Funnel crimper with tissue compressor

Abstract

A funnel crimper includes a body having a tapered portion, an extending outflow portion, and a tissue compressor. The tissue compressor is configured to apply a radially inward force to tissue of a prosthetic valve of the transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the lumen of the funnel crimper, the prosthetic valve disposed on an inner surface of a frame of the transcatheter heart valve prosthesis. The tissue compressor may be a ring having a relatively soft material extending into the lumen of the funnel crimper, or a pressurized fluid applied radially inward to the lumen of the funnel crimper.

Description

Technical Field

[0001] The present invention is generally directed to a funnel-style crimping and loading assembly having a tissue compressor to reduce strut crossing, infolding, and / or trauma to the tissue of a transcatheter heart valve prosthesis during the crimping process. Background Art

[0002] The human heart is a four-chambered muscular organ that provides blood circulation throughout the body during the cardiac cycle. The four main chambers include the right atrium and right ventricle that provide pulmonary circulation and the left atrium and left ventricle that provide oxygenated blood received from the lungs to the systemic circulation. To ensure that blood flows through the heart in one direction, there are atrioventricular valves (tricuspid and mitral valves) between the junctions of the atria and ventricles, and semilunar valves (pulmonary and aortic valves) control the exit of the ventricles to the lungs and other parts of the body. These valves contain leaflets or cusps that open and close in response to changes in blood pressure caused by the contraction and relaxation of the heart chambers. The valve leaflets separate from each other to open and allow blood to flow downstream of the valve, and close to close and prevent backflow or regurgitation in an upstream manner.

[0003] Diseases associated with heart valves (such as those caused by damage 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 the downstream heart chambers at an appropriate flow rate and may cause the heart to work harder to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve is not completely closed, causing blood to flow back, resulting in decreased heart efficiency. Diseased or damaged valves may be congenital, age-related, drug-induced, or in some cases caused by infection, which may cause the heart to enlarge and thicken, and lose elasticity and efficiency. Some symptoms of heart valve disease may include weakness, shortness of breath, dizziness, syncope, palpitations, anemia and edema, and 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.

[0004] Heart valve prostheses have been developed for repairing and replacing diseased and / or damaged heart valves. Such heart valve prostheses can be delivered percutaneously through a catheter-based delivery system and deployed at the site of a diseased heart valve. 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.

[0005] The present disclosure relates to improvements in radially compressing or crimping a heart valve prosthesis to prevent tissue of the heart valve prosthesis from being pinched between struts of the frame of the heart valve prosthesis, thereby reducing the risk of tissue damage, strut crossing and infolding during the crimping process. Summary of the invention

[0006] According to a first example of the present invention, a funnel-type crimper comprises a body having a first end, a second end, and an inner cavity extending from the first end to the second end. The inner cavity is defined by the inner surface of the body. The body comprises a tapered portion and an extended outflow portion, wherein the inner cavity in the tapered portion tapers from a first diameter at the first end to a second diameter less than the first diameter. The extended outflow portion extends from the tapered portion to the second end of the body. The funnel-type crimper further comprises a tissue compressor, which is coupled to the body so that the tissue compressor extends into the inner cavity relative to the inner surface of the body. The tissue compressor comprises a relatively soft material that is softer than the relatively hard material of the body, and the relatively soft material is configured to apply a radially inward force to the tissue of the artificial valve of the transcatheter heart valve prosthesis when the transcatheter heart valve prosthesis advances through the inner cavity of the body, and the artificial valve is disposed on the inner surface of the frame of the transcatheter heart valve prosthesis.

[0007] In a second example, in the funnel-style crimper of the first example, the relatively soft material of the tissue compressor has a Shore A hardness in the range of 20A to 80A.

[0008] In a third example, in the funnel-type crimper of the second example, the relatively soft material of the tissue compressor is selected from the group consisting of: closed-cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer (EDPM), nitrile, fluorocarbon-based fluoroelastomer (FKM), polychloroprene (chloroprene) and / or combinations thereof.

[0009] In a fourth example, in the funnel-type crimper of any one of the first to third examples, an inner surface of the body at the extended outflow portion further includes a recess, and wherein the tissue compressor is disposed in the recess.

[0010] In a fifth example, in the funnel-type crimper of any one of the first to fourth examples, the tissue compressor is a ring having an outer surface, an inner surface, a thickness defined between the inner surface and the outer surface, a width, and a ring lumen defined by the inner surface of the ring.

[0011] In a sixth example, in the funnel crimper of the fifth example, a thickness of the ring is greater than a depth of the recess.

[0012] In a seventh example, in the funnel-style crimper of any one of the first to sixth examples, the tissue compressor further includes a plurality of fingers extending radially inwardly into the inner cavity of the body.

[0013] In an eighth example, a funnel-type crimper includes a body having a first end, a second end, and an inner cavity extending from the first end to the second end. The inner cavity is defined by an inner surface of the body, and the body includes a tapered portion and an extended outflow portion, wherein the inner cavity in the tapered portion tapers from a first diameter at the first end to a second diameter less than the first diameter. The extended outflow portion extends from the tapered portion to the second end of the body. The funnel-type crimper further includes a tissue compressor configured to apply a radially inward force to tissue of an artificial valve of a transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the inner cavity of the body, the artificial valve being disposed on an inner surface of a frame of the transcatheter heart valve prosthesis. The tissue compressor includes a plurality of ports through the extended outflow portion of the body, the plurality of ports being configured to provide a pressurized fluid to the inner cavity of the body.

[0014] In a ninth example, in the funnel-type crimper of the eighth example, the tissue compressor further includes a ring disposed around an outer surface of the extended outflow portion, the ring defining a channel between the outer surface of the extended outflow portion and an inner surface of the ring, wherein the plurality of ports are disposed within the ring.

[0015] In a tenth example, in the funnel crimper of the ninth example, the funnel crimper further includes an inlet port coupled to the ring, wherein the inlet port is in fluid communication with the channel of the ring.

[0016] In an eleventh example, a method for radially compressing a transcatheter heart valve prosthesis includes the following steps: advancing the transcatheter heart valve prosthesis through a tapered portion of a funnel-type crimper, the tapered portion having an inner cavity tapering from a first diameter to a second diameter smaller than the first diameter, and the transcatheter heart valve prosthesis includes a frame and an artificial valve disposed within the frame; advancing the transcatheter heart valve prosthesis through an extended outflow portion of the funnel-type crimper, the extended outflow portion extending from the tapered portion at the second diameter of the inner cavity; and applying a radially inward force to tissue of the artificial valve when the transcatheter heart valve prosthesis is advanced through the extended outflow portion, causing the tissue to move radially inward relative to the frame.

[0017] In a twelfth example, in the method of the eleventh example, the method further includes loading the transcatheter heart valve prosthesis onto or into a delivery catheter system.

[0018] In a thirteenth example, in the method of the eleventh example or the twelfth example, the radially inward force is applied through cells of the frame.

[0019] In a fourteenth example, in the method of any one of the eleventh to thirteenth examples, wherein the radially inward force is applied by a relatively soft material extending into the inner cavity of the funnel-type crimper relative to the inner surface of the extended outflow portion, and wherein the relatively soft material is softer than the relatively hard material of the funnel-type crimper.

