Patent Description:
Handles of endoscopes house multiple components (e.g., steering components) that are kept separate from one another. Placement of such components in handles has involved the use of chains or similar components. Such components increase manufacturing costs by increasing part cost and assembly cost, rendering them unsuitable for use in production of disposable devices. Therefore, a need exists for simple and cost-effective steering assemblies of endoscopes, or other medical devices.

<CIT> discloses a steering mechanism for a medical device. The steering mechanism comprises a first spool disposed centrally on a central axle of the steering mechanism and being rotatable about a longitudinal axis of the central axle. A first steering element is attached to the first spool and rotatable therewith. A first retaining tube is attached along a portion of its length to a portion of a first circumferential edge of the first spool and a first drive cable passes through the first retaining tube and beyond first and second ends of the first retaining tube such that a distal end of the first drive cable extends toward a distal end of the medical device.

<CIT> discloses a wire-tensioning mechanism of a steerable catheter. The mechanism includes a spool and a gear mechanism for tensioning and manipulating at least two steering/deflection control wires of a steerable catheter device.

<CIT> discloses an apparatus comprising a stationary plate, a guide and a cable. The stationary plate comprises an opening and the guide is retained in the opening and pivotable relative to the stationary plate. The guide comprises a through hole and the cable is disposed in and axially slidable in the through hole.

In one example, steering assembly of a medical device may comprise a handle having a recess and first and second wire guides disposed within the recess. At least one of the first or second wire guides may be keyed to the recess to prevent rotation of the first or second wire guide within the recess. First and second wire segments may be configured to steer a sheath coupled to the steering assembly in first and second directions. The first wire segment may pass through a first gap between the first wire guide and the second wire guide. The second wire segment may pass through a second gap between the first wire guide and the second wire guide. Neither of the first nor the second gap may occupy any overlapping space.

Any example of steering assemblies described herein may have any of the following features. The steering assembly may further include a third wire guide and third and fourth wire segments configured to steer the sheath in third and fourth directions. The third wire segment may pass through a third gap between the second wire guide and the third wire guide. The fourth wire may pass through a fourth gap between the second wire guide and the third wire guide. The first gap and the second gap may be offset from one another. The first and second wire segments may be configured to control left/right movement of the sheath coupled to the steering assembly. The third and fourth wire segments may be configured to control up/down movement of the sheath coupled to the steering assembly. None of the first, second, third or fourth gaps may occupy any overlapping space. The first wire guide may include a first opening for receiving a first axle component. The second wire guide may include a second opening for receiving a second axle component. The third wire guide may include a third opening for receiving a third axle component. Each of the first, second, and third openings may have a different diameter. Each of the first and second wire guides may be keyed to the recess to prevent rotation relative to the recess when disposed therein. Each of the first, second, and third wire guides may be disposed in the recess. Each of the first, second, and third wire guides may be keyed to the recess to prevent rotation relative to the recess when disposed therein. The steering assembly may further include a first pulley coupled to the first and second wire segments. The first pulley may be disposed between the first wire guide and the second wire guide. A second pulley may be coupled to the third and fourth wire segments. The second pulley may be disposed between the second wire guide and the third wire guide. A thickness of the first pulley may maintain the first and the second gaps. A thickness of the second pulley may maintain the third and the fourth gaps. The first wire guide may have first and second offset surfaces that define first portions of the first and the second gaps, respectively. The second wire guide may have third and fourth offset surfaces that define second portions of the first and second gaps, respectively. The first wire guide may have a first step surface extending from the first offset surface to the second offset surface. The second wire guide may have a second step surface extending from the third offset surface to the fourth offset surface. The first and second step surfaces may define third portions of the first and second gaps, respectively.

In a further example, a steering assembly of a medical device may include a handle, first, second, and third wire guides disposed in the handle. At least one of the first, the second, or the third wire guide may be constrained by an axle. First and second wire segments may be configured to control movement of a sheath coupled to the handle in first and second directions, and third and fourth wire segments may be configured to control movement of the sheath in third and fourth directions. The first wire segment may pass through a first gap between the first wire guide and the second wire guide. The second wire segment may pass through a second gap between the first wire guide and the second wire guide. The third wire segment may pass through a third gap between the second wire guide and the third wire guide. The fourth wire segment may pass through a fourth gap between the second wire guide and the third wire guide.

Any example of steering assemblies described herein may have any of the following features. None of the first, the second, the third, or the fourth gaps may occupy any overlapping space. The first gap and the second gap may be offset from one another.

In another example, a steering assembly of a medical device may include first, second, and third wire guides disposed in a handle and a first pulley having first and second wires. The first pulley may be disposed between the first and second wire guides. A second pulley may have third and fourth wires. The second pulley may be disposed between the second and third wire guides. The first, second, and third wire guides and first and second pulleys may be stacked relative to one another to completely contain the first, second, third, and fourth wire segments in separate compartments.

Any example of steering assemblies described herein may further include the handle. The handle may include a recess. Each of the first, second, and third wire guides may be keyed to the recess to prevent rotation relative to the recess when contained therein.

As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," rather than "ideal. " As used herein, the term "proximal" means a direction closer to an operator and the term "distal" means a direction further from an operator. Although endoscopes are referenced herein, reference to endoscopes or endoscopy should not be construed as limiting the possible applications of the disclosed handles and other aspects. For example, the disclosed aspects may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and together with the description, serve to explain the principles of the disclosure.

Handles of endoscopes (e.g., operational portions of endoscopes) may include components that are used by an operator when performing a procedure with the endoscope. For example, a handle of an endoscope may include steering components or assemblies, which may be used to deflect a distal end of a sheath of the endoscope. These steering components or assemblies may include, for example pulleys, drums, and/or wires. Wires of a steering assembly may pass distally from the handle (e.g., handle), into a sheath of an endoscope (e.g., an insertion portion), and through the sheath toward the distal end of the sheath. The wires may be used to deflect the distal end of the sheath in one or more directions. For example, the sheath may include an articulation joint that may be capable of movement in a variety of directions (e.g., <NUM>-<NUM> degrees of movement). Alternatively, the sheath may include any other mechanisms or structures that may be used to achieve movement of the distal end of the sheath. In order to effectively deflect the distal end of the sheath, it may be important to prevent wires of a steering assembly from crossing one another. It also may be important to minimize friction of drums and/or pulleys and to optimize control of drums and/or pulleys. It also may be desirable to utilize components that are relatively inexpensive and/or easier to assemble. Therefore, aspects of the present disclosure are directed to wire guides for positioning and containing wires, drums, and/or pulleys within an endoscope.

