Hemostasis valve for vascular device

Abstract

A hemostasis valve assembly may include a housing with a lumen extending between a proximal and distal opening. A nonpermeable membrane may have a proximal and distal ends operably coupled to a proximal and distal housing portions, respectively, so that a fluidly-sealed volume is created which is bounded in part by the membrane and in part by an interior surface of the housing, the lumen being bounded in part by the membrane. A piston is positioned at least partially within the housing, and a biasing member is operably coupled to the piston and is configured to apply force on the piston in a direction toward the membrane. When the fluidly sealed volume is filled with a noncompressible fluid, a first portion of the membrane is in contact with a second portion of the membrane to seal a portion of the lumen between the proximal opening and the distal opening.

Description

Hemostasis Valve for Vascular DeviceCross-reference to Related Applications

[0001] This application claims priority to the filing date of U.S. Provisional Patent Application No. 63 / 711,182, filed October 24, 2024, the disclosure of which is hereby incorporated by reference herein.Background of the Disclosure

[0002] Valvular heart disease, 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 “TA VI”) 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 balloon-expandable frame, often made of nitinol or another shape-memory metal or metal alloy (for self-expanding 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 luminalsurface, its exterior or abluminal surface, and / or on both surfaces. A cuff helps to ensure that blood docs 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] According to one aspect of the disclosure, a hemostasis valve assembly includes a housing having a proximal opening and a distal opening defining a lumen therebetween. The assembly may include a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly- sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane. The assembly may include a piston positioned at least partially within the housing, and a biasing member operably coupled to the piston, the biasing member configured to apply force on the piston in a direction toward the nonpermeable membrane. When the fluidly-sealed volume is filled with a noncompressible fluid, a first portion of the nonpermeable membrane may be in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening. A distal fitting may be coupled to the housing within the distal openingof the housing, the distal fitting including internal threaded configured to couple to a threaded hub of a catheter. A proximal fitting may be coupled to the housing within the proximal opening of the housing. A proximal gasket may be positioned between the proximal fitting and the housing, and a distal gasket may be positioned between the distal fitting and the housing. The proximal end of the nonpermeable membrane may be sandwiched between the proximal gasket and the housing, and the distal end of the nonpermeable membrane may be sandwiched between the distal gasket and the housing. The housing may include an extension member extending radially outward from the lumen, the biasing member and the piston being received within the extension member. The nonpermeable membrane may be formed of ePTFE. The assembly may include the noncompressible fluid, which may be saline. A piston gasket may form a seal between the piston and the housing. A cap may be coupled to the housing, the cap being translatable toward and away from the housing. The biasing member may have a first end in contact with the cap such that translation of the cap toward the housing is configured to compress the biasing member. The piston may include a shaft that extends through the housing to an exterior surface of the housing, the shaft being configured to be manually gripped to allow for manual compression of the biasing member.

[0006] According to another aspect of the disclosure, a hemostasis valve assembly includes a housing having a proximal opening and a distal opening defining a lumen therebetween. The assembly may include a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing, the lumen being bounded in part by the nonpermeable membrane. An inflatable balloon may be positioned between the nonpermeable membrane and the housing, a fluidly- sealed volume being created in part by the inflatable balloon. When the fluidly- sealed volume is filled with a noncompressible fluid, the inflatable balloon may be relatively inflated so that the inflatable balloon forces a first portion of the nonpermeable membrane into contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening. A piston may be positioned at least partially within the housing, and a biasing member may be operably coupled to the piston, the biasing member configured to apply force on the piston in a direction toward the nonpermeable membrane. When a device passes through the lumen, force applied from the device onto the nonpermeable membrane may be configured to deflate the balloon and force the noncompressible fluid fromthe balloon into contact with the piston to move the piston away from the nonpermeable membrane and compress the biasing member. A piston may be positioned at least partially within the housing, the piston having a first surface facing toward the nonpermeable membrane and a second surface facing away from the nonpermeable membrane, a closed chamber being formed between the housing and the second surface of the piston. A compressible gas may be within the closed chamber, the compressible gas configured to apply force on the piston in a direction toward the nonpermeable membrane. When a device passes through the lumen, force applied from the device onto the nonpermeable membrane may be configured to deflate the balloon and force the noncompressible fluid from the balloon into contact with the first surface of the piston to move the piston away from the nonpermeable membrane and to compress the compressible gas within the closed chamber. A diaphragm may be positioned at least partially within the housing, the diaphragm having a first surface facing toward the nonpermeable membrane and a second surface facing away from the nonpermeable membrane, a closed chamber being formed between the housing and the second surface of the diaphragm. A compressible gas may be within the closed chamber, the compressible gas configured to apply force on the diaphragm in a direction toward the nonpermeable membrane. When a device passes through the lumen, force applied from the device onto the nonpermeable membrane may be configured to deflate the balloon and force the noncompressible fluid from the balloon into contact with the first surface of the diaphragm to deflect the diaphragm away from the nonpermeable membrane and to compress the compressible gas within the closed chamber.

[0007] According to a further aspect of the disclosure, a hemostasis valve assembly may include a housing having a proximal opening and a distal opening defining a lumen therebetween. A nonpermeable membrane may have a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly- sealed volume is created, the fluidly- sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane. A compliant sleeve may surround an exterior portion of the housing, the fluidly- sealed volume being bounded in part by the compliant sleeve. A displacement volume may be bounded in part by the compliant sleeve and in part by the exterior portion of the housing. An aperture may be formed in a wall of the housing, the aperture fluidly connecting an interior portion of the housing with the displacement volume.When the fluidly-sealed volume is filled with a noncompressible fluid, a first portion of the nonpcrmcablc membrane may be in contact with a second portion of the nonpcrmcablc membrane to seal a portion of the lumen between the proximal opening and the distal opening. A recessed area may be formed in the exterior portion of the housing, the displacement volume being bounded in part by the recessed area. A proximal clamp ring may sandwich a proximal portion of the compliant sleeve against the housing, and a distal clamp ring may sandwich a distal portion of the compliant sleeve against the housing. The recessed area may be positioned between the proximal clamp ring and the distal clamp ring. The compliant sleeve may be formed of polyethylene terephthalate. When a device passes through the lumen, force applied from the device onto the nonpermeable membrane may be configured to displace fluid into the displacement volume and to cause the compliant sleeve to bulge radially outwardly.

[0008] According to an aspect of the disclosure, a method of positioning a device within a vasculature of a patient may include inserting a catheter into the vasculature, the catheter being coupled to a hemostasis valve assembly. Prior to advancing a device through the hemostasis valve assembly, a nonpermeable membrane within the hemostasis valve assembly may create a first seal due to a first portion of the nonpermeable membrane being in contact with a second portion of the nonpermeable membrane. While the first seal exists, the device may be advanced through the hemostasis valve assembly until the device presses against the nonpermeable member so that noncompressible fluid within a housing of the hemostasis valve assembly is displaced into a displacement chamber without substantially altering a pressure of the noncompressible fluid. The device may be continued to be advanced through the hemostasis valve assembly until the device is positioned at least partially within the catheter. While the device is positioned at least partially within the catheter, a second seal may be maintained by the nonpermeable member pressing against an outer surface of the device. The device may be a first device, and after continuing to advance the first device through the hemostasis valve assembly until the first device is at least partially within the catheter, a second device may be advanced over the first device until the second device presses against the nonpermeable member so that noncompressible fluid within the housing of the hemostasis is further displaced into the displacement chamber without substantially altering the pressure of the noncompressible fluid. The second device may be continued to be advanced through the hemostasis valve assembly until the second device is at least partially within the catheter,wherein while the second device is positioned at least partially within the catheter, a third seal is maintained by the nonpcrmcablc member pressing against an outer surface of the second device. The first device may be a guidewire having a diameter of between about 0.014 inches (about 0.35mm) and about 0.035 inches (about 0.9mm). The second device may be a delivery catheter of a prosthetic heart valve delivery device, the delivery catheter having an outer diameter between about 14 French (about 4.66mm) and about 40 French (about 13.33mm). Displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber may result in a piston moving away from the nonpermeable membrane and a spring in contact with the piston compressing. Displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber may result from a balloon deflating. The balloon may be filled with the noncompressible fluid and may be positioned between the nonpermeable membrane and the housing, the balloon being in fluid communication with the displacement chamber. Displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber may result in a compliant sleeve, which at least partially surrounds the housing, distending radially outwardly.

[0009] According to yet another aspect of the disclosure, a hemostasis valve assembly may include a housing having a proximal opening and a distal opening defining a lumen therebetween. A nonpermeable membrane may have a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly- sealed volume is created, the fluidly- sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane. A piston may be positioned at least partially within the housing. A biasing member may be operably coupled to the piston. When the fluidly-sealed volume is filled with a noncompressible fluid, (i) the biasing member may be configured to apply force on the piston in a direction toward the noncompressible fluid, and (ii) a first portion of the nonpermeable membrane may be in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening. A distal fitting may be coupled to the housing within the distal opening of the housing, the distal fitting having a proximal extension extending proximally from the distal fitting. The piston may have an annular shape, including an interior opening into which the proximal extension extends. A first gasket may be in contact with both (i) an interior surface of the pistonforming the interior opening and (ii) an exterior surface of the proximal extension. A second gasket may be in contact with both (i) an exterior surface of the piston confronting an interior surface of the housing and (ii) the interior surface of the housing. The biasing member may be a coil spring through which the proximal extension extends. The coil spring may have a first end in contact with the piston and a second end in contact with the distal fitting.

[0010] According to still another aspect of the disclosure, a hemostasis valve assembly may include a housing having a proximal opening and a distal opening defining a lumen therebetween. A nonpermeable membrane may have a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly-sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane. A first syringe may be coupled to the housing so that the first syringe is in fluid communication with an interior of the housing, the first syringe including a barrel, a plunger, a piston, and a biasing member operably coupled to the piston. When the fluidly-sealed volume is filled with a noncompressible fluid, (i) the biasing member may be configured to apply force on the piston in a direction toward the noncompressible fluid, and (ii) a first portion of the nonpermeable membrane may be in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening. The biasing member may be a coil spring through which a portion of the plunger extends. The coil spring may have a first end in contact with the piston and a second end in contact with the barrel. A second syringe may be coupled to the housing so that the second syringe is configured to be in fluid communication with the interior of the housing. A valve may be positioned between the second syringe and the housing, the valve having an open condition in which the second syringe is in fluid communication with the interior of the housing, and a closed condition in which the second syringe is not in fluid communication with the interior of the housing.