[0020] In a fifteenth example, in the method of the fourteenth example, the relatively soft material has a Shore A hardness in a range of 20A to 80A.

[0021] In a sixteenth example, in the method of the fifteenth example, the relatively soft material is selected from the group consisting of: closed-cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer (EDPM), nitrile, fluorocarbon-based fluoroelastomer (FKM), polychloroprene (chloroprene) and / or combinations thereof.

[0022] In a seventeenth example, in the method of any one of the eleventh to thirteenth examples, applying the radially inward force to tissue of the prosthetic valve includes applying a pressurized fluid to tissue in the extended outflow portion of the funnel crimper.

[0023] In an eighteenth example, in the method of the seventeenth example, applying the pressurized fluid includes providing the pressurized fluid into the lumen of the funnel crimper through a port in the extended outflow portion.

[0024] In a nineteenth example, in the method of the eighteenth example, the pressurized fluid is provided by a ring disposed around the extended outflow portion, the ring defining a passage between an inner surface of the ring and an outer surface of the extended outflow portion, the passage being in fluid communication with the ports.

[0025] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in the disclosure will become apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The foregoing and other features and advantages of the present disclosure will become apparent from the following description of the embodiments of the present disclosure as shown in the accompanying drawings. The accompanying drawings, which are incorporated herein and constitute a part of the specification, are further used to explain the principles of the present disclosure and to enable those skilled in the relevant art to make and use the embodiments of the present disclosure. The accompanying drawings may not be drawn to scale.

[0027] Figure 1A A side view of an exemplary transcatheter heart valve prosthesis is shown.

[0028] Figure 1B Shows Figure 1A Top view of a transcatheter heart valve prosthesis.

[0029] Figure 2A A side perspective view of a crimping and loading assembly is shown in accordance with an embodiment of the present invention.

[0030] Figure 2B Shows Figure 2A A cross-sectional perspective view of a crimping and loading assembly, wherein a plunger of the crimping and loading assembly is disposed within a funnel-type crimper of the crimping and loading assembly.

[0031] Figure 2C Shows Figure 2A and Figure 2B Cross section of a crimped and loaded assembly.

[0032] Figure 2D Shows Figure 2C A close-up view of a portion of a cross section.

[0033] Figure 2E A close-up view of a portion of a funnel crimper is shown with a transcatheter heart valve prosthesis being loaded into a delivery catheter.

[0034] FIG. 3A to FIG. 3B An embodiment of a tissue compressor with a funnel-style crimper according to an embodiment of the present invention is shown.

[0035] Figure 4 is the use according to an embodiment of the present invention FIG. 2A to FIG. 2D and FIG. 3A to FIG. 3B A block diagram of the curling and loading assembly methods.

[0036] Figure 5A A side perspective view of a crimping and loading assembly is shown in accordance with an embodiment of the present invention.

[0037] Figure 5B Shows Figure 5A Side perspective view of the crimping and loading assembly.

[0038] Figure 5C Shows Figure 5A and Figure 5B A cross-sectional perspective view of a funnel crimper.

[0039] Figure 5D Shows FIG. 5A to FIG. 5C Cross section of a funnel crimper.

[0040] Figure 5E Shows Figure 5D A close-up view of a portion of a cross section.

[0041] Fig. 5F A close-up view of a portion of a funnel crimper is shown with a transcatheter heart valve prosthesis being loaded into a delivery catheter.

[0042] Figure 6 The embodiment according to the present invention is shown Figure 5A Schematic diagram of a curling and loading assembly, which further includes a fluid source.

[0043] Figure 7 is a diagram showing the use of an embodiment according to the present invention FIG. 5A to FIG. 5F and Figure 6 A block diagram of a method of a funnel-type crimper and a tissue compressor. DETAILED DESCRIPTION

[0044] It should be understood that a plurality of different embodiments disclosed herein can be combined into a combination different from the combination specifically presented in the specification and the drawings. It should also be understood that, according to the examples, certain actions or events of any process or method described herein can be performed in different orders, can be added, merged or completely omitted (for example, all described actions or events may not be necessary for implementing these technologies). In addition, although for the sake of clarity, some aspects of the present disclosure are described as being performed by a single device or component, it should be understood that the technology of the present disclosure can be performed by a combination of devices or components associated with, for example, a medical device. The following detailed description is merely exemplary in nature and is not intended to limit the invention of the present application and the use of the present invention. In addition, it is not intended to be bound by any express or implied theory presented in the aforementioned technical field, background technology, summary of the invention or the following detailed description.

[0045] As used in this specification, the singular forms "a", "an", "the" also specifically encompass the plural forms to which the term refers, unless the context clearly indicates otherwise. The term "about" as used herein means approximately, within a range, roughly or approximately. When the term "about" is used in conjunction with a numerical range, it modifies the range by extending the boundaries above and below the listed numerical values. In general, the term "about" as used herein modifies the numerical value above and below the stated value by a variation of 20%. It should be understood that the use of the term "about" also includes specifically recited numbers or values.

[0046] The terms "proximal" and "distal" herein when used with respect to delivery devices (such as a delivery catheter) are used with respect to a clinician using these devices. Thus, "proximal" and "proximally" refer to in a direction toward the clinician, and "distal" and "distally" refer to in a direction away from the clinician. The terms "proximal" and "distal" herein when used with respect to a device to be implanted in the body (such as a transcatheter heart valve prosthesis) are used with respect to the direction of blood flow. Thus, "proximal" and "proximally" refer to the upstream or inflow direction, and "distal" and "distally" refer to the downstream or outflow direction.

[0047] As used herein, the terms "substantially" and "substantially" mean approximately. When used to describe an angle, such as "substantially parallel" or "substantially perpendicular," the term "substantially" means within 10 degrees of the angle. When used to describe a shape, such as "substantially" or "substantially" cylindrical or "substantially" or "substantially" tubular or "substantially" or "substantially" conical, these terms mean that to one of ordinary skill in the art observing the shape with the naked eye, the shape would appear cylindrical or tubular or conical.

[0048] Embodiments of the present invention relate to a funnel-type crimper having a tissue compressor configured for use with a transcatheter heart valve prosthesis when compressing the transcatheter heart valve prosthesis radially into a curled configuration for loading into a delivery catheter and delivery within a vascular system. More particularly, the tissue compressor is configured to push or urge valve tissue of the transcatheter heart valve prosthesis radially inward during the curling process to avoid protrusion of the valve tissue into the frame of the transcatheter heart valve prosthesis, which may result in folding within the frame, strut crossing, tissue clamping and / or tissue damage. The tissue compressor is coupled to the funnel-type crimper and directly contacts the transcatheter heart valve prosthesis during the curling process so that the tissue compressor can push or urge tissue of the transcatheter heart valve prosthesis radially inward relative to the frame of the transcatheter heart valve prosthesis, thereby reducing the chance of tissue protruding between the struts of the frame of the heart valve prosthesis.

