Patent Application
20250205050
Heart valve disease continues to be a significant cause of morbidity and mortality. Heart valve replacement has become a routine surgical procedure for patients suffering from valve regurgitation or stenotic calcification of the leaflets. Until recently, the vast majority of heart valve replacements entailed a full sternotomy and placing the patient on cardiopulmonary bypass. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications. To address these concerns, within the last fifteen years efforts have been made to perform cardiac valve replacements using minimally-invasive techniques, such as a percutaneous entry with a transluminal delivery. These surgical techniques, generally referred to as Transcatheter Aortic Valve Implantations (TAVI) or Transcatheter Aortic Valve Replacements (TAVR), use a catheter to deliver a prosthetic valve to an implantation site using a patient's lumen of the vascular system. There remains a need for improvements to the prosthetic valves used in TAVI/TAVR and the mechanisms used to deliver them into the patient's body.
The present invention is directed to a catheter apparatus, a self-expanding prosthetic valve for use with the catheter apparatus, a method of loading the catheter apparatus with the self-expanding prosthetic valve, and a method for implanting the self-expanding prosthetic aortic valve into a patient using the catheter apparatus.
In one aspect, the invention may be a catheter apparatus comprising: a handle assembly comprising: a handle housing comprising a longitudinal axis, an outer surface and an inner surface that defines a handle cavity; a rotating member positioned around a portion of the outer surface of the handle housing and configured to rotate relative to the handle housing, the rotating member comprising a threaded inner surface; a slider at least partially positioned within the handle cavity and comprising a threaded portion that mates with the threaded inner surface of the rotating member; an inlet port defining a passageway into the handle cavity; and a flushing tube having a coiled configuration, the flushing tube comprising a first end fluidly coupled to the inlet port, a second end fluidly coupled to the slider, and a lumen extending from the first end to the second end; and wherein rotation of the rotating member causes the slider to move axially within the handle cavity, and wherein the flushing tube compresses as the slider moves in a proximal axial direction and expands as the slider moves in a distal axial direction.
In another aspect, the invention may be a catheter apparatus comprising: a catheter assembly comprising: an inner shaft comprising a lumen; a first axial wire and a second axial wire disposed within the lumen of the inner shaft, wherein when the inner shaft is bent into a U-shaped bend configuration the first and second axial wires are aligned on a vertical plane; and a pusher comprising a plurality of indentations that are configured to receive tabs of a frame of a prosthetic aortic valve, wherein the pusher is coupled to the inner shaft so that one of the plurality of indentations is aligned on the vertical plane when the inner shaft is bent into the U-shaped bend configuration.
In yet another aspect, the invention may be a catheter apparatus comprising: a catheter assembly comprising: an inner shaft comprising a lumen; a first axial wire and a second axial wire disposed within the lumen of the inner shaft, wherein when the inner shaft is bent into a U-shaped bend configuration the first and second axial wires are aligned on a vertical plane; and a pusher comprising a plurality of indentations that are configured to receive tabs of a frame of a prosthetic aortic valve, wherein the pusher is coupled to the inner shaft so that one of the plurality of indentations is angularly offset 90° from the vertical plane.
In a further aspect, the invention may be a catheter apparatus comprising: a handle assembly; and a catheter assembly coupled to the handle assembly, the catheter assembly comprising a pusher configured for engagement with a prosthetic aortic valve to facilitate implantation of the prosthetic aortic valve into a patient, the pusher comprising at least one indentation that is configured to receive a tab of a frame of the prosthetic aortic valve, the at least one indentation comprising a proximal end surface that is sloped.
In a still further aspect, the invention may be a catheter assembly comprising a pusher configured for engagement with a prosthetic aortic valve to facilitate implantation of the prosthetic aortic valve into a patient, the pusher comprising at least one indentation that is configured to receive a tab of a frame of the prosthetic aortic valve, the at least one indentation comprising a proximal end surface that is sloped.
In another aspect, the invention may be a catheter system comprising: a catheter apparatus comprising: a catheter assembly comprising: a deployment assembly comprising an outer sheath defining a sheath cavity, a distal tip assembly configured to close an open distal end of the outer sheath, and a pusher that is located within the sheath cavity when the outer sheath is in a non-deployed position, the pusher and the distal tip assembly spaced apart from one another by an axial space, the pusher comprising a plurality of indentations; a handle assembly operably coupled to the catheter assembly and configured to move the outer sheath in a proximal axial direction to alter the outer sheath from the non-deployed position into a deployed position; a self-expanding prosthetic valve in a radially compressed state located within the axial space between the pusher and the distal tip assembly, the self-expanding prosthetic valve comprising a frame and a valve component coupled to the frame, the frame comprising a tubular body portion and a plurality of tabs extending from an end of the tubular body portion, each of the tabs nesting within one of the plurality of indentations of the pusher; and wherein actuation of the handle assembly causes the outer sheath to move in the proximal axial direction to alter the outer sheath from the non-deployed position to the deployed position, and wherein when the plurality of tabs remain in the sheath cavity and the tubular body portion is removed from the sheath cavity, no more than 70% of the self-expanding prosthetic valve is in a fully expanded state.
In still another aspect, the invention may be a method for implanting a self-expanding prosthetic aortic valve in a patient, the method comprising: loading a self-expanding prosthetic aortic valve into a catheter apparatus with the self-expanding prosthetic aortic valve in a radially compressed state; inserting a distal end of the catheter apparatus into a vasculature of a patient until the self-expanding prosthetic aortic valve is positioned at an implantation location, the catheter apparatus comprising an outer sheath having a sheath cavity within which the self-expanding prosthetic aortic valve and a pusher are located, the self-expanding prosthetic aortic valve comprising a tubular body portion and a plurality of tabs of identical length extending from an end of the tubular body portion, the plurality of tabs being in engagement with the pusher; moving the outer sheath in a proximal axial direction while the self-expanding prosthetic aortic valve and the pusher are in a fixed axial position; and wherein the plurality of tabs are released from the pusher in a sequential manner as the plurality of tabs become removed from the sheath cavity to deploy the self-expanding prosthetic aortic valve into the patient during the movement of the outer sheath in the proximal axial direction.
In a further aspect, the invention may be a method of loading a self-expanding prosthetic aortic valve into a catheter apparatus, the method comprising: radially compressing a self-expanding prosthetic aortic valve with a radial compression device; positioning the radially compressed self-expanding prosthetic aortic valve onto a pusher of a catheter assembly of the catheter apparatus so that the self-expanding prosthetic aortic valve is engaged with the pusher; sliding the pusher of the catheter apparatus in a proximal axial direction until the pusher and the radially compressed self-expanding prosthetic aortic valve are disposed within a sheath cavity of an outer sheath of the catheter apparatus, wherein a proximal cap assembly of the catheter apparatus slides in the proximal axial direction during the sliding of the pusher in the proximal axial direction; rotating a rotating member of a handle assembly of the catheter apparatus in a first rotational direction to move the proximal cap assembly in a distal axial direction until the proximal cap assembly is adjacent to a proximal end of a handle housing of the handle assembly; and coupling the proximal cap assembly to the handle housing to prevent further axial movement of the proximal cap assembly to axially fix a position of the pusher and the self-expanding prosthetic aortic valve.
In a still further aspect, the invention may be a self-expanding prosthetic valve for implantation into a body lumen, the self-expanding prosthetic valve comprising: a frame comprising: a tubular body portion having a proximal end, a distal end, and a first height measured between the proximal and distal ends; and a plurality of tabs extending from the proximal end of the tubular body portion, each of the plurality of tabs having a second height measured from the proximal end of the tubular body portion to a terminal end of the tab; a valve component coupled to the frame; and wherein a ratio of the first height to the second height is between 5.2:1 and 6.6:1.