[0011] According to still a further aspect of the disclosure, a hemostasis valve assembly may include an inner housing having a proximal opening and a distal opening defining a lumen therebetween. An outer housing may at least partially surround the inner housing to create a pressure chamber between the inner housing and the outer housing, the inner housing defining at least one opening so that the pressure chamber is in fluid communication with an interior ofthe inner housing. A nonpermeahle membrane may have a proximal end operably coupled to a proximal portion of the inner housing and a distal end operably coupled to a distal portion of the inner housing. A pump may have an interior volume in fluid communication with the pressure chamber via a port in the outer housing so that a fluidly- sealed volume is created, the fluidly- sealed volume being bounded in part by an interior of the pump, in part by the outer housing, in part by the inner housing, and in part by the nonpermeable membrane. When the fluidly- sealed volume is filled with a compressible fluid and the compressible fluid is pressurized via the pump, a first portion of the nonpermeable membrane may be in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening. The compressible fluid may be a gas. The gas may be air. A proximal end of the nonpermeable member may be exposed to atmosphere so that, when the fluidly- sealed volume is filled with the compressible fluid and the compressible fluid is pressurized via the pump to a pressure that is greater than atmospheric pressure, the first portion of the nonpermeable membrane is in contact with the second portion of the nonpermeable membrane to seal the portion of the lumen between the proximal opening and the distal opening. The pump may include a pressure-relief valve. The pump may be a manually compressible pump. The pump may be a syringe.Brief Description of the Drawings

[0012] Fig. 1 is a perspective view of an example of a prosthetic heart valve.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] Fig. 5 is an enlarged view of the handle of the delivery system shown in Fig. 4.

[0017] Fig. 6 is an enlarged view of a distal end of the delivery system shown in Fig. 4.

[0018] Fig. 7 is a top view of an example of a balloon catheter when the balloon is inflated.

[0019] 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.

[0020] Fig. 9 is a side view of the inflation system of Fig. 8.

[0021] 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.

[0022] 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.

[0023] Fig. 12A is a side view of a hemostasis valve assembly according to an aspect of the disclosure.

[0024] Fig. 12B is a cross-section of the hemostasis valve assembly of Fig. 12A.

[0025] Fig. 12C shows the hemostasis valve assembly of Fig. 12B after a bladder thereof has been filled with fluid.

[0026] Fig. 12D shows the hemostasis valve assembly of Fig. 12C after fluid in the bladder has been displaced.

[0027] Figs. 13A-B are cross-sections of another example of a hemostasis valve assembly in two different sealing states.

[0028] Fig. 14A is a cross-section of a sealing mechanism having an alternate mechanism of action compared to that shown in Figs. 13A-B.

[0029] Figs. 14B-D are cross-sections of alternative options for pressure chambers to control the sealing mechanism of Fig. 14A.

[0030] Fig. 15A is a perspective view of a hemostasis valve assembly according to another aspect of the disclosure.

[0031] Fig. 15B is a cross-section of the hemostasis valve assembly of Fig. 15A.

[0032] Fig. 15C shows the hemostasis valve assembly of Fig. 15B after a bladder thereof has been filled with fluid.

[0033] Fig. 15D shows the hemostasis valve assembly of Fig. 15C after fluid in the bladder has been displaced.

[0034] Figs. 16A-16B are perspective and side views, respectively, of a hemostasis valve assembly according to another aspect of the disclosure.

[0035] Figs. 16C-16D are cross-sections of the hemostasis valve assembly of Figs. 16A-B in closed and open conditions, respectively.

[0036] Fig. 16E is a cross-section of an alternate view of the hemostasis valve of Figs. 16A-D.

[0037] Figs. 17A-B are cross-sections of a hemostasis valve assembly according to another aspect of the disclosure, in sealed and open conditions, respectively.

[0038] Fig. 18 is a cross-section of a hemostasis valve assembly according to a further aspect of the disclosure, shown in a pressurized condition.Detailed Description of the Disclosure

[0039] 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.

[0040] Fig. 1 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 outflow end 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 ofprosthetic 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.

[0041] 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.

[0042] 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 hexagon- shaped 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 zig-zag 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 zigzag 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 connectionwith hexagonal cells 32, additional frame structure, described in more detail below, is still provided in the outflow direction relative to the outflow-most row of hexagonal cells 32.

[0043] 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.

[0044] 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.

[0045] 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 strut 29 of the cell 32 attached to the first linking strut 35a.

[0046] 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 arc very stiff, particularly in comparison to self-expanding 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.

[0047] 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 byeach larger cell 34 when the 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.

[0048] 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.

[0049] 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, suchas 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”) or polytetrafluoroethylene (“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.

[0050] 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 thecircumference 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 not cover 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.

[0051] 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 examples 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 arecontrolled 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. Laflct 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.

[0052] The prosthetic heart valve 10 may be delivered via any suitable transvascular route, for example transapically or transfemorally. 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.

[0053] 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.

[0054] 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 anintroducer 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.

[0055] 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 tip 138 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.

[0056] 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, whenthere 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.

[0057] 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, handle 110 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.

[0058] 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 beoperably 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 the carriage 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.

[0059] 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 beactuated 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 prosthetic heart valve 10 from contact with the anatomy during deliver)'. 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.

[0060] 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 engagesinflation, 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 figure for 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.

[0061] 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 axiallyand 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.

[0062] 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 172 may 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.

[0063] 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 172via 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.

[0064] 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 (i.e. fluidly coupled to) 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 for withdrawal of fluid from the balloon 136 toward the syringe 174, for example based on whether the balloon actuator 120 is pressed forward or backward.

[0065] 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.

[0066] 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 withimplantation 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 of the 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 (includingrotational 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 be omitted, steps not shown may be included, and steps may be provided in any order deemed appropriate by the physician and / or medical personnel.

[0067] 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.

[0068] As noted above, delivery system 100 may be used with an introducer 150 that may have various different configurations. Introducers are used in many vascular procedures to assist in providing access of a treatment catheter into the patient’s vasculature through the introducer.For example, introducer 150 may be inserted into a patient’s femoral artery to provide access, with the remainder of the delivery system 100 (not including handle 110) being introduced into the patient’s vasculature through the introducer 150. Typically, introducer 150 includes a hemostasis valve or seal at or near a proximal hub thereof to help ensure that blood does not travel from the patient’s vasculature into and through the proximal end of the introducer 150 that remains outside the patient’s body. In certain procedures, including transcatheter aortic valve replacement procedures, devices of significantly different sizes (e.g. diameters) need to be inserted into the patient through the introducer 150 at different times. For example, at one or more points in the procedure, the only device that may pass through the introducer 150 is a guidewire GW having a very small diameter. At other points, a device (such as delivery catheter 130 or an overlying component) having a diameter of up to about 36 French (12mm) or 40 French (13.33mm) more may pass through the introducer 150. In some examples, delivery catheter 130 has a size of about 14 French (4.66mm). At other points in the procedure, no devices at all may pass through the introducer 150. It would be preferable for the hemostasis valve within introducer 150 to appropriately seal whether a large device, a small device, or no device passes through the introducer 150. It would also be preferable for the hemostasis valve provide an effective seal in all of these situations without the need for a user actively managing the seal (e.g. without having to actively manipulate or pressurize or depressurize the seal). The hemostasis valve assemblies described below may address one or more of these objectives. It should be understood that, although the hemostasis valve assemblies described below are generally described in the context of use with an introducer for a transcatheter aortic valve replacement procedure, the hemostasis valve assemblies described herein may be used with introducers for any other procedure that requires vascular access.

[0069] Fig. 12A is a side view of a hemostasis valve assembly 300 according to an aspect of the disclosure, and Fig. 12B is a cross-section of the hemostasis valve assembly 300. The hemostasis valve assembly 300 may be generally cylindrical (although variations from generally cylindrical shapes are possible). In the illustrated embodiment, the hemostasis valve assembly 300 includes a main housing or body 302 that may at least partially define an interior volume, described in greater detail below. In the specific embodiment shown in Figs. 12A-B, the hemostasis valve assembly 300 includes a proximal fitting 304 and a distal fitting 306. As best shown in Fig. 12B, the proximal fitting 304 may be a compression fitting that has anenlarged proximal head and an externally threaded shaft that may thread into a corresponding internally threaded proximal end of the housing 302. However, in both this embodiment and other embodiments described herein, the proximal fitting 304 may have a snap fit connection to the housing 302. In this embodiment, a seal or gasket such as an O-ring 304a may be positioned between an external shoulder of the proximal fitting 304 and a corresponding internal shoulder of the proximal housing 302 so that, upon threading the proximal fitting 304 into the housing 302, the O-ring 304a is compressed and a fluid tight seal is created around the outer surface of the proximal fitting 304. In the illustrated embodiment, the proximal fitting 304 includes an internal lumen that may be generally cylindrical, with an outward flare or taper at the inlet or proximal end to help guide devices, such as catheters, into the proximal fitting 304.

[0070] In the embodiment shown in Figs. 12A-B, the distal fitting 306 may also be a compression fitting that has an enlarged distal head and an externally threaded shaft that may thread into a corresponding internally threaded distal end of the housing 302. However, in both this embodiment and other embodiments described herein, the distal fitting 306 may have a snap fit connection to the housing 302. In this embodiment, a seal or gasket such as an O-ring 306a may be positioned between an external shoulder of the distal fitting 306 and a corresponding internal shoulder of the distal housing 302 so that, upon threading the distal fitting 306 into the housing 302, the O-ring 306a is compressed and a fluid tight seal is created around the outer surface of the distal fitting 306. In the illustrated embodiment, the distal fitting 306 includes an internal lumen that is generally cylindrical and which includes a smaller diameter proximal section, and a larger diameter distal section that is internally threaded. The internal threading 306b of the larger diameter distal section may allow for mating with external threading of a catheter to be inserted into the vasculature of a patient. In other words, the internal threading 306b may allow for modularity in that different types and sizes of catheters may be coupled to the hemostasis valve assembly 300 via threading into the distal fitting 306. However, in other embodiments a catheter may be fixedly coupled to (including being integrally formed with) the housing 302 and / or the distal fitting 306 without the ability to be modular. Similarly, in some embodiments, the proximal fitting 304 may instead be fixedly coupled to (including being integrally formed with) the housing 302. In these embodiments, the O-rings 304a and / or 306a may be able to be omitted if a suitable seal is provided as a result of direct coupling.Further, although threaded connections are one option to allow for coupling between the proximal fitting 304 and the housing 302, as well as between the distal fitting 306 and the housing 302, other options such as tapered connections may be suitable instead of the threaded connections shown, and in some cases if the coupling provides a suitable seal, the corresponding O-rings may be omitted.

