Patent Description:
<CIT> discloses medical devices and delivery systems for delivering medical devices to target locations within a subject. <CIT> discloses systems and methods for deploying implantable devices within the body. <CIT> discloses a connector which comprises the male portion of a Luer connector. <CIT> discloses medical device delivery systems. <CIT> discloses a prosthetic heart valve and a heart valve delivery apparatus. <CIT> discloses prosthetic heart valve delivery device.

The present invention pertains to medical device as set forth in the claims.

The medical device comprises a handle housing having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and an interior space therein; an elongated outer sheath having a lumen therein extending distally from the distal end of the handle housing; an elongated inner member extending distally through the distal end of the handle housing within the lumen of the elongated outer sheath. The handle housing includes a side wall defining the interior space and extending from the proximal end to the distal end, a proximal aperture extending through the side wall of the handle housing to the interior space, and a distal aperture extending through the side wall of the handle housing to the interior space. A proximal flush port is disposed within the interior space and in fluid communication with the elongated inner member, the proximal flush port is configured to be directly accessible from an exterior of the handle housing through the proximal aperture. A distal flush port is disposed within the interior space and in fluid communication with the lumen of the elongated outer sheath wherein the distal flush port is configured to be directly accessible from an exterior of the handle housing through the distal aperture.

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:.

Diseases and/or medical conditions that impact the cardiovascular system are prevalent in the United States and throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the system. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed, for example, where a blocked coronary artery could be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.

Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.

<FIG> is a side view of an example medical device system <NUM>. It should be noted that some features of system <NUM> are either not shown, or are shown schematically, in <FIG> for simplicity. Additional details regarding some of the components of system <NUM> are provided in other figures in greater detail. System <NUM> may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy. In at least some embodiments, system <NUM> is a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a replacement heart valve. This, however, is not intended to be limiting as system <NUM> may also be used for other interventions including mitral valve replacement, valve repair, valvuloplasty, and the like, or other similar interventions.

System <NUM> may generally be described as a catheter system that includes an outer sheath or catheter <NUM> and an inner catheter or tube <NUM> (a portion of which is shown in <FIG> in phantom line) extending at least partially through outer sheath <NUM>. A medical device implant <NUM> may be coupled to inner catheter <NUM> and disposed within outer sheath <NUM> during delivery of implant <NUM>. A handle <NUM> is disposed at the proximal end of outer sheath <NUM> and inner catheter <NUM>. In general, handle <NUM> may be configured to manipulate the position of outer sheath <NUM> relative to inner catheter <NUM> as well as aid in the deployment of implant <NUM>.

In use, system <NUM> may be advanced percutaneously through the vasculature to a position adjacent to an area of interest. For example, system <NUM> may be advanced through the vasculature to a position adjacent to a defective aortic valve. During delivery, implant <NUM> may be generally disposed in an elongated and low profile "delivery" configuration within outer sheath <NUM>. Once positioned, outer sheath <NUM> may be retracted to expose implant <NUM>. Implant <NUM> may be actuated in order to expand implant into a generally shortened and larger profile "deployed" configuration suitable for implantation within the anatomy. When implant <NUM> is suitably deployed within the anatomy, system <NUM> can be removed from the vasculature, leaving implant <NUM> in place to function as, for example, a suitable replacement for the native aortic valve. In at least some interventions, implant <NUM> may be deployed within the native valve (e.g., the native valve is left in place and not excised). Alternatively, the native valve may be removed and implant <NUM> may be deployed in its place as a replacement.

<FIG> (as well as other figures) illustrate some of the components of system <NUM>. For example, <FIG> is a cross-sectional side view of outer sheath <NUM>. Here it can be seen that outer sheath <NUM> has a proximal portion <NUM> and a distal portion <NUM>. Distal portion <NUM> may have a slightly enlarged or flared inner diameter, which may provide additional space for holding implant <NUM> therein. For example, the inner diameter of outer sheath <NUM> along proximal portion <NUM> may be in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> ± <NUM> (<NUM> ± <NUM> inches). The inner diameter of outer sheath <NUM> along distal portion <NUM> may be in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches). At the distal end of distal portion <NUM> may be a distal tip <NUM>, which may be flared or otherwise have a funnel-like shape. The funnel-like shape increases the outer diameter (and inner diameter) of outer sheath <NUM> at distal tip <NUM> and may aid in the sheathing and/or re-sheathing of implant <NUM> into outer sheath <NUM>. Other than at distal tip <NUM>, outer sheath <NUM> may have a generally constant outer diameter. For example, outer sheath <NUM> may have an outer diameter in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> (<NUM> inches). These are just examples. Other embodiments are contemplated that have differing dimensions (including those appropriate for differently sized patients including children) and/or arrangements for the outer diameter and/or inner diameter of outer sheath <NUM>. These contemplated embodiments include outer sheaths with flared or otherwise variable outer diameters, embodiments with constant inner diameters, combinations thereof, and the like. Outer sheath <NUM> may also have a length that is appropriate for reaching the intended area of interest within the anatomy. For example, outer sheath <NUM> may have a length in the range of about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> ± <NUM>. Outer sheath <NUM> may also be curved. For example, a distal section of outer sheath <NUM> may be curved. In one example, the radius of the curve (measured from the center of outer sheath <NUM>) may be in the range of about <NUM> to <NUM> (<NUM> to <NUM>), or about <NUM> to <NUM> (<NUM> to <NUM>), or about <NUM> (<NUM>). Again, these dimensions are examples and are not intended to be limiting.

