containing portion 2355 and a barrel flange 2360 connected to the fluid-containing portion 2355 and positioned proximally relative to the fluidcontaining portion 2355. As shown in Fig. 23, the fluid-containing portion 2355 can be generally cylindrical and can define a circular cross section, with an internal surface of the fluid-containing portion 2355 defining an internal space for receiving a fluid. In other examples, the fluidcontaining portion can be any three-dimensional shape or have any cross-sectional shape capable of defining an internal space for receiving a fluid. An external surface of the fluid-containing portion 2355 can include one or more visual markings indicative of a volume of fluid within the fluid-containing portion 2355, such as graduation lines and / or numerals. If included, the visual markings can be applied in any suitable fashion, including for example by being printed (e.g. pad printed) or laser etched on the barrel 2350.

[0175] The plunger 2320 can include one or more projections comprising one or more detents 2325 that extend radially outward from the plunger 2320. The detents 2325 can be spherical or semi-spherical, and can be at least partially embedded within the plunger 2320 such that a portion of the detent 2325 extends radially outward from the plunger 2320. The detents 2325 can be spaced axially along the plunger 2320 such that each detent corresponds to a volume of fluid in the barrel 2350 when the particular detent 2325 is received within recess 2365, described in more detail below.

[0176] The barrel flange 2360 can define a recess 2365 configured to receive the detents 2325. In this regard, a surface of the barrel flange 2360 defining the recess 2365 can be spherical or semispherical and can conform to the shape of the detents 2325.

[0177] In operation, and beginning from a state in which the plunger 2320 and the seal 2330 are completely advanced, the indeflator 2300 can be withdrawn in order to fill the indeflator 2300 with a desired volume of fluid. The plunger 2320 can be withdrawn until the proximal -most detent 2325 encounters the barrel flange 2360. Upon further withdrawal, the detent 2325 can at least partially recede within plunger 2320. Upon further withdrawal, the detent 2325 returns to its original position and is received within the recess 2365. The contact between the detent 2325 and the recess 2365 may generate audible or tactile feedback, such as a clicking noise or a vibration detectableABTSJM-0662PCT15979WOO1by the user’s hand. In other examples, the detent 2325 may not recede within the plunger 2320, but may instead temporarily flex or compress to be withdrawn into the recess 2365.

[0178] If the detent 2325 received within recess 2365 corresponds to the desired volume, the user can halt withdrawing, with the indeflator being accurately and precisely filled with the desired volume. If the desired detent 2325 is still distally positioned relative to recess 2365, the user can continue to withdraw the plunger 2320 such that the recess 2365 sequentially engages with detents 2325 until the desired detent 2325 is received within the recess 2365. With the desired volume of fluid in the indeflator 2300, the indeflator 2300 can then be completely expelled of fluid to deliver an accurate and precise volume of fluid during inflation.

[0179] To expel the fluid, the plunger 2320 can be distally advanced. In doing so, the plunger 2320 can be advanced such that the recess 2365 sequentially engages with detents 2325 until the plunger 2320 is completely advanced, expelling all fluid from the indeflator. Since the detents 2325 recede within the plunger 2320 (or flex and / or compress), the detents 2325 do not significantly interfere with complete advancement of the plunger 2320. While visual measurement is not necessary, the indeflator 2300 can nonetheless include one or more visual markings (such as graduation lines and / or numerals described above) for secondary confirmation that the desired fill volume is achieved.

[0180] Upon completion of the filling procedure, the barrel flange 2360 can be adjusted or disengaged such that the detents 2325 no longer encounter the barrel flange 2360 during advance or withdrawal of the plunger 2320. For example, all or a portion of the barrel flange 2360 can be retracted radially outward to provide clearance for the detents 2326.

[0181] Fig. 24 is a perspective view of a indeflator 2400 (also referred to as a syringe, such as, for example, syringe 174 described above) for use in a balloon inflation system. Indeflator 2400 may be particularly useful for use in manual inflation of a balloon on a balloon catheter in which the indeflator 2400 is intended to be fully depressed to fully expel fluid within the indeflator 2400 toward the balloon. However, in some examples, indeflator 2400 may be useful in an automated or semi-automated balloon inflation system, such as balloon inflation system 170 described above, or more particularly in any balloon inflation system (whether manual, automated, or semi-automated) in which the indeflator 2400 is intended to be fully depleted of fluid during balloon expansion. Indeflator 2400 is shown in Fig. 24 in connection with an indeflator pump 2500.ABTSJM-0662PCT15979WOO1

[0182] The indeflator 2400 can be similar to any one of indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100, 2200, and / or 2300 described above and can include a moving member 2410 and a barrel 2450, and can include at least some or all of the elements or components described above with respect to indeflators 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100, 2200, and / or 2300.

