Patent Description:
The present disclosure generally relates to a medical device delivery cable and methods of making and using the same. In particular, the present disclosure relates to a medical device delivery cable including a flexible inner member, an outer member, and a pull wire disposed between the inner member and the outer member to deflect a deflectable portion of the delivery cable. Methods of manufacturing and using the medical device delivery cables are also disclosed.

Delivery devices including, among other components, catheters and delivery cables are used for an ever-growing number of procedures, and in particular, for the delivery of medical devices to a target site. Typically, the catheter is manipulated through the patient's vasculature and to the intended site, for example, a site within the patient's heart or other organ and the delivery cable is used to advance the medical device through the catheter and to the target site. Once the medical device has reached the target site, the delivery cable may be detached or uncoupled from the medical device such that the medical device is deployed from both the catheter and the delivery cable.

Generally, the catheter would have an overall outside diameter small enough to negotiate blood vessels or other anatomy while retaining an inner diameter ("bore size") large enough to accommodate the medical device (and delivery cable) therethrough. Because the path within the patient may be long, tortuous, and/or involve intricate placement of a medical device(s), maneuverability via steering the catheter may be particularly beneficial.

In addition, it would be desirable for the delivery cable to be deflectable to enable additional maneuverability of the medical device coupled thereto. It has been contemplated to couple a pull wire to a delivery sheath, which enables deflection of the delivery sheath. However, such an arrangement reduces a usable inner diameter of the delivery sheath, which limits the outer diameter of delivery cables and medical devices that can be delivered through such a delivery sheath.

<CIT> discloses a steerable guide sheath system adapted for delivery a patient's vasculature. The pull wire which is used to tension the deflectable portion of the sheath is wrapped ' twisted around the axis of the sheath.

<CIT> discloses medical devices and systems comprising medical devices. The kit includes a catheter-introducer comprising a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon and a catheter comprising an elongate body and at least two flexible electrode segments on the distal end. The shaft includes an inner liner and outer layer. The system comprises a first medical device having a shaft and an electroanatomical system imaging element mounted thereon and a second medical device having an elongate body and at least two flexible electrodes mounted on the distal end. The shaft has a major lumen sized to receive the second medical device. The system further comprises an electroanatomical navigation system configured to receive signals from the electroanatomical system imaging element and to determine a position of the electroanatomical system imaging element and/or monitor electrophysiological data.

<CIT> discloses delivery cables for delivering a medical device. In one embodiment, a delivery cable includes a flexible inner core, a proximal outer coil, and a distal outer coil. The proximal outer coil has a first rigidity. The distal outer coil surrounds at least a portion of a distal section of the flexible inner core and has a second rigidity less than the first rigidity thereby, thereby reducing bias placed on the medical device by the delivery cable.

The invention is defined in independent claims <NUM> and <NUM>. Certain optional features of the invention are defined in the dependent claims. In one aspect of the present disclosure, a delivery cable is provided. The delivery cable includes a flexible inner core, an outer coil surrounding at least a portion of the flexible inner core, and a pull wire disposed between the flexible inner core and the outer coil. The pull wire is configured to deflect a distal deflectable portion of the delivery cable upon manipulation thereof. The delivery cable includes an endscrew coupled to a distal end of the flexible inner core and configured to engage the medical device.

In another aspect, a delivery device for delivering a medical device to a target site is provided. The delivery device includes an outer sheath, and a delivery cable according to the above-mentioned aspect of the present disclosure, such delivery cable being positioned within the outer sheath and movable along a longitudinal axis with respect to the outer sheath.

In a further aspect, a method for implanting a medical device at a target site in a subject using a delivery cable and a delivery sheath is provided. The method includes deploying the delivery sheath into the subject, and advancing the delivery cable through the deployed delivery sheath. The delivery cable includes a flexible inner core, an outer coil surrounding at least a portion of the inner core, and a pull wire disposed between the flexible inner core and the outer coil. The method also includes deflecting a distal deflectable portion of the delivery cable by manipulating the pull wire, and deploying the medical device at the target site by detaching the medical device from the delivery cable.

In yet another aspect, a method of manufacturing a delivery cable is provided. The method includes providing a flexible inner core, inserting the flexible inner core at least partially into an outer coil, inserting a pull wire between the flexible inner core and the outer coil, and coupling the pull wire to the outer coil.

