Patent Description:
Endovascular delivery devices are used in various procedures to deliver prosthetic medical devices or instruments to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. Access to a target location inside the body can be achieved by inserting and guiding the delivery device through a pathway or lumen in the body, including, but not limited to, a blood vessel, an esophagus, a trachea, any portion of the gastrointestinal tract, a lymphatic vessel, to name a few. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size such as by inflating a balloon on which the prosthetic valve is mounted, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

The usefulness of delivery devices is largely limited by the ability of the device to successfully navigate through small vessels and around tight bends in the vasculature, such as through the inferior vena cava or around the aortic arch. Various techniques have been employed to adjust the curvature of a section of a delivery device to help "steer" the valve through bends in the vasculature. Typically, a delivery device employs a pull wire having a distal end fixedly secured to the steerable section and a proximal end operatively connected to an adjustment knob located on a handle of the delivery device outside the body. The pull wire is typically disposed in a pull-wire lumen that extends longitudinally in or adjacent to a wall of the delivery device, for example, a sheath or catheter. Adjusting the adjustment knob, for example, rotating the knob, applies a pulling force on the pull wire, which in turn causes the steerable section to bend.

A drawback of many guide sheaths is that they are prone to undesirable deformation when deflected or flexed. For example, a guide sheath subject to significant curvature, such as when accessing the mitral valve in a transseptal approach, may kink at one or more locations along the radius of curvature, dramatically reducing the inner diameter of the guide sheath and resulting in unpredictable movement of the distal end of the guide sheath. A flexed guide sheath may also "pancake," in which the cross-section of the catheter is ovalized due to a lack of adherence between the materials of adjacent layers of the sheath. Additionally, a flexed guide sheath may be reduced in length, or foreshortened, due to axial compression of the shaft as it is flexed. Such deformation of the guide sheath, especially at the distal end, can interfere with the precise positioning of an implant at the treatment site. Thus, a need exists for improved steerable shaft devices. For background prior art, reference is made to <CIT>, <CIT>, <CIT> and <CIT>.

The disclosure concerns delivery apparatuses with steerable shafts.

The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

In particular embodiments, a delivery apparatus that can be used to deliver a medical device, tools, agents, or other therapy to a location within the body of a subject can include one or more steerable catheters or sheaths. Examples of procedures in which steerable catheters and sheaths are useful include neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

In some embodiments, the delivery apparatus includes a steerable shaft such as a guide sheath having one or more delivery catheters coaxially disposed within the guide sheath. In certain configurations, the delivery catheters can comprise one or more balloons at or near a distal end portion of the catheter. In some implementations, the delivery apparatus can be used to deliver a medical device through the vasculature, such as to a heart of the subject. These devices may comprise one or more eccentrically positioned pull wires configured to cause the steerable shaft to curve in a given direction, or to straighten. The steerable shaft can further comprise a steerable portion located near the distal end of the shaft including a compression-resistance portion that reduces foreshortening of the shaft and increases the degree of curvature attainable for a given pulling force applied to the shaft by the pull wires, thereby enhancing the steerability of the delivery apparatus.

<FIG> illustrates a representative embodiment of a delivery apparatus <NUM> including a handle portion <NUM> and a shaft configured as a steerable guide sheath <NUM>. The delivery apparatus <NUM> can be used to perform any diagnostic, therapeutic, or interventional procedure where access to a target location inside the body of a patient is desired. For example, the delivery apparatus <NUM> can be used to deliver and deploy a prosthetic device in the body, to deliver tools to a target location in the body, or to deliver or introduce drugs or other agents, to name a few exemplary uses.

The delivery apparatus can include one or more catheters coaxially disposed within and movable relative to the guide sheath <NUM>. For example, in the illustrated configuration, the delivery apparatus includes an intermediate catheter configured as a steerable catheter <NUM> disposed within the guide sheath <NUM>, and an inner catheter configured as a delivery or implant catheter <NUM> coaxially disposed within the steerable catheter <NUM>. The implant catheter <NUM> can have a prosthetic device <NUM> mounted on a distal end of the implant catheter in a radially compressed state. In the illustrated configuration, the prosthetic device <NUM> is a prosthetic heart valve mounted on an inflatable balloon <NUM> at the distal end of the implant catheter, and the delivery apparatus can be configured to deliver the prosthetic heart valve <NUM> to one of the native valves of the heart (the aortic, mitral, pulmonary, or tricuspid valves).