In still another aspect, the invention may be a catheter system comprising: a catheter apparatus comprising: a handle assembly comprising: a handle housing having an outer surface and an inner surface defining a handle cavity; a rotating member configured to rotate around the handle housing, the rotating member comprising a threaded inner surface; and a slider at least partially positioned within the handle cavity and comprising a threaded portion that mates with the threaded inner surface of the rotating member; a catheter assembly comprising: a deployment assembly comprising a distal tip assembly, an outer sheath defining a sheath cavity, and a pusher that is located within the sheath cavity of the outer sheath when the outer sheath is in a non-deployed position, the pusher comprising a plurality of indentations; an outer shaft having a proximal end that is coupled to the slider of the handle assembly and a distal end that is coupled to the outer sheath; and an inner shaft at least partially located within a lumen of the outer shaft, the inner shaft having a proximal end that is coupled to the handle housing and a distal end that is coupled to the distal tip assembly, the inner shaft being in a fixed axial position relative to the handle assembly; a self-expanding prosthetic valve in a radially compressed state located within the sheath cavity between the pusher and the distal tip assembly, the self-expanding prosthetic valve comprising a tubular body and a plurality of tabs protruding from an end of the tubular body, each of the plurality of tabs having an identical length, and each of the plurality of tabs nesting within one of the indentations of the pusher; and wherein rotation of the rotating member of the handle assembly relative to the handle housing in a first rotational direction causes the slider, the outer shaft, and the outer sheath to move in a proximal axial direction to expose the self-expanding prosthetic valve which radially expands upon being fully exposed, and wherein the plurality of tabs of the self-expanding prosthetic valve are released from the pusher in a sequential manner.
In yet another aspect, the invention may be a method for implanting a self-expanding prosthetic aortic valve in a patient, the method comprising: loading a self-expanding prosthetic aortic valve into a catheter apparatus with the self-expanding prosthetic aortic valve in a radially compressed state, the catheter apparatus comprising a deployment assembly that comprises an outer sheath and a pusher, the outer sheath having a sheath cavity within which the self-expanding prosthetic aortic valve and the pusher are located, the self-expanding prosthetic aortic valve comprising a tubular body portion and a plurality of tabs extending from an end of the tubular body portion, the plurality of tabs being in engagement with the pusher; inserting the deployment assembly of the catheter apparatus into the patient until the self-expanding prosthetic aortic valve is positioned at an implantation location, wherein a shaft assembly of the catheter apparatus bends into a U-shape having a first leg and a second leg whereby a first circumferential portion of an outer surface of the second leg faces the first leg; moving the outer sheath in a proximal axial direction while the self-expanding prosthetic aortic valve and the pusher are in a fixed axial position to remove the self-expanding prosthetic aortic valve from the sheath cavity and deploy the self-expanding prosthetic aortic valve into the patient at the implantation location; and wherein during deployment of the self-expanding prosthetic aortic valve, one of the plurality of tabs is circumferentially located along the first circumferential portion of the outer surface of the second leg of the shaft assembly of the catheter apparatus.
In another aspect, the invention may be a catheter apparatus comprising: a catheter assembly comprising: an inner shaft comprising a lumen; a first axial wire and a second axial wire disposed within the lumen of the inner shaft, wherein when the inner shaft is bent into a U-shaped bend configuration the first and second axial wires are aligned on a vertical plane; and a pusher comprising a plurality of indentations that are configured to receive tabs of a frame of a prosthetic aortic valve, wherein the pusher is coupled to the inner shaft so that one of the plurality of indentations is angularly offset between 80° and 100° from the vertical plane.
In yet another aspect, the invention may be a catheter apparatus comprising: a catheter assembly comprising: an inner shaft comprising a lumen; a wire assembly disposed within the lumen of the inner shaft to control a bend configuration of the inner shaft such that when the inner shaft is bent into a U-shaped bend configuration, first and second legs of the inner shaft are aligned on a vertical plane; and a pusher comprising a plurality of indentations that are configured to receive tabs of a frame of a prosthetic aortic valve, wherein the pusher is coupled to the inner shaft so that one of the plurality of indentations is angularly offset between 80° and 100° from the vertical plane.
In another aspect, the invention may be a catheter apparatus comprising: a catheter assembly comprising: an inner shaft comprising a lumen; an axial wire assembly disposed within the lumen of the inner shaft, the axial wire assembly comprising a first wire portion and a second wire portion that are aligned on a vertical plane when the inner shaft is bent into a U-shaped bend configuration; and a pusher comprising a plurality of indentations that are configured to receive tabs of a frame of a prosthetic aortic valve, wherein the pusher is coupled to the inner shaft so that one of the plurality of indentations is angularly offset between 80° and 100° from the vertical plane.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.
The description of illustrative embodiments according to principles of the present invention is intended to be read in connection with the accompanying drawings. which are to be considered part of the entire written description. In the description of embodiments of the invention disclosed herein, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present invention. Relative terms such as “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description only and do not require that the apparatus be constructed or operated in a particular orientation unless explicitly indicated as such. Terms such as “attached,” “affixed,” “connected,” “coupled,” “interconnected,” and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. Moreover, the features and benefits of the invention are illustrated by reference to the exemplified embodiments. Accordingly, the invention expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features that may exist alone or in other combinations of features; the scope of the invention being defined by the claims appended hereto.
As used herein, the words, “proximal” and “distal,” refer to positions or directions closer to and further from, respectively, a physician implanting the replacement aortic valve using the catheter apparatus described herein.
Referring first to
The prosthetic valve 100 generally comprises a frame portion 110 and a valve portion 180. The frame portion 110 is illustrated by itself in
The prosthetic valve 100 is illustrated in its natural state in
The frame portion 110 forms a rigid structure so that the valve portion 180 may be anchored thereto and is capable of maintaining the desired configuration. The frame portion 110 provides the mechanism by which the prosthetic valve 100 may be retained in the prior position and orientation at the desired implantation site. The prosthetic valve 100 may be retained in the proper position and orientation at the desired implantation site by any known means known in the art. none of which are to be considered limiting of the present invention unless specifically recited in the claims. For example, the frame 100 may be anchored directly to the inner wall of the body lumen (or to a secondary frame or stent in which the prosthetic valve 100 is positioned). Such anchoring can be achieved, for example, via known techniques, including without limitation, suturing, stapling, puncturing, clamping or combinations thereof. In the exemplified embodiment, the frame 110 is a self-retaining structure that utilizes its tendency to diametrically expand to a diameter greater than the diameter of the body lumen at the implantation site, thereby creating a compression fit between the prosthetic valve 100 and the body lumen to retain the prosthetic valve 100 in place at the implantation site. The tendency of the frame 110 to diametrically expand can be achieved by forming the frame 110 out of a shape memory material. In some embodiments, the frame 110 is formed of nickel titanium. Other shape memory materials can be utilized in other self-retaining embodiments. In embodiments wherein the frame 110 is not a self-retaining structure, the frame can be constructed of any biocompatible material that is sufficiently rigid to provide the required support to the valve portion 180. Suitable alternate materials include, without limitation, polymers, platinum, stainless steel, chonichrom, or combinations thereof.
The frame portion 110 comprises a tubular body portion 111 having an inner surface 112, an outer surface 113, a proximal end 114, and a distal end 115. The tubular body portion 110 comprises a central axis A-A which extends between the proximal and distal ends 114, 115. The inner surface 112 of the frame portion 110 defines a fluid passageway 116 through which a bodily fluid can flow when the prosthetic valve 100 is installed in a patient. The valve portion 180 is at least partially located within the fluid passageway 116 to control the flow of the bodily fluid through the fluid passageway 116 when the prosthetic valve 100 is installed in the patient. The valve portion 180 is the working component of the prosthetic valve 100 and is alterable between: (1) an open state in which the fluid passageway 116 is open and allows a body fluid to pass therethrough; and (2) a sealed state in which the fluid passageway 116 is sealed and prevents backflow of bodily fluid that has exited the fluid outlet. The valve portion 180 is disposed within and anchored to the tubular body portion 111 of the frame 110 so as to be capable of repetitively alternating between the open and closed states when the prosthetic valve 100 is anchored at the implantation site. The valve portion 180 may comprise three flaps as depicted, or other numbers of flaps as may be appropriate. Additional details about the valve portion 180 may be found in U.S. Pat. No. 8,992,599, which was incorporated herein by reference above.
