Transcatheter heart valve delivery system handle

Abstract

A handle is configured for delivery of a prosthetic valve. The handle includes an upper portion, a lower portion opposite the upper portion, side portions between the upper portion and the lower portion, a proximal portion, and an opposed distal portion. The distal portion extends longitudinally along a longitudinal axis from a first end to a second end thereof. The distal portion includes a cross-sectional width defined by a first diameter adjacent the first end and a second diameter adjacent the second end, wherein the first diameter is less than the second diameter. The distal portion includes a cross-sectional height that increases from the first end to the second end. The cross-sectional width and cross-sectional height allow a user to determine a location of their hand on the handle via tactile feedback.

Description

TRANSCATHETER HEART VALVE DELIVERY SYSTEM HANDLECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 674,542, filed July 23, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates to a handle to be used for the delivery of a cardiovascular prosthesis, such as a prosthetic heart valve, and in particular, a handle for use by a surgeon to control the delivery and deployment of the prosthetic heart valve.BACKGROUND

[0003] During a procedure involving the percutaneous insertion and implantation a prosthetic heart valve replacement in a patient’s heart, a surgeon typically monitors a screen to track the position and orientation of the prosthetic heart valve delivery system. Therefore, the surgeon cannot take their eyes off of the monitor to look at a handle of the delivery system. In addition, the surgeon may need to rest handle on a surface to obtain better control of the tracking, positioning, and deployment of the prosthetic heart valve. In doing so, the handle may be obstructed by the surface or objects on the surface such that the surgeon is unable to operate the handle effectively to control the deployment of the prosthetic heart valve.SUMMARY

[0604] Embodiments according to the present invention address the delivery and deployment of a prosthetic heart valve in a patient’s heart. Specifically, embodiments of the present invention provide apparatuses for enabling a surgeon to identify a location of a handle by tactile feedback and for unrestricted control over the deployment of the prosthetic heart valve.10005] In embodiments, a handle is configured for delivery of a prosthetic valve. The handle includes an upper portion, a lower portion opposite the upper portion, side portions between the upper portion and the lower portion, a proximal portion, and an opposed distal portion. The distal portion extends longitudinally along a longitudinal axis from a first end toa second end thereof. The distal portion includes a cross-sectional width defined by a first diameter adjacent the first end and a second diameter adjacent the second end, wherein the first diameter is less than the second diameter. The distal portion includes a cross-sectional height that increases from the first end to the second end. The cross-sectional width and cross- sectional height allow a user to determine a location of their hand on the handle via tactile feedback.[00061 In embodiments, a handle includes a cross-sectional width of a distal portion increases gradually from a first end to a second end and symmetrically relative to side portions.

[0907] In embodiments, a handle includes a third diameter spaced apart from a first diameter and a fourth diameter disposed between a third diameter and a second diameter. The third diameter is greater than the first diameter and less than the fourth diameter, and the fourth diameter is less than the second diameter

[0998] In embodiments, a handle includes a cross-sectional width of a distal portion increases gradually from a first end to a second end and symmetrically relative to side portions.

[0009] In embodiments, a handle includes a cross-sectional height is defined by a first height adjacent a first end and a second height adjacent a second end, and wherein the first height is less than the second height.

[0910] In embodiments, a handle includes an increase in a cross-sectional height that is asymmetrical such that a segment of a lower portion extends away from a longitudinal axis at a greater rate than an upper portion.

[0911] In embodiments, a handle includes a cross-sectional width and a cross-sectional height that increase at different rates.

[0012] In embodiments, a handle includes a flush port disposed in a distal portion and on an upper portion of the handle, wherein an orientation of the flush port corresponds to an orientation of a delivery of a prosthetic valve.

[0013] In embodiments, a handle includes a distal portion includes a plurality of diameters taken along a longitudinal axis, wherein the plurality of diameters increase along the longitudinal axis from a first end toward a second end, and wherein a rate of change of the increase in the diameters decreases continuously from the first end to the second end.