[0049] Figure 1A and Figure 1BAn exemplary transcatheter heart valve prosthesis 125 is shown that can be used with embodiments of the crimping and loading assemblies described herein. The transcatheter heart valve prosthesis 125 is shown herein to facilitate description of the present invention. The following description of the transcatheter heart valve prosthesis 125 is merely exemplary in nature and is not intended to limit the present invention or the application and use of the present invention. It should be understood that any number of alternative heart valve prostheses can be used with the crimping and loading assemblies and methods described herein. Although the transcatheter heart valve prosthesis 125 is a self-expanding heart valve prosthesis constructed for placement within an aortic heart valve, the embodiments of the crimping and loading assemblies described herein can be used with any transcatheter heart valve prosthesis that is crimped onto and / or enters a delivery system. For example, embodiments of the crimping and loading assemblies described herein may be used with a transcatheter heart valve prosthesis constructed for placement within the pulmonary valve, aortic valve, mitral valve, or tricuspid valve, or may be used with a transcatheter valve prosthesis constructed for placement within a venous valve or other body passageway where it is deemed useful.

[0050] Figure 1A and Figure 1B A side view and a top view of a transcatheter heart valve prosthesis 125 are shown, respectively. The transcatheter heart valve prosthesis 125 includes a radially expandable frame 126 and an artificial valve 127. The frame 126 of the transcatheter heart valve prosthesis 125 is a stent or framework that supports the artificial valve 127 within the interior of the frame 126. The frame 126 can be self-expanding or balloon expandable. The artificial valve 127 includes at least one leaflet 128 disposed within the frame 126 and fixed to the frame. In an embodiment, the artificial valve 127 of the transcatheter heart valve prosthesis 125 includes exactly three leaflets 128, such as Figure 1B The artificial valve 127 of the transcatheter heart valve prosthesis 125 is capable of blocking flow in one direction to regulate flow therethrough via the valve leaflets 128. The transcatheter heart valve prosthesis 125 has a radially compressed or curled configuration for delivery within the vascular system and a radially expanded configuration (such as Figure 1A and Figure 1B shown).

[0051] like Figure 1AAs shown, the transcatheter heart valve prosthesis 125 includes an inflow portion 141 including an inflow end 131 and an outflow portion 142 including an outflow end 132. The frame 126 of the transcatheter heart valve prosthesis 125 includes a plurality of struts 134 arranged to form a plurality of side openings or cells 135 that are arranged circumferentially and longitudinally around a central longitudinal axis of the transcatheter heart valve prosthesis 125 to form a tubular structure defining a central lumen 136 of the frame 126. Two struts 134 together form a crown 133. Four struts 134 together form a node 137, as shown in FIG. Figure 1A Each cell 135 of the plurality of cells 135 is defined by four struts 134 and four nodes 137, or three nodes 137 and a crown 133. The frame 126 is configured to secure the artificial valve 127 within the central lumen 136 of the frame 126 and to secure the transcatheter heart valve prosthesis 125 in place in the patient's vasculature.

[0052] The inflow end 131 of the frame 126 includes a plurality of crowns 133, wherein each crown 133 is formed between a pair of adjacent struts 134. Similarly, the outflow end 132 of the frame 126 includes a plurality of crowns 133, wherein each crown 133 is formed between a pair of adjacent struts 134. The outflow end 132 of the frame 126 may include one or more paddles 140 coupled to one or more crowns 133 at the outflow end 132 of the frame 126, which are coupled to a delivery system when the transcatheter heart valve prosthesis 125 is delivered to a target site. Although Figure 1A Two (2) paddles 140 are shown, but those skilled in the art will recognize that paddles 140 may be replaced with other components (e.g., eyelets, rings, grooves, or any other suitable coupling members), and that more or fewer paddles or other coupling members may be used. In some embodiments, paddles 140 are radiopaque so as to be visible under fluoroscopy, wherein one of the paddles 140 includes a C-shaped marking to assist in orienting transcatheter heart valve prosthesis 125 during implantation. Those skilled in the art will recognize that other asymmetric shapes may be utilized to assist in determining the orientation of transcatheter heart valve prosthesis 125 during implantation. In embodiments (e.g., Figure 1A In the embodiment of the present invention, the paddle 140 having a C-shaped marking is axially aligned with one of the commissures 130 of the valve structure 127, such as Figure 1A Best seen in.

[0053] In an embodiment, the plurality of cells 135 may be diamond-shaped, such as Figure 1AIn the embodiment described herein, the plurality of cells 135 located at the outflow portion 142 are relatively larger than the plurality of cells 135 located at the inflow portion 141 of the frame 126 to improve access to the coronary arteries. More specifically, the cells 135 located at the outflow portion 142 are configured to be large enough to easily pass through a coronary guide catheter into the right coronary artery or the left main coronary artery after the transcatheter heart valve prosthesis 125 is deployed in situ.

[0054] The artificial valve 127 of the transcatheter heart valve prosthesis 125 is capable of regulating flow therethrough via valve leaflets 128 that may form a replacement valve. Figure 1A and Figure 1B An exemplary artificial valve 127 having three leaflets 128 is shown, although a single leaflet, a bicuspid leaflet, or a four leaflet configuration may alternatively be used in embodiments of the present invention. When deployed in situ, the artificial valve 127 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen 136 of the frame 126 of the transcatheter heart valve prosthesis 125. Figure 1A A side view of a transcatheter heart valve prosthesis 125 is depicted, wherein an artificial valve 127 is shown disposed within and secured to a frame 126 of the heart valve prosthesis 125 . Figure 1B Depicted Figure 1A An inflow end view of transcatheter heart valve prosthesis 125 is shown.

[0055] The leaflets 128 can be attached to a graft material or skirt 129 that surrounds or is lined with a portion of the frame 126, for example using sutures or suitable biocompatible adhesives, as known to those of ordinary skill in the art of prosthetic tissue valve structures. The leaflets 128 are sutured or otherwise firmly and sealingly attached to the inner surface of the graft material along their bases, or otherwise attached to the frame 126. Adjacent pairs of leaflets are attached to each other at their lateral ends to form commissures 130, wherein the free edges of the leaflets 128 form abutment edges that meet in a closed configuration. The orientation of the leaflets 128 within the artificial valve 127 depends on which end of the transcatheter heart valve prosthesis 125 is the inflow end 131, and which end of the transcatheter heart valve prosthesis 125 is the outflow end 132, thereby ensuring unidirectional flow of blood through the transcatheter heart valve prosthesis 125.

[0056] The valve leaflets 128 and the graft material may be formed from a variety of flexible materials including, but not limited to, natural materials (such as tissue of bovine, equine, or porcine origin) or synthetic materials (such as polytetrafluoroethylene (PTFE), Polyester, pyrolytic carbon or other biocompatible materials). For some prosthetic leaflet materials, it may be desirable to cover one or both sides of the replacement valve leaflet with a material that prevents or minimizes overgrowth. It is further desirable that the prosthetic leaflet material is durable and does not stretch, deform or fatigue.