[0071] Still referring to Fig. 12B, a fluid bladder 310 (which may also be referred to as a membrane, sock, or extrusion) may be provided interior to the housing 302. It should be understood that, in the view of Fig. 12B, the fluid bladder 310 is in a fully or nearly fully closed state, such that the interior lumen of proximal fitting 304 is not in fluid communication with the interior lumen of distal fitting 306 through the interior of the closed fluid bladder 310. In some embodiments, the fluid bladder 310 is formed as an extrusion or laminate. The fluid bladder 310 is substantially non-permeable, such that fluid cannot flow across a wall of the fluid bladder 310, and is substantially non-elastic. Preferably, the material forming the fluid bladder 310 is lubricious so that devices passing from the proximal fitting 304 to the distal fitting 306 readily slide axially along the fluid bladder 310 without being caught on the material forming the fluid bladder 310. In some examples, the fluid bladder 310 may be formed from expanded polytetrafluoroethylene (“ePTFE”), a material with both high tensile strength and natural lubricity, although other materials may be suitable alternatives. The fluid bladder 310 in some examples may be generally cylindrical. A first or proximal end of the fluid bladder 310 may be coupled to a proximal portion of the housing 302, such as by being sandwiched or pinched between the O-ring 304a and the internal shoulder of the housing 302 against which the O-ring 304a presses. Similarly, the second or distal end of the fluid bladder 310 may be coupled to a distal portion of the housing 302, such as by being sandwiched or pinched between the O-ring 306a and the internal shoulder of the housing 302 against which the O-ring 306a presses. In other embodiments, for example in which the O-rings 304a, 306a are omitted, the ends of the fluid bladder 310 may be otherwise sealingly secured against the housing 302 so that, when fluid is pressurized between the outer surface of the fluid bladder 310 and the interior of the housing 302, that pressurized fluid will not escape the housing 302 from the proximal or distal ends of the housing 302.

[0072] Referring to Fig. 12C, the hemostatic valve may be created, in pail, by injecting a non- compressible fluid F, such as saline, through an inflation lumen 320 and closing a valve 322to close the inflation lumen 320. Preferably, the fluid F completely fills the cavity volume positioned interior to the housing 302 and exterior to the wall of the fluid bladder 310, without activating the relief chambers 330, described in greater detail below.

[0073] Referring briefly back to Fig. 12A, the housing 302 may include one or more extensions 332 extending radially outwardly therefrom. In the illustrated embodiment, two extensions 332 are provided. In some embodiments, only a single extension 332 may be provided, or more than two extensions 332 may be provided. If multiple extensions 332 are provided, they are preferably, but not necessarily, spaced evenly around the circumference of the housing 302. For example, in the embodiment illustrated in Fig. 12A, two extension 332 are provided on diametrically opposite sides of the housing 302. Each extension 332 may include a cap 334 to close an opening of the extension 332, although in some embodiments, instead of a separate cap 334, the extension 332 may be formed integrally as a closed member. However, for purposes of ease of manufacturing and / or assembly, it may be preferable to form each extension 332 with an open end that is later closed with a separate cap 334. If one or more separate caps 334 are included, they may be fixed to the respective extension 332 in any suitable way, such as threads, adhesives, snap fit, etc.

[0074] Referring again to Fig. 12C, each extension 332 may each define a substantially cylindrical interior wall, with one end of the cylindrical volume being closed by the cap 334, and the other end of the cylindrical volume being closed by a piston 336, which may sealingly abut the cylindrical interior wall. In some examples, a separate gasket or O-ring 336a may be provided on or around the piston 336 to enhance the seal. Preferably, a biasing member such as a compression spring 340 is positioned within this space with one end of the compression spring 340 abutting the surface of the piston 336 facing away from the fluid F. The other end of the compression spring 340 may be in contact with (or fixed to) any supporting point, such as the interior-facing surface of the cap 334. As is explained in greater detail below, with this configuration, as pressure is applied to the fluid F, since the fluid F is non-compressible and there is no other pathway allowing the fluid F to escape, the pressure applied to the fluid F will tend to act on the piston 336 and cause the spring 340 to compress, moving the piston 336 toward the cap 334 and allowing the fluid F to occupy space within the relief chamber 330. It should be understood that due to the seal of the piston 336 against the interior wall of the extension 332, the fluid F can only occupy space within the relief chamber 330 on the side ofthe piston 336 opposite the spring 340. Fig. 12C shows the interior volume of the housing 302 filled with in initial scaling volume of fluid F that is the volume required to maintain a closed hemostasis valve (e.g. the fluid F creates enough pressure to force the fluid bladder 310 to remain closed) To ensure that the initial sealing volume (volume required to seal with no devices inserted through the hemostasis valve assembly 300) does not immediately fill the relief chambers 330 (which may also be referred to as displacement chambers), a volume of fluid F is introduced through the inflation lumen 320 with valve 322 open such that the interior pressure does not become greater than the combined force of the (1) resistance provided by the spring 340 and (2) friction between the piston 336 (and / or O-ring 336a) and the interior cylindrical wall of the relief chamber 330. With this initial condition shown in Fig. 12C, the volume of fluid F is enough to completely fill the interior volume of the housing 302, excluding the volume taken up by the material of the closed / compressed fluid bladder 310, and with the pistons 336 in their fully extended position (i.e. with the spring 334 at maximum relaxation or minimum compression), such that none of the fluid F occupies volume of the relief or displacement chamber(s) 330.

[0075] Fig. 12D illustrates the hemostasis valve assembly 300 in an example use configuration, where a catheter C has already been attached to distal fitting 306. Catheter C is illustrated in broken lines to illustrate that the specific details of catheter C are not important, and it may be any one of a plurality of different sizes or types of catheters C capable of modular use with the hemostasis valve assembly 300. In Fig. 12D, an example interventional device D has been passed through the proximal fitting 304, through the interior of the fluid bladder 310, through the distal fitting 306, and into an interior space of the catheter C coupled to the distal fitting 306. As with the catheter C, device D is illustrated in broken lines to illustrate that the specific details of device D are not important, and it may be any one of a plurality of different sizes or types of devices D capable of use with the hemostasis valve assembly 300, such as delivery system 100 (or components thereof such as delivery catheter 130).

[0076] As can be seen in Fig. 12D, as the device D is inserted through the seal (formed by fluid bladder 310 and the pressure acting on it by fluid F to tend to keep the fluid bladder 310 closed), a volume of the fluid F must be displaced to allow the fluid bladder 310 to open and to allow the device D to pass through the housing 302. As should be understood, the housing 302 is preferably constructed of a substantially non-compliant material, such as a non-compliantpolymer. In other words, the housing 302 is prevented from bulging or otherwise expanding outwardly as a result of the device D passing into the interior space of the housing 302. As the device D passes through the housing 302 and the fluid bladder 310 begins to open, the resulting forces - instead of causing the fluid F to compress (which is avoided because the fluid F is substantially non-compressible) - the forces overcome the resistance force of the spring(s) 340 and the friction between the piston 336 (and / or the O-ring 336a) and the interior wall of the relief or displacement chamber 330. This results in the spring(s) 340 compressing, and the piston(s) 336 moving radially outwardly, while maintaining a fluid-tight seal, creating additional available volume within the relief or displacement chamber 330 to receive displaced fluid F.

[0077] As should be understood from the above, if a relatively small device D (or no device D) passes through the interior of the housing 302, the spring(s) 340 remain relatively elongated and the piston(s) 336 are positioned relatively close to the interior volume of housing 302, which helps ensure the fluid F is able to help seal the fluid bladder 310 over the relatively small device D (or maintain a seal in the absence of device D). On the other hand, if a relatively large device D passes through the interior of the housing 302, the spring(s) 340 become relatively compressed and the piston(s) 336 are positioned relatively far from the interior volume of housing 302, which helps create enough space for the relatively large device D to pass through the housing 302 while the fluid F is able to maintain the seal between the fluid bladder 310 and the device D. In other words, manual adjustment of the hemostasis valve assembly 300 to maintain the seal for small (or no) devices D or for large devices D can be mostly or completely avoided, which may reduce or eliminates the complexity of the system and may reduce or eliminate the likelihood of user error resulting in blood flowing backwards from the patient’s vasculature proximally through the catheter C and through the hemostasis valve assembly 300.

[0078] In order to help ensure that the fluid bladder 310 is able to maintain a seal for all desired sizes of devices D that will pass through the hemostasis valve assembly 300, it may be important to provide relief or displacement chambers 330 having a total available interior volume to receive fluid F that is about equal to or larger than the maximum volume expected to be displaced by the largest-sized device D expected for use with the hemostasis valve assembly 300. For example, devices D that pass through the hemostasis valve assembly 300 are generally expected to have the same or similar outer profile as a cylinder. Thus, the totalamount of volume of fluid F that needs to be displaced when device D traverses the interior of the housing 302 can be estimated to be the same as the volume of a cylinder having the same outer diameter of the device D. Thus, the total displacement of volume of fluid F can be estimated as 7t*r2*h where r is the radius of the device D and h is the axial length of the fluid bladder 310. As one example, the largest device D that may be expected to pass through the hemostasis valve assembly 300 may be 36 French, which is an outer diameter of 12mm. In this example, the hemostasis valve assembly 300 may be designed to seal for all device D sizes of 36 French and smaller (including no device D passing through the hemostasis valve assembly, which may be represented as 0 to 36 French sealing range). It should be understood that this is just one example, and the hemostasis valve assembly 300 may be designed to seal against a range of sizes between 0 French and larger than 36 French, although as another example, the hemostasis valve assembly 300 may be designed to seal against a range of sizes between 0 French and about 24 French. However, in the specific example of a maximum sealing size of 36 French (12mm outer diameter or 6mm radius), and in this example the length of the fluid bladder 310 is 25.4mm, the maximum volume displacement of fluid F is about 2,872 mm3, calculated as v = 7r*6mm*6mm*25.4mm.

[0079] Continuing with the specific example above, the total volume available for filling within all of the relief or displacement chambers 330 should be about equal to 2,872 mm3. In this specific example, hemostasis valve assembly 300 includes a total of two relief or displacement chambers 330, meaning that - assuming each relief or displacement chamber 330 is identical - each should have an available internal volume of about 1,436 mm3. Suitable stroke lengths and internal diameters of the relief or displacement chambers 330 may thus be chosen to achieve the desired internal available volume of each relief of displacement chamber 330 to accommodate the maximum size device D contemplated for the particular hemostasis valve assembly 300. For example, continuing with the specific example above, each of the two relief or displacement chambers may be formed with a radius of 15mm and have a stroke length of 4mm (which may be defined as the maximum axial travel distance of the associated piston 336). As should be understood, the sum of the total available internal volume of the relief or displacement chambers 330 in this example is about 2,872 mm3, which allows for a device D of 36 French to pass through the hemostasis valve assembly 300.

[0080] It should be understood that, in some examples, the maximum sealing diameter of the hemostasis valve assembly 300, which may be the maximum diameter of the device D for which sealing is desired, may be about equal to the internal lumen diameter of the housing 302. In other words, it may be desirable to design the hemostasis valve assembly 300 to be capable of sealing across the entire range of sizes of device D which are capable of fitting within the housing 302.

[0081] It should be understood that the example calculations provided above are based on a total of two identical relief or displacement chambers 330, but the same calculations may be used to design a hemostasis valve assembly 300 with the desired total available displacement volume whether one, or more than three, relief or displacement chambers 330 are used, and whether the relief or displacement chambers 330 are identically or differently sized.