The tubular body portion 111 of the frame portion 110 may comprise a plurality of posts 120 and a plurality of lattice structures 121 circumferentially extending between and connected to the posts 120. The posts 120 extend from the proximal end 114 to the distal end 115 of the tubular body portion 111 and, in the exemplified embodiment are substantially linear structures that are substantially parallel to the axis A-A. The posts 120 are arranged about the circumference of the tubular body portion 111 in a spaced-apart manner. More specifically, the posts 120 are arranged in an equi-spaced manner about the circumference of the tubular body portion 111. In certain embodiments, the number of posts 120 will correspond with the number of commissures present on the valve portion 180 because the posts 120 provide structures within the tubular body portion 111 to which the commissures are mounted. The tubular body portion 111 may comprise one of the posts 120 for each commissure of the valve portion 180.
In the exemplified embodiment, there are three posts 120 because the valve portion 180 is a tricuspid type valve, thereby having three commissures. However, in alternate embodiments the tubular body portion 111 can include more or less than three posts 120 as desired. Moreover, in certain embodiments, it is possible that the number of posts 120 can be greater than the number of commissures of the valve portion 180 in an effort to increase axial rigidity of the frame portion 110.
As mentioned above, the tubular body portion 111 of the frame portion 110 may comprise lattice structures 121 that extend between each adjacent pair of the posts 180. The lattice structures 1221 also extend from the proximal end 114 to the distal end 115. In the exemplified embodiment, the lattice structures 121 and the posts 120 are integrally formed as a unitary structure free of seams. Thus, the tubular body portion 111 is a unitary/monolithic structure. In some embodiments, the tubular body portion 111 may be made from wire or may be laser cut from a tube, sheath, or the like. In the exemplified embodiment, the lattice structures 121 define a plurality of open cells 122 formed by intersecting struts 123. In the exemplified embodiment, all of the open cells 122 within all of the lattice structures 121 are diamond-shaped or partially diamond-shaped. The invention, however, is not to be so limited in all embodiments and other shapes for the open cells 122 are possible in other embodiments.
The frame portion 110 may further comprise a plurality of tabs 130 that protrude from the proximal end 114 of the tubular body portion 111 of the frame portion 110. In the exemplified embodiment, there are three of the tabs 130. However, the exact number of the tabs 130 is not to be limiting of the present invention in all embodiments and in other embodiments it may be possible to have just a single tab, or two tabs, or more than three tabs. The plurality of tabs 130 are circumferentially spaced apart along the circumference of the tubular body portion 111 of the frame portion 110. In the exemplified embodiment, the tabs 130 are equidistantly spaced apart along the circumference of the tubular body portion 111, although this is not required in all embodiments and different spacing arrangements may be used in other embodiments.
The tabs 130 may comprise a stem portion 131 that extends from the proximal end 114 of the tubular body portion 111 and an engagement portion 135 that is coupled to a terminal end of the stem portion 131. In the exemplified embodiment, the stem portion 131 comprises a first stem arm 132 and a second stem arm 133 that extend from the proximal end 114 of the tubular body portion 111. In alternative embodiments, a single stem arm may be used instead of two stem arms, and in other embodiments more than two stem arms may be included. In the exemplified embodiment, each of the tabs 130 is aligned with one of the posts 120 of the tubular body portion 111. Thus, in the exemplified embodiment the first and second arms 132. 133 of each of the stem portions 131 extends from the proximal end 114 of the tubular body portion 111 at a position that is aligned with one of the posts 120 (stated another way, the tabs 130 protrude from the posts 120 at the proximal end 114 of the tubular body portion 111 of the frame portion 110). In the exemplified embodiment, the first and second arms 132, 133 are spaced apart to define a diamond-shaped opening. In other embodiments, openings between the first and second arms 132, 133 may have other shapes.
The engagement portion 135 of the tabs 130 may extend from an end of the stem portion 131 which is furthest from the proximal end 114 of the tubular body portion 111. In the exemplified embodiment, the engagement portion 135 is oval shaped and elongated in a direction that is transverse to the axis A-A. In some embodiments, the engagement portion 135 may have a height (measured in a direction of the axis A-A) of about 1.6 mm (the term “about” as used herein including plus or minus 0.1 mm) and a width (measured in a direction perpendicular to the axis A-A) of about 2.5 mm (the term “about” as used herein including plus or minus 0.1 mm). The underside of the engagement portion 135 which faces the proximal end 114 of the tubular body portion 111 may form an engagement feature that serves to facilitate a coupling between the prosthetic valve 100 and the catheter apparatus 200 as described in more detail below. In the exemplified embodiment, the engagement portion 135 of the tabs 130 does not have any holes or apertures therein, although in other embodiments holes or apertures may be formed in the engagement portion 135.
In the exemplified embodiments, there are two sizes for the frame portion 110 of the prosthetic valve 100 with different heights and diameters for the frame portion 110 and for the tab portions 130. Of course, the frame portion 110 of the prosthetic valve 100 may be formed in other sizes as well. The tubular body portion 111 of the frame portion 110 comprises a first height H1 measured from the proximal end 114 of the tubular body portion 111 to the distal end 115 of the tubular body portion 111. Furthermore, the tabs 130 of the frame portion 110 comprise a second height H2 measured from the proximal end 114 of the tubular body portion 111 to a terminal end 136 of the tab 130.
In a first embodiment, the frame portion 110 has an outer diameter which is approximately 25 mm (the term “approximately” in this instance including plus or minus 1 mm). In the first embodiment, the first height H1 may be between 18 mm and 23 mm, more specifically between 19 mm and 22 mm, more specifically between 20 mm and 21 mm, and still more specifically approximately 20.6 mm (the term approximately in this instance including a plus/minus difference of 0.3 mm). In the first embodiment, the second height H2 may be between 3.4 mm and 4.0 mm, more specifically between 3.5 mm and 3.9 mm, more specifically between 3.6 mm and 3.8 mm, and still more specifically approximately 3.7 mm (the term approximately in this instance including a plus/minus difference of 0.05 mm). Thus, in the first embodiment a ratio of the first height H1 to the second height H2 may be in a range of 5.2:1 and 5.8:1, or more specifically a range of 5.3:1 and 5.7:1. or still more specifically 5.4:1 and 5.6:1.
In a second embodiment, the frame portion 110 has an outer diameter which is approximately 28 mm (the term “approximately” in this instance including plus or minus 1 mm). In the second embodiment, the first height HI may be between 21 mm and 27 mm, more specifically between 22 mm and 26 mm, more specifically between 23 mm and 25 mm, and still more specifically approximately 24 mm (the term approximately in this instance including a plus/minus difference of 0.3 mm). In the second embodiment, the second height H2 may be between 3.5 mm and 4.1 mm, more specifically between 3.6 mm and 4.0 mm, more specifically between 3.7 mm and 3.9 mm, and still more specifically approximately 3.8 mm (the term approximately in this instance including a plus/minus difference of 0.05 mm). Thus, in the second embodiment a ratio of the first height H1 to the second height H2 may be in a range of 6.2:1:1 and 6.6:1, or more specifically a range of 6.3:1 and 6.5:1. In some embodiments, the frame portion 110 may be configured so that a ratio of the first height H1 to the second height H2 is between 5.2:1 and 6.6:1.