[0057] like Figure 1A and Figure 1B As shown, the artificial valve 127 includes at least one leaflet 128 disposed within and secured to a frame 126 of a transcatheter heart valve prosthesis 125. A funnel-type crimper can be used to radially compress the transcatheter heart valve prosthesis 125 from an expanded configuration to a crimped configuration for delivery within the vascular system. During the crimping process, the radial compression applied by the funnel-type crimper causes the area of ​​the cells 135 of the frame 126 to decrease. In some examples, tissue of the artificial valve 127 may protrude through the cells 135 of the frame 126 during the process, which may cause the tissue to be clamped between the struts 134 of the frame 126 and suffer damage. For example, as the area of ​​the cells 135 increases and / or in view of the higher crimping forces that may be required to crimp the balloon-expandable implant, tissue protrusion may become increasingly likely.

[0058] FIG. 2A to FIG. 2D 2 is an illustration of a crimping and loading assembly 200 including a funnel-type crimper 201 and a guide plunger 280. Those skilled in the art will recognize that the crimping and loading assembly 200 may include other portions and / or components not described herein for crimping and loading a transcatheter heart valve prosthesis into a delivery catheter. The crimping and loading assembly 200 is constructed for use with a transcatheter valve prosthesis (such as, but not limited to, the transcatheter heart valve prosthesis 125 described herein) to radially compress the transcatheter valve prosthesis into a crimped configuration and load the transcatheter heart valve prosthesis onto or into a delivery catheter for delivery within the vascular system. For illustrative purposes only, the crimping and loading assembly 200 used with the transcatheter heart valve prosthesis 125 will be described, wherein it should be understood that the crimping and loading assembly 200 may be used with other prostheses (including prostheses not explicitly disclosed herein).

[0059] FIG. 2A to FIG. 2BA funnel crimper 201 according to embodiments herein is shown. The funnel crimper 201 includes a body 202 having a first end 204, a second end 206, and an inner cavity 208 extending through the body from the first end 204 to the second end 206. The body 202 includes a tapered portion 210 and an extended outflow portion 212, wherein a boundary 215 is defined between the tapered portion 210 and the extended outflow portion 212. The tapered portion 210 extends from the first end 204 of the body 202 to the boundary 215, and the extended outflow portion 212 extends from the boundary 215 to the second end 206 of the body 202. In some embodiments, the body 202 can be a single component (e.g., molded, machined, extruded) such that the tapered portion 210 and the extended outflow portion 212 are integral and the boundary 215 is continuous. In other embodiments, the body 202 may be provided as a plurality of separate components such that the boundary 215 is defined at the interface where the second end 214 of the tapered portion 210 is coupled to the first end 216 of the extended outflow portion 212. In some embodiments, the second end 214 of the tapered portion 210 may be removably coupled to the first end 216 of the extended outflow portion 212 by one or more of a threaded connection, a snap connection, a fastener connection, or a press-fit connection. Alternatively, the second end 214 of the tapered portion 210 may be permanently coupled to the first end 216 of the extended outflow portion 212 using one or more of a glued connection or a bonded connection.

[0060] like FIG. 2A to FIG. 2C As shown, the lumen 208 in the tapered portion 210 has a first diameter at the first end 204 of the body 202 and a second diameter at the second end 214 defined at the boundary 215, the second diameter being smaller than the first diameter, such that the lumen 208 in the tapered portion 210 tapers in a direction toward the boundary 215. The extended outflow portion 212 is substantially cylindrical in shape, such that the lumen 208 in the extended outflow portion 212 has a substantially constant diameter and is substantially equal to the second diameter of the tapered portion 210 at the second end 214 defined at the boundary 215. In an embodiment, the first diameter D1 is about 25 mm to 60 mm, and the second diameter D2 is about 3 mm to 12 mm. In the illustrated embodiment, the first end 204 and the second end 206 are both substantially circular in shape. In the embodiment shown and used with transcatheter heart valve prosthesis 125, second end 206 is considered the outflow end because the outflow end of transcatheter heart valve prosthesis 125 is disposed at second end 206 when coupled to a delivery catheter.

[0061] The tapered portion 210 further has a length L1 of about 20 mm to 60 mm from the first end 204 of the body 202 to the second end 214 of the tapered portion 210 defined at the boundary 215. Thus, the length L1 and the decrease in diameter from the first end 204 of the body 202 to the second end 214 of the tapered portion 210 result in a curl angle θ of about 10 degrees to 50 degrees, about 15 degrees to 25 degrees, or about 20 degrees. As used herein, the curl angle θ refers to the angle between the inner surface of the tapered portion 210 and the inner surface of the extended outflow portion 212, as shown in FIG. Figure 2C The smaller curl angle θ disclosed above (ie, about 10 to 25 degrees) helps reduce strut crossing and infolding.

[0062] The funnel crimper 201 further includes a tissue compressor 250 coupled thereto. FIG. 2A to FIG. 2D As shown, the tissue compressor 250 is disposed within a cavity or recess 218 in the inner surface of the extended outflow portion 212 of the funnel-type crimper 201. In an embodiment, the recess 218 extends around the circumference of the inner surface of the extended outflow portion 212. However, in other embodiments, the recess 218 need not extend around the entire circumference of the extended outflow portion 212. The tissue compressor 250 is annular in shape and is disposed within the recess 218 such that the inner surface 252 of the tissue compressor 250 extends into the inner cavity 208 of the extended outflow portion 212. For example, as Figure 2B As shown, in an embodiment, the thickness T1 of the tissue compressor 250 from its outer surface 252 to its inner surface 254 is greater than the depth d of the recess 218 .

[0063] FIG. 3A to FIG. 3B Two embodiments of tissue compressors are shown, labeled as tissue compressor 250 and tissue compressor 250 ′. Figure 3A The illustrated tissue compressor 250 includes an outer surface 252, an inner surface 254, and a central lumen 256 extending therethrough. Figure 3B The tissue compressor 250' shown in FIG. 1 is similar to the tissue compressor 250 in that it includes an outer surface 252', an inner surface 254', and a central lumen 256'. In addition, the tissue compressor 252' includes a finger-like portion 258' extending inwardly at its inner surface 254'. As will be appreciated by those skilled in the art, the tissue compressor 250' may include more than one finger-like portion 258'. Figure 3B More or fewer fingers 258' are shown. Further, the fingers 258' can be any shape suitable for the purposes described herein, such as but not limited to semicircular, dome-shaped, dot-shaped, triangular, semi-elliptical and / or cylindrical. The length of the fingers 258' can be about 0.5 mm to 2.0 mm.

[0064] like FIG. 3A to FIG. 3BAs shown, the tissue compressor 250, 250' has an inner diameter ID and an outer diameter OD, a width W1 and a thickness T1. The inner diameter ID is smaller than the diameter D2 of the lumen 208 in the extended outflow portion 212 of the funnel-type compressor 201. Therefore, the inner diameter ID of the tissue compressor 250, 250' can be in the range of about 1mm to 10mm. For example, the inner diameter ID of the tissue compressor 250, 250' can be in the range of 15% to 60% smaller than the second diameter D2 of the lumen 208 in the extended outflow portion 212. The outer diameter OD and thickness T1 of the tissue compressor 250, 250' depend on the inner diameter ID and depth d of the recess 218 in the extended outflow portion 212. In an embodiment, the outer diameter OD can be in the range of 7mm to 20mm, and the thickness T1 can be in the range of 2mm to 4mm. The width W1 of the tissue compressor 250, 250' is equal to the length of the tissue compressor 250, 250' extending along the extended outflow portion 212. In an embodiment, the tissue compressor 250, 250' may have a width W1 in the range of approximately 2 mm to 5 mm.

