Patent ID: 12213650

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Embodiments of the present invention will now be described with reference to the drawings where like numerals correspond to like elements. Embodiments of the present invention are directed to systems of the type broadly applicable to numerous medical applications in which it is desirable to insert one or more steerable or non-steerable imaging devices, catheters or similar devices into a body lumen or passageway. Specifically, several embodiments of the present invention are generally directed to medical visualization systems that comprise combinations of disposable and reusable components, such as catheters, functional handles, hubs, optical devices, etc.

Other embodiments of the present invention are generally directed to features and aspects of an in-vivo visualization system that comprises a catheter having a working channel through which a catheter having viewing capabilities is routed. As will be described in detail below, the catheter may obtain viewing capabilities by being constructed as a vision catheter or by having a fiberscope or other viewing device selectively routed through one of its channels. The catheter is preferably of the steerable type so that the distal end of the catheter may be steered from its proximal end as it is advanced within the body. A suitable use for the in-vivo visualization system includes but is not limited to diagnosis and/or treatment of the duodenum, and particularly the biliary tree.

Several embodiments of the present invention include medical devices, such as catheters, that incorporate endoscopic features, such as illumination and visualization capabilities, for endoscopically viewing anatomical structures within the body. As such, embodiments of the present invention can be used for a variety of different diagnostic and interventional procedures. Although exemplary embodiments of the present invention will be described hereinafter with reference to duodenoscopes, it will be appreciated that aspects of the present invention have wide application, and may be suitable for use with other endoscopes (e.g., ureteroscopes) or medical devices, such as catheters (e.g., guide catheters, electrode catheters, angioplasty catheters, etc.). Accordingly, the following descriptions and illustrations herein should be considered illustrative in nature, and thus, not limiting the scope of the present invention. Additionally, the catheter with vision capabilities may be utilized alone, as well as in conjunction with a conventional endoscope.

FIG.1illustrates an optical catheter system8in accordance with one embodiment of the present invention. The primary components of the system8include a sterile, single-use, disposable catheter10, a sterile, single-use, disposable hub20, and a reusable handle30. In the illustrated embodiment, the hub20is integral, i.e., permanently part of, the disposable catheter10such that they together define a sterile, single-use, disposable catheter assembly. For example, the hub20may be joined to the catheter10with injection molding or adhesive bonding. The catheter assembly defined by the hub20and catheter10is preferably packaged in a sterile container or package (not illustrated) prior to use by a physician. In an alternative embodiment, the hub20is integral, i.e., permanently part of, the handle30. In a further embodiment, the hub20is not integral with the catheter10or the handle30, but connects to these items with connectors, such as male and female threaded connectors, quick lock connectors, bayonet connectors, snap connectors, or other known connectors.

As is illustrated inFIGS.2-4, the catheter10includes an elongated, preferably cylindrical, body38that extends the entire length of the catheter10. In one embodiment, the catheter body38has an outer diameter between approximately 5 and 12 French, and preferably between approximately 7 and 10 French. The catheter body38may be constructed from any suitable material, such as Pebax® (polyether block amides), nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane, fluorinated ethylene propylene (FEP), thermoplastic elastomers and the like, or combinations thereof. The body38may be formed of a single material using known techniques in the art, such as extrusion, or multiple materials by joining multiple extruded sections by heat bonding, adhesive bonding, lamination or other known techniques (e.g., juxtaposed Nitinol tubes wrapped with an adhesive bonding.

In some applications, e.g. urological, it is desirable that the catheter10have a varying degree of stiffness from the distal (e.g., renal pelvis) end18towards the proximal (e.g., bladder) end16. The proximal end16should be stiff enough for the device to advance in the tract to the desired location (e.g., in the urinary tract to the renal pelvis/kidney area). The distal end18should be soft enough to provide a reduction in trauma during insertion but rigid enough to provide adequate support during the procedure and prevent collapse or kinking. According to an embodiment of the present invention for urological application, the distal portion of the catheter (approximately 1-2 inches where the flexing occurs) is made more flexible (i.e., less stiff) than the remainder of the catheter to allow for steerability of the catheter in vivo. Several techniques for constructing a catheter having a more flexible distal portion than the remainder of the catheter will be described in more detail below.

In the embodiment shown inFIG.1, the catheter10includes a proximal portion42that extends the majority of the catheter10and a distal portion44. The catheter10preferably varies in stiffness between the proximal portion42and the distal portion44. More preferably, the proximal portion42is stiffer than the distal portion44. This allows the catheter10to be easily advanced without compressing and with minimal twisting while providing deflection capabilities to the distal portion42for deflecting the distal end18. In one embodiment, the proximal portion42has a durometer value between 35 and 85 shore D, preferable 60-80 shore D, and the distal portion44has a durometer value between 5 and 55 shore D, preferable 25-40 shore D.

As is illustrated inFIGS.2and3, the catheter10may optionally include an inner sheath56and/or an outer sleeve58that encase the length of the elongated body38or portions thereof. In one embodiment, the sheath56is a woven or layered structure, such as a braided design of fine wire or polymeric elements woven or coiled together along the longitudinal axis of the catheter with conventional catheter braiding (e.g.,2wires having a diameter ranging from 0.001 to 0.010 inches wound in a 2-over, 2-under helical fashion from the proximal to distal end of the catheter10). This allows the catheter10to be advanced to the desired anatomical site by increasing the column strength of the assembly while also increasing the torsional rigidity of the catheter. Conventional coiled polymer or braid wire may also be used for this component with coil wire dimensions ranging in width from 0.002 to 0.120 inches and thickness from 0.002 to 0.10 inches. Braided ribbon wire (e.g., 0.002×0.005 inches; 0.003×0.012 inches) may also be used for the sheath56.

The outer sleeve58may comprise of any number of polymer jackets that are laminated over the first sheath56. Suitable materials for the sleeve58include, but without limitation, polyethylene, such as polyethylene having a molecular weight in the range of 50,000 to 100,000; nylon, such as nylon 12, nylon 4-6, and nylon 6-6; Pebax (polyether block amides); polyurethane; polytetrafluoroethylene (PTFE), particularly fluorinated ethylene propylene (FEP) copolymers; and polyethylene impregnated with PTFE. The outer sleeve58may be used to vary the stiffness of the catheter, if desired, or to provide improved torque transfer and/or other desirable catheter properties. Additionally, the sleeve58may be used as one convenient method for securing a more flexible deflection section to the proximal section, as will be described in detail below. In one embodiment, as will be described in more detail below, the outer sleeve58is coextruded, coated, or otherwise attached once the sheath56is applied, to lock the sheath56in place and secure it to the catheter body38, thereby forming a composite catheter.

In several embodiments, the external surface of the catheter, for example, the outer sleeve58, can have a hydrophilic coating or a silicone coating to ease the passage of the device in vivo. Such a hydrophilic coating can be, for example, but without limitation, N-Vinyl Pyrrolidone, Poly Vinyl Alcohol, and Poly Vinyl Pyrrolidone. The hydrophilic coating can be accomplished by coating the device with a primer, such as Bayhydrol 110 (an anionic dispersion of an aliphatic polyester urethane resin in water/n-methyl-2pyrrolidone) and then bonding a primary layer over the primer. The primary layer can be, without limitation, an acrylamide or a polyurethane-based acrylamide. Alliphatic polyether and polyester polyurethanes also can be used as lubricous coatings.

In a further embodiment, the distal portion44of the catheter10may contain a preset curve detail that allows a physician to easily access various locations (e.g., the renal pelvis) with minimal manipulation via passive deflection (i.e., without ex-vivo steering mechanism actuation). In one embodiment, the durometer of the sleeve58varies from 35 Shore D to 85 Shore D (preferably in the region of 70-80D) at the proximal end16to 20 Shore D to 55 Shore D (preferably in the region of 30-43D) at the distal end18. Curves of various shapes and geometries may be preset to the distal portion44of the catheter10as desired. For example, these curves may be pre-baked into the sleeve58at an elevated temperature below the melting point of the polymer. This pre-baked curve can vary between 10 and 270 degrees from vertical, depending upon the specific application of the system8. To insert the catheter10, the curve should be such that when a dilator or stiff guidewire is inserted into a working channel of the catheter10(described below), the curve is straight, while once the dilator or guidewire is removed, the distal portion44reverts to the pre-baked curve providing access to a desired location. In one embodiment, the distal portion44of the sleeve58has a radiopaque marker band46mounted thereon to provide confirmation of the location of the distal end18via fluoroscopy.

Referring now toFIGS.2-4, the elongated body38of the catheter10defines a working channel60that extends the entire length of the catheter and allows for the passage of various treatment or diagnostic devices, such as guide wires, stone retrieval baskets, lasers, biospy forceps etc. The working channel60preferably has a diameter sufficient to accept up to a 4 French working device, such as a retrieval basket device or biopsy forceps. The elongated body38of the catheter10may also include additional channels62, for use, e.g., as irrigation/insufflation channels or additional working channels for one or more of the instruments mentioned above. The channels62each extend the entire length of the catheter10and, like the working channel60, allow the passage of devices, liquids and/or gases to and from the treatment area. The channels62each have a diameter similar to or smaller than main working channel60. In one embodiment, the channels62each have a diameter of about 0.020 inches. The catheter may also include a channel64that extends the entire length of the catheter through which a fiberscope, fiber optic cables or other small diameter imaging devices (e.g., 0.25 mm-1.5 mm diameter) can be routed to the distal end of the catheter10. It will be appreciated that one or more of the channels62may be eliminated or dimensioned to accommodate the necessary diameter needed for the working channel60and optic lumen.

As is illustrated inFIGS.2-4, the catheter10also includes a pair of control or steering wires68that cause a distal portion44of the catheter10to deflect in one or more directions as indicated by the dashed lines inFIG.1. The steering wires68are located on opposite sides of the catheter10and slide within grooves70in opposite sides of the elongated body38. In other embodiments, the steering wires68may reside in the sheath56or outer sleeve58. In yet another embodiment, the steering wires68may be routed through dedicated steering wire lumens in the catheter. The steering wires68extend from the distal end18of the catheter10to the opposing, proximal end16of the catheter10, and then through the hub20. The steering wires68may be attached to the distal end18of the catheter10in a conventional manner, such as adhesive bonding, heat bonding, crimping, laser welding, resistance welding, soldering or other known techniques, at anchor points such that movement of the wires causes the distal end to deflect in a controllable manner. In one embodiment, the steering wires68are attached via welding or adhesive bonding to a fluoroscopy marker band46(seeFIG.1) fixedly attached to the distal end. In one embodiment, the band may be held in place via adhesive and/or an outer sleeve, as will be described in more detail below. The steering wires68preferably have sufficient tensile strength and modulus of elasticity that they do not deform (elongate) during curved deflection. In one embodiment, the steering wires are made from 304 stainless steel with an 0.008 inch diameter and have a tensile strength of approximately 325 KPSI. The steering wires68can be housed in a PTFE thin-walled extrusion (not shown) to aid in lubricity and prevent the catheter10from binding up during deflections, if desired.