<FIG> depicts a device <NUM>. Device <NUM> may be an endoscope, duodenoscope, bronchoscope, ureteroscope, colonoscope, catheter, or other type of medical device. Device <NUM> may include a handle <NUM>. Handle <NUM> may have any of the features described in the concurrently-filed U. Provisional Patent Application entitled "Chambered Handle for a Medical Device".

Device <NUM> also may include a sheath <NUM> or other type of tool, which may be inserted into a body lumen of a subject during a medical procedure. A proximal end of sheath <NUM> may be joined to handle <NUM>. Sheath <NUM> may include a distal end <NUM>. A distal tip <NUM> may be the distalmost feature of distal end <NUM>. Distal tip <NUM> may include a variety of components, such as elevators, air/water/suction openings, working channel opening(s), optical elements (e.g., cameras and/or lenses), lighting devices (e.g., light emitting diodes), etc. An articulation section <NUM> may be proximal of distal tip <NUM>. Articulation section <NUM> may include mechanisms configured to facilitate deflection of distal end <NUM> in one or more directions (e.g., in an up-, down-, left- and/or right-ward directions, perpendicular to a longitudinal axis of device <NUM>).

An umbilicus <NUM> may extend from handle <NUM>. Umbilicus <NUM> may be used to connect device <NUM> to components, such as a controller (for providing, e.g., optical controls including camera, video, light, or other optical controls), an air and/or water supply, and/or a suction supply.

Handle <NUM> may include a number of components used by an operator to control device <NUM> before, during, or after a procedure involving device <NUM>. For example, handle <NUM> may include steering components <NUM>. Steering components <NUM> may be used to control deflection of articulation section <NUM>. Steering components <NUM> may be a part of a steering assembly <NUM> (see <FIG>), discussed in further detail below. For example, steering components <NUM> may include two knobs, <NUM>, <NUM>, used for deflecting distal end <NUM> of sheath <NUM>. For example, one of knobs <NUM>, <NUM> may be used to deflect distal end <NUM> of sheath <NUM> in a left/right direction, and the other of knobs <NUM>, <NUM> may be used to deflect a distal end <NUM> of sheath <NUM> in an up/down direction. Steering components <NUM> also may include locking mechanisms <NUM>, <NUM>, which may be used to prevent or limit distal end <NUM> from moving in a left/right and/or up/down direction when in a locking position. For example, locking mechanism <NUM> may be a knob that is operable to prevent knob <NUM> from moving, thereby preventing deflection of distal end <NUM> in a left/right direction. Locking mechanism <NUM> may be a lever that is operable to prevent knob <NUM> from moving, thereby preventing deflection of distal end <NUM> in an up/down direction. Any other suitable feature can be used to prevent movement of knobs <NUM>, <NUM>.

Handle <NUM> also may include a number of ports and/or valves. For example, handle <NUM> may include a working channel port <NUM> that may be used for passing instruments or other devices down a working channel of sheath <NUM>. Working channel port <NUM> may be housed in a port housing <NUM>. Port <NUM> may include a valve to prevent leakage. Handle <NUM> also may include fluidics components, such as valves <NUM> for providing air, water, and/or suction. Valves <NUM> may connect to tubing in umbilicus <NUM>, handle <NUM>, and/or sheath <NUM>, such that pressing on valves <NUM>, <NUM> permits the corresponding function. For example, one of valves <NUM> may be used to provide air and/or water. Another of valves <NUM> may be used to provide suction and may connect to a working channel extending from working channel port <NUM>.

Handle <NUM> also may include other components such as elevator lever <NUM>, which may be used to move an elevator (not shown) at distal tip <NUM> of sheath <NUM> up and/or down. For example, elevator lever <NUM> may be included where device <NUM> is a duodenoscope.

A longitudinal axis of device <NUM> is an axis extending along handle <NUM> and sheath <NUM>, and a longitudinal direction is a direction along the longitudinal axis. A radial direction is a direction perpendicular to the longitudinal axis.

<FIG> shows a body <NUM> of handle <NUM>, without many of the components used for operation of device <NUM> installed. Body <NUM> may include a first recess <NUM>. First recess <NUM> may have walls <NUM> surrounding some but not all of first recess <NUM>. First recess <NUM> may be open at a distal end of first recess <NUM> and at an external side of body <NUM>. First recess <NUM> may have a rounded proximalmost side or end <NUM>, which may be semicircular or u-shaped. An internal surface (which may be a bottom surface) <NUM> of first recess <NUM> may extend from the open distal end to rounded proximalmost end <NUM>, opposite the open external side. Internal surface <NUM> may be parallel or approximately parallel to a longitudinal axis of body <NUM> and/or device <NUM>. First recess <NUM> may have two lateral surfaces <NUM> extending between the open distal end and the rounded proximalmost side <NUM>. As used herein, an outward direction is a direction extending from internal surface <NUM> through the open external side of first recess <NUM>, and an inward direction is the opposite direction. Alternatively, first recess <NUM> may have walls <NUM> surrounding other subsets of first recess <NUM>. First recess <NUM> may include a second recess <NUM>, which may be more deeply recessed than first recess <NUM> relative to the open external side of first recess <NUM>. For example, second recess <NUM> may be recessed from internal surface <NUM>.

Walls <NUM> may have a uniform height or may have a varying height measured along a radial direction of main body <NUM>. A ridge <NUM> may extend around a portion of a perimeter of first recess <NUM>. For example, ridge <NUM> may extend around a curved, proximalmost side <NUM> of first recess <NUM>. Ridge <NUM> also may extend along part of a lateral surface <NUM> of first recess <NUM>. For example, ridge <NUM> may extend along a part of a straight side of first recess <NUM> that is closer to umbilicus <NUM>.

