Medical tool positioning device, system, and method of use and manufacture

Abstract

The present invention discloses an intravascular catheter, which includes a handle assembly having a first handle actuator and a second handle actuator, wherein the actuators are adapted to control at least one of axial displacement, deflection or rotation of an inner shaft of the catheter and an outer shaft of the catheter, respectively. The catheter may also include a medical tool fixed to the outer shaft.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 722,105, filed on August 23, 2018, and U.S. Provisional Application No. 62 / 741,375, filed on October 4, 2018, each of which is incorporated herein by reference in its entirety for all purposes.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated 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 Art

[0005] 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

[0006] One aspect of the present disclosure is an intravascular catheter and a medical tool, comprising: an outer shaft, which is connected to a handle assembly at a proximal end region of the outer shaft; an inner shaft, which is arranged inside the outer shaft, and the inner shaft is connected to the handle assembly at a proximal end region of the inner shaft, the handle comprising a first handle actuator, which is operably connected to the outer shaft, so that actuation of the first handle actuator relative to a second handle actuator causes the outer shaft to rotate relative to the inner shaft; and a second handle actuator is operably connected to the inner shaft, so that actuation of the second handle actuator causes the inner shaft to deflect.

[0007] A medical tool may be secured to the distal end of the outer shaft.

[0008] The inner shaft may be coupled to the handle by at least one tensioning element. Actuation of the second actuator may apply tension on the tensioning element to deflect the inner shaft. The tensioning element may be connected to the deflecting portion of the inner shaft.

[0009] The outer shaft and the inner shaft may be coaxial.

[0010] The outer shaft and the inner shaft may be sized, configured, and adapted to move axially relative to each other.

[0011] The distal ends of the inner and outer shafts may not be axially attached, and the outer and inner shafts may be axially movable relative to each other.

[0012] The inner shaft may include a deflection portion in which the inner shaft is adapted to deflect when the second actuator is actuated, wherein the deflection portion may be more flexible than a proximal portion of the inner shaft disposed proximal to the deflection portion. The deflection portion may be formed of a polymer material having a lower hardness than the hardness in the proximal portion. The deflection portion may include a weakened sidewall adapted to deflect.

[0013] The inner shaft may include an outer layer of braided material and an inner layer of braided material.

[0014] The outer shaft may be coupled to the tip portion. The tip may include an imaging element. The tip may include an ultrasound transducer. The tip may include an ablation element (e.g., an ablation electrode). The tip may include a structural heart device (e.g., an occlusive device, a stent, a valve).

[0015] The outer shaft may have at least a first segment and a second segment axially spaced apart, the first segment and the second segment having varying stiffness (e.g., different hardnesses), and the varying stiffness is used to selectively control at least one of: the position of the deflection segment of the device relative to the distal end of the device, and the curvature of the device when the device is deflected.

[0016] The first actuator may also be in operable communication with the outer shaft such that actuation of the first actuator causes the outer shaft to axially move relative to the inner shaft.

[0017] The first actuator may be configured and adapted to rotate to cause rotation of the outer shaft relative to the inner shaft.

[0018] The first actuator may be configured and adapted to be axially displaced to cause axial movement of the outer shaft relative to the inner shaft.

[0019] The inner shaft and the outer shaft may be arranged such that a deflection of the inner shaft causes a deflection of the outer shaft due to the relative position of the outer shaft and the inner shaft.

[0020] The outer shaft can include a distal portion that includes at least a portion of a medical implement, and wherein the medical implement is encapsulated within a material, optionally a flexible material such as a polymeric material (eg, PEBAX).

[0021] The outer shaft can be coupled to a distal portion that includes at least a portion of a medical tool.

[0022] The outer shaft can be coupled to a distal portion that includes at least a portion of a medical tool including at least one electrical connector extending axially within the outer shaft.

[0023] The outer shaft may be flexible and optionally comprise a braided material.

[0024] The outer shaft can be coupled to a distal portion (e.g., permanently attached with an adhesive or otherwise) that includes at least a portion of the medical tool, and wherein the outer shaft and distal portion have the same outer dimensions where they are coupled, and optionally have the same maximum outer dimensions.

[0025] The medical tool disposed in the distal tip region may include at least one electrical connector (and optionally a cable harness) extending axially within at least a portion of the inner shaft and being freely axially movable within the inner shaft.

[0026] The distal end of the outer shaft can extend further distally than the distal end of the inner shaft.

[0027] The inner shaft may include a deflectable section proximate a distal end of the inner shaft.

[0028] The inner shaft may include at least one axially extending tensioning member or element, such as at least one pull wire.

[0029] The inner shaft may include a first axially extending tensioning member and a second axially extending tensioning member, such as pull wires.

[0030] The inner shaft may include a first axially extending tension member and a second axially extending tension member, such as a pull wire, wherein in a deflection segment of the inner shaft, the first axially extending tension member and the second axially extending tension member are spaced apart around the inner shaft by less than 180 degrees, optionally less than 135 degrees, optionally less than 90 degrees, optionally less than 45 degrees, optionally less than 30 degrees, optionally less than 20 degrees, optionally less than 10 degrees.

[0031] The inner shaft may include a first axially extending tensioning member and a second axially extending tensioning member, such as a pull wire, wherein in a portion of the inner shaft located proximal to the steerable segment, the first axially extending tensioning member and the second axially extending tensioning member are separated from each other around the inner shaft and spaced 180 degrees (+ / - 5 degrees) from each other.

[0032] The inner shaft may include a third axially extending member adapted to straighten the inner shaft after the inner shaft has been deflected.

[0033] Any axially extending tensioning members (eg, pull wires) may be interwoven within the braided material in the inner shaft.

[0034] Any axially extending tensioning member (e.g., a pull wire) may have a distal region within a braided material interwoven within the inner shaft to at least help secure a distal end of the axially extending tensioning member, and optionally wherein the distal ends are interwoven and the tensioning member extends orthogonal to the longitudinal axis within a steerable segment of the elongated inner body and optionally is wrapped at least one turn around the inner shaft.

[0035] The device may be adapted so that any type of relative movement of the outer and inner shafts may occur before, during or after any type of movement of the other of the outer and inner shafts, wherein the movement may optionally be facilitated by actuation of one or both of the actuators.

[0036] The device may not include a flush line.

[0037] One aspect of the present disclosure is a method of controlling a catheter device, the method comprising: moving an outer shaft of the catheter device relative to an inner shaft of the catheter device in at least one of an axial movement and a rotational movement; and deflecting the inner shaft to cause deflection of the catheter.

[0038] The moving step may be performed by actuating a first handle actuator.

[0039] The deflecting step may be performed by actuating a second handle actuator.

[0040] Axially moving the outer shaft relative to the inner shaft can selectively control at least one of: a position of the deflection section of the device relative to the distal end of the device, and a degree of curvature (eg, angle of bend) of the device in the deflection section.

[0041] One aspect of the present disclosure is a steerable elongated body comprising: a shaft comprising a braided material; and at least one tensioning member (e.g., a pull wire) wherein a distal region of the tensioning member is interwoven in the braided material to help secure a distal end of the at least one tensioning member at a position of the steerable elongated body.

[0042] At least one tensioning member may have a distal region that is more orthogonal to the longitudinal axis of the steerable elongate body than the distal region in the deflectable section, optionally between 0 degrees and at least 90 degrees relative to the longitudinal axis.

[0043] In at least a portion of the deflectable section, at least one tensioning member may be parallel to the longitudinal axis.

[0044] The steerable elongate body may not include an adhesive or marker band to help secure the distal end of the at least one tensioning member.

[0045] The interwoven distal region may allow the distal end of the tensioning member to be secured without the need for adhesive or marker tape.

[0046] One aspect of the present disclosure is a steerable medical member comprising: a deflectable slender body having a deflectable segment, the deflectable slender body comprising a first tensioning member and a second tensioning member (e.g., a pull wire), wherein in the deflectable segment, the first tensioning member and the second tensioning member are closer together (in degrees) than in a proximal segment located proximal to the deflectable segment.

[0047] The first tensioning member and the second tensioning member may be spaced apart less than 180 degrees in the deflectable segment, optionally spaced apart less than 135 degrees, optionally spaced apart less than 90 degrees, optionally spaced apart less than 45 degrees, optionally spaced apart less than 40 degrees, optionally spaced apart less than 35 degrees, optionally spaced apart less than 30 degrees, optionally spaced apart less than 25 degrees, optionally spaced apart less than 20 degrees, optionally spaced apart less than 15 degrees, optionally spaced apart less than 10 degrees.

[0048] The first and second tensioning members may be spaced 180 degrees apart in a proximal section proximal to the deflectable section.

[0049] The first and second tensioning members may be brought closer together (in degrees) in a second proximal section proximal to the proximal section.

[0050] One aspect of the present disclosure is a handle stabilization member comprising: a handle guide area having a configuration suitable for interfacing with a handle of a medical device; a patient interface area configured to interface with a portion of a patient (including clothing worn by the patient so that direct contact with the skin does not occur); and an optional stabilization aid portion that is weighted to further stabilize the stabilization member relative to the patient.

[0051] The handle guiding region may be located at an end of the handle stabilizing member.

[0052] An optional stabilization aid may be located at the end of the handle stabilization member.

[0053] The patient interface region may be deformable.

[0054] The patient interface region may be rigid.

[0055] The handle guide may be more rigid than the patient interface.

[0056] The handle guide and the patient interface may be made of different materials.

[0057] The handle guide may have a curved configuration, such as U-shaped or C-shaped.

[0058] The handle guide may have at least one flat surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1A Exemplary embodiments of systems including steering and medical devices are shown.

[0060] Figure 1B Shows Figure 1A Cross section AA of the turning and device portion of the medical device.

[0061] Figure 2 An exemplary system including a handle assembly having multiple actuators, a steerable sheath, and a medical tool is shown.

[0062] Figure 3 and Figure 4 An exemplary embodiment of the system is shown, wherein the cross-section of the steerable portion may be equal to Figure 2 Cross section shown.

[0063] 5 and 6 illustrate an exemplary distal region of the system, wherein the steerable portion may include Figure 1B Cross section shown.

[0064] Figure 7Ai , Figure 7Ai i and Figure 7Ai ii shows an exemplary steerable axle with a pull wire.

[0065] 7Bi and 7Bii illustrate exemplary steerable axles with pull wires.

[0066] 7Ci and 7Cii illustrate exemplary steerable axles with pull wires.

[0067] Figure 7Di to Figure 7Diiii An exemplary steerable axle with a pull wire is shown.

[0068] Fig. 7E An exemplary steerable shaft having one or more pull wires in a braided wire circumferentially interwoven into the shaft is shown.

[0069] Figure 8 An exemplary system including a medical tool within a steerable sheath or shaft is shown, the system being designed with modular components that are provided to the user in an integrated manner.

[0070] Fig. 9A and Fig. 9B Embodiments are shown in which the sheath handle includes a removable or breakable handle portion.

[0071] Fig. 10A and Fig. 10B A portion of an exemplary system is shown in which a tool lock and a handle are configured to limit the range of rotation of a medical device.

[0072] 11A and 11B illustrate an embodiment of a system including a steerable sheath having exemplary modular features to facilitate repositioning of a device.

[0073] Fig. 12A and Fig. 12B An alternative embodiment of the system is shown in which the tool lock is included within the sheath handle but is coupled to an external control.

[0074] Figure 13Ai, Figure 13Aii, Figure 13Bi, Figure 13Bii and Fig. 13C An exemplary system is shown in which a medical tool includes a proximal electrical connector including a plurality of electrical contacts.

[0075] Fig.14A , Fig. 14B and Fig. 14C An exemplary proximal coupling between a medical implement and a connector is shown.

[0076] Fig.15A and Fig. 15B An exemplary system is shown having a connector including internal features designed to enclose a tool lock attached to a tool part.

[0077] Fig.16 An exemplary system is shown that includes a separate medical tool torque device that can be attached to a medical tool to provide the ability to translate and torque the tool relative to a steerable sheath.

[0078] Fig.17A , Fig. 17B and Fig. 17C An exemplary tool including an outer member and an inner lead assembly is shown.

[0079] Fig.18 An exemplary portion of an exemplary system including a bundle is shown.

[0080] Fig.19 An exemplary proximal end of a medical tool is shown, the tool including a bundle of conductors extending into a proximal connector within which a printed circuit board (PCB) is housed.

[0081] Fig. 20A A portion of an exemplary medical tool including a flexible circuit strip is shown.

[0082] Fig. 20B An exemplary proximal portion of a strip is shown.

[0083] Fig. 20C A detailed view of an exemplary proximal portion of a strip is shown.

[0084] Fig.20D An end view of an exemplary flex strip is shown.

[0085] FIG. 20E shows an exemplary stack of flexible strips.

[0086] FIG. 20F shows an exemplary stack of flex strips and ground and shield strips.

[0087] Figure 20GAn exemplary bundle is shown including tubing material surrounding the strips as well as shielding and grounding strips.

[0088] Fig.21A and Fig. 21B An embodiment is shown in which the plurality of flex circuit strips have staggered lengths and the exposed locations are attached to the PCB at contacts arranged at similarly staggered lengths.

[0089] Fig. 21C An exemplary method of moving a tool distally and out of a sheath, optionally a steerable sheath, is shown.

[0090] Fig. 22 Exemplary embodiments are shown in which a conductor bundle may be reversibly rolled or wound around a spool comprising a rod, tube, spindle, or similar rotatable structure.

[0091] Fig.23 A portion of an exemplary embodiment is shown in which an exposed flex circuit end is attached to a disposable micro PCB component having equal sized connectors on one side but larger exposed connectors on the opposite side.

[0092] Fig.24 An exemplary embodiment of a plurality of intermediate flexible extension strips bonded to the main flexible strips is shown.

[0093] Fig.25 An embodiment is shown having a printed circuit board designed with redundant attachment locations.

[0094] FIG. 26A to FIG. 26F It shows how the flexible strip may change as sections are trimmed off at each relocation cycle.

[0095] FIG. 27A to FIG. 27G An exemplary embodiment is shown in which each stack of redundancy extensions is interleaved.

[0096] Figure 28, Figure 29, Fig.30 , Fig.31 and Fig.32 An alternative exemplary embodiment is shown of a cross-section of a bundled stack in a lumen that may be incorporated into any of the systems herein.

[0097] Fig.33 An exemplary embodiment is shown in which a medical implement and a steerable sheath are configured to interface.

[0098] Fig.34 An exemplary embodiment is shown in which a medical implement and a steerable sheath are configured to interface.

[0099] Fig.35AAn exemplary embodiment is shown in which a medical implement and a steerable sheath are configured to interface.

[0100] Fig.35B An exemplary embodiment is shown in which a medical implement and a steerable sheath are configured to interface.

[0101] 36A and 36B illustrate an exemplary system including a handle assembly adapted to effect axial and rotational movement of a medical tool separate from a steerable shaft.

[0102] 37A and 37B illustrate an exemplary embodiment of a handle assembly.

[0103] 38A and 38B illustrate an exemplary embodiment of a handle assembly.