[0183] The indeflator pump 2500 can include a indeflator holder block 2510 and adjustable clamp 2520 configured to secure the indeflator 2400 relative to a housing 2530 of indeflator pump 2500. The indeflator pump 2500 can also include a pusher block 2540 coupled to one or more rails 2550 such that the pusher block 2550 can be axially advanced, thereby advancing a moving member 2410 of indeflator 2400 and delivering fluid, or axially withdrawn, thereby allowing fluid to be received within the barrel 2450. The indeflator pump 2500 includes a user interface 2560 including a display 2570 and one or more inputs 2580, such as buttons. However, in other embodiments, the balloon inflation system 170 may be used in place of the indeflator pump 2500.

[0184] In operation, a user can mount the indeflator 2400 relative to indeflator pump 2500, with the moving member 2410 advanced completely relative to barrel 2450. In the example of Fig. 24, the indeflator 2400 can be a indeflator capable of receiving up to 60cc (60mL) of fluid within its fluid-containing portion and have visual markings at ImL or 2mL increments. The indeflator 2400 and any tubing (not shown, but which may be similar or identical to the tubing described elsewhere herein) in the system can be de-aired, for example using a three-way stopcock (not shown, but which may be similar or identical to the stopcock described elsewhere herein). The user can then input, using the user interface 2560, a desired amount of fluid to be received within barrel 2450 of indeflator 2400. The indeflator pump 2500, via one or more processors and / or motors onboard and the pusher block 2540, can withdraw the moving member 2410 until the desired volume of fluid is received within the barrel 2450 (e.g. from a fluid reservoir that is fluidically coupled to the indeflator 2400, not shown in Fig. 24). The indeflator 2400 can be filled at any fill speed by the indeflator pump 2500, and in one example can be filled at a rate of at least ImL / s or faster. The indeflator 2400 can be filled by the indeflator pump 2500 with an accuracy of + / - 0.5mL, which accuracy is less the increments of visual markings on the indeflator 2400 itself. While visual measurement is not necessary, the indeflator 2400 can nonetheless include one or more visual markings (such as graduation lines and / or numerals described above) for secondary confirmationABTSJM-0662PCT15979WOO1that the desired fill volume is achieved. The indeflator 2400 can then be used during an inflation operation.

[0185] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

ABTSJM-0662PCT15979WOO1CLAIMS1. An indeflator for a balloon inflation system, the indeflator comprising:a moving member; anda barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the cylindrical portion, wherein the visual markings include one of: (i) graduation lines at intervals of 0.5mL or (ii) numerals at intervals of 0.5mL.

2. The indeflator of claim 1, wherein the fluid-containing portion has a length between 20-40cm.

3. The indeflator of claim 1 or 2, wherein the fluid-containing portion has a length of 30cm and a diameter of 1.34cm.

4. The indeflator of any preceding claim, wherein the visual markings include graduation lines having a thickness of approximately 0.5mm.

5. The indeflator of any preceding claim, further comprising an optical element positioned over the fluid-containing portion of the barrel, the optical element configured to magnify at least a subset of the visual markings.

6. The indeflator of claim 5, wherein the visual markings include numerals having a font size of 1mm or less.

7. An indeflator for a balloon inflation system, the indeflator comprising:a moving member including a plunger and a seal, wherein the seal includes a seal visual marking; anda barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the fluid-containing portion.ABTSJM-0662PCT15979WOO18. The indeflator of claim 7, wherein the seal visual marking comprises a line having a color that is different from a color of the seal and / or a color of the fluid.

9. An indeflator for a balloon inflation system, the indeflator comprising:a moving member including a plunger and a seal; anda barrel having a fluid-containing portion defining an internal space to receive a fluid, wherein the fluid-containing portion has a plurality of visual markings indicative of a volume of fluid within the fluid-containing portion, wherein, when the fluid is received within the fluidcontaining portion, the fluid is a different color than a color of the seal.