[0014] In embodiments, a handle is configured for delivery of a prosthetic valve. The handle includes an upper portion, a lower portion opposite the upper portion, side portions between the upper portion and the lower portion, a distal portion, and a proximal portion opposite the distal portion. An actuator grip is disposed on the proximal portion of the handle and is operatively connected to a catheter and configured for controlling implantation of the prosthetic valve by rotational movement of the actuator grip. The actuator grip has a concave shape to allow a user to rotate the actuator grip without impedance from an underlying work surface in contact with at least a part of the lower portion.

[0015] In embodiments, an actuator grip includes grooves for providing tactile feedback to a user and for more easily rotating the actuator grip.

[0016] In embodiments, an actuator grip and a proximal portion of a handle are contoured so as to provide a smooth outer surface profile along the proximal portion.

[0017] In embodiments, all outer diameters of an actuator grip are less than adjacent outer diameters of a handle that are directly adjacent the actuator grip.

[0018] In embodiments, an actuator grip has an hourglass shape.

[0019] In embodiments, a delivery system for implanting a prosthetic heart valve includes a control handle. The control handle includes an upper portion, a lower portion opposite the upper portion, side portions between the upper portion and the lower portion, a proximal portion, and an opposed distal portion. The distal portion extends longitudinally along a longitudinal axis from a first end to a second end thereof. The distal portion includes a cross- sectional width defined by a plurality of diameters taken along the longitudinal axis, wherein the diameters increase along the longitudinal axis from the first end toward the second end, and wherein a rate of change of the increase in the diameters decreases continuously from the first end to the second end. An actuator grip with a concave shape is disposed on the proximal portion. The concave shape allows a user to rotate the actuator grip without impedance from an underlying work surface in contact with at least a part of the lower portion. A catheter portion is operatively coupled to the control handle at a proximal end of the catheter portion. The catheter portion includes a capsule disposed adjacent a distal end of the catheter portion. The actuator grip is configured for controlling translation movement of the capsule to expose the prosthetic heart valve by rotation of the actuator grip.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1A is a side view of a delivery system for a prosthetic heart valve;]0021] FIG. IB is an englarged view of the delivery system of FIG. 1A illustrating the prosthetic heart valve attached to a catheter portion of the delivery system;

[0022] FIG. 2 is a side view of a handle for delivering a prosthetic heart valve;

[0023] FIG. 3 is a top view illustrating of a distal portion of the handle of FIG. 1 according to an embodiment;

[0024] FIG. 4 is an enlarged top view of the distal portion of the handle illustrated in FIG. 2, according to an embodiment;

[0025] FIG. 5 is an enlarged side view of the distal portion of the handle illustrated in FIG. 2, according to an embodiment;

[0026] FIG. 6 is a side view of a proximal portion of the handle of FIG. 1, having an actuator grip according to an embodiment; and

[0027] FIG. 7 is an exemplary view of FIG. 6 illustrating rotational movement of the actuator grip and separation of the actuator grip from a work surface.DETAILED DESCRIPTION

[0028] Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative bases for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical application. Various combinations and modifications of the featuresconsistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.

[0029] “A”, “an”, and “the” as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a processor” programmed to perform various functions refers to one processor programmed to perform each and every function, or more than one processor collectively programmed to perform each of the various functions.

[0930] Directional terms used herein are made with reference to the views and orientations shown in the exemplary figures. A central axis is shown in the figures and described below. Terms such as “outer” and “inner” are relative to the central axis. For example, an “outer” surface means that the surfaces faces away from the central axis, or is outboard of another “inner” surface. Terms such as “radial,” “diameter,” “circumference,” etc. also are relative to the central axis. The terms “front,” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.

[0031] Unless otherwise indicated, for the delivery system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. For a stent-graft prosthesis, “proximal” is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path. For a heart valve prostheses, “proximal” may refer to an inflow end and “distal” may refer to an outflow end.

