Over-the-wire medical tool positioning devices, systems, and methods of use and manufacture

Abstract

To provide a medical device configured and sized to be positioned within a subject.SOLUTION: A medical device may comprise an ultrasound transducer in a distal region of the medical device, the ultrasound transducer secured to an outer shaft, the ultrasound transducer at least partially enclosed by a material to define a distal tip of the medical device. The medical device may comprise a tip extension disposed adjacent to the distal tip and extended longitudinally from the distal tip, the tip extension comprising a first end adjacent to the distal tip and a second end opposite the first end. The tip extension may comprise a tapered tip at or adjacent to the second end. The tip extension may comprise a guidewire lumen formed therein and configured to receive a guidewire therethrough.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] (Incorporation by Reference) This application incorporates by reference in its entirety the disclosures of the following applications, which are hereby incorporated by reference for all purposes: PCT / US2019 / 061228, filed November 13, 2019; U.S. Provisional Patent Application No. 62 / 760,784, filed November 13, 2018; International Publication No. WO 2018 / 017717, published January 25, 2018; U.S. Patent Application Publication No. 20220401070(A1); and International Publication No. WO 2018 / 182836, published October 4, 2018.

[0002] All publications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

Background Art

[0003] A wide variety of intravascular medical devices are known.

Summary of the Invention

Problems to be Solved by the Invention

[0004] There is a need for improved systems, devices, and methods that facilitate better control, positioning, and ease of use of medical devices.

Means for Solving the Problems

[0005] The disclosure herein relates to medical devices and their use. One aspect of the disclosure is generally a method of using a medical device configured and sized to be disposed within a subject. The medical device may comprise an ultrasonic transducer in a distal region of the medical device, the ultrasonic transducer being fixed to an outer shaft and the ultrasonic transducer being at least partially surrounded by a material that defines a distal tip of the medical device. The medical device may comprise a tip extension disposed adjacent to and extending longitudinally from the distal tip, the tip extension comprising a first end adjacent to the distal tip and a second end opposite the first end. The tip extension may comprise a tapered tip at or adjacent to the second end. The tip extension may comprise a guidewire lumen formed therein and configured to receive a guidewire therethrough. The tip extension may exhibit a stiffness transition. The tip extension may exhibit a first stiffness at the first end and a second stiffness adjacent to the second end, the first stiffness being greater than the second stiffness.

[0006] One aspect of the disclosure is a medical device configured and sized to be disposed within a subject, such as within a blood vessel, heart chamber, or other body lumen or space.

[0007] The medical device herein may include a medical instrument, such as an ultrasonic transducer, in a distal region of the medical device. The medical instrument may be (directly or indirectly) fixed to a flexible member, such as a flexible electronic device (e.g., a flexible conductor bundle), at a first location. The flexible member may be able to extend proximally (and optionally inwardly) toward a handle assembly. In some examples, the disclosure relates to attempts to prevent the flexible electronic device from deforming to an undesirable extent and / or attempts to maintain the configuration of the flexible electronic device (even if there is some degree of deformation).

[0008] The medical device can include one or more elongated shafts through which a flexible member extends. The medical device can include two or more elongated shafts, such as an outer shaft and an inner shaft, through which the flexible member extends, and the inner shaft extends through at least a portion of the outer shaft. The inner shaft can be movable relative to the outer shaft. The inner shaft can be deflectable independently of the outer shaft.

[0009] The flexible member (e.g., a flexible conductor bundle) may be axially movable within one or more of the elongated shafts or may be fixed to a shaft such as the outer shaft.

Brief Description of the Drawings

[0010]

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Modes for Carrying Out the Invention

[0011] Figure 1A shows an example of a system that integrates a steering and a medical device. System 1000 includes a handle assembly 1002 and a steering and medical device portion 1004. The steering and medical device portion 1004 includes a proximal portion 1006 and an actuatable portion 1008. The system is adapted such that the handle assembly 1002 can be actuated to steer the actuatable portion 1008 and, optionally further actuated to move a medical device 1010 relative to the steering and medical device portion 1004. In this embodiment, the handle assembly 1002 includes a first actuator 1001, a second actuator 1003, and a third actuator 1005. The first actuator 1001 is adapted to be actuated (rotated in this example) relative to the handle body 1007 to steer the actuatable portion 1008, specifically to steer the outer sheath 1102. The actuatable portion 1008 can be steered or bent into the configuration shown by the solid lines in Figure 1A, and can also be steered into the configuration shown by the dashed lines or any position therebetween. In some embodiments, the opposite steering function is limited to simply straightening the shaft from an initial bent configuration, such as the solid line bent configuration in Figure 1A. The term "steer" in this disclosure means to deflect or bend, optionally via actuation of at least one pull wire, although in some examples the term can include rotation (torque) and axial movement of the shaft. The term "pull wire" as used herein refers to any element capable of transmitting tension from the proximal end to the distal end region of the device. The pull wire may be composed of a metal wire such as stainless steel or nickel titanium, either solid or twisted / braided, or may be composed of a polymer such as aramid fiber (Kevlar®), polyethylene, ptfe, eptfe, etc., preferably twisted / braided, but may also be in the form of a monofilament. In one embodiment, the pull wire is constructed from a bundle of aramid fibers having four 50 denier multifilament (about 25 filaments) yarns braided together with a high pick per inch.The cross-sectional diameter of the wire is typically in the range of 0.005 inches to 0.012 inches, more preferably 0.008 inches to 0.010 inches. However, braided or twisted wires may be flattened or ovalized within the lumen of the device. Certain embodiments are believed to provide optimized strength and wear resistance with respect to the size required to minimize the diameter of the shaft. The optional second actuator 1003 is adapted to be actuated (rotated in this example) relative to the handle body 1007 to rotate (rotation movement "R" is labeled) the medical instrument 1010 relative to the shaft 1102, and the optional actuator 1005 is adapted to be actuated (axially in this example) relative to the handle body 1007 to move the medical instrument 1010 axially (distal-proximal) relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the manipulable portion 1008 is manipulated (bent / deflected), but the proximal portion can bend and flex to conform to the anatomical structure in which the proximal portion is used internally. In many aspects, this is achieved by constructing the manipulable portion 1008 from a material that is softer or less rigid than the proximal portion 1006 and / or a composite structure.

[0012] The embodiment shown in FIG. 1A is an example of an apparatus that includes an integrated handle assembly that is operably in communication with both a manipulable outer shaft and an inner medical instrument. The handle assembly is integrated in that it is assembled and constructed to be operably in communication with the outer shaft and the inner medical instrument prior to packaging and use. "Integrated", as used in the context of an integrated handle assembly, refers to a handle assembly that requires at least a portion of the handle assembly to be broken or disassembled before it is possible to remove the medical instrument from within the outer shaft.

[0013] FIG. 1B shows an exemplary cross-section A-A (shown in FIG. 1A) of the steering and instrument portion 1004, specifically of the steerable portion 1008. In this embodiment, the medical device 1010 is sized and configured to be disposed within a steerable sheath. The steerable sheath includes an outer shaft 1102 and a set of pull wires 1104 that are axially fixed in the distal region of the steerable portion 1008.

[0014] The medical instruments of FIGS. 1A and 1B can be any medical instrument herein, such as, for example, an ultrasonic instrument. When the term "ultrasonic probe" is used herein, it generally refers to an elongated instrument that includes at least one ultrasonic transducer and one or more conductive elements that electrically connect the at least one ultrasonic transducer to the proximal region of the elongated instrument. The proximal region of the ultrasonic probe is in electrical communication with at least one ultrasonic transducer and includes or is modified to include at least one proximal contact that can be electrically communicated with electrical contacts on another device, cable, or connector, optionally via an attachment thereto.

[0015] FIG. 2 shows an exemplary system 10 adapted to function in a manner similar to the systems of FIGS. 1A and 1B, and also shows exemplary internal components (internal components shown as dashed lines) of the handle assembly 12. The handle assembly 12 is integrated with an outer operable shaft 20 and a medical instrument 30 and is operably in communication with the outer operable shaft 20 and the medical instrument 30. The handle assembly 12 includes an actuator 14 adapted to operate the operable shaft 20 when actuated with respect to the handle body 15. The actuator 14 is operably in communication with the operable shaft 20 via a steering control unit 16 disposed within the handle assembly 12. The medical instrument 30 is disposed within the handle assembly 12 and includes a proximal portion 18 incorporated into the handle assembly 12. An actuator 13 is operably in communication with the medical instrument 30, and by actuating (in this example, rotating) the actuator 13 with respect to the handle body 15, the medical instrument 30 is rotated with respect to the outer shaft 20 via a rotation control unit 1215. An optional third actuator 17 is also operably in communication with the medical instrument 30 and, in this embodiment, is adapted to axially move the medical instrument 30 with respect to the outer operable shaft 20 by axially actuating (with respect to the handle body 15) via an axial control unit 1217.

[0016] The medical instrument of FIG. 2 can be any medical instrument in this specification, such as an ultrasonic instrument.

[0017] Figures 3A - 3E depict exemplary embodiments of the distal region of the sheath portion 1208 of the steerable sheath 1202 within the system 1200. For simplicity, the cross - sections shown depict only the outer sheath 1208 and not the inner instrument 1212. The outer sheath 1208 preferably has a composite structure to improve torque transmission applied to the outside of the shaft from the proximal end or to resist torque forces applied to the outer sheath 1208 from within the shaft, such as from the instrument 1212. As shown in FIGS. 3Ai - 3Aiii, to form the composite, a plurality of braiding elements 1250, preferably formed from metal wires (round, pairs of round, or ribbon - shaped) and / or a plurality of fibers (e.g., aramid or nylon), may be braided directly onto a thin - walled (e.g., 0.0010 inches ± 0.0005 inches) lubricious liner tube 1251, such as a PTFE or FEP material. A thermoplastic polymer 1252 (such as Pebax in the range of 25D - 72D durometer, or nylon, or other common catheter materials) can be heat - laminated using a heat - shrink tube (such as FEP) to re - flow the polymer over the braiding elements 1250 and the liner tube 1251 to form a uniform member. The thermoplastic polymer 1252 may also have a radiopaque compound containing a material such as bismuth, barium sulfate, or tungsten so that the tip of the sheath is visible to the user under fluoroscopy. In the embodiments of FIGS. 3Ai - 3Aiii, the pull wire 1104 is preferably parallel to the central access in the steerable (deflectable) portion 1222 of the sheath and is preferably provided within a lumen 1253 made within the wall of the steerable sheath 1208. This lumen can be created during the extrusion process of a thermoplastic polymer tube or during a shaft heat - laminate fusion process using a removable mandrel. The pull - wire lumen 1253 may be further created by incorporating a pull - wire tube 1254, preferably temporarily supported by a removable mandrel, within the wall.The removable mandrel may also be disposed along the pull line 1104 or 1104' during the fusion process, resulting in a somewhat oval lumen 1253, inside of which the fibrous pull wire can be flattened and space is provided for the pull wire to move freely. The tube 1254 may include PTFE, FEP, polyimide, or other materials that maintain the integrity of the wall of the tube 1254 during a heat lamination process up to about 500°F. The tube is preferably surrounded and supported by a thermoplastic polymer 1252, which is preferably heat laminated to the tube. In another embodiment, a pull wire lumen, preferably including a pull wire tube, is incorporated inside the fabric of the braiding element 1250. For example, a braiding element 1250 extending in one direction will pass below the pull wire lumen, while a braiding element 1250 extending in the opposite direction will pass above the pull wire lumen. The braided reinforcement provides a more stable lumen during catheter manipulation and also helps to ensure the straightness of the lumen as needed. Proximal to the steerable portion, the pull wire may extend proximally parallel to the central axis on the same side of the outer sheath 1208, as shown in FIGS. 3Ai-3Aiii. In this and other embodiments below, an additional pull wire 1104' within an additional pull wire lumen routed within the wall of the sheath 1208 through the steerable portion 1222 may be required to straighten the steerable portion of the device. This straightening pull wire 1104' is preferably routed within the steerable portion 1222 on the opposite side of the pull wire(s) 1104 used for steering (deflection) at the steerable portion 1222. In another embodiment not shown, two lumens and two straightening pull wires 1104' can be used, essentially reflecting a paired 1104 pull wire configuration. These straightening wires can also be configured to allow deflection in opposite directions by applying tension over a longer distance within the handle (beyond simply straightening).