In some embodiments, the stem portions 131 may have a height between 2 mm and 2.2 mm. In some embodiments, when the frame portion 110 has an outer diameter of 25 mm the stem portion 131 may have a height of approximately 2.05 mm and when the frame portion 110 has an outer diameter of 28 mm the stem portion 131 may have a height of approximately 2.15 mm (the term approximately in this instance including plus or minus 0.05 mm). In both exemplary embodiments. the engagement portions 135 may have a height of between 1.6 mm and 1.7 mm, and more specifically approximately 1.66 mm.
It should be noted that the frame portion 110 may be formed with other diameters and the examples described herein are intended to be exemplary. In some embodiments, the frame portion 110 may have an outer diameter of 22 mm. In some embodiments, the frame portion 110 may have an outer diameter of 25 mm. In some embodiments, the frame portion 110 may have an outer diameter of 28 mm. In some embodiments, the frame portion 110 may have an outer diameter of 31 mm.
Thus, in both of the embodiments noted herein, the tabs 130 have a length which is significantly less than a length of the tubular body portion 111 of the frame portion 110. This may allow for repositioning, retrieving, and/or recapturing of the prosthetic valve 100 during an installation procedure. That is, as will be described in greater detail below, when the prosthetic valve 100 is being deployed from the catheter apparatus 200 and installed in a patient, the tabs 130 are the last part of the prosthetic valve 100 that remain coupled to or engaged with the catheter apparatus 200. Because the overall height of the tubular body portion 111 of the frame portion 110 is quite small in comparison to other prosthetic aortic valves, the tubular body portion 111 may still be capable of being recaptured, retrieved, and/or repositioned even when only the tabs 130 remain engaged with the catheter apparatus 200. This provides the physician with a great deal of flexibility during the installation procedure and a great deal of confidence that the prosthetic valve 100 will be installed in the appropriate location within the patient.
The valve portion 180 may be cinched at the locations of the posts 120 and the tabs 130. The valve portion 180 may be coupled to the frame portion 110 at the locations of the posts 120 and the tabs 130 with the use of a commissure strip or the like.
Referring to
Referring to
In the exemplified embodiment, the handle housing 301 may comprise first and second handle parts 307, 308, that are coupled together to define a handle cavity 309. The first handle part 307 has first connection features (e.g., snap-fit protrusions) 310 that engage with second connection features (e.g., apertures) 311 of the second handle part 308 to couple the first and second handle parts 307, 308 together. Of course, the first connection features 310 could be apertures and the second connection features 311 could be protrusions in other embodiments. Moreover, the handle housing 301 may be formed from a single part rather than two parts in other embodiments or may be coupled together in other ways, including friction or press fit, welding, fasteners such as screws, combinations thereof, or other known attachment techniques.
The handle housing 301 may comprise a proximal portion 312, a distal portion 313, and a central portion 314 located between the proximal and distal portions 312, 313. Furthermore, the handle housing 301 may comprise an inner surface 315 that defines the handle cavity 309 and an outer surface 316. The central portion 314 may have a reduced diameter as compared with the proximal and distal portions 312, 313. Thus, the central portion 314 may be recessed relative to the proximal and distal portions 312, 313 along the outer surface 316 of the handle housing 301. However, the invention is not to be so limited in all embodiments and the central portion 314 may not be recessed relative to the remainder of the handle housing 301 in all embodiments.
In the exemplified embodiment, the inner surface 315 of the proximal portion 312 of the handle housing 301 comprises a threaded portion 317 that is configured to engage with the proximal cap assembly 304 to couple the proximal cap assembly 304 to the handle housing 301. In the exemplified embodiment, the threaded portion 317 is located at the proximal-most end portion of the proximal portion 312 of the handle housing 301, although other locations for the threaded portion 317 may be permissible in other embodiments. Furthermore, the inner surface 315 of the proximal portion 312 of the handle housing 301 may comprise a first angular alignment feature 318, which is best shown in
The rotating member 302 of the handle assembly 300 comprises a threaded inner surface 319 and an outer surface 320. The rotating member 302 of the handle assembly 300 is positioned around the central portion 314 of the handle housing 301 of the handle assembly 300. In the exemplified embodiment the rotating member 302 of the handle assembly 300 comprises a first rotating handle part 321 and a second rotating handle part 322 that are snap-fit connected together using snap-fit features. Of course, other connection techniques may be used including welding. fasteners, adhesives, or the like. Moreover, the rotating member 302 may be a singular part rather than two parts in other embodiments. The first and second rotating handle parts 321, 322 may be positioned around the central portion 314 of the handle housing 301 and then snap-fit connected together. The rotating member 302 may comprise ribs 323 that protrude from the threaded inner surface 319. When the rotating member 302 is positioned around the central portion 314 of the handle housing 301, the ribs 323 may contact the outer surface 316 of the handle housing 301 along the central portion 314 of the handle housing 301 and the threaded inner surface 319 of the rotating member 302 may be spaced apart from the outer surface 316 of the handle housing 310. This allows the threaded inner surface 319 of the rotating member 302 to engage the slider 303 to cause the slider to move axially as the rotating member 302 rotates relative to the handle housing 301, as discussed below.
The slider 303 may comprise a hub portion 324 that is disposed within the handle cavity 309 along the central portion 314 of the handle housing 301 and an engagement portion 325 that extends from the hub portion 324 and terminates in a threaded outer surface 326. The engagement portion 325 may comprise an arm that extends from the hub portion 324 and an arcuate threaded portion that terminates in the threaded outer surface 326. The threaded outer surface 326 may be arcuate, and more specifically convex, to facilitate the mating interaction between the threaded outer surface 326 of the slider 303 and the threaded inner surface 319 of the rotating member 302. A portion of the engagement portion 325 which includes the threaded outer surface 326 may be located outside of the handle cavity 309 in the space between the threaded inner surface 319 of the rotating member 302 and the outer surface 316 of the central portion 314 of the handle housing 301. In the exemplified embodiment, there are two engagement portions 325 located on opposite sides of the hub portion 324, although the invention is not to be so limited and the engagement portion 325 may be a continuous annular structure in other embodiments or there may just be a single engagement portion 325 that is semi-annular.
The slider 303 is positioned within the handle cavity 309 so that the threaded outer surface 326 of the slider 303 is in threaded engagement with the threaded inner surface 319 of the rotating member 302. Thus, as the rotating member 302 rotates relative to the handle housing 301, the engagement of the inner threaded surface 319 of the rotating member 302 with the threaded outer surface 326 of the slider 303 causes the slider 303 to move axially in a proximal axial direction (towards the proximal portion 312 of the handle housing 312) or a distal axial direction (towards the distal portion 313 of the handle housing 301), depending on the direction of rotation of the rotating member 302. For example, in one embodiment rotation of the rotating member 302 in a counterclockwise direction may cause the slider 303 to move in a proximal axial direction and rotation of the rotating member 302 in a counterclockwise direction may cause the slider 303 to move in a distal axial direction. In other embodiments, the opposite may be true such that counterclockwise rotation of the rotating member 302 moves the slider 303 in the distal axial direction and counterclockwise rotation of the rotating member 302 moves the slider 303 in the proximal axial direction. The rotation of the rotating member 302 of the handle assembly 300 and the resultant axial movement of the slider 303 controls movement of various components of the catheter apparatus 400 which may be coupled to the slider 303, as described in more detail below.