In one specific example, the prosthetic heart valve <NUM> can be a plastically-expandable prosthetic heart valve, and the inflatable balloon <NUM> can be configured to expand and deploy the valve <NUM> at a treatment site. Exemplary configurations of the balloon <NUM> and implant catheter <NUM> are further disclosed in <CIT>, <CIT>, <CIT>, and<CIT>. Exemplary plastically-expandable prosthetic heart valves are disclosed in <CIT> and<CIT>.

In another example, the delivery apparatus <NUM> can be used to deliver and deploy a self-expandable prosthetic heart valve (e.g., a prosthetic valve having a frame formed from a shape-memory material, such as nitinol). To deliver a self-expandable prosthetic valve, the prosthetic valve can be loaded into a delivery sheath or sleeve in a radially compressed state and advanced from the distal open end of the sheath at the target location to allow the prosthetic valve to expand to its functional size. The delivery sheath can be the distal end portion of the implant catheter <NUM>, or the distal end portion of another shaft that extends through the guide sheath <NUM>. Further details regarding a self-expandable prosthetic valve and delivery devices for a self-expandable prosthetic valve are disclosed in <CIT>and <CIT>. Additionally, it should be understood that the delivery apparatus <NUM> can be used to deliver any of various other implantable devices, such as docking devices, leaflet clips, etc..

Referring to <FIG> and <FIG>, the steerable guide sheath <NUM> can include a proximal portion <NUM> coupled to the handle portion <NUM>, and a distal portion <NUM>. The distal portion <NUM> can include low durometer atraumatic tip portion <NUM> coupled to a coupling portion <NUM> positioned proximally of the atraumatic tip <NUM>. In certain configurations, the atraumatic tip <NUM> can be radiopaque. The distal portion <NUM> of the guide sheath <NUM> can include a steerable portion <NUM> located proximally of the coupling portion <NUM> and configured to flex and unflex to adjust the curvature of the distal portion of the guide sheath, as described in detail below.

<FIG> illustrate the construction of the guide sheath <NUM>, and particularly of the distal portion <NUM>, in greater detail. The curvature of the guide sheath <NUM> can be controlled by one or more eccentrically-positioned pull wires (see, e.g., <FIG>, <FIG>, and <FIG>). For example, in the illustrated configuration the guide sheath <NUM> includes two pull wires <NUM>, <NUM> extending longitudinally through respective pull-wire lumens or conduits <NUM>, <NUM>. The assembled pull wires <NUM>, <NUM> and conduits <NUM>, <NUM> can be disposed in a pull-wire conduit portion <NUM> of the guide sheath. In the illustrated configuration, the pull-wire conduit portion <NUM> is at least partially defined by a recess <NUM> of an inner layer <NUM> of the guide sheath. In the illustrated configuration, the recess <NUM> can extend into an inner diameter Di of the guide sheath <NUM>, although other configurations are possible. In certain embodiments, the pull-wire conduits <NUM>, <NUM> can be made from a lubricious material, such as polytetrafluoroethylene (PTFE) to reduce friction between the pull wires <NUM>, <NUM> and the respective conduits <NUM>, <NUM> as the pull wires move within the conduits.

The pull wires <NUM>, <NUM> can be coupled at one end to a pull ring <NUM> embedded in the coupling portion <NUM>, and coupled at the opposite end to a control mechanism configured as a rotatable knob <NUM> of the handle <NUM> (see <FIG>). Rotation of the knob <NUM> can increase and decrease tension in the pull wires <NUM>, <NUM> which, in turn, can cause the distal portion <NUM>, and particularly the steerable portion <NUM>, to flex and unflex to control the curvature of the guide sheath. A cross-sectional view of the coupling portion <NUM> illustrating the pull ring <NUM> encapsulated in the coupling portion is shown in <FIG>.