[0032] A delivery system is shown in U.S. Application Publication No. US2022 / 0175527, the entirety of which is incorporated by reference herein. FIGS. 1A and IB illustrate a delivery system 2 for the percutaneous insertion and implantation of a prosthesis to a desired implant location. The delivery system 2 generally includes a catheter portion 4 with a capsule 6 connected to the distal end of the catheter portion 4. A prosthetic heart valve 8 is connected to the distal end of the catheter portion 4. In some embodiments, the prosthetic heart valve 8 is self-expanding and the capsule 6 is configured to compressively retain the prosthetic heart valve 8. Proximally retracting the capsule 6 exposes the prosthetic heart valve 8, whereby the prosthetic heart valve 8 is released from the catheter portion 6 after being fully exposed.The prosthetic heart valve 8 can be designed for replacement of the aortic valve, mitral valve, tricuspid valve, or pulmonary valve by way of a patient's vasculature, such as including access through a patient's femoral artery or femoral vein, or otherwise, as appropriate in accordance with known or developed delivery techniques utilizing percutaneous delivery.

[0033] The delivery system 2 may include a handle 10 for use as part of a delivery system. Handles 10 according to embodiments of the present disclosure improve the ease and accuracy of prosthetic valve delivery through the vasculature and avoid deployment difficulties related to the need to control the delivery and deployment actions at a distal end of delivery systems from a proximally provided control handle 10. Generally, a catheter portion 6 is operatively connected to the handle 10 and a proximal end of the catheter portion 6 extends from the handle 10. The handle 10 is configured to control the translational movement of the capsule 6, thereby controlling the deployment of the prosthetic heart valve 8. For example, the handle 10 can actuate the capsule 6 to be proximally retracted and expose the prosthetic heart valve 8 and / or distally advance the capsule 6 to recapture or re-cover the prosthetic heart valve 8 (i.e., the handle 10 can control the advancement and withdrawal of the capsule 6). While disclosed herein with reference to a heart valve prosthesis, the handle 10 and delivery system 2 may be used with any catheter-based medical device, such as a stent graft for treatment of aortic aneurysms or dissections.

[0034] Referring to FIGS. 2 and 3, the handle 10 has a distal portion 12 and a proximal portion 14 opposite the distal portion 12. The handle 10 has an upper portion 16, a lower portion 18, and side portions 20, each of which may be curvilinear, planar, or the like, or a combination or sub-combination thereof. The handle 10 has a generally elongated shape suitable for a surgeon to hold with their hand(s) during a procedure, such as a cylindrical, oval, elliptical, or rectangular shape, or the like. For example, the handle 10 has a length 22 (which may be defined by the distal portion 12 and the proximal portion 14) that is greater than a width 24 (which may be defined by the side portions 20). The length 22 of the handle 10 may define a longitudinal axis 25 such that the width 24 and height 26 (which may be defined by the upper portion 16 and the lower portion 18) of the handle 10 may be defined relative to the longitudinal axis. The width 24 and / or the height 26 of the handle 10 may uniform or nonuniform along the length 22 of the handle 10.