The slider 303 comprises a top surface 327 and a bottom surface 328. Furthermore, the slider 303 may comprise a through-hole 329 extending through the slider 303 in the axial direction from the top surface 327 to the bottom surface 328. In the exemplified embodiment, the through-hole 329 is located centrally along the slider 303 such that the through-hole 329 is formed through the hub portion 324 of the slider 303. The through-hole 329 forms a lumen in the slider 303 within which components of the catheter assembly 400 may be positioned as described below with reference to
The slider 303 may also comprise a flushing passageway 330 that extends from an opening 331 in the bottom surface 328 of the slider 303 to an outlet 332 that is fluidly coupled to the through-hole 329. The outlet 332 may be located internally within the slider 303 and not along any part of the outer surface of the slider 303. Rather, the outlet 332 may be positioned so as to ensure that any fluid introduced into the flushing passageway 330 will pass into the through-hole at a location between the top and bottom surfaces 327, 328 of the slider 303. In the exemplified embodiment, the flushing passageway 330 comprises a vertical portion 333 that extends from the opening (or inlet 331) to an elbow 334 and a horizontal portion 335 that extends from the elbow 334 to the outlet 332. Of course, the flushing passageway 330 may take on other pathway designs and configurations in other embodiments, including undulating paths, straight paths, linear paths, arcuate paths, or the like.
In the exemplified embodiment, the flushing passageway 330 is located at least partially within one of the engagement portions 325 of the slider 303. That is, in the exemplified embodiment the inlet 331 of the flushing passageway 330 is located along the engagement portion 325 of the slider, but the horizontal portion 335 of the flushing passageway 330 extends into the hub portion 324 of the slider 303 to place the flushing passageway 330 into fluid communication with the through-hole 329. In other embodiments, the flushing passageway 330 t could be located fully within the hub portion 324 of the slider 303 in other embodiments. Fluids introduced into the flushing passageway 330 through the opening 331 in the bottom surface 328 of the slider 303 may exit the flushing passageway 330 at the outlet 332 for introduction into the through-hole 329. Additional details about the usage and function of the flushing passageway 330, and in particular its relationship to the inner and outer shafts 401, 402 of the catheter assembly 400, will be described below with specific reference to
The proximal cap assembly 304 may comprise a proximal cap 336 and a proximal key 337. In the exemplified embodiment, the proximal cap 336 and the proximal key 337 are separate components that are coupled together, although in other embodiment the proximal cap 336 and the proximal key 337 may be integrally formed as a single component. The proximal cap 336 may comprise an end cap portion 338 and a threaded portion 339 that protrudes from a distal end of the end cap portion 338. The threaded portion 339 may comprise external threads 340 that are configured to mate with the threaded portion 317 of the proximal portion 312 of the handle housing 301, as best shown in
The proximal key 337 may comprise an angular alignment member 342 comprising a proximal end 343 and a distal end 344, a distal post 345 protruding from the distal end 344, and a proximal post 346 protruding from the proximal end 343. The proximal post 346 may nest within the through-hole 341 in the end cap portion 338 of the proximal cap assembly 304 to couple the proximal key 337 to the end cap portion 338. The distal post 345 may protrude through an opening formed in a wall that is an integral part of the handle housing 301. The coupling between the proximal key 337 and the end cap portion 338 may be a press-fit connection in some embodiments, although other types of connections may be used in other embodiments, including adhesives, fasteners, welding, or the like. The proximal key 337 and the end cap portion 338 could be a monolithic component in other embodiments. The proximal key 337 may comprise a through-hole 347 that extends through each of the distal post 345, the angular alignment member 342, and the proximal post 346.
The angular alignment member 342 may comprise an outer surface that extends between the proximal and distal ends 343, 344. The outer surface of the angular alignment member 342 may comprise a rounded portion 348 and a flat portion 349. In the exemplified embodiment, the proximal key 337 is only capable of being inserted into the proximal portion 312 of the handle housing 301 when the flat portion 349 of the outer surface is angularly (or rotationally) aligned with the first angular alignment feature 318 of the handle housing 301. As can be seen from
As mentioned above, there are a plurality of flushing ports 306 included as part of the handle assembly 300. One of the flushing ports 306 comprises an inlet port 380 which may comprise a check valve 381, a connector 382, and an elbow luer 383, although fewer components may make up the inlet port 380 in other embodiments. The inlet port 380 defines a passageway from a location external to the handle cavity 309 into the handle cavity 309 for purposes of flushing in between the inner and outer shafts 401, 402 of the catheter assembly 400, as discussed further below.
As noted above, the handle assembly 300 also comprises the flushing tube 305. The flushing tube 305 may comprise a first end 350, a second end 351, and a lumen 352 extending from the first end 350 to the second end 351. The lumen 352 is a flow channel that extends through the full length of the flushing tube 305 from the first end 350 to the second end 351. The first end 350 of the flushing tube 305 may be coupled to the inlet port 380. The second end 351 of the flushing tube 305 may be coupled to the slider 303, and more specifically to the flushing passageway 330 of the slider 303. Thus, fluid introduced into the inlet port 380 will pass into the lumen 352 of the flushing tube 305, through the second end 351 of the flushing tube 305 and into the flushing passageway 330 of the slider 303. This fluid is then introduced into the space between the inner and outer shafts 401, 402 of the catheter assembly 400 within the through-hole 329 in the slider 303, as will be discussed in greater detail below. The flushing tube 305 may be formed from polyvinyl chloride (PVC) tubing or any other type of flexible tubing as should be appreciated based on the operation of the flushing tube 305 as described further below.
In the exemplified embodiment, the flushing tube 305 has a coiled configuration. That is, the flushing tube 305 is arranged in a coiled configuration as it extends from the first end 350 to the second end 351. The flushing tube 305 has a pitch, which is the distance from the center of one coil to the center of an adjacent coil. Due to its coiled configuration, the flushing tube 305 is capable of compressing and expanding (like a compression spring) as the slider 303 moves axially within the handle cavity 309.
In particular, referring to
With continued reference to
The proximal end 403 of the outer shaft 401 is located within the through-hole 329 formed in the slider 303. More specifically, in the exemplified embodiment the proximal end 403 of the outer shaft 401 is located within the through-hole 329 of the slider 303 at a position that is immediately adjacent and distal to the outlet 332 of the flushing passageway 330 in the slider 303. The inner shaft 402 extends through the entirety of the through-hole 329 in the slider 303. The outer shaft 401 is axially aligned with a portion of the flushing passageway 330 such that an axis that is parallel to a longitudinal axis B-B of the handle assembly 300 intersects a portion of the outer shaft 401 and a portion of the flushing passageway 330. In the exemplified embodiment, the outlet 332 of the fluid passageway 330 abuts against the outer surface of the inner shaft 402 at a position immediately below (or proximal to) the outer shaft 401. Stated another way, the outlet 332 of the fluid passageway 330 is positioned radially inward of the outer shaft 401 so that the fluid introduced into the inlet port 380 of the handle assembly 300 flows between the inner and outer shafts 401, 402 for purposes of removing any air in the space between the inner and outer shafts 401, 402 and/or otherwise flushing the space between the inner and outer shafts 401, 402.
Moreover, the inner and outer shafts 401, 402 are not coupled together, but rather the outer shaft 401 is movable axially relative to the inner shaft 402 which is fixed axially, as described further below. Thus, there may be a small annular gap between the outer surface of the inner shaft 402 and the inner surface of the outer shaft 401. Thus, as the fluid exits the outlet 332 of the flushing passageway 330, the fluid may pass into the annular gap between the inner and outer shafts 401, 402. Due to the arrangement of the flushing tube 305, the space between the inner and outer shafts 401, 402 can be casily flushed regardless of the location or axial positioning of the slider 303 within the handle cavity 309.
