Monolithic swap medical tool positioning devices, systems, and methods of use and manufacture

Abstract

A medical device may include 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 surrounded by a material to define a distal tip of the medical device. The medical device may include a tip extension disposed adjacent to 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 may include a tapered tip at or adjacent to the second end. The tip extension may include a guidewire lumen formed in the tip extension and configured to receive a guidewire therethrough.

Description

[0001] Incorporated by reference

[0002] This application incorporates by reference in its entirety the following applications, which are incorporated by reference herein for all purposes: PCT / US2019 / 061228, filed November 13, 2019; U.S. Provisional Application No. 62 / 760,784, filed November 13, 2018; WO2018 / 017717, published January 25, 2018; US20220401070A1; and WO 2018 / 182836, published October 4, 2018.

[0003] All publications and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND OF THE INVENTION

[0004] A variety of intravascular medical devices are known. There is a need for improved systems, devices, and methods that facilitate better control, positioning, and usability of medical devices. SUMMARY OF THE INVENTION

[0005] The present disclosure relates to medical devices and their uses. The present disclosure generally relates to a medical device that is configured and sized to be positioned within a subject. The medical device may include an ultrasound transducer in a distal region of the medical device, the ultrasound transducer being fixed to an outer shaft, the ultrasound transducer being at least partially surrounded by material to define a distal end of the medical device. The medical device may include a distal extension that is disposed adjacent to and longitudinally extends from the distal end, the distal extension including a first end adjacent to the distal end and a second end opposite the first end. The distal extension may include a tapered end at or adjacent to the second end. The distal extension may include a guidewire lumen formed in the distal extension and configured to receive a guidewire passing through the guidewire lumen. The distal extension may exhibit a stiffness transition. The distal extension may exhibit a first stiffness at the first end and a second stiffness adjacent to the second end, wherein the first stiffness is greater than the second stiffness.

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

[0007] The medical device of the present disclosure may include a medical tool, such as an ultrasonic transducer in the distal region of the medical device. The medical tool may be (directly or indirectly) fixed to a flexible member, such as flexible electronics (e.g., a flexible conductor bundle), at a first position. The flexible member may extend proximally toward the handle assembly (and optionally into the handle assembly). In some examples, the present disclosure is directed to attempting to prevent the flexible electronics from deforming to an undesirable extent and / or attempting to maintain the configuration of the flexible electronics (even in the presence of some minor degree of deformation).

[0008] The medical device may include one or more elongate shafts through which the flexible member extends. The medical device may include more than one elongate shaft through which the flexible member extends, such as an outer shaft and an inner shaft, with the inner shaft extending through at least a portion of the outer shaft. The inner shaft may be movable relative to the outer shaft. The inner shaft may be deflected independently of the outer shaft.

[0009] The flexible member (e.g., a flexible conductor bundle) may move axially within one or more elongate shafts and may be fixed to a shaft, such as the outer shaft. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1A An example of a system including a steering and a medical device is shown.

[0011] Figure 1B Shown is Figure 1A a cross-section A-A of the steering and device portion of the medical device of

[0012] Figure 2 An example system including a handle assembly having a plurality of actuators, a steerable sheath, and a medical tool is shown.

[0013] Figure 3Ai , Figure 3Aii and Figure 3Aiii Examples of steerable shafts having pull wires are shown.

[0014] Figure 3Bi and Figure 3Bii Examples of steerable shafts having pull wires are shown.

[0015] Figure 3Ci and Figure 3Cii Examples of steerable shafts having pull wires are shown.

[0016] Figures 3Di to 3Div Examples of steerable shafts having pull wires are shown.

[0017] Figure 3E Examples of steerable shafts having one or more pull wires circumferentially intertwined into a braided wire of the shaft are shown.

[0018] Figure 4 An example portion of an example system including a bundle is shown.

[0019] Figure 5 Shows an exemplary proximal end of a medical tool that includes a conductor bundle extending into a proximal connector within which a printed circuit board (PCB) is received.

[0020] Figure 6A Shows a portion of an exemplary medical tool that includes a flexible circuit strip.

[0021] Figure 6B Shows an exemplary proximal portion of the strip.

[0022] Figure 6C Shows a detailed view of an exemplary proximal portion of the strip.

[0023] Figure 6D Shows an end view of an exemplary flexible strip.

[0024] Figure 6E Shows an exemplary stack of flexible strips.

[0025] Figure 6F Shows an exemplary stack of a flexible strip and ground and shield strips.

[0026] Figure 6G Shows an exemplary bundle that includes a tubing material surrounding a stack of a strip and shield and ground strips.

[0027] Figure 7 Shows an integrated system of a steerable sheath and a medical tool, where the system is connected to a console via a connector cable.

[0028] Figure 8A and Figure 8B Shows an exemplary handle assembly that can be used with either an inner elongate body or an outer elongate body or shaft herein.

[0029] Figure 9A Shows a portion of an exemplary inner elongate body or inner shaft.

[0030] Figure 9B Shows a portion of an exemplary outer elongate body or outer shaft.

[0031] Figure 9C Shows an exemplary medical device portion of an elongate body (or shaft) that includes Figure 9A and Figure 9B .

[0032] Figure 9D Shows Figure 9C a cross-section of a device within a deflectable portion of

[0033] Figure 10A Shows a portion of an exemplary handle assembly.

[0034] Figure 10B Shows an exploded view of an exemplary outer elongate body (or outer shaft) motion subassembly.

[0035] Figure 10C Shows from Figure 10A a side cross-sectional view of the handle assembly.

[0036] Figure 11 Shows an exemplary handle assembly including a rotation indicator for a first actuator and a second actuator.

[0037] Figure 12A Shows internal components of an exemplary handle assembly including a tension member or a flattening member.

[0038] Figure 12B Shows (in a side view) internal components of an exemplary handle assembly including a tension member or a flattening member.

[0039] Figure 12C Shows (in a side view on the other side relative to Figure 12B ) internal components of an exemplary handle assembly including a tension member or a flattening member.

[0040] Figure 12D Shows internal components of an exemplary handle housing that include one or more guiding features positioned to assist in stabilizing a tension member in the handle assembly.

[0041] Figure 12E Shows a side view of an exemplary handle housing.

[0042] Figure 12F Shows a side view of an exemplary handle housing.

[0043] Figure 13A Shows an exemplary flexible cable harness with at least a portion twisted relative to the long axis.

[0044] Figure 13B Shows an exemplary flexible cable harness with at least a portion twisted relative to the long axis.

[0045] Figure 13C Shows an exemplary flexible cable harness with at least a portion twisted relative to the long axis.

[0046] Figure 13D Shows an exemplary flexible cable harness with at least a portion twisted relative to the long axis.

[0047] Figure 13E Shows from Figure 13D the details.

[0048] Figures 14 to 18An example medical device having a navigation interface is shown.

[0049] Figures 19 to 24 An example transducer tip for a medical device is shown.

[0050] Figure 25 An example component for a medical device is shown.

[0051] Figure 26 An arrangement of navigation sensors for a medical device is shown.

[0052] Figures 27 to 29 Various configurations of a pull wire for deflecting a portion of a shaft or sheath of a medical device are shown.

[0053] Figures 30 to 31 Various arrangements of components in a handle assembly of a medical device are shown.

[0054] Figure 32 and Figures 33A to 33B An example medical device having a tip extension is shown. Detailed Description

[0055] Figure 1A An example of a system integrating steering and a medical device is shown. 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 a steerable portion 1008. The system is adapted such that the handle assembly 1002 can be actuated to cause steering of the steerable portion 1008 and optionally further actuated to cause movement of the medical device 1010 relative to the steering and medical device portion 1004. In this example, 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 actuate (rotate in this example) relative to the handle body 1007 to cause steering of the steerable portion 1008 and, in particular, to steer the outer sheath 1102. The steerable portion 1008 can be steered or bent to the configuration shown by the solid line in Figure 1A and can also be steered to the configuration shown by the dashed line, or anywhere in between, and in some examples, the opposite steering function is limited to only causing the shaft to move from an initial bent configuration (such as Figure 1AThe solid line bending configuration in) is straightened. The term "steering" in the present disclosure means deflected or bent, optionally via actuation of at least one pull wire, but in some cases, the term may include shaft rotation (twisting) and axial movement. The term "pull wire" herein refers to any element that can transmit tension from the proximal end of the device to the distal end region. The pull wire can be composed of solid or stranded / braided metal wires (such as stainless steel or nitinol), or it can be composed of preferably stranded / braided polymers (such as aramid fibers polyethylene, PTFE, ePTFE, etc.), but can also be in the form of a monofilament. In an example, the pull wire is composed of a bundle of aramid fibers, and the aramid fiber bundle has four 50 denier multifilament (about 25 filaments) wires woven together with a high number of picks per inch. The cross-sectional diameter of the wire is generally in the range of 0.005" to 0.012", more preferably 0.008" to 0.010", but the braided or stranded wire can be flattened or ovalized in the device lumen. It is believed that certain examples provide optimized strength and wear resistance for the dimensions required to keep the shaft diameter to a minimum. The optional second actuator 1003 is adapted to actuate (rotate in this example) relative to the handle body 1007 to cause rotation of the medical tool 1010 relative to the shaft 1102 (labeled as rotational movement "R"), and the optional actuator 1005 is adapted to actuate (axially in this example) relative to the handle body 1007 to cause axial (distal-proximal) movement of the medical device 1010 relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the steerable portion 1008 is steered (bent / deflected), but the proximal portion can flex and bend to conform to the anatomy in which the proximal portion is used. In many aspects, this is achieved by constructing the steerable portion 1008 from a material and / or composite construction that is softer or less rigid than the proximal portion 1006.

[0056] Figure 1A The example shown is an example of a device including an integrated handle assembly that is operatively communicable with both a steerable outer shaft and an internal medical tool. The handle assembly is integrated because it is assembled and constructed to be operatively communicable with the outer shaft and the internal medical tool before packaging and use. The term "integrated" when used in the context of an integrated handle assembly refers to a handle assembly where at least a portion of the handle assembly must be broken or separated before the medical tool can be removed from within the outer shaft.

[0057] Figure 1B Showing the steering and device portion 1004, and specifically the example cross-section A-A in the steerable portion 1008 (shown in Figure 1AIn this example, 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.

[0058] Figure 1A and Figure 1B The medical tool in may be, for example, any of the medical tools herein, such as an ultrasound tool. When the term "ultrasound probe" is used herein, it generally refers to an elongate tool that includes at least one ultrasound transducer and one or more conductive elements that electrically connect the at least one ultrasound transducer to the proximal region of the elongate tool. The proximal region of the ultrasound probe includes or is modified to include at least one proximal contact that is in electrical communication with the at least one ultrasound transducer and is optionally placed in electrical communication with an electrical contact on another device, cable, or connector via an electrical contact attached to the another device, cable, or connector.