[0065] Tissue compressor 250, 250' may include a relatively soft material compared to the material from which body 202 is made, such as, but not limited to, closed-cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer (EDPM), nitrile, fluorocarbon-based fluoroelastomer (FKM) (e.g., VITON), and / or polychloroprene (chloroprene), or any combination thereof. In embodiments, the material used for tissue compressor 250, 250' may have a Shore A hardness in the range of approximately 20A to 80A, or in the range of 20A to 60A, or in the range of 30A to 50A. In other embodiments, an outer portion of tissue compressor 250, 250' may be a harder material than an inner portion of tissue compressor 250, 250' that will be in contact with transcatheter heart valve prosthesis 125, as explained in more detail below. As described in more detail below, interior portions of tissue compressors 250, 250' come into contact with transcatheter heart valve prosthesis 125 as transcatheter heart valve prosthesis 125 moves through funnel-style crimper 201 during the crimping and loading process.

[0066] In the illustrated embodiment, a single tissue compressor 250, 250' is disposed in the extended outflow portion 212 of the funnel-type crimper 201. However, this is not meant to be limiting. For example, but not by way of limitation, multiple rows of tissue compressors 250, 250' may be disposed in the extended outflow portion 212 and / or the tapered portion of the funnel-type crimper 201.

[0067] In some embodiments, the crimping and loading assembly 200 includes a guide plunger 280 . FIG. 2A to FIG. 2DAn embodiment of a guide plunger 280 is shown. The guide plunger 280 guides the transcatheter heart valve prosthesis 125 through the lumen channel 208 of the funnel-type crimper 201. Those skilled in the art will recognize that other devices for holding and pushing the transcatheter heart valve prosthesis 125 through the funnel-type crimper 201 may be used, and that the guide plunger 280 is merely one exemplary embodiment. The plunger 280 includes a base 285 and a shaft 290. The base 285 of the plunger 280 is a solid, disc-shaped element that includes a first surface 286 and a second surface 287 that is opposite the first surface 286. The base 285 is sized and shaped to allow the inflow end 131 of the transcatheter heart valve prosthesis 125 to rest on the first surface 286 of the base 285 in an expanded configuration. In an embodiment, base 285 may include features for retaining inflow end 131 of transcatheter heart valve prosthesis 125 when in the radially expanded configuration, such as a bumper or lip 288 extending from first surface 286. In the illustrated embodiment, lip 288 protrudes from the entire outer edge of first surface 286, such as Figure 2C 280. The lip 288 is configured to secure the inflow end 131 of the transcatheter heart valve prosthesis 125 in place when the transcatheter heart valve prosthesis 125 is loaded onto the plunger 280. The lip 288 protrudes from the first surface 286 of the base 285 by approximately 2 mm to 6 mm and surrounds the transcatheter heart valve prosthesis 125. In some embodiments, the lip 288 may completely or partially surround the transcatheter heart valve prosthesis 125. The base 285 of the plunger 280 has a thickness of approximately 2 mm to 6 mm defined between the first surface 286 and the second surface 287 and a diameter of less than 10 mm.

[0068] The shaft 290 of the plunger 280 is a longitudinal cylindrical member including a first end 291 and a second end 292. In the illustrated embodiment, the shaft 290 of the plunger 280 extends through the center of the base 285 such that the first end 281 and the second end 292 are disposed on opposite sides of the base 285. However, this is not meant to be limiting, and the second end 292 may terminate flush with the second surface 287 of the base 285, or extend beyond the second surface 287 more away from the base 285 to serve as a surface for a user to grip the plunger 280. The outer circumference of the first end 291 of the shaft 290 is sized and shaped to fit within the lumen 208 of the extended outflow end 212 of the funnel crimper 201, with sufficient space between the outer surface of the shaft 290 and the inner surface of the extended outflow portion 212 for the transcatheter heart valve prosthesis 125. When the transcatheter heart valve prosthesis 125 is loaded onto the plunger 280, the first end 291 of the shaft 290 extends through the central lumen 136 of the transcatheter heart valve prosthesis 125 through the inflow end 131 until the inflow end 131 of the transcatheter heart valve prosthesis 125 contacts the first surface 286 of the base 285 of the plunger 280, as shown in FIG. Figure 2A The shaft 290 of the plunger 280 has a longitudinal length of about 30 mm to 100 mm and a diameter of about 2.8 mm to 11.8 mm. In the illustrated embodiment, the shaft 290 includes a central passage 294 extending therethrough. The central passage 294 can be configured to receive the shaft through which the delivery catheter passes during crimping and loading.

[0069] Now refer to Figure 4 and FIG. 2A to FIG. 2E A method of crimping a transcatheter heart valve prosthesis 125 and loading the transcatheter heart valve prosthesis 125 into and / or onto a delivery catheter using a crimp loading assembly 200 is described. FIG. 2A to FIG. 2D A tissue compressor 250 is shown, but the method and FIG. 2A to FIG. 2D The same applies to the tissue compressor 250'. For example, the tissue compressor 250' can replace FIG. 2A to FIG. 2D The tissue compressor 250 in the embodiment of the present invention is shown in Figure 1. Further, the method is not limited to the transcatheter heart valve prosthesis 125 and can be used with other transcatheter heart valve prostheses. Further, additional or fewer steps of the described method can be used, and some steps can be omitted in this description as known to those skilled in the art.

[0070] refer to Figure 4 As shown in step 602 of method 600, the transcatheter heart valve prosthesis 125 is loaded onto the plunger 280 in an expanded configuration, such as Figure 2AThe first end 291 of the shaft 290 of the plunger 280 is advanced through the central lumen 136 of the transcatheter heart valve prosthesis 125, enters through the inflow end 131, and extends therethrough until the inflow end 131 of the transcatheter heart valve prosthesis 125 rests on the first surface 286 of the base 285, as shown in FIG. Figure 2A In some embodiments, the outer circumference of the inflow end 131 of the transcatheter heart valve prosthesis 125 is radially displaced inward from the circumferential lip 288 of the base 285, so that the transcatheter heart valve prosthesis 125 is fixed to the plunger 280 based on the outer circumference of the inflow end 131 exerting an outward radial force on the circumferential lip 288, as shown in FIG. Figure 2C Although this step has been described as advancing shaft 290 of plunger 280 through central lumen 136 of transcatheter heart valve prosthesis 125, transcatheter heart valve prosthesis 125 may alternatively be advanced over shaft 290 toward base 285, or both heart valve prosthesis 125 and plunger 280 may be moved relative to one another so that inflow end 131 of transcatheter heart valve prosthesis 125 is positioned at base 285 of plunger 280.

[0071] In the next step 604 of method 600, frame 126 of transcatheter heart valve prosthesis 125 mounted on plunger 280 is advanced through lumen 208 of conical portion 210 of funnel crimper 201 to crimp transcatheter heart valve prosthesis 125, such as Figure 2C shown.