As shown in <FIG>, a cable steering assembly <NUM> may be fit within, disposed upon, or otherwise attached to handle <NUM>. For example, cable steering assembly <NUM> may be received in first recess <NUM>. Cable steering assembly <NUM> may include an axle assembly <NUM>, which may include one or more axles, as discussed in further detail below. Cable steering assembly also may include two pairs of wires <NUM>, <NUM> for effecting deflection of a distal end <NUM> of sheath <NUM>. Pairs of wires <NUM>, <NUM> may each include two separate wires, which may each terminate in a ferrule and be affixed to a slot in a pulley (as discussed in further detail below). Alternatively, each pair of wires <NUM>, <NUM> may include a pair of wire segments formed from one single wire looped around a spool or pulley. First pair of wires <NUM> may control movement in one direction, such as in a left/right direction. Second pair of wires <NUM> may control movement in another direction, such as in an up/down direction. The configuration of pairs of wires <NUM>, <NUM> is merely exemplary. Alternative structures may be used, and pairs of wires <NUM>, <NUM> may be omitted in favor of other types of mechanisms for deflecting distal end <NUM> of sheath <NUM>.

First pair of wires <NUM> may include a first wire (or wire segment) <NUM> and a second wire (or wire segment) <NUM>. Moving first wire <NUM> proximally may cause distal end <NUM> of sheath <NUM> to deflect in a first direction (e.g., a rightward direction). Moving second wire <NUM> proximally may cause distal end <NUM> of sheath <NUM> to deflect in a second direction that is opposite the first direction (e.g., a leftward direction). Proximal movement of first wire <NUM> may accompany distal movement of second wire <NUM>. Proximal movement of second wire <NUM> may accompany distal movement of first wire <NUM>. First wire <NUM> and second wire <NUM> may be moved either proximally or distally by, for example, turning knob <NUM> or by activating an alternative mechanism, such as another component of steering components <NUM>. Turning knob <NUM> in a first direction may cause deflection in a first direction, and turning knob <NUM> in a second direction may cause deflection in a second direction.

Second pair of wires <NUM> may include a third wire <NUM> and a fourth wire <NUM>. Moving third wire <NUM> proximally may cause a distal end <NUM> of sheath <NUM> to deflect in a third direction (e.g., a downward direction). Moving fourth wire <NUM> proximally may cause a distal end <NUM> of sheath <NUM> to deflect in a fourth direction that is opposite of the third direction (e.g., an upward direction). Proximal movement of third wire <NUM> may accompany distal movement of fourth wire <NUM>. Proximal movement of fourth wire <NUM> may accompany distal movement of third wire <NUM>. Third wire <NUM> and fourth wire <NUM> may be moved either proximally or distally by, for example, turning knob <NUM> or by activating an alternative mechanism, such as another component of steering components <NUM>. Turning knob <NUM> in a first direction may cause deflection in a third direction, and turning knob <NUM> in a second direction may cause deflection in a fourth direction.

As shown in <FIG>, first wire <NUM> and second wire <NUM> may be spaced apart from one another and maintained substantially parallel to one another in first recess <NUM> of handle <NUM> by a first wire guide <NUM> and/or a second wire guide <NUM>. Interaction between first wire guide <NUM> and second wire guide <NUM>, as discussed in further detail below, may facilitate spacing of first wire <NUM> and second wire <NUM> from one another. Third wire <NUM> and fourth wire <NUM> may be spaced apart from one another and maintained substantially parallel to one another in first recess <NUM> of handle <NUM> by a second wire guide <NUM> and/or a third wire guide <NUM>. Interaction between second wire guide <NUM> and third wire guide <NUM>, as discussed in further detail below, may facilitate spacing of third wire <NUM> and fourth wire <NUM> from one another. As also shown in <FIG>, second wire guide <NUM> may serve to space first pair of wires <NUM> from second pair of wires <NUM>. Second wire guide <NUM> may keep first wire <NUM> substantially parallel to third wire <NUM> in first recess <NUM>. Second wire guide <NUM> also may keep second wire <NUM> substantially parallel to fourth wire <NUM> in first recess <NUM>.

Wire guides <NUM>, <NUM>, <NUM> may keep wires <NUM>, <NUM>, <NUM>, and <NUM> apart from one another. For example, wire guides <NUM>, <NUM>, <NUM> may be arranged to space apart wires <NUM>, <NUM>, <NUM>, and <NUM> from one another and maintain their positions on their respective pulleys. In other words, wire guides <NUM>, <NUM>, and <NUM> may form barriers that prevent wires <NUM>, <NUM>, <NUM>, and <NUM> from contacting one another. This may help avoid crossing of wires <NUM>, <NUM>, <NUM>, and <NUM>, which may interfere with steering distal end <NUM> of sheath <NUM>. In addition, this may help ensure wires are maintained in appropriate positions with respect to the pulleys.

<FIG> shows first recess <NUM> and ridge <NUM>, isolated from other components of handle <NUM>. An axle <NUM> of steering components <NUM> may be fixed to a body of handle <NUM>. For example, axle <NUM> may be fixed to a body of handle <NUM> using a washer or flange <NUM>. Flange <NUM> may have a complementary shape to second recess <NUM> so that there is a keyed relationship between flange <NUM> and second recess <NUM>. A keying relationship between flange <NUM> and second recess <NUM> may minimize or entirely prevent rotation of flange <NUM> within second recess <NUM>.

<FIG> show aspects of first wire guide <NUM>. <FIG> shows a front view of first wire guide <NUM>. <FIG> and <FIG> show perspective views of first wire guide <NUM>. <FIG> shows a bottom view of first wire guide <NUM>. <FIG> show first wire guide <NUM> positioned in first recess <NUM>. First wire guide <NUM> may have a perimeter that complements a shape of first recess <NUM>. For example, as shown in <FIG>, a proximalmost portion or side <NUM> of first wire guide <NUM> may have a rounded shape. A radius of curvature of proximalmost side <NUM> of first wire guide <NUM> may be the same as or slightly less than a radius of curvature of proximalmost side <NUM> of first recess <NUM>. First wire guide <NUM> may have a keyed relationship with first recess <NUM> to minimize or prevent rotation of first wire guide <NUM> relative to first recess <NUM>. As also shown in <FIG>, first wire guide may include a distalmost side <NUM>, which may be straight. First wire guide <NUM> also may include a first lateral side <NUM> and a second lateral side <NUM>, each of which may extend between proximalmost side <NUM> and distalmost side <NUM>. Shapes of first and second lateral sides <NUM>, <NUM> may be such that they mate with walls <NUM> of first recess <NUM>. For example, first and second lateral sides <NUM>, <NUM> may be straight. A shape of first wire guide <NUM> may assist in quick installation of first wire guide <NUM>, because wire guide <NUM> is not symmetrical and should be installed so that curved proximalmost side <NUM> of first wire guide <NUM> is adjacent to proximalmost side <NUM> of first recess <NUM>.

