Prosthetic heart valve expansion device

Abstract

A prosthetic heart valve assembly includes an annular frame including a first section, a second section, and a waist section between the first section and the second section. The inflation device includes a first balloon for positioning in the first section. The first balloon includes a first balloon diameter in the inflated state such that the first balloon is configured to contact the first section. The inflation device includes a second balloon for positioning in the second section. The second balloon includes a second balloon diameter in the inflated state such that the second balloon is configured to contact the second section. A fluid source is in fluid communication with the catheter to deliver fluid to the first balloon and the second balloon. Methods of positioning a heart valve prosthesis and using an inflation device are provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 441,513, filed January 27, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to an inflation device for positioning within a heart valve prosthesis. Background Art

[0003] It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis into a target location in a patient's vasculature. The heart valve prosthesis can be moved from a radially contracted position to a radially expanded position. However, expansion of the heart valve prosthesis can be difficult. Summary of the Invention

[0004] The following presents a simplified summary of the disclosure in order to provide a basic understanding of some aspects described in the detailed description.

[0005] In some aspects, an inflation device for expanding a prosthetic heart valve is provided, the inflation device comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end. The frame comprises a plurality of struts and is configured to be adjustable between a radially collapsed position and a radially expanded position. The frame comprises a first section at the inflow end, a second section at the outflow end, and a waist section positioned between the first and second sections. The valve prosthesis comprises at least one leaflet attached to the plurality of struts. The inflation device is configured to be positioned within the frame. The inflation device comprises a first balloon configured to be positioned in the first section. The first balloon is configured to be pressurized from a collapsed state to an inflated state. In the inflated state, the first balloon comprises a first balloon diameter such that the first balloon is configured to contact an interior surface of the first section. A second balloon is configured to be positioned in the second section. The second balloon is configured to be pressurized from a collapsed state to an inflated state. The second balloon comprises a second balloon diameter in an inflated state such that the second balloon is configured to contact an interior surface of the second segment. The catheter is configured to extend through the waist segment between the first and second balloons. The catheter comprises a first hollow chamber in fluid communication with the first balloon and a second hollow chamber in fluid communication with the second balloon.

[0006] In some aspects, the first balloon is spaced apart from the second balloon by a separation distance, and a gap is defined between the first balloon and the second balloon. The catheter extends within the gap.

[0007] In some aspects, the first balloon is configured to be spaced a first distance from the at least one leaflet, and the second balloon is configured to be spaced a second distance from the at least one leaflet.

[0008] In some aspects, the first balloon diameter is substantially equal to the maximum first diameter of the first segment.

[0009] In some aspects, the second balloon diameter is substantially equal to the maximum second diameter of the second segment.

[0010] In some aspects, the catheter includes a first shaft portion positioned within a first balloon. The first shaft portion includes a first opening defining a first fluid passageway between the first hollow chamber and the first interior chamber of the first balloon.

[0011] In some aspects, the catheter includes a second shaft portion positioned within the second balloon. The second shaft portion includes a second opening defining a second fluid passageway between the second hollow chamber and the second interior chamber of the second balloon.

[0012] In some aspects, an inflation device for expanding a prosthetic heart valve is provided, the inflation device comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end. The frame comprises a plurality of struts and is configured to be adjustable between a radially collapsed position and a radially expanded position. The frame comprises a first section at the inflow end, a second section at the outflow end, and a waist section positioned between the first and second sections. The valve prosthesis comprises at least one leaflet attached to the plurality of struts. The inflation device is configured to be positioned within the frame. The inflation device comprises a first balloon configured to be positioned in the first section. The first balloon is configured to be pressurized from a collapsed state to an inflated state. In the inflated state, the first balloon comprises a first balloon diameter such that the first balloon is configured to contact an interior surface of the first section. The first balloon extends between the first balloon end and a second balloon end. The first balloon end is configured to be spaced a first distance from the at least one leaflet, and the second balloon end is configured to be spaced a second distance from the at least one leaflet. The catheter is configured to extend through the interior of the frame and includes a first hollow chamber in fluid communication with the first balloon. A fluid source is in fluid communication with the catheter. The fluid source is configured to deliver a fluid through the first hollow chamber to the first balloon.

[0013] In some aspects, the inflation device further includes a second balloon configured to be positioned in the second section. The second balloon is configured to be pressurized from a collapsed state to an inflated state. The second balloon comprises a second balloon diameter in the inflated state such that the second balloon is configured to contact an interior surface of the second section. The center balloon is configured to be positioned in the waist section and is attached to the first balloon at one end and to the second balloon at an opposite end. The first balloon, the second balloon, and the center balloon define a continuous interior chamber.

[0014] In some aspects, the center balloon comprises a center balloon diameter that is smaller than the first balloon diameter and the second balloon diameter.

[0015] In some aspects, the catheter extends through the first balloon, the second balloon, and the center balloon.The catheter includes one or more openings defining a fluid pathway between the first hollow chamber and the interior chamber.

[0016] In some aspects, a method for expanding a heart valve prosthesis positioned at a treatment site within a patient is provided. The heart valve prosthesis includes a first segment at an inflow end of the heart valve prosthesis, a second segment at an outflow end of the heart valve prosthesis, and a waist segment positioned between the first segment and the second segment. The heart valve prosthesis is positioned such that the first segment is within the annulus at the treatment site. The method includes positioning an inflation device within a central lumen of the heart valve prosthesis. The inflation device includes a first balloon positioned in the first segment, a second balloon positioned in the second segment, and a catheter extending between the first and second balloons. The method includes inflating the first balloon such that the first balloon contacts an interior surface of the first segment to increase a diameter of the first segment. The method includes inflating the second balloon such that the second balloon contacts an interior surface of the second segment to increase a diameter of the second segment.

[0017] In some aspects, the method includes, prior to positioning the inflation device, determining at least one of: radially expanding the first segment to a first initial diameter smaller than the first desired diameter; or radially expanding the second segment to a second initial diameter smaller than the second desired diameter.

[0018] In some aspects, inflating the first balloon includes contacting an interior surface of the first segment to radially expand the first segment from a first initial diameter to a first desired diameter.

[0019] In some aspects, inflating the second balloon includes contacting an interior surface of the second segment to radially expand the second segment from the second initial diameter to a second desired diameter.

[0020] In some aspects, inflating the first balloon comprises delivering a first fluid through a first hollow lumen of the catheter, and inflating the second balloon comprises delivering a second fluid through a second hollow lumen of the catheter.The first hollow lumen is isolated from the second hollow lumen.

[0021] In some aspects, inflating the second balloon occurs before inflating the first balloon.

[0022] In some aspects, positioning the inflation device within the central lumen includes aligning a balloon radiopaque marker of the inflation device with a valve radiopaque marker of the valve prosthesis.

[0023] In some aspects, aligning the balloon radiopaque marker occurs prior to one or more of inflating the first balloon or inflating the second balloon.

[0024] In some aspects, the heart valve prosthesis includes at least one leaflet positioned within a central lumen. After positioning the inflation device within the central lumen of the heart valve prosthesis, the first balloon is spaced apart from the second balloon and is not in contact with the at least one leaflet.