[0059] Figure 2 illustrates an example system 10 adapted to operate similarly to the systems in Figure 1A and Figure 1B and also illustrates example internal components of the handle assembly 12 (the internal components are shown in dashed lines). The handle assembly 12 is integrated with and operatively communicable with an external steerable shaft 20 and a medical tool 30. The handle assembly 12 includes an actuator 14 that is adapted to cause steering of the steerable shaft 20 when actuated relative to the handle body 15. The actuator 14 is operatively communicable with the steerable shaft 20 via a steering control 16 disposed within the handle assembly 12. The medical tool 30 includes a proximal portion 18 disposed within and incorporated into the handle assembly 12. The actuator 13 is operatively communicable with the medical tool 30, and actuation of the actuator 13 relative to the handle body 15 (rotation in this example) causes rotation of the medical tool 30 relative to the outer shaft 20 via a rotation control 1215. An optional third actuator 17 is also operatively communicable with the medical tool 30 and is adapted in this example to be actuated axially (relative to the handle body 15) to cause axial movement of the medical tool 30 relative to the external steerable shaft 20 via an axial control 1217.

[0060] Figure 2 The medical tool in may be, for example, any of the medical tools herein, such as an ultrasound tool.

[0061] Figures 3A to Figure 3EAn exemplary illustration of the distal region of the sheath portion 1208 of the steerable sheath 1202 in the system 1200. For simplicity, the cross-section shown only depicts the outer sheath 1208 and not the inner tool 1212. The outer sheath 1208 preferably has a composite construction to improve torque transfer applied to the outside of the shaft from the proximal end or to resist torque forces applied to it from within the shaft (such as from the tool 1212). As Figures 3Ai to 3Aiii shown, to form the composite, a plurality of braided elements 1250 preferably formed from metal wires (round, paired round or ribbon-shaped) and / or multiple fibers (e.g., aramid or nylon) can be directly braided over a thin-walled (e.g., 0.0010” ± 0.0005”) lubricious liner tube 1251 (such as PTFE or FEP material). A thermoplastic polymer 1252 (such as Pebax with a hardness in the range of 25D to 72D, or nylon, or other common catheter materials) can be laminated by heat using a heat-shrinkable tubing (such as FEP) so that the polymer flows back over the braided elements 1250 and the liner tube 1251 to form a uniform member. The thermoplastic polymer 1252 can also have a radiopaque compound that includes materials such as bismuth, barium sulfate, or tungsten so that the end of the sheath is visible to the user during fluoroscopic examination. In Figures 3Ai to 3Aiii the example, the pull wire 1104 preferably runs parallel to the central passageway in the steerable (deflectable) portion 1222 of the sheath and is also preferably disposed within a lumen 1253 formed within the wall of the steerable sheath 1208. This lumen can be formed by means of a removable mandrel during the thermoplastic polymer tubing extrusion process or during the shaft heat lamination fusion process. The pull wire lumen 1253 can be further formed by incorporating a pull wire tube 1254 preferably temporarily supported by a removable mandrel within the wall. During the fusion process, the removable mandrel can also be placed next to the pull wire 1104 or 1104' to create a somewhat elliptical lumen 1253 within which the fiber pull wire can be allowed to flatten, thus leaving room for the free movement of the pull wire. The tube 1254 can comprise PTFE, FEP, polyimide, or another material that maintains the integrity of its walls during the heat lamination process up to approximately 500°F. The tube is preferably surrounded and supported by the thermoplastic polymer 1252, which is preferably laminated to the tube by heat. In another example, the pull wire lumen (preferably including the pull wire tube) is incorporated within the braid of the braided elements 1250. For example, the braided elements 1250 extending in one direction will pass under the pull wire lumen, while those extending in the opposite direction will pass over the pull wire lumen. The braided reinforcement provides a dimensionally 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 can continue proximally parallel to the central axis on the same side of the outer sheath 1208, such as Figures 3Ai to 3AiiiAs shown. In this and subsequent other examples, additional pull wires 1104' within additional pull wire lumens that may need to be routed within the wall of the sheath 1208 are routed upward through the steerable portion 1222 to straighten the steerable portion of the device. This straightening pull wire 1104' is preferably routed within the steerable portion 1222 on the side opposite the pull wire 1104 used for steering (deflecting) within the steerable portion 1222. In another example (not shown), two lumens and two straightening pull wires 1104' may be used, substantially mirroring the paired pull wire 1104 configuration. These straightened wires may also be configured to allow deflection in the opposite direction by tensioning over a greater distance (beyond just straightening) within the handle.

[0062] During use, the portion 1223 of the distal catheter just proximal to the steerable (deflectable) portion 1222 may be forced to conform to a curve based on the constraints of the anatomy in which it is used. For a specific example of advancing the device from a femoral access to the ventricle, it is expected that the length of the portion 1223 forced to be curved will be in the range of 5 cm to 25 cm. 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 of the device within this region 1223 can cause a tendency for the shaft to accumulate and suddenly release torque, resulting in a rotational "jitter" or sudden jerk during torsion. To minimize the likelihood of jitter, it is optional to distribute the pull wire tension and construction material around the surface of the curved region 1223. In one example, such as Figures 3Bi to 3Bii as shown in i, the pull wire 1104 may spiral around the central axis of the sheath within at least the curved region 1223 proximal to the portion 1222. The pull wire of this example may form a complete circumferential wrap within a length of approximately 10 cm, where this value is in the range of 5 cm to 15 cm. The spiral may only need to be present within the curved region 1223 and then continue to be straightened proximally through the proximal portion 1224 (similar to 1006), which can minimize friction within the pull wire lumen and the associated pull wire force required to steer (deflect) the steerable portion 1222. The spiral may also make at least one turn before continuing to straighten, or spiral the entire length of the shaft. In another example of minimizing jitter, it may only be necessary to distribute the pull wire tension to opposite sides of the shaft. As Figures 3Ci to 3CiiAs shown, the deflection of the steerable segment 1222 is achieved using two parallel tension cables 1104 positioned adjacent to each other on the same side of the sheath 1208. In the bending region 1223 and the proximal portion 1224 (similar to 1006) proximal to the steerable segment 1222, the tension cables are routed to opposite sides of the shaft, each side being at 90° to the position in the steerable segment 1222, to more evenly distribute the tension. Although it is preferred to actuate the two parallel tension cables simultaneously with equal force using a handle actuator, in other examples, different forces may be applied when actuating the two parallel tension cables with equal force to deflect the tip to one side or the other of the plane formed. In other examples, any number of tension cables can be routed in the same configuration as shown in FIG. 3B or FIG. 3C, where multiple proximal tension cables are evenly distributed around the circumference of the shaft. Additionally, as Figures 3Ci to 3Cii shown, the tension cables 1104 can be routed proximally along opposite sides of the shaft for most of the length of the proximal portion 1124 of the shaft, but are preferably pulled back adjacent to each other near the proximal end portion of the shaft to allow the cables to exit the same side of the proximal shaft together, to facilitate securing them together to the handle member for simultaneous actuation of the tension.

[0063] Figures 3Di to 3Div Another example of the distal region of the catheter is shown, which is constructed similarly to the previously described construction, but is alternatively configured to provide a distal steerable portion 1222 that can be deflected in two different directions. As shown, two pairs of tension cables 1105 / 1107 and 1106 / 1108 are along the proximal shaft region 1224 and the bending region 1223. This is similar to Figures 3Ai to 3Aiii , except that the cables are in pairs on each side of the shaft. The routing can also be helical as in Figures 3Bi to 3Bii , or other configurations discussed. Within the distal steerable portion 1222, the cables are routed at 90° to the proximal portion, but other angles are also conceivable. At the junction 1225 within 1222, one or more of the tension cables (e.g., 1105 and 1107) can terminate and be anchored to the shaft, where the remaining tension cables (e.g., 1106 and 1108) continue to their more distal end positions 1226 where they are anchored. This configuration allows for independent actuation of the tension cables terminating at 1225 and 1226, such that different shapes can be formed during actuation. Figure 3Dii Both tension cables 1107 and 1108 are shown being tensioned to form a variable curve in the same direction. Figure 3Diii Tension cables 1107 and 1106 are shown being tensioned to form an "S" curve. Other configurations are also possible.

[0064] The tension cables (such as 1104 and 1104') must terminate at their distal ends in a manner that securely attaches them to the wall of the distal steerable shaft portion 1222 such that they do not break or become slack under repeated application of tension. In Figure 3EIn the example shown, the pull wires 1104 and 1104' circumferentially interweave into the braid 1250 (shown without the thermoplastic polymer 1252) of the distal shaft 1222 as they exit the distal pull wire lumen 1253. One or more of the pull wires 1104 or 1104' may additionally or alternatively be wrapped and / or tied around the outside of the braid 1250 for additional fixation. The braid 1250 may then be trimmed distal to the fixation point, where the interwoven and / or wrapped pull wires prevent the braid from expanding and / or unraveling. Additional adhesives such as UV curable or cyanoacrylate may also be used to secure the pull wires to the braid. The braid and / or wrap of the pull wires and the braid are then laminated with a thermoplastic polymer that melts and cools within the space around the wires to secure the wires in place. The thermoplastic polymer may also have a radiopaque compound that includes materials such as bismuth, barium sulfate, or tungsten so that the end of the sheath is visible to the user under fluoroscopy.

[0065] In an additional example, the tool 1212 may also or alternatively be configured to have one or more pull wires to deflect the distal end in a manner similar to any of the previous examples described for the outer sheath 1208. In addition to routing the pull wires within the wall of the tubular member of the tool 1212, the pull wires may also be routed near the conductors within the lumen of the tubular element 1212. Actuation of the pull wires may come from an actuator located in the proximal handle 1206. The distal shaft of the tool 1212 may also be formed into a particular shape (e.g., arcuate) such that it bends into that shape as it exits the distal end of the steerable portion 1222 of the outer sheath 1208. The stiffness of the distal shaft of the tool 1212 is such that it substantially does not deform the outer sheath 1208 when inside, but allows the outer sheath to bend when exiting. The shape may be set by any one or combination of the following: thermally shaping the polymeric material, using a movable or fixed shape mandrel within the inner lumen of the shaft 1212 or within the lumen within the wall of the shaft 1212. The cross-section of such a mandrel may be circular, oval, or rectangular and is formed of stainless steel, nitinol, or a rigid polymer such as PEEK, Vestamid, or the like. The outer steerable sheath may alternatively be made curved using a method similar to the above, with or without additional pull wire deflection and with or without an additional shape or deflection of the distal portion of the tool shaft 1212.