[0035] FIGS. 3 and 4, wherein FIG 4. corresponds to box 4 shown in FIG. 3, illustrate an embodiment of the handle 10 wherein the distal portion 12 includes a cross-sectional areawith varying diameters. In some embodiments, the cross-sectional area of the distal portion 12 relates to the width 24 of the handle 10. The distal portion 12 has a first end 27 and a second end 28 spaced apart from the first end 27. A first diameter dl is adjacent the first end 27 and a second diameter d2 is spaced apart from the first diameter dl. The first diameter dl is less than the second diameter d2 such that the cross-sectional width of the first diameter dl is less than the cross-sectional width of the second diameter d2. The distal portion 12 may further include a third diameter d3 and a fourth diameter d4, wherein the fourth diameter is adjacent the second end 28 and the third diameter d3 is between the second diameter d2 and the fourth diameter d4. The third diameter d3 may be greater than the second diameter d2 and less than the fourth diameter d4. In this way, the cross-sectional width of the distal portion 12 increases from the first end 27 to the second end 28 allowing for the surgeon to identify the location of their hand (e.g., their left hand) on the handle 10. In other words, the plurality of different diameters allows the surgeon to use tactile feedback to determine the location of their hand on the handle 10 without visually looking at the handle 10 (e.g., the surgeon may place the palm of their hand on the lower portion 18 and by the contact / feel of the distal portion 12 on the surgeon’s palm, fingers, and / or wrist the surgeon can identify the location of their hand on the handle 10 relative to the distal portion 12 and / or the first end 27 and the second end 28). This method is intuitive and allows the surgeon to remain visually focused on the monitor during the procedure.

[0036] The cross-sectional width of the distal portion 12 increases from the first diameter dl to the second diameter d2. The increase of the cross-sectional width of the distal portion 12 may be symmetrical or asymmetrical relative to the side portions 20 and may be gradual, intermittent, or the like, or a combination or sub-combination thereof. In embodiments, the increase of the cross-sectional width of the distal portion 12 is symmetrical on both side portions 20 and gradual such that the cross-sectional width of the distal portion 12 has a smooth contoured outer surface, allowing the surgeon to easily slide their hand along the distal portion and preventing a glove of the surgeon from pinching or being caught on the distal portion 12.

[0037] In some embodiments, the distal portion 12 includes a plurality of diameters (e.g., the first, second, third, and fourth diameters dl, d2, d3, d4) taken along the longitudinal axis 25, wherein the plurality of diameters increase along the longitudinal axis 25 from the first end 27 toward the second end 28, and wherein a rate of change of the increase in the plurality of diameters decreases continuously from the first end 27 to the second end 28.

[0038] Referring to FIG. 5, in some embodiments, the cross-sectional area of the distal portion 12 relates to the height 26 of the handle 10. A first height hl is adjacent the first end 27 and a second height h2 is adjacent the second end 28, wherein the first height hl is less than the second height h2. One or more heights may be between the first height hl and the second height h2. The increase of the cross-sectional height of the distal portion 12 from the first height hl to the second height h2 may be symmetrical or asymmetrical relative to the upper portion 16 and the lower portion 18, and may be gradual, intermittent, or the like, or a combination or sub-combination thereof. In embodiments, the increase of the cross-sectional height of the distal portion 12 is asymmetrical such that a segment of the lower portion 18 extends away from the longitudinal axis 25 at a greater rate than the upper portion 16 (e.g., the cross-section height of the distal portion increases primarily as a result of a change in the lower portion 18 rather than the upper portion 16). The increase in the cross-sectional height of the distal portion 12 from the first end 27 to the second end 28 further allows for the surgeon to identify the location of their hand on the handle 10 by tactile feedback without having to visually look at the handle 10. Additionally, in the embodiment illustrated in FIG. 4, the upper portion 16 is flatter than the lower portion 18; in other words, the rate of increase in the distance between the upper portion 16 and the longitudinal axis 25 can be generally constant, while the rate of increase in the distance between the lower portion 18 and the longitudinal axis 25 can decrease in a direction away from the first end 27. In certain embodiments, the cross-sectional width of the distal portion 12 and the cross-sectional height of the distal portion 12 increase at different rates.

[0039] Referring to FIGS. 2 and 5, in an embodiment the handle 10 has a nose 29 located in the distal portion 12 at the first end 27. The upper portion 16 and the lower portion 18 merge or connect at the nose 29, wherein the nose 29 is located above the longitudinal axis 25. In other words, the nose 29 is closer to or more aligned with the upper portion 16 than the lower portion 18 of the distal portion 12. As stated above, the location and / or formation of the nose 29 provides an asymmetrical shape that allows the surgeon to identify the location of their hand on the handle 10 by tactical feedback.