Outer sheath <NUM> may be formed from a singular monolithic tube or unitary member. Alternatively, outer sheath <NUM> may include a plurality of layers or portions. One or more of these layers may include a reinforcing structure such as a braid, coil, mesh, combinations thereof, or the like. <FIG> illustrates one example of a multilayer structure for outer sheath <NUM>. For example, outer sheath <NUM> may include an inner liner or layer <NUM>. An intermediate or tier layer <NUM> may be disposed on inner liner <NUM>. A reinforcement <NUM> may be disposed on intermediate layer <NUM>. A topcoat or outer layer <NUM> may be disposed on reinforcement <NUM>. Finally, an outer coating <NUM> (e.g., a lubricious coating, a hydrophilic coating, a hydrophobic coating, etc.) may be disposed along portions or all of topcoat <NUM>. These are just examples. Several alternative structural configurations are contemplated for outer sheath <NUM> including embodiments including two or more layers that may be different from those shown in <FIG> , embodiments without a reinforcement, and the like, or other suitable configurations.

The dimensions and materials utilized for the various layers of outer sheath <NUM> may also vary. For example, inner liner <NUM> may include a polymeric material such as fluorinated ethylene propylene (FEP) and may have a thickness in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches) or about <NUM> ± <NUM> (<NUM> ± <NUM> inches), intermediate layer <NUM> may include a polymer material such as polyether block amide (e.g., PEBAX <NUM>) and may have a thickness in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches) or about <NUM> ± <NUM> (<NUM> ± <NUM> inches), outer coating <NUM> may include a polymer material such as polyether block amide (e.g., PEBAX <NUM>) and may have a thickness in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches). In some embodiments, outer coating <NUM> may vary in thickness. For example, along proximal portion <NUM> outer coating <NUM> may have greater thickness, such as about <NUM> to about <NUM> or about <NUM> (<NUM> to <NUM> inches or about <NUM> inches), than along distal portion <NUM> and/or distal tip <NUM>, which may be about <NUM> to about <NUM> or about <NUM> (e.g., about <NUM> to <NUM> inches or about <NUM> inches). These are just examples as other suitable materials may be used.

The form of distal tip <NUM> may also vary. For example, in at least some embodiments, inner liner <NUM> (i.e., a <NUM> section thereof) may be extended up and around the distal end of outer sheath <NUM> (e.g., around reinforcement <NUM> and topcoat <NUM>). A ring member (not shown) made from a suitable material such as a 55D polyether block amide (e.g., 55D PEBAX) may be disposed over inner liner <NUM> and heat bonded to form distal tip <NUM>. This may form the funnel-like shape of distal tip <NUM>.

Reinforcement <NUM> may also vary in form. In at least some embodiments, reinforcement <NUM> may take the form of a braid, coil, mesh, or the like. For example, in some embodiments, reinforcement <NUM> may include a metallic braid (e.g., stainless steel). In some of these embodiments, reinforcement <NUM> may also include additional structures such as one or more longitudinally-extending strands. For example, reinforcement <NUM> may include a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of the braid. These strands may or may not be woven into portions or all of the braid.

<FIG> is a side view of the inner catheter <NUM>. A distal end region of inner catheter <NUM> may include a step in outer diameter <NUM> that defines a decreased outer diameter section <NUM>. For example, decreased outer diameter section <NUM> may have an outer diameter in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> ± <NUM> (<NUM> ± <NUM> inches) as opposed to the remainder of inner catheter <NUM> where the outer diameter may be in the range of about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> to <NUM> (<NUM> to <NUM> inches), or about <NUM> ± <NUM> (<NUM> ± <NUM> inches). Decreased outer diameter section <NUM> may define a region where other components of system <NUM> may be attached. Some additional details regarding these components can be found herein.

In general, inner catheter <NUM> may take the form of an extruded polymer tube. Other forms are also contemplated including other polymer tubes, metallic tubes, reinforced tubes, or the like including other suitable materials such as those disclosed herein. In some embodiments, inner catheter <NUM> is a singular monolithic or unitary member. In other embodiments, inner catheter <NUM> may include a plurality of portions or segments that are coupled together. The total length of inner catheter may be in the range of about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> ± <NUM>. Just like outer sheath <NUM>, inner catheter <NUM> may also be curved, for example adjacent to the distal end thereof. In some embodiments, inner catheter <NUM> may have one or more sections with a differing hardness/stiffness (e.g., differing shore durometer). For example, inner catheter may have a proximal region 44a and an intermediate region 44b. Proximal region 44a may include a generally stiff polymeric material such as a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> ± <NUM>. Intermediate region 44b may include a 40D polyether block amide (e.g., 40D PEBAX) and may have a length in the range of about <NUM> to <NUM>, or about <NUM> to <NUM>, or about <NUM> ± <NUM>. Decreased outer diameter section <NUM> may also differ from regions 44a/44b and, in some embodiments, may include a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about <NUM> to <NUM> (<NUM> to <NUM>), or about <NUM> to <NUM> (<NUM> to <NUM>), or about <NUM> ± <NUM> (<NUM> ± <NUM>). These are just examples.