10. The indeflator of claim 9, wherein, when the fluid is received within the fluid-containing portion, the fluid is a contrasting color from the color of the seal.

11. A balloon inflation system, comprising:an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; anda flow meter fluidically connected to the indeflator by a tubing, the flow meter configured to measure a rate of fluid flow to or from the indeflator, wherein a volume of fluid is determined based upon the rate of fluid flow.

12. The balloon inflation system of claim 11, further comprising:a stopcock fluidically coupled to the flow meter.

13. A method of filling an indeflator for use in a balloon inflation system, the method comprising:measuring a volume of fluid with a secondary measurement device, wherein the secondary measurement device is a graduated cylinder;transferring the measured volume of fluid to the indeflator; andABTSJM-0662PCT15979WOO1completely advancing a plunger of the moving member to pass an entirety of the measured volume of fluid to inflate a balloon of the balloon inflation system.

14. The method of claim 13, wherein the indeflator is devoid of visual markings indicative of volume15. A balloon inflation system, comprising:an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a cylindrical portion defining an internal space to receive a fluid; anda scale configured to measure a weight of the fluid, wherein the balloon inflation system is configured to determine a volume of the fluid based upon the measured weight of the fluid and an identified density of the fluid.

16. The balloon inflation system of claim 15, wherein (i) the identified density of the fluid is based upon a known constant density for an entirety of the fluid; or (ii) the identified density of the fluid is based on a real-time measurement by one of a hydrometer or a densimeter.

17. A balloon inflation system, comprising:an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; anda pressure sensor configured to measure a differential pressure of the fluid, wherein the balloon inflation system is configured to determine a volume of the fluid inside the fluidcontaining portion based upon the measured differential pressure.

18. An indeflator for a balloon inflation system, comprising:a moving member including a plunger and a seal, wherein the plunger includes a plurality of plunger projections extending radially outward from the plunger, each adjacent pair of the plurality of plunger projections defining a recess therebetween; andABTSJM-0662PCT15979WOO1a barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid and to receive a barrel flange, the barrel flange having at least one barrel flange projection configured to be received by the recess between any adjacent pair of the plurality of projections such that the indeflator defines a plurality of predetermined fill volumes.

19. The indeflator of claim 18, wherein the plurality of plunger projections includes a plurality of first plunger projections and a plurality of second plunger projections opposed to the plurality of first plunger projections.

20. The indeflator of claim 19, wherein the plurality of first plunger projections are axially aligned with each other.

21. The indeflator of claim 20, wherein the plunger is rotatable such that the plurality of first plunger projections are rotatable into and out of axial alignment with the at least one barrel flange projection such that, when the plurality of first plunger projections is axially aligned with the at least one barrel flange projection, axial movement of the plunger relative to the barrel is prevented.

22. An indeflator for a balloon inflation system, comprising:a moving member including a plunger and a seal, wherein the plunger includes a plurality of plunger projections extending radially outward from the plunger;a barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid;a locking mechanism including a rotatable stopper, the rotatable stopper configured to confront at least one of the plurality of plunger projections to prevent axial movement of the plunger relative to the fluid-containing portion.

23. A balloon inflation system, comprising:an indeflator including a moving member and a barrel, the moving member including a plunger, a handle, and a seal, the barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid; andABTSJM-0662PCT15979WOO1at least one spacer positionable between the handle and the barrel flange and configured to prevent distal axial movement of the moving member relative to the barrel when the handle and the barrel flange both contact opposite ends of the at least one spacer, wherein the at least one spacer has a height corresponding a predetermined volume to be expelled from the fluid-containing portion.

24. An indeflator for a balloon inflation system, comprising:a moving member including a plunger and a seal, wherein the plunger includes a plurality of detents extending radially outward from the plunger; anda barrel having a barrel flange and a fluid-containing portion defining an internal space to receive a fluid, the barrel flange having at least one recess configured to receive at least one of the plurality of detents.

25. A balloon inflation system, comprising:an indeflator including a moving member and a barrel, the moving member including a plunger and a seal, the barrel having a fluid-containing portion defining an internal space to receive a fluid; andan indeflator pump configured to operate the moving member to fill the indeflator with a predetermined volume of fluid.

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