The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.

Septal occluders or other collapsible medical devices may be delivered through a catheter or delivery sheath and to a target site using a delivery cable. However, the collapsible medical device may not be precisely located at the target site, such that the delivery cable may need to be withdrawn, repositioned, adjusted, and the like, in order to properly position the collapsible medical device. Accordingly, the present disclosure is directed to a delivery cable including a distal deflectable portion that is deflectable using an internal pull wire.

The delivery cable includes a flexible inner member, or core, and an outer member, or coil. A pull wire is disposed between the outer coil and the flexible inner member. Manipulation of the pull wire causes the distal deflectable portion of the delivery cable to deflect, which may enhance positioning of a medical device coupled to the delivery cable at a target location.

The delivery cable also includes an endscrew coupled to a distal end of the delivery cable and configured to engage with a medical device to be delivered using the delivery cable. In one example embodiment, the endscrew is threaded to the medical device. Accordingly, to release the medical device at the target location, the endscrew must be rotated to disengage with the medical device. However, the delivery cable cannot be rotated while the distal deflectable portion is deflected without undesirably displacing the medical device. Therefore, the flexible inner core is rotatable, which enables rotation of the endscrew without displacement thereof. The delivery cable further includes a bushing to provide a bearing interface between the endscrew and the outer coil.

Additionally, a steerable delivery cable as described herein may provide an additional plane of deflection when combined with a steerable sheath. Moreover, the steerable delivery cable may be used to optimize alignment of a proximal end of the medical device prior to release.

Referring now to the Figures, <FIG> is a perspective view of a catheter assembly or introducer assembly <NUM> according to one embodiment including a catheter or an introducer <NUM> having a proximal portion <NUM> and a distal portion <NUM>. The introducer <NUM> may be operably connected to a handle assembly <NUM>, which assists in guiding or steering the introducer <NUM> during procedures. The introducer assembly <NUM> further includes a hub <NUM> operably connected to an inner lumen (not shown) within the handle assembly <NUM> for insertion or delivery of catheter assemblies, fluids, or any other devices known to those of ordinary skill in the art. Optionally, introducer assembly <NUM> further includes a valve <NUM> operably connected to hub <NUM>.

<FIG> is a schematic diagram of a portion of the introducer <NUM> shown in <FIG> in combination with one embodiment of a delivery cable <NUM> and a medical device <NUM>. As shown in <FIG>, the delivery cable <NUM> extends from the distal portion <NUM> of the introducer <NUM> (i.e., a delivery sheath <NUM> of the introducer <NUM>), and is coupled to the medical device <NUM>. In this embodiment, the medical device <NUM> is a collapsible occluder. Alternatively, the medical device <NUM> may be any device capable of being coupled to the delivery cable <NUM>.

<FIG> is a longitudinal cross-sectional view of the delivery cable <NUM>. The delivery cable <NUM> may be used to facilitate delivering a medical device (e.g., the medical device <NUM>, shown in <FIG>) such as, but not limited to, a collapsible occluder or the like. It should be noted that although the delivery cable <NUM> is described herein as being useful in combination with the introducer <NUM> illustrated in <FIG> and <FIG>, the delivery cable <NUM> may be used in the delivery process of many various medical devices and in combination with many various sheaths, loaders, valves, etc..

As shown in <FIG>, the delivery cable <NUM> includes a flexible inner member (also referred to herein as a flexible core) <NUM>. The delivery cable <NUM> has a distal section <NUM> and a proximal section <NUM> (see <FIG> and <FIG>). At least a portion of the inner member <NUM> is surrounded by an outer member or outer coil <NUM> at least at the distal section <NUM>. In some embodiments, at least a portion of the inner member <NUM> is also surrounded by the outer coil <NUM> at the proximal section <NUM> thereof. In the example embodiment, the distal section <NUM> includes a distal deflectable portion <NUM> (see also <FIG> and <FIG>).