The pull ring <NUM> and the distal portions of the pull wires <NUM>, <NUM> are shown in isolation in <FIG>. In the illustrated configuration, the pull ring <NUM> can define a plurality of openings <NUM> about its circumference. During fabrication of the guide sheath <NUM>, the polymeric material of the coupling portion <NUM> can be reflowed over the pull ring <NUM>, and the material can flow through the openings <NUM> to encapsulate the pull ring in the coupling portion, as shown in <FIG>. Additionally, although the illustrated embodiment includes two pull wires <NUM>, <NUM>, it should be understood that other configurations are possible. For example, the guide sheath <NUM> can include any suitable number of pull wires having any suitable size or layout, including a single pull wire (see <FIG>), or more than two pull wires, depending upon the requirements of the device. The particular embodiment illustrated herein includes two pull wires because, in some configurations, two pull wires can occupy a smaller cross-sectional area than that of a single larger pull wire for transmitting a given force to the pull ring <NUM>, particularly when relatively large forces are required (such as when flexing the guide sheath loaded with the steerable catheter <NUM> and the implant catheter <NUM>).

Referring to <FIG>, the guide sheath <NUM> can include a plurality of layers comprising a variety of different materials at different locations along the length of the guide sheath and configured to impart various properties to the guide sheath. For example, with reference to <FIG> and <FIG>, the steerable portion <NUM> of the guide sheath <NUM> comprises a first inner layer <NUM> defining an inner diameter Di of the guide sheath <NUM>, and a second pull-wire conduit encapsulating layer <NUM> disposed radially outward of the inner layer <NUM>. A third helically coiled layer <NUM> extends over the pull-wire conduit encapsulating layer <NUM>. A fourth braided layer <NUM> is disposed over the helically coiled layer <NUM>, and a fifth outer layer <NUM> is disposed over the braided layer, and defines an outer diameter D<NUM> of the guide sheath. <FIG> illustrates a plan view of the distal portion <NUM> of the guide sheath <NUM> with each of the outer layer <NUM>, the braided layer <NUM>, the helically coiled layer <NUM>, and the pull-wire conduit encapsulating layer <NUM> shown partially removed to illustrate the construction of the guide sheath.

The first layer <NUM> extends along the full length of the guide sheath <NUM>, and can be made from (or coated with) a lubricious material (e.g., PTFE) to allow the steerable intermediate catheter <NUM> to slide relative to the guide sheath <NUM> within the guide sheath's lumen. As stated above, the first layer <NUM> can also define the recess <NUM> of the pull-wire conduit portion <NUM> in which the pull wires <NUM>, <NUM> and conduits <NUM>, <NUM> are received.

The pull-wire conduit encapsulating layer <NUM> can be disposed between the first inner layer <NUM> and the helically coiled layer <NUM>, and can have a thickness that varies angularly around the circumference of the guide sheath. For example, with reference to <FIG>, the portion of the pull-wire conduit encapsulating layer <NUM> proximate the pull-wire conduit portion <NUM> can be sufficiently thick such that the layer <NUM> encapsulates the pull-wire conduits <NUM>, <NUM> in the pull-wire conduit portion. Meanwhile, the portion of the pull-wire conduit encapsulating layer <NUM> opposite the pull-wire conduit portion <NUM> can be relatively thin. Alternatively, the pull-wire conduit encapsulating layer <NUM> can extend around only a portion of the cross-section of the guide sheath, such as around the portion (e.g., half) including the pull-wire conduits <NUM>, <NUM>. In such a configuration, the helically coiled layer <NUM> can directly contact the inner layer <NUM> along the portion of the inner layer's cross-section that is opposite the pull-wire conduits, and can transition over the pull-wire conduit encapsulating layer <NUM> at the location along the circumference of the inner layer <NUM> where the pull-wire conduit encapsulating layer originates. In some embodiments, the pull-wire conduit encapsulating layer <NUM> can be made from any suitable polymer, such as any of various polyether block amides (e.g., Pebax®). In certain configurations, the pull-wire conduit encapsulating layer <NUM> can extend from the proximal end of the coupling portion <NUM>, through the steerable portion <NUM>, to the pull wire exit <NUM> (<FIG>).