[0066] One aspect of the present disclosure includes a method of separating at least a portion of a system from other components, optionally as part of a relocation process. In some examples, a medical tool includes one or more electrical contacts coupled to other electrical contacts that are in electrical communication with an energy console, and examples of consoles are known in the field of ultrasound.

[0067] Figure 4 Only a portion of an exemplary medical tool, such as an ultrasound probe, is shown, which may be electrically coupled directly or indirectly to an energy console, such as an ultrasound console.

[0068] Relocating the device may involve disconnecting one or more proximal electrical contacts and moving the tool portion distally out of the distal end of the sheath portion. In this example, the tool portion 1212 includes at least a tool outer sheath or member 2010, a distal working end 1821 (which may include at least one ultrasound transducer), and a conductor bundle 2020. The conductor bundle 2020 extends from the distal working end 1821 through the tool outer member 2010 to a proximal connector (the connector and handle mechanism are not shown for clarity). Figure 18 In some examples, the medical tool is for ultrasound imaging, optionally where the distal working end 1821 includes a two-dimensional (2D) array of piezoelectric components mounted on an ASIC (application specific integrated circuit).

[0069] Figure 5 Only an exemplary proximal end of the medical device is shown (the medical device is shown on the right), and in this example, the medical device is an ultrasound probe. The proximal end 2015 of the medical device is adapted to be electrically coupled to a connector cable 270, which is adapted to be electrically coupled directly or indirectly to an energy console, such as an ultrasound energy console. As Figure 5 shown, a flexible conductor bundle 2020 extends from a distal region (not shown) of the medical tool into the proximal connector 2015, and a rigid or flexible printed circuit board (“PCB”) 2030 is housed within the proximal connector. The connector bundle 2020 includes a plurality of contacts 2024 (examples of which are described below) attached to PCB board contacts 2031. Each individual trace from each contact 2031 connects to an individual exposed contact 2050 on another part of the PCB (optionally closer to the PCB). The individual PCB traces may also pass through other available circuitry on the PCB. The exposed contacts 2050 are configured to mate mechanically with similar contacts 2060 on a mating connector cable 2070 for electrical conduction, which is conceptually similar to the previously described proximal tool connector 1990 that connects the tool 1204 to the user interface console. The proximal connector 2015 may be incorporated into any of the systems, handles, steerable sheaths, medical tools, etc. herein.

[0070] Unless otherwise stated herein, as used herein, the term “conductor bundle” may be used interchangeably with “flexible conductor bundle”.

[0071] Figure 6A and Figure 6B An example conductor strip (also referred to herein as a flexible circuit strip) 2021 that may be included in any of the conductor bundles herein is shown.Figure 6A and Figure 6B The examples in Figure 4 and Figure 5 are examples of conductor bars that may be included in the bundle 2020 of Figure 6A and Figure 6B The examples in

[0072] such as Figure 6A , Figure 6B and Figure 6G As shown, the conductor bundle 2020 includes a plurality of flexible circuit bars, including multi-trace bars 2021, and conductive bars 2022 for grounding and conductive bars 2023 for shielding (only a part of which is shown). Each multi-trace bar includes a plurality of conductive traces 2025, which can be clearly seen in Figure 6B , Figure 6C and Figure 6D The number of traces 2025 in Figures 6D to 6G is twelve, and Figures 6A to 6C the number of traces in Figures 6D to 6G is sixteen, and both of them are examples with respect to the number of traces 2025 that can be used. Each bar 2021 can be approximately 0.072” wide and 0.0022” thick, and optionally includes sixteen conductive (e.g., copper) traces that are 0.0022” wide × approximately 0.0007” thick, each spaced apart by approximately 0.0022”. The traces are disposed on an insulating substrate layer 2027, such as a polyimide substrate, and the traces can be at least partially covered by a cover layer 2026, such as a photoimageable film cover (“PIC”) layer or other dry film solder mask (DFSM) or other similar materials. The cover layer generally extends along most of the bundle, except at discrete locations in the proximal and distal regions for electrical connection. In other examples, the bar 2021 is approximately 0.055” wide and includes twelve conductive traces (see Figure 6E shows a portion of an example bundle 2020 having nine bars 2021 stacked together. Figure 6F shows a portion of the bundle that includes nine stacked bars 2021, and a ground bar 2022 and a shield bar 2023 (only the top ones are labeled). The complete bundle can optionally be associated with (e.g., but not limited to) a shrink tube with a wall thickness of approximately 0.001” (such as Figure 6GThe tubing 2028) in is held together. The flexible circuit dimensions and the number of traces discussed above are for a particular configuration of the piezoelectric array (and / or its ASIC controller) and may vary depending on the number and size of the array elements optimized for a particular application.

[0073] The proximal end of each flexible circuit strip has conductive material (e.g., gold-plated copper) exposed over a length of approximately 3 mm, for example, by removing the cover layer 2026 at position 2024. Position 2024 and other exposed positions described herein are generally referred to as "contact portions". It should be understood that when used in this context, a contact portion actually includes multiple separate conductive traces (such as those shown in the area positions), each conductive trace being adapted to be in electrical communication with its corresponding conductive element. Thus, a "contact portion" is not limited to meaning only a single electrical connection between two conductive elements. Although Figure 6A multiple exposed areas 2024 are shown, Figure 6A the examples in will first be described herein as if there were only one exposed area (i.e., area 2024 at the proximal end). The strip 2021 can be made to form an electrical connection with a mating exposed contact portion 2031 for the conductive traces on the PCB 2030, which is shown in Figures 6A to 6C In some examples, the dimensions and spacing are set such that sixteen separate traces that mate with the sixteen traces in the multi-trace strip 2021 will be provided within a given contact portion 2031. ACF (anisotropic conductive film), soldering, conductive adhesives, mechanical connections, or any combination thereof can be used to achieve a suitable electrical connection (electrical coupling) between the strip traces and the PCB contact portion.

[0074] Figure 7 An integrated system 1200 of a steerable sheath 1202 and a medical tool 1204 is shown, where the system 1200 is connected to a console 4000 via a connector cable 2070. As previously described, such as for Figure 5, the tool 1204 includes a proximal connector 2015 that forms a mating connection with the cable 2070. As previously described, it is desirable to relocate (e.g., reprocess and reuse) the system 1200. It is further desirable to ensure that the system is relocated only by the original manufacturer and not by unaffiliated third parties, and to ensure that the device is reused only a specified number of times. To control the relocation process, a password authentication chip (password chip) is incorporated into the tool 1204, preferably on the PCB 2030, but other locations are also contemplated, such as within the steerable handle 1206 or within the tip 3000. The password chip can only be programmed 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 an authentication key. During use of the system 1200, the console 4000 is able to authenticate the system 1200 via the password chip and can read and write information to the chip as needed (e.g., via the EEPROM feature). In any of the scenarios discussed, an RFID chip (preferably encrypted) can be used to read and transfer data between the console, the connector, and the device.

[0075] As used herein, "cleaning" can refer to any type of cleaning, such as but not limited to: flushing the interior of the outer shaft using a cleaning agent and / or disinfectant rinse system, and optionally mechanically scrubbing with a small brush; mechanically cleaning (e.g., wipes, brushes) the outer portion of the outer shaft and / or the outer portion of a medical device shaft (e.g., an ultrasound probe) with a cleaning agent / disinfectant, and optionally immersing the shaft in an ultrasonic bath of the cleaning agent / disinfectant for a specified period of time; and optical cleaning methods, such as including the use of UV light. As used herein, "cleaning" does not refer to a specific cleaning process, but rather to the overall concept of cleaning an object.

[0076] The disclosure herein also includes methods of assembling or reassembling any of the subassemblies or assemblies herein (including any of the subassemblies within any of the handle assemblies of the handle assemblies herein). For example but not limited to, the disclosure herein includes methods of winding one or more drawstrings above a support surface in a spindle support and then around the spindle.

[0077] The methods herein also include manufacturing or constructing any individual part of any of the subassemblies or assemblies herein. For example, the present disclosure includes methods of manufacturing a handle housing part having a specific configuration (e.g., guides, walls, etc.) that can accommodate internal parts that allow the assemblies or subassemblies herein to function as intended.

[0078] Regardless of the reference numerals labeled, the handle assemblies, medical tools, steerable sheaths, and electrical connectors herein can be used together in any combination with each other in a system.

[0079] Any technology (including ultrasound and steering technologies) in any of the following U.S. patent references may be incorporated into any of the medical tools, devices, systems, or methods of use herein, the disclosures of which are 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.

[0080] Any of the above suitable disclosures may be incorporated into any of the following examples. For example, unless otherwise specifically stated to the contrary, aspects of the devices, systems, and methods of manufacture and use are incorporated herein and may be incorporated into any of the following examples.

[0081] Figure 8A and Figure 8BIllustrated is only an example handle assembly that can be operatively coupled to outer shaft 131 and inner shaft 132. In this exemplary embodiment, handle assembly 120 includes handle body 123, first actuator 121, and second actuator 122, the handle body having an outer surface graspable by a user. Actuator 121 can be operatively coupled to outer shaft 131, and actuator 122 can be operatively coupled to inner shaft 132. Actuator 121 is adapted to rotate and axially move relative to handle body 123 (and relative to second actuator 122). This allows actuator 121 to cause axial movement of medical tool 103 and rotation of medical tool 103 relative to the distal end of inner shaft 132. Second actuator 122 is adapted to actuate (e.g., rotate in this example) 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 end of a pull wire such that actuation of actuator 122 tensions one or more pull wires to cause deflection of the inner shaft. In this example, actuator 121 is located distally of actuator 122, but in other designs, their relative positions can be reversed. Figure 8B Illustrated is handle assembly 120 after actuator 121 has been advanced distally relative to its position in Figure 8A . This distal advancement causes outer shaft 131 to be advanced distally and, thus, causes the medical tool to be advanced distally. Actuator 121 can similarly be retracted proximally relative to its position in Figure 8B . The tensioning member, described further below, is referred to with respect to actuator 121 being retracted proximally.

[0082] In other designs, actuator 121 can be operatively coupled to the inner shaft, and actuator 122 can be operatively coupled to the outer shaft.