Referring to
The outer shaft 402 may comprise the proximal end 403 that is coupled to the slider 303 of the handle assembly 300 and the distal end 404 that is coupled to the proximal end 422 of the outer sheath 420. While the proximal end distal ends 403, 404 are referred to as being coupled to the slider 303 and the outer sheath 420 respectively, in other embodiments other parts of the outer shaft 402 may be coupled to those components, such as locations between the proximal and distal ends 403, 404. Furthermore, as noted above, the slider 303 moves axially in the proximal and distal directions when the rotating member 302 of the handle assembly 300 is rotated. Thus, when the rotating member 302 is rotated in a first rotational direction, the slider 303 moves in the proximal axial direction Z. Furthermore, because the outer shaft 401 is coupled (or fixedly attached) to the slider 303, movement of the slider 303 in the proximal axial direction Z results in movement of the outer shaft 401 in the proximal axial direction Z. Finally, because the outer shaft 401 is coupled (or fixedly attached) to the outer sheath 420 of the deployment assembly 410 of the catheter assembly 400, as the slider 303 and the outer shaft 401 move in the proximal axial direction Z, the outer sheath 420 also moves in the proximal axial direction Z. Similarly, when the rotating member 302 of the handle assembly 300 is rotated in the opposite rotational direction, each of the slider 303, the outer shaft 401, and the outer sheath 420 moves in the distal axial direction Y.
In use, a prosthetic valve such as the prosthetic valve 100 described above may be positioned within the outer sheath 420 in the space 424 between the pusher 440 and the distal tip assembly 460. Thus, the pusher 440 and the distal tip assembly 460 may be spaced apart a sufficient axial distance to ensure that the prosthetic valve 100 will fit therein. This axial distance may be modifiable depending on the size of the prosthetic valve being used for a particular implantation operation. Movement of the outer shaft 420 in the proximal axial direction Z may cause the prosthetic valve 100 and the pusher 440 to become exposed so that the prosthetic valve 100 can be deployed and installed a patient, as described in more detail below. That is, movement of the outer shaft 420 in the proximal axial direction Z while the pusher 440 and the prosthetic valve 100 are stationary will cause the prosthetic valve 100, and then the pusher 440, to emerge from the opening in the distal end 423 of the outer sheath 420 for implantation or the like.
The inner shaft 402 of the catheter assembly 400 may comprise a proximal end 405 and a distal end 406. The pusher 440 may be fixedly coupled to the inner shaft 402 at a position that is adjacent to the distal end 406 of the inner shaft 402. That is, the pusher 440 may be located between the proximal and distal ends 405, 406 of the inner shaft 402, but in the exemplified embodiment the pusher 440 may be positioned much closer to the distal end 406 than to the proximal end 405. The pusher 440 may be fixed axially relative to the inner shaft 402 by any means desired, such as adhesive, welding, bonding, combinations thereof, or other technical means now known or later discovered. The pusher 440 may also be fixed rotationally relative to the inner shaft 402 such that the pusher 440 may be non-movable relative to the inner shaft 402.
In the exemplified embodiment, the proximal end 405 of the inner shaft 402 is coupled to the proximal cap assembly 304, and more specifically to the proximal key 337. However, the invention is not to be so limited in all embodiments and the proximal end 405 of the inner shaft 402 may be coupled to other parts of the handle assembly 300 in other embodiments, including being coupled directly to the handle housing 301 in some embodiments. Furthermore, it is possible that other portions of the inner shaft 402 than the proximal end 402 may be coupled to the handle assembly 300. In the exemplified embodiment, the distal end 406 of the inner shaft 402 is coupled to the distal tip assembly 460, and more specifically to the distal thread assembly 462 thereof. Other portions of the inner shaft 402 may be coupled to the distal tip assembly 460 in other embodiments. Furthermore, the distal end 406 of the inner shaft 402 may be coupled to other components of the distal tip assembly 460 in other embodiments. As noted above, the proximal cap assembly 304 may be threadedly and therefore fixedly (although detachably) coupled to the handle housing 301. By fixedly, it is meant that when the proximal cap assembly is coupled to the handle housing 301, the proximal cap assembly 304 is fixed such that it cannot move axially relative to the handle housing 301. However, due to the threaded attachment, the proximal cap assembly 304 may be entirely detached from the handle housing 301 and this will be discussed below with reference to the loading of the catheter apparatus 200 with the prosthetic valve 100. Because the inner shaft 402 is fixedly coupled to the proximal cap assembly 304, the angular orientation or positioning of the proximal cap assembly 304 due to the angular alignment features noted above may dictate the angular orientation or positioning of the inner shaft 402. This may help to ensure that the inner shaft 402 is oriented to bend in a proper direction during a valve replacement procedure.
In accordance with the exemplified embodiment, the inner shaft 402 is fixed axially between the proximal cap assembly 304 and the distal tip assembly 460. Thus, rotation of the rotating member 302 of the handle assembly 300 and the related axial movement of the slider 303, the outer shaft 401, and the outer sheath 420 is relative to the inner shaft 402 which is stationary and does not move axially or otherwise during the movement of the slider 303. Thus, as the outer sheath 420 moves in the proximal axial direction Z as noted above, the pusher 440 and the distal tip assembly 460 remain stationary due to their attachment to the inner shaft 402. As such, the pusher 440 becomes “unsheathed” or exposed and removed from the sheath cavity 421 once the outer sheath 420 moves a sufficient distance in the proximal axial direction Z. By coupling the inner shaft 402 to the proximal key 337 and including the angular orientation feature on the proximal key 337 and the handle housing 301, the proximal key 337 may serve to maintain the axial wires of the inner shaft 402 in alignment with the axial wires of the outer shaft 401 to ensure that both the inner and outer shafts 401, 402 curve in the same, desired direction during use.
As noted above, the pusher 440 may be coupled to the inner shaft 402 at a position that is near, but spaced apart from the distal end 406 of the inner shaft 402. In the exemplified embodiment, the distal thread assembly 462 comprises a distal thread component 463 and a cap component 464 that are coupled together. However, in other embodiments the distal thread component 463 and the cap component 464 may be an integral unitary structure. In the exemplified embodiment, the distal thread assembly 462 may be coupled to the inner shaft 402 at the distal end 406 of the inner shaft 402. That is, in the exemplified embodiment the inner shaft 402 may extend through a through-hole or passageway or lumen in the distal thread assembly 462 so that the distal end 406 of the inner shaft 402 is essentially flush with the distal end of the distal thread assembly 462. In other embodiments, the distal end 406 of the inner shaft 402 may be recessed relative to or slightly protrude from the distal end of the distal thread assembly 462. The distal thread component 463 comprises an outer threaded surface 465. The distal thread assembly 462, and more specifically the cap component 464 thereof, closes the distal end of the sheath cavity 421 when the outer sheath 420 is in a non-deployed or closed configuration, as shown in
The distal tip assembly 460 may also comprise a nose cone 466. The nose cone 466 may comprise an inner surface 468 that defines an interior lumen 467. Furthermore, at least a portion of the inner surface 468 of the nose cone 466 is a threaded portion 469. Thus, the nose cone 466 may be detachably coupled to the distal thread component 463 via engagement between the threaded portion 469 of the nose cone 466 and the outer threaded surface 465 of the distal thread component 463. The interior lumen 467 may provide a passageway for fluid that is flushing the interior of the inner shaft 402 to exit the catheter assembly 400.