[0025] Additional features and advantages of the aspects disclosed herein will be set forth in the following detailed description and will, in part, be clear to those skilled in the art from that description or recognized by practicing the aspects described herein (including the following detailed description, claims, and drawings). It should be understood that both the foregoing general description and the following detailed description present aspects that are intended to provide an overview or framework for understanding the nature and characteristics of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The accompanying drawings illustrate various aspects of the present disclosure and, together with the description, explain the principles and operation of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] These and other features, aspects and advantages will be better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0027] Figure 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0028] Figure 2 shows a top view of a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0029] Figure 3 shows a side view of a delivery assembly for delivering a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0030] Figure 4 shows a side view of a delivery assembly for delivering a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0031] Figure 5 An introducer sheath according to aspects of the present disclosure is shown;

[0032] Figure 6 An introducer sheath according to aspects of the present disclosure is shown;

[0033] Figure 7 schematically illustrates a side view of a transcatheter heart valve prosthesis positioned at a treatment site according to aspects of the present disclosure;

[0034] Figure 8 shows a perspective view of an inflation device according to aspects of the present disclosure;

[0035] Figure 9 Demonstrates aspects of the present disclosure along Figure 8 a cross-sectional view of the catheter viewed along line 9-9;

[0036] Figure 10 Demonstrates aspects of the present disclosure along Figure 8 a cross-sectional view of the inflation device as viewed along line 10-10;

[0037] Figure 11 shows a side view of a transcatheter heart valve prosthesis positioned at a treatment site according to aspects of the present disclosure;

[0038] Figure 12 illustrates a side view of an inflation device positioned within a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0039] Figure 13 illustrates a side view of an inflation device positioned within a transcatheter heart valve prosthesis according to aspects of the present disclosure;

[0040] Figure 14 Additional aspects of inflation devices according to aspects of the present disclosure are presented; and

[0041] Figure 15 Demonstrates positioning of a transcatheter heart valve prosthesis according to aspects of the present disclosure Figure 14 Inflation equipment. DETAILED DESCRIPTION

[0042] Various aspects will now be described more fully hereinafter with reference to the accompanying drawings, in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. However, the present disclosure may be implemented in many different forms and should not be construed as limited to the aspects set forth herein.

[0043] As used herein, the term "about" means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller as necessary, reflecting tolerances, conversion factors, rounding, measurement errors, etc., and other factors known to those skilled in the art.

[0044] Ranges may be expressed herein as from "about" one value and / or to "about" another value. When such ranges are expressed, the aspect includes from the one value to the other value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the value forms another aspect. It will be further understood that the endpoints of each range are significant both relative to the other endpoint and independently of the other endpoint.

[0045] Directional terms used herein, such as up, down, right, left, front, back, top, bottom, upper, lower, etc., are only used with reference to the drawings in which they are drawn and are not intended to imply an absolute orientation.

[0046] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order, nor that any apparatus be required to have a specific orientation. Accordingly, in the absence of a method claim that actually recites the order in which its steps are to be followed, or in the absence of any apparatus claim that actually recites the order or orientation of individual components, or in the absence of other specific statements in the claims or specification that the steps are to be limited to a specific order, or in the absence of recitation of a specific order or orientation of components of an apparatus, it is in no way intended that an order or orientation be inferred in any respect. This applies to any possible non-express basis for interpretation, including problems of logic relating to arrangement of steps, flow of operations, order of components, or orientation of components; ordinary meaning derived from grammatical organization or punctuation; and the number or type of aspects described in the specification.

[0047] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0048] The words "exemplary," "example," or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "exemplary" or "example" is not necessarily to be construed as preferred or advantageous over other aspects or designs. Furthermore, the examples are provided for purposes of clarity and understanding only and are not intended to limit or restrict the disclosed subject matter or the relevant portions of this disclosure in any way. It is understood that numerous additional or alternative examples of varying scope may be presented, but these examples have been omitted for the sake of brevity.

[0049] As used herein, unless otherwise indicated, the terms "include," "comprising," and variations thereof should be interpreted as synonymous and open ended. A list of elements following the transitional phrase "include" or "comprising" is a non-exclusive list such that elements other than those specifically recited in the list may also be present.

[0050] As used herein, the terms "substantial," "substantially," and variations thereof are intended to mean that the described feature is equal to or approximately equal to a value or description. For example, a "substantially planar" surface is intended to mean a planar or approximately planar surface. Additionally, "substantially" is intended to mean that two values ​​are equal or approximately equal. The term "substantially" can mean values ​​that are within about 10% of each other, for example, within about 5% of each other or within about 2% of each other.

[0051] The present disclosure may be modified without departing from the scope or spirit of the claimed subject matter. Unless otherwise specified, "first," "second," and the like are not intended to imply temporal aspects, spatial aspects, ordering, and the like. Rather, such terms are merely used as identifiers, names, and the like of features, elements, items, and the like. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0052] Unless otherwise indicated, the terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to a treating clinician. "Distal" and "distally" are positions away from or in a direction away from the clinician, and "proximal" and "proximally" are positions close to or in a direction toward the clinician. Additionally, the term "self-expanding" may be used in the following description of one or more valve or stent structures of the prostheses herein, and is intended to convey that these structures are formed or shaped from a material that can be provided with a mechanical memory to return the structure from a compressed or contracted delivery configuration to an expanded deployed configuration, and vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, pseudo-elastic metals (such as nickel titanium alloy or nitinol), various polymers, or so-called superalloys (which can have a base metal of nickel, cobalt, chromium, or other metals). Mechanical memory can be imparted to a wire or stent structure by heat treatment to achieve, for example, spring tempering in stainless steel, or to provide shape memory in susceptible metal alloys (such as nitinol). Various polymers that can be prepared to have shape memory properties may also be suitable for use in the present invention, including polymers such as polynorbornene, trans-polyisoprene, styrene-butadiene, and polyurethane. Poly (LD) lactic acid copolymers, oligomeric octalactone copolymers, and polycyclooctyne may also be used alone or in combination with other shape memory polymers.

[0053] Diseases associated with heart valves, such as those caused by injury or defects, may include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis narrows and stiffens the valve, which may prevent blood from flowing to downstream heart chambers at an appropriate rate and may cause the heart to work harder to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow back, resulting in decreased heart efficiency. Diseased or damaged valves may be congenital, age-related, medication-induced, or in some cases caused by infection, which may cause the heart to enlarge and thicken, losing elasticity and efficiency. Some symptoms of valvular heart disease may include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, as well as blood clots that may increase the possibility of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life-threatening.

[0054] Heart valve prostheses have been developed for repairing and replacing diseased and / or damaged heart valves. Such heart valve prostheses can be delivered percutaneously via a catheter-based delivery system and deployed at the site of the diseased heart valve. Such heart valve prostheses typically include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or curled configuration so that the heart valve prosthesis can be advanced through the patient's vascular system. Once positioned at the treatment site, the heart valve prosthesis expands to engage tissue located at the diseased heart valve region, thereby, for example, retaining the heart valve prosthesis in place.

[0055] Figure 1 and Figure 2 An example transcatheter heart valve prosthesis 10 is shown. The delivery assembly described herein can be used with the transcatheter heart valve prosthesis 10 and / or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis 10 is shown to facilitate the description of the present disclosure. The following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the present invention or its applications and uses.

[0056] Figure 1 and Figure 2 A side view and a top (outflow end) view of a transcatheter heart valve prosthesis 10 are shown, respectively. The transcatheter heart valve prosthesis 10 includes a radially expandable frame or stent 15 and a prosthetic valve 20. The frame 15 of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within the interior of the frame 15. Figure 1 and Figure 2 In the example transcatheter heart valve prosthesis 10 shown in FIG, frame 15 is self-expandable. However, this is not intended to be limiting, and in other embodiments, frame 15 may be balloon-expandable or mechanically expandable.

[0057] The prosthetic valve 20 includes at least one leaflet 21 disposed within and secured to the frame 15. Figure 1 and Figure 2 In the embodiment shown, the prosthetic valve 20 includes exactly three leaflets 21, such as Figure 2 However, this is not intended to be limiting, as prosthetic valve 20 may include more or fewer leaflets 21. Valve leaflets 21 open and close to regulate flow through transcatheter heart valve prosthesis 10.

[0058] like Figure 1 As shown in FIG, a transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12. Prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when the pressure at the inflow end 11 exceeds the pressure at the outflow end 12, the prosthetic leaflets 21 open to allow blood to flow from the inflow end 11 to the outflow end 12 through the heart valve prosthesis 10. When the pressure at the outflow end 12 exceeds the pressure at the inflow end 11, the prosthetic leaflets 21 close to prevent blood from flowing from the outflow end 12 to the inflow end 11. Accordingly, at least one leaflet (e.g., the prosthetic leaflet 21) can be attached to the plurality of struts 16, for example, by being directly attached to the plurality of struts 16 at the commissures 25, or indirectly attached to the plurality of struts 16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., a mechanical actuator) attached to the plurality of struts 16.