[0104] Figure 39A to Fig.39E An exemplary embodiment of a handle assembly including a steerable sheath control is shown.

[0105] FIG. 40A to FIG. 40B Exemplary aspects of a steerable sheath control mechanism are shown.

[0106] Fig.41 An exemplary gasket is shown.

[0107] Fig.42A and Fig.42B An exemplary probe control system within an exemplary handle assembly is shown.

[0108] FIG. 43A to FIG. 43C An exemplary portion of an exemplary probe control system is shown.

[0109] FIG. 44A to FIG. 44E An exemplary portion of an exemplary steerable sheath control system is shown.

[0110] 45A and 45B illustrate exemplary combinations of audible and / or tactile cue features incorporated into a knob to signal the position of the knob relative to a neutral start or stop position.

[0111] Fig.46 An exemplary handle assembly is shown.

[0112] Fig.47 An exemplary hemostasis valve is shown.

[0113] Fig.48 An exemplary handle assembly with room for bundle slack is shown.

[0114] Figure 49A to Fig.49C Various adaptations for reversibly attaching a medical tool from a steerable shaft are shown.

[0115] Fig.50 An integrated system of a steerable sheath and medical tool is shown, wherein the system is connected to a console via a connector cable.

[0116] Fig.51 An exemplary process of the systems herein and how a console may be connected to control the use and reuse of the systems herein is shown.

[0117] Fig.52 Various expandable atraumatic tip features are shown.

[0118] Fig.53 A portion of an exemplary outer elongated body is shown.

[0119] Fig.54A and Fig.54B A portion of an exemplary inner elongated body is shown.

[0120] Fig.55A A portion of an exemplary medical device including an outer elongated body and an inner elongated body is shown.

[0121] Figures 55B and 55C show the use of Fig.55A Exemplary methods for a medical device in or any other related medical device herein.

[0122] Fig.56 Shows Fig.55A Section AA is shown in FIG.

[0123] Fig.57A and Fig.57B Exemplary handle assemblies that may be used with either of the inner and outer elongated bodies or shafts herein are shown.

[0124] Fig.58A A portion of an exemplary inner elongated body is shown.

[0125] Fig.58B A portion of an exemplary outer elongated body is shown.

[0126] Fig.58C Shown include Fig.58A and Fig.58B A portion of an exemplary medical device having an elongated body.

[0127] Fig.59A A portion of an exemplary handle assembly is shown.

[0128] Fig.59B An exploded view of an exemplary outer elongated body movement subassembly is shown.

[0129] Fig.59C Shows Fig.59AA side cross-sectional view of the handle assembly.

[0130] Fig.60 An exemplary handle assembly including rotation indicators for a first actuator and a second actuator is shown.

[0131] FIG. 61A illustrates an exemplary handle stabilization member.

[0132] 61B illustrates an example handle assembly configured for use with the example handle stabilization member of FIG. 61A. DETAILED DESCRIPTION

[0133] Figure 1A An exemplary embodiment of a system integrating a steering and medical device is shown. System 1000 includes a handle assembly 1002 and a steering and medical device portion 1004. Steering and medical device portion 1004 includes a proximal portion 1006 and a steerable portion 1008. The system is adapted such that handle assembly 1002 can be actuated to cause steering of steerable portion 1008, and optionally can be further actuated to cause movement of medical device 1010 relative to steering and medical device portion 1004. In this exemplary embodiment, handle assembly 1002 includes a first actuator 1001, a second actuator 1003, and a third actuator 1005. First actuator 1001 is adapted to actuate (in this example, rotate) relative to handle body 1007 to cause steering of steerable portion 1008, and in particular, to steer outer sheath 1102. In this embodiment, steerable portion 1008 can be steered or bent to a position in which the steerable portion 1008 is steered or bent to a position in which the steerable portion 1008 is steerable and medical device portion 1004 is moved. Figure 1A The configuration shown in solid lines in FIG. 1 and may also be turned to the configuration shown in dashed lines, or anywhere in between, and in some embodiments, the reverse turning function is limited to only turning the shaft from an initial bent configuration (such as Figure 1A The term "steering" in this disclosure means deflection or bending, optionally via actuation of at least one pull wire, but in some cases, the term may include shaft rotation (torsion) 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 twisted / braided metal wire such as stainless steel or nickel titanium, or it can be composed of a preferably twisted / braided polymer such as aramid fiber. The pull wire is made of polyethylene, ptfe, eptfe, etc., but can also be in monofilament form. In a preferred embodiment, the pull wire is made of an aramid fiber bundle having four 50 denier multifilament (approximately 25 filaments) wires woven together with a high pick count per inch. The cross-sectional diameter of the wire is typically in the range of 0.005" to 0.012", more preferably 0.008" to 0.010", but the braided or twisted wire may be flattened or ovalized in the lumen of the device. It is believed that the preferred construction embodiment provides optimized strength and wear resistance for keeping the shaft diameter to the minimum required size. The optional second actuator 1003 is adapted to actuate (in this example, rotate) relative to the handle body 1007 to cause rotation of the medical tool 1010 relative to the axis 1102 (labeled as rotational movement "R"), and the optional actuator 1005 is adapted to actuate (in this example, axially) 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 anatomical structure in which the proximal portion is used. In many embodiments, 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.

[0134] Figure 1A The illustrated embodiment is an example of an apparatus including an integrated handle assembly that is in operable communication with both a steerable outer shaft and an internal medical tool. The handle assembly is integrated because it is assembled and configured to be in operable communication with the outer shaft and the internal medical tool prior to packaging and use. The term "integrated" when used in the context of an integrated handle assembly refers to a handle assembly in which at least a portion of the handle assembly must be broken or separated before the medical tool can be removed from the outer shaft.

[0135] Figure 1B An exemplary cross section AA (shown in FIG. 1 ) of the steering and device portion 1004, and in particular in the steerable portion 1008, is shown. Figure 1A In this embodiment, the size and configuration of the medical device 1010 are designed to be disposed within a steerable sheath. The steerable sheath includes an outer shaft 1102 and a set of pull wires 1104, which are axially fixed in the distal region of the steerable portion 1008.

[0136] Figure 1A and Figure 1BThe medical tool in the can be, for example, any medical tool herein, such as an ultrasonic tool. When "ultrasound probe" is used herein, it generally refers to an elongated tool that includes at least one ultrasonic transducer and one or more conductive elements that electrically connect the at least one ultrasonic transducer to the proximal region of the elongated tool. The proximal region of the ultrasound probe includes or is modified to include at least one proximal contact that is electrically connected to the at least one ultrasonic transducer and can be placed in electrical communication with electrical contacts on another device, cable, or connector, optionally via electrical contacts attached to the other device, cable, or connector.

[0137] Figure 2 Shows the suitability for Figure 1A and Figure 1B 1 and 2, and further illustrate exemplary internal components of a handle assembly 12 (the internal components are shown as dashed lines). The handle assembly 12 is integrated with and operably connected to an external steerable shaft 20 and a medical tool 30. The handle assembly 12 includes an actuator 14 adapted to cause steering of the steerable shaft 20 when actuated relative to a handle body 15. The actuator 14 is operably connected to the steerable shaft 20 via a steering control 16 disposed in 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 operably connected to the medical tool 30, and actuation (in this example, rotation) of the actuator 13 relative to the handle body 15 causes rotation of the medical tool 30 relative to the external shaft 20 via a rotation control 1215. The optional third actuator 17 is also operably connected to the medical tool 30 and, in this embodiment, is adapted 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 .

[0138] Figure 2 The medical tool in can be, for example, any medical tool described herein, such as an ultrasonic tool.

[0139] Figure 3 and Figure 4 An exemplary embodiment of a system 1200 is shown, wherein the steerable portion may have a Figure 1BThe cross section shown. System 1200 includes a steerable portion 1202 and a medical tool 1204, both of which are configured to interface with each other. The steerable portion 1202 includes a handle portion 1206 and a sheath portion 1208, the sheath portion including a steerable portion 1222. The sheath portion 1208 includes an outer tubular member 1207. The medical tool 1204 includes a handle portion 1210 and a tool portion 1212, the tool portion including at least one shaft and a working distal region at its distal end. The handle portion 1206 includes a steering actuator 1220, which, in this embodiment, is adapted to rotate relative to the handle body 1209 to cause steering of the steerable portion 1222.

[0140] The medical tool 1204 is configured to be advanced through the steerable portion 1202, which are configured to interface with each other. When advanced, the tool portion 1212 of the medical tool 1204 is advanced through the sheath portion 1208 until its distal end is close to the distal end of the sheath portion 1208, and a portion of the handle portion 1210 is advanced distally at the handle portion 1206. The handle portion 1210 of the medical tool 1204 includes a handle 1214 and a stabilizer 1218. The stabilizer 1218 is configured to interface with each other in a secure relationship with the inner portion of the handle portion 1206 to prevent relative movement between them in at least one direction. The handle portion 1210 also includes a nut 1216, which is configured to interface with the proximal end of the handle portion 1206. The stabilizer 1218 acts as an axial constraint of the medical tool 1204 relative to the steerable sheath 1202.

[0141] like Figure 4 As shown, when the medical tool 1204 and the steerable sheath 1202 are stably engaged with each other, the distal working area of ​​the tool portion 1212 extends distally out of the sheath portion 1208. In this embodiment, the distal end of the tool portion 1212 is not axially fixed relative to the distal end of the sheath portion 1208.

[0142] Figure 3 and Figure 4 The medical tool in can be, for example, any medical tool described herein, such as an ultrasonic tool.

[0143] The handle 1214 may optionally include at least one actuator that can cause axial movement and / or rotational movement of the medical device relative to the steerable sheath. Thus, once the tool and sheath are stably engaged, one or more tool handle actuators can control the movement (e.g., rotational movement or axial movement) of the medical tool. The tool and sheath can be engaged after packaging and just before use, or they can be integrated before packaging. The handle 1214 may also include other controls that control the functions of the medical tool.

[0144] 5 and 6 illustrate an exemplary distal region of a steerable system including an internal medical tool. System 1300 includes a steerable sheath 1302 and a medical tool portion 1304. Steerable sheath 1302 includes an outer member 1308 and one or more pull wires 1306, which are fixed to the distal side of the steerable portion and are configured so that when the handle actuator is actuated, they move axially proximally of the steerable portion, which causes their relative axial movement in the steerable portion, thereby causing the steerable portion to be steered (as described above). Pull wire 1306 may be parallel to the central axis in the steerable portion of the sheath.

[0145] In this exemplary embodiment only, tool portion 1304 includes an elongated medical tool 1310 and a guidewire lumen 1312, the elongated medical tool including an RF tip electrode at its distal end, but the medical tool can be any other medical tool herein. In this embodiment, tool 1310 and steerable sheath 1302 are configured so that the distal end of the tool (including the area very close to the distal end) is not able to move axially but can move rotationally relative to the distal end of steerable sheath 1302 (including the area very close to the distal end). In order to make the component not able to move axially but able to move rotationally, outer member 1308 includes an extension 1314, which extends radially inward relative to the inner surface of the outer member 1308 proximal to the extension 1314. Tool 1310 includes an area having an external configuration 1315 (radially inwardly shaped) corresponding to the extension 1314. The two components similarly have forming elements 1317 and 1318 distal to elements 1314 and 1315. When tool and sheath are interlocked as shown in the figure, the configuration of tool and external member therefore prevents tool from moving relative to external member and therefore relative to the distal and proximal side of steerable sheath. In this embodiment, tool 1310 is free or can move relative to steerable sheath rotation. That is, although tool 1310 can not move axially at fixed position (it is at the distal side of steerable part), it can rotate. If medical tool (including one or more instruments thereon) should be oriented in a specific direction or facing a specific direction, then freedom of rotation can be beneficial.

[0146] Because the tool and sheath are axially fixed distal to the steerable portion, the proximal end of the tool is configured to be able to move axially slightly during steering. For example, a spring built into the handle can allow the tool shaft to move slightly relative to the steerable sheath. Other means of allowing proximal axial movement can also be incorporated.

[0147] The proximal end of the system 1300 may include two handle components, such as Figure 3 and Figure 4 The handle components are similar to those shown in the embodiments of the present invention and can be similarly interfaced, except for the moderate axial movement of the tool at the proximal end.

[0148] In other embodiments, the distal region shown in FIGS. 5 and 6 may be Figure 1A or Figure 2 The handle assembly shown is combined.

[0149] One aspect of the present disclosure is a method of rendering two coaxial components that were previously axially movable non-axially movable (axially fixing them). This aspect also includes a method of removing the axial fixation so that the components can be axially moved again. This can be considered a releasable axial fixation. Generally speaking, the axial fixation is formed before the system is pushed into the patient's body, and in some embodiments, the axial fixation is formed during manufacturing. The release of the axial fixation can occur during the renovation process, and the axial fixation can be formed again during the renovation process.

[0150] In some embodiments, the system can be modified to include a component whose volume can be modified (increased or decreased) to cause axial fixation of the medical implement. In some embodiments, the component has a configuration that changes to cause axial fixation of the medical implement.

[0151] In some embodiments, the system 1300 is adapted so that the extension 1314 is configured so that its volume can be modified to induce or release axial fixation. In this particular modification, the fillable annular volume 1319 (shown and labeled only once in the cross section, but it should be understood that it exists on the other side due to its annular configuration) is adapted to be filled with a filler material and so that the filler material can also be removed. In these alternative embodiments, the outer member includes an annular fill volume 1319 defined by a radially outer dashed surface and by a radially inner portion of the aforementioned extension 1314. That is, the extension 1314 is modified to include a fillable annular chamber or volume 1319, but the outer surface of the extension 1314 maintains and defines the fillable annular volume 1319.

[0152] When it is desired to allow the tool 1310 and the sheath 1302 to be relatively axially movable, such as during manufacture of the system, the fillable volume 1319 remains at least partially unfilled so that the tool 1310 can be easily advanced or retracted axially within the sheath 1302. When it is desired to render the tools 1310 and 1302 axially immovable, or fixed (after they are in a desired relative axial position, such as during manufacture or refurbishment), the fillable volume 1319 is filled with a filler material so that the extension extends radially inward and becomes more rigid, thereby preventing axial movement of the tool 1310 relative to the sheath 1302. Thus, the extension in this embodiment is a reconfigurable axial constraint.

[0153] If it is desired to move the tool 1310 and sheath 1302 axially at a later time, such as during refurbishment (e.g., at least one of cleaning and sterilization), the fillable material can be removed from the volume (or chamber) 1319, thereby making the extension less rigid so that the tool 1310 can be moved axially relative to the sheath 1302.

[0154] In these alternative embodiments, the extension 1314 may be considered to be expandable and non-expandable; fillable and non-fillable; reconfigurable; configured and adapted to have a modifiable stiffness; configured so that its stiffness can be modified; and having a modifiable volume.

[0155] In some embodiments, fillable material may be inserted and removed from annular fill volume 1319 using a filling device, such as a needle.