[0040] Referring to FIG. 3, an embodiment of the handle 10 includes a distal flush port 30 disposed on the distal portion 12. The distal flush port 30 may be disposed on the upper portion 16 or side portions 20 adjacent to the first end 27. The orientation of the distal flush port 30 may correspond to the orientation of the delivery system (i.e., the catheter portion 4and / or the prosthetic heart valve 8) so as to indicate that the delivery system is in the proper orientation before the surgeon begins implantation of the prosthetic heart valve 8. The distal flush port 30 is in fluid communication with a flush tube of the catheter portion 4 for transporting fluid distally from the distal flush port 30 through the catheter portion 4 in order to removing air from the delivery system.

[0041] FIGS. 2, 6, and 7 illustrate an embodiment of the handle 10 having an actuator grip 32 for controlling the implantation of the prosthetic heart valve 8 in the desired location (e.g., by controlling the advancement and / or withdrawal of the capsule 6). The actuator grip 32 may control the implantation of the prosthetic heart valve 8 by rotational movement of the actuator grip 32 relative to the handle 10. For example, the actuator grip 32 may be rotated clockwise or counterclockwise to proximally retract the capsule 6 and expose the prosthetic heart valve 8 and / or distally advance the capsule 6 to recapture the prosthetic heart valve 8. A handle for a delivery system using micro and macro actuation deployment of a prosthetic heart valve 8 is discussed in U.S. Patent Application Publication No. 2023 / 0093706, the entirety of which is incorporated by reference herein.

[0042] The actuator grip 32 may be disposed in the proximal portion 14 of the handle 10. The actuator grip 32 has a concave shape. In other words, a central region of the actuator grip 32 has a width, height, diameter, or the like, that is smaller than end regions of the actuator grip 32. This allows the actuator grip 32 to be rotated by the surgeon’s hand (e.g., the surgeon’s right hand) without contacting or being impeded by a work surface 34 underneath. For example, during the procedure the surgeon may rest the handle 10 on a work surface 34 such as a bed or table to obtain better control of the tracking, positioning, and deployment of the prosthetic heart valve 8. The surgeon would still be able to rotate the actuator grip 32 while it is resting on the work surface 34 without having to move the handle 10. The work surface 34 would not contact a majority of the actuator grip 32, allowing the actuator grip 32 to rotate unobstructed by the underlying work surface 34, as shown in FIG. 7. Furthermore, in instances where the work surface 34 includes cloths, drapes, towels, blankets, or the like, the surgeon would still be able to rotate the actuator grip 32 while it is resting on the work surface 34 without having to move the handle 10 and / or adjust the cloth because the concave profde of the actuator grip 32 prevents the snagging of, wrapping, catching, or impedance by the cloth. The concave shape of the actuator grip 32 is advantageous over a convex or bulbous shape because such profdeswould case rotation of the actuator grip 32 to be impeded by the work surface 34 and would prevent the surgeon from more easily resting the handle 10 on the work surface 34.

[0043] In an embodiment, a clearance 35 of the actuator grip 32 is defined by a distance between the central region of the actuator grip 32 and the work surface 34. In some embodiments, the clearance 35 is at least 3 mm, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, or the like, or a combination or sub-combination thereof. In some embodiments, the clearance 35 is within a range from 3-50 mm.

[0044] The actuator grip 32 may have grooves 36 for providing tactile feedback to the surgeon and for more easily gripping the actuator grip 32. The concave shape of the actuator grip 32 may be contoured and contiguous with the proximal portion 14 so as to provide a smooth outer surface profile along the proximal portion 14 of the handle 10. In some embodiments, the actuator grip 32 has a cylindrical, hourglass-like shape, wherein the central region of actuator grip 32 has a diameter that is less than a diameter of the end regions of the actuator grip 32. In some embodiments, the actual grip 32 has a parabolic shape. The contoured profile of the concave shape of the actuator grip 32 may be uniform or non-uniform along a length of the actuator grip 32. In some embodiments, the actuator grip 32 has a height and width along an entire length of the actuator grip 32 that is less than an adjacent width and height of a tip retractor portion 40 and / or a segment of the proximal portion 14 adj acent the end regions of the actuator grip 32.