In the illustrated embodiment shown inFIG.1, the steering wires68terminate in a wire connector70, which may also be part of the hub20. The wire connector70is a mechanical device that provides a detachable, preferably quick-fit, connection between the steering wires of the catheter10and the controller74or handle steering wires (not illustrated) associated with the handle30. Various types of detachable mechanical connectors, such as joints and linking elements, are capable of forming a connection that allows active deflection of the wires68via the controller74of the handle30. In the illustrated embodiment, the catheter10includes two steering wires68that controllably steer the catheter distal end18within one plane. In alternative embodiments, the catheter10includes additional wires that allow a user to steer the distal end18in multiple planes. In a further embodiment, the catheter10only includes one control wire that allows the user to steer the distal end18in one direction. In another embodiment, such as described below, the steering wires68are not part of the catheter10. In such an embodiment, the catheter can be advanced over a guidewire (not shown) pre-placed in the region of interest.

Referring now toFIG.5, there is shown a cross-sectional view of an alternative embodiment of a catheter510suitable for use with the optical catheter system8. The catheter510illustrated inFIG.5also includes additional features and inherent functions, as described further below. Unlike the catheter10, the catheter510has one large lumen512as opposed to multiple lumens. This is referred to as a “loose tube” configuration. The steering wires568run along the inner diameter of the catheter510to the distal end and are located within channels defined by an internal sleeve or liner547. The liner547has a low co-efficient of friction to facilitate the passage of working devices through the catheter during surgery. The liner547has a wall thickness from 0.0005 to 0.010 inches and is preferably formed from nitinol tubing, a polymer containing a degree of fluoroethylene such as, but not limited to, FEP, PTFE or PTFE impregnated thermoplastic elastomers like Pebax or is formed from a polymer having fluoroethylene combined with thermoplastic materials such as polyamides, polyurethane, polyethylene and block co-polymers thereof. The optical assembly, any working devices, and any irrigation tubes pass through the lumen512and connect with the hub as described above and below. In an alternative embodiment, the elongated body538ofFIGS.2-4passes through the lumen512, where the elongated body538routes any working devices, the optical assembly, and any irrigation tubes as described above.

The catheter10may be constructed in many different ways to achieve the desired result of a catheter having varying stiffness along its length, a few of which will now be described in more detail.FIG.12Ais a longitudinal cross-section view of one embodiment of a catheter1210constructed in accordance with aspects of the present invention. As best shown inFIG.12A, the catheter1210comprises a catheter body1238that is constructed with discrete proximal, deflection, and distal tip sections1282,1284,1288. In this embodiment, the proximal section1282is stiffer than the deflection section1284. Each section may be constructed in any suitable manner, such as extrusion or milling, with any suitable materials, such as polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), thermoplastic elastomers, chosen for the desired application. The sections1282,1284, and1288are then coupled together to form an integral body by encasing the length of the body1238or portions thereof with an outer sleeve1258. The deflection section may contain one or both of section elements1284and1288to impart the required deflection at the distal end to the system. The outer sleeve1258may comprise one of any number of polymer jackets that are laminated, co-extruded, heat shrunk, adhesive bonded, or otherwise attached over the catheter body1238. Suitable materials for the sleeve1258include, but are not limited to, polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers to name a few. It will be appreciated that the sections1282,1284, and1288may also be heat bonded or adhesive bonded prior to outer sleeve attachment.

The catheter1210may optionally include an inner reinforcement sheath1256, for example, a metallic braid, disposed between sections1282,1284, and1288of the elongated body1238and the outer sleeve1258, as best shown inFIG.12B. The reinforcement sheath1256encases the length of the catheter body1238or portions thereof. In one embodiment, the reinforcement sheath extends from the proximal end of the catheter body to proximal an optional radio opaque band (not shown) at the distal tip section. The reinforcement sheath increases the kink resistance of the deflecting section1284to ensure that internal lumens remain patent during bending.

FIG.13Ais a longitudinal cross section view of another embodiment of a catheter1310constructed in accordance with aspects of the present invention. As best shown inFIG.13A, the catheter1310defines a proximal section1382, a deflection section1384, and a distal tip section1388. The catheter1310comprises a catheter body1338and an outer sleeve1358. The catheter body1338is a unitary core that is formed, preferably by extrusion, with one suitable material, such as nylon, Pebax®, PTFE, etc. In one embodiment, the body1338is a PTFE extrusion. When assembled, the outer sleeve1358encases the length of the elongated body1338or portions thereof. The outer sleeve1358comprises a number of polymer jackets1358A,1358B, and1358C that are laminated, co-extruded, heat shrunk, adhesive bonded, or otherwise attached over sections1382,1384, and1388respectively, of the catheter body1338. The stiffness value of each jacket is specifically selected to achieve the desired results, and may vary upon different catheter applications.

In one embodiment, the jacket1358A, which corresponds to the proximal section1382, is constructed of a material having a greater stiffness value than the jacket1358B, which corresponds to the deflection section1384. Suitable materials for the sleeve1358include, but are not limited to, polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), to name a few. If PTFE is chosen for the body1338, it may be necessary to etch or otherwise prepare its outer surface to promote suitable adhesion of the outer sleeve1358.

The catheter1310may optionally include an inner reinforcement sheath1356, for example, a metallic braid, disposed between the elongated body1338and the outer sleeve1358, as best shown inFIG.13B. The reinforcement sheath encases the length of the elongated body1338or portions thereof. In one embodiment, the reinforcement sheath extends from the proximal end of the catheter body to proximal an optional radio opaque band (not shown) at the distal tip section. The reinforcement sheath increases the kink resistance of the deflecting section to ensure that internal lumens remain patent during bending.

FIGS.14A-14C and15illustrate another embodiment of a catheter1410constructed in accordance with aspects of the present invention. As best shown inFIG.14A, the catheter includes a catheter body1438having a proximal section1482, a deflecting section1484, and a distal tip section1488. In one embodiment, the proximal section1482is constructed of a material that is stiffer than the deflecting section1484. The proximal section1482and the deflecting section1484may be extrusions constructed from any suitable material, such as polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers, to name a few. In one preferred embodiment for urological application, the proximal section is a multi-lumen, PTFE extrusion approximately 200 to 220 cm in length, and the deflecting section1484is a multi-lumen, Pebax® extrusion approximately 2 to 10 cm in length. The deflection section1484may be coupled to the proximal section1482via suitable adhesive or joined by other techniques. The distal tip section1488may be coupled to the distal end of the deflection section1484via suitable adhesive. The distal tip section1488may be constructed of any suitable material, such as stainless steel or engineering plastics, including but not limited to polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers. The catheter body1438may also include a radio opaque marker band1446that encircles a portion of the distal tip section1488.

The catheter1410(seeFIG.14B) also includes a reinforcement sheath1456that extends from the proximal end of the catheter to or immediately proximal of the radio opaque marker band1446. The sheath1456may be a woven or layered structure, such as a braided design of fine wire or polymeric elements (0.001 inches to 0.010 inches in diameter) woven or coiled together along the longitudinal axis of the catheter with conventional catheter braiding techniques. This allows the catheter to be advanced to the desired anatomical site by increasing the column strength of the assembly while also increasing the torsional rigidity of the catheter. The reinforced catheter body shown inFIG.14Bis then encased by an outer sleeve1458comprising of one or more sleeve sections1458A,1458B, and1458C, having the same or different stiffness values, as best shown inFIG.14C, to form the catheter1410.

Returning toFIG.14A, the catheter also includes a plurality of steering wires1468that extend through grooves or slots formed in the catheter body from the proximal end of the catheter past the deflecting section1484. In one embodiment, the steering wires1468terminate at the radio opaque marker band1446to which the steering wires1468are joined by adhesive bonding, laser welding, resistance welding, soldering or other known techniques.

In several embodiments, it is preferable for the steering wires to be encased with a laminate structure1496for allowing the steering wires1468to move freely within or along the catheter body, and thus, make the mechanics of actuation as smooth as possible. As best shown inFIG.15, the laminate structure1496is formed by outer jacket1497constructed of a thermoplastic polymer, such as polyurethane, Pebax®, thermoplastic elastomer etc. which encases an inner reinforcement member1498, such as a metallic braid (e.g., stainless steel braid having, for example, a 0.0015″×0.006″ helically wound). Inside the reinforcement member1498, is a layer1499of a friction reducing material, such as PTFE or FEP tubing, over which the aforementioned layers are formed. The laminate structure1496begins at the proximal section1482and extends to just proximate the radio opaque marker band1446, as best shown inFIG.14A.

As was described above, in several embodiments of the catheter, it is desirable for the deflection section or distal portion to be configured to deflect more easily than the proximal section or portion. In one embodiment, the deflection section or distal portion has a durometer value less than the proximal section. In other embodiments, the flexibility may be varied gradually (e.g., increasingly) throughout the length of a catheter tube from its proximal end to its distal end. In other embodiments, the deflection section may be an articulating joint. For example, the deflection section may include a plurality of segments that allow the distal section to deflect in one or more directions. For examples of articulation joints that may be practiced with the present invention, please see co-pending U.S. patent application Ser. Nos. 10/406,149, 10/811,781, and 10/956,007, the disclosures of which are hereby incorporated by reference.

Other mechanical joints or configurations may be utilized that allow the distal portion of the catheter to flex or bend in one or more directions more easily. Turning now toFIG.16, there is shown one embodiment of a catheter1610formed in accordance with aspects of the present invention.FIG.16shows a partial view of the distal portion1646of a catheter1610constructed from a metal or plastic tube with slots1694cut 180 degrees and spaced an even distance apart to form a deflecting section. The slots will allow the catheter1610to deflect in two directions or in a single plane at the distal end1618. The proximal section of the tube is not slotted and may be used as the non-deflecting portion of the catheter. If preferred, the slotted section may be used in embodiments discussed above. The slotted section can be useful when the catheter profile is not symmetrical or is irregular. It will be appreciated that the slots1694can be V-shaped, semi-circle, wave or any preferred configuration.

FIG.17illustrates another embodiment of a catheter1710having a deflectable distal portion. In this embodiment, the catheter is constructed from a very flexible plastic extrusion with multiple lumens. The two main lumens, the working channel1760and the optical assembly channel1762, are reinforced with coils1796to minimize out-of plane deflection. As shown inFIG.17, the center of both lumens and both coils lie on the Y-axis to provide less resistance against deflection in the x-plane. When the steering wires (not shown) are pulled along the direction of the steering wire slots, the catheter will tend to bend about the y-axis or in the x plane. The coils1796also prevent the lumen from kinking as the catheter deflection radius becomes tighter. The catheter1710may further include an outer braid and outer layer, as described in detail above.

FIG.18illustrates yet another embodiment of a catheter1810having a flexible distal portion1846. In this embodiment, the multiple lumen extrusion is preferred to be flexible. Slots1894are cut on both sides of the extrusion to assist and bias the catheter1810in the preferred direction of deflection. As was described above, coils1896may be used to support the main lumens, if preferred, but are not required. The coil or coils can be useful if the slot cuts are deep to penetrate the main lumens. The coils could be used to line the lumens such that the devices do not inadvertently get caught against the slots. The catheter may further include a braided sheath and outer sleeve, as described above.