First wire guide <NUM> may have an opening <NUM>. Opening <NUM> may have a rounded shape (e.g., a circular shape). Opening <NUM> may be sized so as to have approximately the same diameter as axle <NUM> or a diameter that is slightly larger than a diameter of axle <NUM>. Opening <NUM> may be positioned closer to proximalmost side <NUM> than distalmost side <NUM>. Openings in any of the wire guides disclosed herein may be constrained via interactions between openings of the wire guides and axle <NUM> (or other axles or shafts).

First wire guide <NUM> may have a first side <NUM> and a second side <NUM>, each of which may extend from proximalmost side <NUM> to distalmost side <NUM>. <FIG>, in particular, shows aspects of first side <NUM>. <FIG>, in particular, shows aspects of second side <NUM>.

First wire guide <NUM> may have a proximal portion <NUM>. Proximal portion <NUM> may have a washer-type shape. For example, proximal portion <NUM> may include opening <NUM> and may include a portion of first wire guide <NUM> that is concentric to opening <NUM>.

First wire guide <NUM> may also have a first distal portion <NUM> and a second distal portion <NUM>. First distal portion <NUM> may extend from first lateral side <NUM> toward second lateral side <NUM>, but may terminate prior to second lateral side <NUM>. Second distal portion may <NUM> may extend from second lateral side <NUM> toward first lateral side <NUM>, but may terminate prior to first lateral side <NUM>. For example, each of first distal portion <NUM> and second distal portion <NUM> may terminate halfway or approximately halfway between first lateral side <NUM> and second lateral side <NUM>, although other dimensions are contemplated. Each of first distal portion <NUM> and second distal portion <NUM> may have a thickness that is greater than a thickness of proximal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> may be greater at each of first distal portion <NUM> and second distal portion <NUM> than at proximal portion <NUM>. As shown in <FIG>, first distal portion <NUM> and second distal portion <NUM> may be raised or protruding with respect to proximal portion <NUM> on first side <NUM>.

With particular reference to <FIG>, on first side <NUM>, first distal portion <NUM> may be more raised relative to proximal portion <NUM> than second distal portion <NUM>. First distal portion <NUM> may be thicker than second distal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> may be greater at first distal portion <NUM> than at second distal portion <NUM>.

<FIG> shows a bottom view of first wire guide <NUM>, so that distalmost side <NUM> is shown. Along distalmost side <NUM>, second side <NUM> may be flat. Along distalmost side <NUM>, first side <NUM> may be staggered so that there is a first flat portion <NUM> (along first distal portion <NUM>) and a second flat portion <NUM> (along second distal portion <NUM>), with a step <NUM> between first flat portion <NUM> and second flat portion <NUM>. First flat portion <NUM> and second flat portion <NUM> may be offset from one another. First flat portion <NUM> and second flat portion <NUM> may be substantially parallel to one another. Step <NUM> may form a boundary between first flat portion <NUM> and second flat portion <NUM>. Step <NUM> may be substantially perpendicular to both first flat portion <NUM> and second flat portion <NUM>.

On first side <NUM>, first distal portion <NUM> may have a proximal edge <NUM>, and second distal portion <NUM> may have a proximal edge <NUM>. Proximal edges <NUM>, <NUM> of first and second distal portions <NUM>, <NUM>, respectively, may be adjacent to proximal portion <NUM>. Proximal edges <NUM>, <NUM> may have a rounded, concave shape that each may be segments of a same circle. Proximal edges <NUM>, <NUM> may have a same or similar shape when first side <NUM> is viewed head-on, as shown in <FIG>, although proximal edges <NUM>, <NUM> may have different thicknesses. For example, proximal edge <NUM> may be thicker than proximal edge <NUM>. A difference in thickness between proximal edge <NUM> and proximal edge <NUM> may correspond to a difference in thickness between first distal portion <NUM> and second distal portion <NUM>.

With particular reference to <FIG>, first distal portion <NUM> may be hollow so that first distal portion <NUM> includes a recess <NUM> on second side <NUM>. Recess <NUM> may have interior walls <NUM> that follow the contours of first distal portion <NUM>. The fact that first distal portion <NUM> may be hollow may result in decreased manufacturing costs and mass of first wire guide <NUM>. Recess <NUM> may maintain a constant thickness of walls of first wire guide <NUM>, facilitating molding of first wire guide <NUM> or other manufacturing techniques of first wire guide <NUM>. Alternatively, recess <NUM> may have any of the properties of recess <NUM>, discussed below with respect to third wire guide <NUM>. Recess <NUM> or another portion of first wire guide <NUM> also may include an indicator <NUM>. Indicator <NUM> may indicate, for example, an orientation of wire guide <NUM> within handle <NUM>. For example, indicator <NUM> may be a "B," e.g., a first symbol, or any other suitable symbol, indicating that first wire guide <NUM> is the bottom wire guide that will be adjacent to internal surface <NUM> of recess <NUM>. Alternatively, other indicators may be used.