[0059] The frame 15 of the transcatheter heart valve prosthesis 10 further includes a plurality of struts 16 arranged to form a plurality of openings or cells 18 that are arranged circumferentially about the longitudinal axis LA of the transcatheter heart valve prosthesis 10 and longitudinally to form a tubular structure that defines a central lumen 13 of the transcatheter heart valve prosthesis 10. For example, the frame 15 can extend along the longitudinal axis LA between the inflow end 11 and the outflow end 12. The frame 15 is configured to secure the prosthetic valve 20 within the central lumen 13 of the frame 15 and to secure the transcatheter heart valve prosthesis 10 in an appropriate position in the patient's vasculature. The struts 16 are defined herein as elongated, connected segments of the frame 15. The struts 16 come together to form crowns 17 or nodes 19, as Figure 1 Frame 15 of heart valve prosthesis 10 includes a plurality of cells 18 defined by a plurality of crowns 17, a plurality of nodes 19, and spaces between a plurality of struts 16. Frame 15, and therefore struts 16, are adjustable between a radially collapsed position and a radially expanded position.

[0060] exist Figure 1In the example embodiment shown, the plurality of cells 18 can be diamond-shaped. In the example embodiment shown, the plurality of cells includes a plurality of first cells 18 and an access cell 14. In particular, the access cell is larger than the first cell 18 and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in the patient. In the embodiment shown, there are exactly three access cells 14. However, this is not intended to be limiting, as the frame 15 of the transcatheter heart valve prosthesis 10 can include more, fewer, or no access cells 14. The access cells 14 each have an enlarged area relative to or compared to the first cell 18, as shown. Figure 1 Further, the entry unit 14 may be located in addition to Figure 1 Although not shown, in some embodiments, the transcatheter heart valve prosthesis 10 can include an outer skirt that extends circumferentially around the periphery of the stent 15 at or near the inflow end 11 to prevent blood from creating paravalvular leakage around the exterior of the transcatheter heart valve prosthesis once the transcatheter heart valve prosthesis 10 is implanted in a patient.

[0061] Figure 3 and Figure 4 A side view of a delivery assembly 30 for delivering and deploying a transcatheter heart valve prosthesis (eg, transcatheter heart valve prosthesis 10) according to embodiments herein is schematically shown. Those skilled in the art will recognize that Figure 3 and Figure 4 An example of a delivery assembly 30 is shown and can be removed Figure 3 and Figure 4 The components shown in FIG. 3 and / or additional components may be added. Delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33. Handle 33 enables a physician to manipulate the distal portion of delivery assembly 30 and includes an actuator for moving components of delivery assembly 30 relative to one another. In delivery assembly 30, outer shaft 34 is coupled to actuator 39 of handle 33, which is used to move outer shaft 34 relative to inner shaft 36.

[0062] The distal portion of the outer shaft 34, referred to as the sac 35, is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to a treatment site (e.g., a native heart valve) and to be retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis so that it self-expands. The inner shaft 36 is coupled to the handle 33, and movement of the handle 33 translates into movement of the inner shaft 36 and a distal tip or nose cone 37 coupled to the distal end of the inner shaft 36. The inner shaft 36 and the distal tip or nose cone 37 can also translate relative to the outer shaft 34 and the handle 33 via a tip retractor. In the illustrated embodiment, the inner shaft 36 includes a retainer or main shaft 38 for receiving the tabs of the transcatheter heart valve prosthesis 10.

[0063] When the actuator 39 is actuated, the actuator 39 moves the outer shaft 34 and the capsule 35 relative to the inner shaft 36, as shown in FIG. Figure 4 As known to those skilled in the art, when delivery assembly 30 is in position such that transcatheter heart valve prosthesis 10 is in a desired position at a treatment site in the patient's vasculature, actuator 39 is actuated to move balloon 35 relative to inner shaft 36 and transcatheter heart valve prosthesis 10 disposed therebetween, thereby enabling transcatheter heart valve prosthesis 10 to deploy via self-expansion at the treatment site and release from retainer 38, as shown. Figure 4 (transcatheter heart valve prosthesis 10 is not shown).

[0064] Minimally invasive percutaneous interventional procedures (including endovascular procedures) require access to the venous or arterial system. Generally, it is desirable to minimize the incision point and minimize tissue contact time when entering the body. Small incisions and short tissue contact times generally improve patient outcomes, reduce complications, and reduce trauma to the vessel or organ being entered, as well as to the skin and tissues used to create the entry point. Various medical procedures for percutaneously delivering or implanting structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) require access. Some procedures use relatively large devices that require relatively large sheaths to deliver the devices to the intended site in the body. Such procedures can cause access site trauma, often leading to vascular injury, excessive bleeding, increased case handling time, increased risk of infection, and increased hospital stays. To reduce access trauma, doctors try to use the smallest possible device and place the smallest sheath possible. However, if the doctor discovers during the procedure that a larger device is needed, this can be problematic. This results in the need to increase the size of the sheath, which is a lengthy procedure and increases the risk to the patient. The expandable sheath can be expanded within the body and therefore does not need to be removed to increase size.

[0065] The expandable sheath design can be regionally or locally expandable to selectively and temporarily expand when a device passes through the area of ​​the sheath and to retract or recover when the device has not passed through or has passed through the sheath. The embodiments disclosed herein can be used with an expandable introducer sheath that can address these and other issues that contribute to vascular trauma. The expandable introducer sheath disclosed herein is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath can be used alone or in combination for other medical procedures requiring percutaneous access, including but not limited to stent placement, angioplasty, decalcification of arterial or venous calcifications, and pre- or post-dilation.

[0066] Various embodiments disclosed herein may include an introducer sheath having a selectively expandable diameter to allow relatively large devices to pass through, and further configured to return to the original diameter of the introducer sheath upon device passage. Various embodiments can reduce damage to surrounding tissue by reducing contact with such tissues and by eliminating the need to change sheaths of different sizes. Thus, compared to known sheaths, these embodiments can shorten procedure time, reduce vascular trauma, reduce bleeding, and reduce the risk of infection and other complications resulting therefrom. However, it should be understood that the present disclosure is not limited to use with expandable introducer sheaths. Rather, one or more features of the present disclosure can be used alone or in combination without an introducer sheath, with a non-expandable introducer sheath, or with an expandable introducer sheath. Similarly, if an introducer sheath is used, the introducer sheath can be an integral introducer sheath (e.g., an introducer sheath integrated with a delivery assembly) or a non-integrated introducer sheath (e.g., an introducer sheath separate from a delivery assembly but configured for use with a delivery assembly).

[0067] Figure 5 and Figure 6 One embodiment of an introducer sheath 50 is depicted positioned through an incision 60 in a patient's skin 65 and into the patient's blood vessel 40. The sheath 50 has a tubular shaft 55 and a proximal hub 56 having a hemostatic seal and Luer lock 57. Figure 5 The sheath 50 is shown positioned in a blood vessel 40 in a normal, unexpanded state. Figure 6 The sheath 50 is shown positioned in a blood vessel 40, with a delivery device 75 delivering another device 70 that is advanced through the sheath 50, causing the tubular shaft 55 to expand or deform at the location where the device 70 is passed through. As the device 70 is passed through, the shaft 55 expands at the expansion region 58, and then retracts or returns to its original diameter after the device 70 is moved past or removed from the shaft 55. Thus, the tubular shaft 55 is configured to be both expandable and retractable.

[0068] In certain embodiments, the expandability of the shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticity of the shaft 55, which can cause the shaft 55 to be self-expandable or self-expandable or mechanically expandable or mechanically expandable. For the purposes of this application, self-expandable means that the shaft 55 is configured to automatically expand to a predetermined or nominal diameter (without any type of actuation, mechanical or otherwise). Further, for the purposes of this application, mechanically expandable means that the shaft 55 is configured to expand when a positionable medical device is positioned through the shaft 55. That is, the device being passed through the shaft 55 itself causes the shaft 55 to expand, such as Figure 6 Alternatively, the expandable property of shaft 55 may be caused by factors other than elasticity.