Returning now toFIGS.1-4, the elongated body38of the catheter10includes a lumen64that holds an optical assembly40or portions thereof, as described briefly above. The optical assembly40is defined, e.g., by a cylindrical, elongated tubular member24and optic bundles32,34. The optical assembly40permits a user of the system8to view objects at or near the distal end18of the catheter10. In the illustrated embodiment, the distal end18of the catheter includes a clear lens or window22that sealingly encloses the distal end of the lumen64to protect the optic bundles32,34inside the lumen16. The member24defines multiple lumens26that each contain one fiber optic bundle32,34. The first fiber optic bundle32illuminates the area or objects to be viewed, while the second fiber optic bundle34communicates the illuminated image to an eyepiece or ocular lens device36located at the handle30through which a user can view the images communicated via the fiber optic bundle. The handle30can also be configured to connect to a camera or imaging system such that users can save images and view them on a display. The fiber optic bundles32,34each comprise one or more fiber optics cables, preferably multiple fiber optical cables, but may also include lenses, rods, mirrors, hollow or solid light guides, etc. The bundles32,34are attached to the lens22with a clear adhesive, bond, or other connection, but can also abut the lens or be located adjacent the lens without any attachment. In an alternative embodiment, the lens22is not attached to the distal end18of the catheter, but is instead attached directly to the elongated member24and fiber optic bundles32,34.

As will be appreciated, the optical components of the catheter10may take many other forms and configurations. For example, the lumen64can include one fiber optic bundle for communicating images and one or more single illumination fibers that are not fixed relative to each other by the elongated member24. That is, the fibers can be freely located in the lumen64. Additionally, the elongated member24can have more or less lumens26that contain more or less fibers and/or bundles for illuminating and/or communicating images. For example, in an alternative embodiment, a single fiber replaces one or both of the bundles32,34. Furthermore, the elongated body38need not include the lumen64. For example, one or more optical fibers or bundles of fibers can be molded in the elongated body38. Alternatively, the elongated body38may include two lumens64for receiving separate fiber optic bundles32and34, respectively. Possible alternative known configurations for the optical assembly40are described in U.S. Pat. Nos. 4,782,819; 4,899,732; 5,456,245; 5,569,161; and 5,938,588, the entire disclosures of which are hereby incorporated by reference.

In the illustrated embodiment, the tubular optical assembly40is part of the disposable catheter assembly defined by the catheter10and hub20. Hence, the tubular optical assembly40and its fiber optic bundles32,34extend from the distal end18of the catheter10to the opposing, proximal end16of the catheter10, and then through the hub20. As is illustrated inFIG.1, the hub20includes a fiber optic connector72in which the fiber optic bundles32,34terminate. The fiber optic connector72is a mechanical device that provides a detachable optical connection between the fiber of the optical assembly40and the fiber or lens system of the handle30. Thus, the optical assembly40extends continuously through the disposable catheter10and hub20, without interruption, to the fiber optic connector72. In one embodiment, the fiber optic connector72is a detachable, simple point-to-point connection or splice. In other embodiments, the connector72is a more complex design having multi-port or other types of optical connections. For example, the connector72can be configured to redistribute (combine or split) optical signals, such as with an active or passive fiber optic couplers, e.g., splitters, optical combiners, X couplers, star couplers, or tree couplers. The fiber optic connecter72can also include a micro lens, graded-refractive-index (GRIN) rods, beam splitters, and/or optical mixers, and may twist, fuse, and taper together the fiber optic bundles32,34. In other embodiments, such as those described below, the optical assembly40is not part of the disposable catheter10.

Referring again toFIG.1, the handle30is generally an endoscopic handle that connects to the connectors70,72of the hub20such that a user of the system can view images communicated by the fibers of the catheter10and such that a user can controllably steer or deflect the distal end18of the catheter. The handle30includes one or more shafts78that connect to and interact with the fiber optic connector72and the wire connector70. The handle30also includes a controller or actuator74by which a user can steer the distal end18of the catheter10. In the illustrated embodiment, the handle30generally includes a pair of steering wires (not illustrated), each of which is associated with one of the steering wires68of the catheter10. The wires of the handle30are connected to the controller74at one end and are connected at the other end to the wires68via the connector70. To steer the catheter10, a user actuates the controller74, which causes the wires68to deflect, which in turn forces the distal end18of the catheter to deflect as illustrated inFIG.1. In the illustrated embodiment, the controller74is a user-operated mechanical slide or rotatable lever that is adapted to pull and release the wires68connected to the handle30by the connector70. In an alternative embodiment, the controller74may take other forms, such as a rocker arm or rotating knob, adapted to pull and release the wires. In another alternative embodiment in which the catheter10has two or more pairs of steering wires, the handle30includes additional actuators and corresponding controls to drive the additional pairs of steering wires. In one embodiment, the handle30includes a locking mechanism, such that when a curve is activated by the controller74, the curve may be locked in place. The use of wires to steer a tip of a catheter is well-known. Suitable examples are set forth in U.S. Pat. Nos. 4,899,723; 5,273,535; 5,624,397; 5,938,588, 6,544,215, and International Publication No. WO 01/78825 A2, the entire disclosures of which are hereby incorporated by reference.

As is described above, the handle30includes steering wires and fiber optics that connect to the steering wires68and fiber optic bundles32,34of the catheter10via the connectors70,72. As will be appreciated, the handle30may be battery powered or connect to a power supply. The handle30also includes a light source, or connects to a light source, that illuminates the fiber bundle32. In addition, the handle30has an eyepiece80for a user to view an image transmitted by the image bundle34from the distal end18.

Referring again toFIG.1, the hub20also includes connectors or ports50that each communicate with one of the lumens62of the catheter10, as well as a connector or port52that communicates with the working channel60. The connectors50,52are preferably integral with the hub20and thus are disposable with the hub20and catheter10. In the illustrated embodiment, connector72is separate from the connector70and connects to two separate portions, shafts, or projections of the handle30. In an alternative embodiment, the connectors70and72are combined into a single connector that interfaces with a single portion of the handle30, such that the optics handle and actuator for steering are disconnectable as a unit and reusable.

In a further embodiment of a system608in which the connectors670and672are separate connectors, such as is illustrated inFIG.6, the optical catheter system608includes a first handle630A that steers the catheter610and a second handle or component630B having the eyepiece680through which the user can view images communicated by the catheter optics. In this embodiment, the first handle630A connects to the connector670and the second handle630B connects to the connector672to couple and decouple from the fiber bundle in the catheter610. The handle630A may be disposable, while the handle630B is reusable. The handle630B includes a sleeve682, such as an extrusion over the fiber optic/illumination fiber component of the handle, to protect fiber sterility and prevent damage during the procedure due to the miniature nature of the fiber.

As will be appreciated from the foregoing, the optical catheter system8(SeeFIG.1) in accordance with one embodiment of the present invention includes a sterile, single-use, disposable optical catheter10, a sterile, single-use, disposable hub20, and a reusable handle30for viewing images and steering the catheter. Because the catheter10and hub20are disposed of after a procedure, delays and costs associated with cleaning, sterilizing, and maintaining conventional scopes are avoided.

Set forth below is a description of an exemplary clinical application of the optical catheter system8according to the invention. The sterile single-use catheter10and hub20are removed from a factory package and then connected to the reusable handle30via the connectors70and72. A guidewire is advanced into the urinary tract and the catheter10with or without a dilator is inserted over the guidewire. The guidewire may be withdrawn. The catheter10is then steered with the controller74to deflect the distal end18to the desired location in the kidney. The connectors/ports50and52are then associated with various working device and irrigation lines, as needed, and the desired treatment and/or diagnosis are performed. The catheter10is then withdrawn and discarded.

In an alternative embodiment of the optical catheter system708illustrated inFIG.7, the optical assembly740is not attached to the distal end718of the catheter and instead extends from the distal end718, through the hub720, and into the handle730without interruption. Additionally, the steering wires768extend from the distal end718, through the hub720, and into the handle730without interruption. When fully inserted into the catheter710, the steering wires768each attach to the distal end718of the catheter710such that movement of the wires causes the distal end718to deflect in a controllable manner. The steering wires768attach to the distal end718of the catheter with a detachable connection (not shown), such as a snap or quick lock connection, that permits the steering wires to be easily detached from the distal end718after use of the catheter such that the wires can be withdrawn from the catheter. In this embodiment, the system708does not include the optical and wire connectors, and the wires768and optical assembly740are not disposable. That is, the wires768and optical assembly740are part of the reusable handle730. Hence, in this embodiment, the lumens and channels of the elongated body receive the elongated wires768and elongated optical assembly740of the reusable handle730b. The catheter710and hub720are still disposable.

FIG.8illustrates an alternative embodiment of a handle830suitable for use with an optical catheter system8. The handle830includes an optical portion686and a snap-on, slide-on, or clip-on steering portion688. The optical portion686is the same as that of the handle30(seeFIG.1), but does not include the features for steering the catheter10. The steering portion688is the same as that of the handle30(seeFIG.1), but does not include the optical features of the handle30. The steering portion688may be disposable or reusable. The optical portion680is reusable.

In a further embodiment of the optical catheter system908illustrated inFIG.9, the connectors970and972are not part of the hub920, but are respectively attached to the optical assembly940and the steering wires968. The fibers of the optical assembly940are not attached to the distal end918of the catheter910and, when inserted into catheter, extend from the distal end918, through the hub920, and terminate at the connector972, which is integral with the optical assembly. The reusable handle930is configured to connect directly to the connector972of the optical assembly and functions as described above. When fully inserted into the catheter910, the steering wires968each attach to the distal end918of the catheter910such that movement of the wires causes the distal end918to deflect in a controllable manner. The steering wires968attach to the distal end918of the catheter with a detachable connection, such as a snap or quick lock connection, that permits the steering wires to be easily detached from the distal end918after use of the catheter such that the wires can be withdrawn from the catheter. When inserted into the catheter910, the wires968extend from the distal end918, through the hub920, and terminate at the connector970, which is integral with the wires. Hence, the wires968and the connector970form a control wire assembly. The handle930is configured to connect directly to the connector970of the steering wire assembly and function as described above. In this embodiment, the optical assembly940(and its connector972) and the wires968(and their connector970) are both disposable. The optical assembly940and its connector972, and the wires968and their connector970may be sterilely packaged separately or in combination with the catheter910.

FIG.10illustrates an additional embodiment of an optical catheter system1008of the present invention. In this embodiment, the handle1030for steering the catheter1010is integral with the hub1020and catheter1010, and are together packaged as a single-use, sterile, disposable assembly. The optical handle1030B and its optical assembly1040are reusable. Hence, the optical assembly1040is received by the hub1020and catheter1010for use, and then removed therefrom after the procedure has been performed. The steering wires of the handle1030A are attached to the distal end1018of the catheter1010and extend from the distal end1018, through the hub1020, and into the handle1030A without interruption. In this embodiment, the system1008does not include the optical fiber and steering wire connectors, and the optical assembly1040is part of, i.e., integral with, the reusable handle1030B.

FIG.11illustrates an additional embodiment of an optical catheter system1108of the present invention. In this embodiment, the handle1030A for steering the catheter1110is integral with the hub1020and catheter1110, and are together packaged as a single-use, sterile, disposable assembly. The optical handle1030B is reusable and is connectable to the disposable optical assembly1140via a connector1172. Hence, the optical assembly1140is disposable with the integral assembly defined by the handle1130A, the hub1120, and catheter1110, and may also be packaged with these items. The optical assembly1140is received by the hub1120and catheter1110for use, removed therefrom after the procedure has been performed, and then discarded with the handle1130A, the hub1120, and catheter1110. The optical handle1130B is reused. The steering wires of the handle1130A are attached to the distal end1118of the catheter and extend from the distal end1118, through the hub1120, and into the handle1130A without interruption. In this embodiment, the system1108does not include the steering wire connector, and the optical assembly1140is not integral with the reusable handle1130B.