[0018] The portion 1223 of the distal catheter that is immediately proximal to the in-use, steerable (deflectable) portion 1222 may be biased to conform to a curve based on the constraints of the anatomical structure within which the portion 1223 is used. For a particular embodiment where the device advances from a groin access into the heart cavity, the portion 1223 that is biased to curve is expected to be in the range of 5 - 25 cm in length. During rotation of the sheath shaft 1208 from the proximal end, torque is transmitted through this distal curved region 1223 to the catheter tip. Non-uniform cross-sections and / or tensions in the device in this region 1223 can induce the shaft to accumulate torque and have a tendency to suddenly release, causing a "whipping" or sudden rattling of rotation when torque is applied. To minimize the possibility of whipping, optionally, around the surface of the curved region 1223, the tension of the pull wire and the constituent materials are dispersed. In one embodiment as shown in FIGS. 3Bi - 3Biii, the pull wire 1104 may be spirally wound around the central axis of the sheath in the curved region 1223 that is at least proximal to the portion 1222. The pull wire of this embodiment may be wound around the entire circumference over a length of about 10 cm (this value is in the range of 5 - 15 cm). The helix need only be present in the curved region 1223 and then extend proximally straight through the proximal portion 1224 (similar to 1006), thereby minimizing the friction within the pull wire lumen and the associated pull wire force required to manipulate (deflect) the steerable portion 1222. The helix may extend straight after at least one rotation or may be spirally wound over the entire length of the shaft. In another embodiment for minimizing whipping, it may be sufficient to simply disperse the tension of the pull wire to the opposite side of the shaft. As shown in FIGS. 3Ci - 3Cii, deflection of the steerable section 1222 is achieved by two parallel pull wires 1104 positioned adjacent to each other on the same side of the sheath 1208. In the curved region 1223 and the proximal portion 1224 (similar to 1006) that are proximal to the steerable section 1222, the pull wires are routed 90° each from the position in the steerable section 1222 to the opposite side of the shaft to more evenly disperse the tension.It is preferable to actuate two parallel pull wires simultaneously with equal force by a handle actuator, but in other embodiments, a difference in force can be applied to manipulate the tip to one side or the other side of the plane formed when the two pull wires are actuated with equal force. In other embodiments, any plurality of pull wires can be routed in the same configuration as shown in FIG. 3B or FIG. 3C, and the plurality of proximal pull wires are evenly distributed around the circumference of the shaft. Also, as shown in FIGS. 3Ci-3Cii, the pull wire 1104 can be routed proximally along the opposite side of the shaft over most of the length of the shaft proximal portion 1124, but preferably, they are rejoined adjacent to each other again near the proximal end portion of the shaft so that the wires can exit together from the same side of the proximal shaft, facilitating their being fixed together to the handle component for simultaneous actuation tension.

[0019] Figures 3Di through 3Div illustrate another embodiment of the distal region of a catheter configured to provide a distally manipulable portion 1222 that can be deflected in two different directions, having a structure similar to that described above. As shown, the pair of pull wires 1105 / 1107 and 1106 / 1108 run along the proximal shaft region 1224 and the bending region 1223. This is similar to FIGS. 3Ai through 3Aiii, except that the wires are paired on each side of the shaft. The routing may be helical as in FIGS. 3Bi through 3Bii, or any other configuration discussed. Within the distally manipulable portion 1222, the wires are routed 90° from the proximal portion, although other angles are contemplated. At the junction 1225 within 1222, one or more of the pull wires (e.g., 1105 and 1107) may be terminated and secured to the shaft, and the remaining pull wires (e.g., 1106 and 1108) extend to a more distal tip location 1226 where they are secured. This configuration allows for independent actuation of the pull wires terminating at 1225 and 1226, enabling different shapes to be formed during actuation. FIG. 3Dii shows where tension is applied to both wires 1107 and 1108 to create a variable curve in the same direction. FIG. 3Diii shows where tension is applied to wires 1107 and 1106 to create an "S" curve. Other configurations are possible.

[0020] When repetitive tension is applied, the pull wires (such as 1104 and 1104') need to be terminated at the distal end of the pull wire so that the pull wire is securely fixed to the wall of the distal operable shaft portion 1222 to prevent the pull wire from breaking or being pulled freely. In the embodiment shown in FIG. 3E, when the pull wires 1104 and 1104' exit the distal pull wire lumen 1253, they are woven circumferentially into the braided wire 1250 of the distal shaft 1222 (shown without the thermoplastic polymer 1252). Additionally or alternatively, one or more of the pull wires 1104 or 1104' can be wound around and / or tied to the outside of the braided wire 1250 for further fixation. The braided wire 1250 can then be cut off distal to the fixed point, and the woven and / or wound pull wires prevent the braided wire from expanding and / or fraying. Also, a further adhesive such as UV curing or cyanoacrylate can be used to fix the pull wire to the braided wire. The weaving and / or winding of the pull wire and the braided wire is then laminated with a thermoplastic polymer, which melts within the space around the wire and cools to fix the wire in place. The thermoplastic polymer can also have a radiopaque compound containing a material such as bismuth, barium sulfate, or tungsten so that the tip of the sheath is visible to the user under fluoroscopy.

[0021] In a further embodiment, the instrument 1212 can be constructed using one or more pull wires to deflect the tip in the same manner as or alternatively to any of the foregoing embodiments described for the outer sheath 1208. In addition to routing the pull wires within the wall of the tubular member of the instrument 1212, the pull wires may be routed alongside conductors within the lumen of the tubular element 1212. Actuation of the pull wires may be derived from an actuator located within the proximal handle 1206. The distal shaft of the instrument 1212 may be formed in a particular shape (e.g., arcuate) so as to bend into a particular shape when exiting from the tip of the steerable portion 1222 of the outer sheath 1208. The rigidity of the distal shaft of the instrument 1212 is such that while inside, the distal shaft does not substantially deform the outer sheath 1208 and bends after exiting. The shape can be defined by any one or a combination of the following means: thermosetting of a polymeric material, use of a movable or fixed shaped stylet within the inner lumen of the shaft 1212 or within a lumen within the wall of the shaft 1212. Such a stylet may have a round, oval, or rectangular cross-section and may be formed from stainless steel, nitinol, or a rigid polymer such as PEEK, Vestamid. Alternatively, the outer steerable sheath can be bent in a manner similar to the above with or without further deflection of a pull wire and with or without further shaping or deflection of the distal portion of the instrument shaft 1212.

[0022] One aspect of the present disclosure includes a method of selectively decoupling at least a portion of a system from other components as part of an optional rearrangement process. In some embodiments, a medical instrument includes one or more electrical contacts coupled to other electrical contacts that are in electrical communication with an energy console, examples of consoles being known in the field of ultrasound.

[0023] FIG. 4 shows only a portion of an exemplary medical instrument, such as an ultrasonic probe, that can be electrically coupled directly or indirectly to an energy console, such as an ultrasonic console.

[0024] Relocating the device can involve disconnecting one or more proximal electrical contacts and moving the instrument portion distally from the distal end of the sheath portion. In this embodiment, the instrument portion 1212 includes at least an outer instrument sheath or outer instrument member 2010, a distal working end 1821 (which can include at least one ultrasonic transducer), and a conductor bundle 2020. The conductor bundle 2020 extends from the distal working end 1821 through the outer instrument member 2010 to a proximal connector (for clarity, the connector and handle mechanism are not shown in FIG. 18). In some embodiments, the medical device is used for ultrasonic imaging, and optionally, the distal working end 1821 includes a two-dimensional (2D) array of piezoelectric elements mounted on an application-specific integrated circuit (ASIC).

[0025] FIG. 5 shows merely an exemplary proximal end of a medical device (the medical device is shown on the right side), and in this embodiment, the medical device is an ultrasonic probe. The proximal end 2015 of the medical device is adapted to be electrically coupled directly or indirectly to an energy console such as an ultrasonic energy console or to a connector cable 270 adapted to be electrically coupled to it. As shown in FIG. 5, the flexible conductor bundle 2020 extends from the distal region of the medical instrument (the distal region is not shown) into the proximal connector 2015 in which a rigid or flexible printed circuit board ("PCB") 2030 is housed. The connector bundle 2020 includes a plurality of contacts 2024 that are attached to PCB board contacts 2031 (an example of which will be described later). Each individual wiring from each contact 2031 is coupled to a separate exposed contact 2050 on another part of the PCB, optionally more proximal. The individual PCB wirings can also pass through other useful circuits on the PCB. The exposed contacts 2050 are configured for mechanical engagement for electrical conduction to similar contacts 2060 on a mating connection connector cable 2070 in a similar concept to the proximal instrument connector 1990 described above, connecting the instrument 1204 to a user interface console. The proximal connector 2015 can be incorporated into any of the systems, handles, steerable sheaths, medical instruments, etc. described herein.

[0026] As used herein, the term "bundle of conductors" can be used interchangeably with "flexible bundle of conductors" unless otherwise specified herein.

[0027] Figures 6A and 6B show an exemplary conductor strip 2021 (also referred to herein as a flexible circuit strip) that can be included in any of the bundles of conductors herein. The embodiments of Figures 6A and 6B are an example of a conductor strip that can be included in the bundle 2020 of Figures 4 and 5. The embodiments of Figures 6A and 6B can be incorporated into any other system herein.

[0028] As shown in FIGS. 6A, 6B, and 6G, the conductor bundle 2020 includes a plurality of strip 2021 of wiring, and a plurality of flexible circuit strips including conductive strips for ground 2022 and shielding 2023 (only a portion of which is shown). Each strip 2021 of the plurality of wiring includes a plurality of conductive traces 2025 that can be clearly seen in FIGS. 6B, 6C, and 6D. The number of traces 2025 in FIGS. 6D-6G is 12, and the number of traces in FIGS. 6A-6C is 16, both of which are exemplary with respect to the number of traces 2025 that can be used. Each strip 2021 may be about 0.072 inches wide and 0.0022 inches thick, and optionally may include 16 conductive (e.g., copper) wirings that are each about 0.0022 inches apart and are about 0.0022 inches wide × about 0.0007 inches thick. The wiring is disposed on an insulating substrate layer 2027 such as a polyimide substrate, and the wiring may be at least partially covered by a cover layer 2026 such as a photosensitive film cover ("PIC") layer or other dry film type solder mask (DFSM), or other similar material. The cover layer extends generally along most of the bundle, except for separate locations in the proximal and distal regions for electrical coupling. In other embodiments, strip 2021 is about 0.055 inches wide and includes 12 conductive traces (see FIGS. 6D-6G). In other embodiments, strip 2021 is about 0.037 inches wide and includes 8 copper conductive traces. The outer strips 2022 and 2023 used for ground and shielding may have a similar configuration and dimensions, except that they may include a single full-width strip of copper. As optimized for a 2D piezoelectric array, along each one of strips 2022 and 2023 on each side of the stack of strips 2021 of the plurality of wiring, a stack of about 7 sixteen-wiring strips 2021 (or 9 twelve-wiring, or 14 eight-wiring) will be required. FIG. 6E shows a portion of an exemplary bundle 2020 having nine strips 2021 stacked on top of each other. FIG. 6F shows a portion of a bundle including nine stacked strips 2021, as well as a ground strip 2022 and a shield strip 2023 (only the upper strip is labeled).The complete bundle may optionally be held with a shrink tube having a wall thickness of about 0.001 inches, such as tube 2028 in FIG. 6G, for example, but not limited to. The dimensions and number of wirings of the above-described flex circuits are for a particular configuration of the piezoelectric array (and / or its ASIC controller) and may be varied according to how the number and size of the array elements are optimized for a particular application.