[0069] The shaft 55 is configured to be collapsible, retractable, or return to its original unexpanded state after the device has passed through it, such as Figure 5 As depicted in . In some embodiments, retractability can be achieved by the elasticity of the shaft 55, which can make the shaft 55 self-retractable or self-retracting, self-recovering, or self-contracting, or mechanically retractable or mechanically retractable, mechanically recoverable, or mechanically contractible. For the purposes of this application, self-retractable means that the shaft 55 is configured to automatically retract to a predetermined or nominal diameter (without any type of actuation, i.e., mechanical actuation or otherwise). Further, for the purposes of this application, mechanically retractable means that the shaft 55 is configured to retract when a device or component is used to retract or restore the shaft 55. Alternatively, the retractable property of the shaft 55 can be caused by factors other than elasticity.

[0070] For the purposes of this application, any device that can be positioned by a guide sheath according to any embodiment disclosed or contemplated herein may be referred to as a positionable medical device or an insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivering and / or placing structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guide sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices may include non-vascular devices, such as endoscopes and other common surgical instruments. Further, the guide sheath is configured to receive tissue or organs. Thus, as a non-limiting example, the guide sheath 50 is described as an expandable guide sheath 50 for introducing a delivery assembly 30 including a transcatheter heart valve prosthesis 10. In another example, the guide sheath 50 is used to introduce a catheter 851 that includes an inflation device 801 for a pre-dilation procedure or a post-dilation procedure.

[0071] Figure 7A heart valve prosthesis 10 is shown at a treatment site 701 within the vasculature of a patient. In some aspects, the treatment site 701 can include the location of a native aortic annulus (hereinafter referred to as the "annulus") 703 of a native heart valve (e.g., the annulus of the patient's left ventricle). The treatment site 701 can include one or more native valve leaflets 705 and corresponding native sinus cavities 707. Although disclosed with respect to placing the heart valve prosthesis 10 within the patient's native anatomy, in some aspects, without departing from the scope of the present disclosure, the heart valve prosthesis 10 can be implanted within a previously implanted prosthetic valve (e.g., a surgical or transcatheter transposition valve) to facilitate a valve-in-valve (e.g., TAV-in-SAV or TAV-in-TAV) procedure. In some aspects, paravalvular leak can occur when blood travels through a gap 709 surrounding the exterior of the transcatheter heart valve prosthesis 10, where the gap 709 is formed between the transcatheter heart valve prosthesis 10 and the annulus 703. To prevent paravalvular leakage, the heart valve prosthesis 10 can be radially expanded so that the outer radial surface of the heart valve prosthesis 10 can contact the annulus 703 and / or the native valve leaflets 705, thereby reducing or eliminating the gap 709 and allowing blood to flow through the central lumen 13 of the heart valve prosthesis 10. The frame 15 of the heart valve prosthesis 10 can include an asymmetric hourglass shape having a first section 713 at the inflow end 11, a second section 715 at the outflow end 12, and a waist section 717 positioned between the first section 713 and the second section 715. In some aspects, the first section 713 can include a first diameter 721, and the second section 715 can include a second diameter 723, wherein the second diameter 723 is larger than the first diameter 721. Additionally, as discussed above, in some embodiments, the transcatheter heart valve prosthesis 10 can include an outer skirt that extends circumferentially around the periphery of the prosthesis 15 at or near the inflow end 11 to prevent blood from leaking around the exterior of the transcatheter heart valve prosthesis once the transcatheter heart valve prosthesis 10 is implanted in a patient. Thus, the features of the present disclosure can be used alone or in combination with prosthetic heart valves 10 having an outer skirt or other external sealing member (not shown) or with prosthetic heart valves 10 without an outer skirt.

[0072] Figure 8A perspective view of an inflation device 801 is shown that can be positioned within a heart valve prosthesis 10 to facilitate radial expansion of the heart valve prosthesis 10. For example, in some aspects, the heart valve prosthesis 10 can be partially but not fully radially expanded when positioned at the treatment site 701, such that a gap 709 can exist. To assist in achieving full radial expansion of the heart valve prosthesis 10, after the prosthesis 10 is positioned at the treatment site 701, the inflation device 801 can be positioned within the central lumen 13 of the heart valve prosthesis 10 to apply an outward radial force to the frame 15, thereby achieving full radial expansion (e.g., post-dilation) of the heart valve prosthesis 10.

[0073] Additionally or alternatively, prior to placement of the heart valve prosthesis 10, the inflation device 801 can be used to apply an outward radial force to the native annulus or to a previously implanted transposed valve to prepare the treatment site 701 for placement of the heart valve prosthesis 10 (e.g., pre-expansion). The inflation device 801 can be used to independently or simultaneously apply an outward radial force to one or more of the frame 15, the annulus 703, and the native leaflets 705. The outward radial expansion of the inflation device 801 can also loosen, rupture, or break off calcifications (e.g., calcified leaflets 705) that may have accumulated on or around the treatment site 701. The inflation device 801 can soften the treatment site 701 (e.g., increase or restore the elasticity of the treatment site) by applying force to the calcified deposits, thereby enabling the heart valve prosthesis 10 to more fully expand (e.g., self-expand) and seal against the annulus 703, thereby reducing or eliminating the risk of paravalvular leak. In some aspects, the inflation device 801 can be used to change the shape and / or size of the treatment site 701 and the shape and / or size of the heart valve prosthesis 10 before or after placement of the inflation device 801 on the heart valve prosthesis 10. For example, in some aspects, the inflation device 801 can be used in conjunction with a pre-expansion or post-expansion procedure to expand the native valve annulus 701 and / or the heart valve prosthesis 10 from a non-circular (e.g., elliptical) shape to a more circular shape. Without intending to be bound by theory, it is believed that for some patients, a circular annulus can provide better hemodynamic function compared to the relative hemodynamic function of a non-circular annulus. Outward radial expansion of the inflation device 801 can also increase the effective orifice area (EOA) at the treatment site 701, thereby further improving hemodynamics. In some aspects, the inflation device 801 can further be used to fracture a previously implanted heart valve prosthesis, such as before implanting a new or restored heart valve prosthesis. For example, in some aspects, the inflation device 801 can be used to fracture a surgical prosthetic transposition valve and / or a transcatheter prosthetic transposition valve. A previously implanted prosthetic heart valve can epithelialize over time, thereby making the radial stiffness of the previously implanted prosthetic heart valve more rigid than when the valve was first implanted. By fractureing the previously implanted prosthetic heart valve with the inflation device 801 (e.g., by mechanically bending or breaking one or more components of the valve by applying a stress-inducing force), the previously implanted valve can expand, thereby creating a larger treatment site 701 in which to place the new or restored prosthetic valve, and can also reduce radial stiffness (e.g., become more elastic), enabling better implantation, paravalvular sealing, and hemodynamics of the new or restored prosthetic transposition valve compared to the relative paravalvular sealing and hemodynamics of an unfractured, endothelialized prosthetic transposition valve.

[0074] The inflation device 801 can extend along an inflation axis 803 and can include a first balloon 805 and a second balloon 807. The first balloon 805 and the second balloon 807 are arranged in a Figure 8 801 through the patient's vasculature to and from the heart valve prosthesis 10 (e.g., delivery, retraction, etc.). The first balloon 805 is configured to be positioned in the first section 713 of the heart valve prosthesis 10 and can include a first balloon diameter 809. The first balloon 805 can extend along the inflation axis 803 between a first balloon end 811 and a second balloon end 813, wherein the second balloon end 813 is closer to the second balloon 807 (e.g., the first balloon end 811 is separated from the second balloon 807 by a greater distance than the second balloon end 813 is separated from the second balloon 807).