FIGS.19A-19D and20illustrate another embodiment of an optical catheter system constructed in accordance with the present invention. As best shown inFIGS.19and20, the optical catheter system includes a sterile, single-use, disposable catheter assembly1912(SeeFIGS.19A-19D) and a reusable optical system2040(SeeFIG.20). The catheter assembly1912includes a handle1930A and a catheter1910. The optical system2040includes an optical handle2030B connected to an optical cable2042. The optical handle2030B, in one embodiment, may comprise an image viewing device, such as an ocular2080, and a coupler2084.

As best shown inFIG.19, the catheter1910is functionally connected to the catheter handle1930B. The catheter1910may be any suitable catheter for use in vivo, such as any one of the catheters described in detail herein. The handle1930A includes a handle housing1932to which a steering mechanism1974, optional lock mechanism1976, and one or more ports1958,1960are operatively connected. In one embodiment, the handle housing1932comprises an upper, proximal section1934and a lower, distal hub1936. In the embodiment shown inFIG.19A, the distal hub1936of the handle housing is Y-shaped. The Y-shaped hub1936includes a distal stem section1938to which the proximal end1912of the catheter1910is functionally connected. The Y-shaped hub1936further includes first and second branch sections1940and1942, the first branch section1940is connected to the distal end of the housing upper section1934while the second branch section1942includes an opening through which an interior channel of the catheter, such as the working channel, may be accessed. The first branch section1940may be connected to the upper section1934in such a manner as to permit free or limited rotation of the Y-shaped hub1936with respect to the housing upper section1934about a longitudinal axis of the handle1930A. In one embodiment, this may be accomplished by a circular flange (not shown) formed at the proximal end of the first branch section and being captured in a cooperating slot (not shown) formed by the distal end of the housing upper section.

In one embodiment, handle housing sections are formed by housing halves1934A and1934B and1936A and1936B joined by appropriate removable fasteners, such as screws, or non removable fastening techniques, such as heat bonding, ultrasonic welding or adhesive bonding. As best shown inFIG.19A, the housing halves (only1936B is shown) of the Y-shaped hub1936define respective passageways1948and1950for communicating with the remainder of the handle housing1934and exterior the handle, respectively. The handle1930A further includes a bifurcation1954. The bifurcation1954is preferably insert molded to connect the proximal end1916of the catheter1910and its lumens to the working channel port1958and optical assembly port1960. In embodiments where the bifurcation1954is insert molded, the catheter steering wires1968are sleeved with a PTFE sleeve or a metal sleeve or similar coiled or braided tube such that molten polymer from the bifurcation process will bond to the sleeve and allow the steering wire within the sleeve to move respectively therein.

As was described above, the handle housing1932includes one or more ports1958and1960for providing access to the respective channels of the catheter1910. In the embodiment shown, the ports include, but are not limited to, a working channel port1958and an optical assembly port1960. The ports may be defined by any suitable structure. For example, the working channel port1958and the optical assembly port1960may be defined by fittings1962and1964, respectively, such as luer fittings, that may be bonded or otherwise secured to the handle housing1932when assembled. In one embodiment, the housing halves may define cooperating structure that securely locks the fittings1962and1964in place when assembled. The fitting1962and1964are connected to the appropriate catheter channels via tubing1966, as best shown inFIG.19C. In one embodiment, the handle1930A also includes a loop hub1970interconnected between the optical assembly port1960and the tubing1966. The loop hub1970has an oversized chamber to allow the optical cable of the optical system to be deflected to account for the change (shortening) in catheter length when the distal end of the catheter is deflected by the steering wires1968.

The catheter handle1930A may also include a steering mechanism1974, as best shown inFIGS.19A and19B. The steering mechanism1974of the catheter handle1930A controls the deflection of the distal end1918of the catheter1910. The steering mechanism1974may be any known or future developed mechanism that is capable of deflecting the distal end of the catheter by selectively pulling one or more steering wires1968. In the embodiment shown inFIGS.19A and19B, the steering mechanism1974includes an activation lever1980for effecting 2-way steering of the catheter distal end in a single plane. By actuating the activation lever1980in one direction the distal end will deflect in one direction. Turning the activation lever1980in the other direction will deflect the catheter distal end in the opposite direction. It is preferred that the catheter distal end will travel in a single plane when sweeping from one direction to the other. The activation lever1980is connected to the distal end1918of the catheter10via steering wires1968(SeeFIG.19C), respectively, that extend through the catheter1910. While a manually actuated steering mechanism for effecting 2-way steering of the distal end is shown, it will be appreciated that a manually actuated steering mechanism that effects 4-way steering may be practiced with and is therefore considered to be within the scope of the present invention.

Referring now toFIGS.19A-19D, there is shown one embodiment of the steering mechanism1974that may be practiced with the present invention. The steering mechanism1974includes the activation lever1980secured for rotation with a pulley1982. The pulley1982is rotatably supported by a boss1984integrally formed or otherwise positioned to extend into the interior of the handle housing1932in a fixed manner from the housing half1934B. The pulley1982is either integrally formed or keyed for rotation with the activation lever1980. The proximal ends of one pair of steering wires1968are connected to opposite sides of the pulley1982in a conventional manner. In the embodiment shown, the steering wires1968are placed into respective slots1986and secured thereto by suitable fasteners, such as set-screws1988. Each set-screw pinches the steering wires1968against the pulley1982to secure it in place. When assembled, the pulley1982provides control of the distal end1918of the catheter1910in two directions. In these embodiments, the catheter1910is straight in the neutral position.

It will be appreciated that the steering mechanism may be configured such that the direction of catheter deflection in both directions is either equal or such that preferential one side deflection is realized (e.g., 180 degree deflection in one direction vs. 90 degree deflection in the other, etc.). For equal directional deflection, the steering wires1968are of equal length when the catheter is in the neutral (i.e., straight or unbent) position and are attached to the pulley1982at positions located along an axis of the pulley that is perpendicular to the longitudinal axis of the catheter, as best shown inFIG.19D. For unequal angles of deflection, the steering wires are not equivalent in length and the steering wires are attached to the pulley in other positions around the circumference thereof. As will be appreciated, the catheter side related to the side with the greater steering wire displacement will deflect to the greater angle. In embodiments where there is only a single deflection of the shaft required, a single pull wire system may be used. The steering wire maybe attached to the pulley at a position proximal the perpendicular axis of the pulley to maximize the full swing of the pulley.

In other embodiments, it is also understood that changes could be made to the design to achieve a mechanical advantage such as to increase the diameter of the pulley for a longer steering wire displacement length. Other configurations that achieve a mechanical advantage may also be used. For example, instead of the steering wires terminating at the pulley, the steering wires may be wrapped around pins positioned on the pulley and then anchored on the handle at points distal the pulley. In this case, the steering wires will displace up to twice its normal distance when compared to the device shown inFIG.19D. This feature may be used for larger diameter catheter deflection where longer steering wire displacement is utilized.

As best shown inFIGS.19A-19D, the handle1930A may further include a lock mechanism1976that functions to lock the catheter1910in a desired deflection position or apply tension on the pulley1982during use. The lock mechanism1976includes a tension knob1988that is actuatable between a locked position, selectively tensioned positions, and an unlocked position. As best shown inFIG.19C, the tension knob1988is threaded onto a thread post1990extending from the activation lever1980. The thread post1990extends through the handle housing to allow the tension knob1990to be externally mounted. In use, by tightening the tension knob1990on the thread post1990against the handle housing1932will also bring the activation lever1980into contact with the other handle housing half. The user can adjust the tension of the activation lever1980, as desired, by rotation of the tension knob1990. Further tightening of the tension knob1990will prevent rotation of the activation lever1980, thereby locking the steering wires1968in place, and in turn, locking the deflected position of the catheter1910.

In accordance with another aspect of the present invention, it may be desirable to adjust the tensioning of the steering wires after the handle1930A has been assembled. Turning now toFIG.21, there is shown a handle having a tension adjustment assembly2188accessible from exterior the housing through a window2190. The tension adjustment assembly includes an adjustment screw2192cooperatingly engaged with a stationary nut2194. The nut2194may be held stationary and non-rotatable, for example, via molded structure in the handle housing. When assembled, the steering wires1968are threaded through the longitudinal lumen of the adjustment screw2192. The adjustment screw2192is designed with teeth on the side of its head portion to allow a user to rotate the screw. Rotation of the screw to advance the adjustment screw2192in the direction of arrow A will increase steering wire tension while rotation of the screw for advancing the screw2192in the direction of arrow B will decrease tension on the steering wires1968. Proper tension will allow quicker response of the steering wire to actuation of the activation lever.

As was discussed briefly above, a small diameter viewing device, such as a fiberscope or other imaging device, may be slidably routed through one channel (e.g., optical assembly channel) of the catheter1910to the distal end thereof. The viewing device permits the user of the optical catheter assembly to view objects at or near the distal end or tip of the catheter1910. Turning now toFIG.20, there is shown one suitable embodiment of a viewing device or optical assembly2040formed in accordance with aspects of the present invention. The optical assembly2040includes a fiber optic cable2072connected to an optical handle2030B comprising a coupler2084and an ocular or eyepiece2080. The fiber optic cable2072is defined, for example, by one or more optical fibers or bundles2032and2034encased by a cylindrical, elongated tubular sleeve2076, as best shown inFIG.22. The outer diameter of the fiber optic cable2072is preferably between 0.4 mm and 1.2 mm, although other sizes may be used depending on its application and the lumen size of the catheter. The tubular sleeve2076of the fiber optic cable2072may be constructed of any suitable material, such as nylon, polyurethane, polyether block amides, just to name a few. Additionally, a metallic hyptotube may be used.

In the illustrated embodiment, as best shown inFIGS.20and22, the fiber optic cable2072includes one or more centrally extending coherent imaging fibers or fiber bundles2034and one or more circumferentially extending illumination fibers or fiber bundles2032(which may not be coherent) that generally surround the one or more imaging fibers of fiber bundles2034. The fibers or fiber bundles2032and2034may be attached to the tubular sleeve2076via suitable adhesive. The distal end of the fiber optic cable2072includes a distal lens and/or window (not shown) that encloses the distal end to protect the fiber bundles. Alternatively, the optical assembly lumen of the catheter1910(SeeFIG.19) may include a lens or window positioned at its distal end, as was described in detail above. The distal lens (not shown) also projects the image from the field of view onto the distal end of the image bundle2034. The image bundle2034then transmits the image from the distal end of cable2072to the handle2030B.

The optical assembly2040may have a stop collar or sleeve (not shown) to limit movement of the cable2072through the optical assembly channel of the catheter and limit the length by which the cable2072can extend beyond the distal end of the catheter1910. The inner surface of the imaging channel of the catheter may have color markings or other calibration means to indicate to the user when inserting the cable2072that the end of the catheter is approaching or has been reached.