[0045] Therefore, according to an embodiment of the handle 10, the surgeon may operate the handle 10 using both hands without having to look at the handle 10. The surgeon may hold the distal portion 12 with their left hand and operate the actuator grip 32 with their right hand. The surgeon can identify the location of their left hand on the handle 10 as a result of the plurality of diameters providing tactile feedback to the surgeon’s left hand. The surgeon may also identify the location of or where to position their right hand based on the tactile feedback provided to their left hand. Furthermore, the concave shape of the actuator grip 32 allows the surgeon to rotate the actuator grip 32 with their right hand and control the implantation of the prosthetic heart valve 8. In this way, a single surgeon can effectively hold and operate the handle 10 (and subsequently the delivery system 2) while remaining visually focused on the monitoring screen to track the procedure (i.e., the surgeon has improved control of the handle and delivery system 2 during the procedure without having to look at the handle 10). A single surgeon holding and operating the handle 10 may also reduce complications,reduce the duration of the procedure, simplify the procedure for the surgeon and other surgeons or staff, or the like. For example, the surgeon can single handedly operate the handle 10 such that other surgeons do not need to hold or operate the handle 10, which can simplify the operation of the handle 10 and reduce the need for communication between the surgeon and another surgeon holding the handle 10, thus allowing the surgeon to remain more focused on the procedure rather than cooperatively working or communication with the other surgeon (e.g., during a procedure multiple surgeons may have their hands on a handle, resulting in crossing of arms or hands, and the surgeons may need to spend time or focus communicating with each other to effectively operate the handle).

[0046] Referring to FIG. 2 and 3, an embodiment of the handle 10 includes a hard stop 38. The hard stop 38 may be disposed on the distal portion 12 and the upper portion 16. The hard stop 38 may resemble a knob, wherein rotation of the hard stop 38 releases or enables the prosthetic heart valve 8 to be released from the delivery system and subsequent rotation of the actuator grip 32 further releases or recaptures the prosthetic heart valve 8.

[0047] Referring to FIG. 6, an embodiment of the handle 10 includes the tip retractor portion 40 disposed in the proximal portion 14 and a trigger 42. A tip retractor is discussed in U.S. Patent Application Publication No. 2023 / 0093706, the entirety of which is incorporated by reference herein. In some embodiments, a proximal flush port 44 may be disposed on the proximal portion 14 of the handle 10. The proximal flush port 44 is in fluid communication with the flush tube of the catheter portion 4 for transporting fluid distally from the proximal flush port 44 through the catheter portion 4 in order to remove air from the delivery system. The distal flush port 30 and the proximal flush port 44 may also be in fluid communication with each other.

[0048] While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can becompromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments are described as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.

[0049] The following examples are illustrative of the techniques described herein.

[0950] Example 1. A handle configured for delivery of a prosthetic valve, the handle comprising: an upper portion, a lower portion opposite the upper portion, and side portions between the upper portion and the lower portion; a proximal portion and an opposed distal portion; wherein the distal portion extends longitudinally along a longitudinal axis from a first end to a second end thereof; and wherein the distal portion includes a cross-sectional width defined by a first diameter adjacent the first end and a second diameter adjacent the second end, wherein the first diameter is less than the second diameter; and wherein the distal portion includes a cross-sectional height that increases from the first end to the second end; and wherein the cross-sectional width and cross-sectional height allow a user to determine a location of their hand on the handle via tactile feedback.

[0051] Example 2. The handle of Example 1 wherein the cross-sectional width of the distal portion increases gradually from the first end to the second end and symmetrically relative to the side portions.