[0072] In the next step 606 of method 600, the transcatheter heart valve prosthesis 125 continues to advance into the inner cavity 208 of the extended outflow portion 212 so that when the transcatheter heart valve prosthesis 125 passes through the inner cavity 256, 256' of the tissue compressors 250, 250', the tissue compressors 250, 250' push the tissue of the artificial valve 127 of the transcatheter heart valve prosthesis 125 radially inward relative to the frame 126. As transcatheter heart valve prosthesis 125 is advanced through lumen 208 of extended outflow portion 212 and lumens 250, 250' of tissue compressors 250, 250', inner surfaces 254 or a plurality of fingers 258' of tissue compressors 250, 250', respectively, protrude inwardly through cells 135 of frame 126 to push tissue of prosthetic valve 127 radially inwardly, thereby minimizing leaflet protrusion through cells 135 to avoid pinching or damage thereto and minimizing strut crossing and intra-frame folding, as shown. Figure 2D Best shown in .

[0073] In the next step 608 of method 600, the assembly of transcatheter heart valve prosthesis 125 and plunger 280 is advanced through passage 208 of funnel crimper 201 along extended outflow portion 212 toward second end 206 of body 202 until an outer surface of base 285 and / or lip 288 of plunger 280 abuts an inner surface of tapered portion 210 of funnel crimper 201, as shown. Figure 2B and Figure 2C Once the base 285 of the plunger 280 abuts the inner surface of the tapered portion 210 of the funnel-type crimper 201, the transcatheter heart valve prosthesis 125 is partially crimped, and the paddle 140 on the outflow portion 132 is exposed outside the second end 206 of the funnel-type crimper 201 at the end of the extended outflow portion 212. In other embodiments, the base 285 may abut another portion of the funnel-type crimper 201 or may not abut any portion thereof. In such an embodiment, step 608 is to advance the transcatheter heart valve prosthesis 125 until its outflow end reaches the second end 206 of the funnel-type crimper 201.

[0074] In another step 610 of method 600, transcatheter heart valve prosthesis 125 is loaded into a delivery catheter system (eg, delivery catheter system 800) having a portion of a delivery catheter system disposed at a position adjacent to the delivery catheter system. Figure 2E In an exemplary embodiment, the outflow paddle 140 of the frame 126 of the transcatheter heart valve prosthesis 125 is aligned with and inserted into the pocket 822 of the main shaft or retainer 820 of the delivery catheter system 800 ( Figure 2EOnly one pocket 822 is shown in the figure). The sac 810 of the delivery catheter system 800 is advanced over the retainer 820 to retain the outflow paddle 140 in the pocket 822 (not shown). The sac 820 can be adjacent to or enter the second end 206 of the funnel crimper 201. The transcatheter heart valve prosthesis 125 is then pulled through the funnel crimper 201 and into the sac by pulling a shaft (not shown) coupled to the retainer 822, thereby crimping the transcatheter heart valve prosthesis 125 as it is pulled through the tapered portion 210 and the extended inflow portion 212, and into the sac 820 of the delivery catheter system 800 in the compressed configuration. Those skilled in the art will recognize that other delivery catheter systems may be used in place of the delivery catheter system 800, and other methods of loading the transcatheter heart valve prosthesis from the funnel crimper onto or into the delivery catheter system may be used. For example, in some embodiments, the transcatheter heart valve prosthesis 125 may be pulled through the funnel crimper 201 and / or the funnel crimper 201 may be moved relative to the transcatheter heart valve prosthesis 125 in a direction away from the delivery catheter system 800. Additionally, the sac 810 may be advanced in a direction toward the funnel crimper 201 such that the sac 810 causes relative movement between the transcatheter heart valve prosthesis 125 and the funnel crimper 201, thereby pushing the funnel crimper 201 away from the retainer 820 of the delivery catheter system 800. Thus, relative movement of the funnel crimper 201 relative to the transcatheter heart valve prosthesis 125 may be achieved while covering the prosthesis 125 with the sac 810.

[0075] FIG. 5A to FIG. 5E and Figure 6 A funnel-style crimper 201 is shown having another embodiment of a tissue compressor 500 according to embodiments herein. FIG. 5A to FIG. 5E and Figure 6 The funnel curler 201 with FIG. 2A to FIG. 2E The present invention is identical to the funnel-type crimper 201 of the present invention, except that the tissue compressor 500 replaces the tissue compressors 250, 250' and the associated changes to the parts of the funnel-type crimper 201 that replace the tissue compressor 500. Therefore, the unchanged details of the funnel-type crimper 201 will not be discussed again with reference to the present invention. FIG. 5A to FIG. 5E and Figure 6 Describe, and the above description is combined with FIG. 5A to FIG. 5E and Figure 6 Further, the plunger 280 will not be described again, and the above description is incorporated into this embodiment.

[0076] The tissue compressor 500 includes an annular channel 510, an inlet port 520, and a plurality of circumferentially spaced perforations on the outflow port 530 in the extended outflow portion 212 of the funnel-type crimper 201. The tissue compressor 500 is configured to receive a fluid 570 during the crimping process and apply the fluid 570 to the tissue of the artificial valve 127 of the transcatheter heart valve prosthesis 125. The term "fluid" as used herein includes gas (i.e., air) and liquid (such as water, saline, etc.). In an embodiment, the fluid 570 is pressurized at a pressure between 5 psi and 50 psi.

[0077] As described above, the funnel-type crimper 201 configured for use with the tissue compressor 500 described herein is similar to the funnel-type crimper 201 configured for use with the tissue compressors 250, 250' described above, however, instead of having a circumferential cavity or recess 218 in the inner surface of the extended outflow portion 212, the funnel-type crimper 201 configured for use with the tissue compressor 500 includes a plurality of circumferentially spaced perforations or ports 530 in the extended outflow portion 212 positioned adjacent the first end 216 of the extended outflow portion 212, as shown. FIG. 5C to FIG. 5E shown and described in further detail below.

[0078] Figure 5A 2 is an illustration of a crimping and loading assembly 200 according to an embodiment of the present invention, the crimping and loading assembly including a funnel-type crimper 201 having a tissue compressor 500 and a guide plunger 280. The crimping and loading assembly 200 is configured for use with a transcatheter heart valve prosthesis (such as, but not limited to, the transcatheter heart valve prosthesis 125 described herein) when radially compressing the transcatheter heart valve prosthesis 125 into a crimped configuration and loading it into a delivery catheter system for delivery within a vascular system. For illustrative purposes only, since the structure of the crimping and loading assembly 200 has been described herein, the crimping and loading assembly will be described for use with the transcatheter heart valve prosthesis 125. Those skilled in the art will understand that the crimping and loading assembly 200 (wherein the funnel-type crimper 201 has a tissue compressor 500) can be used with other transcatheter heart valve prostheses.

[0079] As in FIG. 5A to FIG. 5C As can be seen in FIG. 5 , the tissue compressor 500 includes a ring 505 coupled to the outer surface of the extended outflow portion 212 of the tissue compressor 201. In the illustrated embodiment, the cross-section of the ring 510 is semicircular, such that the circumferential ends 513, 514 of the semicircle contact the outer surface of the extended outflow portion 212, thereby forming an inner cavity or channel 515 between the inner surface 511 of the ring 510 and the outer surface of the extended outflow portion 212, as shown in FIG. Figure 5C515. Although the ring 510 is described as being attached to the extended outflow portion 212, this is not meant to be limiting, and the ring 510 can be formed integrally (as one piece) with the extended outflow portion 212. Further, although the ring 510 has been described as being semicircular in cross-section, this is not meant to be limiting, and any cross-sectional shape that produces the channel 515 can be used.