<FIG> shows first wire guide <NUM> placed in recess <NUM>. <FIG> shows a first pulley <NUM> installed adjacent to first side <NUM> of first wire guide <NUM> (above first wire guide <NUM>). As used herein, the term "above" or "on top of" indicates an outward direction, toward the open external side of recess <NUM>. The term "below" or "underneath" indicates an inward direction, toward internal surface <NUM>. First wire guide <NUM> may be positioned in first recess <NUM> so that second side <NUM> of first wire guide <NUM> is adjacent to internal surface <NUM> of first recess <NUM>. First side <NUM> may face the open external side of first recess <NUM>. Axle <NUM> may extend through opening <NUM>. For example, first wire guide <NUM> may be positioned so that axle <NUM> is aligned with opening <NUM>, and then first wire guide <NUM> may be advanced along axle <NUM> until it rests on internal surface <NUM> of first recess <NUM>. First pulley <NUM> may abut first wire guide <NUM>, or there may be a gap between first pulley <NUM> and first wire guide <NUM>. First pulley <NUM> may have a spool shape. First pulley <NUM> may have an outer diameter such that first pulley <NUM> aligns with proximal portion <NUM> of first wire guide <NUM> and abuts proximal edges <NUM>, <NUM>. For example, a diameter of proximal portion <NUM> may be substantially equal to a diameter of first pulley <NUM>. First pair of wires <NUM> (first wire <NUM> and second wire <NUM>) may be wrapped around first pulley <NUM>. As discussed above, first pair of wires <NUM> may be one continuous wire or may include separate wires. First pulley <NUM> may be attached to a first pulley axle <NUM>, which may be a component of axle assembly <NUM>, and which may be coaxial with axle <NUM>. First pulley axle <NUM> may be fixed relative to first pulley <NUM> so that rotation of first pulley axle <NUM> causes rotation of first pulley <NUM>. First pulley axle <NUM> may be operatively connected to knob <NUM> for causing rotation of first pulley axle <NUM>. First wire <NUM> may pass along first flat surface <NUM> of first distal portion <NUM>. Second wire <NUM> may pass along second flat surface <NUM> of second distal portion <NUM>.

<FIG> show aspects of second wire guide <NUM>. <FIG> show second wire guide <NUM> installed in first recess <NUM> of handle <NUM>. A perimeter shape of second wire guide <NUM> may have any of the features of a perimeter shape of first wire guide <NUM>, discussed above. For example, second wire guide <NUM> may have a same perimeter shape as first wire guide <NUM>. For example, as discussed above with respect to first wire guide <NUM>, second wire guide <NUM> may have a perimeter shape that complements a shape of first recess <NUM>.

Second wire guide <NUM> may include a proximalmost side <NUM>, which may be curved, and a distalmost side <NUM>, which may be straight. Second wire guide <NUM> also may include a first lateral side <NUM> and a second lateral side <NUM>, each of which may extend between proximalmost side <NUM> and distalmost side <NUM>. Shapes of first and second lateral sides <NUM>, <NUM> may be such that they mate with lateral surfaces <NUM> of first recess <NUM>. For example, first and second lateral sides <NUM>, <NUM> may be straight. A shape of first wire guide <NUM> may assist in quick installation of second wire guide <NUM>.

Second wire guide <NUM> may have an opening <NUM>. Opening <NUM> may have a rounded shape (e.g., a circular shape). Opening <NUM> may be sized so as to have approximately the same diameter as first pulley axle <NUM>. Opening <NUM> may have a diameter that is slightly larger than a diameter of first pulley axle <NUM>. Opening <NUM> may be positioned closer to proximalmost side <NUM> than to distalmost side <NUM>. Opening <NUM> may have a larger diameter than opening <NUM> because first pulley axle <NUM> may have a larger diameter than axle <NUM>.

Second wire guide <NUM> may have a first side <NUM> (see <FIG>) and a second side <NUM> (see <FIG>), each of which may extend from proximalmost end <NUM> to distalmost end <NUM>. First and second sides <NUM>, <NUM> may be the same as one another when viewed head-on. Thus, although <FIG> specifically depicts first side <NUM>, first side <NUM> may be the same as second side <NUM>.

Second wire guide <NUM> may have a proximal portion <NUM>. Proximal portion <NUM> may have a washer-type shape. For example, proximal portion <NUM> may include opening <NUM> and may include a portion of second wire guide <NUM> that is concentric to opening <NUM>.

Second wire guide <NUM> may also have a first distal portion <NUM> and a second distal portion <NUM>. First distal portion <NUM> may extend from first lateral side <NUM> toward second lateral side <NUM>, but may terminate prior to second lateral side <NUM>. Second distal portion <NUM> may extend from second lateral side <NUM> toward first lateral side <NUM>, but may terminate prior to first lateral side <NUM>. For example, each of first distal portion <NUM> and second distal portion <NUM> may terminate halfway or approximately halfway between first lateral side <NUM> and second lateral side <NUM>. Each of first distal portion <NUM> and second distal portion <NUM> may have a thickness that is greater than a thickness of proximal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> may be greater at each of first distal portion <NUM> and second distal portion <NUM> than at proximal portion <NUM>. As shown in <FIG>, first distal portion <NUM> and second distal portion <NUM> may be raised or protruding with respect to proximal portion <NUM> on first side <NUM> and on second side <NUM>.

As shown in <FIG>, on first side <NUM>, first distal portion <NUM> may be more raised or further protruding than second distal portion <NUM>, relative to a plane defining proximal portion <NUM>. On second side <NUM>, second distal portion <NUM> may be more raised or further protruding than first distal portion <NUM>, relative to a plane defining proximal portion <NUM>.

<FIG> shows a bottom view of second wire guide <NUM> in a proximal direction, so that distalmost side <NUM> is shown. A thickness of first distal portion <NUM> at distalmost side <NUM> may be the same as a thickness of second distal portion <NUM> at distalmost side <NUM>. Alternatively, first distal portion <NUM> may have a different thickness than second distal portion <NUM> at distalmost side <NUM>. Along both first side <NUM> and second side <NUM>, distalmost side <NUM> may be staggered. On first side <NUM>, there may be a first flat portion <NUM> (along first distal portion <NUM>) and a second flat portion <NUM> (along second distal portion <NUM>), with a first step <NUM> between first flat portion <NUM> and second flat portion <NUM> (as discussed below, first distal portion <NUM> may be hollow on a surface of first side <NUM> but may be flat along distalmost side <NUM> and second side <NUM>). First flat portion <NUM> may be substantially parallel to and offset from second flat portion <NUM>, and step <NUM> may be substantially perpendicular to both first flat portion <NUM> and second flat portion <NUM>. On second side <NUM>, there may be a third flat portion <NUM> and a fourth flat portion <NUM> (as discussed below, second distal portion <NUM> may be hollow on a surface of second side <NUM> but may be flat along distalmost side <NUM> and first side <NUM>), with a second step <NUM> between third flat portion <NUM> and fourth flat portion <NUM>. Third flat portion <NUM> may be substantially parallel to and offset from fourth flat portion <NUM>, and step <NUM> may be substantially perpendicular to both third flat portion <NUM> and fourth flat portion <NUM>. First step <NUM> and second step <NUM> may be approximately halfway between first lateral side <NUM> and second lateral side <NUM>, although other dimensions are contemplated. First step <NUM> and second step <NUM> may align or may be offset from one another.