[0083] As described herein, the outer shaft can move axially relative to the deflectable inner shaft. The outer shaft can be constructed of material segments that vary in stiffness (e.g., hardness) along at least a portion of the length of the outer shaft. For example, the first portion distal to the second portion can have a lower hardness than the second portion. Since the outer shaft can move axially relative to the deflectable inner shaft and since the stiffness of the outer shaft can vary along its length, the deflection of the entire device, 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 axial movement of the outer shaft can selectively control the deflection of the device. For example, a user (e.g., a physician) can change or control the location along the length of the device (measured from the distal end) at which bending occurs by moving the outer shaft axially relative to the inner shaft. Additionally, for example, depending on the relative position of the outer shaft relative to the deflectable inner shaft, segments of varying stiffness in the outer shaft can allow for more or less deflection. For example, the inner shaft can cause less deflection when deflected in a region of the outer shaft having a relatively high stiffness compared to when the inner shaft is deflected in a region of the outer shaft having a relatively low stiffness. Although the differences in the characteristics and control of the inner shaft and the outer shaft have been referenced, this control of the inner shaft and the outer shaft can be reversed, where the inner shaft is configured for rotation and the outer shaft is configured for deflection.

[0084] Figure 9C An exemplary device, a medical device 130, is shown that includes an elongate inner shaft 132 (see Figure 9A ) and an elongate outer shaft 131 (see Figure 9B ). The medical device 130 may also be referred to herein as a "catheter" or other medical device that includes at least one elongate shaft.

[0085] Figure 9D Shown is Figure 9C section A-A as shown in the components of Figures 9A to 9C , which is a segment in the deflectable segment of the device. Figure 9D The components of

[0086] are similarly labeled. As can be seen in Figure 9DAs shown, the elongate inner shaft 132 includes two layers of braided material 119, and the pull wire is substantially sandwiched between the two layers of braided material at least at the location of this segment. The annular space 118 allows freedom of movement and space for an optional lubricant. The inner shaft 132 can be made of, for example but not limited to, a polymeric material such as Pebax, optionally with a lubricating additive. The inner shaft 132 can include a lining 125, such as a PTFE lining. The flexible cable bundle 105 can be surrounded by one or more layers of insulator 126, such as a PTFE insulator. The outer shaft 131 can comprise a polymeric material 127, such as Pebax. The outer shaft 131 can also include a radially inner lining 128, such as a PTFE lining. Any one of the pull wires (e.g., 111, 112, 116) can be disposed in a lumen having a lining such as a PTFE lining 129.

[0087] The medical device 130 (or either the elongate shaft 132 or the elongate shaft 131 alone) can be operatively communicable with any one of the handle assemblies herein (including Figure 8A and Figure 8B the handle assembly 120 shown).

[0088] Figures 10A to 10C and Figure 11 Additional example handle assemblies are shown that can be operatively communicable with any one of the medical devices herein (including ultrasound probes). For example, Figures 10A to 10C the example handle assembly shown can be coupled (directly or indirectly) to Figures 9A to 9D the medical device 130 shown and be operatively communicable with that medical device. In a specific example, both the elongate outer shaft 131 and the elongate inner shaft 132 are coupled to Figures 10A to 10C the handle assembly shown and are operatively communicable with that handle assembly.

[0089] Figures 10A to 10C and Figure 11 the handle assemblies in Figure 8A and Figure 8B have some similarities to the handle assemblies, individual components, and subcomponents shown in Figures 10A to 10C Unless otherwise stated, the concepts, features, and methods of use from Figure 8A and Figure 8B that can be incorporated into the handle assemblies in Figures 10A to 10C are hereby incorporated by reference for all purposes into the disclosure of the handle assembly shown in and described with respect to Figures 10A to 10C Similarly, the concepts, features, and methods of use shown and described in Figures 10A to 10C that can be incorporated into other handle assemblies herein are hereby incorporated by reference for all purposes into the disclosure of any one of the handle assemblies set forth herein.

[0090] Figure 10A is a side view of the handle assembly 140, with a portion of the handle body 141 removed to show some of the internal components of the handle assembly. The handle assembly 140 includes a first actuator 143 and a second actuator 142, and in this example, the first actuator 143 is distal to the second actuator 142. The first actuator 143 is axially movable and rotatable both relative to the handle body and relative to the second actuator (actuator 142 in this example). The first actuator 143 is operatively connected to an external elongate body such as an outer shaft 131 (see Figure 9B ). Axial movement (distal or proximal) of the actuator 143 causes axial movement of the outer shaft 131, whereas rotation of the actuator 143 causes rotation of the outer shaft. The second actuator 142 is operatively connected to an inner shaft such as an inner shaft 132 (see Figure 9A ). Actuation (rotation in this example) of the second actuator 142 causes deflection of the inner shaft. In this embodiment, a rotatable and axially movable actuator (i.e., the first actuator 143) is operatively connected to the outer shaft. Although reference has been made to actuation of the second actuator 142 causing deflection of the inner shaft, alternatively, actuation of the second actuator 142 may cause rotation of the inner shaft. Similarly, actuation of the actuator 143 may alternatively cause deflection of the outer shaft.

[0091] The first actuator 143 is coupled to Figure 10B the elongate outer shaft motion assembly 150 shown in the exploded view such that movement of the first actuator 143 causes movement of the assembly 150. The elongate outer shaft motion assembly 150 is similarly coupled to the elongate outer shaft such that movement of the first actuator also causes movement of the elongate outer shaft. In this embodiment, the external elongate shaft is attached to the removable member 153 after it is inserted into the channel 156. The removable member 153 and the channel 156 are configured such that the removable member 153 is constrained by at least one inner surface of the channel when inserted into the channel 156. The elongate outer shaft motion assembly 150 also includes a distal head portion 151 fixed to the first actuator. The elongate outer shaft motion assembly 150 also includes a rotation limiting mechanism similar to the rotation limiting mechanism described herein that limits rotation of the first actuator 143 and thus limits rotation of the external elongate shaft. Any disclosure above regarding the rotation limiting subassembly, function, and use is incorporated into this example for all purposes and may be incorporated into this design and similar designs. During rotation, the member 157 (see Figure 10B ) interacts with the member 161, and the member 162 interacts with the member 158. The physical interaction of these two sets of members limits rotation to a desired rotation limit, e.g., such as limiting rotation to at most 630 degrees of rotation of the external body (in other examples, the allowed rotation may be greater than 630 degrees, such as at most 720 degrees and including 720 degrees).

[0092] If it is desired to clean the outer shaft, for example, after use, the removable component 153 can be separated from the outer shaft to allow the outer shaft to be removed from the handle assembly and cleaned before being reinserted and reattached to the removable component 153 or a new removable component if the component 153 is damaged or broken.

[0093] The handle assembly 140 also includes an inner shaft deflection assembly 146 that is operatively communicable with the 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 engages the first main shaft 148 and the second main shaft 149 via a gear interface such that rotation of the central gear 147 causes the main shafts to rotate in opposite directions. The inner shaft deflection assembly 146 (including the main shafts) extends further proximally than the elongate outer body motion assembly 150. The inner shaft extends through the outer shaft and extends further proximally within the handle assembly 150 than the outer shaft. This allows one or more drawstrings that are part of the inner shaft to extend radially outward and interface with the spool 160.

[0094] The absence of interaction between the elongate outer shaft motion assembly 150 and the elongate inner shaft motion assembly 146 allows the inner elongate shaft and the outer elongate shaft to be independently controlled by the first actuator 143 and the second actuator 142.

[0095] The handle assembly 140 also includes a printed circuit board (“PCB”) 170 disposed within the handle body 141 that is in electrical communication with a cable harness such as Figure 9D the flexible cable harness 105 in, or any one of the cable harnesses in the cable harnesses herein that are in communication with a medical tool such as an ultrasonic transducer.

[0096] The handle assembly 140 also includes a rotation indicator 180 that can be used to show a user the degree to which at least one of the first actuator and the second actuator has rotated relative to an original or neutral position. The first actuator 143 can include a rotation indicator 181 that, when the first actuator 143 is in the neutral position, is aligned along an axis with the rotation indicator 180, as Figure 11 shown. When the first actuator 143 rotates, the rotation indicator 181 rotates relative to the axis along which the rotation indicator 180 extends, which enables the user to visually understand to what extent the first actuator 143 and thus the outer shaft has rotated relative to the neutral position. Similarly, the second actuator 142 can also have a rotation indicator 182 that, when the second actuator 142 is in the neutral position, is aligned along an axis with the rotation indicator 180, as Figure 11As shown, when the second actuator 143 rotates, the rotation indicator 182 rotates about the axis along which it extends relative to the rotation indicator 180, which enables a user to visually understand that the second actuator 143 and thus the inner shaft is deflected to some extent relative to its neutral position.

[0097] In some alternative examples, the handle assembly may include one or more sensors to track how much rotation the outer shaft undergoes, or how much deflection the inner shaft undergoes. In some examples, the handle assembly may include encoders for each actuator.

[0098] In any of the examples herein that include an outer shaft and an inner shaft, the device may include one or more lubricants between the inner shaft and the outer shaft to make it easier for the inner shaft and the outer shaft to move relative to each other by reducing the friction between both the inner shaft and the outer shaft. If the medical device needs to be cleaned for reuse, additional lubricant may be added between the inner shaft and the outer shaft after the cleaning process.

[0099] In some examples herein, 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), that is coupled to the distal region of the medical device (e.g., the probe tip) and extends from the distal region toward the proximal region of the medical device (see, for example, the conductor bundle 2020 shown in the example Figures 4 to 6G ; or the bundle 105 from Figure 9B ). The probe tip may include an ultrasonic transducer in electrical communication with the flexible conductor bundle. In some examples herein (e.g., Figures 9A to 11 ), the probe tip and the conductor bundle may be axially displaced (toward the proximal and / or toward the distal) by actuation of a handle actuator (e.g., the actuator 143 as shown in Figure 10A ). In some cases, the conductor bundle is disposed within an elongate member (e.g., the steerable inner elongate body 132; or the elongate member 131) and moves axially relative to the elongate member when the probe tip advances distally or retracts proximally. When the distal region (e.g., the ultrasonic probe) and the conductor bundle retract proximally (after advancing distally), the conductor bundle may tend to fold, bunch up, or otherwise bend near or adjacent to its distal end due to friction between the bundle and, for example, the elongate member in which the conductor bundle is disposed (e.g., the steerable inner shaft 132). Bunching up may occur when the medical device is in a straight configuration as well as when the medical device has a degree of bend (e.g., after deflection from a straight or linear configuration).

[0100] To reduce the degree of the tendency to bunch or bend or even completely prevent the tendency to bunch or bend, any of the medical devices of the present disclosure may include a structural tensioning member that is 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 tool. By tensioning the flexible member, folding or bunching of the flexible member can be minimized or even prevented. When used in this context, a "tensioning" member is adapted and configured to reduce bunching of one or more distal regions of the flexible conductor by causing at least a distal portion of the flexible conductor bundle to move proximally as the distal probe is retracted proximally (compared to a device without a tensioning member). In some embodiments, the structural tensioning member (e.g., a tensioning rod) may be physically fixed to the flexible conductor bundle (e.g., attached directly or indirectly). Generally, the tensioning member of the present disclosure is operatively communicable with the flexible member (e.g., a flexible conductor bundle) such that movement or actuation of the tensioning member applies a force to the flexible member and can cause movement of the flexible member (e.g., proximally). In some exemplary examples, the structural tensioning member may be disposed in or carried by a handle assembly of the medical device. In such cases, the structural tensioning member may be a single component or an assembly of discrete components.