[0075] The first balloon 805 can include one or more walls that can surround and define the interior chamber of the first balloon 805. For example, the first balloon 805 can include a first wall 815, a second wall 817, and an intermediate wall 819 extending between the first wall 815 and the second wall 817. In some aspects, the first wall 815 can be positioned at the first balloon end 811, and the second wall 817 can be positioned at the second balloon end 813. In some aspects, one or both of the first wall 815 or the second wall 817 can be substantially flat or planar, such that one or both of the first wall 815 or the second wall 817 can be substantially perpendicular to the inflation axis 803. The intermediate wall 819 can extend circumferentially along and around the inflation axis 803. In some aspects, the intermediate wall 819 can taper toward the first wall 815, for example, by including a cross-sectional dimension that gradually decreases toward the first wall 815.

[0076] The first wall 815, the second wall 817, and the intermediate wall 819 can be substantially continuous and, in some aspects, can be a single-piece formed material or composite material. In some aspects, the walls 815, 817, 819 of the first balloon 805 can comprise a non-compliant material, such as polyester or nylon. The first balloon 805 can be relatively rigid compared to the stiffness of the second balloon 807 to ensure conformity to the shape of the native valve annulus 703. In some aspects, the first balloon 805 can include various sizes based on the cross-sectional dimensions of the native valve annulus 703. For example, the first balloon diameter 809 can be in a range from about 17 millimeters ("mm") to about 38 mm, but other diameters less than or greater than this range can also be provided in other aspects.

[0077] The second balloon 807 is configured to be positioned in the second section 715 of the heart valve prosthesis 10 and can include a second balloon diameter 829. The second balloon 807 can extend along the inflation axis 803 between a first balloon end 831 and a second balloon end 833, wherein the second balloon end 833 is closer to the first balloon 805 (e.g., the first balloon end 831 is separated from the first balloon 805 by a greater distance than the second balloon end 833 is separated from the first balloon 805). The second balloon 807 can include one or more walls that can surround and define an interior chamber of the second balloon 807. For example, the second balloon 807 can include a first wall 835, a second wall 837, and an intermediate wall 839 extending between the first wall 835 and the second wall 837. In some aspects, the first wall 835 can be positioned at the first balloon end 831, and the second wall 837 can be positioned at the second balloon end 833. In some aspects, one or both of the first wall 835 or the second wall 837 can be substantially flat or planar such that one or both of the first wall 835 or the second wall 837 can be substantially perpendicular to the inflation axis 803. The intermediate wall 839 can extend circumferentially along and about the inflation axis 803. In some aspects, the intermediate wall 839 can taper toward the first wall 835, for example, by including a cross-sectional dimension that gradually decreases toward the first wall 835.

[0078] The first wall 835, the second wall 837, and the intermediate wall 839 can be substantially continuous and, in some aspects, can be formed of a single piece or composite material. In some aspects, the walls 835, 837, 839 of the second balloon 807 can comprise a semi-compliant material, such as a high-durometer polyurethane material, a polyether block amide, or the like. For example, the stiffness of the second balloon 805 can be relatively low compared to the stiffness of the first balloon 807. In some aspects, by providing the second balloon 807 with relatively less stiff (e.g., more compliant) properties compared to the relatively stiff (e.g., less compliant) properties of the first balloon 805, the second balloon 807 can anchor the inflation device 801 within the second segment 715 of the prosthetic heart valve 10 without deforming the native anatomical structure at the second segment 715, while the first balloon 805 can radially expand the first segment 713 of the prosthetic heart valve 10 and the native anatomical structure (e.g., the native annulus 703 and / or the native leaflets 705) at the first segment 713. Accordingly, in this manner, the first balloon 805 and the second balloon 807 can comprise different materials, or in some aspects, the first balloon 805 and the second balloon 807 can comprise the same material. In some aspects, the first balloon 805 can comprise various sizes based on the cross-sectional dimensions of the native annulus 703 and / or the second segment 715 of the heart valve prosthesis 10. For example, the second balloon diameter 829 can be in the range of about 19 millimeters ("mm") to about 38 mm. In some aspects, the second balloon diameter 829 can be larger than the first balloon diameter 809. In some aspects, the catheter 851 can comprise a material that does not radially expand, such as a polymer, such as high-density polyethylene (HDPE), polyethylene high density, or polyethylene terephthalate.

[0079] The inflation device 801 may include a catheter 851 extending between the first balloon 805 and the second balloon 807. For example, the inflation device 801, and therefore the catheter 851, may be part of the delivery assembly 30 (e.g., Figures 3 and 4 33 , for example, the catheter 851 extends toward the handle 33. In some aspects, the catheter 851 can be operatively associated with and thus moved and / or controlled by one or more of the handle 33, shafts 34, 36, 55, and actuator 39. In some aspects, the inflation device 801 and catheter 851 can be separate devices from the devices of the delivery assembly 30. For example, the inflation device 801 and catheter 851 can correspond to the delivery device 75 and can be used with the introducer sheath 50. Thus, the catheter 851 can extend from the exterior of the patient through the incision 60 in the skin 65 (e.g., within the introducer sheath 50) within the introducer sheath 50. Figures 5 and 6) and into the blood vessel 40, at which point the catheter 851 can extend through the first balloon 805, the second balloon 807, and within the gap 847 between the first balloon 805 and the second balloon 807. In some aspects, the delivery assembly 30 ( Figures 3 and 4 ) can be combined with the guide sheath 50 ( Figures 5 and 6 ) are used together to deliver and implant a transcatheter prosthetic heart valve 10. After the transcatheter prosthetic heart valve 10 is placed at the treatment site 701, the delivery assembly 30 can be removed from the patient via the introducer sheath 50. The introducer sheath 50 can remain in place within the incision 60, thereby maintaining percutaneous access to the blood vessel 40. Thus, after the delivery assembly 30 is removed from the introducer sheath 50, the same introducer sheath 50 can then be used to percutaneously introduce a catheter 851 and an inflation device 801 into the blood vessel 40. The inflation device 801 can be used to provide post-expansion of the transcatheter prosthetic heart valve 10.

[0080] The inflation device 801 can include a fluid source 855 positioned external to the patient, wherein the fluid source 855 is attached to and in fluid communication with the catheter 851. Due to the fluid communication, the fluid source 855 can deliver fluid through the catheter 851 to the first balloon 805 and the second balloon 807. In some aspects, the fluid delivered by the fluid source 855 can include saline mixed with a contrast agent, although other fluids are contemplated. In some aspects, the fluid source 855 and / or the catheter 851 can include a flow control device (e.g., a valve, etc.) that can control the flow of fluid from the fluid source 855 through the catheter 851.

[0081] In some aspects, the first balloon 805 can be spaced apart from the second balloon 807 by a separation distance 845 to define a gap 847 between the first balloon 805 and the second balloon 807. The separation distance 845 can be measured along the inflation axis 803 between the second balloon end 813 of the first balloon 805 and the second balloon end 833 of the second balloon 807. In some aspects, the first balloon 805 can include a different shape than the second balloon 807. For example, the axial length of the first balloon 805 (e.g., along the inflation axis 803) can be greater than the axial length of the second balloon 807. In some aspects, the axial length of the middle wall 819 of the first balloon 805 can be greater than the axial length of the middle wall 839 of the second balloon 807. The middle wall 819 of the first balloon 805 can extend concentrically about the inflation axis 803 from the second wall 817 toward the first wall 815, then taper and have a decreasing cross-sectional dimension at the first wall 815. 803. In some aspects, the first and second walls 815, 835 can be substantially parallel to each other and substantially perpendicular to the inflation axis 803. Similarly, the second walls 817, 837 can be substantially parallel to each other (e.g., and in some aspects, parallel to the first walls 815, 835) and substantially perpendicular to the inflation axis 803. In this manner, in some aspects, the first balloon 805 can include a shape that substantially matches the shape of the first segment 713, and the second balloon 807 can include a shape that substantially matches the shape of the second segment 715.