On first side <NUM>, first distal portion <NUM> may have a first side proximal edge <NUM>, and second distal portion <NUM> may have a first side proximal edge <NUM>. On second side <NUM>, first distal portion <NUM> may have a second side proximal edge <NUM>, and second distal portion <NUM> may have a second side proximal edge <NUM>. Proximal edges <NUM>, <NUM>, <NUM>, <NUM> may be adjacent to proximal portion <NUM>. Proximal edges <NUM>, <NUM>, <NUM>, <NUM> may have a rounded, concave shape that each may be segments of the same circle. Proximal edges <NUM>, <NUM>, <NUM>, <NUM> may have a same or similar shape when first side <NUM> or second side <NUM> is viewed head-on (although proximal edges <NUM>, <NUM>, <NUM>, <NUM> may have different thicknesses). First side proximal edge <NUM> of first distal portion <NUM> may have a greater thickness than second side proximal edge <NUM> first distal portion <NUM>. Second side proximal edge <NUM> of second distal portion <NUM> may have a greater thickness than first side proximal edge <NUM> of second distal portion <NUM>. First side proximal edge <NUM> of first distal portion <NUM> may have a greater thickness than first side proximal edge <NUM> of second distal portion <NUM>. Second distal portion <NUM> may be more raised or protruding than first distal portion <NUM> on second side <NUM>, second side proximal edge <NUM> of second distal portion <NUM> may have a greater thickness than second side proximal edge <NUM> of first distal portion <NUM>.

First and second distal portions <NUM>, <NUM> may be hollow. For example, first distal portion <NUM> may include a recess <NUM> on first side <NUM>. Recess <NUM> may have interior walls <NUM> that follow contours of first distal portion <NUM>. Second distal portion <NUM> may include a recess <NUM> on second side <NUM>. Referring to <FIG>, recess <NUM> may have interior walls <NUM> that follow contours of second distal portion <NUM>. The fact that first distal portions <NUM>, <NUM> may be hollow may result in decreased manufacturing costs and mass of second wire guide <NUM>.

One or both of recesses <NUM>, <NUM> may include an indicator <NUM>. Indicator <NUM> may indicate, for example, an orientation of second wire guide <NUM> in handle <NUM>. For example, indicator <NUM> may be an "M," or a second symbol different than indicator <NUM>, indicating that second wire guide <NUM> is the middle wire guide that will be above first wire guide <NUM>. Alternatively, other indicators may be used.

<FIG> shows second wire guide <NUM> placed in recess <NUM>. <FIG> shows a second pulley <NUM> installed adjacent to first pulley <NUM> (above first pulley <NUM>). Second wire guide <NUM> may be positioned in first recess <NUM> so that second side <NUM> of second wire guide <NUM> faces internal surface <NUM> of first recess <NUM>. First side <NUM> may face the externally open side of first recess <NUM>. It should be noted that since first side <NUM> and second side <NUM> may be identical, that second wire guide <NUM> may be positioned so that second side <NUM> faces internal surface <NUM>. As shown in <FIG>, first pulley axle <NUM> may be extend through opening <NUM>. For example, second wire guide <NUM> may be positioned so that first pulley axle <NUM> is aligned with opening <NUM>, and then second wire guide <NUM> may be advanced along first pulley axle <NUM> until second side <NUM> is adjacent to first pulley <NUM>.

Proximal portion <NUM> of second wire guide <NUM> may be positioned adjacent to a surface of first pulley <NUM>, facing an open exterior side of recess <NUM>. Second side <NUM> of proximal portion <NUM> of second wire guide <NUM> may rest upon an outward surface of first pulley <NUM>, and second side <NUM> may face an open exterior side of recess <NUM>. First pulley <NUM> may have an outer diameter such that first pulley <NUM> may align with proximal portion <NUM> of second wire guide <NUM>. For example, first pulley <NUM> may have a diameter substantially equal to that of proximal portion <NUM>. A gap may be formed between a first side <NUM> of first wire guide <NUM> and a second side <NUM> of second wire guide <NUM> due to a thickness of first pulley <NUM> and a relative height difference between wire guides <NUM>, <NUM> and pulley <NUM>. More specifically, a first gap <NUM> may be formed between first side <NUM> of a first distal portion <NUM> of first wire guide <NUM> and second side <NUM> of first distal portion <NUM> of second wire guide <NUM>. A second gap <NUM> may be formed between first side <NUM> of second distal portion <NUM> of first wire guide <NUM> and second side <NUM> of second distal portion <NUM> of second wire guide <NUM>. First gap <NUM> and second gap <NUM> may not occupy any overlapping space. First gap <NUM> may be offset from second gap <NUM>. First wire <NUM> may pass through gap <NUM>, and second wire <NUM> may pass through gap <NUM>. Walls <NUM> and/or <NUM> may constrain first wire <NUM> and/or second wire <NUM> from moving laterally past wall <NUM> and/or wall <NUM>. For example, walls <NUM> and/or <NUM> may limit wires <NUM> and/or <NUM> from moving past a centerline of first recess <NUM>. Gap <NUM> may be an aperture or compartment formed by first side <NUM> of a first distal portion <NUM> of first wire guide <NUM>, second side <NUM> of first distal portion <NUM> of second wire guide <NUM>, step <NUM>, and lateral surface <NUM> of first recess <NUM>. Gap <NUM> may be an aperture or compartment formed by first side <NUM> of second distal portion <NUM> of first wire guide <NUM>, second side <NUM> of second distal portion <NUM> of second wire guide <NUM>, step <NUM>, and lateral surface <NUM> of first recess <NUM>. Gaps <NUM> and/or <NUM> may have a substantially rectangular cross-section. Gaps <NUM> and/or <NUM> may be enclosed on four sides or may not be fully enclosed. For example, gap <NUM> may be open to gap <NUM> via a space between walls <NUM> and <NUM>.