[0101] Figures 12A to 12F A portion of a handle assembly of an exemplary medical device that may be incorporated into any suitable medical device of the present disclosure is shown. For example, Figures 12A to 12F the handle assembly in Figures 12A to 12F may be part of a medical device that includes a medical tool (e.g., an ultrasound imaging probe) at or near its distal end, examples of which are described herein. Any other examples or features of the present disclosure are incorporated by reference

[0102] into the exemplary handle assembly shown. Figure 9B The exemplary handle assembly 310 includes a first actuator 314 and a second actuator 322, where the first actuator 314 is 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 optionally may also rotate relative to the second actuator) and may be operatively communicable with an elongate body (e.g., 131 or 132) that may include a medical tool (e.g., 103) in a distal region. The handle assembly 310 (including the actuators) may incorporate any relevant disclosures from any other handle assembly of the present disclosure. The medical device of which the handle assembly 310 is a part also includes a flexible member (e.g., Figure 9B the flexible conductor bundle 105 in Figure 9B and Figure 9CAs shown, where the medical tool 103 is fixed to the flexible member 105) and extends proximally from the medical tool towards the handle assembly 310. The flexible member can be a flexible conductor bundle and can extend into the handle assembly 310, as shown. 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 further includes a tension member that is fixed to the flexible member at a second position 316 that is proximal to a first position (in this context, the "first position" can be referred to as a first distal position or a derivative thereof). Figure 12A An exemplary tension member 312 is shown, and Figure 12A the reference numeral 312 in also refers to an optional elongate rigid member of the tension member (in this example, the elongate rigid member is linear and axially extending). The tension member 312 is adapted and configured to tension the flexible member when the medical tool is retracted proximally. This can be referred to herein as applying tension to the flexible member, or tensioning the flexible member, or maintaining tension in the flexible member. In this exemplary example, the tension member 312 is adapted and configured to tension the flexible member when the medical tool is retracted proximally, which in this example occurs when the first actuator 314 is retracted proximally from its position in Figures 12A to 12C shown. The tension member herein can apply tension when the medical device is in a straight configuration and when the medical device is in a non-straight (linear) configuration, such as when the device is deflectable or bendable.

[0103] In this example, the tension member 312 (which can include Figure 12A the tension rod shown in) is fixed (e.g., directly attached) to the flexible conductor bundle at position 316, which in this example is within the handle assembly. The tension member can alternatively be fixed to the flexible member at a position that is not within the handle (such as outside the handle, such as within one or both of the outer shaft and the inner shaft). In this example, the tension member is also axially fixed relative to the first actuator 314 such that axial movement of the first actuator 314 causes axial movement of the tension member 312 (which can 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 is retracted proximally, the flexible member is tensioned distal to the position where the tension member is fixed to the flexible member, which prevents the flexible member from folding or bunching up in the vicinity of or adjacent to the medical tool in its distal region (or at least reduces the degree of folding / bunching compared to a device without a tension member).

[0104] The flexible member can include a flexible conductor bundle, such as any of the flexible conductor bundles herein. In Figures 12A to 12FIn, the tension member includes a rigid elongate member having a fixed length (commonly referred to as 312 in Figure 12A ). The rigid tension member as shown has a generally longitudinal axis which, in this example, 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 a variety of materials such as a rigid plastic member.

[0105] The tension member of the present disclosure can ensure that the distance traveled by the medical tool is the same as the distance traveled by any point between the first and second positions on the flexible member. The tension member of the present disclosure can ensure that the distance traveled by the medical tool is the same as the distance traveled by the position where the tension member is fixed to the flexible member (e.g., Figure 12A position 316 in).

[0106] When the medical tool is retracted proximally (when the medical device is in a straight configuration), the fixed relationship between the tension member and the flexible member keeps the flexible member in a substantially flat or straight configuration between the first and second positions. In this context, a flattened configuration can include examples where the flexible member can also be twisted (i.e., the flexible member can be flat and still be twisted, but not bunched / folded). As used herein, a flattened configuration indicates that the flexible member is not folded or bunched.

[0107] The medical device incorporating the tension member can also be steerable or deflectable. The tension member of the present disclosure is adapted and configured to apply tension to the flexible member even when the medical device (including the flexible member) is in a non-straight (e.g., deflected, steered, bent) configuration. When the present disclosure refers to maintaining a substantially flattened configuration in the flexible member, it refers to the situation where the medical device can be in a straight configuration, which is not necessarily the case, such as when the medical device has been steered, bent, or deflected.

[0108] When the medical tool is retracted proximally, the fixed relationship between the tension member and the flexible member of the present disclosure prevents the flexible member from forming a fold (i.e., bend or bunch) between the first and second positions. In this context, folding, bending, and bunching include a first region of the flexible member that axially overlaps a second region of the flexible member and also includes a generally bending and bunching of the flexible member, such as an unevenness of the flexible member and, for example, the formation of a bend, a bent region, and / or a zigzag region.

[0109] The flexible member can have a flat top surface and a bottom surface (e.g., a conductor bundle having one or more flat surfaces), and optionally, the tension member can be fixed to at least one of the top surface and the bottom surface. For example, Figures 6A to 6GA flexible member having a flat or substantially flat first surface and a second surface (e.g., a top surface and a bottom surface) is shown, and a tensioning member may be secured to one or both of the flat or substantially flat surfaces (e.g., such as at location 316). They may be secured using a variety of techniques, such as using adhesives, welding, or other bonding techniques.

[0110] The tensioning member may be operatively connected (directly or indirectly) to the handle actuator such that axial movement of the actuator causes axial movement of the tensioning member. The handle actuator may also be adapted and configured to rotate (e.g., actuator 314) to cause rotation of the medical tool, and optionally, wherein rotation of the actuator does not cause rotation of the tensioning member. Thus, the tensioning member may be adapted to move axially when the actuator moves axially, but not rotate when the actuator rotates. This may be achieved by the tensioning member being operatively connected (directly or indirectly) to the actuator.

[0111] The medical device may include an inner elongated body (e.g., 132) including a lumen in which at least a portion of the flexible member is disposed. The inner elongated body may be independently steerable, such as with separate independently actuatable handle actuators (e.g., actuator 322). Aspects of other examples herein in which the medical device includes an inner member and an outer member, the inner member being independently controllable (e.g., axially and rotationally) are fully incorporated into any of the examples herein.

[0112] The flexible member can be coupled to a printed circuit board (e.g., Figure 12A 321 "plate" shown). The tension member can be coupled to the flexible member proximal to the printed circuit board. In an alternative example, the tension member can be coupled to the flexible member distal to the printed circuit board.

[0113] Figures 12A to 12F An example of a portion of a medical device comprising an elongated outer body (e.g., 131) comprising a probe tip in a distal region of the elongated body; a flexible conductor bundle (e.g., 105) securely coupled to the probe tip at a first location (e.g., Figure 9B and Figure 9C(shown in FIG. 0) and extends proximally from the medical tool and into the handle assembly, the flexible member being disposed within the outer surface of the elongate body; an inner elongate body (e.g., 131), at least a portion of which is disposed within the elongate outer body, the inner elongate body being optionally steerable, wherein at least a portion of the flexible conductor bundle is disposed within the inner elongate body and is configured to be axially movable relative to the inner elongate body; a tension member that is fixed to the flexible member at a second position within the handle assembly, the tension member being adapted and configured to apply tension to the flexible member when the probe tip is retracted proximally. As used herein, the probe tip may include one or more ultrasonic transducers.

[0114] Figures 12E to 12F Half of the handle outer housing 320 is shown, with two forming a portion of the outer surface of the handle assembly 310. The handle housing 320 includes a radially inwardly extending feature 315 that is adapted to interface with a controller that controls the movement of the tension member 312. The feature 315 may include a guide that is configured to interface with the tension member at one or more locations and to assist in stabilizing the tension member.

[0115] Any other handle assembly components in any other examples herein that may be suitably integrated into the handle assembly 310 are incorporated herein by reference.

[0116] In any of the examples and claims herein, the phrase "tension member" may be replaced with "straightening member", "flattening member", or derivatives thereof. As described herein, a straightening member or flattening member refers to maintaining a substantially straight or flattened configuration in the flexible member when the medical device is in a straightened configuration, and the device is not required to always have a straightened configuration. Thus, even if the flexible member is not necessarily placed under tension, it may still be maintained in a straightened (i.e., non-folded configuration) along at least a portion of its length due to the straightening member. For example, Figure 12A member 312 in FIG. is an example of a straightening member, even though it also functions as a tension member. This applies to all tension members described, shown, and claimed herein. In some examples herein, a "member" may be a straightening member (or flattening member) and also function as a tension member. Additionally, the phrase "tension member" herein may be replaced with "anti-folding member", "anti-bending member", "anti-gathering member", or derivatives thereof.

[0117] The foregoing disclosure describes that in some examples, a flexible member such as the 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 will undergo deflection.

[0118] Figures 13A to 13EShows a portion of an exemplary medical device that includes a flexible member (such as a flexible conductor bundle) that is twisted. Figures 13A to 13E The examples in [[ ]] can be combined with any other suitable features and / or medical devices described herein.

[0119] Figures 13A to 13E The portion 330 of the medical device shown in [[ ]] includes a medical tool 332 located in the distal region, a flexible member 331 coupled to the medical tool and extending proximally therefrom, and a proximal end region 333 that includes a plurality of electrical connectors. The flexible member 331 can be a flexible conductor bundle, such as any of the bundles herein. The medical tool 332 can include an ultrasonic imaging 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 tool 332 can be coupled to an outer shaft, such as Figure 9B the outer shaft 131 shown in [[ ]].

[0120] The length of the twisted region 338 from its distal end to its proximal end can vary, and in some examples is 5 cm to 15 cm, such as 8 cm to 15 cm, such as 11 cm. The length over which a complete turn is formed can vary widely, such as 1 cm to 5 cm, such as 3 cm.

[0121] The number of twists over the length of the twisted region can also vary, such as but not limited to 7 to 9 complete twists.