The delivery cable <NUM> further includes a pull wire <NUM> disposed between the inner member <NUM> and the outer coil <NUM>. The pull wire <NUM> extends longitudinally through the delivery cable <NUM>, between the inner member <NUM> and the outer coil <NUM>, from the proximal section <NUM> to the distal section <NUM>. In the example embodiment, the pull wire <NUM> is coupled (directly or indirectly) to the outer coil <NUM>. In particular, the pull wire <NUM> is coupled to the outer coil <NUM> at a distal end <NUM> thereof, within the distal deflectable portion <NUM> of the delivery cable <NUM>. Upon manipulation of the pull wire <NUM>, as described further herein, the pull wire <NUM> causes deflection of the outer coil <NUM>, which causes deflection of the distal deflectable portion <NUM>. Although not shown, in some embodiments, the pull wire <NUM> includes a coating or jacket provided on an outer surface thereof. The jacket may be a polymer jacket that reduces friction between the pull wire <NUM> and adjacent components (e.g., an inner surface of the outer coil <NUM> and/or an outer surface of the inner member <NUM>).

An endscrew <NUM> is coupled to a distal end <NUM> of the inner member <NUM> to facilitate selectively attaching and detaching a medical device (e.g., the medical device <NUM>, shown in <FIG>) to the delivery cable <NUM>. The endscrew <NUM> includes a threaded portion <NUM> configured to cooperate with a corresponding threaded portion (not shown) positioned on or within the medical device to be delivered, such that the medical device may be engaged or disengaged (i.e., coupled to or released from) the delivery cable <NUM> upon rotation of the endscrew <NUM>.

The endscrew <NUM> is attached to the inner member <NUM> via any method suitable to sufficiently secure the endscrew <NUM> to the inner member <NUM>. For example, suitable methods include, but are not limited to, bonding via an adhesive (such as an epoxy), connecting (e.g., using a coupling member, such as a stainless steel tube or platinum-iridium marker band that is dome welded to a distal end of the inner member <NUM> prior to being crimp or spot welded to the endscrew <NUM>), soldering, welding, spot welding or crimp welding, clamping, swaging, crimping, or any combination thereof. In the illustrated embodiment, a proximal portion <NUM> of the endscrew <NUM> is coupled to the distal end <NUM> of the inner member <NUM>. More specifically, the proximal portion <NUM> includes a pocket <NUM> formed therein that receives the distal end <NUM> of the inner member <NUM> therein. As described above, the inner member <NUM> may be adhered, welded, and/or otherwise coupled within the pocket <NUM>.

In other embodiments, the endscrew <NUM> and the inner member <NUM> may also be integrally formed (e.g., an overmolded screw). In still other embodiments, as an alternative to the endscrew <NUM>, any suitable device for attaching and detaching a medical device may be used.

Turning now to <FIG> and <FIG>, deflection of the distal deflectable portion <NUM> of the delivery cable <NUM> is illustrated. In the example embodiment, a handle assembly <NUM> is coupled to the proximal section <NUM> of the delivery cable <NUM>. The handle assembly <NUM> may be integral to the handle assembly <NUM> of the introducer assembly <NUM>, or may be separate therefrom. The handle assembly <NUM> includes a grip member <NUM> including at least one deflection control <NUM> that, upon manipulation thereof, causes deflection of the distal deflectable portion <NUM> from a first, non-deflected position <NUM> (see <FIG>) to a second, deflected position <NUM> (see <FIG>), and vice versa. The deflection control <NUM> may include a knob, a lever, a button, and/or any suitable control that may be manipulated by a physician.

In particular, the deflection control <NUM> is coupled to a proximal end (not shown) of the pull wire <NUM>. Manipulation of the deflection control <NUM> increases tension in the pull wire <NUM>, which causes the distal end of the pull wire <NUM> to exert a pulling force on the outer coil <NUM> (and, therefore, on the distal deflectable portion <NUM> of the delivery cable <NUM>). This pulling force causes deflection of the outer coil <NUM>, and, therefore, deflection of the distal deflectable portion <NUM> of the delivery cable <NUM>. Deflection of the delivery cable <NUM> may enhance the ability of a physician to accurately and precisely locate a medical device (e.g., an occluder) at a target location.

Opposite or subsequent manipulation of the deflection control <NUM> reduces tension in the pull wire <NUM>, which causes the pull wire <NUM> to reduce the force exerted on the outer coil <NUM>. In tum, the outer coil <NUM> straightens.