The helically coiled layer <NUM> can be formed from, for example, a wire helically wrapped or wound about the pull-wire conduit encapsulating layer <NUM> or the first layer <NUM>. In the illustrated embodiment, the helically coiled layer <NUM> can extend from adjacent the pull ring <NUM> proximally through the coupling portion <NUM> and the steerable portion <NUM> to a transition region <NUM> (<FIG>) located between the proximal and distal portions <NUM>, <NUM>. In certain embodiments, the transition region <NUM> where the helically coiled layer <NUM> ends can be the location at which the outer layer <NUM> changes from a material having a relatively higher durometer or hardness (e.g., 63D Pebax®) to a material having a relatively lower durometer (e.g., a polyamide such as VESTAMID®). In some embodiments, gradually varying (e.g., stepwise) the hardness of the outer layer <NUM> or the other layers of the shaft along their length can reduce the likelihood of kinking, fracture, or warping of the shaft during flexing, or when traversing vessels of the body. Additionally, in certain examples, the helically coiled layer <NUM> can be made from stainless steel or titanium flat wire wound at, for example, <NUM> coils per <NUM> (<NUM> inch) with a pitch of <NUM> (<NUM> inch), and can be configured to resist kinking or crushing of the guide shaft <NUM>, and particularly of the steerable portion <NUM>, when it is flexed.

The braided layer <NUM> can extend over the helically coiled layer <NUM>. In the illustrated configuration, the braided layer <NUM> can extend from the coupling portion <NUM> proximate the pull ring <NUM> proximally to, for example, the pull wire exit <NUM>. The braided layer <NUM> can be, for example, metal wires braided together in a pattern to form a tubular layer over the helically coiled layer <NUM>. For example, in the illustrated embodiment the braided layer <NUM> is made from stainless steel or titanium flat wires braided in an over <NUM> under <NUM> pattern, although any suitable braid pattern can be used. For example, in another representative embodiment, the wires of the braided layer <NUM> can be braided in a lover <NUM>, under <NUM> pattern with a pick count of <NUM> picks per <NUM> (<NUM> inch) (PPI). The braided layer <NUM> can be configured to, for example, resist undesirable torsional deformation of the guide sheath <NUM> to allow the guide sheath to transmit torque, which can aid in positioning the implant at the treatment site. The braided layer <NUM> can also provide crush or kink-resistance properties to the guide sheath <NUM>. In the illustrated configuration, the coupling portion <NUM> can also include a braided layer <NUM> disposed beneath the pull ring <NUM>, as shown in <FIG> and <FIG>.

The outer layer <NUM> can comprise, for example, any of a variety of polymeric materials such as polyamides (e.g., VESTAMID®), polyether block amides (e.g., Pebax®), nylon, or any other suitable biocompatible polymer or combinations thereof along its length. In the illustrated configuration, the pull-wire conduit encapsulating layer <NUM>, the helically coiled layer <NUM>, and the braided layer <NUM> can terminate distally of the proximal end of the guide sheath <NUM>. For example, in some configurations these layers can terminate at the pull wire exit <NUM>. Proximally of the pull wire exit <NUM>, the outer layer <NUM> can increase in thickness to maintain a substantially uniform outer diameter along the length of the guide sheath, as illustrated in <FIG>.

Referring to <FIG> and <FIG>, the distal portion <NUM> of the guide sheath <NUM> can include a compression-resistance portion <NUM>. In the illustrated configuration, the compression-resistance portion <NUM> is incorporated into the outer layer <NUM>, and forms a respective part of the steerable section <NUM>. As illustrated in <FIG>, the compression-resistance portion <NUM> can extend along a length L of the steerable portion <NUM>. The compression-resistance portion <NUM> can also extend circumferentially or angularly along, or occupy a respective portion of, the cross-section of the outer layer <NUM>. For example, with reference to <FIG>, the angular extent of the compression-resistance portion <NUM> along the cross-section of the outer layer <NUM> is denoted by the angle θ. In some embodiments, the angle θ can be from <NUM> degrees to <NUM> degrees (or half of the circumference of the cross-section). In some embodiments, the angle θ can be from <NUM> degrees to <NUM> degrees. In the embodiment of <FIG>, the angle θ is <NUM> degrees.

In certain configurations, the compression-resistance portion <NUM> can be disposed opposite the pull wire conduits <NUM>, <NUM>. For example, in the illustrated configuration, the compression-resistance portion <NUM> is angularly offset from the pull wire conduit portion <NUM> by <NUM> degrees such that it is located diametrically opposite the pull wire conduits <NUM>, <NUM>. In this configuration, a plane <NUM> that bisects the pull wire conduit portion <NUM> also bisects the compression-resistance portion <NUM>, as shown in <FIG>. In the configuration of <FIG> including two pull wires and conduits, the plane <NUM> bisecting the pull-wire conduit portion <NUM> passes between the respective conduits <NUM>, <NUM>. However, in configurations including a single pull wire, such as the alternative configuration illustrated in <FIG>, a single pull wire <NUM> and conduit <NUM> can be coaxially aligned with the pull-wire conduit portion <NUM> such that the plane <NUM> bisecting the pull-wire conduit portion <NUM> and the compression-resistance portion <NUM> also bisects the pull wire <NUM> and the conduit <NUM>. In other configurations, the compression-resistance portion <NUM> can be angularly offset from the pull-wire conduit portion <NUM> along the cross-section of the outer layer <NUM> by, for example, from <NUM> degrees to <NUM> degrees, as desired.