[0122] An exemplary way to form the twisted region of a flexible member (e.g., a flexible conductor bundle) is to couple the flexible member to the medical tool at the distal end (e.g., the probe tip). A thin PET heat shrink segment can then be advanced over the flexible conductor bundle. One portion of the device can be held in place while another portion is twisted to the desired number of turns to form the twisted region. While maintaining the twisted configuration, the PET can be heat shrunk over the twisted bundle region. Additional PET layers can then be added. An elongate member (e.g., shaft 131) can then be placed over the bundle (including the twisted region), and the elongate member can be bonded to the medical tool.

[0123] Referring to [[ ]], system 2800 includes a handle assembly 2802 and a steering and medical device portion 2810 (e.g., shown as being similar to sheath 1208 ( Figures 14 to 18 ), Figure 4) outer sheath), and the outer sheath may also surround the inner shaft and the tool. The system is adapted such that the handle assembly 2802 can be actuated to cause steering of the steerable portion of the steerable and medical device portion 2810, and optionally can be further actuated to cause movement of the medical device coupled thereto. As an illustrative example, the handle assembly 2802 includes a first actuator 2806 and a second actuator 2808. One or more of the first actuator 2806 or the second actuator 2808 is adapted (e.g., configured) to be actuated (rotated in this example) relative to the handle body of the handle assembly 2802 to cause steering of the steerable portion 2810, such as steering the outer sheath. Steering may include rotation or deflection. As an example, one of the actuators 2806, 2808 controls rotation, while the other of the actuators 2806, 2808 controls deflection. As another example, one of the actuators 2806, 2808 controls rotation of one or more of the inner shaft or the outer shaft, while the other of the actuators 2806, 2808 controls deflection of one or more of the inner shaft or the outer shaft.

[0124] As Figure 17 more clearly shown, a neutral position marker 3102 may be provided on the body of the handle assembly 2802 to indicate (e.g., visually, tactilely, etc.) a fixed reference point. One or more of the actuators 2806, 2808 may also include markers 3104, 3106 to indicate the alignment or position of the actuators 2806, 2808 relative to the neutral position marker 3102. As an example, the marker 3104 may indicate deflection of the shaft relative to the neutral position marker 3102, and the marker 3106 may indicate rotation of a component (e.g., a transducer face disposed in the sheath 2810) relative to the neutral position marker 3102, or vice versa. The markers 3104, 3106 may indicate other positions. Additionally or alternatively, a mechanical registration mechanism (such as a stopper) may be used to provide tactile feedback to the user to indicate certain positions of the actuators 2806, 2808, such as when the actuators 2806, 2808 are in the neutral position.

[0125] The handle assembly 2802 may include any other handle components or functionality described in any other handle herein. For example, a jack 2804 may be provided at the proximal end of the handle assembly 2802 and is adapted to receive a plug such as a detachable plug. As Figure 16 more clearly shown, the jack 2804 may include visual and / or tactile orientation markers for registration and alignment of the detachable plug and the jack 2804.

[0126] The navigation connector 2812 can be coupled to the handle assembly 2802 via a navigation catheter 2814 (e.g., a navigation cable sheath). The navigation connector 2812 can be configured to interface with a navigation system such 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 catheter 2814 can be coupled to the body of the handle assembly 2802 to provide a passage for one or more cables from the navigation connector 2812 to components within the housing of the handle assembly 2802. As Figure 18 more clearly shown, the navigation connector 2812 can be configured to interface with a navigation system connector 3204 (e.g., a jack), which can be proprietary to the navigation system manufacturer. The jack 2804 can be configured to interface with the controller interface 3202. Other configurations can be used.

[0127] Figures 19 to 24 An example distal region of a steerable system including a medical tool is shown. As an illustrative example, Figure 19 the medical tool shown can include a steerable tip 3300 disposed at the distal end of a sheath. The steerable tip 3300 can include a transducer 3304 (e.g., an ultrasonic transducer) at least partially surrounded by a material 3302 (e.g., a polymer). The tip 3300 can include an electronic module 3306, which can include sensors, a control board, a thermistor, etc. As an example, a TAS sensor 3308 can be disposed to communicate with the module 3306. As another example, a sensor cable harness 3310 can be disposed to provide electrical connectivity to one or more components coupled to the module 3306.

[0128] As an illustrative example, Figure 20 the medical tool shown can include a steerable tip 3400 disposed at the distal end of a sheath. The steerable tip 3400 can include a transducer 3404 (e.g., an ultrasonic transducer, a folding transducer) at least partially surrounded by a material 3402 (e.g., a polymer). The tip 3400 can include sensors, a control board, a thermistor, etc. As an example, when compared to the configuration of the tip 3300 in Figure 19 the TAS sensor 3406 can be disposed in a configuration closer to the distal end of the tip 3400. By shifting the sensor 3406, the proportion of the tip 3400 that can be deflected is increased.

[0129] As an illustrative example, Figure 21The illustrated medical tool may include a steerable tip 3500 disposed at the distal end of a sheath. The steerable tip 3500 may include a transducer 3502 (e.g., an ultrasonic transducer, a folded transducer). As an example, an ASIC 3504 may be disposed adjacent to the transducer 3502. As another example, a passive piezoelectric element may be disposed adjacent to the transducer 3502. The tip 3500 may include various sensors, a control board, a thermistor, etc. As shown, the tip 3500 includes a thermistor 3506 disposed proximal to the transducer 3502. As Figure 23 More clearly shown, 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 the same or different properties, such as different stiffnesses (e.g., hardnesses). As an illustrative example, the first material 3700 may have a higher hardness than the second material 3704. As Figure 23 Further shown, 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 of the tip 3500 and the position of the tip and provide feedback to the user.

[0130] As an illustrative example, Figure 22 The illustrated medical tool may include a steerable tip 3600 disposed at the distal end of a sheath. The steerable tip 3600 may include a transducer 3602 (e.g., an ultrasonic transducer, a folded transducer). When compared to the tip 3500, the tip 3600 may include a shortened folded end 3601. The passive piezoelectric material of adjacent transducers 3602 may be minimized. As an example, an ASIC 3604 may be disposed adjacent to the transducer 3602. The tip 3600 may include various sensors, a control board, a thermistor, etc. As shown, the tip 3600 includes a thermistor 3606 disposed proximal to the transducer 3602. A circuit (such as a flexible circuit) may be in electrical communication with one or more components in the tip 3600. As an example, the flexible circuit may be divided into layers and selectively communicate with the components. As Figure 24 More clearly shown, at least a portion of the tip 3600 may be at least partially surrounded by a first material 3800 (e.g., a polymer), and at least a portion of the 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 the same or different properties, such as different stiffnesses (e.g., hardnesses). As an illustrative example, the first material 3800 may have a higher hardness than the second material 3804. As Figure 24Further shown, the navigation sensor 3802 can be arranged adjacent to the transducer 3602. The navigation sensor 3802 can communicate with a navigation system to provide tracking of the tip 3600 and the position of the tip and provide feedback to a user.

[0131] Figure 25 A medical tool is shown that can include a steerable tip 3902 disposed at a distal end of a sheath 3906. As shown, a DAS sensor 3908 can be arranged at or adjacent to a proximal end of the tip 3902. The inner sheath 3904 can include segments configured for deflection 3912 and can be arranged adjacent to the tip 3902 and within the sheath 3906. One or more DAS sensors 3910, 3910' can be arranged along the length of the sheath 3904.

[0132] Figure 26 An example configuration of a navigation transducer 4002 is shown. For example, a measurement can be made at a first length 4003 from the tip of the device to the center of the y-coil. The distance from the center of the active transducer 4002 to the y-coil can be a second length 4004. The distance from the sensor axis to the tip axis can be a third length 4006. The distance from the sensor axis to the face of the ultrasonic transducer can be a fourth length 4008.

[0133] Figures 27 to 29 Various arrangements of the pull wires are shown. For example, the handle assembly can have an internal component that interfaces with the proximal ends of the pull wires such that actuation of one or more actuators tensions one or more pull wires to cause deflection of the inner shaft. From left to right, the configuration of the inner shaft and the wires (two versions of a vertical pairing are shown for comparison) can represent the distal portion, the intermediate portion, and the proximal portion along the length of the inner shaft. The wire 4102 can have a relative configuration within the outer sheath 4100. The wire 4106 can have a relative configuration within the outer sheath 4104. The wire 4110 can have a relative configuration within the outer sheath 4108. The wire 4114 can have a relative configuration within the outer sheath 4112. The wire 4118 can have a relative configuration within the outer sheath 4116. The wire 4122 can have a relative configuration within the outer sheath 4120. Figures 28 to 29 It is shown that the pull wires can change their spacing and configuration along their length on one or more shafts or sheaths.

[0134] Figures 30 to 31 Various configurations of components of an example handle assembly are shown. By way of illustration, the handle assembly 4400 can include one or more printed circuit boards 4402 in a stacked arrangement. As a further illustration, the handle assembly 4500 can include one or more printed circuit boards 4502 in a stacked arrangement. Other arrangements can be used.

[0135] This document describes medical devices with maneuverability, such as catheters. However, certain procedures may still be difficult, for example, introducing a medical device into certain areas of the heart, such as through a perforation in the septum and into the left atrium (LA). Such procedures may require locating the perforation and then pushing the medical device (e.g., a catheter) through the puncture site. Other procedures and devices may benefit from additional guiding mechanisms and navigation methods.

[0136] 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 2-way or 4-way steering as described herein, but may benefit from a guidewire. Alternatively, the catheter may not have deflectable steering at all and instead rely solely on advancing along a guidewire. As another example, the catheter may advance within a fixed or steerable sheath.

[0137] In certain aspects, the guidewire lumen may include a distal extension disposed at or adjacent to the distal end of the medical device. The distal extension may be formed at least in part of a soft polymer material (e.g., equivalent to Pebax 25 or 35 durometer). Other materials may be used. The distal extension may include a guidewire lumen sized to receive a guidewire passing through the guidewire lumen (e.g., a 0.018” to 0.035” guidewire; e.g., an inner diameter of about 0.021” to 0.042”). Other sizes may be used.

[0138] As an illustrative example, to use the device, the guidewire itself may be placed into the target location alone or preferably with the aid of a long introducer sheath or guiding catheter into the heart. Example target locations may include the coronary sinus, pulmonary artery, or through a transseptal hole from the right to the left atrium. The catheter will then be advanced along the guidewire to the target location. Alternatively, for example, the catheter and guidewire may be advanced together into the heart, and the catheter may be advanced forward to the target location before tracking the catheter along the guidewire.

[0139] During use, it may be desirable to remove the wire and use the catheter without the aid of the wire. In this case, curling the distal end into a “pigtail” shape ( Figure 33B ) will reduce the potential trauma to tissue when manipulating the device. Alternatively, the catheter may be removed, the wire repositioned, and the catheter advanced again along the back end of the wire to the target location. Other configurations and methods of use may be achieved.