[0156] In one exemplary use, the tool 1310 is advanced axially to the position in FIG6 and then the fill volume 1319 is filled with a fill material to axially secure the tool 1310 and the sheath 1302 (e.g., during manufacturing or refurbishment). The method may also include removing the fill material and axially moving at least one of the tool 1301 and the sheath 1302 (e.g., during refurbishment).

[0157] In an exemplary embodiment, the fill material can be changed from solid to liquid, or vice versa, by changing its temperature. In some embodiments, the fillable (also referred to herein as "fill") material is solid at operating temperature to increase the volume or rigidity of extension 1314, but can be melted (or made less viscous) to allow it to be removed from annular volume 1319.

[0158] In some embodiments, the filler material is wax. In some embodiments, the wax may have a melting point less than the polymer material of an adjacent component, such as an inner member or an outer member.

[0159] This concept of creating axial fixation (and allowing removal of axial fixation) by, for example, adding and removing filler material can be used to axially fix any two components herein, including an outer sheath of a steerable sheath and a medical tool therein.

[0160] Figure 7A to Fig. 7E An exemplary embodiment of a distal region of a sheath portion 1208 of a steerable sheath 1202 in a system 1200 is shown. For simplicity, the cross-section shown only shows the outer sheath 1208 and not the inner tool 1212. The outer sheath 1208 preferably has a composite construction to improve the transmission of torque applied from the proximal end to the exterior of the shaft, or to resist torque forces applied thereto from within the shaft (e.g., from the tool 1212). Figure 7Ai to Figure 7AiAs shown in ii, to form a composite, a plurality of braided elements 1250, preferably formed of metal wires (round, paired rounds, or ribbons) and / or multiple fibers (e.g., aramid or nylon), may be braided directly onto a thin-walled (e.g., 0.0010" ± 0.0005") lubricated liner tube 1251 (such as PTFE or FEP material). A thermoplastic polymer 1252 (such as Pebax with a hardness ranging from 25D to 72D, or nylon, or other common catheter materials) may be laminated using heat shrink tubing (such as FEP) to cause the polymer to reflow over the braided elements 1250 and liner tube 1251 to form a uniform member. The thermoplastic polymer 1252 may also have a radiopaque compound including materials such as bismuth, barium sulfate, or tungsten so that the end of the sheath is visible to the user under fluoroscopy. Figure 7Ai to Figure 7Ai In the embodiment of ii, the pull wire 1104 is preferably parallel to the central passage in the steerable (deflectable) portion 1222 of the sheath, and is also preferably disposed in a lumen 1253 formed in the wall of the steerable sheath 1208. The lumen may be formed with the aid of a removable mandrel during the thermoplastic polymer tubing extrusion process or during the shaft heat lamination fusion process. The pull wire lumen 1253 may be further formed by incorporating a pull wire tube 1254, which is preferably temporarily supported by a removable mandrel, into the wall. During the fusion process, a removable mandrel may also be placed next to the pull wire 1104 or 1104', thereby creating a somewhat ovalized lumen 1253 within which the fiber pull wire may be allowed to flatten, thereby leaving room for free movement of the pull wire. Tube 1254 may include PTFE, FEP, polyimide, or another material that maintains its wall integrity during a heat lamination process of up to about 500°F. The tube is preferably surrounded and supported by a thermoplastic polymer 1252 which is preferably heat laminated against the tube. In another embodiment, the pull wire lumen (preferably including a pull wire tube) is incorporated into the braid of the braid element 1250. For example, braid 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 braid reinforcement provides a more dimensionally stable lumen during catheter manipulation and also helps to ensure the straightness of the lumen as desired. Proximal to the steerable portion, the pull wire may continue proximally parallel to the central axis on the same side of the outer sheath 1208, such as Figure 7Ai to Figure 7Aiii. In this embodiment and other subsequent embodiments, it may be necessary to pass an additional pull wire 1104' within an additional pull wire lumen routed within the wall of the sheath 1208 upward through the steerable portion 1222 to straighten the steerable portion of the device. The straightening pull wire 1104' is preferably routed within the steerable portion 1222 on the opposite side from the pull wire 1104 used for steering (deflection) in the steerable portion 1222. In another embodiment (not shown), two lumens and two straightening pull wires 1104' can be used, essentially making the paired pull wires 1104 configured as mirror images. These straightened wires can also be configured to allow deflection in opposite directions by tensioning a larger distance (more than just straightening) within the handle.

[0161] During use, the portion 1223 of the distal catheter just proximal to the steerable (deflectable) portion 1222 can be forced to conform to the curve based on the constraints of the anatomical structure used. For the specific embodiment of advancing the device from the inguinal channel into the ventricle, it is expected that the length of the portion 1223 forced to be a curve is in the range of 5cm to 25cm. During the rotation of the sheath shaft 1208 from the proximal end, the torque is transmitted to the catheter end through the distal curved region 1223. The uneven cross-section and / or tension of the device in this region 1223 can cause the shaft to accumulate and suddenly release the torque, thereby causing the "jitter" or sudden twitch of the rotation when twisting. In order to minimize the possibility of jitter, it is optional to distribute the tension of the pull wire and the material of construction around the surface of the curved region 1223. In one embodiment, such as shown in Figures 7Bi to 7Biii, the pull wire 1104 can spiral around the central axis of the sheath in at least the curved region 1223 proximal to the portion 1222. The pull wire of this embodiment can form a complete circumferential winding 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 exist in the curved area 1223, and then continue to straighten toward the proximal side through the proximal portion 1224 (similar to 1006), which can minimize the friction in the pull wire lumen and the associated pull wire force required to turn (deflect) the steerable portion 1222. Before continuing to straighten, the spiral can also be performed at least one turn, or the entire length of the shaft can be spiraled. In another embodiment that minimizes jitter, it may only be necessary to distribute the pull wire tension to the opposite side of the shaft. As shown in Figures 7Ci to 7Cii, the deflection of the steerable segment 1222 is achieved using two parallel pull wires 1104 positioned adjacent to each other on the same side of the sheath 1208. In the bend region 1223 and proximal portion 1224 (similar to 1006) proximal to the steerable segment 1222, the pull wires are routed to opposite sides of the shaft, each side at 90° from the position in the steerable segment 1222, to more evenly distribute the tension. Although it is preferred to use a handle actuator to actuate two parallel pull wires simultaneously with equal force, in other embodiments, when the two parallel pull wires are actuated with equal force, different forces may be applied to steer the ends to one side or the other of the formed plane. In other embodiments, any multiple pull wires can be routed in the same configuration as shown in Figure 7B or Figure 7C, where multiple proximal pull wires are evenly distributed around the circumference of the shaft. 7Ci-7Cii, the pull wires 1104 can be routed proximally along opposite sides of the shaft over a majority of the length of the proximal portion 1124 of the shaft, but are preferably pulled back together adjacent to one another near the proximal end portion of the shaft to allow the wires to exit the same side of the proximal shaft together to facilitate securing them together to the handle component for simultaneous actuation of tension.

[0162] Figure 7Di to Figure 7Div shows another embodiment of the distal region of the catheter, which is similar in construction to that previously described, but is alternatively configured to provide a distal steerable portion 1222 that is deflectable in two different directions. As shown, two pairs of pull wires 1105 / 1107 and 1106 / 1108 are along the proximal shaft region 1224 and the bend region 1223. This is similar to Figure 7Ai to Figure 7Ai ii, except that the wires are paired on each side of the shaft. The wiring can also be spiral as in Figures 7Bi to 7Bii, or other configurations discussed. Within the distal steerable portion 1222, the wires are routed at 90° to the proximal portion, but other angles are also contemplated. At a junction 1225 within 1222, one or more of the pull wires (e.g., 1105 and 1107) can terminate and anchor to the shaft, with the remaining pull wires (e.g., 1106 and 1108) continuing to a more distal end position 1226 where they are anchored. This configuration allows independent actuation of the pull wires terminating at 1225 and 1226, so that different shapes can be formed during actuation. Figure 7Dii Both wires 1107 and 1108 are shown being tensioned to form a variable curve in the same direction. Figure 7Diii Lines 1107 and 1106 are shown tensioned to form an "S" curve. Other configurations are possible.

[0163] Pull wires (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 so that they do not break or pull under repeated application of tension. Fig. 7E In the preferred embodiment shown, the pull wires 1104 and 1104' are circumferentially interwoven into the braided wire 1250 (shown without the thermoplastic polymer 1252) of the distal shaft 1222 when leaving the distal pull wire lumen 1253. One or more of the pull wires 1104 or 1104' may also be additionally or alternatively wrapped and / or tied around the outside of the braided wire 1250 for additional fixation. The braided wire 1250 can then be trimmed distally of the fixation point, wherein the interwoven and / or wrapped pull wires prevent the braided wire from expanding and / or unraveling. Additional adhesives such as UV curing or cyanoacrylates may also be used to secure the pull wire to the braided wire. The braid and / or wrap of the pull wire and braided wire is then laminated with a thermoplastic polymer that melts and cools in the space around the wire to secure the wire 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 fluoroscopic fluoroscopy.

[0164] In additional embodiments, the tool 1212 may also or alternatively be configured with one or more pull wires to deflect the tip in a manner similar to any of the aforementioned embodiments 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 conductor within the lumen of the tubular member 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., an arc) so that it bends into that shape when it exits the 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 does not substantially deform the outer sheath 1208 when inside, but allows the outer sheath to bend when exiting. The shape can be set by any one or combination of the following means: heat setting the polymer material, using a movable or fixed shape stylet within the interior lumen of the shaft 1212 or within the lumen of the wall of the shaft 1212. Such a stylet can be circular, oval, or rectangular in cross-section and formed of stainless steel, Nitinol, or a rigid polymer such as PEEK, Vestamid, or the like. The outer steerable sheath can alternatively be made curved using similar methods as described above, with or without additional pull wire deflection, and with or without additional shape or deflection of the distal portion of the tool shaft 1212.

[0165] Figure 8 A system 1400 is shown that includes a medical tool 1204 partially disposed within a steerable sheath 1202. The medical tool 1204 and sheath 1202 can be any of the medical tools and sheaths described herein, even though they are labeled 1204 and 1202. Although the steerable sheath 1202 is preferably "steerable", such as by using a pull wire or other functional deflection mechanism (any of those functional deflection mechanisms set forth herein), it should be understood that the "steerable" sheath (or any steerable sheath herein) can also be non-steerable in that it is simply a straight tubular element, or has a fixed, non-deflectable distal curve shape. With or without the use of a deflection mechanism, steering can also be achieved via twisting the sheath.

[0166] Figure 8The system 1400 shown is designed to have modular components that are provided to the user in an integrated manner, but can be disassembled to clean, repair and / or replace any of the modular components of the system after a procedure using a dedicated process. The system 1400 can then also be reassembled, sterilized and repackaged. This process, or part of this process in some cases, may be referred to as "relocation" or "refurbishment" in this article, and any system herein may be relocated or refurbished using any of the methods herein. The performance of the system 1400 is optimized so that the medical tool 1204 and the sheath 1202 only work together with each other, without replacing other devices that may have similar functions on the market. In addition, the relocation of the device requires special care to ensure the continued safety and performance quality of the system.

[0167] In the following disclosure, many references are made to ways of separating the various modular components of the system by breaking or using a controlled process. According to an embodiment, the handle portion 1960 (see Fig. 9A and Fig. 9B ), rear handle 1961 (see FIG. 11 ) and handle flange 1962 (see Fig. 12A ) can be separated from the handle assembly. The tool lock 1955 (e.g., the shaft 1240 shown in Figures 42 and 43) can be separated from the tool portion 1212 of the medical tool 1204 or from the handle assembly 1206. The tool connector 1210 (see Figure 8 ) or 1990 (see FIG. 13A ), for example, may be separated from tool portion 1212. Hemostatic valve 1950 assembly (see Figure 8 ) can be separated from the handle assembly 1206. The sheath portion 1208 can be separated from the handle assembly 1206. The outer member 2010 of the tool portion 1212 (see Fig. 17B ) can be separated from the internal lead assembly 2011 and its internal electrical connections. Many similar controlled processes and materials can be used to achieve the initial assembly of the components of any of the embodiments herein and the subsequent disassembly and reassembly.

[0168] Any given process or combination of processes can be used at any one or all of the aforementioned modular separation points. The process includes, but is not limited to, the following examples. Components can be bonded using materials that act like adhesives or mechanical locks, but can be deformed by heating to remove components. This includes materials such as waxes and thermoplastic elastomers (to name a few, polyurethane, polyethylene, polyamide). Materials such as hydrogels (such as those previously described herein) can be swollen with aqueous solutions to change their properties so that they soften or become sufficiently lubricated to separate components. Sugar, salt, starch, or other similar materials in the form of crystals or powders can be used to produce mechanical interference fits between components, but then are easily dissolved in aqueous solutions to separate components. These materials can also be used as substrates in non-degradable materials, and once the crystalline structure dissolves, the non-degradable material is compressed like foam. Other polymers known to decompose over time after contact with fluids (such as polymers introduced during use), including those polymers also known in the art as biodegradable, can be used in systems so that they will be forced to be replaced due to their weakening characteristics. Other materials that lose their retention strength in the presence of chemical solvents can be used. Strong acids or bases can be used to dissolve certain metals and plastics. For example, silicone can swell and tear easily in the presence of heptane, hexane, or isopropyl alcohol. In cases where liquid materials are to be dispensed to change the seal, the seal can be protected during use within a protective space that can only be accessed with a special tool, such as a needle-pierced septum or Luer-activated valve.

[0169] Certain parts can be joined using welding or a process similar to welding, in which reheating the solder will separate the parts. In some embodiments, electrolysis can be used to separate metal joints. Mechanical interference can also be used to hold parts (e.g., screws, pins, threads, wedges, etc.) together. Ratchet mechanisms (e.g., cable ties, belt loop styles, roller-wedges, cam-actuated clamps) can also be used to hold parts together, but require manufacturers to approach parts to break and replace, or use tools to temporarily separate parts. Parts can be held in place by magnetic attraction (magnet to magnet or magnet to iron). In a specific embodiment, magnetic retention cannot be released without demagnetizing the magnet. This can be achieved by physically breaking or mechanically fatigued the magnet, raising the temperature of the magnet to its Curie point (e.g., 80°C for neodymium magnets) or applying alternating current to the magnet to destroy the dipole. In another embodiment, the parts can be engaged and held in place by a lock, such as a rod or other capture feature structure (similar to a door lock) that fits into the hole. The rod can be heat set in a curved or hinged structure that is usually engaged in the hole, but when exposed to heat exceeding the transition temperature, it changes shape to exit the hole (allowing the component to be disassembled). In a similar manner, the rod can be magnetized and forced to leave the hole when exposed to a magnetic field. Other similar mechanisms can use coils or other springs or spring-actuated devices that change shape to unlock in the presence of heat or a magnetic field. In another embodiment, the components can be kept together under hydraulic pressure (e.g., water or oil, such as mineral oil or silicone oil), such as a sealed cylinder, bellows, diaphragm, balloon, etc. with a piston. In order to separate the components, the pressure can be discharged by puncturing or otherwise destroying the seal of the pressurized chamber. It is also possible to open or loosen the valve to release the pressure. In many cases, the process for separating the components will also cause them to be contaminated or damaged enough to require replacement, further repair and / or additional cleaning before reassembly and other subsequent processing steps. Any combination of the above exemplary processes can also be used.