[0082] In some embodiments, it may be preferable that the maximum volume of fluid F that would get displaced into the relief or displacement chambers 330 is no more than about 20% of the total volume of fluid F within the housing 302. This may help to ensure there is enough fluid F within the housing 302 to press against the fluid bladder 310 and to ensure no leaks occur across the hemostasis valve assembly 300. In some examples, it may be preferable for the diameter of the fluid bladder 310 larger than the maximum diameter of the device D that will pass through the hemostasis valve assembly 300, including for example at least about 10% or about 20% larger.

[0083] It should be understood that sealing valves within hemostasis valve assemblies for introducer catheters have been used previously. However, these sealing or hemostasis valves are typically either duckbill or slit seals that are formed of a material such as silicone. Although such seals may work for their intended purpose, they do not work well across a large range of sizes of devices that are becoming more prevalent (for example the need to seal against both a small guidewire (e.g. between about 0.014 inches or 0.35mm to about 0.035 inches or 0.9mm in diameter) and a large e.g. 36F) delivery catheter. These older style valves may tend to tear if large devices are passed through them, and may also create high friction making use difficult. On the other hand, hemostasis valve assembly 300 provides a mechanism for constant (or substantially constant) pressure to be applied to keep a hemostasis valve closed whether a small or large device passes through the hemostasis valve assembly 300. Notably, this seal will be maintained across differently-sized devices without the need for any active management of theseal by the user. In some examples (including other embodiments described herein), the housing 302 may include an additional lumen to allow for purging of any air as needed, including for example during the initial filling, but in some examples such an additional lumen may be omitted and the presence of at least some air within the housing does not materially affect the functionality of the hemostasis valve assembly 300.

[0084] Figs. 13A-B are cross-sections of a hemostasis valve assembly 400 that has many similarities to hemostasis valve assembly 300. Hemostasis valve assembly 400 may include a housing 402 (preferably formed of a non-compliant material such as a non-compliant polymer) configured to allow a device D to pass through while maintaining a seal. The hemostasis valve assembly 400 may define a lumen for receiving a device D therethrough. For example, a distal opening 406 may be provided in a distal end of the housing 402, and a proximal opening 404 may be provided in a cap 460 (described in greater detail below) on a proximal end of the housing 402. In some embodiments, a fitting similar to proximal fitting 304 may be used on the proximal end of the hemostasis valve assembly 400, and / or a fitting similar to distal fitting 306 may be used on the distal end of the hemostasis valve assembly 400. At least part of the lumen may be surrounded by a fluid bladder 410, which may be substantially similar or identical to fluid bladder 310. For example, the fluid bladder 410 may be substantially cylindrical and may be formed of an elastomer such as a silicone material. In the particular example illustrated in Figs. 13A-B, the fluid bladder 410 has an hourglass-type shape, with the fluid bladder 410 extending radially inwards near an axial center thereof.

[0085] Referring to Fig. 13A, the housing 402 may include a fluid bladder 410 positioned therein, with a top or distal end of the fluid bladder 410 being coupled to the housing 402 on an interior of the distal surface defining the distal opening 406, and a proximal or bottom end of the fluid bladder 410 being coupled to an interior shelf 412 of the housing 402. The interior shelf 412 may be positioned in a middle axial portion of the housing 402, and may have a generally annular shape with an interior opening that defines part of the lumen extending between the proximal opening 404 and distal opening 406. One or more apertures 450 may be positioned through the thickness of the interior shelf 412, with each aperture 450 leading into a relief or displacement chamber 430 which may function similar to relief or displacement chambers 330. In the illustrated embodiment, two displacement chambers 430 are provided, but as withhemostasis valve assembly 300, one or more than two displacement chambers 430 may be provided in alternate embodiments.

[0086] Still referring to Fig. 13A, each displacement chamber 430 may include a piston 436 which may have a leading end that seals directly against an interior surface of the chamber 430. In some embodiments, a separate or additional gasket or seal 436a may be provided on or with the head of the piston 436 to assist in maintaining a good seal. In the illustrated embodiment, biasing member such as a spring 440 may be positioned around a shaft of the piston 436, such that a leading end of the spring 440 contacts a surface of the head of the piston 436 facing away from the fluid F, and a trailing end of the spring 440 is secured to or in contact with another surface, such as a distal surface of cap 460. In some embodiments, the shaft of the piston 436 may extend through the cap 460 to be accessible by a user for a quick-release functionality, described in greater detail below. With this configuration, similar to hemostasis valve assembly 300, an enclosed volume is created that has boundaries of (i) interior surfaces of the housing 402, (ii) the surface of the fluid bladder 410 facing away from the axial center of the assembly 400, and (iii) the leading surface of the piston 436 (or the seal 436a). This interior volume may be filled with a non-compressible fluid F, such as a biocompatible liquid, such as saline or other biocompatible liquids such as glycerin or biocompatible oils, similar or identical to the fluid F of hemostasis valve assembly 300. It should be understood that, as with fluid bladder 310, fluid bladder 410 is non-permeable so that the fluid F cannot pass through the material forming the fluid bladder 410.

[0087] Still referring to Fig. 13A, when no devices D pass through the hemostasis valve assembly 400, the springs 440 are in a relatively extended positions which imparts force on the piston 436 (and / or seal 436a) toward the fluid F, and since the fluid F cannot meaningfully compress, the fluid F causes a middle portion of the fluid bladder 410 to compress radially inward to have the hourglass shape shown in Fig. 13A, in which the fluid bladder 410 is contacts itself across the lumen between proximal opening 404 and distal opening 406. This results in the hemostasis valve assembly 400 being sealed even when no devices D pass through the hemostasis valve assembly 400, in substantially the same fashion as described in connection with hemostasis valve assembly 300.

[0088] Still referring to Fig. 13A, in some embodiments, the hemostasis valve assembly 400 may include a cap 460 that is movably coupled to the housing 402. For example, in the illustratedembodiment, the cap 460 includes an internal sidewall with threads that engage complementary threads on an external sidewall of the housing 402. With this configuration, the cap 460 may be rotated to cause the springs 440 to either compress or relax, which may allow an initial pressure of the fluid F to be set (or at least an initial distribution of where the fluid F is located if there is not a substantial change in pressure of the fluid F). In some embodiments, the sides of the cap 460 may be able to rotate without causing corresponding rotation of a proximal face of the cap, while translation of the sides of the cap 460 does result in translation of the proximal face of the cap and thus elongation or relaxation of the springs 440 that contact the cap 460. For example, if the fluid bladder 410 does not adequately seal the central lumen of the hemostasis valve assembly 400 when there are no devices extending through the hemostasis valve assembly 400, the cap 460 may be rotated to compress the springs 440, which will tend to drive the pistons 436 forward to press against the fluid F, which in turn will tend to force the middle portion of the fluid bladder 410 to collapse radially inwardly to create (or enhance) the seal. It should be understood that this rotatable cap 460 is not a necessary feature, and may be omitted if the fluid F is properly pressurized initially. However, the rotatable cap 460 may provide additional levels of control which may be desirable. And while cap 460 is described as functioning via rotation to cause the desired translations that compresses or elongates the springs 440, other mechanisms may be used to achieve the translational movement, such as a ratcheting mechanism or any other suitable mechanism.

[0089] In some embodiments, the proximal face of the cap 460 may include through bores so that shafts of the pistons 436 are accessible outside of the cap 460. If this optional feature is included, the user may be able to manually adjust the pressure acting on the fluid F quickly by pulling the shaft(s) of the piston(s) 436 proximally. This quick-adjust feature may be desirable just prior to inserting a large device D through the hemostasis valve assembly 400 to move the middle of the fluid bladder 410 radially outwardly. It should be understood that this feature may not be necessary, and contact between the device D and the closed fluid bladder 410 may suitably force the fluid bladder 410 to open while maintaining a seal. However, depending on the particular size and shape of the device D, some amount of undesirable friction may result from contact of the device D and the fluid bladder 410, and such friction could be avoided or relieved by manually pulling the shaft(s) of the piston(s) 436. If this method is used, once the device D fully traverses the hemostasis valve assembly 400, the manual force on the piston(s)436 may be released to allow the spring(s) 440 to begin to extend again, helping to ensure a proper seal between the outer surface of the device D and the radially-inward facing surface of the fluid bladder 410. One particular example of the benefit of this quick-release mechanism is if a balloon-expandable prosthetic heart valve is being passed through the hemostasis valve assembly 400 without a separate loader sheath or other protective member overlying the collapsed prosthetic heart valve. In such examples, high levels of friction acting on the prosthetic heart valve could dislodge it from the desired position it has on the collapsed balloon of the delivery device. Another example of the benefit of this quick-release mechanism is if a self-expanding prosthetic heart valve is loaded within a delivery sheath being pushed through the hemostasis valve assembly 400. In that example, if there is too much friction between the fluid bladder 410 and the delivery sheath, the delivery sheath may become momentarily “stuck” while an inner catheter carrying the prosthetic heart valve continues to advance, which could result in the prosthetic heart valve being prematurely pushed out of the delivery sheath due to the friction. However, as noted above, if the fluid bladder 410 has sufficient lubricity, the resulting friction may not be large enough to cause issues that would require the use of the optional quick-release mechanism.

[0090] Fig. 13B illustrates an example of the hemostasis valve assembly 400 after a device D has been passed through the hemostasis valve assembly 400 such that the device D fully traverses the assembly 400. As with hemostasis valve assembly 300, the device D is shown with respect to hemostasis valve assembly 400 in dashed lines to represent the fact that the specific construction of the device D is not particularly important, and it could be a device as small as a guidewire or as large as a large bore catheter. Although not shown in Fig 13B, another catheter or sheath would be expected to extend distally from the housing 402 such that the device D is positioned interior to that sheath, at least for some length. As can be seen in Fig.13B, the device D forces the middle portion of the fluid bladder 410 to extend radially outwardly, pushing fluid F through the aperture(s) 450 and fill some amount of the relief or displacement chamber(s) 430. This in turn pushes the piston(s) 436 proximally, compressing spring(s) 440 in the process. The compressed spring(s) 440 help maintain pressure on the fluid F to force the fluid bladder 410 to seal against the outer surface of the device D, regardless of whether the device D has a large diameter or smaller diameter (or even, as noted above, when no such device D passes through the hemostasis valve assembly 400.

[0091] It should be understood that, although fluid F is described as a substantially non- comprcssiblc liquid, in some examples, fluid F may be a compressible gas. In this type of example, the compressive nature of the gas itself may be used to expand or compress the fluid bladder 410, instead of movement of the fluid F into or out of the relief or displacement chamber(s) 430. Thus, if a compressible gas is used for fluid F, the mechanism of the piston(s) 436 and spring(s) 440 nay be omitted. However, even if a compressible gas is used for fluid F, the inclusion of the piston(s) 436 and spring(s) 440, particularly with the adjustable cap 460, may be useful to allow for manual adjustment of the pressure acting on the compressible gas. It should be understood that this alternative generally applies to the embodiment of hemostasis valve assembly 300 described above.