The compression-resistance portion <NUM> can be made from a material having a relatively higher hardness or durometer than the remainder of the outer layer <NUM> in the steerable portion <NUM> in which the compression-resistance portion is incorporated. For example, in certain embodiments the compression-resistance portion <NUM> can have a durometer that is from <NUM> times to <NUM> times greater than a durometer of the remainder of the outer layer <NUM> in the steerable portion <NUM>. In some embodiments, the durometer of the compression-resistance portion <NUM> can be from <NUM> times to <NUM> times greater than the durometer of the remainder of the outer layer <NUM> in the steerable portion <NUM>. In an exemplary embodiment, the compression-resistance portion <NUM> can be made from PEBAX® having a durometer of 72D, and the remainder of the outer layer <NUM> of the steerable portion <NUM> can be made from PEBAX® having a durometer of 25D, such that a ratio of the durometer of the compression-resistance portion <NUM> and the durometer of the remainder of the outer layer <NUM> in the steerable portion <NUM> is <NUM>:<NUM>. In some embodiments, the ratio of the durometer of the compression-resistance portion <NUM> to the durometer of the remainder of the outer layer <NUM> in the steerable portion <NUM> can be <NUM>:<NUM>.

In other embodiments, the compression-resistance portion <NUM> can be made of any of various materials exhibiting suitable hardness properties, including metals such as stainless steel, titanium, nickel titanium alloys such as nitinol, cobalt chromium, or other polymers. In addition, in certain configurations, the compression-resistance portion need not have a thickness equal to the overall thickness of the outer layer <NUM>. For example, the compression-resistance portion <NUM> can have a thickness that is less than the overall thickness of the outer layer, and may be encapsulated within the outer layer, as desired. The durometer of the compression-resistance portion <NUM> can also vary along its length. For example, the proximal portion of the compression-resistance portion <NUM> can have a relatively lower durometer than the distal portion, or vice versa.

The compression-resistance portion <NUM> can provide a variety of advantageous characteristics to the steerable portion <NUM> of the guide sheath <NUM>. For example, the relatively higher durometer of the compression-resistance portion <NUM> can provide axial strength to the steerable portion <NUM>. This can significantly reduce or prevent undesirable foreshortening of the guide sheath <NUM>, and particularly of the steerable portion <NUM>, when the guide catheter is flexed. More particularly, the compression-resistance portion <NUM> can reduce axial compression of the guide sheath and associated wrinkling of the material when the guide sheath is flexed compared to when it is in a non-deflected state. Such axial compression and wrinkling of the material can decrease the length of the guide sheath <NUM> as the material is deformed, and can damage the guide sheath. By reducing or eliminating foreshortening of the guide sheath <NUM> when it is flexed, the compression-resistance portion <NUM> can reduce the need for the operator to longitudinally reposition the delivery apparatus (e.g., by advancing or retracting the delivery apparatus through the patient's vasculature) in order to obtain or regain a desired position of the implant at the treatment site after flexing the guide sheath.

Additionally, the location of the compression-resistance portion <NUM> angularly offset from the pull wire conduits <NUM>, <NUM> can aid in initiating deformation of the steerable portion <NUM> of the guide sheath in a specified direction. For example, when the compression-resistance portion <NUM> is located opposite the pull wire conduits <NUM>, <NUM>, the axial stiffness of the compression-resistance portion can induce deflection of the steerable portion <NUM> in a direction away from the compression-resistance portion when the guide sheath is flexed, as illustrated in <FIG>. The compression-resistance portion <NUM> can also reduce or prevent ovalizing (also referred to as "pancaking") of the guide sheath by reducing longitudinal movement of the different layers of the sheath relative to one another when the sheath is flexed, especially in cases in which one or more constituent layers (e.g., PTFE layers such as inner layer <NUM>) are not strongly adhered to the surrounding layer(s).