Inner catheter <NUM> may include one or more lumens. For example, <FIG> (which is a cross-sectional view of inner catheter <NUM> adjacent to proximal end portion <NUM>) illustrates that inner catheter <NUM> may include a first lumen <NUM>, a second lumen <NUM>, a third lumen <NUM>, and a fourth lumen <NUM>. In general, lumens <NUM>/<NUM>/<NUM>/<NUM> extend along the entire length of inner catheter <NUM>. Other embodiments are contemplated, however, where one or more of lumens <NUM>/<NUM>/<NUM>/<NUM> extend along only a portion of the length of inner catheter <NUM>. For example, fourth lumen <NUM> may stop just short of the distal end of inner catheter <NUM> and/or be filled in at its distal end to effectively end fourth lumen <NUM> proximal of the distal end of inner catheter <NUM>, as illustrated in <FIG> by the absence of fourth lumen <NUM> adjacent to the distal end of inner catheter <NUM>.

Disposed within first lumen <NUM> may be push-pull rods <NUM> (not shown in <FIG> , seen in other figures including <FIG> ), which are used to expand and/or elongate implant <NUM> as explained in more detail herein. In at least some embodiments, first lumen <NUM> may be lined with a low friction liner <NUM> (e.g., a FEP liner). Disposed within second lumen <NUM> may be a pin release mandrel <NUM> (not shown in <FIG> , seen in other figures including <FIG> ), which is also explained in more detail herein. In at least some embodiments, second lumen <NUM> may be lined with a hypotube liner <NUM>. Third lumen <NUM> may be a guidewire lumen and this lumen may also be lined with a hypotube liner <NUM>.

Fourth lumen <NUM> may be used to house a non-stretch wire <NUM>. The form of non-stretch wire <NUM> may vary. In some embodiments, non-stretch wire <NUM> may take the form of a stainless steel braid. The non-stretch wire <NUM> may optionally include a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of the braid. In general, rather than being "disposed within" fourth lumen <NUM>, non-stretch wire <NUM> may be embedded within fourth lumen <NUM>. In addition, non-stretch wire <NUM> may extend to a position adjacent to distal end portion <NUM> but not fully to the distal end of inner catheter <NUM> as illustrated in <FIG> by the absence of fourth lumen <NUM> adjacent to the distal end of inner catheter <NUM>. For example, a short distal segment of fourth lumen <NUM> may be filled in with polymer material adjacent to the distal end of inner catheter <NUM>.

Inner catheter <NUM> may also include a guidewire extension tube <NUM> that extends distally from distal end portion <NUM>. A nose cone <NUM> is attached to guidewire extension tube <NUM>. Nose cone <NUM> generally is designed to have an atraumatic shape. Nose cone <NUM> may also include a ridge or ledge <NUM> that is configured to abut the distal tip <NUM> of outer sheath <NUM> during delivery of implant <NUM>.

<FIG> illustrates some of the additional components of system <NUM> and implant <NUM>. For example, here it can be seen that implant <NUM> includes a plurality of valve leaflets <NUM> (e.g., bovine pericardial) which are secured to a cylindrical braid <NUM> at a post or commissure post <NUM>, for example at the commissure portions of the leaflets <NUM>. In this example, implant <NUM> includes three leaflets <NUM> secured to braid <NUM> with three posts <NUM>. Leaflets <NUM> may also be secured to the base or "distal end" of braid <NUM>. The posts <NUM>, in turn, may be secured to braid <NUM> (e.g., along the interior of braid <NUM>) with sutures or other suitable mechanisms. Positioned adjacent to (e.g., longitudinally spaced from and aligned with) posts <NUM> are a plurality of buckles <NUM>, which may also be sutured to braid <NUM> (e.g., along the interior of braid <NUM>). In this example, one buckle <NUM> is attached to braid <NUM> adjacent to each of the three posts <NUM>. Accordingly, braid <NUM> has a total of three buckles <NUM> and three posts <NUM> attached thereto. Other embodiments are contemplated where fewer or more buckles <NUM> and posts <NUM> may be utilized. A seal <NUM> (shown in cross-section) may be disposed about braid <NUM> and, as the name suggests, may help to seal implant <NUM> within a target implant site or area of interest.

Attachment between implant <NUM> and inner catheter <NUM> (and/or outer sheath <NUM>) may be effected through the use of a three finger coupler <NUM>. Coupler <NUM> may generally include a cylindrical base (not shown) that is attached to inner catheter <NUM> (e.g., disposed about and attached to reduced outer diameter section <NUM>). Projecting distally from the base are three fingers that are each configured to engage with implant <NUM> at posts <NUM> and buckles <NUM>. A collar <NUM> may further assist in holding together these structures. A guide <NUM> may be disposed over each of the fingers and may serve to keep the fingers of coupler <NUM> associated with push-pull rods <NUM> extending adjacent to coupler <NUM>. Finally, a pin release assembly <NUM> may be a linking structure that keeps posts <NUM>, buckles <NUM>, and push-pull rods <NUM> associated with one another. Pin release assembly <NUM> includes a plurality of individual pins <NUM> that may be joined together via a coiled connection <NUM> and held to a pin release mandrel <NUM> with a ferrule <NUM>.