[0029] The proximal end of each flex circuit strip has a conductive material (e.g., gold-plated copper) exposed over a length of, for example, about 3 mm by removing the cover layer 2026 at location 2024. Location 2024 and other exposed locations described herein are generally referred to as “contacts”. As used in this context, a contact actually includes a plurality of separated conductive traces (such as those shown at the location of the area), and it is understood that each of these wirings is adapted to be in electrical communication with the corresponding conductive element itself. Thus, a “contact” is not limited to meaning only a single electrical connection between two conductive elements. FIG. 6A shows a plurality of exposed regions 2024, but the embodiment of FIG. 6A is described herein as if initially only one exposed region (i.e., the proximal end region 2024) were present. Strip 2021 can be manufactured to create an electrical connection to a matching exposed contact 2031, shown in FIGS. 6A-6C, for the conductive traces on PCB 2030. In some embodiments, 16 individual traces sized and spaced to match the 16 traces within the multi-trace strip 2021 will be provided within a given contact 2031. A suitable electrical connection (electrical coupling) between the strip wiring and the PCB contacts may be achieved using an anisotropic conductive film (ACF), soldering, a conductive adhesive, a mechanical connection, or any combination thereof.

[0030] FIG. 7 shows an integrated system 1200 of an operable sheath 1202 and a medical instrument 1204, and the system 1200 is connected to a console 4000 via a connector cable 2070. As described above, for example with respect to FIG. 5, the instrument 1204 includes a proximal connector 2015 that forms a mating connection to the cable 2070. As described above, it is desired to relocate (e.g., reprocess and reuse) the system 1200. It is further desired to ensure that the system is relocated only by the original manufacturer and not by an unrelated third party, and that the device is reused a specific number of times. To control the relocation process, an encryption authentication chip (encryption chip) is preferably incorporated into the instrument 1204 on the PCB 2030, although other locations such as within the operable handle 1206 or within the tip 3000 are contemplated. The encryption chip is programmable only by the original manufacturer who controls the authentication key. The console 4000 to which the system 1200 is connected has a Trusted Platform Module (TPM) that also has the authentication key. During use of the system 1200, the console 4000 can authenticate the system 1200 via the encryption chip and, if desired, read information (e.g., via an EEPROM mechanism) and write information to the chip. In any of the scenarios considered, an RFID chip, preferably an encrypted RFID chip, can be used to read and transmit data between the console, the connector, and the device.

[0031] As used herein, "cleaning" can refer to any type of cleaning, including, but not limited to, cleaning the interior of the outer shaft using a cleaning system of a cleaner and / or disinfectant, optionally mechanically scrubbing with a small brush, mechanically cleaning (e.g., wiping, brushing) the outer portion of the outer shaft and / or the outer portion of the shaft of a medical device (e.g., an ultrasonic probe) with a cleaner / disinfectant, optionally immersing the shaft in an ultrasonic bath of a cleaner / disinfectant for a specific period of time, and optical cleaning methods such as using UV light. As used herein, "cleaning" does not refer to a specific cleaning process, but rather to the general concept of cleaning an object.

[0032] The disclosure herein also includes methods of assembling or reassembling any of the subassemblies or assemblies herein, including any internal subassemblies of any of the handle assemblies herein. For example, but not limited to, the disclosure herein includes methods of winding one or more pull wires around a spindle and then onto a bearing surface of a spindle support.

[0033] The methods herein also include manufacturing or constructing any of the individual components of any of the subassemblies or assemblies herein. For example, the disclosure includes methods of manufacturing components of a handle shell having a particular configuration (e.g., guides, walls, etc.) that can house internal parts that enable the assemblies or subassemblies herein to function as intended.

[0034] Regardless of the reference numbers with which they are labeled, any of the handle assemblies, medical instruments, steerable sheaths, and electrical connectors herein can be used together within a system in any combination with each other.

[0035] Any of the techniques, including ultrasonic and manipulation techniques, in any of the following U.S. patent references may be incorporated into any of the medical devices, instruments, systems, or methods of using them herein, and these disclosures are hereby incorporated by reference herein: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833, 7783339, 7791252, 7791252, 7819802, 7824335, 7966058, 8057397, 8096951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 8659212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

[0036] Any of the above suitable disclosures can be incorporated into any of the following examples. For example, aspects of the instruments, systems, and methods of manufacture and use are incorporated herein and can be incorporated into any of the following examples, unless otherwise indicated.

[0037] Figures 8A and 8B show an exemplary handle assembly that can operably communicate with outer shaft 131 and inner shaft 132. In this embodiment, handle assembly 120 includes a handle body 123 having an outer surface that can be gripped by a user, a first actuator 121, and a second actuator 122. Actuator 121 can operably communicate with outer shaft 131, and actuator 122 can operably communicate with inner shaft 132. Actuator 121 is adapted to rotate and move axially relative to handle body 123 (and relative to second actuator 122). Thereby, actuator 121 can cause axial movement and rotation of medical instrument 103 relative to the distal end of inner shaft 132. Second actuator 122 is adapted to be actuated (e.g., rotated in this embodiment) relative to handle body 123 to cause deflection of inner shaft 132. For example, the handle assembly can have internal components that interface with the proximal ends of pull wires such that actuation of actuator 122 places tension on one or more pull wires to cause deflection of the inner shaft. In this embodiment, actuator 121 is distal to actuator 122, but in other designs, their relative positions can be reversed. Figure 8B shows handle assembly 120 after actuator 121 has advanced distally relative to its position in Figure 8A. This distal advancement causes outer shaft 131 to advance distally, and thus the medical instrument advances distally. Actuator 121 can similarly retreat proximally relative to its position in Figure 8B. Reference is made to a tension member described further below with respect to the proximal retreat of actuator 121.

[0038] In other designs, actuator 121 can operably communicate with the inner shaft, and actuator 122 can operably communicate with the outer shaft.

[0039] As described herein, the outer shaft can move axially relative to the inner deflectable shaft. The outer shaft may be composed of a portion of a material whose stiffness (e.g., durometer) varies along at least a portion of the length of the outer shaft. For example, a first portion distal to a second portion may have a lower durometer than the second portion. Since the outer shaft can move axially relative to the deflectable inner shaft and the stiffness of the outer shaft can vary along the length of the outer shaft, the deflection of the device as a whole, including the degree (or amount), can be selectively controlled by controlling the axial position of the outer shaft (relative to the inner shaft). Thus, the deflection of the device can be selectively controlled by the axial movement of the outer shaft. For example, a user (e.g., a physician) can change or control the location where bending occurs along the length of the device (measured from the distal end) by moving the outer shaft axially relative to the inner shaft. Additionally, for example, various stiffness sections in the outer shaft can allow for more or less deflection depending on the relative position of the outer shaft relative to the deflectable inner shaft. For example, by deflecting the inner shaft in a region where the outer shaft has a relatively high stiffness, the inner shaft can deflect less than when the outer shaft has a lower stiffness. Although the distinction between the characteristics and control of the inner shaft and the outer shaft is referenced, such control of the inner shaft and the outer shaft may be reversed, with the inner shaft configured for rotation and the outer shaft configured for deflection.

[0040] FIG. 9C shows an exemplary medical device 130 that includes an elongate inner shaft 132 (see FIG. 9A) and an elongate outer shaft 131 (see FIG. 9B). The medical device 130 may be referred to herein as a "catheter" or other medical device that includes at least one elongate shaft.

[0041] FIG. 9D shows cross-section A-A shown in the assembly of FIG. 9C, which is a cross-section in the deflectable portion of the device. The parts in FIGS. 9A-9C are similarly numbered. As seen in FIG. 9D, pull wires 111 and 112 are very close to each other and are approximately 180 degrees away from the straightening pull wire 116.

[0042] Also, as shown in FIG. 9D, the elongate inner shaft 132 includes two layers of braided material 119, and the pull wires are essentially sandwiched between the two layers of braided material at least in this portion of the position. The annular space 118 allows for freedom of movement and space for an optional lubricant. The inner shaft 132 can be manufactured, for example, but not limited to, from a polymeric material such as Pebax, optionally with a lubricity additive. The inner shaft 132 may include a liner 125 such as a PTFE liner. The flexible cable bundle 105 may be surrounded by one or more layers of an insulator 126 such as a PTFE insulator. The outer shaft 131 may include a polymeric material 127 such as Pebax. The outer shaft 131 may also include a radially inner liner 128 such as a PTFE liner. Any of the pull wires (e.g., 111, 112, 116) may be disposed within a lumen having a liner such as a PTFE liner 129.

[0043] The medical device 130 (or, individually, either the elongate shaft 132 or the elongate shaft 131) can operably communicate with any of the handle assemblies herein, including the handle assembly 120 shown in FIGS. 8A and 8B.

[0044] Figures 10A - 10C and 11 illustrate additional exemplary handle assemblies that can operably communicate with any medical device, including an ultrasonic probe, of this specification. For example, the exemplary handle assemblies shown in Figures 10A - 10C can be (directly or indirectly) coupled to and operably communicate with the medical device 130 shown in Figures 9A - 9D. In certain embodiments, both the elongated outer shaft 131 and the elongated inner shaft 132 are coupled to and operably communicate with the handle assembly shown in Figures 10A - 10C.

[0045] The handle assemblies of Figures 10A - 10C and 11 have several similarities to the handle assemblies, individual components, and sub - assemblies shown in Figures 8A and 8B. Unless otherwise noted, all concepts, features, and methods of use of Figures 8A and 8B that can be incorporated into the handle assemblies of Figures 10A - 10C are incorporated by reference into the disclosure of the handle assemblies shown in and described with respect to Figures 10A - 10C for all purposes. Similarly, all concepts, features, and methods of use shown in and described with respect to Figures 10A - 10C that can be incorporated into other handle assemblies of this specification are incorporated by reference into the disclosure of any of the handle assemblies described herein for all purposes.

[0046] FIG. 10A is a side view of a handle assembly 140 with a part of the handle body 141 removed so that some internal components of the handle assembly can be seen. The handle assembly 140 includes a first actuator 143 and a second actuator 142. In this embodiment, the first actuator 143 is distal to the second actuator 142. The first actuator 143 can move axially and rotate with respect to the handle body and also with respect to the second actuator (actuator 142 in this embodiment). The first actuator 143 is operably communicated with an outer elongated body such as an outer shaft 131 (see FIG. 9B). The axial movement (distal or proximal) of the actuator 143 causes the axial movement of the outer shaft 131, while the rotation of the actuator 143 causes the rotation of the outer shaft. The second actuator 142 is operably communicated with an inner shaft such as an inner shaft 132 (FIG. 9A). The operation of the second actuator 142, rotation in this embodiment, causes the deflection of the inner shaft. In this embodiment, the rotatable and axially movable actuator (i.e., the first actuator 143) is operably communicated with the outer shaft. Although it is referenced that the operation of the second actuator 142 can cause the deflection of the inner shaft, alternatively, the operation of the second actuator 142 can cause the rotation of the inner shaft. Similarly, the operation of the actuator 143 can alternatively cause the deflection of the outer shaft.

[0047] The first actuator 143 is coupled to an elongated outer shaft movement assembly 150 shown in the exploded view of FIG. 10B, whereby movement of the first actuator 143 causes movement of the assembly 150. The elongated outer shaft movement assembly 150 is similarly coupled to an elongated outer shaft, whereby movement of the first actuator causes movement of the elongated outer shaft as well. In this embodiment, the outer elongated shaft is attached to a removable part 153 after being inserted into the channel 156. The removable part 153 and the channel 156 are configured such that the removable part 153 is constrained by at least one inner surface of the channel when the removable part 153 is inserted into the channel. The elongated outer shaft movement assembly 150 also includes a distal head portion 151 fixed to the first actuator. The elongated outer shaft movement assembly 150 also includes a rotation limiting mechanism similar to that described herein, which limits the rotation of the first actuator 143 and thereby limits the rotation of the outer elongated shaft. Any of the above disclosures regarding the rotation limiting subassembly, functionality, and use are incorporated into this embodiment for all purposes and may also be incorporated into this design and similar designs. During rotation, part 157 (see FIG. 10B) interacts with part 161 and part 162 interacts with part 158. The physical interaction of these two sets of parts limits the rotation to a desired rotation limit, such as limiting the rotation of the outer body up to a maximum of 630 degrees of rotation (in other embodiments, the allowable rotation may be more than 630 degrees, such as 720 degrees or less, for example).