[0140] Figure 32 and Figures 33A to 33B An example medical device with a distal extension is shown. Figure 32A medical device 5000 is shown, which includes a probe 5020, a distal extension 5010, a guidewire 5030, a transducer 5040, and an outer shaft 5050. The distal extension 5010 may include 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 5010 may include an inlet orifice 5032 to receive the guidewire 5030. The distal extension 5010 may include a guidewire lumen 5034. Figure 33A A medical device 5100 is shown, which includes a probe 5120, a distal extension 5110, a guidewire 5130, a transducer 5140, and an outer shaft 5050. The distal extension 5110 may include a tapered tip 5114, a first portion 5112, and a second portion 5116. The first portion may have a lower stiffness than the second portion. The distal extension 5110 may include a guidewire lumen 5134. The guidewire lumen 5134 may be aligned 180 degrees with the face of the transducer 5140 and extend the entire length of the medical device 5100. Figure 33B A medical device 5200 is shown. The medical device 5200 may include the medical device 5100 (or the medical device 5000) after removal of the guidewire (e.g., the guidewire 5130 or the guidewire 5030). As shown, the distal extension 5110 may be configured to assume a non-invasive "pigtail" shape when the guidewires 5030, 5130 are not loaded. As an illustrative example, the medical devices 5000, 5100, 5200 may include a catheter, such as an ICE catheter.

[0141] The first (e.g., soft) portions 5012, 5112 may comprise a soft polymer material (e.g., equivalent to Pebax 25 or 35 hardness). The sizes of the guidewire lumens 5034, 5134 may be sized for a 0.018 to 0.035 guidewire (typically ID = 0.021" to 0.042"). The stiffness of the distal extensions 5010, 5110 may be more rigid at the distal ends of the transducers 5040, 5140 (at the second (e.g., stiff) portions 5016, 5116) and soften towards the distal ends of the distal extensions 5010, 5110 (at the first (e.g., soft) portions 5012, 5112) to better transition to a stiffness more closely similar to that of the guidewires 5030, 5130. The stiffness transition may be facilitated by one or more of an outer diameter (or other dimension), an internal longitudinal strengthening member, a coil, a braid, and / or a transition of materials of different hardnesses (e.g., polymers). Other methods and stiffness controls may be used. The stiffness may transition linearly or by region / segment or some other transition curve to exhibit a change in stiffness from the distal end of the transducer to the distal end of the distal extension. The distal extensions 5010, 5110 may also be configured to assume a non-invasive "pigtail" shape when the guidewires 5030, 5130 are not loaded, as shown for the medical device 5200.

[0142] The guidewire lumens 5034, 5134 may include a lubricious lining such as polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP), or polyethylene such as high density polyethylene or a mixture thereof with low density polyethylene. Other materials may be used. The length of the distal extensions 5010, 5110 may be from 1 cm to 6 cm. In some aspects, the length of the distal extensions 5010, 5110 may be about 2.5 cm. The length of the guidewire lumens 5034, 5134 may be from 0.5 cm to 5.5 cm. The length of the guidewire lumens 5034, 5134 may be 2 cm. Other sizes may be used. The guidewire lumens 5034, 5134 may be distal single track lumens. In another example, a separate flush lumen may be routed through the length of the medical device 5000 (or medical device 5100) and behind the transducer 5040 (or transducer 5140) to connect to the guidewire lumen 5034 (or guidewire lumen 5134) so as to keep the guidewire lumen 5034 (or guidewire lumen 5134) flushed with saline to prevent blood clotting.

[0143] A navigation sensor may be incorporated into a portion (e.g., the tip or end) of the distal extensions 5010, 5110 for precise visualization in mapping or navigation techniques such as the Biosense Webster cardiac 3D mapping system (CARTO). The distal extensions 5010, 5110 may comprise a polymer mixed with a radiopaque material such as barium sulfate or tungsten powder. Radiopaque marker bands, braids, and / or coils containing platinum and other materials known in the art may also be incorporated into the distal extensions 5010, 5110.

[0144] As an example, the guidewire lumen 5134 may extend the entire length of the medical device 5100. The proximal end may include an attachment for a rotary hemostatic valve to allow saline to be infused through the full length of the guidewire lumen 5134.

[0145] To use the medical device 5000 (or medical device 5100), the guidewire 5030 (or guidewire 5130) may be independently placed into the target location. The guidewire 5030 (or guidewire 5130) may be placed into the target location by means of a long introducer sheath or guiding catheter into the heart. The target location may include the coronary sinus, the pulmonary artery, or across the interatrial septum from the right to the left atrium. The medical device 5000 (or medical device 5100) may then be advanced along 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 into the target location before tracking the medical device 5000 (or medical device 5100) to the target location.

[0146] During use, the guidewire 5030 (or guidewire 5130) can preferably be removed and the medical device 5000 (or medical device 5100) can be used without the aid of the guidewire 5030 (or guidewire 5130). In this case, as Figure 33B shown, the distal extension 5010 (or distal extension 5110) curled into a pigtail shape will reduce potential trauma to tissue when manipulating the medical device 5000 (or medical device 5100). Alternatively, the medical device 5000 (or medical device 5100) can be removed, the guidewire 5030 (or guidewire 5130) repositioned, and the medical device 5000 (or medical device 5100) advanced again along the back end of the guidewire 5030 (or guidewire 5130) to the target position.

[0147] The medical devices 5000, 5100 can include steering capabilities, such as the designs described herein (e.g., 2-way steering or 4-way steering). The medical devices 5000, 5100 can be manufactured without deflectable steering but rather rely on advancement along the guidewires 5030, 5130. The medical devices 5000, 5100 can be advanced within a fixed or steerable sheath.

[0148] Aspects of the embodiments

[0149] Example aspect 1: A medical device configured and sized to be positioned within a subject, the medical device comprising: an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer at least partially surrounded by material to define a distal end of the medical device; and a distal extension disposed adjacent to and longitudinally extending from the distal end, the distal extension including a first end adjacent to the distal end and a second end opposite the first end, wherein the distal extension includes a tapered end at or adjacent to the second end, wherein the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire passing through the guidewire lumen, and wherein the distal extension exhibits a first stiffness at the first end and a second stiffness adjacent to the second end, wherein the first stiffness is greater than the second stiffness.

[0150] Example Aspect 2: The medical device according to Aspect 1 further includes an ultrasound probe, the ultrasound probe includes the ultrasound transducer and a flexible circuit strip electrically connected to the ultrasound 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, and a part of one or more of the plurality of conductive traces is covered by an insulating member.

[0151] Example Aspect 3: The medical device according to Aspect 1, wherein the guidewire lumen includes one or more lumen orifices configured to allow a guidewire to enter the guidewire lumen and to be removed from the guidewire lumen.

[0152] Example Aspect 4: The medical device according to Aspect 1, wherein the guidewire lumen includes a first lumen orifice disposed along the length of the distal extension and a second lumen orifice disposed at the tapered distal end, and wherein the first lumen and the second lumen are configured to allow a guidewire to enter the guidewire lumen and to be removed from the guidewire lumen.

[0153] Example Aspect 5: The medical device according to Aspect 1, wherein the guidewire lumen extends along at least a portion of the length of the ultrasound transducer.

[0154] Example Aspect 6: The medical device according to any one of Aspects 1 to 4, wherein the ultrasound transducer includes a transmitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasound transducer opposite the transmitter face.

[0155] Example Aspect 7: The medical device according to Aspect 1, wherein the distal extension is coupled to the distal end.

[0156] Example Aspect 8: The medical device according to Aspect 1, wherein the distal extension is fused to the distal end.

[0157] Example Aspect 9: The medical device according to any one of Aspects 1 to 8 further includes an outer shaft coupled to the proximal end of the distal end.

[0158] Example Aspect 10: The medical device according to Aspect 9, wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

[0159] Example Aspect 11: A medical device configured and sized to be positioned within a subject, the medical device comprising: an ultrasound transducer disposed in a distal region of the medical device, the ultrasound transducer at least partially surrounded by material to define a distal end of the medical device; and a distal extension disposed adjacent to and longitudinally extending from the distal end, the distal extension including a first end adjacent to the distal end and a second end opposite the first end, wherein the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire passing through the guidewire lumen, and wherein the distal extension exhibits a transition in stiffness along the length of the distal extension.

[0160] Example Aspect 12: The medical device according to Aspect 11, wherein the distal extension exhibits a first stiffness at the first end and a second stiffness adjacent to the second end, wherein the first stiffness is greater than the second stiffness.

[0161] Example Aspect 13: The medical device according to any one of Aspects 11 to 12, wherein the distal extension includes a tapered end at or adjacent to the second end.

[0162] Example Aspect 14: The medical device according to any one of Aspects 11 to 13, the medical device further comprising an ultrasound probe including the ultrasound transducer and a flexible circuit strip in electrical communication with the ultrasound transducer, the flexible circuit strip further including an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of one or more of the plurality of conductive traces being covered by an insulating member.

[0163] Example Aspect 15: The medical device according to any one of Aspects 11 to 14, wherein the guidewire lumen includes one or more lumen apertures configured to permit entry of a guidewire into the guidewire lumen and removal of the guidewire from the guidewire lumen.

[0164] Example Aspect 16: The medical device according to any one of Aspects 11 to 14, wherein the guidewire lumen includes a first lumen aperture disposed along the length of the distal extension and a second lumen aperture disposed adjacent to an end of the distal extension, wherein the first lumen and the second lumen are configured to permit entry of a guidewire into the guidewire lumen and removal of the guidewire from the guidewire lumen.

[0165] Example aspect 17: The medical device according to any one of aspects 11 to 16, wherein the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer.

[0166] Example aspect 18: The medical device according to any one of aspects 11 to 16, wherein the ultrasonic transducer includes a transmitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer opposite to the transmitter face.

[0167] Example aspect 19: The medical device according to any one of aspects 11 to 16, wherein the distal extension is coupled to the distal end.

[0168] Example aspect 20: The medical device according to any one of aspects 11 to 16, wherein the distal extension is fused to the distal end.

[0169] Example aspect 21: The medical device according to any one of aspects 11 to 20, the medical device further includes an outer shaft coupled to the proximal end of the distal end.

[0170] Example 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.

[0171] Example aspect 23: A medical device configured and sized to be positioned within a subject, the medical device comprising: an ultrasound probe disposed adjacent a distal region of a rotatable shaft, the ultrasound probe including an ultrasound 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; a handle assembly including: a handle body having an outer surface graspable by a user; a first actuator configured to move relative to the handle body; and a second actuator configured to move relative to the handle body, wherein the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body, wherein the rotatable shaft is operatively communicable with the first actuator of the handle assembly such that actuation of the first actuator causes a rotational movement of at least a portion of the rotatable shaft relative to the deflectable shaft, and wherein the deflectable shaft is operatively communicable with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft and thereby deflection of the rotatable shaft; and a distal extension disposed adjacent the ultrasound probe and longitudinally extending from the ultrasound probe, the distal extension including a first end adjacent the distal ultrasound probe and a second end opposite the first end, wherein the distal extension includes a guidewire lumen formed therein and configured to receive a guidewire passing through the guidewire lumen, and wherein the distal extension exhibits a transition in stiffness along the length of the distal extension.