The proximal end of the fiber optic cable2072is functionally connected to the coupler2084of the handle2030B. In use, the illumination fibers or fiber bundles2032illuminate the area or objects to be viewed, while the imaging fibers or fiber bundles2034communicates the illuminated image to an image viewing device, such as an eyepiece or ocular lens device2080, connected to the coupler2084through which a user can view the images communicated via the imaging fibers or fiber bundles2034. The eyepiece2080may either be permanently or detachably connected to the coupler2084as shown inFIGS.23A and23B. In one embodiment, the eyepiece2080is detachably connected via a snap fit connector2098; however, other selectively detachable connectors may be used, such as male and female threaded connectors, quick lock connectors, bayonet connectors, to name a few. In this embodiment, the coupler2084and cable2072can be detached from the eyepiece2080after a procedure and discarded, while the eyepiece2080may be sterilized and reused. The optical handle2030B can also be configured to connect to a camera or imaging system such that users can save images and view them on display. It will be appreciated that the handle2030B may include other known components, such as adjustment knobs (not shown), that adjust the relative positioning of the lenses and, thus, adjusts the focus of the image transmitted through them. The coupler2084may also includes a light post2086that is connected to the proximal end of the illumination fibers or fiber bundle2032. The light post2086is configured to be releasably connected to a light cable for supplying light from a light source external the optical assembly2040to the illumination fibers or fiber bundle2032.

In one embodiment, the optical assembly may optionally include a contamination sleeve2090for protecting fiber sterility and preventing damage during the procedure due to the miniature nature of the fiber, as best shown inFIG.20. The contamination sleeve2090when attached to the handle extends from the coupler2084distally to a section of the optical cable2072. The end of the contamination sleeve2090terminates in a distal connector2092. The distal connector2092is configured to connect to the optical assembly port of the steering handle1930A, preferably in a sealable manner.

FIG.24illustrates another embodiment of a catheter handle2430constructed in accordance with aspects of the present invention that is suitable for use with the catheter1910described above and shown inFIG.19A. The catheter handle2430is substantially similar in construction, materials, and operation as the catheter handle1930A described above and shown inFIGS.19A-19D, except for the differences that will now be described. As best shown inFIG.24, the distal hub section2436of the handle housing2432is not formed as a Y-shaped distal hub but instead is formed as a tapering cylindrical body. In this embodiment, both working channel and optical channel ports/luer connectors2458-2460are located at the proximal end of the handle housing2432. The connectors2458and2460are connected in communication with the respective catheter channels via tubes (not shown). Since the Y-shaped distal hub is not required in this embodiment, the entire handle housing can be formed by two molded housing halves.

FIG.25illustrates another embodiment of a catheter handle2530constructed in accordance with aspects of the present invention that is suitable for use with the catheter1910ofFIG.19A. The catheter handle2530is substantially similar in construction, materials, and operation as the catheter handle described above and shown inFIGS.19A-19D, except for the differences that will now be described. The catheter handle2530shown inFIG.25includes the coupler2584and optical cable (not shown) of the optical assembly2540, the coupler2584being slid, snapped into, molded, or otherwise mounted onto or within the handle2530. The components of the optical assembly2540are substantially similar in construction, materials, and operation as the components of the optical assembly described inFIGS.20and23A,23B. The light post2588may be included with the coupler2584and may be located in a recessed fitting at the rear of the handle. The working channel port2558is shown to be side mounted and distal to the activation lever2580. In this embodiment, an ocular (not shown) can be removably attached to the coupler2584for direct viewing if a monitor is not available or connected to a monitor if preferred.

FIG.26illustrates another embodiment of a catheter handle2630constructed in accordance with aspects of the present invention that is suitable for use with the catheter1910described above and shown inFIG.19A. The catheter handle2630is substantially similar in construction, materials, and operation as the catheter handle1930described above and shown inFIGS.19A-19D, except for the differences that will now be described. As best shown inFIG.26, the proximal portion2690of the handle2630has been lengthened such that the handle can be gripped at either the distal and proximal portions to manipulate the activation lever2680with the thumb or other finger of the user. It is desirable that sufficient distance exist between the working channel port2658and the handle activation lever2680, so that the user can comfortable hold the handle without blocking access to the working channel port for device feed. The optic assembly hub2660is not shown but can be positioned at the proximal handle end or exiting another side port at the Y-connector. It will be appreciated that the distal portion2692can be shortened such that the user uses and holds the proximal end only. Further, it will be appreciated that additional ports and hubs can be added, removed or repositioned as desired.

In accordance with another aspect of the present invention, it may be desirable to the user to provide a way to detect the orientation of the optical catheter assembly once in vivo. To that end,FIGS.27A and27Billustrate one suitable technique for indicating the orientation of optical catheter assembly when routed to a site within the patient. As best shown inFIG.27A, an indicator, such as a marker2764, is placed on the optical cable2772of optical assembly2740to indicate a relative position, e.g., left side of the optical catheter assembly, when assembled with the catheter to aid the user in orientation and manipulation of the system. For illustration proposes only, the selected marking is shown inFIG.27Aat the distal end of the optic fiber cable2772and oriented coplanar with the deflection of the catheter distal end as indicated by arrows A-A. In this embodiment, an insert2770, such as a metallic insert, is positioned at the distal end of the catheter optical assembly lumen and may be locked into place when the distal end of the catheter is formed. The insert2770is formed with the back end angle cut2774oriented to the plane of deflection. The cable sleeve2776is also configured to have a matching front end angle cut2778so that when meshed, the marker2764is oriented to indicate the desired position on the image transmitted to the handle. The meshed cuts2774,2778also perform an anti-rotation function, that is, the cable2772is not allowed to rotate with respect to the catheter2710once meshed, as shown inFIG.27B. The cable2772in this embodiment is made slightly longer than the catheter2710such that the cable deflects slightly in the loop hub chamber (seeFIG.19C) when mated to create a constant force against the insert2770. It will be appreciated that other angles, geometries, keyways, etc. may be used to inhibit rotation of the cable with respect to the catheter and to orient the indicator in the specified location.

In operation, when the distal end of the catheter is deflected, the lumen length of the catheter becomes shorter due to the radius of the deflection curve. The insert2770prevents the cable2772from extending any further beyond the catheter distal end. The cable length is displaced by means of the fiber deflecting in the loop hub. As the catheter is straightened, the viscoelastic properties of the cable2772allows it to relax to the center of the loop hub, while still maintaining its position and contact with the insert2770at the distal end.

FIG.28illustrates a distal end cap2896that may be practiced with one of the catheters described above. A hole2858through the cap for the working channel is the same or larger than the working lumen of the catheter body. The distal hole2560in the cap for the optic fiber is size slightly smaller than the optical cable, establishing a stop mechanism for preventing the cable from exiting the cap yet providing a ledge for the cable to constantly abut against. The cable in this embodiment is made slightly longer than the catheter. The distal cap2876includes tapered sides2898to minimize the cross sectional area of the catheter distal end for reducing trauma when advanced in-vivo.

FIG.29illustrates another embodiment of a catheter assembly2912where a balloon2914is mounted on the catheter2910at or near the distal end2918with an accompanying inflation/deflation port2962at the proximal end of the handle. It will be appreciated that different types of balloons can be used for occlusion, dilatation, anchoring, or stabilizing yet still allow the working channel to remain patent for other uses. Other embodiments may include side ports for injections or suction. Other features may also be included, including an additional working channel as well as elevators, etc. Complex curve deflection can also be achieved as well as four or multiple way deflections.

FIG.30illustrates a cross section of another embodiment of a catheter3010. In this embodiment, it may be desired due to economies of manufacture and in the interests of reducing the overall outer diameter of the catheter to split the elements of the optical cable. As best shown inFIG.30, there is shown a multi-lumen catheter having separate lumens3062A and3062B to house the illumination and image fiber bundles3032and3034, respectively. By separating both optic cable components in this way, a reduced catheter outer diameter may be realized.

It will be appreciated that the optical catheter system in the various embodiments described above could be used in other applications, such as a colonoscope, bronchoscope, gastroscope or similar visual device. Additionally, various modifications to the configurations, such as the number and dimension of working/optic channels, the length of the catheter, the materials used in construction, etc., may be made to accommodate the specific application without departing from the spirit of the invention.

FIG.31illustrates one exemplary embodiment of an in-vivo visualization system3120constructed in accordance with the present invention. The visualization system3120includes an endoscope3124, such as a duodenoscope, to which a steerable catheter assembly3128is operatively connected. As will be described in more detail below, the steerable catheter assembly3128includes a catheter3130and a catheter handle3132. The assembly3128may further include a viewing device2040, such as a fiberscope (SeeFIGS.20and23A-23B), or other small imaging device that is routed through a channel of the catheter3130for viewing objects at the distal end thereof. While the illustrative embodiments described below will reference the catheter3130and the handle3132, other suitable catheters, catheter handles, and combinations thereof may be utilized in the visualization system3120, such as those catheters and catheter/optical handles described above with regard toFIGS.1-30.

In one suitable use, the endoscope3124is first navigated down the esophagus of a patient and advanced through the stomach and into the duodenum to the approximate location of the entrance to the common bile duct (also known as the papilla). After positioning the endoscope3124adjacent the common bile duct entrance, the catheter3130of the catheter assembly3128is advanced past the distal end of the endoscope3124and into the common bile duct entrance. Alternatively, the catheter3130may be routed prior to endoscope insertion. Once inside the common bile duct, the fiberscope allows a physician to view tissue in the bile duct, pancreatic duct and/or intrahepatics for diagnosis and/or treatment.

As best shown inFIG.31, one suitable embodiment of an endoscope3124includes an endoscope handle3140and an insertion tube3142. The insertion tube3142is an elongated flexible body that extends from the distal end of the endoscope handle3140. In one embodiment, the insertion tube3142includes an articulation section3144disposed at its distal region, and a distal tip3146. The insertion tube3142is constructed of well known materials, such as polyether block amides (e.g., Pebax®), polyurethane, polytetrafluoroethylene (PTFE), nylon, to name a few.

As best shown in the cross sectional view ofFIG.32, the insertion tube3142defines a working channel3150that extends the entire length thereof and allows for the passage of various treatment or diagnostic devices, such as guide wires, biopsy forceps, and the steerable catheter3130(FIG.31). The insertion tube3142also includes one or more lumens for the purpose of facilitating the insertion and extraction of fluids, gases, and/or additional medical devices into and out of the body. For example, the insertion tube3142may include an irrigation and/or insufflation lumen3152and an optional suction lumen3154. The insertion tube3142further includes one or more lumens for the purpose of providing endoscopic viewing procedures. For example, the insertion tube3142includes one or more lumens3156that extend the entire length of the catheter and allows for light and optical fiber bundles3158and3160to be routed to the distal end thereof. Alternatively, the insertion tube3142may include one or more LED's and an image sensor, such as a CCD or CMOS, for capturing images at the distal tip and transmitting them to the endoscope handle3140. Finally, the insertion tube3142includes at least one pair of steering wires3162A and3162B, and preferably two pairs of steering wires3162A,3162B and3164A,3164B that are connected at the insertion tube's distal tip and terminate through the proximal end of the insertion tube3142. It will be appreciated that the insertion tube3142may include other features not shown but well known in the art.