[0170] In any embodiment herein, the medical tool may be an ultrasound device having one or more ultrasound transducers disposed at its distal region.For example, the ultrasound device may be an ultrasound imaging device, such as a 4D-ICE (Intracardiac Echocardiography) imaging tool.

[0171] Figure 8 The tool portion 1212 of the medical tool 1204 is shown to be rotatable within and relative to the steerable sheath 1202, and optionally also capable of axial translation within the sheath. Figure 842 and 43 ). A tool lock 1955 disposed within the body of the handle 1206 is secured to the tool portion 1212 and may have one or more functions to constrain movement within the sheath 1202 and / or control the function of the medical tool 1204 (e.g., shaft 1240 in FIGS. 42 and 43 ). In some embodiments that constrain axial movement of the tool 1212 in the proximal direction, the tip of the tool 1212 may be prevented from entering the interior of the sheath where the tool may be rendered inoperative (e.g., if the purpose is to deliver electrical energy to tissue or to send / receive ultrasonic pulses). In other embodiments, a lumen seal may be provided on the tool 1212 just proximal to the functional portion of the distal working end, forming a seal within the lumen when the functional portion is retracted into a specific position within the distal lumen space of the sheath 1208 defined by the proximal retraction limit. In other embodiments where the distal end area of ​​tool 1212 is larger than the ID of the sheath, as shown by tip 1821 in FIG. 13A , the proximal limit can prevent damage to the sheath, other devices, or tissue if the tool tip is retracted against the distal end of sheath portion 1208. The proximal travel limit of tool 1212 provides a slight offset (e.g., 0.5 mm to 3.0 mm) between the proximal end of tip 1821 and the distal end of sheath portion 1208, which can be useful to allow space for irrigated fluid to exit the sheath lumen and / or avoid pinching tissue structures or interventional devices between tip 1821 and sheath 1208 when the tip is pulled back near the distal end of sheath 1208.

[0172] Constraints on the axial movement of the tool 1212 in the distal direction may be necessary to ensure adequate control of the tool 1212. For example, extending too far without distal steering may result in accidental damage to tissue structures by the user, or the tool 1212 may become too soft to be twisted and steered with sufficient precision using the system 1200, thereby limiting its performance. The use of a tool lock 1955 constrained within the handle 1206 to limit axial movement will also have a practical limit on the length of the handle 1206. In view of the above considerations, the optional practical distal extension limit of the tool 1212 resulting from the interaction of the tool lock 1955 in the handle 1206 will be approximately 3 cm. Other embodiments may be considered to be up to 5 cm tool extension. Other configurations are also conceivable, with up to 20 cm extension to track into various anatomical structures using the advantages of a soft tool shaft, or a preformed steerable tool shaft, or a deflectable tool shaft. The elimination of a travel limiter such as tool lock 1955 will limit the travel by the length of the tool shaft that has sufficient clearance to pass within the lumen of sheath portion 1208 . Figure 8Also shown is a hemostatic valve assembly 1950 within the handle portion 1206 , which can be used to prevent leakage of blood or other fluids from the proximal end of the steerable sheath 1202 and allow flushing of the luminal space between the tool 1204 and the interior lumen of the sheath 1202 .

[0173] Fig. 9A and Fig. 9B Another embodiment of the system is shown, in which the handle assembly 1206 includes a removable or breakable handle portion 1960 that can be removed from the handle assembly 1206 or broken from the assembly 1206 to allow access to the interior space of the handle assembly 1206. Once removed or broken, as shown Fig. 9A As shown, the tool lock 1955 provided with the handle assembly 1206 can be accessed. The tool lock 1955 can then be separated from the tool portion 1212, as shown in FIG. Figure 8 A. Once the tool lock 1955 is removed, the tool 1204 can be removed from the sheath 1202, as shown. Fig. 9B shown.

[0174] In some embodiments, handle portion 1960 (and any other handle portion herein that can be removed or broken from the handle assembly) can be configured to interface with a corresponding component of handle assembly 1206 so that it can be stable relative to 1206 when in use, but can be removed from handle 1206 in a controlled manner without breaking the interface between handle 1206 and portion 1960. For example, but not limited to, the two components can have a threaded interface. Alternatively, for example, portion 1960 can be configured so that the interface between it and handle assembly 1206 must be broken, but where the interface is such that its breaking can be performed in a relatively easy and predictable manner.

[0175] One function of the tool lock 1955 is to prevent the medical tool 1204 from being removed from the sheath 1202 to ensure system integrity as previously described. The tool lock also limits axial translation of the medical tool within the handle assembly by being physically constrained within the handle assembly. This may be desirable to ensure that the medical tool does not move axially or that movement is constrained within the safety and functionality of the medical tool beyond the end of the sheath.

[0176] exist Fig. 10A and Fig. 10B In another embodiment shown, both the tool lock 1955 and the handle assembly 1206 can be configured to limit the range of rotation of the medical tool. This may be desirable to prevent the accumulation of torque in one direction, which may cause the outer member 2010 or the inner lead assembly 2011 to twist and damage the portion (see FIG. 17A to FIG. 17C ).

[0177] like Fig. 10A and Fig. 10B As shown, the tool lock 1955 has a feature structure 1956, which in this embodiment is a radial protrusion located on one side, which allows it to be rotated through an angle of less than 360° in either direction. The handle assembly 1206 has a radially inwardly extending protrusion (disposed at the bottom of the figure) that is positioned and configured to engage with the feature structure 1956, and therefore the tool lock 1955 and the medical tool 1212 and stop their movement. Other torque limiters known in the art may also be used, including those that limit torque to a limited number of full rotations in a given direction. Axial travel and torque may also be limited by opposing magnets. When a magnet in the tool lock approaches (via axial or rotational travel) an opposing magnet positioned in the handle portion, resistance is encountered. The rotational limit may be incorporated into any of the systems herein, and the rotational limit is illustrated in FIG. Fig. 10A and Fig. 10B Shown in.

[0178] Figures 42 and 43 show an alternative exemplary medical tool rotation limiting mechanism in the handle. In this embodiment, the rotation limiter is a composite rotation limiter, also disposed proximal to the hemostatic valve, and allows the medical tool shaft to rotate greater than 360 degrees at the location of the rotation limiter within the handle.

[0179] In embodiments including a tool lock, the tool lock rotation and / or axial movement may also have a friction fit with a feature structure within the handle so that it can move, but will not rotate or slide back to the original position except by action by the user. For example, either or both of the outer surface of the tool lock and the inner surface of the handle portion (such as handle portion 1960) may include a lubricating material such as PTFE, FEP, Delrin (acetal). Unless formed from the same material, the mating material may be a smoothly polished polymer or metal. The two components may have a precise gap or interference of, for example, up to 0.0002". Friction may also be controlled by slight interference of a portion of the surface of the tool lock with a portion of the handle portion (such as portion 1960). The interference may be a small integrated feature structure and / or a separate component mounted on an elastic material such as a compressible polymer (silicone, polyurethane, etc.), in solid or foam form, or a metal or rigid polymer spring formed from a coil or flat strip. A slidable wedge may also be used to adjust the compression. The amount of compression interference may also be adjusted at the time of manufacture by a lead screw or pressurized chamber that drives the interfering features together. In During the relocation process, this compression friction interference will need to be disassembled and then reassembled and returned to the manufacturer's settings. In another embodiment, the compression feature structure can be assembled into the handle portion (such as portion 1960) to act directly on the tool portion 1212 without the need for a tool lock feature structure. Although the tool lock is shown as integrated into the tool portion 1212, it can also be integrated directly into the tool handle portion 1210, which will be engaged in the sheath handle portion 1960. This is particularly useful in the case where axial translation of the medical tool 1204 relative to the sheath 1202 is not required.

[0180] Tool lock 1955 may also have an electronic or electromagnetic feature structure that senses the presence of handle portion 1960 (or other handle portions). Once the handle portion (e.g., portion 1960) is removed, the tool lock may deactivate the function of medical tool 1204. For example, the handle portion may include a magnet mounted near the tool lock. The magnet may keep a reed switch closed in the tool lock, which completes a functional circuit in the medical tool. When the magnet is removed together with the handle portion (e.g., portion 1960), the reed switch opens and deactivates the medical tool. Other proximity switches that achieve the same function may also be used. Once the tool lock is removed from the medical tool, the tool lock may also or alternatively deactivate the medical tool function (e.g., as would be required if the medical tool were removed from the sheath). For example, the tool lock may have a direct wired connection to the medical tool (e.g., within tool portion 1212), which is disconnected from the medical tool when the tool is removed. The medical tool may also include a proximity sensor in tool portion 1212, which is deactivated once the medical tool is removed from the sheath. For example, similar to the above, a reed switch that completes a functional circuit in a medical tool may be held closed by a magnet in a tool lock. Removal of the tool lock will then disconnect the reed switch and disable the medical tool. Other proximity sensors known in the art may also be utilized. Replacing the tool lock may re-enable the functionality; however, additional reprogramming of the control tool software may also be necessary to reset the functionality of the medical tool once the software detects a circuit interruption. In a related scenario, removal or breaking of a handle portion (such as portion 1960) may interrupt the circuit within the tool lock, which is sensed by the medical tool and / or more specifically the control tool software. Functionality may then be restored by repair, replacement, or reprogramming of the tool lock and replacement and / or repair of the handle portion (such as portion 1960).

[0181] FIG. 11A and FIG. 11B show another embodiment of a system having a modular feature structure that facilitates the repositioning of the device. In this embodiment, the handle assembly 1506 can be disassembled by removing or breaking the handle rear component 1961 from the remainder of the handle assembly 1506. This allows access to the tool lock (not shown, but it can be any tool lock described herein) and the hemostatic valve assembly 1950. Depending on the configuration of the tool handle, the handle rear 1961 can be removed from the tool in a proximal direction (without removing the tool lock), or the tool lock can be easily accessed to remove the tool lock compared to the previous embodiment in which only the handle portion 1955 is removed. In this configuration, the hemostatic valve assembly 1950 can be accessed to remove and replace the valve assembly. Alternatively, the valve assembly, including any of its individual components, can be removed, disassembled, cleaned, repaired and replaced. Repair can involve only replacing the hemostatic seal 1951 in the assembly 1950. The seal can have a slit silicone or other soft polymer compound known in the art, or any of the seals in the present disclosure. The hemostasis valve assembly preferably includes a Luer fitting 1952 on its distal end so that it can be simply pressed into and out of a mating Luer fitting in the handle.Alternative fittings may also be used.

[0182] The steerable sheath 1202 may also be adapted to allow the sheath portion 1208 to be separated from the handle assembly 1506. Similar to other modular components, this may allow removal for cleaning, repair or replacement. The sheath 1202 may be equipped with a tensile element to deflect the catheter tip. A tensile element similar to these elements is shown as element 1970 in FIG. 11B. One or more tensile elements 1970 are preferably permanently fixed to a fastener 1971, such as by welding, soldering, crimping, swaging or an adhesive / epoxy bonding process. If the ends are potted with an adhesive / epoxy resin, the ends of the tensile element are preferably formed into an enlarged ball, coil, ring or other similar feature structure that is larger than the cross-section of the tensile element itself. Alternatively, the tensile element may be releasably fixed using a set screw or other mechanical fastener. An enlarged welded ball end or a separate tube crimped to the proximal end of the tensile element may help the tensile element 1970 to be mechanically captured in the fastener 1971. Fastener 1971 is configured to act through engagement feature 1972 and is connected to steerable actuator 1520. Engagement feature 1972 includes portions 1972' and 1972", each of which includes threads that are in opposite directions to one another. Actuator 1520 includes double threads that are in opposite directions to one another so that when actuator 1520 is rotated, portions 1972' and 1972" of the engagement feature are driven in opposite directions, thereby causing the steerable segment to deflect in one direction or the other. The fastener may be designed to be easily disconnected and reconnected from the actuator for quick and cost-effective handling during relocation. Alternatively, the tensile element may be removably connected directly to the engagement feature without the use of a fastener.

[0183] Fig. 12A and Fig. 12BAn alternative embodiment of an integrated medical device (e.g., ultrasound) or system 1700 is shown, which includes an integrated handle assembly, a steerable sheath, and a medical tool, and can be reused using any of the methods herein. In system 1700, a handle assembly 1703 is operably connected to a steerable sheath 1702 and a medical tool 1704, and the handle assembly 1703 includes a handle body 1705 having an outer surface positioned to be grasped by a user, a first actuator 1720 adapted to move relative to the handle body 1705, and a second actuator 1780 adapted to move relative to the handle body 1705. The steerable sheath 1702 has a distal deflectable region (not labeled) operably connected to at least one pull wire. In some embodiments, the medical tool 1704 is an elongated ultrasonic device having a distal portion including an ultrasonic transducer, at least a portion of the elongated ultrasonic device is disposed within the steerable sheath 1702, and the elongated ultrasonic device is operably connected to the second actuator 1780. The first actuator 1720 is in operative communication with at least one pull wire such that actuation of the first actuator 1720 relative to the handle body 1705 causes deflection of the distal deflectable region of the steerable sheath 1702 .

[0184] The second actuator 1780 is adapted to rotate relative to the handle body 1705 and is also adapted to move axially relative to the handle body 1705. The second actuator 1780 is in operative communication with the elongated medical device 1704 such that axial movement of the second actuator relative to the handle body 1705 causes axial movement (distal and proximal) of the elongated medical device 1704 relative to the distal end of the steerable sheath, and such that rotation of the second actuator 1780 relative to the handle body 1705 causes rotation of the elongated medical device 1704 relative to the distal end of the steerable sheath, as in Fig. 12A and Fig. 12B Shown in FIG. 1 as a rotational movement “R”.

[0185] If the tool is an ultrasound imaging tool, axial movement of the tool relative to the sheath is generally desirable because it improves the probe's ability to image larger areas of the body after the probe has been steered to a particular position and allows the operator to more easily fine-tune the field of view once the probe has been steered to a roughly workable position.

[0186] The system 1700 also includes an optional tool lock 1755. The tool lock 1755 is included within the handle assembly 1703 but is coupled to the second actuator 1780. The tool lock 1755 and the second actuator 1780 may, for example, be equipped with magnets to engage with each other. Alternatively, one of the components may include iron and the other component may include a magnet. The tool lock 1755 is securely and releasably coupled to the tool portion 1712 of the medical tool 1704. Advancing the second actuator 1780 distally or retracting the second actuator 1780 proximally moves the tool lock 1755 distally or proximally, respectively. The resulting axial movement of the actuator tool 1755 causes axial movement of the medical tool 1704. Similarly, rotation of the second actuator 1780 relative to the handle body 1705 causes rotation of the tool lock 1755, which causes rotation of the medical tool 1704 (in Fig. 12A and Fig. 12B 1762). In this embodiment, the axial movement of the tool (relative to the sheath) and its rotational movement (relative to the sheath) are limited to a fixed range of motion. In one embodiment, in order to remove the medical tool 1704 from the steerable sheath 1702 (such as during refurbishment), the rear lip 1762 of the handle can be removed or broken to remove the tool lock 1755 (and the remainder of the tool portion 1712) from the handle 1706. In addition, the second actuator 1780 can be disconnected from the tool lock 1755. This may require a custom clamp to pry the connected units apart, or the use of special tools to demagnetize or otherwise change the polarity of the external connector or tool lock (at least temporarily). As previously described, the tool lock may include a feature structure for deactivating the tool function when the magnet or other proximity controller is removed. The rear lip 1762 is an exemplary and optional component, and the handle assembly may have different components.