The compression-resistance portion <NUM> can also increase the degree of flexion of the distal portion <NUM> attainable for a given force applied to the distal portion by the pull wires <NUM>, <NUM>, without damaging the guide sheath. The angle of flexion of the distal portion <NUM> is denoted α, and is illustrated in <FIG>. For example, by reducing foreshortening of the guide sheath <NUM>, a greater proportion of the force applied by the pull wires <NUM>, <NUM> is available to flex the guide sheath instead of elastically compressing the guide sheath. Additionally, the compression-resistance portion <NUM> can reduce or prevent slackening of the pull wires <NUM>, <NUM> attendant to foreshortening of the guide sheath <NUM> when it is flexed, resulting in a greater degree of curvature attainable for a given pull wire travel as compared to typical guide sheaths. As used herein, the term "pull wire travel" refers to the linear distance that a given point along the length of a pull wire moves with respect to a stationary reference (e.g., a pull wire conduit) when tension is applied to the pull wire.

Additionally, the compression-resistance portion <NUM>, together with the helically coiled layer <NUM>, and the braided layer <NUM> described above, can provide significant synergistic advantages that improve the performance of the guide sheath <NUM> over known steerable sheaths and catheters. For example, the distal portion of an unloaded guide sheath (e.g., a guide sheath without a delivery catheter or other shaft extending through its lumen) having an inner diameter of <NUM> (<NUM> Fr) and including the compression-resistance portion, helically coiled layer, and braided layer features is capable of flexing nearly <NUM> degrees without kinking, and without significant foreshortening, under a force of <NUM> N applied by the pull wires. In this example, <NUM> of pull wire travel were required to apply a force of <NUM> N to the distal portion of the guide sheath. In contrast, for a typical steerable catheter device without the compression-resistance portion and without a delivery catheter or other sheath extending through its lumen, a force of <NUM> N produces <NUM> degrees of flexure and requires <NUM> of pull wire travel, and the guide sheath can be expected to foreshorten by <NUM> to <NUM>.

In another example, the distal portion of a guide sheath having an inner diameter of <NUM> (<NUM> Fr) and including the above compression-resistance portion, helically coiled layer, and braided layer features, and loaded with a delivery catheter and an implant catheter extending coaxially within the lumen of the guide sheath, was capable of flexing <NUM> degrees without kinking, and without significant foreshortening, under a force of <NUM> N applied by the pull wires. In this example, <NUM> of pull wire travel were required to apply a force of <NUM> N to the distal portion of the guide sheath. In contrast, for a steerable catheter device without the compression-resistance portion and loaded with a delivery catheter and an implant catheter, a force of <NUM> N produces <NUM> degrees of flexure and requires <NUM> of pull wire travel, and the guide sheath can be expected to foreshorten by <NUM> to <NUM>.

In use, the delivery apparatus <NUM> can be introduced and advanced through the patient's vasculature using any known delivery technique. In a transfemoral procedure, the delivery apparatus can be inserted through a femoral artery and the aorta to access the heart (typically, but not exclusively used for aortic valve replacement). In a transeptal procedure (typically used for aortic or mitral valve replacement), the delivery device can be advanced to the right atrium, such as via a femoral vein, and through the septum separating the right and left ventricles. The disclosed embodiments can be particularly useful for delivering a prosthetic valve to the native mitral valve, as the torqueability of the guide sheath <NUM> and the relatively high degree of curvature achievable with the distal portion <NUM> allows for precise positioning of the prosthetic valve at the target site despite the tortuous pathway the delivery apparatus must follow to access the mitral valve in some approaches. In a transventricular procedure, the delivery apparatus can be inserted through a surgical incision made on the bare spot on the lower anterior ventricle wall (typically, but not exclusively used for aortic or mitral valve replacement). In a transatrial procedure, the delivery apparatus can be inserted through a surgical incision made in the wall of the left or right atrium. In a transaortic procedure, the delivery apparatus can be inserted through a surgical incision made in the ascending aorta and advanced toward the heart (typically, but not exclusively used for aortic valve replacement).