[0092] Fig. 14A is a cross-section of another hemostasis valve assembly 500 according to an aspect of the disclosure. It should be understood that Fig. 14A only shows a portion of the hemostasis valve assembly 500, and components not shown or described may be similar or identical to their counterpart components described in connection with hemostasis valve assembly 400. For example, Fig. 14A shows a fluid bladder 510 that may be similar or identical to fluid bladder 410. Fig. 14A also shows a housing 502 which may be generally similar to housing 402. However, in this embodiment, instead of a volume between the housing 402 and fluid bladder 410 being filled with a fluid F, instead a balloon B is positioned between the fluid bladder 510 and the housing 502. In the illustrated example, the housing 502 may include a recess in which the balloon B at least partially sits, although other specific constructions of housing 502 may be suitable. In one example, the balloon B may have the general shape of a toms or donut, but the balloon B may take other shapes as well.

[0093] Whereas in the embodiment of hemostasis valve assembly 400, it is the fluid F acting directly on the fluid bladder 410 to cause the center portion thereof to collapse or expand to maintain a seal against a device D passing through the hemostasis valve assembly 400, the embodiment of hemostasis valve assembly 500 relies on inflation or deflation of the balloon B to achieve the same effect. The balloon B may be pressurized (or depressurized) to inflate (or deflate) the balloon B by any suitable mechanism. In on example, shown in Fig. 14B, a pressure chamber that is similar or identical to piston-and- spring configuration of hemostasis valve assembly 400 may be used. For example, in Fig. 14B, a piston 536’ may include a gasket or seal, such as O-ring 536a’, that seals against an internal surface of a relief or displacementchamber 530’. A biasing member such as a spring 540’ may surround at least a portion of a shaft extending from the piston 536. Although not explicitly shown in Fig. 14B, a distal end of the relief or displacement chamber 530’ may be in fluid communication with an interior of the balloon B, with the balloon B and the relief or displacement chamber 530’ being filled with a fluid F, which may be a non-compressible liquid as described for the embodiments above. In this particular example, the balloon B will be inflated enough to seal the hemostasis valve assembly 500 when no devices pass through the hemostasis valve assembly 500. As a device D passes through the hemostasis valve assembly 500, force from the device D pressing on the balloon B will tend to deflate the balloon B and fill the relief or displacement chamber 530’, with compression of the spring 540’ helping to maintain a constant sealing force between the balloon B and the device D. This particular mechanism is similar to hemostasis valve assembly 400 and the other components and functions described in connection with hemostasis valve assembly 400 may apply with equal force to the version of hemostasis valve assembly 500 that includes the mechanism of Fig. 14B.

[0094] Instead of using the spring-loaded piston of Fig. 14B to maintain pressure in the balloon B, other mechanisms that use a compressible gas G may be used, such as those shown in Figs.14C-D. For example, in Fig. 14C, an alternative relief or displacement chamber 530” is provided that is filled mostly with fluid F (e.g. a non-compressible liquid) that is in fluid communication with the interior of the balloon B. However, instead of a spring-loaded piston, the mechanism of Fig. 14C includes an impermeable diaphragm 536”, with a compressible gas G occupying volume on the side of the diaphragm 536” opposite the fluid F. In this embodiment, as a device D passes through the hemostasis valve assembly 500, force from the device D pressing on the balloon B will tend to deflate the balloon B and fill the relief or displacement chamber 530”, with the diaphragm 536” flexing downwardly and compressing gas G, causing an increase in pressure of the gas G, which has an effect similar to compressing the spring 540’ of the mechanism in Fig. 14B. Fig. 14D shows another alternate version of the mechanism of Fig. 14C. The mechanism of Fig. 14D also includes a compressible gas G, but instead of the compressible gas G and the non-compressible fluid F being separate by a diaphragm 536’ ’ , the are separated by a piston head 536’ ” , which may include a gasket or seal such as an O-ring 536a”’. The mechanism of action of the example of Fig. 14D is essentially equivalent to that shown in Fig. 14C, with the exception that it is the movement of the pistonhead 536”’ which compresses or decompresses the gas G, instead of flexing of the diaphragm 536” shown and described in connection with Fig. 14C. Although Figs. 14C-D describe a bottom chamber that is filled with a compressible gas G, it should be understood that other media, such as a compressible foam, may be used in place of the compressible gas G.

[0095] Fig. 15A shows a perspective view of a hemostasis valve assembly 600 according to another aspect of the disclosure. Hemostasis valve assembly 600 is substantially similar to hemostasis valve assembly 300, with one main exception being that pressure to maintain the seal is achieved by a compliant sleeve in hemostasis valve assembly 600, compared to the spring-loaded piston(s) of hemostasis valve assembly 300. Thus, certain features of hemostasis valve assembly 600 are either similar or identical to those described and / or shown in connection with hemostasis valve assembly 300, and those components will not be described in detail again here.

[0096] Referring to still to Fig. 15A, hemostasis valve assembly 600 may include a proximal fitting 604 which may be substantially similar or identical to proximal fitting 304, and a distal fitting 606 which may be substantially similar or identical to distal fitting 306. The proximal fitting 604 and distal fitting 606 may each be connected to a housing or body 602 which may be generally similar to housing 302, with certain differences described in greater detail below. Instead of including extensions 332, hemostasis valve assembly 600 may include a compliant sleeve 634 that overlies portions of the housing 602. The compliant sleeve 634 may be coupled to the housing 602 in any suitable fashion, including via a proximal crimp ring 632a and a distal crimp ring 632b.

[0097] Fig. 15B shows a cross-section of the hemostasis valve assembly 600 prior to being filled with any fluid. The proximal fitting 604 may be coupled to the housing 602 via threads or any other suitable mechanism, as described in connection with proximal fitting 302. The distal fitting 606 may be coupled to the housing 602 via threads or any other suitable mechanism, as described in connection with distal fitting 306. The distal fitting 606 may also include internal threads 606b for connection to a catheter C, similar or identical to distal fitting 306. It should also be understood that the possible variations described in connection with proximal fitting 304 and distal fitting 306 may apply to proximal fitting 604 and distal fitting 606.

[0098] Still referring to Fig. 15B, hemostasis valve assembly 600 may include a fluid bladder 610, which may be similar or identical to fluid bladder 310, including the option of coupling thefluid bladder 610 to housing 602 with the aid of proximal gasket or O-ring 604a (which may be similar or identical to O-ring 304a) and distal gasket or O-ring 606a (which may be similar or identical to O-ring 306a). As noted above, and as shown in Fig. 15B, a compliant sleeve 634, which may be substantially cylindrical in shape (when the compliant sleeve is nonextended), overlies and surrounds at least a part of the housing 602. The wall of the housing 602 may include or define one or more through bores 602a, which may be generally circular or cylindrical ports (although other shapes may be suitable). As shown in Fig. 15B, the ports 602a may be positioned only along portions of the housing 602 between the crimp rings 632a, 632b. With this configuration, the interior of the housing 602 (not including space partitioned by the fluid bladder 610) is in fluid communication with a volume between the exterior of the housing 602 and the interior of the compliant sleeve 634. In some embodiments, including that shown in Fig. 15B, the wall of the housing 602 may include a recess or divot or other depression in an exterior surface thereof that defines a relief or displacement chamber 630. This relief or displacement chamber 630 may have an annular shape and may be fluidly sealed between the compliant sleeve 634 and the fluid bladder 610. The compliant sleeve 634 may be formed of any suitable compliant polymer, including for example a polyethylene terephthalate (“PET”) weave that is coated to make the sleeve 634 fluid-impermeable In some examples, the sleeve 634 may be formed as an extrusion or a laminate. As explained in more detail below, the compliant sleeve 634 is capable of expanding under pressure to increase the size of the relief or displacement chamber 630, providing a similar effect as hemostasis valve assembly 300, with a different mechanism of action.

[0099] Fig. 15C illustrates the hemostasis valve assembly 600 after being initially filled with a fluid, for example using an inflation lumen 620 and valve 622 (which may be similar or identical to inflation lumen 320 and valve 322). In some examples (including other embodiments described herein), the housing 602 may include an additional lumen to allow for purging of any air as needed, including for example during the initial filling, but in some examples such an additional lumen may be omitted and the presence of at least some air within the housing does not materially affect the functionality of the hemostasis valve assembly 600. After the initial fill with fluid F (which may be any of the fluids described above, including a substantially non-compressible biocompatible liquid such as saline), the fluid occupies space between the exterior of the material forming the fluid bladder 610 and the interior surface ofthe compliant sleeve 634, including the relief or displacement chamber 630. However, while the initial fill preferably occupies the entire available internal volume such that little or no air remains, the fill volume preferably is not so large as to cause pressure that meaningfully deforms the initial shape of the compliant sleeve 634.

[0100] Fig. 15D illustrates the hemostasis valve assembly 600 after a catheter C has been coupled to distal fitting 606, after the initial fluid F fill has occurred as shown in Fig. 15C, and after a device D has been inserted into the hemostasis valve assembly 600 and fully traverses the hemostasis valve assembly 600. It should be understood that the configuration of Fig. 15D is identical to that of Fig. 12D, other than the specific different components between the two hemostasis valve assemblies 300, 600. As explained in connection with hemostasis valve assembly 300, as the device D passes through the interior of the hemostasis valve assembly 600, it forces the material forming the fluid bladder 610 radially outwardly toward the interior walls of the housing 602. This tends to pressurize the fluid F, but because the fluid is non- compressible, it becomes displaced instead of having a significant change in pressure. Due to the fact that this space is sealed, the fluid F presses on the compliant sleeve 634, causing the compliant sleeve 634 to extend or distend or “bullfrog” radially outwardly. The ends of the compliant sleeve 634 may not extend or distend due to the proximal clamp 632a and distal clamp 632b firmly securing the ends of the compliant sleeve 634 to the housing 602 (and helping to maintain a fluid tight interior volume). While the compliant sleeve 634 is deformed or distended, it will put force back on the fluid F tending to push the fluid F through the ports 602a and against the exterior surface of the material forming the fluid bladder 610. This, in turn, results in the fluid bladder 610 pressing against the device D to help maintain a seal. In other words, the compliant sleeve 634 may effectively act as a constant pressure spring when it is expanded or distended. As with housing 302, housing 602 is preferably formed from a noncompliant material, such as a noncompliant polymer. In some circumstances, the housings 302, 602 may be formed of a compliant material, but in all cases the housings 302, 602 should not meaningfully deform under pressure of the fluid F.