[0187] Figure 13Ai to Figure 13Aii to Fig. 13C An embodiment of the system is shown in which a medical tool 1204 (which may also be any other medical tool herein) includes a plurality of electrical contacts 1992. Figures 13Ai and 13Aii show the disassembled components. Figures 13Bi and 13Bii show the tool portion 1212 loaded back into the sheath portion 1208. Fig. 13CA proximal tool connector 1990 (which may be attached directly or indirectly to an energy console) is shown connected to a tool portion 1212 such that the tool portion 1212 is in electrical communication with the connector 1990. The tool portion 1212 is assembled on the proximal end using a plurality of mating electrical contacts 1992. The tool 1204 includes a distal working end 1821 (e.g., an ultrasound imaging tool) having a diameter greater than the lumen of the tool portion 1212, which is illustrated in FIG. 13Bii. In this embodiment, the outer dimensions of the tool portion 1212 and the electrical contacts 1992 are sized to pass through the lumen of the sheath portion 1208, but the distal working end 1821 is too large to pass through the lumen. Therefore, assembly of the tool through the sheath portion 1208 requires that the proximal end of the tool portion 1212 be advanced past the distal end of the sheath and advanced proximally until the electrode leaves the proximal end of the sheath handle 1206. This construction helps to reduce the outer dimensions of the sheath portion 1208 so that it is not necessarily larger than the distal working end 1821. In certain uses, the distal working end may need to be at a maximum allowable size to accommodate electronic components and their connections, or in certain applications, to minimize the density of current or acoustic energy to minimize overheating or cavitation of tissue. The proximal electrical contacts 1992 can be discrete conductive surfaces (e.g., disks, rods, bars, balls, etc.), or circumferential or partially circumferential rings. In preferred embodiments, the contacts are formed from exposed conductive material of an otherwise insulated flexible circuit (e.g., an insulator is not disposed over the exposed conductive material). The mating contacts 1991 in the connector can be similarly designed to make contact. The contact surface can be annular or flat, and is preferably spring loaded or otherwise mechanically compressed for secure contact. Figures 13A to 13B are schematically illustrated in Figures 13C to 13D. Fig. 13C The handle assembly in the present invention can be any of the handle assemblies in the present invention; the steerable sheath can be any of the steerable sheaths in the present invention; and the medical tool can be any of the medical tools in the present invention. The front loading assembly can be used during assembly of any system in the present invention.

[0188] FIG. 14A to FIG. 14C An exemplary proximal portion of the system is shown, and can be the proximal portion of any of the systems described herein. Fig.14A As shown, the proximal contact 1992 of the medical tool can be pressure-fitted into the connector 1990 against the contact 1991. Alternatively, as shown in FIG. Fig. 14B As shown, connector 1990' may be adapted to open until it receives contact 1991 before it clamps down over contact 1991, as shown in FIG. Fig. 14C1212. The connector 1990' may be sealed with a seal 1995 during manufacture. The seal 1995 may include, but is not limited to, a hydrogel, wax, a silicone ring or gasket, or other devices and combinations previously described in the present disclosure. In order to relocate the device, the connector 1990' contacts must be broken or carefully disassembled to remove the shaft of the tool 1212 in the distal direction through a sheath (such as a steerable sheath). Removal of the seal 1995 may be accomplished by heating and melting wax or other meltable substances, dissolving dry materials in an aqueous solution, and / or swelling silicone with heptane or a similar chemical compound.

[0189] FIG. 15A to FIG. 15B Shows something like FIG. 14A to FIG. 14C 1900', except that the connector 1990' includes an internal feature structure 2000 designed to stably interface with and enclose a tool lock 1955 attached to the tool portion 1212. Fig.15A The system is shown just before connector 1990" is connected to tool portion 1212, and Fig. 15B The completed connection is shown. Although the tool lock 1955 is shown as being just distal to the proximal tool contact 1992, it may also be configured to be located on the proximal side of the contact, with the corresponding internal feature structure 2000 being located proximal to the connector contact 1991. As previously described, the tool lock may include a feature structure for deactivating the tool function when the magnet or other proximity controller is removed. In this embodiment, the deactivation feature structure may alternatively be built into the connector 1990", particularly within the internal feature structure 2000, where the circuit connection leading to the cable back to the console depends on the state of the deactivation feature structure. Assembly and disassembly of the portion of the connector including the feature structure 2000 can be achieved by the means previously described for the connector 1990 in Figure 15, the handle portion of Figure 9, or the rear handle of Figure 11. FIG. 15A to FIG. 15B The handle assembly in the invention may be any one of the handle assemblies described herein; the steerable sheath may be any one of the steerable sheaths described herein; and the medical tool may be any one of the medical tools described herein.

[0190] exist Fig.15A and Fig. 15B In a variation of the embodiment of FIG. 13A to FIG. 13B , assembly of tool 1212 may require “post-loading” of tool 1212 through the distal end of steerable sheath portion 1208, as shown in FIG. Fig. 13C In an embodiment, the outer dimensions of the tool and the electrical contacts are sized to pass through the lumen of the sheath portion, but the distal working end may not pass through. Fig.15A and Fig. 15BIn this embodiment, the tool lock must be assembled after the tool is rear-loaded. During relocation, the tool lock will need to be removed to remove the tool 1212 from the sheath portion 1208 and repaired and / or replaced after cleaning and re-reloading the tool 1212 through the sheath portion 1208. In an alternative version of this embodiment, the tool 1212 can be assembled by insertion of the "front-loaded" distal tip through the proximal handle end of the sheath 1202. Fig.15A and Fig. 15B In this alternative embodiment, the tool lock 1955 does not necessarily need to be removable from the tool 1212.

[0191] like FIG. 15A to FIG. 15B As shown, the clamping action of the internal feature 2000 on the tool lock 1955 causes the two features to mechanically engage so that axial translation and torque can be transmitted from the connector 1990" to the tool 1212. This can provide a user with a more convenient means of grasping the tool 1212 to manipulate its position relative to the sheath 1202.

[0192] like Fig.16 As shown in the exemplary system of FIG. 1 , a separate torque device 2005 may be attached to the tool 1212 to provide the ability to translate and torque the tool 1212 relative to the sheath 1202 similar to that described above, but need not be connected to the connector 1990, as previously described in Fig.15A and Fig. 15B The torque device 2005 may also be engaged over the tool lock 1955 to provide enhanced mechanical engagement. The torque device 2005 may also be used for purposes similar to the internal feature 2000 in that the tool function is dependent upon the presence of the torque device 2005. As previously described in FIGS. 13A to 13B , Fig. 13C As described in the embodiments of the present invention, the torque device can be assembled to the tool 1212 so that it is impossible to remove the tool 1212 from the sheath 1202 without destroying the torque device and / or the tool 1212, or without using a customized relocation process to remove the torque device. Fig.16 The handle assembly in the invention may be any one of the handle assemblies described herein; the steerable sheath may be any one of the steerable sheaths described herein; and the medical tool may be any one of the medical tools described herein.

[0193] FIG. 17A to FIG. 17CThe embodiment of the present invention shows an exemplary medical tool, wherein the tool portion 1212 includes an outer member 2010 and an inner lead assembly 2011. The inner lead assembly also includes a distal working end 1821 and a proximal electrical contact 1992. As part of the relocation process, the outer member 2010 can be assembled and disassembled from the inner lead assembly. The outer member 2010 can be a tubular structure capable of transmitting torque via, for example, a braided composite structure. Using the process previously described in the present disclosure, the outer member 2010 is reversibly sealed and fixed to the inner lead assembly at positions 2015 and 2013. Fig. 17B Shows Fig.17A A larger view of the surround area in . Fig. 17C The inner lead assembly 2011 , the distal working end, and the proximal end are shown removed from the outer member 2010 . FIG. 17A to FIG. 17C The handle assembly in the invention may be any one of the handle assemblies described herein; the steerable sheath may be any one of the steerable sheaths described herein; and the medical tool may be any one of the medical tools described herein.

[0194] The disclosure below generally relates to electrical connectors and contacts in medical devices, and optionally to ultrasound probes if not otherwise specified. The disclosure below can be applied to any of the systems or aspects of the systems herein. The electrical connectors, contacts, devices, and methods can be integrated into any of the above systems, such as, but not limited to, the handle assembly in FIG. 12 .

[0195] One aspect of the present disclosure includes methods of separating at least a portion of a system from other components, optionally as part of a relocation process. In some embodiments, the medical tool includes one or more electrical contacts coupled to other electrical contacts, the one or more electrical contacts being in electrical communication with an energy console, and examples of consoles are known in the art of ultrasound.

[0196] Fig.18 Only a portion of an exemplary medical tool is shown, such as an ultrasound probe, which may be electrically coupled directly or indirectly to an energy console, such as an ultrasound console.

[0197] Fig.18 The embodiment shown can be used in the same manner as in FIG. 13A to FIG. Fig. 13CThe embodiment shown is used in a conceptually similar manner, in that repositioning the device involves disconnecting one or more proximal electrical contacts and moving the tool portion distally out of the distal end of the sheath portion. In this embodiment, 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 ultrasonic transducer), and a conductor bundle 2020. The conductor bundle 2020 extends from the distal working end 1821 through the tool outer member 2010 to the proximal connector (for clarity, the connector and handle mechanism are not shown in FIG. 1 ). Fig.18 ). In some embodiments, the medical tool is used for ultrasound imaging, optionally wherein the distal working end 1821 comprises a two-dimensional (2D) array of piezoelectric components mounted on an ASIC (application specific integrated circuit).

[0198] Fig.19 Only an exemplary proximal end of a medical device is shown (the medical device is shown on the right), and in this embodiment, 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 adapted to be electrically coupled directly or indirectly to an energy console, such as an ultrasound energy console. Fig.19 As shown, a conductor bundle 2020 extends from a distal region of the medical tool (the distal region is not shown) to a proximal connector 2015, in which a rigid or flexible printed circuit board ("PCB") 2030 is housed. The connector bundle 2020 includes a plurality of contacts 2024 (examples of which are described below) attached to PCB board contacts 2031. Each individual trace from each contact 2031 is connected to an individual exposed contact 2050 on another portion of the PCB (optionally closer to the PCB). The individual PCB traces may also pass through other available circuits on the PCB. The exposed contacts 2050 are constructed to mechanically mate 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 a user interface console. The proximal connector 2015 may be incorporated into any of the systems, handles, steerable sheaths, medical tools, etc., herein, such as Fig. 12A and Fig. 12B shown.

[0199] Fig. 20A and Fig. 20B An exemplary conductor strip (also referred to herein as a flex circuit strip) 2021 is shown that may be included in any of the conductor bundles herein. Fig. 20A and Fig. 20B The embodiment may include Fig.18 and Fig.19 Example of a conductor strip in a bundle 2020. Fig. 20A and Fig. 20B The embodiments in may be incorporated into any other system described herein.

[0200] like Fig. 20A , Fig. 20B and Figure 20G As shown, the conductor bundle 2020 includes a plurality of flexible circuit strips, including a multi-trace strip 2021, and a conductive strip 2022 for grounding and a conductive strip 2023 for shielding (only a portion of which is shown). Each multi-trace strip includes a plurality of conductive traces 2025, which can be Fig. 20B , Fig. 20C and Fig.20D Clearly seen in. FIG. 20D to FIG. 20G The number of traces 2025 in is twelve, and FIG. 20A to FIG. 20C The number of traces in is sixteen, and both are exemplary with respect to the number of traces 2025 that may be used. Each strip 2021 may be approximately 0.072" wide and 0.0022" thick, and may optionally include sixteen 0.0022" wide x approximately 0.0007" thick conductive (e.g., copper) traces, each spaced approximately 0.0022" apart. The traces are disposed on an insulating substrate layer 2027, such as a polyimide substrate, and the traces may 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 material. The cover layer typically extends along a majority of the bundle, except at discrete locations in the proximal and distal regions for electrical connection. In other embodiments, the strip 2021 is approximately 0.055" wide and includes twelve conductive traces (see FIG. 20D to FIG. 20G ). In other embodiments, strip 2021 is approximately 0.037" wide and includes eight copper conductive traces. The outer strip 2022 for grounding and the outer strip 2023 for shielding can have similar construction and dimensions, except that they can include a single full-width copper strip. As optimized for a 2D piezoelectric array, approximately seven stacks of 16-trace strips 2021 (or nine 12-trace strips, or fourteen 8-trace strips) would be required, with each of the strips 2022 and 2023 located on each side of the stack of multi-trace strips. FIG. 20E shows a portion of an exemplary bundle 2020 having nine strips 2021 stacked together. FIG. 20F shows a portion of a bundle including the stack of nine strips 2021, as well as the ground strip 2022 and the shield strip 2023 (only the top ones are labeled). The complete bundle can optionally be secured with, for example but not limited to, approximately 0.001" wall thickness shrink tubing (such as Figure 20G The flex circuit dimensions and number of traces discussed above are for a particular configuration of a piezoelectric array (and / or its ASIC controller) and may vary depending on the number and size of array elements optimized for a particular application.

[0201] The proximal end of each flex circuit strip has conductive material (e.g., gold-plated copper) exposed over a length of approximately, for example, 3 mm by removing cover layer 2026 at location 2024. Location 2024 and the other exposed locations described herein are generally referred to as "contacts." It should be understood that when used in this context, a contact actually includes a plurality of separate conductive traces (such as shown in the area locations), each conductive trace being adapted to be in electrical communication with its own corresponding conductive element. Thus, a "contact" is not limited to meaning only a single electrical connection between two conductive elements. Although Fig. 20A Multiple exposed areas 2024 are shown, but Fig. 20A The embodiment in will first be described herein as if there is only one exposed area (i.e., area 2024 at the proximal end). Strip 2021 can be made to form an electrical connection with a mating exposed contact 2031 for a conductive trace on a PCB 2030, which is FIG. 20A to FIG. 20C In some embodiments, sixteen individual traces sized and spaced to mate with the sixteen traces in multi-trace bar 2021 are provided within a given contact 2031. ACF (anisotropic conductive film), soldering, conductive adhesives, mechanical connections, or any combination of these may be used to achieve a suitable electrical connection (electrical coupling) between the bar traces and the PCB contacts.