As shown in <FIG>, second pulley <NUM> may be disposed adjacent to second wire guide <NUM> (e.g., above second wire guide <NUM>). Second pulley <NUM> may have a spool shape. An outer diameter of second pulley <NUM> may be such that second pulley <NUM> aligns with an outer diameter of proximal portion <NUM> of second wire guide <NUM>. For example, second pulley <NUM> may have an outer diameter that is substantially equal to an outer diameter of first pulley <NUM> and/or proximal portions <NUM>, <NUM>. Second pair of wires <NUM> (third wire <NUM> and fourth wire <NUM>) may be coupled to second pulley <NUM>. As discussed above, second pair of wires <NUM> may be one continuous wire or may include separate wires. Second pulley <NUM> may be attached to a second pulley axle <NUM>, which may be coaxial with axle <NUM> and/or first pulley axle <NUM>, and which may be a component of axle assembly <NUM>. Second pulley axle <NUM> may be fixed relative to second pulley <NUM> so that rotation of second pulley axle <NUM> causes rotation of second pulley <NUM>. Second pulley axle <NUM> may have a larger outer diameter than first pulley axle <NUM>, and second pulley axle <NUM> may fit over first pulley axle <NUM> as part of axle assembly <NUM>. Second pulley axle <NUM> may be operatively connected to knob <NUM> for causing rotation of second pulley axle <NUM>. Third wire <NUM> may pass along first distal portion <NUM>. Fourth wire <NUM> may pass along second distal portion <NUM>.

<FIG> show aspects of third wire guide <NUM>. <FIG> shows third wire guide installed in cable steering assembly <NUM>. Third wire guide <NUM> may have any of the features of first wire guide <NUM> or second wire guide <NUM>. For example, third wire guide <NUM> may have a shape that is complementary to first recess <NUM>. For example, a proximalmost portion or side <NUM> of third wire guide <NUM> may have a rounded shape. A radius of curvature of proximalmost side <NUM> of third wire guide <NUM> may be the same as or similar to a radius of curvature of proximalmost side <NUM> of first recess <NUM>. Third wire guide <NUM> may have a keyed relationship with first recess <NUM> to minimize or prevent rotation of third wire guide <NUM> relative to first recess <NUM> or ridge <NUM>. Third wire guide <NUM> may include a distalmost side <NUM>, which may be straight. Third wire guide <NUM> also may include a first lateral side <NUM> and a second lateral side <NUM>, each of which may extend between proximalmost side <NUM> and distalmost side <NUM>.

Third wire guide <NUM> may have an opening <NUM>. Opening <NUM> may have a rounded shape (e.g., a circular shape). Opening <NUM> may be sized so as to have approximately the same diameter as second pulley axle <NUM>. Opening <NUM> may have a diameter that is slightly larger than a diameter of second pulley axle <NUM>. Opening <NUM> may be positioned closer to a proximalmost end <NUM> of third wire guide <NUM> than distalmost end <NUM> of third wire guide <NUM>. Opening <NUM> may be larger than each of openings <NUM> and <NUM>.

Third wire guide <NUM> may have a first side <NUM> (see <FIG>) and a second side <NUM> (see <FIG>), each of which may extend from proximalmost side <NUM> to distal most side <NUM>. First side <NUM> of third wire guide <NUM> may be identical to first side <NUM> of first wire guide <NUM>, except an opening <NUM> may be larger than opening <NUM> to account for a larger size of second pulley axle <NUM> than axle <NUM>.

Third wire guide <NUM> may have a proximal portion <NUM>. Proximal portion <NUM> may have a washer-type shape. For example, proximal portion <NUM> may include opening <NUM> and may include a portion of third wire guide <NUM> that is concentric to opening <NUM>. For example, proximal portion <NUM> may have an internal diameter that is approximately the same as a diameter of second pulley axle <NUM>, and an outer diameter may have a diameter that is approximately the same as an outer diameter of second pulley <NUM>. Second pulley <NUM> may align with proximal portion <NUM>.

Third wire guide <NUM> may also have a first distal portion <NUM> and a second distal portion <NUM>. First distal portion <NUM> may extend from second lateral side <NUM> toward first lateral side <NUM>, but may terminate prior to first lateral side <NUM>. Second distal portion <NUM> may extend from first lateral side <NUM> toward second lateral side <NUM>, but may terminate prior to second lateral side <NUM>. For example, each of first distal portion <NUM> and second distal portion <NUM> may terminate halfway or approximately halfway between first lateral side <NUM> and second lateral side <NUM>, although other dimensions are contemplated. Each of first distal portion <NUM> and second distal portion <NUM> may have a thickness that is greater than a thickness of proximal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> may be greater at each of first distal portion <NUM> and second distal portion <NUM> than at proximal portion <NUM>. First distal portion <NUM> and second distal portion <NUM> may be raised or protruding with respect to proximal portion <NUM> on first side <NUM>.

On first side <NUM>, with respect to proximal portion <NUM>, first distal portion <NUM> may be more protruding or raised than second proximal portion <NUM>. First distal portion <NUM> may be thicker than second distal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> may be greater at first distal portion <NUM> than at second distal portion <NUM>.

<FIG> shows a bottom view of third wire guide <NUM>, so that distalmost side <NUM> is shown. Distalmost side <NUM> may have a larger cross-section in a first distal portion <NUM> than in a second distal portion <NUM>. In other words, a distance between first side <NUM> and second side <NUM> along distalmost side <NUM> may be greater in first distal portion <NUM> than in second distal portion <NUM>. Along distalmost side <NUM>, first side <NUM> may be staggered so that there is a first flat portion <NUM> (along first distal portion <NUM>) and a second flat portion <NUM> (along second distal portion <NUM>), and step <NUM> between first flat portion <NUM> and second flat portion <NUM>. First flat portion <NUM> and second flat portion <NUM> may be substantially parallel to and offset from one another. Step <NUM> may form a boundary between first flat portion <NUM> and second flat portion <NUM>. Step <NUM> may be substantially perpendicular to both first flat portion <NUM> and second flat portion <NUM>.