When the distal deflectable portion <NUM> is in the second, deflected position <NUM>, the endscrew <NUM> is oriented at an oblique angle with respect to a longitudinal axis of the delivery cable <NUM>. Accordingly, any rotation of the delivery cable <NUM> while the distal deflectable portion <NUM> is deflected would result in an elliptical movement of the endscrew <NUM>. Such movement may be undesirable, as such movement would also move any medical device coupled to the endscrew <NUM> in a corresponding path. That is, the medical device would be displaced from its proper position at the target location. However, where the endscrew <NUM> is threadably engaged with the medical device, the endscrew <NUM> must be rotated to disengage the endscrew <NUM> from medical device (i.e., to deploy the medical device at the target location).

Therefore, the inner member <NUM>, to which the endscrew <NUM> is coupled, is rotatable within the outer coil <NUM>. Rotation of the inner member <NUM>, but not the outer coil <NUM>, enables rotation of the endscrew <NUM> without elliptical movement thereof. Accordingly, rotating the inner member <NUM> enables disengagement of the endscrew <NUM> from the medical device. In some embodiments, the handle assembly <NUM> further includes a rotation control <NUM> that, upon manipulation thereof, causes rotation of the inner member <NUM> within the outer coil <NUM>. The rotation control <NUM> may include a knob, a rotatable flange, a lever, and/or any other suitable control. In the illustrated embodiment, the rotation control <NUM> is embodied as a rotatable portion <NUM> of the handle assembly <NUM>. Specifically, the grip member <NUM> is split into a fixed or non-rotatable portion <NUM> and a rotatable portion <NUM>. A proximal end <NUM> of the inner member <NUM> is housed or fixed within the rotatable portion <NUM> of the grip member <NUM>. Rotation of the rotational portion <NUM> (i.e., the rotation control <NUM>) causes rotation of the inner member <NUM>.

Returning to <FIG>, the delivery cable <NUM> further includes a bushing <NUM> disposed between the outer coil <NUM> and the endscrew <NUM>, specifically the proximal portion <NUM> thereof. The bushing <NUM> provides a bearing interface between the endscrew <NUM> and the outer coil <NUM> during rotation of the inner member <NUM> and the endscrew <NUM> (e.g., to reduce friction between the endscrew <NUM> and the outer coil <NUM>). In the embodiment of <FIG>, the bushing <NUM> is embodied as a sleeve surrounding the proximal portion <NUM> of the endscrew <NUM>. In at least some embodiments, the bushing <NUM> is embodied as a cylindrical sleeve including a longitudinal slit (not shown) in a cylindrical sidewall thereof. Alternatively, the bushing <NUM> is a continuous, unbroken cylindrical sleeve. In other embodiments, the bushing <NUM> may be any other suitable bearing component. The bushing <NUM> may be coupled (e.g., welded, adhered, etc.) to the pull wire <NUM> and/or to the outer coil <NUM>. In the exemplary embodiment, the pull wire <NUM> is coupled to the outer coil <NUM> via the bushing <NUM>. More specifically, the pull wire <NUM> is coupled to the bushing, and the outer coil <NUM> is coupled to the bushing <NUM>. As described above, however, the outer coil <NUM> may additionally or alternatively be (directly) coupled to the pull wire <NUM>.

In addition, the delivery cable <NUM> includes a proximal disc <NUM> coupled to a proximal end <NUM> of the endscrew <NUM>. The proximal disc <NUM> is positioned proximally of the bushing <NUM> and is configured to prevent longitudinal translation of the bushing <NUM> within the outer coil <NUM>. The proximal disc <NUM> may be welded, adhered, molded, and/or otherwise coupled to the proximal end <NUM> of the endscrew <NUM>. Moreover, in the exemplary embodiment, the bushing <NUM> is extended over at least a portion of the proximal disc <NUM>. Specifically, after the proximal disc <NUM> is coupled to the endscrew <NUM>, the bushing <NUM> is slid over the endscrew <NUM> and extended over at least a portion of the proximal disc <NUM>. In at least some embodiments, the bushing <NUM> may expand to accommodate the proximal disc <NUM> therein (e.g., where the bushing <NUM> is formed with a longitudinal slit). In some embodiments, a proximal surface of the proximal disc <NUM> may be curved or chamfered, which may facilitate extending the bushing <NUM> thereover with less force.