[0202] like Fig.21A and Fig. 21B As shown, a plurality of flexible circuit strips (not all shown) preferably have staggered lengths so that exposed locations 2024 (each strip having an exposed location 2024 at its proximal end) are attached to a PCB 2030 at contacts 2031 arranged at similar staggered lengths. One or more of the arrays (preferably linear arrays) of contacts 2031 may all be on one side of the PCB, or a second array (or arrays) 2031' (see Fig. 21B ) may be disposed on the underside of the PCB. Those on the other side of the PCB may allow exposed areas 2024 of other strips to be attached to the other side of the PCB, thereby creating more space and connection options.

[0203] As part of any of the relocation processes described herein, the strip-to-PCB connection may be disconnected to allow the entire tool portion 1212, including the now disconnected conductor bundle 2020 (disconnected from the PCB), to be moved to the next location. Fig. 21CThe tool portion 1212 is removed from the distal end of the sheath portion 1208 by sliding in the direction of the arrow shown, as shown. Once removed, the exterior of the tool portion 1212 and at least the inner and outer surfaces of the sheath portion 1208 can be cleaned and decontaminated. Then, the tool portion 1212 can be loaded toward the proximal side by the sheath portion 1208 until the distal working end 1821 is properly seated relative to the distal end of the sheath portion 1208, as described in more detail herein. The proximal ends of the strips 2021, 2022, and 2023 are then reattached to the exposed contacts 2031 and 2031', which can be the same contacts or different contacts. In the case of ACF bonding, the same ACF material can be used and / or it can be cleaned and a new ACF material can be applied before bonding. The connection integrity and ultrasonic performance can then be tested to verify acceptable performance. This relocation process can be used for any of the systems herein.

[0204] One aspect of the present disclosure is a method for disassembling a system that has been exposed to a subject's bodily fluid (e.g., exposed to a blood environment, esophagus, etc.), the system comprising a medical tool such as an ultrasound probe, a steerable shaft, and a handle assembly. The method may include providing a handle assembly, a steerable sheath that has been exposed to a subject's bodily fluid environment, and an ultrasound probe that has been exposed to a subject's bodily fluid environment, the handle assembly being operably connected to the steerable sheath and the ultrasound probe, the handle assembly comprising a handle body having an outer surface that can be grasped by a user, a first actuator adapted to move relative to the handle body, and a second actuator adapted to move relative to the handle body, the steerable sheath having a distal deflectable region operably connected to at least one pull wire, wherein the first actuator is operably connected to the pull wire so that actuation of the first actuator relative to the handle body causes deflection of the distal deflectable region, and wherein the second actuator is adapted to rotate relative to the handle body and also adapted to move axially relative to the handle body, and wherein the second actuator is operably connected to the ultrasound probe so that axial movement of the second actuator relative to the handle body causes the ultrasound probe to move relative to the steerable Axial movement of the distal end of the sheath, and rotation of the second actuator relative to the handle body causes rotation of the ultrasound probe relative to the distal end of the steerable sheath, the ultrasound probe having a distal portion including an ultrasound transducer, the distal portion extending further distally than the distal end of the steerable sheath and having an outer dimension greater than the dimension of a lumen of the steerable sheath in which the probe is disposed, the ultrasound probe also comprising a flexible circuit strip, the flexible circuit strip comprising an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of each of the plurality of conductive traces being covered by an insulating member, and a portion of the plurality of conductive traces not being covered by the insulating member, the portions of the plurality of conductive traces not covered by the second insulating layer defining probe contacts, the probe contacts being electrically connected to electrical contacts on a printed circuit board, wherein the printed circuit board or any one of the printed circuit boards herein may be a flexible circuit board. Fig. 12A and Fig. 12B An exemplary system that can be used in the method is shown in . The "providing" step above (or in any other method herein) simply requires that the system be available for the following method steps, and does not require the action of providing or giving the system to another person or entity. Thus, in this context, a system that simply sits on a countertop has been "provided."

[0205] The method of disassembly also includes electrically disconnecting the probe contacts from the electrical contacts on the printed circuit board, as described herein.

[0206] The method of disassembly also optionally includes moving the ultrasound probe distally relative to the steerable sheath and away from the distal end of the steerable sheath, such as Fig. 21C shown.

[0207] The method of disassembling may also optionally include (but need not necessarily include) cleaning at least a portion of the ultrasound probe, which includes an area of ​​the ultrasound probe that does not extend out of the sheath and is optionally disposed within the handle assembly prior to the moving step. Fig. 12A and Fig. 12B In the embodiment, a portion of the medical device is disposed within the handle assembly.

[0208] The method of disassembling may also optionally include (but need not necessarily include) electrically coupling the probe contacts to either the printed circuit board or a different printed circuit board at some time after the optional cleaning step.

[0209] The method of disassembling may also include (and indeed may require) releasing the ultrasound probe from releasably fixed engagement with a handle assembly component at some time prior to the moving step. In some embodiments, the ultrasound probe will not be removable from the handle assembly without first being removed from the handle assembly. Releasing the ultrasound probe from releasably fixed engagement with a handle assembly component may include releasing the probe from releasably fixed engagement with a handle assembly component that is directly or indirectly operably connected to the second actuator. For example, Fig. 12A A medical device is shown releasably secured to a handle assembly component 1755, which in this embodiment is depicted as a tool lock. The method of disassembly may include releasing the ultrasound probe from releasably secured engagement with the tool lock 1755 prior to the moving step, which in this embodiment is also an example of a handle assembly component capable of being directly or indirectly operatively connected to the second actuator 1780.

[0210] In some embodiments herein, the ultrasound probe and handle assembly are adapted to allow the probe to be moved axially (towards the distal side and toward the proximal side) relative to the sheath. Bodily fluids such as blood may enter the space between the probe and the sheath, so it is necessary to clean the probe, which is usually relatively expensive, before reusing it. In some embodiments, the distal end of the ultrasound probe has an outermost dimension that is larger than the distal end of the steerable sheath. This may be desirable as a way to minimize the footprint of the sheath in the patient. After the probe has been used and exposed to bodily fluids, the probe cannot therefore be retracted proximally within the sheath and relative to the sheath to disassemble the probe from the sheath. The probe must then be removed distally relative to the sheath and from the sheath in order to reuse the probe. Since the probe is attached to a certain type of connector (e.g., directly or indirectly attached to an ultrasound console) at its proximal end, the probe must first be disconnected from electrical communication with the connector before moving the probe distally relative to the sheath.

[0211] In an alternative embodiment, it may be more efficient and / or reliable not to reattach the original exposed location 2024 of the conductive strip 2021 (and, if necessary, 2022 and 2023) during the relocation process. Fig. 20A and Fig. 20B As shown, each strip 2021 may be provided with a plurality of exposed locations 2024, 2024', 2024", etc. (optionally each about 3 mm in length) staggered in a distal direction along the length of the strip. Thus, the original location 2024 and segments of layer 2026 may be trimmed away or removed using other techniques, and the next most proximal location 2024' may be used for new connection attachment. This process may also be repeated for future relocation processes until all exposed locations have been used. This will also serve to limit the number of times the device is reused. The exposed but unused locations on the strip may also be protected until ready for use with, for example, a peel-off insulating low-tack adhesive strip. In other embodiments, the protective layer may be a paste, adhesive, or cured polymer having sufficient dielectric properties and compliance to insulate adjacent exposed conductors within a given strip. The material is preferably reversibly adhered so that it can be easily peeled off or dissolved from the exposed conductor without damaging the conductor. In some embodiments, the covering layer provided on the trace may be ablated away (e.g., using a laser, sandblasting, or sanding) to reveal an exposed area of ​​the trace, which may then be used as a contact location.

[0212] exist Fig. 20A and Fig. 20B In some alternative embodiments shown, the strip may first be attached with the only exposed area being the proximal-most area 2024, and with the cover layer 2026 extending distally without any interruption in the layer 2026. After the first use, the area 2024 may be removed. To expose another conductive area, a portion of the now proximal end of the layer 2026 may be removed, such as by ablation, or if the layer 2026 is a peel-away segment, it may be peeled away. After each use, the process may be repeated as needed to form a new exposed conductive area.

[0213] In other embodiments, an intermediate strip-to-strip ACF bonding location may be formed between the PCB and the location where the strip leaves the proximal shaft. This location may be disassembled / rebonded instead of the strip-to-PCB location. The strip-to-strip ACF bonding location just within the catheter shaft proximal to the ultrasonic transducer may also be the location where disassembly / rebonding occurs during the relocation process. As described above, multiple discrete areas on the flexible strip on each side of the original bonding location may have exposed conductor areas for rebonding after the original ACF bond joint is disassembled and trimmed off during the relocation process. In addition, as described above, the exposed areas may be protected until needed for use.

[0214] In embodiments where the flex circuit strip is trimmed or removed using any suitable technique to attach the next exposed element of the flex circuit strip to the PCB, it may be necessary to advance the strip forward to establish an electrical connection. This may be difficult or impossible if the strip is confined within a tube and is not movable within the tube, or otherwise securely contained, up to the PCB. Fig. 22 As shown in the exemplary embodiment of , to allow for additional length to be advanced relative to the tube, a conductor bundle 2020 (which may be the same as the bundle 2020 herein or a different bundle) may be reversibly rolled or wound around a reel 2035 comprising a rod, tube, spindle or similar rotatable structure to a length suitable for pushing out all exposed elements. Before winding, the conductor bundle may first pass through a narrow slot that passes transversely through the central axis, or the bundle may be wound from one end of the outer surface of the reel to the other end. Thus, after trimming off a contact group, the conductor is unwound from the reel to form the next set of connections on the PCB 2030. The reel preferably has a central axis that can be mounted on the distal end of the PCB or in a mechanism that is just distal to the board and is fixed in the proximal connector 2015. The reel may also be used to protect the connection with the PCB from being tightened due to tension or torsional forces applied to the flexible conductor bundle. To prevent premature unwinding, the reel may be equipped with a keying feature structure that is reversibly connected to the PCB or other locations within the proximal connector or connector housing itself.

[0215] To allow access to the PCB 2030 and the reel 2035 (if applicable), the proximal connector (e.g., the proximal connector 2015) may be equipped with a removable housing having a custom design for its mating with other portions of the connector and / or PCB 2030 and / or reel 2035. Optionally, to completely remove the housing would require destroying the housing, rendering it inoperative and requiring replacement before continued use.

[0216] Distal to the reel, the conductor bundle 2020 is optionally irreversibly secured within the tool outer member 2010. The tool outer member 2010 preferably also extends proximally of the handle 1206. To allow the assembly of the tool outer member 2010 and the conductor bundle to be removed from the handle 1206 and the sheath portion 1208 after the flex circuit is disconnected from the PCB, the assembly is preferably slidable within any tubular connection line between the handle 1206 and the proximal connector 2015. Reversible seals similar to those previously described herein may also be used between the tool outer member 2010 and the tubular connection line.

[0217] If removing the original connections to the PCB at connector 2031 compromises the integrity of those connections, the PCB may include multiple arrays of redundant connectors 2031', 2031", etc., to which connections may be made with each relocation cycle of the device.

[0218] In another embodiment, the PCB may simply be replaced with a new, identical PCB to which the exposed ends 2024 (or 2024', etc.) of the flex circuit strips may be attached.

[0219] Fig.23 Another embodiment is shown in which an exposed flex circuit end (2024 or 2024') can be attached to a disposable micro PCB element 2040 having the same connector 2031 on one side, but having a larger exposed connector 2041 on the opposite side, connected by traces in the micro PCB, suitable for reusable mechanical connection to the PCB 2030. The mechanical connection from the connector 2041 on the micro PCB 2040 is made against the matching exposed mechanical connector 2042 on the PCB 2030. A spring clip or other suitable retaining mechanism can be integrated into the PCB to hold the micro PCB contacts against those on the PCB. Each individual trace from each contact 2042 is connected to an individual exposed contact 2050 on another part of the PCB (preferably closer to the PCB). The individual PCB traces can also pass through other available circuits on the PCB. The exposed contacts 2050 are configured to mechanically mate with similar contacts 2060 on a mating connector cable (e.g., cable 2070) for electrical conduction, which mating connector cable connects the medical tool to the console. During the relocation process, the micro-PCB can be loosened from the PCB and the flex circuit disengaged or untied from the micro-PCB (as previously described). After removal, cleaning, and reassembly of the tool in the sheath, the flex circuit can then be reattached to a new micro-PCB, which is reconnected to the original PCB.

[0220] The construction of the medical tool 1212 can be optimized to minimize the diameter and provide the best torque response of the distal working end (e.g., working end 1812). In some embodiments, the flexible circuit is routed through the internal lumen of the tool member 2010, similar to Fig. 17B shown.

[0221] exist Fig.24In another embodiment shown, it may be desirable to have multiple intermediate flexible extension strips 2026 bonded to each main flex strip 2021. Using the example of FIG. 20 , these intermediate extension strips 2026 are bonded at locations 2024', 2024", 2024'", etc. during manufacturing to form new extension bond locations 2027', 2027", 2027'", etc. The multiple strips 2026 can be folded and releasably secured against the original flexure 2021 with tubing, coils, strips, etc. until ready for use. During the relocation process, the original attached extension (location 2024) is cut away from the PCB and the next extension (e.g., including attachment location 2027') is bonded to the PCB. Fig.24 In , the PCB can be replaced whenever the attachment is cut. Fig.25 In the embodiment of the present invention, the PCB can be designed with redundant attachment locations 2031 to allow the attachment of the next flexure without interfering with the attachment of the trimmed original. This may be desirable if the removal of the original results in an open circuit or a crossed circuit connection. The unattached end of each extension strip can also be equipped with a Fig.23 The micro PCB 2040. FIG. 26A to FIG. 26F shows how the deflection changes as each section is trimmed off at each relocation cycle, where Fig.26A shows the original attachment, Fig.26B shows the second use, etc. Fig.26F A sixth use is shown. Since the purpose of trimming the flexures is to remove them through the outer sheath 1202 with tool 1212, each stack of redundant extensions may need to be staggered longitudinally to facilitate removal, such as FIG. 27A to FIG. 27G Shown (only in Fig.27A The staggered lengths between the stacks may be compressed within the connector or the attachment between the connector and the handle until extension is permitted for removal.

[0222] FIG. 28 shows a cross section of a bundle stack 2020 within a member 2010. In this embodiment, the approximately 0.072" width of the flex circuit bundle is optimized for the width of the ASIC to which the piezoelectric components are mounted. Taking into account the shrink tubing around the stack, the stack dimensions are approximately 0.028" thick x 0.085" wide. The internal lumen of the tool member 2010 will require an internal dimension of approximately 0.089" in at least one dimension. This dimension then drives the external dimensions of the member 2010, which also affects the internal and external dimensions of the sheath portion 1208.

[0223] While the conductor bundle 2020 may be simply routed through the circular interior lumen of the tool member 2010, as shown in FIG28, alternatively, it may be constrained within a non-circular lumen, such as shown in FIG29. In this configuration, an additional "D" lumen is also provided so that an additional rigidifier 2100 may be added to create a more uniform bending stiffness in various directions so that the stiffness along the long axis of the conductor bundle 2020 does not dominate the axial stiffness. This will serve to minimize "jitter" or sudden twitches in the torque response when the tool member 2010 is twisted.