[0080] The tissue compressor 500 further includes an inlet port 520 in fluid communication with the channel 515. The inlet port 520 can be a hollow cylindrical tube. However, this is not meant to be limiting, and any inlet port that enables fluid from a fluid source (described in more detail below) to enter the channel 515 of the ring 510 can be utilized. The inlet port 520 defines an inner cavity 523 in fluid communication with the channel 515.

[0081] In an embodiment, the lumen 523 of the inlet port 520 may have a diameter of about 2 mm to 5 mm defined by the inner surface of the inlet port. In an embodiment, the channel 515 of the ring 510 may have a diameter of about 2 mm to 5 mm defined by the outer surface of the extended outflow portion 212 and the inner surface of the ring.

[0082] Figure 5C A perspective view of a cross-section of a funnel-type crimper 201 including a tissue compressor 500 as described herein is shown. As described above, the funnel-type crimper 201 includes a plurality of circumferentially spaced ports 530 in the extended outflow portion 212 that extend from an inner surface of the extended outflow portion 212 to an outer surface of the extended outflow portion 212. The ports 530 are aligned with the ring 510 such that the channel 515 of the ring 510 is in fluid communication with the lumen 208 of the extended outflow portion 212 through the ports 530. In the illustrated embodiment, the port 530 is substantially circular in shape and extends around the entire circumference of the extended outflow portion 212, but this is not meant to be limiting and any shape or size port suitable for the purposes described herein may be used. In particular, fluid from a source 550 (see Figure 6 ) is delivered to lumen 523 of inlet port 520, into passage 515 of ring 510, and through port 530 into lumen 508 of extended outflow portion 212. Pressurized fluid 570 pushes tissue of artificial valve 127 of transcatheter heart valve prosthesis 125 radially inward as prosthesis 125 is advanced through funnel crimper 201, as described below.

[0083] like Figure 6As shown, the crimping and loading assembly 200 further includes a fluid source 550 to provide a fluid 570 to the funnel crimper 201. In the illustrated embodiment, a pump 560 delivers the fluid 570 through a conduit 540 to the aforementioned inlet port 520 to provide the pressurized fluid 570 through a port 530 to the lumen 208 of the extended outflow portion 212 of the funnel crimper 201. Those skilled in the art will recognize that Figure 6 An example of a system for providing pressurized fluid to the funnel crimper 201 is shown, and can be removed Figure 6 The components shown and / or additional components may be added.

[0084] In the illustrated embodiment, there is a single row of circumferentially spaced ports 530 in the extended outflow portion 212 of the funnel crimper 201. However, this is not meant to be limiting. For example, but not by way of limitation, there may be multiple rows of circumferentially spaced ports 530 in the extended outflow portion 212 and / or the tapered portion of the funnel crimper 201.

[0085] Now refer to Figure 7 , FIG. 5A to FIG. 5F and Figure 6 A method of crimping a transcatheter heart valve prosthesis 125 and loading the transcatheter heart valve prosthesis 125 into and / or onto a delivery catheter using a crimp loading assembly 200 including a crimper 201 and a tissue compressor 500 is described. It should be understood that the method is not limited to the transcatheter heart valve prosthesis 125 and can be used with other transcatheter heart valve prostheses. Further, additional or fewer steps of the described method can be used, and some steps can be omitted in this description as known to those skilled in the art.

[0086] In this embodiment, as shown in step 702 of method 700, transcatheter heart valve prosthesis 125 is loaded onto plunger 280 in an expanded configuration, such as Figure 2A The first end 291 of the shaft 290 of the plunger 280 is advanced through the central lumen 136 of the transcatheter heart valve prosthesis 125, enters through the inflow end 131, and extends therethrough until the inflow end 131 of the transcatheter heart valve prosthesis 125 rests on the first surface 286 of the base 285, as shown in FIG. Figure 2C The outer circumference of the inflow end 131 of the transcatheter heart valve prosthesis 125 is radially displaced inward from the circumferential lip 288 of the base 285, so that the transcatheter heart valve prosthesis 125 is fixed to the plunger 280, as shown in FIG. Figure 2CAlthough this step has been described as advancing shaft 290 of plunger 280 through central lumen 136 of transcatheter heart valve prosthesis 125, transcatheter heart valve prosthesis 125 may alternatively be advanced over shaft 290 toward base 285, or both heart valve prosthesis 125 and plunger 280 may be moved relative to one another so that inflow end 131 of transcatheter heart valve prosthesis 125 is positioned at base 285 of plunger 280.

[0087] In the next step 704 of method 700, frame 126 of transcatheter heart valve prosthesis 125 mounted on plunger 280 is advanced through lumen 208 of conical portion 210 of funnel crimper 201 to crimp transcatheter heart valve prosthesis 125, such as Figure 5D As shown (for clarity, the plunger 280 is not Figure 5D ).

[0088] In the next step 706 of method 700, transcatheter heart valve prosthesis 125 continues to be advanced into lumen 208 of extended outflow portion 212 of funnel-type crimper 201. Before or while the transcatheter heart valve prosthesis is advanced through extended outflow portion 212, pressurized fluid 570 (e.g., from Figure 6 510, and the like. Pressurized fluid 570 is provided into inlet port 520, into channel 515 of ring 510, and into lumen 208 of extended outflow portion 212 through port 530. Thus, as transcatheter heart valve prosthesis 125 passes through lumen 280 of extended outflow portion 212 of funnel crimper 201, pressurized fluid 570 pushes tissue of artificial valve 127 of transcatheter heart valve prosthesis 125 radially inward relative to frame 126, thereby minimizing leaflet protrusion through cells 135 of frame 126 to avoid pinching or damage thereto and minimizing strut crossing and intra-frame folding, as in Figure 5E Best shown in .

[0089] In the next step 708 of method 700, the assembly of transcatheter heart valve prosthesis 125 and plunger 280 is advanced through passage 208 of funnel crimper 201 along extended outflow portion 212 toward second end 206 of body 202 until an outer surface of base 285 and / or lip 288 of plunger 280 abuts an inner surface of tapered portion 210 of funnel crimper 201, as shown. Figure 5D and Figure 5EAs shown. Once the base 285 of the plunger 280 abuts the inner surface of the tapered portion 210 of the funnel crimper 201, the transcatheter heart valve prosthesis 125 is partially crimped and the paddle 140 on the outflow portion 132 is exposed outside the second end 206 of the funnel crimper 201 at the end of the extended outflow portion 212. In other embodiments, the base 285 may abut another portion of the funnel crimper 201 or may not abut any portion thereof. In such an embodiment, step 708 is to advance the transcatheter heart valve prosthesis 125 until its outflow end reaches the second end 206 of the funnel crimper 201. During this continued advancement, the pressurized fluid 570 continues to push the tissue of the artificial valve 125 radially inward, as discussed above.