The inner member <NUM> is formed of any material and has any configuration suitable to provide both torque strength and flexibility to the delivery cable <NUM> and enables the delivery cable <NUM> to function or operate as described herein. For example, the inner member <NUM> may be configured so as to optimize torque strength and/or flexibility by modifying a length of the inner member <NUM>, a diameter or number of wires that may form the inner member <NUM>, a number of layers forming the inner member <NUM>, and/or the winding direction for each such layer.

The outer coil <NUM> may be sized and configured so as to provide sufficient column strength to the delivery cable <NUM> to assist in delivering the medical device through a catheter or delivery sheath. Additionally or alternatively, the outer coil <NUM> may be sized and configured to provide sufficient flexibility to the delivery cable <NUM> to prevent the tendency of the medical device being delivered via the delivery cable <NUM> to move, "jump," pull, or bias upon detaching the medical device from the delivery cable <NUM> and to prevent undesired straightening of a delivery sheath during delivery of a medical device. Additionally or alternatively, the outer coil <NUM> may be further sized and configured so as to reduce the ability or tendency of the delivery cable <NUM>, and in particular the distal section <NUM> thereof, to "snake," curve, or bunch within the catheter or delivery sheath. For example, the outer coil <NUM> may have an outer diameter that is slightly smaller than an inner diameter of a catheter or delivery sheath through which the delivery cable <NUM> is advanced during delivery of a medical device. By keeping the space between the catheter or delivery sheath and the outer surface of the outer coil <NUM> minimized, the ability of the outer coil <NUM> to "snake," bunch, or curve within a catheter or delivery sheath during advancement of the delivery cable <NUM> therethrough is reduced, which in turn, reduces the amount of force required to advance a medical device through the catheter or delivery sheath.

The outer coil <NUM> may be formed of any number of wires, having any size and shape, and arranged in any configuration suitable to provide the desired flexibility and/or strength of the outer coil <NUM>. As will be understood by those of skill in the art, the size, shape, diameter, and/or material of the outer coil <NUM> may be modified without departing from the scope of the disclosure. For example, the outer coil <NUM> may be nitinol in some embodiments.

The pull wire <NUM> may be formed from one or more wires of any suitable material, and may have any size or gauge suitable to induce deflection of the distal deflectable portion <NUM> of the delivery cable. The pull wire <NUM> may be formed from, for example, thermoplastic materials, platinum, steel, tantalum, nickel, tungsten, alloys thereof, and/or any other suitable material. Additionally, the pull wire <NUM> may be coated with and/or encased in, for example, nylon, PVC, thermoplastic elastomer (TPE), and/or other suitable coating(s) or jacket(s) to reduce friction between the pull wire <NUM> and adjacent components of the delivery cable <NUM>. Moreover, the pull wire <NUM> may be round or flat or may have any other shape to optimize mechanical properties thereof and/or to ensure an optimal fit within the delivery cable <NUM>. The pull wire <NUM> may be a pull-pull wire, a push-pull wire, and/or may include multiple pull wires.

It should be readily understood that the delivery cable <NUM> may include a material positioned over at least a portion of the outer coil <NUM> to reduce the amount of air ingress during advancement of the medical device through a catheter or other delivery device and/or to increase the lubriciousness of the delivery cable <NUM> thus aiding in a smoother advancement of the delivery cable <NUM> through a patient's vasculature. In one embodiment, at least a portion of the outer surface of the outer coil <NUM>, and in some embodiments an entire outer surface of the outer coil <NUM>, is coated, sealed, or surrounded by a heat shrink material (not shown) suitable to reduce or prevent air ingress during advancement of the medical device during delivery thereof.

<FIG> is a flow diagram of a method <NUM> for manufacturing a delivery cable, such as the delivery cable <NUM> (shown in <FIG>), according to one embodiment. Notably, the steps in method <NUM> may be performed in any suitable order, and are not limited to being performed in the order shown in <FIG>.

Method <NUM> includes providing <NUM> a flexible inner core (e.g., the inner member <NUM>) and inserting <NUM> the flexible inner core at least partially into an outer coil (e.g., the outer coil <NUM>, both shown in <FIG>). Method <NUM> also includes inserting <NUM> a pull wire (e.g., the pull wire <NUM>, also shown in <FIG>) between the flexible inner core and the outer coil, and coupling <NUM> the pull wire to the outer coil.