On first side <NUM>, first distal portion <NUM> may have a proximal edge <NUM>, and second distal portion <NUM> may have a proximal edge <NUM>. Proximal edges <NUM>, <NUM> of first and second distal portions <NUM>, <NUM>, respectively, may be adjacent to proximal portion <NUM>. Proximal edges <NUM>, <NUM> may have a rounded, concave shape that each may be segments of the same circle. Proximal edges <NUM>, <NUM> may have a same or similar shape when first side <NUM> is viewed head-on although proximal edges <NUM>, <NUM> may have different thicknesses. For example, proximal edge <NUM> may be thicker than proximal edge <NUM>, due to the fact that first distal portion <NUM> is more protruding than distal portion <NUM>, relative to proximal portion <NUM>.

With particular reference to <FIG>, first distal portion <NUM> may be hollow so that first distal portion <NUM> includes a recess <NUM> on second side <NUM>. Recess <NUM> may have interior walls <NUM> that follow the contours of first distal portion <NUM>. Alternatively, recess <NUM> may only include interior walls <NUM> corresponding to proximal edge <NUM> and wall <NUM>, so that recess <NUM> is open on distalmost side <NUM> of third wire guide <NUM> and second lateral side <NUM> of third wire guide <NUM>. The fact that first distal portion <NUM> may be hollow may result in decreased manufacturing costs and mass of third wire guide <NUM>. A shape of recess <NUM> may also facilitate placement of other mechanisms in handle <NUM> (e.g., an elevator articulation mechanism or other mechanism). Recess <NUM> or another portion of third wire guide <NUM> also may include an indicator <NUM>. Indicator <NUM> may indicate, for example, an orientation of third wire guide <NUM> within handle <NUM>. For example, indicator <NUM> may be a "T," or a third symbol different from indicators <NUM>, <NUM>, indicating that third wire guide <NUM> is the top wire guide that will face outwardly from recess <NUM>. Alternatively, other indicators may be used.

<FIG> shows third wire guide <NUM> installed in cable steering assembly <NUM>. Third wire guide <NUM> may be positioned in, about, or upon first recess <NUM> so that first side <NUM> of third wire guide <NUM> is adjacent to a surface of second pulley <NUM> facing an open exterior surface of first recess <NUM>. Second side <NUM> may face the open exterior surface of first recess <NUM>. Second pulley axle <NUM> may extend through opening <NUM>. For example, third wire guide <NUM> may be positioned so that axle second pulley axle <NUM> is aligned with opening <NUM>, and then third wire guide <NUM> may be advanced along third pulley axle <NUM> until third wire guide <NUM> rests on a surface of second pulley <NUM> closest to the open exterior surface of first recess <NUM>. Proximal portion <NUM> of third wire guide <NUM> may be positioned adjacent to and rest upon an outward facing surface of second pulley <NUM>. As discussed above, second pulley <NUM> may have an outer diameter such that second pulley <NUM> may align with proximal portion <NUM> of third wire guide <NUM>. For example, second pulley <NUM> may have substantially the same outer diameter as proximal portion <NUM>.

A gap may be formed between a first side <NUM> of second wire guide <NUM> and first side <NUM> of third wire guide <NUM>. More specifically, a third gap <NUM> may be formed between first side <NUM> of first distal portion <NUM> of second wire guide <NUM> and first side <NUM> of second distal portion <NUM> of third wire guide <NUM> due to a thickness of second pulley <NUM>. A fourth gap <NUM> may be formed between first side <NUM> of second distal portion <NUM> of second wire guide <NUM> and first side <NUM> of first distal portion <NUM> of third wire guide <NUM> due to thickness of second pulley <NUM>. Each of third gap <NUM> and fourth gap <NUM> may be offset from each other and each of first gap <NUM> and second gap <NUM>. Third gap <NUM> and fourth gap <NUM> may be separated by one or more of walls <NUM> and <NUM>. None of first, second, third, and fourth gaps <NUM>, <NUM>, <NUM>, <NUM> may occupy any overlapping space. Third wire <NUM> may pass through third gap <NUM>, and fourth wire <NUM> may pass through fourth gap <NUM>. Walls <NUM> and/or <NUM> may limit lateral movement of third wire <NUM> and/or fourth wire <NUM>. For example, walls <NUM> and/or <NUM> may limit wires <NUM> and/or <NUM> from crossing a center line of first recess <NUM>. Third gap <NUM> may be an aperture or compartment formed by first side <NUM> of first distal portion <NUM> of second wire guide <NUM>, first side <NUM> of second distal portion <NUM> of third wire guide <NUM>, wall <NUM>, and lateral surface <NUM> of first recess <NUM>. Fourth gap <NUM> may be an aperture or compartment formed by first lateral side <NUM> of second distal portion <NUM> of second wire guide <NUM>, first lateral side <NUM> of first distal portion <NUM> of third wire guide <NUM>, wall <NUM>, and lateral surface <NUM> of first recess <NUM>. Gaps <NUM> and/or <NUM> may have substantially rectangular cross-section. Gaps <NUM> and/or <NUM> may be enclosed on four sides or may not be fully enclosed. For example, gap <NUM> may be open to gap <NUM> via a space between walls <NUM> and <NUM>.

A second side <NUM> of third wire guide <NUM> may be the component of cable steering assembly <NUM> closest to an open side of first recess <NUM>, and, apart from recess <NUM>, second side of third wire guide <NUM> may form a flat surface.

Claim 1:
A steering assembly (<NUM>) of a medical device (<NUM>), the steering assembly comprising:
a handle (<NUM>) having a recess (<NUM>);
first and second wire guides (<NUM>, <NUM>) disposed within the recess (<NUM>), wherein at least one of the first or second wire guides (<NUM>, <NUM>) is keyed to the recess (<NUM>) to prevent rotation of the first or second wire guide (<NUM>, <NUM>) within the recess (<NUM>); and
first and second wire segments (<NUM>, <NUM>) configured to steer a sheath (<NUM>) coupled to the steering assembly (<NUM>) in first and second directions;
wherein the first wire segment (<NUM>) passes through a first gap between the first wire guide (<NUM>) and the second wire guide (<NUM>), and the second wire segment (<NUM>) passes through a second gap between the first wire guide (<NUM>) and the second wire guide (<NUM>), and wherein neither of the first nor the second gap occupy any overlapping space.