[0082] Figure 9 Shown along Figure 8 FIG8 is a cross-sectional perspective view of catheter 851 as viewed along line 9-9. In some aspects, catheter 851 can include a first hollow chamber 901 in fluid communication with first balloon 805, a second hollow chamber 903 in fluid communication with second balloon 807, and a third hollow chamber 905 that can receive a guidewire for guiding catheter 851. Hollow chambers 901, 903, 905 can extend axially along the length of catheter 851, such that a fluid source 855 can provide fluid to first and second hollow chambers 901, 903 from outside the patient. In some aspects, first hollow chamber 901 can be positioned on a first side of catheter 851, and second hollow chamber 903 can be positioned on an opposite, second side of catheter 851. Third hollow chamber 905 can be located at the center of catheter 851 and surrounded by first and second hollow chambers 901, 903. The conduit 851 may include one or more inner walls that may form the hollow chambers 901 , 903 , 905 such that each hollow chamber is isolated from and not in fluid communication with the other hollow chambers.

[0083] Figure 10 Showing along Figure 8 FIG8 is a cross-sectional view of inflation device 801 as viewed along line 10-10, illustrating the interiors of first balloon 805, second balloon 807, and catheter 851. First balloon 805 may include a first interior chamber 1001 surrounded by walls 815, 817, and 819, and second balloon 807 may include a second interior chamber 1003 surrounded by walls 835, 837, and 839. Catheter 851 may include a first shaft portion 1007 positioned within and extending through first interior chamber 1001 of first balloon 805. First shaft portion 1007 may include a first opening 1009, such as a plurality of first openings 1009, defining a first fluid passageway between first hollow chamber 901 and first interior chamber 1001. For example, first opening 1009 may extend through an outer wall of catheter 851, wherein first opening 1009 is in fluid communication with first hollow chamber 901 of catheter 851. In some aspects, the first shaft portion 1007 can include no openings at the second hollow chamber 903, such that the second hollow chamber 903 is isolated from and not in fluid communication with the first interior chamber 1001. When the fluid source 855 delivers fluid to the first hollow chamber 901, the fluid can pass through the first opening 1009 to inflate the first balloon 805. Further, to deflate the first balloon 805, a vacuum can be created in the first hollow chamber 901 (e.g., via the fluid source 855 or other device) to draw fluid from the first interior chamber 1001 through the first opening 1009 and into the first shaft portion 1007.

[0084] The catheter 851 can include a second shaft portion 1011 positioned within and extending through the second interior chamber 1003 of the second balloon 807. The second shaft portion 1011 can include a second opening 1013, for example, a plurality of second openings 1013, defining a second fluid passageway between the second hollow chamber 903 and the second interior chamber 1003. For example, the second opening 1013 can extend through an outer wall of the catheter 851, wherein the second opening 1013 is in fluid communication with the second hollow chamber 903 of the catheter 851. In some aspects, the second shaft portion 1011 can include no openings at the first hollow chamber 901, such that the first hollow chamber 901 is isolated from and not in fluid communication with the second interior chamber 1003. When the fluid source 855 delivers fluid to the second hollow chamber 903, the fluid can pass through the second opening 1013 to inflate the second balloon 807. Further, to collapse the second balloon 807 , a vacuum may be created in the second hollow chamber 903 (eg, via the fluid source 855 or other device) to draw fluid from the second interior chamber 1003 through the second opening 1013 and into the second shaft portion 1011 .

[0085] The catheter 851 can include a third shaft portion 1015 positioned between the first and second shaft portions 1007, 1011, with the hollow chambers 901, 903, 905 extending through the shaft portions 1007, 1011, 1015. In some aspects, the third shaft portion 1015 can extend between the first and second balloons 805, 807. The third shaft portion 1015 can include zero openings such that fluid can exit the catheter 851 without passing through the third shaft portion 1015. In some aspects, the catheter 851 (e.g., the shaft portions 1007, 1011, 1015) can include a shaft diameter 1017 that is smaller than the diameter 809 of the first and second balloons 805, 807. In some aspects, the shaft diameter 1017 can be less than about 4 mm, or less than about 3 mm, or less than about 2 mm. Accordingly, the inflation device 801 can include a non-constant diameter along the inflation axis 803, with a larger diameter at the ends (e.g., at the first and second balloons 805, 807) and a smaller diameter at the center (e.g., at the third shaft portion 1015).

[0086] Figure 11 A generalized diagram / schematic view of a heart valve prosthesis 10 is shown positioned at a treatment site 701. For illustrative purposes and to more clearly illustrate the position of the first segment 713 relative to the annulus 703, the heart valve prosthesis 10 is shown without the struts 16, valve 20 (e.g., leaflets 21, commissures 25), etc. However, in operation, the heart valve prosthesis 10 will be similar to the one positioned relative to the annulus 703. Figures 1 to 10 as well as Figure 12 to Figure 1 6 shows and describes a heart valve prosthesis 10. In some aspects, a method of positioning a heart valve prosthesis 10 can include moving the heart valve prosthesis 10 to a treatment site 701 within the vasculature of a patient, positioning the heart valve prosthesis 10 at the treatment site such that a first segment 713 is within the annulus 703 at the treatment site 701. The heart valve prosthesis 10 can be moved from a radially collapsed position to a radially expanded position. However, in some aspects, one or more of the first segment 713 or the second segment 715 can be underexpanded, such that a gap 709 can exist between the native annulus 703 and the first segment 713.

[0087] In some aspects, the method can include, prior to positioning the inflation device 801 within the heart valve prosthesis 10, determining one or more of: radially expanding the first segment 713 to a first initial diameter 1101 that is smaller than the first desired diameter 1103; or radially expanding the second segment 715 to a second initial diameter 1107 that is smaller than the second desired diameter 1109. For example, with reference to the first segment 713, when positioned at the treatment site 701, the first segment 713 can include the first initial diameter 1101 (e.g., at Figure 11 1103 is measured relative to the first segment 713 using a solid line). However, the first segment 713 may not be fully radially expanded such that a gap 709 exists on the outer radial side of the first segment 713. The first desired diameter 1103 may correspond to the first segment 713 being fully radially expanded such that the outer radial surface of the first segment 713 may be in contact with the native annulus 703. The first segment 713 is shown in a fully radially expanded state using a dashed line, where the dashed line represents a desired first segment position 1111. The desired first segment position 1111 is the position of the first segment 713 when the first segment 713 is radially expanded to the first desired diameter 1103. In this manner, the first desired diameter 1103 is measured relative to the desired first segment position 1111, where the first desired diameter 1103 is greater than the first initial diameter 1101.

[0088] Additionally or alternatively, with reference to the second segment 715, the second segment 715 can include a second initial diameter 1107 (e.g., at Figure 117. The second segment 715 is shown in FIG. 11 and is measured relative to the second segment 715 using a solid line. However, like the first segment 713, the second segment 715 may not be fully radially expanded. A second desired diameter 1109 may correspond to the fully radially expanded second segment 715. The second segment 715 is shown in a fully radially expanded state using a dashed line, where the dashed line represents a desired second segment position 1113. The desired second segment position 1113 is the position of the second segment 715 when the second segment 715 is radially expanded to the second desired diameter 1109. In this manner, the second desired diameter 1109 is measured relative to the desired second segment position 1113, where the second desired diameter 1109 is greater than the second initial diameter 1107.

[0089] refer to Figure 12 To address the issue of the heart valve prosthesis 10 expanding to less than a desired diameter 1103 , 1109 , the method may include positioning an inflation device 801 within the central lumen 13 of the heart valve prosthesis 10 . Figure 12 A prosthetic heart valve assembly 1200 is shown, wherein the prosthetic heart valve assembly 1200 may include a heart valve prosthesis 10 and an inflation device 801. For illustrative purposes, Figure 12 1 , heart valve prosthesis 10 is shown without valve 20 (e.g., leaflets 21, commissures 25) to more clearly illustrate how inflation device 801 can be positioned within frame 15. In some aspects, first balloon 805 and second balloon 807 can be in a collapsed state when inflation device 801 is moved and positioned within central lumen 13. In their collapsed state, first balloon 805 and second balloon 807 can lie flush with catheter 851, allowing inflation device 801 to occupy a minimal cross-sectional dimension when moved through the patient's vasculature.