[0048] For example, if it is desired to clean the outer shaft after use, the removable part 153 can be removed from the outer shaft, the outer shaft can be removed from the handle assembly and cleaned, and then reinserted and reinstalled into the removable part 153 or a new removable part if the part 153 is damaged or broken.

[0049] The handle assembly 140 also includes an inner shaft deflection assembly 146 that is operably in communication with a second actuator 142. The inner shaft deflection assembly 146 includes a central gear 147 that is adapted and configured to rotate when the second actuator 142 rotates. The central gear 147 interfaces with a first spindle 148 and a second spindle 149 via a toothed interface such that rotation of the central gear 147 causes rotation of the spindles in opposite directions. The inner shaft deflection assembly 146, including the spindles, extends more proximally than the elongate outer body movement assembly 150. The inner shaft extends through the outer shaft and also extends more proximally than the outer shaft within the handle assembly 150. Thereby, one or more pull wires, which are part of the inner shaft, can extend radially outwardly and interface with a reel 160.

[0050] Due to the lack of interaction between the elongate outer shaft movement assembly 150 and the elongate inner shaft movement assembly 146, the inner and outer elongate shafts can be independently controlled by the first actuator 143 and the second actuator 142.

[0051] The handle assembly 140 also includes a printed circuit board (“PCB”) 170 disposed within the handle body 141, and the PCB electrically communicates with either a cable bundle such as the flexible cable bundle 105 of FIG. 53 or any of the cable bundles of the present specification that communicate with a medical instrument such as an ultrasonic transducer.

[0052] The handle assembly 140 can also include a rotation indicator 180 that can be used to indicate to the user the extent to which at least one of the first actuator and the second actuator rotates relative to the home position or the neutral position. The first actuator 143 can include a rotation indicator 181 that is aligned along the axis with the rotation indicator 180 when the first actuator 143 is in the neutral position, as shown in FIG. 11. When the first actuator 143 rotates, the rotation indicator 181 rotates relative to the axis along which the rotation indicator 180 extends, whereby the user can visually understand that the first actuator 143, and thus the outer shaft, rotates to some extent relative to the neutral position. Similarly, the second actuator 142 can also have a rotation indicator 182 that is aligned along the axis with the rotation indicator 180 when the second actuator 142 is in the neutral position, as shown in FIG. 11. When the second actuator 143 rotates, the rotation indicator 182 rotates relative to the axis along which the rotation indicator 180 extends, whereby the user can visually understand that the second actuator 143, and thus the inner shaft, is deflected to some extent relative to its neutral position.

[0053] In some alternative embodiments, the handle assembly can include one or more sensors for tracking how much rotation has occurred in the outer shaft or how much deflection has occurred in the inner shaft. In some embodiments, the handle assembly can include an encoder for each actuator.

[0054] In any of the embodiments of the present specification including the outer shaft and the inner shaft, the device can include one or more lubricants between the inner shaft and the outer shaft, thereby facilitating the movement of the inner shaft and the outer shaft relative to each other by reducing the friction between the two shafts. If the medical device needs to be cleaned for reuse, additional lubricant can be added between the inner shaft and the outer shaft after the cleaning process.

[0055] In some embodiments of the present specification, the medical device may include a flexible member such as a flexible conductor bundle (which may be referred to herein as a conductor bundle, a flex bundle, or other similar derivatives thereof) coupled to the distal region of the medical device (e.g., the probe tip) and extending therefrom toward the proximal region (see, for example, conductor bundle 2020 shown in exemplary FIGS. 4-6G or bundle 105 of FIG. 9B). The probe tip may include an ultrasonic transducer that communicates electrically with the flexible conductor bundle. In some embodiments of the present specification (e.g., FIGS. 9A-11), the probe tip and the conductor bundle may be displaced axially (proximally and / or distally) by the actuation of a handle actuator (e.g., actuator 143 shown in FIG. 10A). In some cases, the conductor bundle is disposed within an elongate member (e.g., an operable inner elongate body 132 or elongate member 131) and moves axially relative thereto as the probe tip advances distally or retracts proximally. When the distal region (e.g., an ultrasonic probe) and the conductor bundle retract proximally (after advancing distally), the conductor bundle tends to fold, bunch, or bend in some other way near or adjacent to its distal end due to friction between the bundle and, for example, the elongate member (e.g., the operable inner shaft 132) in which the conductor bundle is disposed. Bunching can occur when the medical device is in a straight configuration and when there is some degree of flexion in the medical device (e.g., after being deflected from a straight or linear configuration).

[0056] To reduce or even completely prevent the degree of tendency to bunch or bend, any of the medical devices herein may include a structural tension member adapted and configured to apply or maintain tension to a flexible member, such as a flexible conductor bundle, at a location proximal to the location where the conductor bundle is coupled to the distal medical device. By applying tension to the flexible member, folding or bunching of the flexible member can be minimized or even prevented. As used in this context, a "tension" member is adapted and configured to reduce (compared to a device without a tension member) the bunching of the distal region of the flexible conductor by moving at least the distal portion of the flexible conductor bundle proximally as the distal probe retracts proximally. In some embodiments, the structural tension member (e.g., a tension bar) may be physically fixed to the flexible conductor bundle (e.g., directly or indirectly attached). Generally, the tension members herein are operably in communication with a flexible member (e.g., a flexible conductor bundle), such that movement or actuation of the tension member applies a certain amount of force to the flexible member, causing movement (e.g., proximal) of the flexible member. In some exemplary embodiments, the structural tension member may be disposed within or supported by the handle assembly of the medical device. The structural tension member in this context may be a single component or an assembly of discrete components.

[0057] Figures 12A - 12F show portions of an exemplary handle assembly of a medical device, which can be incorporated into any suitable medical device herein. For example, the handle assembly of Figures 12A - 12F may be part of a medical device that includes a medical instrument (e.g., an ultrasonic imaging probe) at or near its distal end, examples of which are described herein. Other embodiments or features herein are incorporated by reference into the exemplary handle assembly shown in Figures 12A - 12F.

[0058] The exemplary handle assembly 310 includes a first actuator 314 and a second actuator 322, with the first actuator 314 being distal to the proximal actuator 322. The first actuator 314 is adapted and configured to move axially (distally and proximally) relative to the second actuator 322 (and is optionally rotatable relative to the second actuator 322), and is operably communicable with an elongate body (e.g., 131 or 132) that can include a medical device (e.g., 103) in a distal region. The handle assembly 310 (including the actuators) can incorporate any of the related disclosures from any other handle assembly herein. The medical device of which the handle assembly 310 is a part is also firmly coupled (either directly or indirectly) to the medical device at a first distal position (e.g., as shown in FIGS. 9B and 9C where the medical device 103 is fixed to the flexible member 105), and includes a flexible member (e.g., the flexible conductor bundle 105 of FIG. 9B) that extends proximally from the medical device towards the handle assembly 310. The flexible member can be, as shown, a flexible conductor bundle and can extend into the handle assembly 310. A portion of the flexible member is disposed within the outer surface of the elongate body (e.g., within 131 and / or 132). The medical device also includes a tension member fixed to the flexible member at a second position 316 proximal to the first position (the "first position" in this context may also be referred to as the first distal position or a derivative thereof). FIG. 12A shows an exemplary tension member 312, and the reference numeral 312 in FIG. 12A also refers to an optional elongate rigid member of the tension member (in this embodiment, the elongate rigid member is linear and extends axially). The tension member 312 is adapted and configured to apply tension to the flexible member when the medical device retracts proximally. This may also be referred to herein as applying tension to the flexible member, or imparting tension to the flexible member, or maintaining the tension of the flexible member. In this exemplary embodiment, the tension member 312 is adapted and configured to apply tension to the flexible member when the medical device retracts proximally, which occurs in this embodiment when the first actuator 314 retracts proximally from its position shown in FIGS. 12A - 12C.The tension member of the present specification can apply tension when the medical device is in a linear configuration and also when the medical device is in a non-linear (curvilinear) configuration, for example, when the medical device may be deflected or bent.

[0059] In this embodiment, the tension member 312 (which may include the tension bar shown in FIG. 12A) is fixed (e.g., directly attached) to the flexible conductor bundle at position 316, which in this embodiment is inside the handle assembly. Alternatively, the tension member may be fixed to the flexible member at a location not within the handle, such as outside the handle, inside one or both of the outer shaft and the inner shaft. In this embodiment, the tension member is also axially fixed to the first actuator 314, such that axial movement of the first actuator 314 causes axial movement of the tension member 312 (which may be a 1:1 movement ratio). Since the tension member 312 is also fixed to the flexible member (e.g., at position 316), axial movement of the tension member 312 also causes axial movement of the flexible member at position 316. By fixing the tension member 312 to the flexible member, when the first actuator 314 retracts proximally, the flexible member is tensioned distally at the location where the tension member is fixed to the flexible member, which prevents (or at least reduces the degree of folding / bundling compared to a device without a tension member) the flexible member from being folded or bundled in its distal region close to or adjacent to the medical instrument.

[0060] The flexible member may include a flexible conductor bundle such as any flexible conductor bundle of the present specification. In FIGS. 12A - F, the tension member includes a rigid elongate member having a fixed length (generally referred to as 312 in FIG. 12A). The illustrated rigid tension member has a general longitudinal axis, which in this embodiment is parallel to the longitudinal axis of the medical device and / or the longitudinal axis of the handle assembly. The rigid tension member can be made of various materials such as a rigid plastic member.

[0061] The tension member of the present specification can ensure that the distance the medical device moves is the same as the distance any point on the flexible member moves between the first position and the second position. The tension member of the present specification can ensure that the distance the medical device moves is the same as the distance the position where the tension member is fixed to the flexible member (e.g., position 316 in FIG. 12A) moves.

[0062] The fixed relationship between the tension member and the flexible member maintains the flexible member in a substantially flat or straight configuration between the first position and the second position when the medical device retracts proximally (when the medical device is in a linear configuration). The flat configuration in this context can include embodiments where the flexible member may be twisted (i.e., the flexible member may still be twisted even though it is flat, but not bundled / folded). The flat configuration used herein indicates that the flexible member is not folded or bundled.

[0063] The medical device incorporating the tension member can also be steerable or deflectable. The tension member of the present specification can be adapted and configured to apply tension to the flexible member even when the medical device including the flexible member is in a non-linear (e.g., deflected, steered, bent) configuration. When the present disclosure refers to maintaining a substantially flat configuration in the flexible member, it does not necessarily mean in cases such as when the medical device is steered, bent, or deflected, but rather refers to cases where the medical device may be in a linear configuration.

[0064] The fixed relationship between the tension member and the flexible member of the present specification prevents the flexible member from forming a crease (i.e., bending or bunching) between the first position and the second position when the medical device retracts proximally. Folding, bending, and bunching in this context include the first region of the flexible member axially overlapping the second region of the flexible member, and also include general bending and bunching of the flexible member, such as forming a curved region that is not flat, and / or a region of the flexible member that meanders back and forth.

[0065] The flexible member may have a flat upper surface and a lower surface (e.g., a bundle of conductors having one or more flat surfaces), and optionally, the tension member may be fixed to at least one of the upper and lower surfaces. For example, FIGS. 6A-6G show a flexible member having flat or substantially flat first and second surfaces (e.g., an upper surface and a lower surface), and the tension member may be fixed to one or both of the flat or substantially flat surfaces (e.g., at position 316). They can be fixed using various techniques such as using adhesives, welding, or other joining techniques.