[0172] Example aspect 24: The medical device according to aspect 23, wherein the distal extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness.

[0173] Example aspect 25: The medical device according to any one of aspects 23 to 24, wherein the distal extension includes a tapered end at or adjacent the second end.

[0174] Example aspect 26: The medical device according to any one of aspects 23 to 25, wherein the ultrasound probe includes a flexible circuit strip electrically communicable with the ultrasound transducer, the flexible circuit strip further including an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, and a portion of one or more of the plurality of conductive traces covered by an insulating member.

[0175] Example aspect 27: The medical device according to any one of aspects 23 to 26, wherein the guidewire lumen includes one or more lumen apertures configured to permit entry of a guidewire into the guidewire lumen and removal of the guidewire from the guidewire lumen.

[0176] Example aspect 28: The medical device according to any one of aspects 23 to 26, wherein the guidewire lumen includes a first lumen aperture disposed along a length of the distal extension and a second lumen aperture disposed adjacent an end of the distal extension, wherein the first lumen and the second lumen are configured to permit entry of a guidewire into the guidewire lumen and removal of the guidewire from the guidewire lumen.

[0177] Example aspect 29: The medical device according to any one of aspects 23 to 28, wherein the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer.

[0178] Example aspect 30: The medical device according to any one of aspects 23 to 28, wherein the ultrasonic transducer includes a transmitter face, and the guidewire lumen extends along at least a portion of the length of the ultrasonic transducer opposite the transmitter face.

[0179] Example aspect 31: The medical device according to any one of aspects 23 to 30, wherein the distal extension is coupled to the ultrasonic probe.

[0180] Example aspect 32: The medical device according to any one of aspects 23 to 30, wherein the distal extension is fused to the ultrasonic probe.

[0181] Example aspect 33: The medical device according to any one of aspects 23 to 32, the medical device further including an outer shaft coupled to a proximal end of the ultrasonic probe.

[0182] Example aspect 34: The medical device according to aspect 33, wherein the guidewire lumen extends along at least a portion of the length of the outer shaft.

[0183] Example aspect 35: A medical device configured and sized to be positioned within a subject, the medical device comprising: a probe tip extension configured to be coupled to the tip of an ultrasound probe, the ultrasound probe configured and sized to be positioned within a subject, wherein the probe tip extension is configured to extend longitudinally from the tip, the tip extension including a first end adjacent to the tip and a second end opposite the first end, and wherein the probe tip extension exhibits a transition in stiffness along the length of the probe tip extension; and a guidewire lumen formed through the probe tip extension and configured to receive a guidewire passing through the guidewire lumen such that the ultrasound probe can move along the length of the guidewire via the guidewire lumen.

[0184] Example aspect 36: The medical device according to aspect 35, wherein the guidewire lumen includes one or more lumen apertures configured to allow a guidewire to enter the guidewire lumen and to remove the guidewire from the guidewire lumen.

[0185] Example aspect 37: The medical device according to aspect 35, wherein the guidewire lumen includes a first lumen aperture disposed along the length of the tip extension and a second lumen aperture disposed adjacent to an end of the tip extension, wherein the first lumen and the second lumen are configured to allow a guidewire to enter the guidewire lumen and to remove the guidewire from the guidewire lumen.

[0186] Example 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, wherein the first stiffness is greater than the second stiffness.

[0187] Example aspect 39: The medical device according to aspect 35, wherein the tip extension includes a tapered tip at or adjacent to the second end.

[0188] Example aspect 40: The medical device according to any one of aspects 1 to 39, wherein the guidewire lumen is disposed distally of the ultrasound transducer.

[0189] Example aspect 41: The medical device according to any one of aspects 1 to 39, wherein the guidewire lumen is entirely disposed distally of the ultrasound transducer.

[0190] Regardless of the reference numerals labeled, the handle assemblies, medical tools, steerable sheaths, and electrical connectors herein can be used together in any combination with one another in the system.

[0191] Any technique (including ultrasound and steering techniques) in any of the following U.S. patent references may be incorporated into any of the medical tools, devices, systems, or methods of use herein, the disclosures of which are 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.

Claims

1. A medical device configured and dimensioned to be positioned within a subject, the medical device comprising: an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material to define a distal tip of the medical device; and a terminal extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the terminal extension including a first end adjacent to the distal tip and a second end opposite the first end, wherein the terminal extension includes a tapered terminal end at or adjacent the second end, wherein the terminal extension comprises a guidewire lumen formed in the terminal extension and configured to receive a guidewire passing through the guidewire lumen, and The terminal extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness.

2. The medical device according to claim 1, further comprising an ultrasound probe, the ultrasound probe comprising the ultrasound transducer and a flexible circuit strip electrically connected to the ultrasound transducer, the flexible circuit strip further comprising an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of one or more of the plurality of conductive traces being covered by an insulating member.

3. The medical device according to claim 1, wherein: The guidewire lumen includes one or more lumen apertures configured to allow entry and removal of a guidewire from the guidewire lumen.

4. The medical device according to claim 1, wherein: The guidewire lumen includes a first lumen aperture disposed along a length of the distal extension and a second lumen aperture disposed at the tapered distal end, wherein the first lumen aperture and the second lumen aperture are configured to allow a guidewire to enter and be removed from the guidewire lumen.

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

6. The medical device according to claim 1, wherein: The ultrasonic transducer includes 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 according to claim 1, wherein: The tip extension is coupled to the distal tip.

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

11. A medical device configured and dimensioned to be positioned within a subject, the medical device comprising: an ultrasonic transducer disposed in a distal region of the medical device, the ultrasonic transducer being at least partially surrounded by a material to define a distal tip of the medical device; and a terminal extension disposed adjacent to the distal tip and extending longitudinally from the distal tip, the terminal extension including a first end adjacent to the distal tip and a second end opposite the first end, Wherein the terminal extension includes a guidewire lumen formed therein and configured to receive a guidewire therethrough, and wherein the terminal extension exhibits a transition in stiffness along a length of the terminal extension.

12. The medical device according to claim 11, wherein: The terminal extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness.

13. The medical device according to claim 11, wherein: The terminal extension includes a tapered terminal end at or adjacent the second end.

14. The medical device according to claim 11, further comprising an ultrasound probe, the ultrasound probe comprising the ultrasound transducer and a flexible circuit strip electrically connected to the ultrasound transducer, the flexible circuit strip further comprising an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of one or more of the plurality of conductive traces being covered by an insulating member.

15. The medical device according to claim 11, wherein: The guidewire lumen includes one or more lumen apertures configured to allow entry and removal of a guidewire from the guidewire lumen.

16. The medical device according to claim 11, wherein: The guidewire lumen includes a first lumen opening disposed along the length of the terminal extension and a second lumen opening disposed adjacent an end of the terminal extension, wherein the first lumen opening and the second lumen opening are configured to allow a guidewire to enter and be removed from the guidewire lumen.

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

18. The medical device according to claim 11, wherein: The ultrasonic transducer includes 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 according to claim 11, wherein: The tip extension is coupled to the distal tip.

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

23. A medical device configured and dimensioned to be positioned within a subject, the medical device comprising: an ultrasound probe disposed adjacent a distal region of the rotatable shaft, the ultrasound probe comprising an ultrasound 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; A handle assembly comprising: a handle body having an outer surface capable of being grasped by a user; a first actuator configured to move relative to the handle body; and a second actuator configured to move relative to the handle body. wherein the first actuator and the second actuator are disposed circumferentially around a longitudinal axis of the handle body, wherein the rotatable shaft is in operative communication with the 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, and wherein the deflectable shaft is in operable communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft, and thereby causes deflection of the rotatable shaft; and a terminal extension disposed adjacent to a distal end of the ultrasound probe and extending longitudinally from the ultrasound probe, the terminal extension including a first end adjacent to the ultrasound probe and a second end opposite to the first end, Wherein the terminal extension includes a guidewire lumen formed therein and configured to receive a guidewire therethrough, and wherein the terminal extension exhibits a transition in stiffness along a length of the terminal extension.

24. The medical device according to claim 23, wherein: The terminal extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness.

25. The medical device according to claim 23, wherein: The terminal extension includes a tapered terminal end at or adjacent the second end.

26. The medical device according to claim 23, wherein: The ultrasound probe includes a flexible circuit strip electrically connected to the ultrasound transducer, the flexible circuit strip also includes an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of one or more of the plurality of conductive traces being covered by an insulating member.

27. The medical device according to claim 23, wherein: The guidewire lumen includes one or more lumen apertures configured to allow entry and removal of a guidewire from the guidewire lumen.

28. The medical device according to claim 23, wherein: The guidewire lumen includes a first lumen opening disposed along the length of the terminal extension and a second lumen opening disposed adjacent an end of the terminal extension, wherein the first lumen opening and the second lumen opening are configured to allow a guidewire to enter and be removed from the guidewire lumen.

29. The medical device according to claim 23, wherein: The guidewire lumen extends along at least a portion of the length of the ultrasonic transducer.

30. The medical device of claim 23, wherein: The ultrasonic transducer includes 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. The medical device of claim 23, wherein: The tip extension is coupled to the ultrasound probe.

32. The medical device of claim 23, wherein: The distal extension is fused to the ultrasound probe.

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

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

35. A medical device configured and dimensioned to be positioned within a subject, the medical device comprising: a probe tip extension configured to couple to a tip of an ultrasound probe configured and dimensioned to be positioned within a subject, wherein the probe tip extension is configured to extend longitudinally from the tip, the probe tip extension includes a first end adjacent to the tip and a second end opposite the first end, and wherein the probe tip extension exhibits a transition in stiffness along the length of the probe tip extension; as well as A guidewire lumen is formed through the probe tip extension and is configured to receive a guidewire passing through the guidewire lumen so that the ultrasound probe can be moved along the length of the guidewire via the guidewire lumen.

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

37. The medical device according to claim 35, wherein: The guidewire lumen includes 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, wherein the first lumen opening and the second lumen opening are configured to allow a guidewire to enter and be removed from the guidewire lumen.

38. The medical device according to claim 35, wherein: The probe tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness.

39. The medical device according to claim 35, wherein: The probe tip extension includes a tapered tip at or adjacent the second end.

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