[0101] Figs. 16A-16B show a perspective and side views, respectively, of a hemostasis valve assembly 700 according to another aspect of the disclosure. Hemostasis valve assembly 700 has a substantially similar function to the other hemostasis valve assemblies described herein, with slightly different mechanisms of achieving the desired seal.

[0102] Hemostasis valve assembly 700 may include a proximal fitting 704 which may be substantially similar or identical to proximal fittings 304 or 604, and a first distal fitting 706 which may be generally similar to distal fittings 306 or 606. The proximal fitting 704 and first distal fitting 706 may each be connected to a housing or body 702 which may be generally similar to the other housings 302 or 602 described herein. However, unlike housing 302, housing 702 may omit extensions 332, and unlike housing 602, housing 702 may omit a compliant sleeve 634. Rather, as described in greater detail below, the housing 702 may be relatively rigid and may include an internal biasing mechanism to automatically or semi- automatically maintain a seal within the hemostasis valve assembly 700, whether a relatively large device, a relatively small device, or no device at all passes through the hemostasis valve assembly 700.

[0103] The hemostasis valve assembly 700 may be generally cylindrical (although variations from generally cylindrical shapes are possible). As best shown in Figs. 16C-16D, the proximal fitting 704 may be a compression fitting that has an enlarged proximal head and an externally threaded shaft that may thread into a corresponding internally threaded proximal end of the housing 702. In this embodiment, a seal or gasket such as an O-ring 704a may be positioned between an external shoulder of the proximal fitting 704 and a corresponding internal shoulder of the proximal housing 702 so that, upon threading the proximal fitting 704 into the housing 702, the O-ring 704a is compressed and a fluid tight seal is created around the outer surface of the proximal fitting 704. In the illustrated embodiment, the proximal fitting 704 includes an internal lumen that may be generally cylindrical, with an outward flare or taper at the inlet or proximal end to help guide devices, such as catheters, into the proximal fitting 704.

[0104] The first distal fitting 706 may also be a compression fitting that has an enlarged distal head and an externally threaded shaft that may thread into a corresponding internally threaded distal end of the housing 702. In the illustrated embodiment, the distal fitting 706 includes an internal lumen that is generally cylindrical and which includes a smaller diameter proximal section, and a larger diameter distal section that is internally threaded. The internal threading of the larger diameter distal section allows for mating with external threading of a second distal fitting 707. The second distal fitting 707 may include a relatively large diameter distal lumen portion configured to mate with a catheter shaft for insertion into a patient, and a relatively small diameter proximal extension 707a that extends within a proximal extension 706a of thefirst distal fitting 706. A gasket such as an O-ring 707b may be positioned around the exterior of the proximal extension 707a and in contact with the interior surface of the proximal extension 706a to create a fluid-tight seal between the two proximal extensions.

[0105] A fluid bladder 710 (which may also be referred to as a membrane, sock, or extrusion) may be provided interior to the housing 702. It should be understood that, in the view of Figs. 16A, 16B, and 16D, the fluid bladder 710 is in a fully or nearly fully open state, such that the interior lumen of proximal fitting 704 is in fluid communication with the interior lumen of distal fitting 706 through the interior of the open fluid bladder 710. On the other hand, in Fig. 16C, the fluid bladder 710 is in a fully or nearly fully closed state, such that the interior lumen of proximal fitting 704 is not in fluid communication with the interior lumen of distal fitting 706 through the interior of the open fluid bladder 710.

[0106] In some embodiments, the fluid bladder 710 is formed as an extrusion or laminate. The fluid bladder 710 is substantially non-permeable, such that fluid cannot flow across a wall of the fluid bladder 710, and is substantially non-elastic. Preferably, the material forming the fluid bladder 710 is lubricious so that devices passing from the proximal fitting 704 to the distal fitting 706 readily slide axially along the fluid bladder 710 without being caught on the material forming the fluid bladder 710. In some examples, the fluid bladder 710 may be formed from expanded polytetrafluoroethylene (“ePTFE”), a material with both high tensile strength and natural lubricity, although other materials may be suitable alternatives. The fluid bladder 710 in some examples may be generally cylindrical. A first or proximal end of the fluid bladder 710 may be coupled to a proximal portion of the housing 702, such as to the distal extension of the proximal fitting 704, for example via glue or other adhesives, the use of an overmolded component, or a clamp (e.g. hose-clamp) type mechanism. In other examples, the first or proximal end of the fluid bladder may be sandwiched between the proximal fitting 704 and O- ring 704a similar’ to other embodiments described herein. A second or distal end of the fluid bladder 710 may be coupled to the hemostasis valve assembly 700 by being sandwiched or pinched between the O-ring 707a and proximal extension of the first distal fitting 706 (or pinched between the O-ring 707a and the proximal extension of the second distal fitting 707. In other embodiments, the fluid bladder 710 may be otherwise sealingly secured against the housing 702 (and / or the fittings) so that, when fluid is pressurized between the outer surfaceof the fluid bladder 710 and the interior of the housing 702, that pressurized fluid will not escape the housing 702 from the proximal or distal ends of the housing 702.

[0107] Referring to Fig. 16C, the hemostatic valve may be created, in pail, by injecting a non- compressible fluid, such as saline, through an inflation lumen 720. The inflation lumen 720 may be closed or locked, including for example via a one-way valve, so that the media cannot exit the inflation lumen 720. In the illustrated example, the fluid may fill the space interior of the housing 702, exterior to the fluid bladder 710, distal to the proximal fitting 704, and proximal to a piston 730 (described in greater detail immediately below), while forcing the bladder 710 to a closed or sealed position shown in Fig. 16C without significantly compressing the biasing member of spring 732 (also described in greater detail immediately below).

[0108] Referring to Fig. 16C, the hemostasis valve assembly 700 is shown after the housing 702 has been filled with a non-compressible fluid so as to force the fluid bladder 710 to close on itself to form a seal. Part of the volume in which the non-compressible fluid is maintained is bounded by a piston 730. In the illustrated example, the piston 730 is annular in shape with an inner opening through which the proximal extension 706a of the first distal fitting 706 extends. A gasket, such as O-ring 730a, may be positioned in contact with the interior surface of the inner opening of the piston 730 and the exterior surface of the proximal extension 706a. Similarly, a gasket, such as O-ring 730b, may be positioned in contact with the outer annular surface of the piston 730 and with an inner surface of the housing 702. With this configuration, as the piston 730 slides relative to the proximal extension 706a, the fluid within the housing 702 is not able to cross the piston 730 (e.g. between the piston 730 and the inner wall of the housing 702 or between the piston 730 and the outer surface of the proximal extension 706a).

[0109] Still referring to Fig. 16C, a biasing element such as a spring 732 may be positioned in contact with the surface of the piston 730 that does not confront the non-compressible fluid. In the illustrated examples, the biasing element takes the form of a spring 732 that is positioned around the proximal extension 706a, with ends of the spring 732 in contact with the piston 730 on one side and a face of the first distal fitting 706 on the other side. After the housing 702 is initially filled with non-compressible fluid to seal the fluid bladder 710 (which may be a similar process as shown and described in connection with Figs. 12B-C), filling may be completed before the spring 732 begins to compress, or before it begins to significantly compress. In use, as a device (such as device D of Fig. 15D) passes through the proximal fitting 704, into theinterior of the fluid bladder 710, and eventually into and through the distal fittings 706, 707, the fluid bladder 710 is forced to open which transfers force to the non-comprcssiblc fluid. Because the fluid is substantially non-compressible, instead of the fluid simply pressurizing, a volume of the fluid begins to displace the piston 730 in a direction that tends to compress the spring 732. Fig. 16D shows an example in which the fluid bladder 710 has opened, although it should be understood that the device passing through the hemostasis valve assembly 700 (such as device D of Fig. 15D) has been omitted for clarity of illustration. The displaced fluid within the housing 702 causes the piston 730 to slide and the spring 732 to compress, without losing any seal between the piston 730 and the housing 702 or proximal extension 706a. The compression of the spring 732 will tend to try to force the piston 730 back toward the fluid, which helps ensure that the fluid bladder 710 is held tightly over the device passing through the interior of the fluid bladder 710, thus maintaining a seal whether a small device, a large device, or no device passes through the hemostasis valve assembly 700.

[0110] Although not shown in detail in connection with Figs. 16A-D, it should be understood that a catheter (similar to catheter C of Fig. 12D) may be coupled to the second distal fitting 707 in a use condition. In some examples, the second distal fitting 707 may include internal threading to connected to a catheter. In some examples, a catheter may be snap fit, friction fit, or otherwise connected to the second distal fitting 707. In some examples, a catheter may be formed integrally with second distal fitting 707. As with the other hemostasis valve described herein, hemostasis valve assembly 700 provides for automatic and passive adjustment of the seal to accommodate devices of different diameters (or no device at all) passing through the hemostasis valve assembly 700 while the fluid bladder 710 maintains a good seal over the device, helping to ensure no fluid, including blood, leaks through the hemostasis valve assembly 700 during use.

[0111] Fig. 16E illustrates a hemostasis valve assembly 700’ that is an alternate embodiment of the hemostasis valve assembly 700 of Figs. 16A-D. Due to similarities between hemostasis valve assembly 700 and 700’, only the differences between the two devices are described below. There are two main differences between hemostasis valve assembly 700 and 700’. The first main difference is that, instead of a piston 730 with two separate O-rings 730a, 730b, hemostasis valve assembly 700’ may include a single thick gasket or O-ring 730’ that serves as both a piston and a gasket. The second main difference is that, instead of a single proximalfitting 704, hemostasis valve assembly 700’ may include a first proximal fitting 704’ with a distal extension, and a second proximal fitting 705’. In this particular example, the second proximal fitting 705’ may be threadedly coupled to housing 702’, and the first proximal fitting 704’ may be threadedly coupled to the second proximal fitting 705’, although in other embodiments other connection mechanisms such as snap fits or friction fits may be suitable. Similar to the distal end of hemostasis valve assembly 700, the proximal end of the fluid bladder 710’ may be sandwiched between the distal extension of the first proximal fitting 704’ and a gasket or O-ring 704a’ that overlies that distal extension and which may be in contact with an interior surface of a distal extension of the second proximal fitting 705’.

[0112] Figs. 17A-17B illustrate another hemostasis valve assembly 800 that is similar to hemostasis valve assembly 700, with the main difference being that the piston 730 and spring 732 of hemostasis valve assembly 700 are effectively moved to another component outside of the housing 702. For example, hemostasis valve assembly 800 may include a housing 802 similar to housing 702, with a proximal fitting 804 similar to proximal fitting 704. Hemostasis valve assembly 800 may also include a distal fitting 806 which may be generally simpler than that of hemostasis valve assembly 700, and for example similar or identical to distal fitting 306 or 606. Hemostasis valve assembly 800 may include a fluid bladder 810 which may be similar or identical to the other fluid bladders described herein, including for example being secured by two gaskets or O-rings that seal the proximal fitting 804 and distal fitting 806 to the housing 802. Because these components (or similar versions of these components) have already been described in various embodiments above, they are not described in detail again here.