[0066] The tension member may be operably communicated with (directly or indirectly) a handle actuator, such that axial movement of the actuator causes axial movement of the tension member. The handle actuator may be further adapted and configured to rotate to cause rotation of the medical instrument (e.g., actuator 314), and optionally, rotation of the actuator does not cause rotation of the tension member. Thus, the tension member can be adapted to move axially when the actuator moves axially but not rotate when the actuator rotates. This can be achieved by a method of operably communicating the tension member with the actuator (directly or indirectly).

[0067] The medical device may include an inner elongated body (e.g., 132) that includes a lumen in which at least a portion of the flexible member is disposed. The inner elongated body may be independently controllable, such as using a separate and independently operable handle actuator (e.g., actuator 322). Aspects of other embodiments of the present specification where the medical device includes an inner member and an outer member and the inner member is independently controllable (e.g., in the axial and rotational directions) are fully incorporated into any of the embodiments of the present specification.

[0068] The flexible member may be coupled to a printed circuit board within the handle assembly (e.g., the 321 "substrate" shown in FIG. 12A). The tension member may be coupled to the flexible member proximal to the printed circuit board. In an alternative embodiment, the tension member may be coupled to the flexible member distal to the printed circuit board.

[0069] FIGS. 12A-12F are an example of a portion of a medical device, which includes an elongated outer body (e.g., 131) including a probe tip in a distal region of the elongated body, and a flexible conductor bundle (e.g., 105) securely coupled to the probe tip at a first position (shown in FIGS. 9B and 9C) and extending proximally into the handle assembly from the medical instrument, wherein the flexible member is disposed within the outer surface of the elongated body, the flexible conductor bundle, and an inner elongated body (e.g., 131), at least a portion of which is disposed within the elongated outer body, the inner elongated body being optionally manipulable, at least a portion of the flexible conductor bundle being disposed within the inner elongated body and configured to be axially movable relative to the inner elongated body, and a tension member fixed to the flexible member at a second position within the handle assembly and adapted and configured to apply tension to the flexible member when the probe tip retracts proximally. As used herein, the probe tip may include one or more ultrasonic transducers.

[0070] FIGS. 12E-F show half of the handle outer shell 320, two of which form a part of the outer surface of the handle assembly 310. The handle shell 320 includes a radially inwardly extending feature 315 adapted to interface with a control portion that controls the movement of the tension member 312. The feature 315 can include a guide configured to interface with the tension member at one or more positions and assist in stabilizing the tension member.

[0071] Any other handle assembly components in any other embodiments herein that can be suitably integrated into the handle assembly 310 are hereby incorporated by reference into this specification.

[0072] In any of the embodiments and claims of this specification, the phrase "tension member" can be replaced with "straightening member", "flattening member", or derivatives thereof. As described herein, a straightening member or a flattening member refers to maintaining a substantially straight or flat configuration in a flexible member when the medical device is in a straight configuration, and the device does not necessarily need to always have a straight configuration. Thus, even when the flexible member is not necessarily under tension, it can still be maintained in a straight (i.e., non-folded) configuration along at least a portion of its length for a straightening member. For example, member 312 in FIG. 12A is an example of a straightening member even if it also functions as a tension member. This applies to all tension members described, shown, and claimed herein. In some embodiments of this specification, a "member" may be a straightening member (or a flattening member) and can also function as a tension member. Alternatively, the phrase "tension member" in this specification can be replaced with "anti-folding member", "anti-bending member", "anti-bundling member", or derivatives thereof.

[0073] The above disclosure describes that in some embodiments, a flexible member such as conductor bundle 2010 may be twisted along a portion of its length. For example, the conductor bundle may be twisted to provide a more balanced cross-section along a portion of the length of the medical device. The conductor bundle may be twisted only in a portion of the medical device that is subject to deflection.

[0074] FIGS. 13A - 13E show a portion of an exemplary medical device including a twisted flexible member such as a flexible conductor bundle. The embodiments of FIGS. 13A - E can be incorporated with any other suitable features and / or medical devices described herein.

[0075] The portion 330 of the medical device shown in FIGS. 13A - E includes a medical instrument 332 in the distal region, a flexible member 331 coupled thereto and extending proximally therefrom, and a proximal end region 333 including a plurality of electrical connectors. The flexible member 331 may be a flexible conductor bundle such as any bundle herein. The medical instrument 332 may include an ultrasonic image transducer 339. The flexible conductor bundle 331 has a region 338 where the conductor bundle is twisted, and the twisted region 338 has a distal end and a proximal end. The flexible conductor bundle 331 also includes an untwisted region 336 distal to the twisted region 334 and an untwisted region 340 proximal to the twisted region 336. The medical instrument 332 may be coupled to an outer shaft such as the outer shaft 131 shown in FIG. 9B.

[0076] The length from the distal end to the proximal end of the twisted region 338 can vary and, in some embodiments, is, for example, 5 - 15 cm, such as 8 - 15 cm, such as 11 cm. The length over which a complete turn is formed can vary sufficiently, for example, 1 - 5 cm, such as 3 cm.

[0077] The number of twists over the length of the twisted region can also vary, for example, but not limited to, 7 - 9 complete twists.

[0078] An exemplary method for forming the twisted region of a flexible member (e.g., a flexible conductor bundle) is to couple the flexible member to the medical instrument at the distal end (e.g., the probe tip). Next, a thin portion of PET heat shrink can be advanced over the flexible conductor bundle. While holding one part of the device in place, another part can be twisted to the desired number of turns to form the twisted region. While maintaining the twisted structure, the PET can be heat shrunk over the twisted bundle region. Thereafter, an additional PET layer can be added. Next, an elongate member (e.g., shaft 131) can be placed over the bundle including the twisted region and the elongate member can be coupled to the medical instrument.

[0079] Referring to FIGS. 14 - 18, system 2800 includes a handle assembly 2802 and a steering and medical device portion 2810 (shown as an outer sheath similar to sheath 1208 (FIG. 4) and may further enclose an inner shaft and instrument). The system is optionally adapted to further actuate handle assembly 2802 to cause movement of a medical device coupled thereto, such that actuation of handle assembly 2802 can be used to manipulate the steerable portion of steering and medical device portion 2810. By way of example, handle assembly 2802 includes a first actuator 2806 and a second actuator 2808. One or more of first actuator 2806 or second actuator 2808 is actuated (rotated in this embodiment) relative to the handle body of handle assembly 2802 and is adapted (e.g., configured) to manipulate the steerable portion 2810, such as steering of the outer sheath. Manipulation can include rotation or deflection. As an example, one of actuators 2806, 2808 controls rotation and the other of actuators 2806, 2808 controls deflection. As a further example, one of actuators 2806, 2808 controls rotation of one or more of an inner shaft or an outer shaft, and another of actuators 2806, 2808 controls deflection of one or more of an inner shaft or an outer shaft.

[0080] As clearly shown by FIG. 17, the neutral position marker 3102 may be disposed on the body of the handle assembly 2802 to indicate a fixed reference point (e.g., visually, tactilely, etc.). One or more of the actuators 2806, 2808 may further include markers 3104, 3106 that indicate the alignment or position of the actuators 2806, 2808 relative to the neutral position marker 3102. As an example, marker 3104 may indicate the deflection of the shaft relative to the neutral position marker 3102, and marker 3106 may indicate the rotation of a component (e.g., a transducer face disposed within the sheath 2810) relative to the neutral position marker 3102, or vice versa. Markers 3104, 3106 may indicate other positions. Additionally or alternatively, a mechanical alignment mechanism such as a detent may be used to provide tactile feedback to the user to indicate a particular position of the actuators 2806, 2808, such as when the actuators 2806, 2808 are in the neutral position.

[0081] The handle assembly 2802 may include any other handle components or functionality described in any of the other handles herein. For example, the receptacle 2804 may be disposed at the proximal end of the handle assembly 2802 and may be adapted to receive a plug such as an umbilical plug. As clearly shown by FIG. 16, the receptacle 2804 may include visual and / or tactile orientation markers for alignment and orientation of the umbilical plug and the receptacle 2804.

[0082] The navigation connector 2812 may be coupled to the handle assembly 2802 via a navigation conduit 2814 (e.g., a navigation cable sleeve). The navigation connector 2812 may be configured to interface with a navigation system so that the system 2800 can communicate with the navigation system. As an example, the navigation system can provide tracking and navigation of a portion of the system (e.g., a medical device) during use. As shown, for example, the navigation conduit 2814 may be coupled to the body of the handle assembly 2802 to provide access for one or more cables to pass from the navigation connector 2812 to components within the housing of the handle assembly 2802. As more clearly shown in FIG. 18, the navigation connector 2812 may be configured to interface with a navigation system connector 3204 (e.g., a receptacle) that may be the property of the navigation system manufacturer. The receptacle 2804 may be configured to interface with a controller interface 3202. Other configurations may be used.

[0083] FIGS. 19-24 show exemplary distal regions of an operable system including a medical device. As an exemplary example, FIG. 19 shows that the medical device may comprise an operable tip 3300 disposed at the distal end of a sheath. The operable tip 3300 may include a transducer 3304 (e.g., an ultrasonic transducer) at least partially surrounded by a material 3302 (e.g., a polymer). The tip 3300 may comprise an electronic module 3306 that may include sensors, control panels, thermistors, etc. As an example, a TAS sensor 3308 may be arranged to communicate with the module 3306. As a further example, a sensor cable bundle 3310 may be arranged to provide electrical communication to one or more components coupled to the module 3306.

[0084] As an illustrative example, FIG. 20 shows that a medical device can include an actuatable tip 3400 disposed at the distal end of a sheath. The actuatable tip 3400 can include a transducer 3404 (e.g., an ultrasonic transducer, a foldable transducer) at least partially surrounded by a material 3402 (e.g., a polymer). The tip 3400 may include sensors, control panels, thermistors, and the like. As an example, a TAS sensor 3406 may be disposed in a configuration closer to the distal end of the tip 3300 as compared to the configuration of the tip 3400 of FIG. 19. By moving the sensor 3406, the percentage of the tip 3400 that can be deflected increases.

[0085] As an illustrative example, FIG. 21 shows that a medical device can include an actuatable tip 3500 disposed at the distal end of a sheath. The actuatable tip 3500 may include a transducer 3502 (e.g., an ultrasonic transducer, a foldable transducer). As an example, an ASIC 3504 can be disposed adjacent to the transducer 3502. As a further example, non-active piezoelectric elements may be disposed adjacent to the transducer 3502. The tip 3500 may include various sensors, control panels, thermistors, and the like. As shown, the tip 3500 includes a thermistor 3506 disposed proximal to the transducer 3502. As more clearly shown in FIG. 23, at least a portion of the tip 3500 may be at least partially surrounded by a first material 3700 (e.g., a polymer), and at least a portion of the tip 3500 may be at least partially surrounded by a second material 3704. The first material 3700 and the second material 3704 may be configured to have different properties such as the same or different rigidity (e.g., durometer). As an illustrative example, the first material 3700 may have a higher durometer than the second material 3704. As further illustrated in FIG. 23, a navigation sensor 3702 may be disposed at or adjacent to the proximal end of the tip 3500. The navigation sensor 3702 may communicate with a navigation system to provide tracking and position of the tip 3500 and to provide feedback to the user.