Returning toFIG.31, the proximal end of the insertion tube3142is functionally connected to the distal end of the endoscope handle3140. At the proximal end of the endoscope handle3140, there is provided an ocular3166through which a user can view the images communicated by the optical fiber bundle3160(SeeFIG.32), and a light cable3168for connecting to an external source of light. While the endoscope shown inFIG.31includes an ocular, the endoscope may be of the electronic type, in which the ocular may be omitted and the images obtained from the distal end of the endoscope are transmitted to a video processor via the light cable3168or other suitable transmission means, and displayed by a suitable display device, such as a LED monitor. Light from the light source can be transmitted to the distal end of the insertion tube3142via the light fiber bundle3158. The endoscope handle3140also includes a steering mechanism3170, as shown in the form of control knobs, that are connected to the steering wires3162A,3162B, and3164A,3164B (seeFIG.32) in a conventional manner for deflecting the distal end of the insertion tube3142in one or more directions. The endoscope handle3140further includes a biopsy port3172connected in communication with the working channel of the insertion tube3142for providing access to the working channel of the insertion tube3142from a position exterior the endoscope handle3140.

The in-vivo visualization system3120further includes the steerable catheter assembly3128which will now be described in more detail. As best shown inFIGS.33and34, one suitable embodiment of the catheter assembly3128includes a catheter handle3132from which the catheter3130extends. The catheter3130includes an elongated, preferably cylindrical, catheter body3176that extends the entire length of the catheter3130from the catheter proximal end3178to the catheter distal end3180. In one embodiment, the catheter body3176has an outer diameter between approximately 5 and 12 French, and preferably between approximately 7 and 10 French. The catheter body3176may be constructed from any suitable material, such as Pebax® (polyether block amides), nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane, fluorinated ethylene propylene (FEP), thermoplastic elastomers and the like, or combinations thereof. The body3176may be formed of a single material using known techniques in the art, such as extrusion, or multiple materials by joining multiple extruded sections by heat bonding, adhesive bonding, lamination or other known techniques. According to a preferred embodiment of the present invention, the distal portion of the catheter (approximately 1-2 inches where the flexing occurs) is made more flexible (i.e., less stiff) than the remainder of the catheter.

In the embodiment shown inFIG.33, the catheter body3176includes a proximal section3182that extends the majority of the catheter3130, a deflection section3184, and a distal tip section3188. The catheter3130preferably varies in stiffness between the proximal section and the distal tip section. More preferably, the proximal section3182is stiffer than the deflection section3184. This allows the catheter to be easily advanced without compressing and with minimal twisting while providing deflection capabilities to the deflection section3184for deflecting the distal end3180. In one embodiment, the proximal section3182has a durometer value between 35 and 85 shore D, preferable 60-80 shore D, and the deflection section3184has a durometer value between 5 and 55 shore D, preferable 25-40 shore D.

FIG.35Ais a cross sectional view of one embodiment of the catheter body3176. The catheter body3176defines a working channel3192that extends the length of the catheter and allows for the passage of various treatment or diagnostic devices, such as guide wires, stone retrieval baskets, lasers, biopsy forceps etc. In one embodiment, the working channel3192preferably has a diameter sufficient to accept up to a 4-French working device, such as biopsy forceps. The catheter body3176may also include a channel3194that extends the entire length of the catheter through which a fiberscope, fiber optic cable, optical assembly or other small diameter viewing device (e.g., 0.25 mm-1.5 mm diameter) can be routed to the distal end of the catheter3130. The catheter body3176may further include additional channels3196,3198for use, e.g., as irrigation channels or additional working channels. The channels3196,3198each extend the entire length of the catheter and, like the working channel3192, allow the passage of devices, liquids and/or gases to and from the treatment area. These channels3196,3198each have a diameter similar to or smaller than the main working channel, and may be symmetrically positioned to balance the remaining channels during extrusion. Such positioning of the channels balances out the wall thickness and stiffness in two transverse directions. Finally, the catheter body3176may include one or more steering wire lumens3200that extend the entire length of the catheter.

Referring toFIGS.33and35A, the catheter3130further includes one or more steering wires3204that cause the distal end3180of the catheter3130to deflect in one or more directions. The steering wires3204are routed through a corresponding number of steering wire lumens3200, extend from the distal end3180of the catheter3130to the opposing, proximal end3182of the catheter3130, and terminate in a suitable manner with the steering mechanism, as will be described in detail below. The steering wires3204may be attached to the distal tip section3188of the catheter3130in a conventional manner, such as adhesive bonding, heat bonding, crimping, laser welding, resistance welding, soldering or other known techniques, at anchor points such that movement of the wires causes the distal end3180to deflect in a controllable manner. In one embodiment, the steering wires3204are attached via welding or adhesive bonding to a fluoroscopy marker band (not shown) fixedly attached to the distal tip section. In one embodiment, the band may be held in place via adhesive and/or an outer sleeve, as will be described in more detail below. The steering wires3204preferably have sufficient tensile strength and modulus of elasticity that they do not deform (elongate) during curved deflection. In one embodiment, the steering wires are made from 304 stainless steel with an 0.008 inch diameter and have a tensile strength of approximately 325 KPSI. The steering wires3204can be housed in a PTFE thin-walled extrusion (not shown) to aid in lubricity and prevent the catheter3130from binding up during deflections, if desired.

In the illustrated embodiment shown inFIG.35A, the catheter3130includes two pairs of steering wires3204that controllably steer the catheter3130in two perpendicular planes. In alternative embodiments, the catheter3130includes one pair of steering wires3204that allow the user to steer the distal tip in one plane. In one embodiment, two steering wires may be provided and are located on opposite sides of the catheter3130and slide within grooves, as opposed to steering wire lumens3200, formed in the elongated body3176or either the sheath or outer sleeve, if included, as will be described in more detail below. In a further embodiment, the catheter3130only includes one steering wire3204that allows the user to steer the distal tip in one direction. In another embodiment, the steering wires may be omitted, and thus, the catheter3130can be of a non-steerable type. In such an embodiment, the catheter can be advanced over a guidewire (not shown) pre-placed in the bile or pancreatic duct.

In one embodiment, the catheter3130may also include an outer sleeve3208that encases the length of the elongated body3176, as shown in cross section inFIG.35B, or sections thereof. The outer sleeve3208may comprise one of any number of polymer jackets that are laminated, co-extruded, heat shrunk, adhesive bonded, or otherwise attached over the catheter body3176. Suitable materials for the sleeve3208include, but are not limited to, polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), thermoplastic elastomers to name a few. The outer sleeve3208may be used to vary the stiffness of the catheter, if desired, or to provide improved torque transfer and/or other desirable catheter properties. Additionally, the sleeve3208may be used as one convenient method for securing a more flexible deflection section to the proximal section, as will be described in detail below. In several embodiments, the external surface of the sleeve3208may have a hydrophilic coating or a silicon coating to ease the passage of the device in-vivo, as was described in detail above with reference toFIGS.2-4.

In other embodiments, the catheter3130may optionally include an inner reinforcement sheath3210disposed between the elongated body3176and the outer sleeve3208. The reinforcement sheath encases the length of the elongated body3176or portions thereof, as shown inFIG.35C. The sheath3210may be a woven or layered structure, such as a braided design of fine wire or polymeric elements (0.001 inches to 0.010 inches in diameter) woven or coiled together along the longitudinal axis of the catheter with conventional catheter braiding techniques. This allows the catheter to be advanced to the desired anatomical site by increasing the column strength of the assembly while also increasing the torsional rigidity of the catheter. Conventional coiled polymer or braid wire may also be used for this component with coil wire dimensioning ranging in width from 0.002 to 0.120 inches and thicknesses from 0.002 to 0.10 inches. Braided ribbon wire may also be used for the sheath. In one embodiment, as will be described in more detail below, the outer sleeve3208is coextruded, coated, or otherwise attached once the reinforcement layer3210is applied, to lock the reinforcement layer in place and secure it to the catheter body3176, thereby forming a composite catheter.

The catheter may be constructed in many different ways to achieve the desired result of a catheter having varying stiffness along its length. For example, the catheter may be constructed in a substantially similar manner to the catheters described above with reference toFIGS.12A-18.

FIGS.36A-36C, and37illustrates one suitable embodiment of a catheter3630constructed in accordance with aspects of the present invention that may be used with the visualization system described above. As best shown inFIG.36A, the catheter includes a catheter body3676having a proximal section3682, a deflecting section3684, and a distal tip section3686. In one embodiment, the proximal section3682is constructed of a material that is stiffer than the deflecting section3684. The proximal section3682and the deflecting section3684may be extrusions constructed from any suitable material, such as polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers, to name a few. In one preferred embodiment, the proximal section is a multi-lumen, PTFE extrusion approximately 200 to 220 cm in length, and the deflecting section3684is a multi-lumen, Pebax® extrusion approximately 2 to 10 cm in length. The deflection section3684may be coupled to the proximal section3682via suitable adhesive or joined by other techniques. The distal tip section3686may be coupled to the distal end of the deflection section3684via suitable adhesive. The distal tip section3686may be constructed of any suitable material, such as stainless steel or engineering plastics, including but not limited to polyethylene, nylon, Pebax® (polyether block amides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers. The catheter body3676may also include a radio opaque marker band3692that encircles a portion of the distal tip section3686.

The catheter3630(seeFIG.36B) also includes a reinforcement sheath3688that extends from the proximal end of the catheter to or immediately proximal of the radio opaque marker band3692. The sheath3688may be a woven or layered structure, such as a braided design of fine wire or polymeric elements (0.001 inches to 0.010 inches in diameter) woven or coiled together along the longitudinal axis of the catheter with conventional catheter braiding techniques. This allows the catheter to be advanced to the desired anatomical site by increasing the column strength of the assembly while also increasing the torsional rigidity of the catheter. The reinforced catheter body shown inFIG.36Bis then encased by an outer sleeve3690comprising of one or more sleeve sections3690A,3690B, and3690C, having the same or different stiffness values, as best shown inFIG.36C, to form the catheter3630.

Returning toFIG.36A, the catheter also includes a plurality of steering wires3694that extend through channels of the catheter body from the proximal end of the catheter past the deflecting section3684. In one embodiment, the steering wires3694terminate at the radio opaque marker band3694to which the steering wires3694are joined by adhesive bonding, laser welding, resistance welding, soldering or other known techniques. In this embodiment, the catheter body includes openings3695formed in the outer surface thereof just proximal the radio opaque marker band3694via any suitable method, such as skiving. These openings3695communicate with the steering wire channels so that the steering wires3694may exit the extruded catheter body and connect to the radio opaque marker band3694, as shown.

In some instances where the catheter body is not extruded or otherwise constructed of PTFE or other friction reducing materials, it may be desirable to encase the steering wires3694with a laminate structure3696for allowing the steering wires3694to move freely within the catheter body, and in particular, the deflecting section3684, and thus, make the mechanics of actuation as smooth as possible. As best shown inFIG.37, the laminate structure3696is formed by outer jacket3697constructed of a thermoplastic polymer, such as polyurethane, Pebax®, thermoplastic elastomer etc. which encases an inner reinforcement member3698, such as a metallic braid (e.g., stainless steel braid having, for example, a 0.0015″×0.006″ helically wound). Inside the reinforcement member3698, is a layer3699of a friction reducing material, such as PTFE or FEP tubing, over which the aforementioned layers are formed. In embodiments where the proximal section3682is extruded or otherwise formed with a friction reducing material, the laminate structure3696begins at the intersection of the proximal section3682and the deflecting section3684and extends to just proximate the radio opaque marker band3694, as best shown inFIG.36A.