[0052] Example 3. The handle of Example 1 further comprising: a third diameter spaced apart from the first diameter and a fourth diameter disposed between the third diameter and the second diameter; wherein the third diameter is greater than the first diameter and less than the fourth diameter; and wherein the fourth diameter is less than the second diameter.

[0053] Example 4. The handle of Example 1 wherein the cross-sectional width of the distal portion increases gradually from the first end to the second end and symmetrically relative to the side portions.

[0054] Example 5. The handle of Example 4 wherein the cross-sectional height is defined by a first height adjacent the first end and a second height adjacent the second end, and wherein the first height is less than the second height.

[0055] Example 6. The handle of Example 5 wherein an increase in the cross- sectional height is asymmetrical such that a segment of the lower portion extends away from the longitudinal axis at a greater rate than the upper portion.

[0056] Example 7. The handle of Example 5 wherein the cross-sectional width and the cross-sectional height increase at different rates.

[0057] Example 8. The handle of Example 1 further comprising a flush port disposed in the distal portion and on the upper portion of the handle, wherein an orientation of the flush port corresponds to an orientation of the delivery of the prosthetic valve.

[0058] Example 9. The handle of Example 1 wherein the distal portion includes a plurality of diameters taken along the longitudinal axis, wherein the plurality of diameters increase along the longitudinal axis from the first end toward the second end, and wherein a rate of change of the increase in the diameters decreases continuously from the first end to the second end.

[0059] Example 10. A handle configured for delivery of a prosthetic valve, the handle comprising: an upper portion, a lower portion opposite the upper portion, and side portions between the upper portion and the lower portion; a distal portion and a proximal portion opposite the distal portion; an actuator grip disposed on the proximal portion of the handle operatively connected to a catheter and configured for controlling implantation of the prosthetic valve by rotational movement of the actuator grip, wherein the actuator grip has a concave shape to allow a user to rotate the actuator grip without impedance from an underlying work surface in contact with at least a part of the lower portion.

[0060] Example 11. The handle of Example 10 wherein the actuator grip includes grooves for providing tactile feedback to a user and for more easily rotating the actuator grip.

[0061] Example 12. The handle of Example 10 wherein the actuator grip and proximal portion are contoured so as to provide a smooth outer surface profile along the proximal portion.

[0062] Example 13. The handle of Example 10 wherein all outer diameters of the actuator grip are less than adjacent outer diameters of the handle that are directly adjacent the actuator grip.

[0063] Example 14. The handle of Example 10 wherein the actuator grip has an hourglass shape.

[0064] Example 15. A delivery system for implanting a prosthetic heart valve comprising: a control handle comprising: an upper portion, a lower portion opposite the upper portion, and side portions between the upper portion and the lower portion, a proximal portion and an opposed distal portion, wherein the distal portion extends longitudinally along a longitudinal axis from a first end to a second end thereof, wherein the distal portion includes a cross-sectional width defined by a plurality of diameters taken along the longitudinal axis, wherein the diameters increase along the longitudinal axis from the first end toward the second end, and wherein a rate of change of the increase in the diameters decreases continuously from the first end to the second end; an actuator grip with a concave shape disposed on the proximal portion, wherein the concave shape to allow a user to rotate the actuator grip without impedance from an underlying work surface in contact with at least a part of the lower portion; a catheter portion operatively coupled to the control handle at a proximal end of the catheter portion, wherein the catheter portion comprises a capsule disposed adjacent a distal end of the catheter portion; and wherein the actuator grip is configured for controlling translation movement of the capsule to expose the prosthetic heart valve by rotation of the actuator grip.