During delivery, implant <NUM> is secured at the distal end of inner catheter <NUM> by virtue of the association of the fingers of coupler <NUM> being coupled with a projecting proximal end of buckles <NUM> (and being held in place with collar <NUM> disposed over the connection) and by virtue of pins <NUM> securing together push-pull rods <NUM> and posts <NUM>. When implant <NUM> is advanced within the anatomy to the desired location, outer sheath <NUM> may be withdrawn (e.g., moved proximally relative to inner catheter <NUM>) to expose implant <NUM>. Then, push-pull rods <NUM> can be used to expand and "lock" implant <NUM> in the expanded or deployed configuration by proximally retracting push-pull rods <NUM> to pull posts <NUM> into engagement with buckles <NUM>. Finally, pins <NUM> can be removed, thereby uncoupling push-pull rods <NUM> from posts <NUM>, which allows implant <NUM> to be released from system <NUM> and deployed in the anatomy.

<FIG> illustrate the locking system utilized with system <NUM>. For simplicity purposes, only one of the three fingers of the coupler <NUM>, only one of the three push-pull rods <NUM>, and only one of the posts <NUM> of the example system <NUM> are shown (and implant <NUM> is not shown). As seen in <FIG> , push-pull rod <NUM> extends through guide <NUM> adjacent to the fingers of coupler <NUM>, through collar <NUM>, through buckle <NUM>, and into a hollow t-shaped bar portion <NUM> of post <NUM>. The distal end of push-pull rod <NUM> may include an opening or aperture (not shown) that can be aligned with an opening <NUM> of t-shaped bar portion <NUM>. When so aligned, pin <NUM> can be looped through opening <NUM> and the opening of push-pull rod <NUM>. This secures push-pull rod <NUM> to post <NUM> and forms a configuration of these structures that can be utilized during delivery of implant <NUM>. As can be appreciated, the proximal end of post <NUM> and the distal end of buckle <NUM> are longitudinally separated and, accordingly, implant <NUM> is in an elongated and generally low-profile configuration suitable for delivery.

When implant <NUM> reaches the intended target site within the anatomy, a clinician can proximally retract push-pull rod <NUM>, thereby moving the proximal ends of posts <NUM> toward the distal ends of buckles <NUM> in order to expand implant <NUM>. Ultimately, push-pull rod <NUM> can be retracted sufficiently far enough to lock post <NUM> with buckle <NUM> so as to lock implant in an expanded configuration suitable for implantation within the anatomy. <FIG> illustrates push-pull rod <NUM> proximally retracted. In doing so, post <NUM> is brought into contact with buckle <NUM>. More particularly, a raised, generally transversely-oriented ridge <NUM> on t-shaped bar portion <NUM> may be pulled proximally past buckle <NUM> so that post <NUM> is secured and held in place by buckle <NUM>. At this point, it is possible to urge push-pull rods <NUM> distally to "unlock" implant <NUM>, thereby allowing for repositioning and/or retraction. Alternatively, if a clinician is satisfied with the positioning and/or locking of implant <NUM> (e.g., after visualization of implant <NUM> via a suitable imaging technique), pins <NUM> may be pulled (e.g., removed from openings <NUM> and the openings in push-pull rods <NUM>) to uncouple push-pull rods <NUM> from posts <NUM> as shown in <FIG>. Further retraction of push-pull rods <NUM> causes a longitudinally-oriented ridge <NUM> on push-pull rods <NUM> to engage collar <NUM> and causes collar <NUM> to slide proximally along the fingers of coupler <NUM>. In doing so, a forked end <NUM> of the fingers, which has a groove <NUM> formed therein, is exposed and can be uncoupled from a rail <NUM>, which has a projection <NUM> formed thereon that is configured to mate with groove <NUM>, as shown in <FIG>. Thereafter, system <NUM> can be removed from the anatomy, leaving behind the expanded and deployed implant <NUM>.

<FIG> illustrate another component that may be included with system <NUM>. For example, <FIG> is a side view of a portion of a sheathing aid <NUM>. Here it can be seen that sheathing aid <NUM> includes a base <NUM> and a group of petals including a set of three longer petals <NUM> and a pair of shorter petals <NUM>. In use, a group of petals <NUM>/<NUM> may be positioned between each of the fingers of coupler <NUM>. Because the coupler <NUM> may have a total of three fingers, sheathing aid <NUM> may have a total of fifteen petals (e.g., three groups that each include three "long" petals <NUM> and two "short" petals <NUM>, with each group being positioned between adjacent pairs of fingers of coupler <NUM>). Base <NUM> may be secured to inner catheter <NUM> adjacent to coupler <NUM> (e.g., underneath coupler <NUM> and between coupler <NUM> and inner catheter <NUM>).

Sheathing aid <NUM>, as the name suggests, may be used to aid in the sheathing of implant <NUM> into outer sheath <NUM>. In addition, sheathing aid <NUM> may aid in the initial sheathing of implant <NUM> (e.g., removing implant <NUM> from a packaging container such as a bottle and pulling implant <NUM> into outer sheath <NUM>) and in re-sheathing implant <NUM> during repositioning and/or retraction of implant <NUM> within the area of interest. Sheathing may be accomplished via the arrangement and positioning of the various petals <NUM>/<NUM>. For example, <FIG> illustrates the longer petals <NUM> woven in and out of braid <NUM>, and the shorter petals <NUM> disposed along the exterior of braid <NUM> acting as a funnel for sheathing.