[0086] As an illustrative example, FIG. 22 shows that a medical device may include an operable tip 3600 disposed at the distal end of a sheath. The operable tip 3600 may include a transducer 3602 (e.g., an ultrasonic transducer, a foldable transducer). Compared to tip 3500, tip 3600 may include a shortened, folded end 3601. The non-active piezoelectric material may be minimized adjacent to transducer 3602. As an example, an ASIC 3604 can be disposed adjacent to transducer 3602. Tip 3600 may include various sensors, control panels, thermistors, etc. As shown, tip 3600 includes a thermistor 3606 disposed proximal to transducer 3602. A circuit such as a flex circuit may communicate electrically with one or more of the components within tip 3600. As an example, the flex circuit may be split into layers and communicate selectively with components. As more clearly shown in FIG. 24, at least a portion of tip 3600 may be at least partially surrounded by a first material 3800 (e.g., a polymer), and at least a portion of tip 3600 may be at least partially surrounded by a second material 3804. The first material 3800 and the second material 3804 may be configured to have different properties such as the same or different rigidity (e.g., durometer). As an illustrative example, the first material 3800 may have a higher durometer than the second material 3804. As further shown in FIG. 24, a navigation sensor 3802 may be disposed adjacent to transducer 3602. The navigation sensor 3802 may communicate with a navigation system to provide tracking and positioning of tip 3600 and to provide feedback to the user.

[0087] FIG. 25 shows a medical device that may include an operable tip 3902 disposed at the distal end of a sheath 3906. As shown, the DAS sensor 3908 may be disposed at or adjacent to the proximal end of the tip 3902. The inner sheath 3904 may include a section configured for deflection 3912 and may be disposed within the sheath 3906 adjacent to the tip 3902. One or more DAS sensors 3910, 3910' may be disposed along the length of the sheath 3904.

[0088] FIG. 26 shows an exemplary configuration of a navigation transducer 4002. For example, from the tip of the device to the center of the y - coil, it may be measured at a first length 4003. From the center of the active transducer 4002 to the y - coil, it may be a second length 4004. From the sensor axis to the tip axis, it may be a third length 4006. From the sensor axis to the face of the ultrasonic transducer, it may be a fourth length 4008.

[0089] FIGS. 27 - 29 show various arrangements of pull wires. For example, the handle assembly may have internal components that interface with the proximal ends of the pull wires such that actuation of one or more actuators places tension on such one or more pull wires to cause deflection of the inner shaft. From left to right, the configurations of the inner shaft and wires (showing two versions in a vertical pairing for comparison) may represent the distal, middle, and proximal portions along the length of the inner shaft. The wire 4102 may have a relative configuration within the outer sheath 4100. The wire 4106 may have a relative configuration within the outer sheath 4104. The wire 4110 may have a relative configuration within the outer sheath 4108. The wire 4114 may have a relative configuration within the outer sheath 4112. The wire 4118 may have a relative configuration within the outer sheath 4116. The wire 4122 may have a relative configuration within the outer sheath 4120. FIGS. 28 - 29 show that the pull wires may vary in spacing and configuration along the length on one or more shafts or sheaths.

[0090] Figures 30-31 show various configurations of components of an exemplary handle assembly. By way of example, the handle assembly 4400 may include one or more printed circuit boards 4402 in a stacked arrangement. As a further example, the handle assembly 4500 may include one or more printed circuit boards 4502 in a stacked arrangement. Other arrangements may be used.

[0091] In this specification, medical devices such as catheters are described with their operability. However, introducing a medical device into a specific region of the heart, such as through a septal puncture into the left atrium (LA), can still present difficulties. Such procedures may require identifying the puncture site and then pushing a medical device (e.g., a catheter) through the puncture site. Other procedures and devices may benefit from additional guidance mechanisms and navigation methods.

[0092] In one aspect, an over-the-guidewire design is provided where the distal end of the catheter includes a monorail (e.g., a guidewire lumen). By way of example, the catheter may have steering capabilities such as two-way or four-way steering as described herein, or may benefit from a guidewire. Alternatively, the catheter may have no deflection steering at all and instead rely only on advancement on the guidewire. As a further example, the catheter may be advanced within a fixed or steerable sheath.

[0093] In certain aspects, the guidewire lumen may include a tip extension disposed at or adjacent to the distal end of the medical device. The tip extension may be at least partially formed from a soft polymer material (e.g., equivalent to Pebax 25 or 35 durometer). Other materials may be used. The tip extension may include a guidewire lumen sized to receive a guidewire (e.g., a 0.018-inch to 0.035-inch guidewire) therethrough. (e.g., inner diameter of about 0.021 inches to 0.042 inches). Other dimensions may be used.

[0094] As an illustrative example, for use of the device, the guide wire can be positioned at the target location by itself or, preferably, with the aid of a long introducer sheath or a guiding catheter to the heart. Illustrative target locations can include the coronary sinus, the pulmonary artery, or the entire interseptal foramen from the right atrium to the left atrium. Next, the catheter is advanced on the guide wire to the target location. Alternatively, the catheter and the guide wire can be advanced together into the heart, and the guide wire can be advanced towards the target location, for example, before the catheter is tracked thereon.

[0095] During use, it may be desirable to remove the wire and use the catheter without the aid of the wire. In this case, a tip that curls into a "pigtail" type shape (Figure 33B) reduces potential trauma to tissue when the device is manipulated. Alternatively, the catheter can be removed, the wire repositioned, and the catheter advanced again on the trailing end of the wire to the target location. Other configurations and methods of use may be implemented.

[0096] Figures 32 and 33A - 33B illustrate exemplary medical devices having a distal extension portion. Figure 32 shows a medical device 5000 comprising a probe 5020, a distal extension portion 5010, a guidewire 5030, a transducer 5040, and an outer shaft 5050. The distal extension portion 5010 may comprise a tapered tip 5014, a first (e.g., soft) portion 5012, and a second (e.g., rigid or stiff) portion 5016. Other configurations may be used. The distal extension portion 5010 may comprise an access opening 5032 for receiving the guidewire 5030. The distal extension portion 5010 may comprise a guidewire lumen 5034. Figure 33A shows a medical device 5100 comprising a probe 5120, a distal extension portion 5110, a guidewire 5130, a transducer 5140, and an outer shaft 5050. The distal extension portion 5110 can comprise a tapered tip 5114, a first portion 5112, and a second portion 5116. The first portion may have less rigidity than the second portion. The distal extension portion 5110 may comprise a guidewire lumen 5134. The guidewire lumen 5134 may be aligned 180 degrees from the face of the transducer 5140 and extend along the entire length of the medical device 5100. Figure 33B shows a medical device 5200. The medical device 5200 may comprise the medical device 5100 (or medical device 5000) after the guidewire (e.g., guidewire 5130 or guidewire 5030) has been removed. As shown, the distal extension portion 5110 may be configured to assume a non - traumatic "pigtail" shape when the guidewires 5030, 5130 are not loaded. By way of example, the medical devices 5000, 5100, 5200 can include a catheter such as an ICE catheter.

[0097] The first (e.g., soft) portions 5012, 5112 may include a soft polymer material (e.g., equivalent to Pebax 25 or 35 durometer). The guide wire lumens 5034, 5134 may be sized for a 0.018 - 0.035 guide wire (typically ID = 0.021 inch - 0.042 inch). The stiffness of the tip extensions 5010, 5110 is more rigid at the distal ends of the transducers 5040, 5140 (at the second (e.g., hard) portions 5016, 5116) and softens towards the distal ends of the tip extensions 5010, 5110 (in the first (e.g., soft) portions 5012, 5112) to transition better to be the same as or more closely similar to the stiffness of the guide wires 5030, 5130. The stiffness transition may be facilitated by one or more of a transition in outer diameter (or other dimension), internal longitudinal stiffening members, coils, braids, and / or materials of different durometers (e.g., polymers). Other methods and controls regarding stiffness may be used. The stiffness may transition linearly, or by regions / sections, or by some other transition curve, as shown by the change in stiffness from the distal end of the transducer to the distal end of the tip extension. The tip extensions 5010, 5110 may also be configured to take on a non - traumatic "pigtail" shape when the guide wires 5030, 5130 are not loaded, as shown by the medical device 5200.

[0098] The guide wire lumens 5034, 5134 may be provided with a lubricious liner such as polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP), or polyethylene such as high density polyethylene or a blend of high density polyethylene with low density polyethylene. Other materials may be used. The length of the distal extensions 5010, 5110 may be 1 - 6 cm. In certain embodiments, the length of the distal extensions 5010, 5110 may be about 2.5 cm. The length of the guide wire lumens 5034, 5134 may be 0.5 - 5.5 cm. The length of the guide wire lumens 5034, 5134 may be 2 cm. Other dimensions may be used. The guide wire lumens 5034, 5134 may be distal monorail lumens. In another example, a separate irrigation lumen may be routed through the length of the medical device 5000 (or medical device 5100) and joined to the guide wire lumen 5034 (or guide wire lumen 5134) behind the transducer 5040 (or transducer 5140) to flush the guide wire lumen 5034 (or guide wire lumen 5134) with saline to prevent blood clotting.

[0099] The navigation sensor may be incorporated into a portion (e.g., the end or tip) of the distal extensions 5010, 5110 for accurate visualization in mapping or navigation techniques such as the cardiac 3D mapping system (CARTO) by Biosense Webster. The distal extensions 5010, 5110 can include a polymer mixed with a radiopaque material such as barium sulfate or tungsten powder. Radiopaque marker bands, braids, and / or coils including platinum and other materials known in the art may also be incorporated into the distal extensions 5010, 5110.

[0100] As an example, the guide wire lumen 5134 may extend over the entire length of the medical device 5100. The proximal end may be provided with an attachment for a rotary hemostatic valve to enable injection of saline throughout the length of the guide wire lumen 5134.

[0101] To use the medical device 5000 (or medical device 5100), the guidewire 5030 (or guidewire 5130) may be placed into the target location by itself. The guidewire 5030 (or guidewire 5130) may be placed within the target location with the aid of a long introducer sheath or a guiding catheter into the heart. The target location may include the coronary sinus, the pulmonary artery, or the entire interseptal foramen from the right atrium to the left atrium. The medical device 5000 (or medical device 5100) may then be advanced over the guidewire 5030 (or guidewire 5130) to the target location. Alternatively, the medical device 5000 (or medical device 5100) and the guidewire 5030 (or guidewire 5130) may be advanced together into the heart, and the guidewire 5030 (or guidewire 5130) may be advanced forward to the target location before the medical device 5000 (or medical device 5100) is tracked across the target location.

[0102] During use, it may be preferable to remove the guidewire 5030 (or guidewire 5130) and use the medical device 5000 (or medical device 5100) without the assistance of the guidewire 5030 (or guidewire 5130). In this case, as shown in FIG. 33B, the tip extension 5010 (or tip extension 5110) that curls into a pigtail type shape reduces potential trauma to the tissue when the medical device 5000 (or medical device 5100) is manipulated. Alternatively, the medical device 5000 (or medical device 5100) may be removed, the guidewire 5030 (or guidewire 5130) may be repositioned, and the medical device 5000 (or medical device 5100) may be advanced again over the rear end of the guidewire 5030 (or guidewire 5130) to the target location.

[0103] The medical devices 5000, 5100 may have steering capabilities such as those described herein (e.g., two-way steering or four-way steering). The medical devices 5000, 5100 may be manufactured to have no deflectable steering and instead rely on advancement over the guidewires 5030, 5130. The medical devices 5000, 5100 may be advanced within a fixed or steerable sheath.

[0104] Exemplary aspect Exemplary aspect 1: A medical device configured and sized to be disposed within a subject, the medical device including an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material defining a distal tip of the medical device, the ultrasonic transducer; a tip extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the tip extension including a first end adjacent to the distal tip and a second end opposite the first end; and a tip extension, the tip extension including a tapered tip at or adjacent to the second end, the tip extension including a guidewire lumen formed therein and configured to receive a guidewire therethrough, the tip extension exhibiting a first stiffness at the first end and a second stiffness adjacent to the second end, the first stiffness being greater than the second stiffness.

[0105] Exemplary aspect 2: The medical device according to aspect 1, further comprising an ultrasonic probe including an ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further including an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate, with one or more portions of the plurality of conductive traces being covered by an insulating member.

[0106] Exemplary aspect 3: The medical device according to aspect 1, wherein the guidewire lumen includes one or more lumen openings configured to permit entry and removal of a guidewire from the guidewire lumen.