In
As noted above, during use when the rotating member 303 of the handle assembly 300 is rotated, the slider 303, the outer shaft 401, and the outer sheath 420 move in either the proximal or distal axial direction, depending on the direction of rotation of the rotating member 303. It is worth repeating that this movement is done relative to the inner shaft 402, the pusher 440, and the distal tip assembly 460, which remains stationary as the outer sheath 420 moves. Thus, when the slider 303 and the outer sheath 420 move in the proximal axial direction Z, because the pusher 440 and the distal tip assembly 460 remain stationary, any components previously located within the shaft cavity 421 exit therefrom and become exposed. In particular, a prosthetic valve 100 located in the axial space 424 between the pusher 440 and the distal tip assembly 460 becomes exposed and then the pusher 440 becomes exposed as the outer sheath 420 continues to move in the proximal axial direction Z. This will be described further below during the discussion of the valve deployment with reference to
Referring to
In the exemplified embodiment, the pusher 440 comprises a cone-shaped proximal portion 444 and a cylindrical shaped distal portion 445. However, the invention is not to be so limited in all embodiments and the pusher 440 may be cone-shaped or cylindrical shaped or any other shape along its entire length in other embodiments. Furthermore, the pusher 440 may comprise at least one indentation (or recess or notch or channel) 446 that extends from the distal end 442 to a proximal end surface 447. In the exemplified embodiment, the pusher 440 comprises three of the indentations 446 that are arranged in a circumferentially and equidistantly spaced apart manner. However, the pusher 440 may have any number of the indentations 446 as may be desired. In certain embodiments, the number of the indentations 446 may correspond to the number of tabs 130 of the prosthetic valve 100 configured to be used with the catheter apparatus 200. The proximal end surface 447 is located distally of the proximal end 441 of the pusher 440 such that the indentations 446 do not extend the full length of the pusher 440. Furthermore, the indentations 446 are elongated in the axial direction between the proximal and distal ends 441, 442 of the pusher 440.
In the exemplified embodiment, the tabs 130 of the prosthetic valve 100 are equidistantly spaced apart by a distance of 120°. Similarly, the indentations 446 of the pusher 440 are equidistantly spaced apart by a distance of 120°. This provides symmetry and strength to the components. However, the invention is not limited by this equidistant spacing in all embodiments and in other embodiments the distances between the tabs 130 may not be the same for each pair of adjacent tabs, and the distances between the indentations 446 may not be the same for each pair of adjacent indentations.
Each of the indentations 446 forms a recess in an outer surface 448 of the pusher 440 that extends to a floor 449 that is recessed relative to the outer surface 448. The pusher 440 comprises a longitudinal axis C-C that extends between the proximal and distal ends 441, 442. In the exemplified embodiment, the proximal end surface 447 of the indentations 446 is sloped. More specifically, the proximal end surface 447 of the indentations 446 is sloped downwardly in a direction away from the distal end 442 and towards the proximal end 441 of the pusher 440 when moving in a direction from the floor 449 to the outer surface 448. The proximal end surface 447 is oriented at an oblique angle relative to the floor 449 and also relative to the longitudinal axis C-C.
Each of the indentations 446 may comprise an entry section 450 adjacent to the distal end 442 of the pusher 440, a nesting section 451 adjacent to the proximal end surface 447, and a neck section 452 located between the entry and nesting sections 450, 451. In the exemplified embodiment, the neck section 452 has a reduced width relative to the entry and nesting sections 450. 451. Furthermore, each of the indentations has a longitudinal axis D-D and a sidewall surface that extends from the floor 449 to the outer surface 448. The sidewall surface comprises a first portion 453 located on a first side of the longitudinal axis D-D and a second portion 454 located on a second side of the longitudinal axis D-D. Furthermore, each of the indentations 446 comprises a first tab 455 protruding from the first portion 453 of the sidewall surface and a second tab 456 protruding from the second portion 454 of the sidewall surface. The first and second tabs 455, 456 extend inwardly towards the longitudinal axis D-D to define the narrowed neck section 452 of the indentations 446. Furthermore, in the exemplified embodiment each of the first and second tabs 455. 456 has a distal surface 457 that faces the distal end 442 of the pusher 440. In the exemplified embodiment, the distal surfaces 457 of the first and second tabs 455, 456 are sloped downwardly in a direction away from the distal end 442 of the pusher 440.
As noted above and discussed in greater detail below, each of the indentations 446 may be configured to receive one of the tabs 130 of the prosthetic valve 100 described above. Thus, the prosthetic valve 100 may be generally positioned so that the proximal end 114 of the prosthetic valve 100 abuts against the distal end 442 of the pusher 440 and the tabs 130 of the prosthetic valve 100 nest within one of the indentations 446 of the pusher 440. The sloping of the proximal end surfaces 447 of the indentations 446 serves a functional purpose in accordance with embodiments of the present invention. In particular, if during deployment of the prosthetic valve 100 one of the tabs 130 becomes stuck within a respective one of the indentations 446, a user will be able to disengage the pusher 440 from the prosthetic valve 100 by moving the entire catheter apparatus 200 in a distal direction. Moving the catheter apparatus 200 in the distal direction will cause the proximal end surface 447 of the indentations 446 to move distally relative to the stuck prosthetic valve 100 so that the tab 130 which is stuck may slide over the sloped proximal end surface 447 to facilitate detachment of the prosthetic valve 100 from the pusher 440. If the proximal end surface 447 were oriented perpendicular to the longitudinal axis C-C, such movement of the pusher 440 relative to the prosthetic valve 100 would only cause the end of the tab 130 to abut against the proximal end surface 447. Thus, the sloping orientation of the proximal end surface 447 allows the tab 130 to easily glide over the proximal end surface 447 to ensure that the prosthetic valve 100 detaches from the pusher 440 to be deployed/installed into a patient.
Referring to
The axial wires 415, 416 may be fixed relative to a sheath portion 417 of the inner shaft 402. Due to the axial wires 415, 416 being positioned within the interior lumen of the inner shaft 402, the inner shaft 402 is only able to bend in certain directions because the axial wires 415, 416 must be located one on top of the other during the bending. That is, attempting to bend the inner shaft 402 with the axial wires 415, 416 positioned in a side-by-side position (with one axial wire 415 adjacent to the inner curve and the other axial wire 416 adjacent to the outer curvature of the inner shaft 402) is not possible because the two axial wires 415, 416 will prevent such bending due to the combined strength of the axial wires 415, 416. Thus, prior to coupling the pusher 440 to the inner shaft 402, the inner shaft 402 is bent into a U-shaped bend configuration as shown in
Thus, with the inner shaft 402 in the U-shaped bend configuration, the pusher 440 may be coupled to the inner shaft 402 in a specific angular orientation to align the indentations 446 in a desired manner. In accordance with one embodiment of the present invention, it may be desirable to align one of the indentations 446 of the pusher 440 with the vertical plane E-E on which the two axial wires 415, 416 of the inner shaft 402 lie when the inner shaft 402 is in the U-shaped bend configuration. However, the invention is not to be limited to this angular orientation of the pusher 440 relative to the inner shaft 402 in all embodiments.