In accordance with one embodiment of the present invention, the multi-lumen catheters described herein may be extruded using known materials, such as PTFE, Nylon, Pebax®, to name a few. The catheters may be extruded using mandrels. In several embodiments of the present invention, the mandrels may be constructed from suitable materials, such as stainless steel, stainless steel with PTFE coating, or a phenol plastic, such as Cellcore®. In the embodiment shown inFIG.35A, the multi-lumen catheter3130has eight lumens that include a working channel3192, a fiberscope or viewing device channel3194, and four smaller steering wire lumens3200spaced 90 degrees apart. To balance out the wall thicknesses and stiffnesses in the traverse directions during extrusion, left and right lumens3196,3198may also be formed using separate mandrels. These lumens3196,3198may be used for air/gas irrigation and insufflation.

The catheter3130shown inFIG.35Bmay optionally include an outer sleeve3208. The sleeve may be constructed of suitable materials by coextrusion, heatshrinking processes, such as reflow, or spray coating. The outer sleeve3208may provide additional rigidity, improved torque transfer, etc. In one embodiment, the outer sleeve may be applied for facilitating the attachment of a flexible distal section, such as a deflection section, that has a lower durometer value than the remaining catheter body. In such an embodiment, one suitable material that may be used includes, but is not limited to, Pebax® (polyether block amide). In other embodiments, the catheter3130may include a reinforcement layer3210or sheath between the catheter body3176and the outer sleeve3208, as best shown inFIG.35C. The reinforcement may be any known catheter reinforcement structure, such as wire coil or braid. In such as embodiment, the outer sleeve3208is coextruded, coated, or otherwise attached once the reinforcement layer3210is applied, to lock the reinforcement layer in place. It will be appreciated that the reinforcement layer3210may extend the entire length of the catheter or portions thereof. In one embodiment, the reinforcement layer3210extends over the deflection section. It will be appreciated that if the body is extruded from PTFE, its outer surface should be etched or otherwise prepared for appropriate bonding with the outer layer.

In accordance with another embodiment, the catheter may be built up using a catheter core3820, an optional reinforcement layer3824, and an outer sheath or jacket3826, as best shown inFIGS.38A-38C. The catheter core3820is an open-lumen core that is extruded from suitable materials, such as nylon, PTFE, Pebax®, etc., with the use of mandrels. In this embodiment, the mandrels (not shown) are placed and configured to produced a plurality of open-lumens3892,3894,3896,3898, and3899when extruded. The mandrels may be constructed from metal, Cellcore®, or PTFE. Once the open-lumen core has been extruded, the mandrels are kept in place and the core is either coextruded to add the outer sleeve3826, as shown inFIG.38B, or braided and coextruded to add a reinforcement layer3824and an outer sleeve3826, as shown best inFIG.38C. As was discussed above, the outer sleeve3826may function to lock the braid in place and/or to facilitate attachment of a distal section, such as a deflection section, having, for example, a lower stiffness value, if desired.

The mandrels (not shown) can then be removed after coextrusion. In one embodiment, the mandrels are constructed of a phenol plastic, such as Cellcore®. To remove these mandrels, the mandrels are pulled from one or both ends. Due to the “necking down” effect inherent to the Cellcore® material, the cross sectional areas of the mandrels decrease when pulled in tension, thereby allowing the mandrels to be removed from the built-up catheter. In one embodiment, this property of Cellcore® may be used to the manufacture's advantage by using such a material for the steering wire lumen mandrels. However, instead of completely removing the mandrels from the steering wire lumens, tension forces may be applied to the steering wire mandrels, and the mandrels may be drawn to a decreased diameter that will be sufficient to function as the steering wires. Thus, to be used as steering wires, the drawn mandrels are then connected to the distal end of the catheter in a conventional manner. While the latter embodiment was described as being coextruded to form the outer sheath, the outer sheath may be formed on the catheter core by a heat shrink process or spraycoating.

It will be appreciated that not all of the lumens in the latter embodiments need to be formed as open-lumens. Thus, as best shown inFIG.39A-39C, only the steering wire lumens3999are formed as open-lumens. This will create over sized lumens for the steering wires and provided the largest possible lumen diameters for the lumens3992,3994,3996, and3998.

As was described above, in several embodiments of the catheter, it is desirable for the deflection section to be configured to deflect more easily than the proximal section. In one embodiment, the deflection section has a durometer value less than the proximal section. In other embodiments, the flexibility may be varied gradually (e.g., increasingly) throughout the length of a catheter tube from its proximal end to its distal end. In other embodiments, the deflection section may be an articulating joint. For example, the deflection section may include a plurality of segments that allow the distal section to deflect in one or more directions. For examples of articulation joints that may be practiced with the present invention, please see co-pending U.S. patent application Ser. Nos. 10/406,149, 10/811,781, and 10/956,007, the disclosures of which are hereby incorporated by reference. Other methods that my be used were described above with reference toFIGS.16-18.

Returning toFIGS.33and34, the catheter3130is functionally connected to the catheter handle3132. The handle3132includes a handle housing3220to which a steering mechanism3224, one or more ports3226,3228,3230, and an endoscope attachment device3234is operatively connected. In one embodiment, the handle housing3220is formed by two housing halves3220A and3220B joined by appropriate removable fasteners, such as screws, or non removable fasteners, such as riveting, snaps, heat bonding or adhesive bonding. In the embodiment shown, the proximal end of the catheter3130is routed through a strain relief fitting3238secured at the distal end of the handle housing3220and terminates at a Y connector3242, as best shown inFIGS.34and45. The Y connector3242may be secured to the handle housing3220via any suitable means, such as adhesive bonding. Similarly, the proximal end of the catheter3130is securely coupled to the Y connector3242via suitable means known in the art, such as adhesive bonding. The Y connector3242includes first and second branch fittings3244and3246that define respective passageways3248and3250for communicating with the catheter working channel and the catheter imaging device channel, respectively, through openings3251and3252located on the outer surface of the catheter, as best shown inFIG.45.

In embodiments of the present invention, the openings3251and3252may be formed by skiving the outer surface of the catheter. This process may be done manually using known mechanical techniques, or may be accomplished by laser micro-machining that removes a localized area of material from the outer surface of the catheter to expose one or more catheter channels. When assembled, the proximal ends of the catheter channels are plugged by adhesive or the proximal end of the catheter is capped to prohibit access to the channels.

As was described above, the handle housing3220includes one or more ports3226,3228,3230for providing access the respective channels of the catheter3130. In the embodiment shown, the ports include, but are not limited to, a working channel port3226, an imaging device port3228, and an irrigation/suction port3230. The ports may be defined by any suitable structure. For example, the working channel port3226and the imaging device port3228may be defined by fittings3254and3256, respectively, that may be bonded or otherwise secured to the handle housing3220when assembled. In one embodiment, the housing halves may define cooperating structure that securely locks the fittings3254and3256in place when assembled. With regard to the irrigation/suction port3230, a luer style fitting3258is preferably used for defining the port3230. The fitting3258defines a passageway3260for fluidly connecting the port3230with the appropriate catheter channels, as best shown inFIG.41. The fitting3258works in conjunction with a barrel connector3264that ensconces the catheter3130. The barrel connector3264defines a cavity3266that surrounds the perimeter of the catheter3130and is fluidly connected to the appropriate catheter channels (irrigation channels) via inlets3270. As such, the port3230is connected in fluid communication with the irrigation channel via passageway3260and cavity3266. In one embodiment, the inlets3270are formed by skiving the outer surface of the catheter. This process may be done manually using known mechanical techniques, or may be accomplished by laser micro-machining that removes a localized area of material from the outer surface of the catheter to expose one or more catheter channels. The working channel port3226and the imaging device port3228are connected in communication with the branch fittings3254and3256of the Y connector, respectively, via appropriate tubing3272, and best shown inFIG.34.

The catheter handle3132also includes a steering mechanism3224. The steering mechanism3224of the catheter handle3132controls deflection of the distal end3180of the catheter3130. The steering mechanism3224may be any known or future developed mechanism that is capable of deflecting the distal end of the catheter by selectively pulling the steering wires. In the embodiment shown inFIGS.33and34, the steering mechanism3224includes two rotatable knobs for effecting 4-way steering of the catheter distal end in the up/down direction and in the right/left direction. This mechanism3224includes an outer knob3280to control up/down steering and an inner knob3284to control right/left steering. Alternatively, the inner knob3284may function to control right/left steering and an outer knob3280may function to control up/down steering. The knobs are connected to the distal end of the catheter3130via the steering wires3204, respectively, that extend through the catheter3130. While a manually actuated steering mechanism for effecting 4-way steering of the distal is shown, it will be appreciated that a manually actuated steering mechanism that effects 2-way steering may be practiced with and is therefore considered to be within the scope of the present invention.

Referring now toFIG.42, there is shown one embodiment of the steering mechanism3224that may be practiced with the present invention. The steering mechanism3224includes inner and outer pulleys3288and3290, and control knobs3280and3284. The inner pulley3288for left and right bending control is mounted via an inner bore3294for rotation on a shaft3296integrally formed or otherwise positioned to extend into the interior of the handle housing3220in a fixed manner from the housing half3220A. The inner pulley3288is integrally formed or keyed for rotation with one end of an inner rotary shaft3300. The opposite end of the inner rotary shaft3300extends outside the handle housing3220to which the control knob3280is attached for co-rotation. In one embodiment, the end3304of the inner rotary shaft3300is configured to be keyed with a cooperatingly configured control knob opening. The control knob3280may then be retained thereon via a threaded fastener. The proximal end of one pair of steering wires3204are connected to opposite sides of the inner pulley3288in a conventional manner.

The outer pulley3290for up and down bending control is rotatably fitted over the inner rotary shaft3300for independent rotation with respect to the inner pulley3288. The outer pulley3290is integrally formed or keyed for rotation with one end of an outer rotary shaft3310. The outer rotary shaft3310is concentrically arranged in a rotational manner over the inner rotary shaft3300. The opposite end of the outer rotary shaft3310extends outside the handle housing3220to which the control knob3284is attached for co-rotation. The rotary shafts3300,3310are further supported for rotation within the housing3220by a boss3316integrally formed or otherwise positioned to extend inwardly into the handle housing3220from the housing half3220B. It will be appreciated that other structure may be provided that rotatably supports the pulleys3288,3290and shafts3300,3310within the handle housing3220. When assembled, the proximal ends of the second pair of steering wires3204are fixedly connected in a conventional manner to the outer pulley3290, respectively.

In one embodiment, a thrust plate3320is positioned between the inner and outer pulleys3288,3290for isolating rotary motion therebetween. The thrust plate3320is restricted from rotation when assembled within the housing3220.

The steering mechanism3224may further includes a lock mechanism3340that functions to lock the catheter3130in a desired deflection position during use. The lock mechanism3340includes a lever3344that is actuatable between a locked position and an unlocked position. In the embodiment shown inFIG.40, detents3346are provided, and may be molded into the exterior housing half3220B to index the movement between the locked and unlocked positions. A small protuberance (not shown) may be included to signal the user that the lever3344has changed positions.