[0107] Exemplary aspect 4: The medical device according to aspect 1, wherein the guidewire lumen includes a first lumen opening disposed along the length of the tip extension and a second lumen opening disposed at the tapered tip, the first lumen and the second lumen being configured to permit entry and removal of a guidewire from the guidewire lumen.

[0108] Exemplary Aspect 5: The guidewire lumen is the medical device according to Aspect 1 that extends along at least a portion of the length of the ultrasonic transducer.

[0109] Exemplary Aspect 6: The ultrasonic transducer comprises an emitter surface, and the guidewire lumen is the medical device according to any one of Aspects 1 to 4 that extends along at least a portion of the length of the ultrasonic transducer on the side opposite to the emitter surface.

[0110] Exemplary Aspect 7: The distal extension is coupled to the distal tip, which is the medical device according to Aspect 1.

[0111] Exemplary Aspect 8: The distal extension is fused to the distal tip, which is the medical device according to Aspect 1.

[0112] Exemplary Aspect 9: The medical device according to any one of Aspects 1 to 8, further comprising an outer shaft coupled to the proximal end of the distal tip.

[0113] Exemplary Aspect 10: The guidewire lumen is the medical device according to Aspect 9 that extends along at least a portion of the length of the outer shaft.

[0114] Exemplary Aspect 11: A medical device configured and sized to be disposed within a subject, the medical device having an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material defining the distal tip of the medical device, the ultrasonic transducer, and a distal extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the distal extension comprising a first end adjacent to the distal tip and a second end opposite the first end, the distal extension having a guidewire lumen formed therein and configured to receive a guidewire therethrough, the distal extension exhibiting a transition in stiffness along its length.

[0115] Exemplary Aspect 12: The medical device according to Aspect 11, wherein the distal extension shows a first rigidity at the first end and a second rigidity adjacent to the second end, and the first rigidity is greater than the second rigidity.

[0116] Exemplary Aspect 13: The medical device according to Aspect 11 or 12, wherein the distal extension comprises a tapered tip at or adjacent to the second end.

[0117] Exemplary Aspect 14: The medical device according to any one of Aspects 11 to 13, further comprising an ultrasonic probe comprising an ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate, and a part of one or more of the plurality of conductive traces is covered by an insulating member.

[0118] Exemplary Aspect 15: The medical device according to any one of Aspects 11 to 14, wherein the guide wire lumen comprises one or more lumen openings configured to allow entry and removal of a guide wire from the guide wire lumen.

[0119] Exemplary Aspect 16: The medical device according to any one of Aspects 11 to 14, wherein the guide wire lumen comprises a first lumen opening disposed along the length of the distal extension and a second lumen opening disposed adjacent to the end of the distal extension, and the first lumen and the second lumen are configured to allow entry and removal of a guide wire from the guide wire lumen.

[0120] Exemplary Aspect 17: The medical device according to any one of Aspects 11 to 16, wherein the guide wire lumen extends along at least a part of the length of the ultrasonic transducer.

[0121] Exemplary Aspect 18: The medical device according to any one of Aspects 11 to 16, wherein the ultrasonic transducer comprises an emitter surface, and the guide wire lumen extends along at least a part of the length of the ultrasonic transducer on the side opposite to the emitter surface.

[0122] Exemplary Aspect 19: The distal tip extension is a medical device according to any one of Aspects 11 to 16, which is coupled to the distal tip.

[0123] Exemplary Aspect 20: The distal tip extension is a medical device according to any one of Aspects 11 to 16, which is fused to the distal tip.

[0124] Exemplary Aspect 21: The medical device according to any one of Aspects 11 to 20, further comprising an outer shaft coupled to the proximal end of the distal tip.

[0125] Exemplary Aspect 22: The medical device according to Aspect 21, wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

[0126] Exemplary Aspect 23: A medical device configured and sized to be disposed within a subject, the medical device being an ultrasonic probe disposed adjacent to a distal region of a rotatable shaft, the ultrasonic probe comprising an ultrasonic transducer, an ultrasonic probe, a deflectable shaft, the deflectable shaft being disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft, a handle body having an outer surface that can be grasped by a user, a first actuator configured to be moved relative to the handle body, and a second actuator configured to be moved relative to the handle body, the handle assembly comprising a first actuator and a second actuator, the first actuator and the second actuator being circumferentially disposed about a longitudinal axis of the handle body, the rotatable shaft being operably in communication with the first actuator of the handle assembly such that actuation of the first actuator causes at least a portion of the rotatable shaft to rotate relative to the deflectable shaft, the deflectable shaft being operably in communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft, a handle assembly, a tip extension disposed adjacent to the ultrasonic probe and extending longitudinally from the ultrasonic probe, the tip extension comprising a first end adjacent to the ultrasonic probe and a second end opposite the first end, the tip extension comprising a guide wire lumen formed therein and configured to receive a guide wire therethrough, the tip extension exhibiting a transition in stiffness along its length, a tip extension, and a medical device.

[0127] Exemplary Aspect 24: The medical device according to Aspect 23, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent to the second end, and the first stiffness is greater than the second stiffness.

[0128] Exemplary Aspect 25: The medical device according to Aspect 23 or 24, wherein the tip extension comprises a tapered tip at or adjacent to the second end.

[0129] Exemplary Aspect 26: The ultrasonic probe includes a flexible circuit strip that communicates electrically with the ultrasonic transducer. The flexible circuit strip further includes an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate. One or more portions of the plurality of conductive traces are covered by an insulating member. The medical device according to any one of Aspects 23 to 25.

[0130] Exemplary Aspect 27: The guidewire lumen includes one or more lumen openings configured to allow entry and removal of a guidewire from the guidewire lumen. The medical device according to any one of Aspects 23 to 26.

[0131] Exemplary Aspect 28: The guidewire lumen includes a first lumen opening disposed along the length of the distal extension and a second lumen opening disposed adjacent to the end of the distal extension. The first lumen and the second lumen are configured to allow entry and removal of a guidewire from the guidewire lumen. The medical device according to any one of Aspects 23 to 26.

[0132] Exemplary Aspect 29: The guidewire lumen extends along at least a portion of the length of the ultrasonic transducer. The medical device according to any one of Aspects 23 to 28.

[0133] Exemplary Aspect 30: The ultrasonic transducer includes an emitter surface, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer on the side opposite the emitter surface. The medical device according to any one of Aspects 23 to 28.

[0134] Exemplary Aspect 31: The distal extension is coupled to the ultrasonic probe. The medical device according to any one of Aspects 23 to 30.

[0135] Exemplary Aspect 32: The distal extension is fused to the ultrasonic probe. The medical device according to any one of Aspects 23 to 30.

[0136] Exemplary Aspect 33: The medical device according to any one of Aspects 23 to 32, further comprising an outer shaft coupled to the proximal end of the ultrasonic probe.

[0137] Exemplary Aspect 34: The medical device according to Aspect 33, wherein the guide wire lumen extends along at least a portion of the length of the outer shaft.

[0138] Exemplary Aspect 35: A medical device configured and sized to be disposed within a subject, the medical device comprising a probe tip extension configured to be coupled to the tip of an ultrasonic probe configured and sized to be disposed within the subject, the probe tip extension being configured to extend longitudinally from the tip, the tip extension comprising a first end adjacent to the tip and a second end opposite the first end, the probe tip extension exhibiting a stiffness transition along its length, the probe tip extension, and a guide wire lumen formed through the probe tip extension, the guide wire lumen being configured to receive a guide wire therethrough such that the ultrasonic probe can move along the length of the guide wire through the guide wire lumen.

[0139] Exemplary Aspect 36: The medical device according to Aspect 35, wherein the guide wire lumen comprises one or more lumen openings configured to permit entry and removal of the guide wire from the guide wire lumen.

[0140] Exemplary Aspect 37: The medical device according to Aspect 35, wherein the guide wire lumen comprises a first lumen opening disposed along the length of the tip extension and a second lumen opening disposed adjacent to an end of the tip extension, the first lumen and the second lumen being configured to permit entry and removal of the guide wire from the guide wire lumen.

[0141] Exemplary Aspect 38: The medical device according to Aspect 35, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent to the second end, the first stiffness being greater than the second stiffness.

[0142] Exemplary Aspect 39: The medical device according to Aspect 35, wherein the distal extension has a tapered tip at or adjacent to the second end.

[0143] Exemplary Aspect 40: The medical device according to any one of Aspects 1 to 39, wherein the guide wire lumen is disposed distal to the ultrasonic transducer.

[0144] Exemplary Aspect 41: The medical device according to any one of Aspects 1 to 39, wherein the guide wire lumen is disposed completely distal to the ultrasonic transducer.

[0145] Regardless of the reference numbers with which they are labeled, any of the handle assemblies, medical instruments, steerable sheaths, and electrical connectors herein can be used together within the system in any combination with each other.

[0146] Any of the techniques, including ultrasonic and manipulation techniques, in any of the following U.S. Patent References may be incorporated into any of the medical instruments, devices, systems, or methods of use herein, and these disclosures are hereby incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833, 7783339, 7791252, 7791252, 7819802, 7824335, 7966058, 8057397, 8096951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 8659212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

[0147] 〔Embodiments〕 (1) A medical device configured and sized to be disposed within a target, an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material defining a distal tip of the medical device, and the ultrasonic transducer; a tip extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the tip extension comprising a first end adjacent to the distal tip and a second end opposite the first end; the tip extension comprising a tapered tip at or adjacent to the second end; the tip extension comprising a guide wire lumen formed therein and configured to receive a guide wire therethrough; the tip extension exhibiting a first stiffness at the first end and a second stiffness adjacent to the second end, the first stiffness being greater than the second stiffness, a medical device. (2) The medical device according to embodiment 1, further comprising an ultrasonic probe comprising the ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate, and a part of one or more of the plurality of conductive traces being covered by an insulating member. (3) The medical device according to embodiment 1, wherein the guide wire lumen comprises one or more lumen openings configured to allow entry and removal of a guide wire from the guide wire lumen. (4) The medical device according to embodiment 1, wherein the guide wire lumen comprises a first lumen opening disposed along a length of the tip extension and a second lumen opening disposed at the tapered tip, and the first lumen opening and the second lumen opening are configured to allow entry and removal of a guide wire from the guide wire lumen. (5) The medical device according to Embodiment 1, wherein the guide wire lumen extends along at least a part of the length of the ultrasonic transducer.

[0148] (6) The medical device according to Embodiment 1, wherein the ultrasonic transducer includes an emitter surface, and the guide wire lumen extends along at least a part of the length of the ultrasonic transducer on the side opposite to the emitter surface. (7) The medical device according to Embodiment 1, wherein the tip extension is coupled to the distal tip. (8) The medical device according to Embodiment 1, wherein the tip extension is fused to the distal tip. (9) The medical device according to Embodiment 1, further comprising an outer shaft coupled to the proximal end of the distal tip. (10) The medical device according to Embodiment 9, wherein the guide wire lumen extends along at least a part of the length of the outer shaft.

[0149] (11) A medical device configured and sized to be disposed within a subject, an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material that defines the distal tip of the medical device, and a tip extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the tip extension including a first end adjacent to the distal tip and a second end opposite the first end. The tip extension includes a guide wire lumen formed therein and configured to receive a guide wire therethrough. The tip extension exhibits a stiffness transition along its length. (12) The medical device according to Embodiment 11, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent to the second end, and the first stiffness is greater than the second stiffness. (13) The medical device according to embodiment 11, wherein the tip extension portion comprises a tapered tip at or adjacent to the second end. (14) The medical device according to embodiment 11, further comprising an ultrasonic probe comprising the ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate, wherein one or more portions of the plurality of conductive traces are covered by an insulating member. (15) The medical device according to embodiment 11, wherein the guide wire lumen comprises one or more lumen openings configured to allow entry and removal of a guide wire from the guide wire lumen.