<FIG> is a side view of handle <NUM> in accordance with the invention. Here it can be seen that handle <NUM> includes a handle housing <NUM>. A rotatable control knob <NUM> may be disposed about handle housing <NUM> (e.g., at a proximal end of handle housing <NUM>) and may be used to move one or more of the components of system <NUM> (e.g., outer sheath <NUM>, push-pull rods <NUM>, etc.). A rotatable collar <NUM> may be disposed about the handle housing <NUM>. In some embodiments, control knob <NUM> may be disposed about a proximal portion of collar <NUM>. A slidable door <NUM> may also be disposed about handle housing <NUM>. Door <NUM> may translate distally to expose a distal portion of rotatable collar <NUM> (not shown in <FIG> , can be seen in other figures including <FIG> ) positioned generally under door <NUM>. Collar <NUM> may be rotated to move one or more components of system <NUM> (e.g., push-pull rods <NUM>, pin release mandrel <NUM>, etc.). Handle <NUM> also includes apertures 129a/129b and flush ports <NUM>/<NUM> that can be used to flush system <NUM>. According to the invention, distal flush port <NUM> and proximal flush port <NUM> are disposed within the handle housing <NUM> and may generally face laterally relative to a longitudinal axis of the handle housing <NUM> so as to be accessible from the exterior of the handle housing <NUM> through distal aperture 129a and proximal aperture 129b, respectively. Some components of system <NUM> related to the flush ports <NUM>/<NUM> may be seen in greater detail in <FIG>.

<FIG> is a side view of handle <NUM> with a portion of handle housing <NUM> removed, exposing at least some of the interior components. It should be noted that some components within handle <NUM> are not shown in <FIG> for clarity. In <FIG> , it can be seen that handle housing <NUM> includes a side wall defining an interior space of the handle housing <NUM>. In some embodiments, the side wall substantially surrounds the interior space. In some embodiments, outer sheath <NUM> and inner catheter <NUM> may extend through a distal end of the handle housing <NUM>. In accordance with the invention, the proximal flush port <NUM> and the distal flush port <NUM> are disposed within the interior space. Outer sheath <NUM> may be attached (e.g., fixedly attached) to an axially movable sheath adapter <NUM>, as seen in <FIG> and <FIG>. Sheath adapter <NUM> is attached to a sheath carriage <NUM>, which may be threaded onto a lead screw <NUM>. Sheath carriage <NUM> may move axially within the handle housing <NUM> in response to rotation of the control knob <NUM>. Distal flush port <NUM> may be disposed on sheath adapter <NUM>. As such, distal flush port <NUM> may be axially and/or longitudinally movable within the interior space of the handle housing <NUM> when the control knob <NUM> is rotated. In general, distal flush port <NUM> is in fluid communication with the interior or lumen of outer sheath <NUM>, so as to provide access to the interior or lumen of outer sheath <NUM> (e.g., access to space between inner catheter <NUM> and outer sheath <NUM>) so that a clinician can flush fluid through the lumen of outer sheath <NUM> to remove any unwanted materials (e.g., air, fluid, contaminants, etc.) therein prior to use of system <NUM>.

In at least some embodiments, distal flush port <NUM> has a luer type connector (e.g., a one-way luer connector) that allows a flushing device such as a syringe with a corresponding connector to be attached thereto for flushing. In some embodiments, the flushing device (e.g., a syringe) can be directly connected to the distal flush port <NUM> through distal aperture 129a. That is, a flushing device may be connected to the distal flush port <NUM> without the aid or presence of other intervening elements or structure such as tubing or adapters, and the like. A direct connection may reduce opportunity for leaks or interference of connecting elements with other components within handle <NUM> during operation, as well as streamline overall assembly of the medical device system <NUM>.

Inner catheter <NUM> may extend through and proximally from sheath adapter <NUM>. A proximal end of inner catheter <NUM> is attached (e.g., fixedly attached) to an interior body or diverter <NUM>. A proximal end of diverter <NUM> is attached (e.g., fixedly attached) to a distal end of a support body <NUM>. The diverter <NUM> and support body <NUM> may be fixed in position relative to the handle housing <NUM>. Accordingly, inner catheter <NUM> may be fixed in position relative to the handle housing <NUM>.

In general, diverter <NUM> and/or support body <NUM> may have one or more passageways or lumens formed therein. In some embodiments, push-pull rods <NUM> and/or pin release mandrel <NUM> may extend through respective passageways. Alternatively, the proximal ends of push-pull rods <NUM> and/or pin release mandrel <NUM> may each be attached to a shaft or hypotube (e.g., solid in cross-section, tubular, etc.), and each of the shafts may extend through the one or more passageways. For example, a first shaft or hypotube <NUM> and a second shaft or hypotube <NUM> may extend through the passageways in diverter <NUM> and/or support body <NUM>, and in some embodiments, the first shaft or hypotube <NUM> extends through a first passageway and the second shaft or hypotube <NUM> extends through a second passageway that is separate or distinct from the first passageway. In at least some embodiments, first shaft <NUM> is attached (e.g., fixedly attached) to pin release mandrel <NUM>. In at least some embodiments, second shaft <NUM> is attached (e.g., fixedly attached) to push-pull rods <NUM>. It should be noted that at in least some embodiments of system <NUM>, three push-pull rods <NUM> are utilized. In these embodiments, the three push-pull rods <NUM> come together (e.g., brought into contact with one another or otherwise brought into relatively close proximity with one another) adjacent to the distal end of inner catheter <NUM> and enter first lumen <NUM>. At one or more positions along their length, push-pull rods <NUM> may be attached to one another. For example, in some embodiments, push-pull rods <NUM> may be welded together about <NUM> (about <NUM> inches) from their distal ends. In some embodiments, push-pull rods <NUM> may be welded together proximate their proximal ends in addition to or instead of the distal weld. Proximally thereafter, push-pull rods <NUM> may extend to second shaft <NUM>.