In certain of these procedures, the combination of the compression-resistance portion <NUM>, the helically coiled layer <NUM>, and the braided layer <NUM> can aid in precisely positioning a prosthetic device, such as the heart valve <NUM>, at a treatment site. For example, in a transseptal procedure to access the mitral valve, after the distal end of the delivery apparatus is advanced to the treatment site, the distal portion <NUM> of the guide sheath <NUM> can be flexed to axially align the prosthetic valve <NUM> with the mitral valve (e.g., <NUM> degrees or more, in certain examples). While the distal portion <NUM> is in a flexed state, the guide sheath <NUM> can also be torqued to radially position the prosthetic valve <NUM> with respect to the mitral valve. The combination of the compression-resistance portion <NUM>, the helically coiled layer <NUM>, and the braided layer <NUM> can allow the guide sheath to flex without significant foreshortening or kinking, and to be torqued without undesirable torsional deformation of the shaft or associated unpredictable rotational motion of the guide sheath.

The disclosed compression-resistance portion, helically coiled layer, and braided layer features described herein can also be applicable to other types of steerable catheter devices, such as delivery catheters.

As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises. " Further, the terms "coupled" and "associated" generally mean electrically, electromagnetically, or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of the valve is its inflow end and the upper end of the valve is its outflow end.

As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

Unless otherwise indicated, all numbers expressing quantities of components, distances, forces, ratios, angles, percentages, and so forth, as used in the specification or claims are to be understood as being modified by the term "about. " Accordingly, unless otherwise indicated, implicitly or explicitly, the numerical parameters set forth are approximations that can depend on the desired properties sought and/or limits of detection under test conditions/methods familiar to those of ordinary skill in the art. When directly and explicitly distinguishing embodiments from discussed prior art, the embodiment numbers are not approximates unless the word "about" is recited. Furthermore, not all alternatives recited herein are equivalents.

In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the invention is determined by the following claims.

The application further comprises the following examples:
In a first example, a delivery apparatus comprises a steerable shaft comprising a proximal portion, a distal portion, and a pull-wire conduit that extends at least partially through the proximal and distal portions of the shaft; a pull wire extending through the pull-wire conduit and having a proximal end portion and a distal end portion, wherein the distal end portion of the pull wire is fixed to the distal portion of the shaft; an adjustment mechanism operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft; and wherein the distal portion of the shaft comprises a steerable portion having one or more layers, the steerable portion including a compression-resistance portion incorporated into a respective layer of the steerable portion and extending angularly along a portion of a cross-section of the layer, the layer of the steerable portion into which the compression-resistance portion is incorporated having a first hardness, the compression-resistance portion having a second hardness that is greater than the first hardness.

In a second example of the delivery apparatus according to the first example, the compression-resistance portion is located opposite the pull-wire conduit.

In a third example of the delivery apparatus according to the first or second example, the compression-resistance portion extends from <NUM> degrees to <NUM> degrees along the cross-section of the second layer.

In a fourth example of the delivery apparatus according to the third example, the compression-resistance portion extends <NUM> degrees along the cross-section of the second layer.

In a fifth example of the delivery apparatus according to any of the first to the fourth examples, the shaft comprises a first inner layer that defines an inner diameter of the shaft; and the layer into which the compression-resistance portion is incorporated is a second outer layer that defines an outer diameter of the shaft.

In a sixth example of the delivery apparatus according to the fifth example, the shaft further comprises a third helically coiled layer between the inner layer and the outer layer.

In a seventh example of the delivery apparatus according to the sixth example, the shaft further comprises a fourth braided layer braided over at least a portion of the helically coiled layer.

In an eighth example of the delivery apparatus according to the seventh example, the shaft further comprises a pull-wire conduit encapsulating layer between the inner layer and the helically coiled layer that encapsulates the pull-wire conduit.

In a ninth example of the delivery apparatus according to the fifth example, the inner layer defines a recess configured to receive the pull-wire conduit.

In a tenth example of the delivery apparatus according to the ninth example, the pull wire is a first pull wire; the pull-wire conduit is a first pull-wire conduit; and the shaft further comprises a second pull wire received in a second pull-wire conduit disposed adjacent the first pull-wire conduit in the recess.

In an eleventh example of the delivery apparatus according to any of the first to the tenth examples, a ratio of the second hardness to the first hardness is from <NUM>:<NUM> to <NUM>:<NUM>.

In a twelfth example of the delivery apparatus according to the eleventh example, the ratio is <NUM>:<NUM>.