[0224] Fig.30 An embodiment similar to that shown in FIG. 29 is shown in which lumens of different sizes are provided to receive rigid members 2101 and 2102. These can also be used to create uniform bending stiffness. Tool member 2010 is preferably constructed with an outer braid of wires and / or fibers with a jacket of a thermoplastic polymer (e.g., Pebax with a hardness ranging from 25D to 72D or other suitable catheter materials known in the art).

[0225] Fig.31 The embodiment shows a "D" shaped member 2103 applied to either side of the flexible circuit bundle 2020. This forms a uniform circular member that can be held in place with a thin wall (approximately 0.001" thick) heat shrink tubing. In one embodiment, the assembly can then be inserted into the tool member shaft 2010. In another embodiment, the tool member shaft can be constructed directly around the conductor bundle. For example, to improve torque response and minimize the size of the tool 1212, multiple fibers and / or wires (round or ribbon) can be directly braided onto the conductor bundle 2020. A polymer jacket (such as pebax or other common catheter material with a durometer ranging from 25D to 72D) can be laminated by heat to cause the polymer to reflow over the entire braid to form a uniform member. A polymer layer similar to the jacket can also be laminated over the conductor bundle prior to braiding to improve the reflow penetration of the polymer into the braid during heat lamination.

[0226] For Figures 28 to Fig.31 In an embodiment of the present invention, the lumen space between the conductor bundle and the inner diameter of the shaft 2010 can be used to route a pull wire that is used to steer the tool 1212 independently of the steerable sheath 1202. The reinforcement itself can be used as a pull wire, or replaced with a more traditional pull wire (e.g., round and / or flat stainless steel or nitinol, or a cable braid of these materials). The pull wire can be fixed at the distal end of the shaft 2010 and actuated in a manner similar to other embodiments described herein.

[0227] In an alternative embodiment, if Fig.32As shown and illustrated in an exemplary bundle 2020, each flex circuit strip can be made of approximately half the number of traces, and therefore has approximately half the width (approximately 0.037" wide). For the specific embodiment described above, this requires doubling the number of multi-trace circuits to approximately 14. This, combined with the grounding and shielding flex circuits, forms a stack of approximately 17 flex circuits. The resulting width and height are more uniform, approaching 0.042" each through heat shrinking. This allows the space within the lumen of component 2010 to be used more efficiently and improves the consistency of torque response. As described with respect to Fig.31 As described above, the stack can be inserted into a tubular shaft or a shaft around which a braid and jacket are constructed. Fig.32 Other configurations are contemplated between those shown, thereby optimizing the transducer assembly. For example, the width of the flex bundle with heat shrink may be limited to approximately 0.068", with a stack of 13 flex circuits being approximately 0.031" thick.

[0228] In another embodiment, the grounding and / or shielding strips are replaced by separate braids or windings of conductor wires (individually insulated or uninsulated) around the flexible multi-trace flex circuit bundle. If the grounding conductor and the shielding conductor are not insulated, an insulating polymer layer can be added between the braids of the grounding conductor and the shielding conductor. The conductor braid can be provided in addition to or in place of the braid of fibers and / or wires / tapes. One or more tubes coated with a metal or conductive polymer (e.g., polyurethane with silver particles) can be applied around the bundle. In some embodiments, the tube can be heat shrinkable. The insulated conductors can also be woven into a braid of fibers and / or wires / tapes in the shaft of the tool 1212 or the wall of the shaft 1208 to optimize the torque response of the tool 1212 or the shaft 1208 and minimize the number of braids.

[0229] In another embodiment, the conductor bundle 2010 may be twisted to provide a more balanced cross section along most of the length of the tool 1212. The twisted bundle may be twisted by securing the ends of a given portion of the bundle and twisting in opposite directions, or the bundle may be wrapped around a mandrel, removing the mandrel, and pulling the bundle onto itself. A full twist of 2 + / - 1 cm is considered optimal, but other tighter or looser wrapping pitches may be considered depending on the thickness of the bundle and the robustness of the conductors. The bundle is preferably only at the portion of the tool shaft 1212 that will be drawn from the outer shaft 1208 (such as in FIG. 7A to FIG. 7B ). Fig. 7E The shaft portion 1222 in any one of the two is twisted in the portion that experiences deflection. The conductor bundle can extend straight in the distal few centimeters to facilitate connection to the distal working end 1821.

[0230] In another embodiment, a separate flexible circuit strip may be wound around the outer dimensions of the elongated central core member. The core may be a solid or tubular construction of a polymer or metal, or a composite braid. The winding may be a set of parallel strips in one layer, but may also be wound in multiple layers. Preferably, the layers are wound in alternating directions to optimize the torque of the unit. The winding strips are preferably laminated against the central core with a polymer jacket. In other embodiments, the interior of the jacket may have a loose gap with the conductor strip to allow some bending movement for stress relief of the strip. A braid may also be provided on the jacket after the second jacket is laminated on the braid. Similar to the above embodiments, the grounding conductor and / or the shielding conductor may be replaced with a braided conductor or a wound conductor. In another embodiment, the stack of flexible strips may be jacketed as previously described and then twisted in a given direction to provide a smaller bias for bending within the lumen of the shaft 2010. The jacketed stack may also be formed into an accordion-like shape within the lumen to improve the ability of the stack to flex by bending of the distal portion of the device, thereby minimizing the possibility of conductor rupture. The torsional or accordion-like shape may be necessary only in the distal portion of the tool 1212 where flexing is likely to occur.

[0231] As previously described, a medical tool (e.g., any of the tools 1212 herein) can be advanced and rotated within the outer shaft, such as shown in the example of FIG. 7. A limiter in the handle can control the amount of axial travel and rotational travel. Preferably, the tip (e.g., 1821 or 1822 in FIG. 13A) attached to the distal end of the tool 1212 is Figure 33 to Figure 3 5) is limited to a maximum of 3 cm in distal advancement, although greater distances may of course be employed. Similarly, rotation of tool 1212 is preferably constrained to approximately 180 degrees in either a clockwise or counterclockwise direction from a neutral starting position. Limiting the rotation of the tip prevents continuous rotation of the tool, and any resulting "winding" of the conductor therein, which can cause damage to the conductor. In the case where the tip includes an ultrasound transducer imaging perpendicular to the central axis of the medical tool, the user will only need to rotate up to a total of approximately 360 degrees to find the desired imaging window. Rotation of the proximal end of the medical tool may be required to exceed 360 degrees (180 degrees in either direction), such as 380 degrees, to overcome torque losses along the length of the shaft so that the tip can achieve the desired rotation. Depending on the user's preference, a greater total rotation may be considered, such as a total of 540 degrees or 720 degrees.

[0232] like Fig.19As shown, tool 1212 may have a connector 2015 that is typically connected to a connector cable 2070 during operation. Proximal to central axis 1240, where it is bonded to tool shaft 1210 (of tool 1212), conductor bundle 2020, either alone when it leaves the proximal end of tool shaft 1210, or when still contained within tool shaft 1210, is contained in a space that allows sufficient slack in bundle 2020 to translate or rotate relative to the space in which it is contained. Fig.48 As shown, the accommodation space 1241 or slack area can be defined by the volume within the handle 1206. The slack area can also be set within the volume of the connector housing proximal to the handle, or within the volume of the strain relief tubing connecting the handle 1206 and the connector 2015. Since the connected connectors 2015 and 2070 are restricted from moving during operation of the device, the translation and rotation of the tool 1212 in the space between the handle 1206 and the connector 2015 must be accommodated. This slack can be accommodated by creating a scanning coil of the bundle 2020 with or without the shaft 1210, so that it can be rotatably wound or unwound, and axially translated back and forth. In another embodiment, the shaft 2010 located in the slack area can be made of a highly compliant material or composite structure that allows it to stretch or easily flex relative to the conductor bundle 2020. Additional compliance of the conductor bundle 2020 itself can be created by creating a conductor structure similar to a sine or accordion in the slack area. To better accommodate axial translation, the conductor may be folded back on itself in an "S" shape a few centimeters (for example) to accommodate the translation.

[0233] Fig.33 A medical device tool 1204 is shown having a tool portion 1212 that can slide within a distal sheath 1208. The tool is preferably an ultrasound imaging device having an imaging tip 3000 that includes an imaging transducer 3005. The imaging tip 3000 is preferably larger than the shaft 1212 and also includes a tip key 3010 located on its proximal edge that is intended to be inserted into a mating sheath key 3020 located on the distal end of the sheath 1208. Fig.33As shown, the end key 3010 is inserted into the sheath key 3020, but the opposite is also contemplated. The mating key allows the orientation of the transducer 3005 to match the key and any other features connected to the sheath 1208 (e.g., steering direction, handle knob orientation, etc.). The key also helps to connect the transmission of torque to the end 3000 between the sheath 1208 and the tool 1212. In one embodiment, sufficient clearance can be provided between the keys so that the end key 3010 can be easily retracted into the sheath key 3020 and pushed away from the sheath key. In other embodiments, the key can be connected by a slight friction fit. In other embodiments, the feature structure on the key can provide automatic locking when engaged, with a mechanical or electromechanical actuator that allows the key to be unlocked by returning to the proximal handle. The key can be formed into an "L" shape or similar shape, which allows a "twist-lock" engagement after being joined together in the axial direction. The mechanical unlocking of the key can be further bound to a circuit including an encryption key that is required to unlock the tool 1212 and advance the tool forward relative to the shaft 1208. In another embodiment, encryption is directly controlled via a cryptographic chip located with the end 3000, preferably in the same circuit that affects the performance of the transducer 3005. In one embodiment, the key may be formed of a conductive material (e.g., platinum or gold) having a separate conductor leading back to the connector through its corresponding shaft. The conductive link may be connected to an authentication circuit that ensures that a given internal tool is properly matched to the external sheath. It can also be used to provide user feedback about the position of the probe (e.g., a visual indicator tilts up on the handle when the key is engaged and the circuit is completed). The keys 3010 and 3020 may also include magnets of opposite polarity for positive axial engagement and rotational alignment. In certain magnet embodiments, the alignment of the magnetic poles may be sufficient to eliminate the need for mechanical (e.g., convex / concave) engagement of the keys. In certain embodiments, the keys may be made of an annular end key material 3011 and a sheath key end material 3021 that are easily bonded to the end and shaft, respectively. The key 3010 / 3011 or 3020 / 3021 is preferably formed of a rigid machined or molded plastic (e.g., polycarbonate, peek, epoxy, etc., as known in the art), or a metal (e.g., stainless steel, platinum, iridium, tungsten, etc.), a rare earth magnet (e.g., neodymium, samarium cobalt, etc.), or any combination thereof. To allow fluoroscopic visualization, such material may itself be radiopaque, or contain a radiopaque filler, such as barium sulfate, tantalum, tungsten, etc.

[0234] Fig.34 Shown with Fig.33A similar embodiment, except that the key 3030 is disposed on the tip 3000 which is raised relative to the surrounding tip surface. The raised portion may be along the entire length of the tip 3000, or only proximal to the transducer 3005, or taper in height anywhere from the proximal edge of the tip 3000 to more distally. Where the raised portion continues above the transducer 3005, the transducer is preferably aligned to form an imaging plane or volume 3006 in a direction opposite to the direction of the raised key feature. The tip 3000 with the key 3030 is designed to pass through the lumen of the shaft 1208 only by providing an additional internal space 3040 that allows the key 3030 to pass through. When aligned in the internal space 3040, the key 3030 does not allow the tip 3030 to rotate freely within the lumen of the shaft 1208. Fig.35A In FIG. 1 , key 3030 is formed as a living hinge 3031 that can be compressed during insertion through shaft 1208 but then automatically pops out upon exiting the shaft. Fig.35B In the embodiment of the present invention, key 3030 is formed with a proximal extension 3032 having a feature 3033 directed radially inwardly to engage with a sheath receptacle 3035. Engagement occurs after tip 3000 is pushed out of sheath 1208 and then retracted against the tip. Rotation of tip 3000 may be required to engage 3033 into 3035.

[0235] FIG. 36A shows another embodiment of a system 1200 including a steerable sheath 1202 including a sheath handle 1206 and a medical tool 1204. A tool 1212 is slidable within the sheath shaft 1208. Actuation of the sheath steering actuator causes the steerable shaft portion 1222 to deflect. The user can also rotate the sheath body 1208 by rotating the handle shell 1206'. Since the tool 1212 enters the sheath portion 1208 at the proximal end of the sheath (preferably via the hemostatic valve 1950 mounted on the proximal end of the steerable sheath), the tool knob 1230 must be in operable communication with an attachment point on the tool 1212 proximal to the proximal end of the sheath shaft 1208 and the hemostatic valve 1950. Preferably, the tool 1212 is equipped with a tip 3000, such as would be adapted to include an imaging transducer as previously described. As shown in FIG. 36B , axial advancement and rotation of the medical tool (shown in FIG. 36B ) is achieved by actuation of a tool knob 1230, which is located just distal to the steering actuator 1220. The distal tool knob 1230 eliminates the need to manipulate the tool 1212 from a position proximal to the handle, such as Figure 8 12, wherein the tool 1212 is manipulated by grasping the tool handle / connector 1210 or the tool shaft 1212 itself.

[0236] Positioning the tool knob 1230 just distal to the steering actuator 1220 helps keep the two controls adjacent to each other to minimize the need for the operator to adjust their hand position and allow for one-handed use. In a preferred embodiment, distal advancement of the tool knob 1230 (as indicated by the distal-to-proximal straight movement arrow) may be limited to 3 cm to facilitate a single movement of the finger without changing the hand's grip. For some users, up to 5 cm may be preferred. Other longer distances are also conceivable and may be selected based on the desired application. Upon full proximal displacement of the tool knob, it may be desirable for the user to provide a viewing gap, e.g., 1 mm to 5 mm, between the tool knob 1230 and the steering actuator 1220 so that the finger has room to reach behind the knob before advancing the knob in the distal direction. As Figure 3 As shown in B6, the diameters of knobs 1220 and 1230 are similar. It is contemplated that the diameters, shapes, lengths, and / or textures of knobs 1220 and 1230 may be differentiated so that a user can intuitively differentiate between them without looking directly at them (such as when the user's attention is maintained on a screen showing the fluoroscopic and / or ultrasound position of the device in the body).