Method <NUM> further includes coupling an endscrew (e.g., the endscrew <NUM>, shown in <FIG>) to a distal end of the flexible inner core. The endscrew may be coupled to the flexible inner core via crimping. The method <NUM> also includes coupling a bushing (e.g., the bushing <NUM>, also shown in <FIG>) to the flexible inner core between a proximal portion of the endscrew and the outer coil to provide a bearing interface between the endscrew and the outer coil. In some such embodiments, coupling <NUM> includes coupling the pull wire to the outer coil via the bushing, by coupling (e.g., welding) the pull wire to the bushing, and coupling (e.g., welding) the bushing to the outer coil.

In further embodiments, method <NUM> may include coupling a proximal disc (e.g., the proximal disc <NUM>, also shown in <FIG>) to a proximal end of the endscrew, the proximal disc configured to prevent proximal translation of the bushing within the outer coil. The proximal disc may be coupled to the endscrew via welding, and this coupling may be performed prior to coupling the bushing to the flexible inner core.

Additionally, method <NUM> may include coupling a handle assembly (e.g., the handle assembly <NUM>) to a proximal end of the delivery cable, wherein the handle assembly includes a rotation control (e.g., the rotation control <NUM>, both shown in <FIG>), and coupling a proximal end of the flexible inner core to the rotation control.

Additionally or alternatively, method <NUM> may include coupling a handle assembly to a proximal end of the delivery cable, wherein the handle assembly includes a deflection control (e.g., the deflection control <NUM>, also shown in <FIG>), and coupling a proximal end of the pull wire to the deflection control.

<FIG> is a flow diagram of a method <NUM> for implanting a medical device (e.g., collapsible occluder) at a target site in a subject using a delivery cable and a delivery sheath, such as the delivery cable <NUM> and the delivery sheath <NUM> (both shown in <FIG>), according to one embodiment. Notably, the steps in method <NUM> may be performed in any suitable order, and are not limited to being performed in the order shown in <FIG>.

Method <NUM> includes deploying <NUM> the delivery sheath into the subject. In some embodiments, the medical device is already attached to a distal end of the delivery cable in a "preloaded" configuration. Alternatively, in other embodiments, method <NUM> may optionally include coupling <NUM> the medical device to a distal end of the delivery cable. As described above, the delivery cable includes at least a flexible inner core, an outer coil surrounding at least a portion of the flexible inner core, and a pull wire disposed between the flexible inner core and the outer coil. Method <NUM> further includes advancing <NUM> the delivery cable through the deployed delivery sheath, for example, until the medical device exits the delivery sheath and reaches the target site. Method <NUM> further includes deflecting <NUM> a distal deflectable portion of the delivery cable by manipulating the pull wire, and deploying <NUM> the medical device at the target site by detaching the medical device from the delivery cable. In some embodiments, detaching the medical device from the delivery cable includes rotating the flexible inner core relative to the outer coil.

Claim 1:
A delivery cable (<NUM>) for delivering a medical device (<NUM>), the delivery cable (<NUM>) comprising:
a flexible inner core (<NUM>);
an outer coil (<NUM>) surrounding at least a portion of the flexible inner core (<NUM>); and
a pull wire (<NUM>) disposed between the flexible inner core (<NUM>) and the outer coil (<NUM>), the pull wire (<NUM>) configured to deflect a distal deflectable portion (<NUM>) of the delivery cable (<NUM>) upon manipulation thereof;
an endscrew (<NUM>) coupled to a distal end (<NUM>) of the flexible inner core (<NUM>) and configured to engage the medical device (<NUM>), wherein the endscrew (<NUM>) includes a threaded portion (<NUM>) for engaging the medical device (<NUM>), wherein the flexible inner core (<NUM>) is rotatable, and wherein rotation of the flexible inner core (<NUM>) causes corresponding rotation of the endscrew (<NUM>) to disengage the endscrew (<NUM>) from the medical device (<NUM>); and
a bushing (<NUM>) coupled between a proximal portion (<NUM>) of the endscrew (<NUM>) and the outer coil (<NUM>) to provide a bearing interface between the endscrew (<NUM>) and the outer coil (<NUM>).