[0113] The main difference between hemostasis valve assemblies 700 and 800 is that the hemostasis valve assembly 800 does not include a piston and spring internal to the housing 802. Rather, in the example of Figs. 17A-17B, a syringe or syringe-like device 822 may be coupled to the housing 802 via inflation port 820. The syringe 822 may be a standard syringe type device with a plunger positioned within a barrel, and a piston or seal at the end of the plunger. Similar to other embodiments described herein, a non-compressible fluid may be passed from plunger 822 into the interior of the housing 802 by depressing the plunger of the syringe 822 while a stop cock or similar valve 824 between the syringe 822 and the port 820 is open. The fluid may be passed into the housing 802 until the housing 802 is substantiallyfilled with the fluid and the fluid bladders 810 is closed, at which point the valve 824 may be actuated to fluidly seal the housing 802 from the syringe 822.

[0114] A second syringe or syringe-like device 832 may be fluidly coupled to the interior of the housing 802 through another port 830 in the housing 802. Syringe 832 may be similar to a typical syringe, including having a plunger within a barrel and a piston 834 or seal at the end of the plunger. However, unlikely a typical syringe, a biasing element such as a spring 836 may be positioned within the barrel proximal to the piston 834 so that one end of the spring 836 contacts a proximal face of the piston 834 and the other end of the spring contacts a distal face of the proximal end of the barrel. Notably, a stop cock or valve may be omitted for syringe 832. With this configuration, generally similar to hemostasis valve assembly 800, the housing 802 may be filled with non-compressible fluid via use of syringe 822, and the valve 824 closed while the housing 802 is filled with non-compressible fluid and with little or no compression placed on the spring 836. As a device is passed through the hemostasis valve assembly 800 (in a similar or identical fashion as described with the other hemostasis valve assemblies herein), the fluid in the housing 802 and in contact with the fluid bladder 810 must be displaced as the device forces the fluid bladder 810 to open. The displaced fluid will move through port 830 into syringe 832, tending to press against the piston 834 and compress the spring 836, in much the same fashion as described in connection with hemostasis valve assembly 700.

[0115] Referring to Fig. 17B, the fluid bladder 810 has been forced open by a device (not illustrated in the figure for clarity) passing through the hemostasis valve assembly 800. This has caused an amount of the fluid to be displaced through the port 830 and into the barrel of the syringe 832, forcing the piston 834 to move proximally and compress the spring 836. As with hemostasis valve assembly 700, the compressed spring 836 tends to push fluid back against the fluid barrier 810, helping to maintain a good seal between the fluid barrier 810 and the device passing through the interior of the fluid barrier 810 and through the hemostasis valve assembly 800. Also similar to other embodiments described herein, the illustrated configuration allows for passive adjustment in size of the seal (e.g. the fluid barrier 810) to accommodate various different diameter devices (or no devices at all) passing through the hemostasis valve 800 while maintaining a fluid-tight seal across the hemostasis valve 800.

[0116] Fig. 18 illustrates another hemostasis valve assembly 900 that is similar to hemostasis valve assembly 800. For example, hemostasis valve assembly 900 may include an inner housing 902which may be a rigid housing similar to housing 802, with a proximal fitting 904 generally similar to proximal fitting 804 and a distal fitting 906 generally similar to distal fitting 806. Hemostasis valve assembly 900 may include a fluid bladder 910 which may be similar or identical to the other fluid bladders described herein, including for example being secured by two gaskets or O-rings 904a, 906a that seal the proximal fitting 904 and distal fitting 906 to the inner housing 902. Because these components (or similar versions of these components) have already been described in various embodiments above, they are not described in detail again here.

[0117] Hemostasis valve assembly 900 may also include an outer housing 902a, which may be rigid, which surrounds inner housing 902. Additional gaskets or O-rings may be positioned between the inner housing 902 and the outer housing 902a to create a fluid-tight seal, with a volume between the inner housing 902 and the outer housing 902a forming a pressure chamber 902b which may be filled with a compressible fluid, as described in greater detail below. The inner housing 902 may include one or more slots 902c or other openings to allow for fluid communication between the pressure chamber 902b and the volume between the inner housing 902 and the fluid bladder 910. With this configuration, the proximal end of the fluid bladder 910 is exposed to atmosphere while the distal end of the fluid bladder 910 faces the catheter sheath (not shown in Fig. 18) that connects to the distal fitting 906, such that if the pressure within the pressure chamber 902b is greater than atmospheric pressure, the fluid bladder 910 will have the sealed condition shown in Fig. 18.

[0118] The outer housing 902a may include an inflation port 920 which a pump 922 may be coupled to. The pump 922, which is not necessarily shown to scale in Fig. 18, may be a manual pump that is filled with compressible fluid, although in other examples the pump 922 may take the form of a syringe like in Figs. 17A-B or similar devices. The pump 922 preferably has a pressure-relief valve 924. With this configuration the pump 922 may be used to initially pressurize the pressure chamber 902b to the desired pressure by compressing the fluid. In some examples, the compressible fluid may be a gas, such as air. In some examples, any gas that is biocompatible and which integrates easily into the blood, including oxygen, atomized heparin, or argon may be examples of a suitable compressible fluid.

[0119] As with other embodiments herein, the fluid bladder 910 may maintain a seal through the hemostasis valve assembly 900 when no device is passed through the hemostasis valveassembly 900. As other devices are passed through the hemostasis valve assembly 900, whether a relatively small guidewire or a relatively large catheter, the fluid within the pressure chamber 902b (and / or within other components such as the pump 922) may further compress to allow the fluid bladder 910 to expand to the required size to allow the device to pass through the hemostasis valve assembly 900 while the fluid bladder 910 maintains a seal over the device passing through the hemostasis valve assembly 900. As with other embodiments, this seal is maintained without user action after the initial pressurization step. The main difference between this embodiment and the others described herein is that the fluid is compressible, which allows the automatic maintenance of the sealing without needing to displace a volume of non-compressible fluids as described in connection with other embodiments. Although pump 922 is described as a manually activated pump, in some examples, pump 922 may be a foot-controlled pump, including a non-sterile device. Whether foot-controlled or hand- controlled, the pump 922 may in some embodiments be used in an active manner, for example with the user actively depressing the pump 922 with a foot to actively close the fluid bladder 910 more tightly when no device (or a small device) extend through the hemostasis valve assembly 900, while partially or completely releasing foot pressure on the pump 922 when a medium or large-sized device extends through the hemostasis valve assembly 900.

[0120] In some or all of the embodiments described above, it should be understood that the fluid F, which is preferably a non-compressible liquid, maintains a substantially constant pressure whether no device D passes through the relevant hemostasis valve assembly, or whether a small or large device D passes through the relevant hemostasis valve assembly. Rather, it is the displacement of volume of fluid F caused by the device D that allows the device to actually move through the hemostasis valve assembly while the constant pressure of the fluid F within the fluid bladder helps to maintain a seal around the device D, regardless of the size of the device D and without requiring any manual adjustments to maintain the seal for different sized devices D. However, as noted above, at least hemostasis valve assembly 900 is preferably used with a compressible fluid, which may be a gas such as air.

[0121] Although the various embodiments described herein are described as separate embodiments, it should be understood that features of the embodiments may be combined. For example, although hemostasis valve assembly 300 is shown as including spring loaded pistons, the alternate options shown and described in connection with Figs. 14C-D may be used in placeof a spring-loaded piston. Further, although the embodiment of Figs. 13A-B is described with a spring-loaded piston, the compliant sleeve of Figs. 15A-D could instead be incorporated into the hemostasis valve assembly 400. Similarly, although hemostasis valve assembly 400 is shown with spring-loaded pistons that are not manually adjustable, the manual adjustment of a spring-loaded piston described in connection with hemostasis valve assembly 400 could be applied to the spring-loaded pistons of hemostasis valve assembly 300 to help adjust an initial pressure of the fluid F (or at least an initial distribution of where the fluid F is located if there is not a substantial change in pressure of the fluid F). Other similar combinations between embodiments would be readily understood by skilled artisans and are thus not explicitly further described herein.

[0122] Each of the embodiments described herein include some form of fluid bladder. The term “bladder” should not be understood to be overly limited. For example, the fluid bladder may be a film or extrusion that does not, by itself, create a closed volume. For example, the closed volume that is filled with fluid F in hemostasis valve assembly 600 is not formed exclusively by the fluid bladder 610, but rather the fluid bladder 610 is one component that helps to form the closed volume, and which allows the particular shape of that closed volume to be changed while fluid F becomes displaced.

[0123] 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

CLAIMS1. A hemostasis valve assembly comprising:a housing having a proximal opening and a distal opening defining a lumen therebetween; a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly-sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane;a piston positioned at least partially within the housing; anda biasing member operably coupled to the piston, the biasing member configured to apply force on the piston in a direction toward the nonpermeable membrane,wherein when the fluidly- sealed volume is filled with a noncompressible fluid, a first portion of the nonpermeable membrane is in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening.

2. The hemostasis valve assembly of claim 1, further comprising a distal fitting coupled to the housing within the distal opening of the housing, the distal fitting including internal threaded configured to couple to a threaded hub of a catheter.

3. The hemostasis valve assembly of claim 2, further comprising a proximal fitting coupled to the housing within the proximal opening of the housing.

4. The hemostasis valve assembly of claim 3, further comprising a proximal gasket and a distal gasket, the proximal gasket being positioned between the proximal fitting and the housing, the distal gasket being positioned between the distal fitting and the housing.

5. The hemostasis valve assembly of claim 4, wherein the proximal end of the nonpermeable membrane is sandwiched between the proximal gasket and the housing, and the distal end of the nonpermeable membrane is sandwiched between the distal gasket and the housing.

6. The hemostasis valve assembly of claim 1, wherein the housing includes an extension member extending radially outward from the lumen, the biasing member and the piston being received within the extension member.

7. The hemostasis valve assembly of claim 1, wherein the nonpermeable membrane is formed of ePTFE.

8. The hemostasis valve assembly of claim 1, further comprising the noncompressible fluid.

9. The hemostasis valve assembly of claim 8, wherein the noncompressible fluid is saline.

10. The hemostasis valve assembly of claim 1, further comprising a piston gasket, the piston gasket forming a seal between the piston and the housing.

11. The hemostasis valve assembly of claim 1, further comprising a cap coupled to the housing, the cap being translatable toward and away from the housing.

12. The hemostasis valve assembly of claim 13, wherein the biasing member has a first end in contact with the cap such that translation of the cap toward the housing is configured to compress the biasing member.

13. The hemostasis valve assembly of claim 1, wherein the piston includes a shaft that extends through the housing to an exterior surface of the housing, the shaft being configured to be manually gripped to allow for manual compression of the biasing member.