[0090] In some aspects, the heart valve prosthesis 10 and inflation device 801 can include radiopaque markers to facilitate alignment. For example, the heart valve prosthesis 10 can include a valve radiopaque marker 1201 that, in some aspects, can be attached to the frame 15. Although not limited to such a location, in some aspects and as Figure 12As shown, a valve radiopaque marker 1201 can be attached to the frame 15 at the inflow end 11. The inflation device 801 can include a balloon radiopaque marker 1203, which in some aspects can be attached to the catheter 851 and positioned within the first balloon 805. The radiopaque markers 1201, 1203 can be made of a radiopaque material and / or have echogenic or other properties so as to be visible from outside the patient's body using appropriate imaging techniques. The radiopaque markers 1201, 1203 can be made of platinum iridium, tungsten, barium sulfate, other radiopaque materials, etc. In this manner, the radiopaque markers 1201, 1203 can be used to visualize the movement of the inflation device 801 relative to the heart valve prosthesis 10 and to determine whether the inflation device 801 is properly positioned. Accordingly, positioning the inflation device 801 within the central lumen 13 of the heart valve prosthesis 10 can include aligning the balloon radiopaque marker 1203 of the inflation device 801 with the valve radiopaque marker 1201 of the heart valve prosthesis 10. By aligning, the first balloon 805 can be positioned within the first section 713, the second balloon 807 can be positioned within the second section 715, and the third shaft portion 1015 of the catheter 851 can be positioned within the waist section 717. In some aspects, aligning the balloon radiopaque marker 1203 can occur prior to one or more of inflating the first balloon 805 or inflating the second balloon 807. Additionally, while Figure 12 Two radiopaque markers are shown, but additional radiopaque markers may be provided to further facilitate positioning of inflation device 801 relative to heart valve prosthesis 10 , with additional radiopaque markers attached to various locations on inflation device 801 and / or heart valve prosthesis 10 .

[0091] Figure 13 Shows something like Figure 10 1, but wherein the inflation device 801 is positioned within the central lumen 13 of the heart valve prosthesis 10 and already inflated. For example, after aligning the inflation device 801 with the frame 15 via the radiopaque markers 1201, 1203, the balloons 805, 807 can be inflated. In some aspects, the balloons 805, 807 can be inflated at different times (e.g., one balloon is inflated first, followed by the other) or simultaneously. In some aspects, the balloons 805, 807 can be partially inflated at different times (e.g., one balloon is partially or fully inflated, followed by the other balloon is partially or fully inflated). In some aspects, the partial, non-simultaneous inflation can be repeated or alternating until the balloons 805, 807 are fully inflated. Additionally or alternatively, the balloons 805, 807 may be partially inflated and / or deflated at different times so that the desired radial expansion of the respective balloons 805, 807 may be selectively controlled.

[0092] In some aspects, when the balloons 805, 807 are not inflated simultaneously, the second balloon 807 can be inflated first. For example, with the second balloon 807 positioned in the second section 715, the second balloon 807 can be inflated from a collapsed state (e.g., Figure 12 851 to the second balloon 807, such that the second balloon 807 can contact the interior surface 1303 of the second segment 715 to increase the diameter of the second segment 715. The second fluid 1301 can be delivered from a fluid source 855, through the second hollow chamber 903, and through the second opening 1013 of the second shaft portion 1011, so that the second fluid 1301 can flow into the second interior chamber 1003 of the second balloon 807. In this manner, inflating the second balloon 807 can include contacting the interior surface 1303 of the second segment 715 of the valve prosthesis 10 to radially expand the second segment 715 from the second initial diameter 1107 to the second desired diameter 1109. Accordingly, the second balloon 807 can include a second balloon diameter 1313 in the inflated state such that the second balloon 807 contacts the interior surface 1303 of the second segment 715. The second balloon diameter 1313 can be substantially equal to the second desired diameter 1109 of the second segment 715.

[0093] In some aspects, after inflating the second balloon 807, the first balloon 805 positioned in the first section 713 can be moved from a collapsed state (e.g., Figure 12805 ). The method may include inflating first balloon 805 by delivering a first fluid 1305 through first hollow chamber 901 of catheter 851 to first balloon 805, such that first balloon 805 may contact interior surface 1307 of first segment 713 to increase the diameter of first segment 713. First fluid 1305 may be delivered from fluid source 855, through first hollow chamber 901, and through first opening 1009 of first shaft portion 1007, so that first fluid 1305 may flow into first interior chamber 1001 of first balloon 805. In this manner, inflating first balloon 805 may include contacting interior surface 1307 of first segment 713 of valve prosthesis 10 to radially expand first segment 713 from first initial diameter 1101 to first desired diameter 1103. Accordingly, the first balloon 805 can comprise a first balloon diameter 1311 in the inflated state such that the first balloon 805 is in contact with the interior surface 1307 of the first segment 713. The first balloon diameter 1311 can be substantially equal to the first desired diameter 1103 of the first segment 713. In some aspects, the delivery of the fluids 1301, 1305 can be controlled by a valve, stopcock, or other flow control device 1341 (e.g., Figure 13 ) control so that one fluid can be selectively and independently delivered to one of the balloons 805, 807 at a time when desired.

[0094] As discussed above, in some aspects, by providing the second balloon 807 with relatively less stiff (e.g., more compliant) properties as compared to the relatively stiffer (e.g., less compliant) properties of the first balloon 805, the second balloon 807 can be inflated first (e.g., before inflating the first balloon 805) to anchor the inflation device 801 within the second section 715 of the prosthetic heart valve 10 without deforming the native anatomy at the second section 715. With the inflation device 801 anchored in the second section 715 upon inflation of the second balloon 807, migration or other movement of the inflation device 801 can be reduced or prevented. With migration of the inflation device 801 restricted, the first balloon 805 can then be inflated (e.g., after inflating the second balloon 807) to radially expand the first segment 713 of the prosthetic heart valve 10 and the native anatomical structures at the first segment 713 (e.g., the native annulus 703 and / or the native leaflets 705). Without intending to be bound by theory, it is believed that in some aspects, inflating the first balloon 805 alone or first inflating the first balloon and then inflating the second balloon 807 may be less predictable and less controllable because, without first inflating the second balloon 807 to anchor the inflation device 801 at the treatment site 701, the inflation device 801 and / or the prosthetic heart valve 10 may migrate (e.g., move axially relative to the native annulus 703), such that radial expansion of the first balloon 805 may undesirably occur at an unintended lateral location within the prosthetic heart valve 10 (e.g., at the waist section 717), thereby applying unintended radial forces to, for example, the prosthetic leaflets 21 and / or causing displacement or undesirable positioning of the prosthetic heart valve 10 relative to the native annulus 703.

[0095] After inflating the balloons 805, 807, the first balloon 805 is inflated and positioned in the first section 713, the second balloon 807 is inflated and positioned in the second section 715, and the catheter 851 can extend through the waist section 717 between the first balloon 805 and the second balloon 807. After inflation, the first balloon diameter 1311 can be substantially equal to the maximum first diameter of the first section 713, wherein the maximum first diameter of the first section 713 is substantially equal to the first desired diameter 1103. Similarly, after inflation, the second balloon diameter 1313 can be substantially equal to the maximum second diameter of the second section 715, wherein the maximum second diameter of the second section 715 is substantially equal to the second desired diameter 1109. In this manner, the balloons 805, 807 can facilitate radial expansion of the heart valve prosthesis 10, for example, when the heart valve prosthesis 10 is initially not fully expanded.