A hypotube (e.g., hypotube liner <NUM> disposed along guidewire lumen <NUM>) may extend through diverter <NUM> within a passageway therein and then be "diverted" around a portion of diverter <NUM> and support body <NUM>, and ultimately be extended to a position at the proximal end of handle <NUM> so as to provide a user access to guidewire lumen <NUM>. In some embodiments, support body <NUM> may have a plurality of lumens <NUM> (e.g. two, or more, lumens) extending longitudinally therethrough, as shown in <FIG>. Proximal flush port <NUM> may be disposed on or attached (e.g., fixedly attached) to the support body <NUM>, and may be in fluid communication with the inner catheter <NUM>. In some embodiments, the proximal flush port <NUM> may be in fluid communication with the lumens <NUM> of support body <NUM>. In some embodiments, the lumens <NUM> of support body <NUM> are fluidly connected to diverter <NUM> and/or inner catheter <NUM>. Proximal flush port <NUM> may be used to flush the lumens <NUM> of inner catheter <NUM> and, for example, may function similarly to distal flush port <NUM> described above.

In some embodiments, fluid introduced into the proximal flush port <NUM> may pass through the inner catheter <NUM> and discharge from a distal end thereof. Fluid introduced into the distal flush port <NUM> may similarly pass through the lumen of outer sheath <NUM> (e.g., within the space between the inner catheter <NUM> and the outer sheath <NUM>) and discharge from a distal end thereof. In general, fluid introduced into one of the outer sheath <NUM> and the inner catheter <NUM> does not enter an interior or lumen of the other (e.g., fluid introduced into the inner catheter <NUM> does not enter the lumen of outer sheath <NUM>) upon discharge from the respective distal end.

Proximal flush port <NUM> may be attached to support body <NUM>, and distal flush port may be attached to sheath adapter <NUM> using one or more of a number of various fastening or attachment means. For example, flush ports <NUM>/<NUM> may be held within the sheath adapter <NUM> and/or support body <NUM> by pins extending across a flange formed on the flush ports <NUM>/<NUM>. In some embodiments, flush ports <NUM>/<NUM> may be threaded and screwed into place within the sheath adapter <NUM> and/or support body <NUM>. In some embodiments, flush ports <NUM>/<NUM> may be attached to sheath adapter <NUM> and/or support body <NUM> via a snap-fit, press-fit, or interference fit. In some embodiments, an adhesive may be added to seal the connections against leaks. In some embodiments, an O-ring or other compression seal may be utilized between adjoining components.

At their respective proximal ends, first shaft <NUM> may be secured to a slider <NUM> and second shaft <NUM> may be secured to a force limiter body <NUM>. The connections between the various components may include a number of different types of connections including mechanical bonding (e.g., pinning, threading, interference fit, etc.), adhesive bonding, thermal bonding, etc. Slider <NUM> may be slidable relative to force limiter body <NUM>. In some embodiments, slider <NUM> may be selectively locked to force limiter body <NUM>, thereby preventing relative movement between the slider <NUM> and the force limiter body <NUM>. Force limiter body <NUM> may be secured to a push-pull rod carriage <NUM>, which may be threaded onto lead screw <NUM>. Thus, movement of lead screw <NUM> can cause movement of push-pull rod carriage <NUM> and force limiter body <NUM> and thus, push-pull rods <NUM> (via second shaft <NUM>). Some additional details regarding this motion can be found herein.

In general, force limiter body <NUM> forms or defines a stop point that provides tactile feedback (e.g., resistance to further rotation of control knob <NUM>) to the user indicating that push-pull rods <NUM> have been retracted proximally a sufficient distance to lock posts <NUM> with buckles <NUM>. To verify proper locking, a clinician may use an appropriate visualization technique to visualize proper locking (e.g., the relative positioning of the posts <NUM> and the buckles <NUM>). A chock <NUM> may be positioned adjacent to slider <NUM> to selectively lock slider <NUM> to force limiter body <NUM>. In order to allow pin release mandrel <NUM> to be proximally retracted to pull pins <NUM>, chock <NUM> can be rotated or otherwise moved to a secondary position or configuration. When in this configuration, chock <NUM> no longer forms a barrier to further movement of, for example, slider <NUM> and pin release mandrel <NUM>. Accordingly, with chock <NUM> no longer acting as an impediment, slider <NUM> and pin release mandrel <NUM> can be proximally retracted to facilitate deployment of implant <NUM> by allowing pins <NUM> to be pulled.

Handle <NUM> also includes a rotatable ring <NUM> with internal teeth that are configured to engage with teeth on a gear <NUM> coupled to lead screw <NUM>. Ring <NUM> is coupled to control knob <NUM> so that rotation of control knob <NUM> results in analogous motion of ring <NUM> and thus lead screw <NUM>.

Handle <NUM> is generally configured for coordinated movement of multiple structures of system <NUM>. For example, handle <NUM> is configured to allow a user to move outer sheath <NUM> (e.g., relative to inner catheter <NUM>), move push-pull rods <NUM>, and move pin release mandrel <NUM>. Moreover, handle <NUM> is configured so that the appropriate structure can be moved at the appropriate time during the intervention so that implant <NUM> can be delivered in an efficient manner. Some examples of how the coordinated movement of system <NUM> may occur within handle <NUM> may be similar to those disclosed in U. Patent Application Pub.