14. A hemostasis valve assembly comprising:a housing having a proximal opening and a distal opening defining a lumen therebetween;a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing, the lumen being bounded in part by the nonpermeable membrane; andan inflatable balloon positioned between the nonpermeable membrane and the housing, a fluidly- sealed volume being created in part by the inflatable balloon;wherein when the fluidly- sealed volume is filled with a noncompressible fluid, the inflatable balloon is relatively inflated so that the inflatable balloon forces a first portion of the nonpermeable membrane into contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening.

15. The hemostasis valve assembly of claim 14, further comprising:a piston positioned at least partially within the housing; anda biasing member operably coupled to the piston, the biasing member configured to apply force on the piston in a direction toward the nonpermeable membrane.

16. The hemostasis valve assembly of claim 15, wherein when a device passes through the lumen, force applied from the device onto the nonpermeable membrane is configured to deflate the balloon and force the noncompressible fluid from the balloon into contact with the piston to move the piston away from the nonpermeable membrane and compress the biasing member.

17. The hemostasis valve assembly of claim 14, further comprising:a piston positioned at least partially within the housing, the piston having a first surface facing toward the nonpermeable membrane and a second surface facing away from the nonpermeable membrane, a closed chamber being formed between the housing and the second surface of the piston; anda compressible gas within the closed chamber, the compressible gas configured to apply force on the piston in a direction toward the nonpermeable membrane.

18. The hemostasis valve assembly of claim 17, wherein when a device passes through the lumen, force applied from the device onto the nonpermeable membrane is configured to deflate the balloon and force the noncompressible fluid from the balloon into contact with the first surfaceof the piston to move the piston away from the nonpermeable membrane and to compress the compressible gas within the closed chamber.

19. The hemostasis valve assembly of claim 14, further comprising:a diaphragm positioned at least partially within the housing, the diaphragm having a first surface facing toward the nonpermeable membrane and a second surface facing away from the nonpermeable membrane, a closed chamber being formed between the housing and the second surface of the diaphragm; anda compressible gas within the closed chamber, the compressible gas configured to apply force on the diaphragm in a direction toward the nonpermeable membrane.

20. The hemostasis valve assembly of claim 19, wherein when a device passes through the lumen, force applied from the device onto the nonpermeable membrane is configured to deflate the balloon and force the noncompressible fluid from the balloon into contact with the first surface of the diaphragm to deflect the diaphragm away from the nonpermeable membrane and to compress the compressible gas within the closed chamber.

21. A hemostasis valve assembly comprising:a housing having a proximal opening and a distal opening defining a lumen therebetween; a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly-sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane;a compliant sleeve surrounding an exterior portion of the housing, the fluidly- sealed volume being bounded in part by the compliant sleeve;a displacement volume being bounded in part by the compliant sleeve and in part by the exterior portion of the housing; andan aperture formed in a wall of the housing, the aperture fluidly connecting an interior portion of the housing with the displacement volume,wherein when the fluidly-sealed volume is filled with a noncompressible fluid, a first portion of the nonpcrmcablc membrane is in contact with a second portion of the nonpcrmcablc membrane to seal a portion of the lumen between the proximal opening and the distal opening.

22. The hemostasis valve assembly of claim 21, further comprising a recessed area formed in the exterior portion of the housing, the displacement volume being bounded in part by the recessed area.

23. The hemostasis valve assembly of claim 22, further comprising a proximal clamp ring that sandwiches a proximal portion of the compliant sleeve against the housing, and a distal clamp ring that sandwiches a distal portion of the compliant sleeve against the housing.

24. The hemostasis valve assembly of claim 23, wherein the recessed area is positioned between the proximal clamp ring and the distal clamp ring.

25. The hemostasis valve assembly of claim 21 , wherein the compliant sleeve is formed of polyethylene terephthalate.

26. The hemostasis valve assembly of claim 21, wherein when a device passes through the lumen, force applied from the device onto the nonpermeable membrane is configured to displace fluid into the displacement volume and to cause the compliant sleeve to bulge radially outwardly.

27. A method of positioning a device within a vasculature of a patient, the method comprising:inserting a catheter into the vasculature, the catheter being coupled to a hemostasis valve assembly;prior to advancing a device through the hemostasis valve assembly, a nonpermeable membrane within the hemostasis valve assembly creating a first seal due to a first portion of the nonpermeable membrane being in contact with a second portion of the nonpermeable membrane;while the first seal exists, advancing the device through the hemostasis valve assembly until the device presses against the nonpcrmcablc member so that noncomprcssiblc fluid within a housing of the hemostasis valve assembly is displaced into a displacement chamber without substantially altering a pressure of the noncompressible fluid; andcontinuing to advance the device through the hemostasis valve assembly until the device is positioned at least partially within the catheter,wherein while the device is positioned at least partially within the catheter, a second seal is maintained by the nonpermeable member pressing against an outer surface of the device.

28. The method of claim 27, wherein the device is a first device, and after continuing to advance the first device through the hemostasis valve assembly until the first device is at least partially within the catheter, advancing a second device over the first device until the second device presses against the nonpermeable member so that noncompressible fluid within the housing of the hemostasis is further displaced into the displacement chamber without substantially altering the pressure of the noncompressible fluid.

29. The method of claim 28, further comprising continuing to advance the second device through the hemostasis valve assembly until the second device is at least partially within the catheter, wherein while the second device is positioned at least partially within the catheter, a third seal is maintained by the nonpermeable member pressing against an outer surface of the second device.

30. The method of claim 29, wherein the first device is a guidewire having a diameter of between about 0.014 inches (about 0.35mm) and about 0.035 inches (about 0.9mm).

31. The method of claim 30, wherein the second device is a delivery catheter of a prosthetic heart valve delivery device, the delivery catheter having an outer diameter between about 14 French (about 4.66mm) and about 40 French (about 13.33mm).

32. The method of claim 27, wherein displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber results in a piston moving away from the nonpermeable membrane and a spring in contact with the piston compressing.

33. The method of claim 27, wherein displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber results from a balloon deflating.

34. The method of claim 33, wherein the balloon is filled with the noncompressible fluid and is positioned between the nonpermeable membrane and the housing, the balloon being in fluid communication with the displacement chamber.

35. The method of claim 27, wherein displacing noncompressible fluid within the housing of the hemostasis valve assembly into the displacement chamber results in a compliant sleeve, which at least partially surrounds the housing, distending radially outwardly.

36. A hemostasis valve assembly comprising:a housing having a proximal opening and a distal opening defining a lumen therebetween; a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly-sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in part by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane;a piston positioned at least partially within the housing; anda biasing member operably coupled to the piston,wherein when the fluidly-sealed volume is filled with a noncompressible fluid, (i) the biasing member is configured to apply force on the piston in a direction toward the noncompressible fluid, and (ii) a first portion of the nonpermeable membrane is in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening.

37. The hemostasis valve assembly of claim 36, further comprising a distal fitting coupled to the housing within the distal opening of the housing, the distal fitting having a proximal extension extending proximally from the distal fitting.

38. The hemostasis valve assembly of claim 37, wherein the piston has an annular shape, including an interior opening into which the proximal extension extends.

39. The hemostasis valve assembly of claim 38, further comprising a first gasket in contact with both (i) an interior surface of the piston forming the interior opening and (ii) an exterior surface of the proximal extension.

40. The hemostasis valve assembly of claim 39, further comprising a second gasket in contact with both (i) an exterior surface of the piston confronting an interior surface of the housing and (ii) the interior surface of the housing.

41. The hemostasis valve assembly of claim 40, wherein the biasing member is a coil spring through which the proximal extension extends.

42. The hemostasis valve assembly of claim 41, wherein the coil spring has a first end in contact with the piston and a second end in contact with the distal fitting.

43. A hemostasis valve assembly comprising:a housing having a proximal opening and a distal opening defining a lumen therebetween; a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the housing and a distal end operably coupled to a distal portion of the housing so that a fluidly-sealed volume is created, the fluidly-sealed volume being bounded in part by the nonpermeable membrane and in pail by an interior surface of the housing, the lumen being bounded in part by the nonpermeable membrane;a first syringe coupled to the housing so that the first syringe is in fluid communication with an interior of the housing, the first syringe including a barrel, a plunger, a piston, and a biasing member operably coupled to the piston,wherein when the fluidly-sealed volume is filled with a noncompressible fluid, (i) the biasing member is configured to apply force on the piston in a direction toward the noncompressible fluid, and (ii) a first portion of the nonpermeable membrane is in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening.

44. The hemostasis valve assembly of claim 43, wherein the biasing member is a coil spring through which a portion of the plunger extends.

45. The hemostasis valve assembly of claim 44, wherein the coil spring has a first end in contact with the piston and a second end in contact with the barrel.

46. The hemostasis valve assembly of claim 43, further comprising a second syringe coupled to the housing so that the second syringe is configured to be in fluid communication with the interior of the housing.

47. The hemostasis valve assembly of claim 46, further comprising a valve positioned between the second syringe and the housing, the valve having an open condition in which the second syringe is in fluid communication with the interior of the housing, and a closed condition in which the second syringe is not in fluid communication with the interior of the housing.

48. A hemostasis valve assembly comprising:an inner housing having a proximal opening and a distal opening defining a lumen therebetween;an outer housing at least partially surrounding the inner housing to create a pressure chamber between the inner housing and the outer housing, the inner housing defining at least one opening so that the pressure chamber is in fluid communication with an interior of the inner housing;a nonpermeable membrane having a proximal end operably coupled to a proximal portion of the inner housing and a distal end operably coupled to a distal portion of the inner housing;a pump having an interior volume in fluid communication with the pressure chamber via a port in the outer housing so that a fluidly- scaled volume is created, the fluidly-scaled volume being bounded in pail by an interior of the pump, in part by the outer housing, in part by the inner housing, and in part by the nonpermeable membrane;wherein when the fluidly- sealed volume is filled with a compressible fluid and the compressible fluid is pressurized via the pump, a first portion of the nonpermeable membrane is in contact with a second portion of the nonpermeable membrane to seal a portion of the lumen between the proximal opening and the distal opening.

49. The hemostasis valve assembly of claim 48, wherein the compressible fluid is a gas.

50. The hemostasis valve assembly of claim 49, wherein the gas is air.

51. The hemostasis valve assembly of claim 48, wherein a proximal end of the nonpermeable member is exposed to atmosphere so that, when the fluidly- sealed volume is filled with the compressible fluid and the compressible fluid is pressurized via the pump to a pressure that is greater than atmospheric pressure, the first portion of the nonpermeable membrane is in contact with the second portion of the nonpermeable membrane to seal the portion of the lumen between the proximal opening and the distal opening.

52. The hemostasis valve assembly of claim 48, wherein the pump includes a pressurerelief valve.

53. The hemostasis valve assembly of claim 48, wherein the pump is a manually compressible pump.

54. The hemostasis valve assembly of claim 48, wherein the pump is a syringe.

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