[0150] (16) The medical device according to embodiment 11, wherein the guide wire lumen comprises a first lumen opening disposed along the length of the tip extension portion and a second lumen opening disposed adjacent to an end of the tip extension portion, the first lumen opening and the second lumen opening being configured to allow entry and removal of a guide wire from the guide wire lumen. (17) The medical device according to embodiment 11, wherein the guide wire lumen extends along at least a portion of the length of the ultrasonic transducer. (18) The medical device according to embodiment 11, wherein the ultrasonic transducer comprises an emitter surface, and the guide wire lumen extends along at least a portion of the length of the ultrasonic transducer on the side opposite the emitter surface. (19) The medical device according to embodiment 11, wherein the tip extension portion is coupled to the distal tip. (20) The medical device according to embodiment 11, wherein the tip extension portion is fused to the distal tip.

[0151] (21) The medical device according to embodiment 11, further comprising an outer shaft coupled to the proximal end of the distal tip. (22) The guide wire lumen is the medical device according to Embodiment 21 that extends along at least a part of the length of the outer shaft. (23) A medical device configured and sized to be placed within a subject, An ultrasonic probe disposed adjacent to the distal region of a rotatable shaft, the ultrasonic probe comprising an ultrasonic transducer, the ultrasonic probe, A deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a part of the rotatable shaft, the deflectable shaft, A handle assembly having an outer surface that can be gripped by a user, a first actuator configured to be moved relative to the handle body, and a second actuator configured to be moved relative to the handle body, The first actuator and the second actuator are circumferentially arranged around the longitudinal axis of the handle body, The rotatable shaft is operably in communication with the first actuator of the handle assembly such that actuation of the first actuator causes a rotational movement of at least a part of the rotatable shaft relative to the deflectable shaft, The deflectable shaft is operably in communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft, the handle assembly, A tip extension disposed adjacent to the distal end of the ultrasonic probe and extending longitudinally from the ultrasonic probe, the tip extension comprising a first end adjacent to the ultrasonic probe and a second end opposite the first end, The tip extension comprises a guide wire lumen formed therein and configured to receive a guide wire therethrough, The tip extension exhibits a transition in rigidity along its length, the tip extension, Comprising a medical device. (24) The tip extension shows a first rigidity at the first end and shows a second rigidity adjacent to the second end, and the first rigidity is greater than the second rigidity. The medical device according to Embodiment 23. (25) The tip extension includes a tapered tip at or adjacent to the second end. The medical device according to Embodiment 23.

[0152] (26) The ultrasonic probe includes a flexible circuit strip that communicates electrically with the ultrasonic transducer. The flexible circuit strip further includes an insulating substrate and a plurality of conductive traces disposed on the insulating substrate and extending along the insulating substrate. One or more portions of the plurality of conductive traces are covered by an insulating member. The medical device according to Embodiment 23. (27) The guide wire lumen includes one or more lumen openings configured to allow entry and removal of a guide wire from the guide wire lumen. The medical device according to Embodiment 23. (28) The guide wire lumen includes a first lumen opening disposed along the length of the tip extension and a second lumen opening disposed adjacent to the end of the tip extension. The first lumen opening and the second lumen opening are configured to allow entry and removal of a guide wire from the guide wire lumen. The medical device according to Embodiment 23. (29) The guide wire lumen extends along at least a portion of the length of the ultrasonic transducer. The medical device according to Embodiment 23. (30) The ultrasonic transducer includes an emitter surface, and the guide wire lumen extends along at least a portion of the length of the ultrasonic transducer on the side opposite to the emitter surface. The medical device according to Embodiment 23.

[0153] (31) The tip extension is coupled to the ultrasonic probe. The medical device according to Embodiment 23. The medical device according to embodiment 23, wherein the tip extension is fused to the ultrasonic probe. The medical device according to embodiment 23, further comprising an outer shaft coupled to the proximal end of the ultrasonic probe. The medical device according to embodiment 33, wherein the guide wire lumen extends along at least a portion of the length of the outer shaft. (35) A medical device configured and sized to be disposed within a subject, A probe tip extension configured to be coupled to the tip of an ultrasonic probe configured and sized to be disposed within a subject, the probe tip extension being configured to extend longitudinally from the tip, the probe tip extension comprising a first end adjacent to the tip and a second end opposite the first end, the probe tip extension exhibiting a transition in rigidity along its length, a probe tip extension, A guide wire lumen formed through the probe tip extension, the guide wire lumen being configured to receive a guide wire therethrough such that the ultrasonic probe can move along the length of the guide wire via the guide wire lumen, a guide wire lumen, Comprising a medical device.

[0154] (36) The medical device according to embodiment 35, wherein the guide wire lumen comprises one or more lumen openings configured to allow entry and removal of a guide wire from the guide wire lumen. (37) The guide wire lumen according to embodiment 35, comprising a first lumen opening disposed along the length of the probe tip extension and a second lumen opening disposed adjacent to an end of the probe tip extension, the first lumen opening and the second lumen opening being configured to allow entry and removal of a guide wire from the guide wire lumen. (38) The medical device according to Embodiment 35, wherein the probe tip extension shows a first rigidity at the first end and shows a second rigidity adjacent to the second end, and the first rigidity is greater than the second rigidity. (39) The medical device according to Embodiment 35, wherein the probe tip extension has a tapered tip at or adjacent to the second end.

Claims

1. 1. A medical device configured and sized to be placed within a subject, comprising: an ultrasound transducer disposed in a distal region of the medical instrument, the ultrasound transducer being at least partially surrounded by a material defining a distal tip of the medical instrument; a tip extension disposed adjacent to and extending longitudinally from the distal tip, the tip extension having a first end adjacent the distal tip and a second end opposite the first end; the tip extension comprises a tapered tip at or adjacent the second end; the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire therethrough; The medical device, wherein the distal extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, the first stiffness being greater than the second stiffness.

2. 10. The medical device of claim 1, further comprising an ultrasonic probe comprising the ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, one or more portions of the plurality of conductive traces being covered by an insulating member.

3. The medical device of claim 1 , wherein the guidewire lumen comprises one or more lumen openings configured to allow for entry and removal of a guidewire from the guidewire lumen.

4. 2. The medical device of claim 1, wherein the guidewire lumen comprises a first lumen opening disposed along the length of the tip extension and a second lumen opening disposed at the tapered tip, the first lumen opening and the second lumen opening configured to allow entry and removal of a guidewire from the guidewire lumen.

5. The medical device of claim 1 , wherein the guidewire lumen extends along at least a portion of the length of the ultrasound transducer.

6. 10. The medical device of claim 1, wherein the ultrasonic transducer comprises an emitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer opposite the emitter face.

7. The medical device of claim 1 , wherein the tip extension is coupled to the distal tip.

8. The medical device of claim 1 , wherein the tip extension is fused to the distal tip.

9. The medical device of claim 1 , further comprising an outer shaft coupled to a proximal end of the distal tip.

10. The medical device of claim 9 , wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

11. 1. A medical device configured and sized to be placed within a subject, comprising: an ultrasound transducer disposed in a distal region of the medical instrument, the ultrasound transducer being at least partially surrounded by a material defining a distal tip of the medical instrument; a tip extension disposed adjacent to and extending longitudinally from the distal tip, the tip extension having a first end adjacent the distal tip and a second end opposite the first end; the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire therethrough; The medical device, wherein the distal extension exhibits a stiffness transition along its length.

12. 12. The medical device of claim 11, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, the first stiffness being greater than the second stiffness.

13. The medical device of claim 11 , wherein the tip extension comprises a tapered tip at or adjacent the second end.

14. 12. The medical device of claim 11, further comprising an ultrasonic probe comprising the ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, one or more portions of the plurality of conductive traces being covered by an insulating member.

15. The medical device of claim 11 , wherein the guidewire lumen comprises one or more lumen openings configured to allow for entry and removal of a guidewire from the guidewire lumen.

16. 12. The medical device of claim 11, wherein the guidewire lumen comprises a first lumen opening disposed along a length of the tip extension and a second lumen opening disposed adjacent an end of the tip extension, the first lumen opening and the second lumen opening configured to allow entry and removal of a guidewire from the guidewire lumen.

17. The medical device of claim 11 , wherein the guidewire lumen extends along at least a portion of the length of the ultrasound transducer.

18. 12. The medical device of claim 11, wherein the ultrasonic transducer comprises an emitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer opposite the emitter face.

19. The medical device of claim 11 , wherein the tip extension is coupled to the distal tip.

20. The medical device of claim 11 , wherein the tip extension is fused to the distal tip.

21. The medical device of claim 11 , further comprising an outer shaft coupled to a proximal end of the distal tip.

22. 22. The medical device of claim 21, wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

23. 1. A medical device configured and sized to be placed within a subject, comprising: an ultrasonic probe disposed adjacent a distal region of the rotatable shaft, the ultrasonic probe comprising an ultrasonic transducer; a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft; 1. A handle assembly comprising: a handle body having an outer surface that can be gripped by a user; a first actuator configured to be moved relative to the handle body; and a second actuator configured to be moved relative to the handle body, the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body; the rotatable shaft is in operative communication with a first actuator of the handle assembly such that actuation of the first actuator causes rotational movement of at least a portion of the rotatable shaft relative to the deflectable shaft; a handle assembly, the deflectable shaft in operative communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft; a tip extension disposed adjacent a distal end of the ultrasonic probe and extending longitudinally from the ultrasonic probe, the tip extension having a first end adjacent the ultrasonic probe and a second end opposite the first end; the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire therethrough; a tip extension, the tip extension exhibiting a stiffness transition along its length; A medical device comprising:

24. 24. The medical device of claim 23, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, the first stiffness being greater than the second stiffness.

25. 24. The medical device of claim 23, wherein the tip extension comprises a tapered tip at or adjacent the second end.

26. 24. The medical device of claim 23, wherein the ultrasonic probe comprises a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, one or more portions of the plurality of conductive traces being covered by an insulating member.

27. 24. The medical device of claim 23, wherein the guidewire lumen comprises one or more lumen openings configured to allow for entry and removal of a guidewire from the guidewire lumen.

28. 24. The medical device of claim 23, wherein the guidewire lumen comprises a first lumen opening disposed along a length of the tip extension and a second lumen opening disposed adjacent an end of the tip extension, the first lumen opening and the second lumen opening configured to allow entry and removal of a guidewire from the guidewire lumen.

29. 24. The medical device of claim 23, wherein the guidewire lumen extends along at least a portion of the length of the ultrasound transducer.

30. 24. The medical device of claim 23, wherein the ultrasonic transducer comprises an emitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer opposite the emitter face.

31. 24. The medical device of claim 23, wherein the tip extension is coupled to the ultrasonic probe.

32. 24. The medical device of claim 23, wherein the tip extension is fused to the ultrasonic probe.

33. 24. The medical device of claim 23, further comprising an outer shaft coupled to a proximal end of the ultrasonic probe.

34. 34. The medical device of claim 33, wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

35. 1. A medical device configured and sized to be placed within a subject, comprising: a probe tip extension configured to be coupled to a tip of an ultrasound probe configured and sized to be placed within a subject, the probe tip extension configured to extend longitudinally from the tip, the probe tip extension having a first end adjacent the tip and a second end opposite the first end, the probe tip extension exhibiting a stiffness transition along its length; a guidewire lumen formed through the probe tip extension, the guidewire lumen configured to receive the guidewire therethrough such that the ultrasonic probe may be moved along a length of the guidewire via the guidewire lumen; A medical device comprising:

36. 36. The medical device of claim 35, wherein the guidewire lumen comprises one or more lumen openings configured to allow for entry and removal of a guidewire from the guidewire lumen.

37. 36. The medical device of claim 35, wherein the guidewire lumen comprises a first lumen opening disposed along a length of the probe tip extension and a second lumen opening disposed adjacent an end of the probe tip extension, the first lumen opening and the second lumen opening configured to permit entry and removal of a guidewire from the guidewire lumen.

38. 36. The medical device of claim 35, wherein the probe tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, the first stiffness being greater than the second stiffness.

39. 36. The medical device of claim 35, wherein the probe tip extension comprises a tapered tip at or adjacent the second end.

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