[0090] In another step 710 of method 700, transcatheter heart valve prosthesis 125 is loaded into a delivery catheter system (eg, delivery catheter system 800) having a portion of a delivery catheter system disposed at a position adjacent to the delivery catheter system. Fig. 5F In an exemplary embodiment, the outflow paddle 140 of the frame 126 of the transcatheter heart valve prosthesis 125 is aligned with and inserted into the pocket 822 of the main shaft or retainer 820 of the delivery catheter system 800 ( Figure 2E Only one pocket 822 is shown in the figure). The sac 810 of the delivery catheter system 800 is advanced over the retainer 820 to retain the outflow paddle 140 in the pocket 822 (not shown). The sac 820 can be adjacent to or enter the second end 206 of the funnel crimper 201. The transcatheter heart valve prosthesis 125 is then pulled through the funnel crimper 201 and into the sac 820 by pulling the shaft (not shown) coupled to the retainer 822, whereby the transcatheter heart valve prosthesis 125 is crimped as it is pulled through the tapered portion 210 and the extended inflow portion 212 and into the sac 820 of the delivery catheter system 800 in the compressed configuration. The pressurized fluid 570 may continue to be provided while the transcatheter heart valve prosthesis 125 is loaded into the delivery catheter system 800, or it may be stopped at any time during the loading process if it is no longer necessary to push the tissue of the prosthetic valve 127 inwardly. Those skilled in the art will recognize that other delivery catheter systems may be used in place of the delivery catheter system 800, and that other methods of loading the transcatheter heart valve prosthesis onto or into the delivery catheter system from the funnel crimper may be used.

[0091] It should be understood that the curling and loading assemblies described herein are merely exemplary in nature and are not intended to limit the invention or the application and use of the invention. It should be understood that the multiple different embodiments disclosed herein can be combined into combinations different from the combinations specifically presented in the specification and the drawings. It should also be understood that, according to the examples, certain actions or events of any process or method described herein can be performed in a different order, can be added, merged, or omitted entirely (for example, all described actions or events may not be necessary to implement these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single device or component, it should be understood that the technology of the present disclosure can be performed by a combination of devices or components.

Claims

1. A funnel-type curling device, comprising: a body having a first end, a second end, and a lumen extending from the first end to the second end, the lumen being defined by an inner surface of the body, the body comprising a tapered portion and an extended outflow portion, wherein the lumen in the tapered portion tapers from a first diameter at the first end to a second diameter that is less than the first diameter, and wherein the extended outflow portion extends from the tapered portion to the second end of the body; and A tissue compressor coupled to the body so that the tissue compressor extends into the lumen relative to the inner surface of the body, wherein the tissue compressor comprises a relatively soft material that is softer than a relatively hard material of the body, and wherein the tissue compressor is configured to apply a radially inward force to tissue of an artificial valve of a transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the inner surface of a frame of the transcatheter heart valve prosthesis.

2. The funnel-type crimper according to claim 1, wherein: The relatively soft material of the tissue compressor has a Shore A hardness in the range of 20A to 80A.

3. The funnel-type crimper according to claim 2, wherein: The relatively soft material of the tissue compressor is selected from the group consisting of closed-cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer (EDPM), nitrile, fluorocarbon-based fluoroelastomer (FKM), polychloroprene (chloroprene) and / or combinations thereof.

4. The funnel-type crimper according to any one of claims 1 to 3, wherein: The inner surface of the body at the extended outflow portion further includes a recess, and wherein the tissue compressor is disposed in the recess.

5. The funnel-type crimper according to any one of claims 1 to 4, wherein: The tissue compressor is a ring having an outer surface, an inner surface, a thickness defined between the inner surface and the outer surface, a width, and a ring lumen defined by the inner surface of the ring.

6. The funnel-type crimper according to claim 5, wherein: The thickness of the ring is greater than the depth of the recess.

7. The funnel-type crimper according to any one of claims 1 to 6, wherein: The tissue compressor further includes a plurality of fingers extending radially inwardly into the lumen of the body.

8. A funnel-type curling device comprising: a body having a first end, a second end, and a lumen extending from the first end to the second end, the lumen being defined by an inner surface of the body, the body comprising a tapered portion and an extended outflow portion, wherein the lumen in the tapered portion tapers from a first diameter at the first end to a second diameter that is less than the first diameter, and wherein the extended outflow portion extends from the tapered portion to the second end of the body; and A tissue compressor configured to apply a radially inward force to tissue of an artificial valve of a transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the inner cavity of the body, the artificial valve being disposed on an inner surface of a frame of the transcatheter heart valve prosthesis, the tissue compressor comprising a plurality of ports extending through an outflow portion of the body, the plurality of ports being configured to provide pressurized fluid to the inner cavity of the body.

9. The funnel crimper according to claim 8, wherein: The tissue compressor further includes a ring disposed around an outer surface of the extended outflow portion, the ring defining a passage between the outer surface of the extended outflow portion and an inner surface of the ring, wherein the plurality of ports are disposed within the ring.

10. The funnel crimper of claim 9, further comprising an inlet port coupled to the ring, wherein The inlet port is in fluid communication with the channel of the ring.

11. A method of radially compressing a transcatheter heart valve prosthesis, the method comprising: advancing a transcatheter heart valve prosthesis through a tapered portion of a funnel crimper, the tapered portion having an inner lumen tapering from a first diameter to a second diameter less than the first diameter, the transcatheter heart valve prosthesis comprising a frame and a prosthetic valve disposed within the frame; advancing the transcatheter heart valve prosthesis through an extended outflow portion of the funnel crimp, the extended outflow portion extending from the tapered portion at a second diameter of the lumen; as well as As the transcatheter heart valve prosthesis is advanced through the extended outflow portion, a radially inward force is applied to tissue of the prosthetic valve causing the tissue to move radially inward relative to the frame.

12. The method of claim 11, further comprising loading the transcatheter heart valve prosthesis onto or into a delivery catheter system.

13. The method of claim 11 or claim 12, wherein: The radially inward force is applied by the cells of the frame.

14. The method according to any one of claims 11 to 13, wherein: The radially inward force is exerted by a relatively soft material extending into the interior cavity of the funnel crimp relative to the interior surface of the extended outflow portion, and wherein the relatively soft material is softer than a relatively hard material of the funnel crimp.

15. The method of claim 14, wherein: The relatively soft material has a Shore A hardness in the range of 20A to 80A.

16. The method of claim 15, wherein: The relatively soft material is selected from the group consisting of closed cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer (EDPM), nitrile, fluorocarbon-based fluoroelastomer (FKM), polychloroprene (chloroprene), and / or combinations thereof.

17. The method according to any one of claims 11 to 13, wherein: Applying a radially inward force to tissue of the prosthetic valve includes applying a pressurized fluid to tissue in the extended outflow portion of the funnel crimp.

18. The method of claim 17, wherein: Applying the pressurized fluid includes providing the pressurized fluid into the inner cavity of the funnel crimper through a port in the extended outflow portion.

19. The method of claim 18, wherein: The pressurized fluid is provided through a ring disposed about the extended outflow portion, the ring defining a passage between an inner surface of the ring and an outer surface of the extended outflow portion, the passage being in fluid communication with the port.

Images