In a thirteenth example of the delivery apparatus according to any of the first to the twelfth examples, the shaft is a guide sheath, and the delivery apparatus further includes an implant catheter coaxially disposed within the guide sheath including a prosthetic valve mounted on a distal end of the implant catheter.

In a fourteenth example a method comprises inserting a shaft of a delivery apparatus into the body of a patient, the shaft having a proximal portion, a distal portion, and a pull-wire conduit that extends at least partially through the proximal and distal portions, a pull wire extending through the pull-wire conduit, the distal portion of the shaft comprising a steerable portion having one or more layers, the steerable portion including a compression-resistance portion incorporated into a respective layer of the steerable portion and extending angularly along a portion of a cross-section of the layer, the layer of the steerable portion into which the compression-resistance portion is incorporated having a first hardness, the compression-resistance portion having a second hardness that is greater than the first hardness; and applying tension to the pull wire to adjust the curvature of the distal portion of the shaft.

In a fifteenth example the method according to the fourteenth example further comprises torqueing the shaft to rotate the distal portion of the shaft after inserting the shaft into the body, and after adjusting the curvature of the distal portion of the shaft.

In a sixteenth example the method according to the fourteenth or the fifteenth example further comprises mounting a prosthetic valve in a radially compressed state on a distal end of an implant catheter extending coaxially through the shaft; inserting the prosthetic valve into the body of the patient when inserting the shaft into the body; and deploying the prosthetic valve within the body.

In a seventeenth example a delivery apparatus comprises a steerable shaft comprising a proximal portion, a distal portion, and a pull-wire conduit that extends at least partially through the proximal and distal portions of the shaft; a pull wire extending through the pull-wire conduit and having a proximal end portion and a distal end portion, wherein the distal end portion of the pull wire is fixed to the distal portion of the shaft; an adjustment mechanism operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft; and the distal portion of the shaft comprises one or more layers and a compression-resistance portion incorporated into a respective layer of the distal portion, the compression-resistance portion extending angularly along a portion of a cross-section of the layer and having a hardness that is greater than a hardness of the layer into which the compression-resistance portion is incorporated, the compression-resistance portion being angularly offset from the pull-wire conduit along the cross-section of the layer.

In an eighteenth example of the delivery apparatus according to the seventeenth example, the compression-resistance portion is located opposite the pull-wire conduit.

In a nineteenth example of the delivery apparatus according to the seventeenth or the eighteenth example, the compression-resistance portion extends from <NUM> degrees to <NUM> degrees along the cross-section of the layer into which the compression-resistance portion is incorporated.

Claim 1:
A delivery apparatus, comprising:
a steerable shaft (<NUM>) comprising a proximal portion, a distal portion, and a pull-wire conduit (<NUM>, <NUM>) that extends at least partially through the proximal and distal portions of the shaft (<NUM>);
a pull wire (<NUM>, <NUM>) extending through the pull-wire conduit (<NUM>, <NUM>) and having a proximal end portion and a distal end portion, wherein the distal end portion of the pull wire (<NUM>, <NUM>) is fixed to the distal portion of the shaft (<NUM>);
an adjustment mechanism (<NUM>) operatively connected to the proximal end portion of the pull wire (<NUM>, <NUM>) and configured to increase and decrease tension in the pull wire (<NUM>, <NUM>) to adjust the curvature of the distal portion of the shaft (<NUM>); and
wherein the distal portion of the shaft (<NUM>) comprises a steerable portion (<NUM>) having an inner layer (<NUM>) that defines an inner diameter of the shaft (<NUM>), an outer layer (<NUM>) that defines an outer diameter of the shaft (<NUM>), a helically coiled layer (<NUM>) between the inner layer (<NUM>) and the outer layer (<NUM>), a braided layer (<NUM>) braided over at least a portion of the helically coiled layer (<NUM>), and a pull-wire conduit encapsulating layer (<NUM>) between the inner layer (<NUM>) and the helically coiled layer (<NUM>) that encapsulates the pull-wire conduit (<NUM>, <NUM>),
wherein the steerable portion (<NUM>) includes a compression-resistance portion (<NUM>) incorporated into the outer layer (<NUM>) of the steerable portion (<NUM>) and extending angularly along a portion of a cross-section of the outer layer (<NUM>), the outer layer (<NUM>) of the steerable portion (<NUM>) having a first hardness, the compression-resistance portion (<NUM>) having a second hardness that is greater than the first hardness.