To help facilitate the coordinated movement, handle <NUM> may include a lost motion barrel <NUM>. Lost motion barrel <NUM> is configured to engage carriages <NUM>/<NUM> and/or screws associated with carriages <NUM>/<NUM> at different times during the intervention to stop motion (e.g., create "lost motion" of the appropriate carriage). <FIG> illustrate some of the coordinated motion achieved by handle <NUM>. It should be noted that some elements of system <NUM> are not shown in <FIG> for clarity. For example, <FIG> illustrates a first position or state for handle <NUM> where outer sheath <NUM> is extended distally relative to inner catheter <NUM> (and handle <NUM>) so as to fully sheath (e.g., contain) implant <NUM>. While in this position, sheath carriage <NUM> is positioned adjacent to the distal end of handle <NUM>. In addition, a rod screw 152a associated with push-pull rod carriage <NUM> is extended distally from push-pull rod carriage <NUM> and positioned within lost motion barrel <NUM>. Upon rotation of control knob <NUM> (e.g., in the clockwise direction), lead screw <NUM> begins to rotate. Rotation of lead screw <NUM> causes sheath carriage <NUM> to move along lead screw <NUM> in the proximal direction, resulting in proximal movement of outer sheath <NUM> (e.g., "unsheathing" implant <NUM>). This initial rotation of lead screw <NUM> also causes rod screw 152a to rotate. This may be because, for example, a knob or projection (not shown) on rod screw 152a may be engaged with a helical thread disposed along the interior of lost motion barrel <NUM>. However, because rod screw 152a is spaced from push-pull rod carriage <NUM>, it does not exert a force onto push-pull rod carriage <NUM>. Thus, initial motion of control knob <NUM> does not result in movement of push-pull rod carriage <NUM> and, instead, only results in translation of sheath carriage <NUM> and rotation (and translation) of rod screw 152a.

Eventually, rod screw 152a (e.g., the knob formed therein) reaches an essentially linear thread or pathway formed at the end of lost motion barrel <NUM>. The linear thread allows rod screw 152a to translate along lead screw <NUM> to a position where rod screw 152a contacts (e.g., is threaded within and abuts) push-pull rod carriage <NUM>. In doing so, rod screw 152a can contact and move proximally push-pull carriage <NUM>. Accordingly, further rotation of lead screw <NUM> not only causes sheath carriage <NUM> to move proximally but also causes push-pull rod carriage <NUM> to move proximally as shown in <FIG>.

When sheath carriage <NUM> reaches lost motion barrel <NUM>, a sheath carriage screw 132a of sheath carriage <NUM> enters lost motion barrel <NUM> as shown in <FIG>. This may occur in a manner similar to how rod screw 152a threads and unthreads with the helical thread formed along lost motion barrel <NUM>. For example, while sheath carriage <NUM> is translating, sheath carriage screw 132a may follow an essentially linear thread or pathway formed along or adjacent to lost motion barrel <NUM>. Upon reaching lost motion barrel <NUM>, sheath carriage screw 132a (e.g., a knob or projection formed thereon) may shift into engagement with the helical thread within lost motion barrel <NUM> and rotate. This rotation "unthreads" sheath carriage screw 132a from sheath carriage <NUM>. Accordingly, additional rotation of lead screw <NUM> results in continued proximal movement of push-pull rod carriage <NUM> while motion of sheath carriage <NUM> ceases.

In at least some embodiments, lead screw <NUM> has a plurality of portions, for example a first portion 134a and a second portion 134b, with a differing pitch to its thread. This may allow carriages <NUM>/<NUM> to travel at different rates along lead screw <NUM>. For example, the pitch of lead screw <NUM> along which sheath carriage <NUM> translates may be generally more spaced or slanted than at positions adjacent to push-pull rod carriage <NUM>. Accordingly, the coordinated movement of carriages <NUM>/<NUM> also may be configured so that sheath carriage <NUM> translates along lead screw <NUM> at a greater rate than push-pull rod carriage <NUM>. Other configurations are contemplated where the above-mentioned configuration is reversed as well as further configurations where the pitch of lead screw <NUM> is essentially constant or includes a number of different pitch regions.

Sufficient proximal retraction of push-pull rod carriage <NUM>, for example as shown in <FIG> , may result in push-pull rods <NUM> being sufficiently retracted so that posts <NUM> can engage and lock with buckles <NUM>. When the clinician is satisfied that locking is complete (e.g., after verification via an appropriate visualization technique), the clinician may proximally retract pin release mandrel <NUM> in order to pull pins <NUM> from openings <NUM> and openings in push-pull rods <NUM> to release implant <NUM>.