Claims

WHAT IS CLAIMED IS:

1. A handle (10) configured for delivery of a prosthetic valve, the handle (10) comprising: an upper portion (16), a lower portion (18) opposite the upper portion (16), and side portions (20) between the upper portion (16) and the lower portion (18); a proximal portion (14) and an opposed distal portion (12); wherein the distal portion (12) extends longitudinally along a longitudinal axis (25) from a first end (27) to a second end (28); wherein the distal portion (12) includes a cross-sectional width defined by a first diameter (dl) adjacent the first end (27) and a second diameter (d2) adjacent the second end (28), wherein the first diameter (dl) is less than the second diameter (d2); wherein the distal portion (12) includes a cross-sectional height (hl, h2) that increases from the first end (27) to the second end (28); and wherein the cross-sectional width and cross-sectional height allow a user to determine a location of their hand on the handle (10) via tactile feedback.

2. The handle according to claim 1, wherein the cross-sectional width of the distal portion (12) increases gradually from the first end (27) to the second end (28) and symmetrically relative to the side portions (20).

3. The handle according to claim 1 or 2, further comprising a third diameter (d3) spaced apart from the first diameter (dl) and a fourth diameter (d4) disposed between the third diameter (d3) and the second diameter (d2), wherein the third diameter (d3) is greater than the first diameter (dl) and less than the fourth diameter (d4), and wherein the fourth diameter (d4) is less than the second diameter (d2).

4. The handle according to any one of claims 1 to 3, wherein the cross-sectional height is defined by a first height (hl) adjacent the first end (27) and a second height (h2) adjacent the second end (28), and wherein the first height (hl) is less than the second height (h2).

5. The handle according to claim 4, wherein an increase in the cross-sectional height is asymmetrical such that a segment of the lower portion (18) extends away from the longitudinal axis (25) at a greater rate than the upper portion (16).

6. The handle according to any one of claims 1 to 5, wherein the cross-sectional width and the cross-sectional height increase at different rates.

7. The handle according to any one of claims 1 to 6, further comprising a distal flush port (30) disposed in the distal portion (12) and on the upper portion (16), wherein an orientation of the flush port (30) corresponds to an orientation of delivery of the prosthetic valve.

8. The handle according to any one of claims 1 to 7, wherein the distal portion (12) includes a plurality of diameters (dl-d4) taken along the longitudinal axis (25), wherein the diameters increase along the longitudinal axis from the first end (27) toward the second end (28), and wherein a rate of change of the increase in the diameters decreases continuously from the first end to the second end.

9. The handle according to any one of claims 1 to 8, further comprising an actuator grip (32) disposed on the proximal portion (14) of the handle (10), operatively connected to a catheter (4) and configured for controlling implantation of the prosthetic valve by rotational movement of the actuator grip (32), wherein the actuator grip (32) has a concave shape to allow a user to rotate the actuator grip (32) without impedance from an underlying work surface (34) in contact with at least a part of the lower portion (18).

10. The handle according to claim 9, wherein the actuator grip (32) includes grooves (36) for providing tactile feedback to a user and for more easily rotating the actuator grip.

11. The handle according to claim 9 or 10, wherein the actuator grip (32) and proximal portion (14) are contoured so as to provide a smooth outer surface profile along the proximal portion (14).

12. The handle according to any one of claims 9 to 11, wherein all outer diameters of the actuator grip (32) are less than adjacent outer diameters of the handle (10) that are directly adjacent the actuator grip (32).

13. The handle according to any one of claims 9 to 12, wherein the actuator grip (32) has an hourglass shape.

14. A delivery system (2) for implanting a prosthetic heart valve (8), comprising: a control handle (10) according to any one of claims 1 to 13; and a catheter portion (4) operatively coupled to the control handle (10) at a proximal end thereof, the catheter portion (4) comprising a capsule (6) disposed adjacent a distal end thereof, wherein the actuator grip (32) is configured for controlling translation movement of the capsule (6) to expose the prosthetic heart valve (8) by rotation of the actuator grip (32).

15. The delivery system according to claim 14, wherein the actuator grip (32) is concave and configured to be operable while resting on an underlying work surface (34) without being impeded by the surface.

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