Referring now toFIGS.42,43A, and43B, the lock mechanism3340further includes a lever member3350and a pulley member3354that are housed within the handle housing3220when assembled. The lever member3350includes a throughbore3358that is size and configured for receiving the outer rotary shaft3310in a rotationally supporting manner. The lever member3350includes a boss section3362that is sized and configured to be rotationally supported by the inwardly extending boss3316when assembled. The boss section3362is configured at one end3364to be keyed for rotation with one end of the lock lever3344. The lever member3350further includes a flange3366integrally formed at the other side of the boss section3362. The end face3368of the flange3366defines a cam profile that annularly extends around the perimeter of the flange3366. In the embodiment shown, the cam profile is formed by varying the thickness of the flange. The pulley member3354includes a boss section3370that is sized and configured for receiving the lever member3350therein. The pulley member3354includes an inwardly extending flange3374that defines a cam profile on the lever member facing surface3378of the flange3374. Similar to the lever member3350, the cam profile of the pulley member3354is formed by varying the thickness of the flanges as it annularly extends. The inwardly extending flange3374further defines a throughbore3380that is sized and configured for receiving the outer rotary shaft3310in a rotationally supporting manner. When assembled, the pulley member33254is restricted from rotating with respect to the housing3220but allowed to linearly translate, as will be described in more detail below.

When assembled, the lever member3350is inserted within the pulley member3354, the cam profiles mate, and the lever3344is keyed for rotation to the lever member3350. The cam profiles on the lever member3350and the pulley member3354are specifically configured to transmit a rotary motion of the lever3344into translational movement of the pulley member3354. Thus, when the lever member3350rotates by movement of the lever3344from the unlocked position to the locked position, the pulley member3354moves away from the lever member3350in a linear manner by coaction of the cam profiles. Therefore, the lever member3350acts like a cam, and the pulley member3354acts like a follower to convert rotary motion of the lever3344into linear motion of the pulley member. The linear movement of the pulley member3354causes the inner pulley3288to frictionally engage the housing3220and the thrust plate3320while the outer pulley3290frictionally engages the thrust plate on one side and the pulley member of the other. The friction present between the engaged surfaces prohibits rotation of the inner and outer pulleys3288and3290, and thus, locks the distal end of the catheter in a deflected position.

To change the deflection of the distal end of the catheter from one position to another, the lock lever3344is moved from the locked position to the unlocked position. This, in turn, rotates the lever member3350with respect to the pulley member3354. Due to the configuration of the cam profiles of the lever and pulley members, the pulley member3354is capable of moving toward the lever member3350. This alleviates the friction between the engagement surfaces and allows the inner and outer pulleys3288and3290to rotates by turning the control knobs3284and3280.

In accordance with aspects of the present invention, the catheter assembly3128can be mounted directly to the endoscope handle3140so that a single user can manipulate both the endoscope3124and the catheter assembly3128using two hands. In the embodiment shown, the catheter handle3132is attached to the endoscope3124via the endoscope attachment device, such as the strap3234. The strap3234can be wrapped around the endoscope handle3140, as best shown inFIG.31. The strap3234includes a number of notches3366into which the head of a housing projection3368is selectively inserted to couple the catheter handle to the endoscope, as best shown inFIG.44. The strap3234allows the catheter handle3132to rotate around the shaft of the endoscope3124, if desired. The strap3234is positioned such that when used to attach the handle3132to the endoscope3130, the longitudinal axes of the both handles are substantially aligned, as shown best inFIG.31. Additionally, the strap orientation and the location of the ports on the catheter handle3132allow for manipulation of diagnostic or treatment devices and viewing devices through the catheter without interfering with control and use of the endoscope. As a result of directly connecting the catheter assembly3128to the endoscope3124, as shown inFIG.31, the catheter3130creates a loop, known as a service loop, prior to entrance into the biopsy port3172. In one embodiment, the catheter may include a proximally located stop sleeve or collar (not shown), which limits the minimum diameter of the service loop and the extension of the catheter3130beyond the distal end of the conventional endoscope. Alternatively, a mark or indicia may be placed on the catheter3130and used to prevent over insertion of the catheter3130.

In embodiments of the present invention that form a service loop by directly connected the catheter handle3132to the endoscope3124, the catheter3130is preferably constructed to be suitably longer than conventional catheters to compensate for the service loop. In several of these embodiments, the catheter handle3132is preferable mounted below the biopsy port3172of the endoscope3124and the catheter3130is preferably looped upward and into the biopsy port3172. In this configuration, the catheter3130is accessible and can be gripped by the user just above the biopsy port for catheter insertion, withdrawal, and/or rotation.

While the embodiment above shows a handle connected below the biopsy port and longitudinally oriented with respect to the catheter, other configurations are possible. For example, the handle can be attached to the endoscope so that the longitudinal axis of the catheter handle is substantially transverse to the longitudinal axis of the endoscope handle. Additionally, the catheter handle may be mounted proximally or distally of the biopsy port or may be mounted directly on the biopsy port so that the longitudinal axis of the catheter is coaxial with the biopsy port.

As was discussed briefly above, a small diameter viewing device, such as a fiberscope or other vision device, may be slidably routed through one channel (e.g., imaging device channel) of the catheter3130(FIG.33) to the distal end thereof. The viewing device permits the user of the catheter assembly to view objects at or near the distal end or tip of the catheter. For a detailed description of one viewing device that may be utilized by the visualization system, please see the optical assembly described above with regard toFIGS.20and23A-23B. For other examples of imaging devices that may be practiced with embodiments of the present invention, please see the description of the fiber optic cable in co-pending U.S. application Ser. No. 10/914,411, filed Aug. 9, 2004 to which priority as been claimed, and the guidewire scope described in U.S. Published Patent Application Number 2004/0034311 A1, the disclosures of which are hereby incorporated by reference.

The imaging device3370may have a stop collar or sleeve (not shown) to limit movement of the cable3372through the imaging device channel of the endoscope and limit the length by which the cable3372can extend beyond the distal tip of the catheter3130. The inner surface of the imaging channel of the catheter may have color markings or other calibration means to indicate to the user when inserting the cable3372that the end of the catheter is approaching or has been reached.

One suitable method of operation of the in-vivo visualization system3120will now be described in detail with reference to the aforementioned FIGURES. The insertion tube3142of the endoscope3124is first navigated down the esophagus of a patient under endoscope visualization. The insertion tube3142of the endoscope3124is advanced through the stomach and into the duodenum at the bottom of the stomach. The biliary tree comprises the cystic duct from the gall bladder, the hepatic duct from the liver and the pancreatic duct from the pancreas. Each of these ducts joins into the common bile duct. The common bile duct intersects with the duodenum a slight distance below the stomach. The papilla controls the size of the opening at the intersection between the bile duct and duodenum.

The papilla must be crossed in order to reach the common bile duct to perform a biliary procedure. The insertion tube3142of the endoscope3124is navigated under direct visualization so that the exit port of the working channel3150is directly across from the papilla or so that the port is slightly below the papilla. After positioning the distal end of the insertion tube3142in the proper position, the catheter3130with the imaging device3370is advanced through the working channel3150the endoscope3124such that the distal end of the catheter3130emerges from the endoscope and cannulates the papilla. The endoscope3124provides viewing of the catheter3130as it emerges from the endoscope3124and is advanced to enter the papilla. After cannulating the papilla, the catheter3130may be advanced into the common bile duct. Once advanced into the common bile duct, the fiber optic cable3372of the viewing device3370located within the catheter3130allows a physician to view tissue in the bile duct for diagnosis and/or treatment.

Alternatively, once the insertion tube3142of the endoscope3124is in place next to the papilla, a conventional guidewire and sphinctertome may be advanced together through the endoscope and through the papilla to enter the common bile duct and pancreatic duct. It may be necessary for the physician to use the sphinctertome to enlarge the papilla. The sphinctertome may then be removed from the patient while leaving the conventional guidewire in place. The catheter3130and the fiber optic cable3372of the viewing device3370may then be advanced together over the conventional guidewire through the papilla and into the common bile duct. Once inside the common bile duct, the fiber optic cable3372of the viewing device3370allows a physician to view tissue in the bile duct for diagnosis and/or treatment.

It will be appreciated that the selection of materials and use of insertable and removable optics in the catheter allow for the catheter to be constructed as a single use device. Once the procedure is performed, the optics can be removed and sterilized for reuse while the catheter may be removed from the endoscope and discarded.

While the steerable catheter assembly3128has been described above for use with an endoscope, it will be appreciated that the catheter assembly may be used with other devices, or may be used as a stand-alone device or in conjunction with the viewing device3370.

FIGS.46A-46Billustrates the distal end of an alternative embodiment of a catheter4630formed in accordance with aspects of the present invention. In this embodiment, the catheter4630has a multi-lumen design with one or more (shown as three) steering wire lumens4640around its perimeter. Steering wires (not shown) extend from the proximal end of the catheter to the distal region of the catheter and terminate in an anchored connection at or near the distal end thereof. Deflection of the distal end of the catheter may be effected by the steering wires in a manner well known in the art. The catheter4630includes other lumens, for example, a guide wire lumen4660, a working channel lumen4662, and a fiberscope or other viewing device lumen4664. As shown, the guide wire lumen4660is offset from the longitudinal axis of the catheter.

In use, the tip of the catheter is advanced beyond the end of the endoscope and is steered in the direction of the papilla. The guide wire is then advanced through the papilla and the catheter is advanced to cannulate the papilla. Once in the biliary tree, and with visualization provided via the fiberscope or other viewing device, the guide wire is advanced again and steered to the target site. The catheter is once more advanced over the guide wire and positioned for use of the accessory instruments at the therapy site while simultaneously viewing such site with the fiberscope.

In an alternative embodiment, instead of extruding the catheter body, a catheter4730may be constructed with an outer sheath4758encasing a bundle4770of smaller diameter tubes, as best shown inFIG.47. Each tube of the bundle of tubes may be formed using any known technique, such as extrusion. Each tube extends the length of the catheter and may be used for a specific function, such as steering wire lumens, device working channel, optic channel, fluid or air infusion channel, or section channel, etc. Each tube is preferably separately constructed with materials specifically selected to maximize performance, lubricity, flexibility, and/or other desirable characteristics. When assembled, one or more steering wires4774are routed through a corresponding number of steering tubes4776of the catheter. The steering wires4774may be connected to the distal end of the catheter via adhesive, heat bonding, crimping, or other known techniques. In one embodiment, the steering wires may be attached to a radio opaque marker band4780for use in fluoroscopy.

Alternatively, as best shown inFIG.48, a catheter4830may be formed from a steering sheath4854, such as a steering guide catheter of appropriate dimensions, by filling the central longitudinal lumen4856with a bundle of tubes. The steering sheath4854typically includes an outer sleeve or jacket4858with an internal sleeve or liner4862. The steering wires4874typically run along the inner surface of the catheter to the distal end and are located within channels4877defined by the internal sleeve or liner4862. The liner preferably has a low coefficient of friction to facilitate the passage of wires, and may be formed from a polymer containing PTFE or PTFE impregnated thermoplastic elastomers, or may be constructed of thermoplastic materials, such as polyamides, polyurethane, polyethylene, and block copolymers thereof.

The principles, preferred embodiments, and modes of operation of the present invention have been described in the foregoing description. However, the invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. Further, the embodiments described herein are to be regarded as illustrative rather than restrictive. Variations and changes may be made by others, and equivalents employed, without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such variations, changes, and equivalents which fall within the spirit and scope of the present invention.