Referring to
In the exemplified embodiment, when the inner shaft 402 (or the shaft assembly generally) is in the U-shaped bend configuration shown in
Referring to
The rotational orientation of the pusher 440 relative to the inner shaft 402 of the catheter assembly 400 may dictate the positioning of the indentations 446 of the pusher 440, and therefore also the tabs 130 of the prosthetic valve 100, relative to the aortic arch during a valve replacement procedure. Specifically, the aortic arch has an outer wall and an inner wall. In some instances, it has been found that when the last tab 130 of the prosthetic valve 100 to be released from the pusher 440 is positioned along the second circumferential portion 482 of the second leg 481 at a position approximately 90° offset from the vertical axis E-E (in a first rotational direction, and thereby positioned closest to the outer wall of the aortic arch), there is a greater likelihood that the tab 130 will become stuck (which may necessitate moving the catheter apparatus 200 distally as discussed above). Thus, there is a desire in some embodiments to keep all of the indentations 446 (and hence also the tabs 130 which are positioned within the indentations 446) as far away as possible from the outermost part of the second circumferential portion 483 of the outer surface of the shaft assembly, and hence also as far away as possible from the outer wall of the aortic arch during an implantation procedure. As noted above, due to the axial wires in the inner and outer shafts 401, 402, the bend direction of the catheter assembly 400 is known. Thus, in some embodiments the pusher 440 may be coupled to the inner shaft 402 in an angular orientation that ensures that each of the tabs 130 is positioned as far away from the outer wall of the aortic arch as possible. As mentioned above, this concept will be described in greater detail below with reference to
Referring to
Referring first to
Next, referring to
Next, referring to
Referring to
While the prosthetic valve 100 is being maintained in a radially compressed state, the prosthetic valve 100 is loaded onto the pusher 440. Specifically, in the exemplified embodiment loading of the prosthetic valve 100 onto the pusher 440 is achieved by aligning the tabs 130 of the frame portion 110 of the prosthetic valve 100 with the indentations 446 of the pusher 440. Once the tabs 130 are aligned with the indentations 446, the radial compression station 500 may further compress the prosthetic valve 100 to pop the tabs 130 into place within the indentations 446 of the pusher 440. The tabs 130 will be positioned within the indentations 446 so that the engagement portion 135 of the tabs 130 nests within the nesting section 451 of the indentations 446 and the stem 131 of the tabs 130 nests within the neck 452 and entry sections 450 of the indentations 446. Furthermore, the proximal end 114 of the prosthetic valve 100 may abut against the distal end 442 of the pusher 440. For features of the prosthetic valve 100 and the pusher 440 described in this paragraph but not labeled in
In some embodiments, the engagement of the tabs 130 of the prosthetic valve 100 with the indentations 446 of the pusher 440 may not be sufficient to maintain the prosthetic valve 100 in the radially compressed state. Rather, the prosthetic valve 100 may need to be positioned within the outer sheath 420 in order to maintain the prosthetic valve 100 in the radially compressed state upon disengagement of the prosthetic valve 100 from the radial compression station 500. Thus, even after the tabs 130 have nested within the indentations 446 of the pusher 440, the radial compression station 500 may maintain contact with the prosthetic valve 100 to maintain the prosthetic valve 100 in the radially compressed state as shown in
Next, referring to
While the prosthetic valve 100, the pusher 440, and the proximal thread assembly 462 are moving in the proximal axial direction Z, the outer sheath 420 is stationary. Thus, the prosthetic valve 100, the pusher 440, and the proximal thread assembly 462 move in the proximal axial direction Z relative to the outer sheath 420 until the pusher 440, the prosthetic valve 100, and the distal thread assembly 462 begin to enter the sheath cavity 421 of the outer sheath 420. In
Referring to
Next, referring to
Finally, referring to
The deployment of the prosthetic valve 100 into a patient body using the catheter apparatus 200 will be described with reference to
Referring first to
As seen in
Referring to
In
In
It should be appreciated that the annulus of the aorta is not usually circular, and is often elliptical. When the annulus is elliptical, there will be greater contact between the prosthetic valve 100 and the annulus of the aorta in the short axis region than in the long axis region of the elliptical shape. However, regardless of whether the annulus is elliptical or circular, the entire tubular body portion 111 of the prosthetic valve 100 will contact the annulus once the tabs 130 are released from the sheath cavity 421. In some embodiments, when the entire tubular body portion 111 of the prosthetic valve 100 is deployed and only the tabs 130 remain in the sheath cavity 421, no more than 70% of the tubular body portion 111 of the prosthetic valve 100 is fully deployed and/or in its fully expanded state. In some embodiments, when the entire tubular body portion 111 of the prosthetic valve 100 is deployed and only the tabs 130 remain in the sheath cavity 421, no more than 50% of the tubular body portion 111 of the prosthetic valve 100 is fully deployed and/or in its fully expanded state. By this, it is meant that no more than 70% or no more than 50% of the length of the tubular body portion 111 of the prosthetic valve 100 (with the length measured between the proximal 114 and distal ends 115) is in contact with the annulus of the aorta. By “fully expanded state” it is meant that the tubular body portion 111 has returned from its radially compressed state to its natural state where it is not under any radial compression. Furthermore, the percentages noted refers to the length of the body portion 111 that has returned to its natural, non-compressed state. That is, if no more than 70% of the body portion 111 is in the fully expanded state, then no more than 70% of the length of the body portion 111 measured between the proximal end distal ends 114, 115 has returned to its non-compressed state (such that it is not compressed radially at all).
In some embodiments, when the annulus of the aortic arch is more circular, when only the tabs remain in the sheath cavity 421 as shown in
Thus, it should be appreciated that regardless of the shape (circular or elliptical) of the annulus, when the full length of the tubular body 111 is removed from the sheath cavity 421 of the outer sheath 420 and only the tabs 130 of the prosthetic valve 100 remain located in the sheath cavity 421 of the outer sheath 420, no more than 70% of the prosthetic valve 100 is fully deployed and in a fully expanded state. This means that no more than 70% of the length of the prosthetic valve 100 is in contact with the annulus of the aortic arch when everything except the tabs 130 have been released from the sheath cavity 421 of the outer sheath 420.
In
It should be appreciated that despite the fact that the tabs 130 all have an identical length, the tabs 130 are removed from the outer sheath 420 sequentially, one at a time. In no case is more than one of the tabs 130 removed from the outer sheath 420 at a time, such that there is no simultaneous removal of multiple ones of the tabs 130 of the prosthetic valve 100 from the outer sheath 420. Without intending to be bound by theory, it is believed that the sequential release of the tabs 130 from the sheath cavity 421 during deployment of the prosthetic valve 100 may be due, at least in part, to the orientation of the pusher 440 relative to the inner shaft 402. Regardless of the reason, the fact remains that the tabs 130 may be released from the pusher 440 and sheath cavity 421 sequentially, one at a time, and never simultaneously in accordance with some of the embodiments described herein. This provides the surgeon with a lot of control during the deployment and installation of the prosthetic valve 100.
Referring to
It is worth repeating that during the deployment and installation of the prosthetic valve 100 into the patient, the tabs 130 of the prosthetic valve 100 are released from the sheath cavity 421 and the pusher 440 sequentially rather than simultaneously despite the fact that the tabs 130 are all the same length as described herein. Thus, the tabs 130 are released one at a time until all of the tabs 130 have been released. This feature of the inventive catheter system (which includes the catheter apparatus 200 and the prosthetic valve 100) allows the prosthetic valve 100 to be repositioned, recaptured, and/or retrieved during the implantation/installation procedure. In particular, this feature allows the surgeon to maintain control of the prosthetic valve 100 and its deployment until the very last tab 130 is released from the pusher 440 and sheath cavity 421. Thus, even after the first tab 130 has been released from the pusher 440, and perhaps after the second tab 130 has been released from the pusher 440, the catheter apparatus 100 may be capable of repositioning, recapturing, and/or retrieving the prosthetic valve 100 as needed. This allows the surgeon or other user to have optimal control for proper positioning of the prosthetic valve 100 during a procedure.
In some embodiments, the systems and methods described herein involve a self-expanding prosthetic valve that comprises: a frame comprising a tubular body; a valve component disposed within and anchored to the tubular body of the frame, the valve component comprising: an annular sleeve having an annular inner wall that forms a fluid passageway along an axis from an inlet edge to an outlet edge, an annular cuff that is concentric to and surrounds the annular inner wall and extends from the inlet edge toward the outlet edge; and an annular belt positioned between the annular inner wall and the annular cuff; wherein the annular belt is concentric to and circumferentially surrounds the annular inner wall; and wherein the annular sleeve and the annular belt are formed of a material selected from the group consisting of a biological tissue and a biocompatible polymer.
While the invention has been described with respect to specific examples including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described systems and techniques. It is to be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present invention. Thus, the spirit and scope of the invention should be construed broadly as set forth in the appended claims.
The present application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 63/322,708, filed Mar. 23, 2022, the entirety of which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/016031 | 3/23/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63322708 | Mar 2022 | US |