[0096] After inflation, the first balloon 805 and the second balloon 807 are spaced apart by a separation distance 845, such that the first interior chamber 1001 is isolated from the second interior chamber 1003. Because the first interior chamber 1001 is isolated from the second interior chamber 1003, when the balloons 805, 807 are inflated, fluid may not flow between the first interior chamber and the second interior chamber. In this way, the balloons 805, 807 may not contact the leaflet 21 (e.g., during Figure 13 13. The first balloon 805 and the second balloon 807 can be spaced apart by a first distance 1317 from the plurality of leaflets 21, and the second balloon 807 can be spaced apart by a second distance 1319 from the plurality of leaflets 21. For example, the first balloon 805 can extend between a first balloon end 811 and a second balloon end 813, wherein the first balloon end 811 is spaced apart by a distance 1321 from the plurality of leaflets 21, and the second balloon end 813 is spaced apart by the first distance 1317 from the plurality of leaflets 21. The second balloon 807 can extend between a first balloon end 831 and a second balloon end 833, wherein the first balloon end 831 is spaced apart by a distance 1323 from the plurality of leaflets 21, and the second balloon end 833 is spaced apart by the second distance 1319 from the plurality of leaflets 21. Accordingly, because the first balloon 805 and the second balloon 807 are spaced apart and do not contact the leaflet 21 , the first balloon and the second balloon may not interfere with the operation of the leaflet 21 by causing undesired radial expansion of the leaflet 21 .

[0097] After the inflation device 801 radially expands the heart valve prosthesis 10, the balloons 805, 807 can be deflated and the inflation device 801 can be removed from the central lumen 13 of the heart valve prosthesis 10. To deflate the balloons 805, 807, a vacuum can be created within the hollow chambers 901, 903 of the catheter 851, thereby drawing fluid from the balloons 805, 807 into the catheter 851. In this manner, fluid can continue to be removed from the balloons 805, 807 until the balloons 805, 807 are in a fully deflated state (e.g., at Figure 12 ). After deflation of balloons 805, 807, inflation device 801 may be retracted and withdrawn from heart valve prosthesis 10 and removed from the patient's vasculature.

[0098] In some aspects, inflation device 801 is not limited to including both first balloon 805 and second balloon 807. Rather, in some aspects, inflation device 801 can include a single balloon. For example, inflation device 801 can include first balloon 805 without second balloon 807. In such an embodiment, first balloon 805 can be used to radially expand first segment 713 to first desired diameter 1103. This radial expansion of first segment 713 can reduce or eliminate gap 709, thereby reducing the likelihood of paravalvular leak. Further, by radially expanding first segment 713 along with first balloon 805, other portions of heart valve prosthesis 10 can also be at least partially radially expanded due to their proximity to first segment 713.

[0099] Figures 14 and 15 An additional embodiment of an inflation device 1401 is shown that can be used to inflate a device similar to that described above with respect to Figures 7 to 13 Heart valve prosthesis 10 can be radially expanded in substantially the same manner as described above. For example, in some aspects, inflation device 1401 can include a first balloon 1403, a second balloon 1405, and a central balloon 1407. First balloon 1403 can be positioned in first section 713, second balloon 1405 can be positioned in second section 715, and central balloon 1407 can be positioned in waist section 717. In some aspects, first balloon 1403, second balloon 1405, and central balloon 1407 can include a single, continuous internal chamber such that balloons 1403, 1405, 1407 are in fluid communication with each other. Central balloon 1407 can be positioned in waist section 717 and can be attached to first balloon 1403 at one end and to second balloon 1405 at an opposite end. The catheter 851 can extend into the interior lumen of the balloons 1403 , 1405 , 1407 to deliver fluid from the fluid source 855 to the interior lumen, thereby inflating the balloons 1403 , 1405 , 1407 .

[0100] Figure 15An inflation device 1401 is shown positioned within a heart valve prosthesis 10. First balloon 1403 can include a first balloon diameter 1501, second balloon 1405 can include a second balloon diameter 1503, and center balloon 1407 can include a center balloon diameter 1505. Center balloon diameter 1505 can be smaller than first balloon diameter 1501 and second balloon diameter 1503. In some aspects, first balloon diameter 1501 can be substantially equal to first desired diameter 1103 of first segment 713, and second balloon diameter 1503 can be substantially equal to second desired diameter 1109 of second segment 715. Center balloon diameter 1505 can be sufficiently small that center balloon 1407 can not contact or radially expand leaflets 21. Accordingly, several different types of inflation devices 801, 1401 are contemplated that can assist in radially expanding heart valve prosthesis 10 to reduce the likelihood of paravalvular leak. Further, because the cross-sectional dimensions of the inflation device 801 , 1401 are not constant (eg, wherein the ends comprise a larger diameter than the center), the inflation device 801 , 1401 will not damage or interfere with the leaflets 21 and will also not damage native structures at the treatment site 701 .

[0101] It should be understood that although various aspects have been described in detail with respect to certain illustrative and specific examples thereof, the present disclosure should not be considered limited thereto since many modifications and combinations of the disclosed features are possible without departing from the scope of the appended claims.

Claims

1. An inflation device for expanding a prosthetic heart valve, the inflation device comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially collapsed position and a radially expanded position, the frame comprising a first segment at the inflow end, a second segment at the outflow end, a waist segment positioned between the first segment and the second segment, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; the inflation device comprising: a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a collapsed state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to contact an interior surface of the first section; a second balloon configured to be positioned in the second segment, the second balloon configured to be pressurized from a collapsed state to an inflated state, the second balloon comprising a second balloon diameter in the inflated state such that the second balloon is configured to contact an interior surface of the second segment; as well as A catheter is configured to extend through the waist section between the first balloon and the second balloon, the catheter comprising a first hollow chamber in fluid communication with the first balloon and a second hollow chamber in fluid communication with the second balloon.

2. The inflation device of claim 1, wherein: The first balloon is spaced apart from the second balloon by a separation distance and defines a gap therebetween, the catheter extending within the gap.

3. The inflation device of claim 2, wherein: The first balloon is configured to be spaced a first distance from the at least one leaflet, and the second balloon is configured to be spaced a second distance from the at least one leaflet.

4. The inflation device of claim 3, wherein: The first balloon diameter is substantially equal to a maximum first diameter of the first section.

5. The inflation device of claim 4, wherein: The second balloon diameter is substantially equal to a maximum second diameter of the second section.

6. The inflation device of claim 1, wherein: The catheter includes a first shaft portion positioned within the first balloon, the first shaft portion including a first opening defining a first fluid passage between the first hollow chamber and a first interior chamber of the first balloon.

7. The inflation device of claim 1, wherein: The catheter includes a second shaft portion positioned within the second balloon, the second shaft portion including a second opening defining a second fluid passage between the second hollow chamber and a second interior chamber of the second balloon.

8. An inflation device for expanding a prosthetic heart valve, the inflation device comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially collapsed position and a radially expanded position, the frame comprising a first segment at the inflow end, a second segment at the outflow end, a waist segment positioned between the first segment and the second segment, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; The inflation device is configured to be positioned within the frame and comprises: a first balloon configured to be positioned in the first segment, the first balloon configured to be pressurized from a collapsed state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to contact an interior surface of the first segment, the first balloon extending between a first balloon end and a second balloon end, the first balloon end configured to be spaced a first distance from the at least one leaflet, and the second balloon end configured to be spaced a second distance from the at least one leaflet; a catheter configured to extend through an interior of the frame and comprising a first hollow chamber in fluid communication with the first balloon; and A fluid source is in fluid communication with the catheter, the fluid source being configured to deliver a fluid through the first hollow chamber to the first balloon.

9. The inflation device of claim 8, further comprising: a second balloon configured to be positioned in the second segment, the second balloon configured to be pressurized from a collapsed state to an inflated state, the second balloon comprising a second balloon diameter in the inflated state such that the second balloon is configured to contact an interior surface of the second segment; as well as A central balloon is configured to be positioned in the waist section and attached to the first balloon at one end and to the second balloon at an opposite end, the first balloon, the second balloon, and the central balloon defining a continuous interior chamber.

10. The inflation device of claim 9, wherein: The center balloon includes a center balloon diameter that is smaller than the first balloon diameter and the second balloon diameter.

11. The inflation device of claim 10, wherein: The catheter extends through the first balloon, the second balloon, and the center balloon, the catheter including one or more openings defining a fluid pathway between the first hollow chamber and the interior chamber.

Images