To initiate release of pins <NUM>, door <NUM> may be slid distally along a collar <NUM> (which is positioned on handle <NUM>) as shown in <FIG>. When door <NUM> is sufficiently advanced, door <NUM> and collar <NUM>, together, can be rotated as shown in <FIG>. Push-pull rod carriage <NUM> may also include a radially-extending proximal flag member <NUM>. In general, flag member <NUM> may be designed as a feature that can prevent collar <NUM> from being rotated earlier than desired (and, thus, prevent pins <NUM> from being pulled earlier than desired). For example, flag member <NUM> may be positioned within and follow a groove (not shown) along the interior of collar <NUM>. While positioned within the groove, flag member <NUM> essentially forms a physical barrier that prevents collar <NUM> from rotating relative to handle housing <NUM>. When push-pull rod carriage <NUM> is translated proximally to the back of handle housing <NUM> (e.g., when push-pull rods <NUM> are proximally retracted so as to lock posts <NUM> with buckles <NUM>), flag member <NUM> exits the groove in collar <NUM>. Accordingly, flag member <NUM> no longer impedes rotation of collar <NUM> and, as such, collar <NUM> can now be rotated to pull pins <NUM>.

Collar <NUM>, via ring <NUM>, is associated with a gear <NUM> engaged with a secondary screw <NUM>. Notches at a proximal end of collar <NUM> engage protrusions on ring <NUM> such that rotation of collar <NUM> causes corresponding rotation of ring <NUM> and thus secondary screw <NUM>. The initial rotation of collar <NUM> is sufficient to rotate chock <NUM> (e.g., via a mechanical interaction between collar <NUM> and chock <NUM> that causes chock <NUM> to shift) from a first configuration where slider <NUM> (and, thus, pin release mandrel <NUM>) is selectively locked to force limiter body <NUM>, to a secondary configuration, which permits slider <NUM> to translate along secondary screw <NUM> as secondary screw <NUM> rotates, to proximally retract and pull pins <NUM> (e.g., via pin release mandrel <NUM>). As seen in <FIG> , chock <NUM> in the first configuration engages a ridge <NUM> along a top portion of force limiter body <NUM> which forms a physical barrier that prevents proximal translation of slider <NUM> relative to force limiter body <NUM>. When collar <NUM> is rotated to shift chock <NUM> into the secondary configuration, slider <NUM> can translate proximally within a groove <NUM> disposed in the top portion of force limiter body <NUM> (e.g., as seen in <FIG> ), as collar <NUM> is rotated about the handle housing <NUM> to pull the pins <NUM> from the openings <NUM> and the openings in the distal ends of the push-pull rods <NUM>. Once pins <NUM> have been removed, push-pull rods <NUM> may be withdrawn from implant <NUM>, thereby deploying the implant at the target site (area of interest).

Following deployment of the implant <NUM>, the control knob <NUM> may be rotated to move the sheath carriage <NUM> distally within the handle housing <NUM>, thereby moving outer sheath <NUM> distally relative to inner catheter <NUM> and three-finger coupler <NUM> so as to cover or re-sheath the elements of system <NUM> disposed at the distal end. System <NUM> may then be removed from the patient's anatomy.

The materials that can be used for the various components of system <NUM> (and/or other systems disclosed herein) and the various tubular members disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to outer sheath <NUM> and/or inner catheter <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar tubular members and/or components of tubular members or devices disclosed herein.

Outer sheath <NUM> and/or inner catheter <NUM> may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol.

Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about <NUM> to <NUM> percent strain before plastically deforming.

of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in <CIT> and <CIT>.

In at least some embodiments, portions or all of outer sheath <NUM> and inner catheter <NUM> may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of system <NUM> in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of system <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into system <NUM>. For example, outer sheath <NUM> and inner catheter <NUM>, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Outer sheath <NUM> and inner catheter <NUM>, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

A sheath or covering (not shown) may be disposed over portions or all of outer sheath <NUM> and inner catheter <NUM> that may define a generally smooth outer surface for system <NUM>. In other embodiments, however, such a sheath or covering may be absent from a portion of all of system <NUM>, such that outer sheath <NUM> and inner catheter <NUM> may form an outer surface. The sheath may be made from a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DLRETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments, the exterior surface of the system <NUM> (including, for example, the exterior surface of outer sheath <NUM> and inner catheter <NUM>) may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc. In these as well as in some other embodiments, a coating, for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the sheath, or in embodiments without a sheath over portion of outer sheath <NUM> and inner catheter <NUM>, or other portions of system <NUM>. Alternatively, the sheath may comprise a lubricious, hydrophilic, protective, or other type of coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves device handling and device exchanges. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility. Some other examples of such coatings and materials and methods used to create such coatings can be found in <CIT> and <CIT>.

Claim 1:
A medical device, comprising:
a handle housing (<NUM>) having a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and an interior space therein;
an elongated outer sheath (<NUM>) having a lumen therein extending distally from the distal end of the handle housing (<NUM>);
an elongated inner member extending distally through the distal end of the handle housing (<NUM>) within the lumen of the elongated outer sheath (<NUM>);
wherein the handle housing (<NUM>) includes a side wall defining the interior space and extending from the proximal end to the distal end, characterized by
a proximal aperture (129b) extending through the side wall of the handle housing (<NUM>) to the interior space, and a distal aperture (129a) extending through the side wall of the handle housing (<NUM>) to the interior space;
wherein a proximal flush port (<NUM>) is disposed within the interior space and in fluid communication with the elongated inner member, wherein the proximal flush port (<NUM>) is configured to be directly accessible from an exterior of the handle housing (<NUM>) through the proximal aperture (129b); and
wherein a distal flush port (<NUM>) is disposed within the interior space and in fluid communication with the lumen of the elongated outer sheath (<NUM>), wherein the distal flush port (<NUM>) is configured to be directly accessible from an exterior of the handle housing (<NUM>) through the distal aperture (129a).