[0237] FIG. 37A shows an embodiment of system 1200, wherein the upper half of handle shell 1206' is removed to visualize the internal components. Steering actuator 1220 can rotate, which drives a pull wire (not shown) to leave near the proximal end of shaft 1208 (just distal to hemostatic valve assembly 1950). In some embodiments, the pull wire can leave the shaft and be routed distally, and then wrapped around the barrel 1221 (see FIG. 38A) of actuator 1220. In another embodiment, the actuator barrel can be composed of a cam, lead screw, or ramp that drives a longitudinal rod or shaft attached to the pull wire to actuate the pull wire in an axial direction. FIG. 38A and FIG. 38B show examples of longitudinal movement mechanisms as described above. In FIG. 38A, handle shell 1206' has been removed to show the actuation mechanism. The steering actuator 1220 drives one or more rods 1403 that travel along an axis parallel to the longitudinal axis of the outer shaft 1208 (i.e., aligned in the distal / proximal direction). One or more pull wires may be attached to each rod 1403. As the rod 1403 travels distally and proximally, the pull wire 1104 shifts, causing the pull wire to tighten or loosen, thereby increasing or decreasing the deflection of 1222. In FIG. 38B, portions of the handle have been removed or segmented to show the concentric spiral ramps 1408 on the inner surface of the actuator 1220 on which the rods 1403 ride. The concentric ramps may be opposite or similar in direction. The ramps may also vary in pitch.

[0238] Figure 39A to Fig.39EAn alternative steering mechanism embodiment is shown, which may also be referred to herein as a control system. In FIG. 39A , the handle housing 1206 ′ has been removed to show the actuation mechanism. The steering actuator 1220 is rotated to drive the rotation of one or more spindles 1400 (in this embodiment, there are two). Fig.39C As shown, the internal gear teeth 1404 on 1220 cooperate with the external gear teeth 1405 at the distal end of the main shaft 1400 to drive the rotation of the main shaft 1400, as shown in Figures 39B and Fig.39C Note that FIG. 39B is shown rotated 90° about the longitudinal axis relative to FIG. 39A and that some components have been segmented or removed to better visualize the internal mechanism. Fig.39D A pull wire 1104 is shown exiting from the proximal end of the steerable shaft 1208 and subsequently secured to the main shaft such that actuation of the actuator 1220 causes tensioning / relaxation of the pull wire.

[0239] FIG. 40A to FIG. 40B A similar but alternative steering mechanism embodiment is shown in which an external gear tooth 1404' coupled to the steering actuator 1220 is provided instead of Fig.39C Internal gear teeth 1404 are shown. External gear teeth 1404' engage external gear teeth 1405 located at the distal end of the main shaft 1400. Other features of the system may be any of the embodiments described herein.

[0240] like Fig.39D and Fig.39E As shown, when the actuator 1220 rotates, the pull wire 1104 is wound onto or off the reel 1407 disposed at the proximal end of the main shaft 1400. The mechanical advantage and steering accuracy can be increased or decreased by increasing or decreasing the diameter of the outer gear 1405 and / or the reel 1407 of the main shaft 1400. For example, Fig.39D The embodiment shown has Fig.40B The embodiments shown have different mechanical advantages. In the exemplary example, as Fig.39D One full rotation of the knob 1220 shown will displace the pull wire 1104 by, for example, 3.59 inches, while Fig.40B One full rotation of the knob 1220 as shown will displace the pull wire 1104 only 0.60 inches.

[0241] like Fig.39D and Fig.39E As shown, distal and proximal spindle supports 1401, 1402 maintain the mating gear engagement of the actuator 1220 and spindle 1400. Spindle supports 1401 and 1402 also hold spindle 1400 fixed in place while still allowing actuator 1220, knob shaft 1231, and spindle 1400 to rotate axially.

[0242] Fig.39D , Fig.39E and Fig.40B The pull wire 1104 is shown routed starting at the point where it exits the outer deflection shaft 1208. The pull wire 1104 exits the shaft 1208 and is routed through the proximal spindle support 1402. Fig.39D As shown, a large radius bearing surface is integrated into the spindle support 1402 to limit wear on the cable as it passes around a 90 degree turn. The radius is oriented to start approximately tangential to the cable's exit point from the shaft to minimize any loading as the cable leaves the shaft away from the cable's central axis. Fig.40B As shown, the large radius bearing surface is provided by a locating pin 1402' incorporated into the spindle support 1402. In another embodiment (not shown), the bearing surface can be a pulley that rotates on its own spindle as the pull wire is advanced around the wheel surface. The bearing surface can be made of polished metal or low friction polymers known in the art, including but not limited to Delrin, polyethylene or Teflon. In these embodiments, two pull wires are wound on one reel and one pull wire is wound on another reel. Alternative embodiments may have more or fewer pull wires, reels and spindles. Alternative embodiments may have more than two pull wires wound on reels.

[0243] The above described embodiments of the steerable sheath control may be incorporated into any of the handles and systems herein, and may be integrated with any of the medical implement control mechanisms herein.

[0244] The handle assembly herein is further adapted to allow actuation of the tool, such as rotation and axial movement.Some embodiments herein include a distal actuator that controls a medical tool, and a handle mechanism that allows the control to extend further proximally than the proximal end of the steerable sheath and the valve.

[0245] FIG. 37B shows an exemplary handle 1206 with half of the handle housing 1206' and the actuator 1220 removed to show how the tool actuator 1230 is in operative communication with the proximal tool portion 1212. In this embodiment, the knob 1230 is attached to a knob shaft 1231, which drives a distal central gear 1235 (in operative communication therewith). The distal central gear 1235 is coupled to a distal lateral gear 1236 (in operative communication therewith), which drives a lateral shaft 1237, which in turn drives a proximal lateral gear 1238. The proximal lateral gear is coupled to a proximal central gear 1239 (in operative communication therewith) which drives a proximal central shaft 1240. The tool portion 1212 is bonded within the shaft 1240. The handle 1206 is designed so that the tool drive assembly (components 1230-1240) can slide axially as a unit in the distal / proximal direction (double arrows in FIG. 37B ) to advance and retract the tool 1212 in the axial direction. The knob shaft 1231 and distal center gear 1235 are adapted to rotate freely around the outside of the outer shaft 1208 of the steerable shaft extending proximally within the handle until it is attached to the hemostatic valve assembly 1950. The length of the lateral shaft 1237 allows the knob assembly to translate axially around the fixed position of the hemostatic valve assembly 1950, which is disposed at the proximal end of the steerable shaft. FIG. 37B shows two lateral gears and shafts to provide symmetry and balance to the mechanism; however, the assembly can be configured with a single lateral gear mechanism, or more gears around the inner circumference of the handle. The gears are shown as having a tooth engagement mechanism, but tensioned friction band mechanisms and other devices known in the art are also contemplated. The steering actuator 1220 and / or the knob 1230 employed may also be coupled to a friction mechanism to maintain the position of the pull wire or tool shaft until further actuated. Compression o-ring or gasket seals, low friction bearings, etc., with a constant interference force or with mechanisms to increase and decrease the locking force by means known in the art are contemplated. Removal and replacement of such seals and bearing surfaces may also be necessary as part of the relocation process.

[0246] Any of the tool control mechanisms herein may be integrated with any of the steerable shaft control mechanisms herein.

[0247] Fig.42A and Fig.42B ( Fig.42B1206) shows the components critical to tool steering that are constrained by the handle housing 1206. For clarity, the steerable axes and controls are not included or labeled. The tool steering components constrained by 1206 include those identified by the following reference numerals: 1240, 1414, 1413, 1239, 1238, 1237, 1236, and 1235. The tool control axis 1231 is indirectly constrained by the handle housing 1206, but is critical to the function of tool rotation and will be referenced in this section. Fig.42A Only the tool turning components, restrained by 1206, are shown in their assembled state. Fig.42B The exploded view shows Fig.42A 1238 and 1239, which helps to illustrate how the components fit within the handle shell 1206. The central shaft 1240 and attached gear 1239 are constrained by the spacer 1414, tool rotation limiters 1413 and 1238, and guide 1515 of the handle shell 1206. The central shaft 1240 and gear 1239 are constrained to allow rotation and translation around and along the axis of the central shaft 1240. The central shaft 1240 is free to rotate until its rotation is blocked, as described herein with respect to the rotation limiter. The spacer 1414 and limiter 1413 interface with and are constrained by a wall 1511 having a recess therein and a wall 1512 having a recess therein, which are integrally formed as part of the handle shell 1206 so that they can only rotate around their central axis and not axially. The walls 1511 and 1512 can be considered to be part of the "guide" of the handle body, as that term is used herein. The lateral shaft 1237 and attached gears 1238 and 1236 are constrained by handle housing walls 1513, 1514, 1516, and 1517, which provide bearing surfaces that allow the lateral shaft 1237 and attached gears 1236 and 1238 to rotate about their central axes and translate axially along their central axes. Walls 1513 and 1514 are part of the proximal guide in the proximal portion of the body 1206, and walls 1516 and 1517 are part of the distal guide in the distal portion of the body 1206, with both guides radially aligned and extending along the length of the body 1206 with their axes parallel to the axis of the handle. Even though the walls are marked only on one side, the walls and guides are integrated into both sides of the handle body. The handle housing walls 1513, 1514, 1516 and 1517 are also configured to keep gear 1238 engaged with mating gear 1239 and keep gear 1236 engaged with gear 1235, while still freely rotating about their respective axes and axially translating along their respective axes. These walls and guides (optionally integral to the handle body, as shown in this embodiment) allow the medical tool to be moved axially and rotated by actuating only the tool knob 1230.

[0248] The guides defined by walls 1513 / 1514 and 1516 / 1517 are orthogonal to the guides defined by walls 1511 / 1512.

[0249] The central shaft 1240 is an example of a tool lock, as the phrase is used herein, such as with reference to Figure 8 .

[0250] The length "L", width "W", and height "H" dimensions that may be used to describe one or more components in any of the embodiments herein are also labeled. The length is generally measured in a proximal-distal direction that is orthogonal to both the width W and the height H. The length L dimension may be considered to be measured in a direction parallel to the longitudinal axis of the handle assembly and / or shaft portion of the system. The width versus height graph is not intended to apply to the views in the figures, it is simply to illustrate the orthogonal nature of the width and height dimensions.

[0251] As previously described herein, such as reference Fig. 10B , which limits the rotation of the tool. FIG. 43A to FIG. 43C An alternative embodiment of a medical tool actuator rotation limiter is shown that allows limited total rotation beyond 360 degrees. FIG. 43A to FIG. 43C Shown in Fig.42A and Fig.42B A rotation limiting component in an embodiment of the present invention. Fig.43A is a cross-sectional view, Fig.43B 43 is a perspective view showing only a portion of the system, and 43C is a side view showing the interaction of the handle and shell. Fig.43B (assembled, 1413 segments) and Fig.42B As shown in (exploded), the embodiment includes a limiter 1413 and a first spacer and a second spacer 1414 positioned at the distal and proximal sides of the limiter 1413, respectively. Each spacer 1414 is formed with an internal keyway 1414' (see Fig.43B ), which internal keyway allows it to slide axially on and rotate with a protruding key feature structure 1415 (similar to the concept of the key feature structure 1956 previously described) which is integrated into the central shaft 1240 (similar to the concept of the tool lock 1955 previously described). The spacer 1414 is also formed with an inner radial lip 1414", which extends axially within the inner diameter of the limiter 1413, thereby providing uniform support for the limiter 1413, thereby allowing it to rotate freely on the central shaft 1240. Fig.43AThe assembly is shown disposed in the handle housing 1206', with the end of the figure shown as a cross section through the limiter 1413. When the actuator knob 1230 is rotated, the rotation is translated to the central axis 1240 through the lateral axis 1237. The actuator knob 1230, the shaft 1240 and the key feature 1415 will rotate freely until the key 1415 contacts the internal nub feature 1416 on the rotation limiter 1413 (see Fig.43A and Fig.43B ). The actuator knob 1230, shaft 1240 and limiter 1413 will rotate freely until two external nub features 1417 on the limiter 1413 contact an internal limiter 1418 integrated into the handle shell 1206'. Two spacers 1414 keep the limiter 1413 concentric with the shaft 1240. Importantly, the proximal compound rotation limiter is also adapted to allow axial translation of the shaft 1240, which is important for allowing axial movement of the medical tool. The degree of rotation allowed can be adjusted by increasing or decreasing the position and / or circumferential extent of one or more of the nub features 1415, 1416, 1417 and 1418. Additional radially nested rings and nubs may also be added to compound the number of rotations allowed. In other embodiments, the nubs may be additionally or alternatively formed in the axial direction to allow compound rotation by adding an engagement ring in the axial direction. For clarity, Fig.43C A side view of some of the components of the system are shown, including limiter 1413 and limiter 1418 integrated into the handle shell.

[0252] Fig.43A Also shown is the direction H in which the height of any one of the components is measured, such as the height of rotation stop 1418 . Fig.43B Also shown is the direction W in which the width of any one of the components is measured and the length L in which the length is measured.

[0253] FIG. 44A to FIG. 44CA deflection actuator knob rotation limiter 1408 is shown for limiting rotation when the actuator 1220 is actuated, which operates similarly to the rotation limiter of a medical tool. The composite rotation limiter allows the deflection actuator knob 1220 to rotate greater than 360 degrees before hitting the rotation limiter hard stop. When the actuator knob 1220 is turned, the convex nub feature 1409 rotates with the actuator knob. The actuator knob 1220 and the convex nub feature 1409 will rotate freely until 1409 contacts the internal convex nub feature 1410 on the rotation limiter 1408. The actuator knob 1220 and the convex nub 1408 will rotate freely until the two external convex nub features 1411 contact the internal convex nub feature 1412 on the handle shell 1206'. The degree of rotation can be adjusted by increasing or decreasing the location and / or circumferential width of one or more of the nub features 1409, 1410, 1411, and 1412. Additional radially nested rings and nubs can also be added to compound the number of revolutions allowed. In other embodiments, nubs can be formed additionally or alternatively in the axial direction to allow for compounding rotation by adding engagement rings in the axial direction.

[0254] Fig.44B and Fig.41 Washers 1406 and 1406' are shown, which add friction to eliminate unwanted rotation or translation of the actuator knob when the handle is not held or used and is pushed. The controlled compression of the washer 1406 between the deflection actuator knob 1220 and the shell 1206' provides friction to prevent the knob 1220 from loosening after rotation. The washer 1406' adds a similar controlled compression friction tool 1212 coupled to the probe actuator knob 1230. It is noted that the washer 1406' can be the same seal used in the hemostatic valve 1950.

[0255] Other embodiments for controlling the friction of the probe actuator knob 1230 may include a means of controlling the friction of a central shaft 1240 coupled to the probe actuator knob 1230. The central shaft 1240 is an example of a tool lock, such as the tool lock 1955 described previously, and the friction control of the tool lock 1955 described previously applies to the central shaft 1240 and the interface between the deflection actuator 1220 and the housing 1206'.

[0256] The actuators controlling the steerable shaft and the medical tool (e.g., knob 1230 and deflection actuator knob 1220) can be provided with features that allow the user to intuitively understand the relationship between the two. When the system 1200 is provided to the user, the steerable sheath 1202 is straight, which means that the deflection actuator 1220 is in a preferred neutral or home position that does not apply tension to the one or more pull wires 1104. Similarly, the tool knob 1230 is in a neutral or home position, where the tip attached to the distal end of the medical tool is in a position set during manufacturing. For example, the tool knob 1230 may be pulled from its original position to the distal end (or slightly offset therefrom) of the deflection knob 1220 and rotated to a given position such that the proximal end of the tip (e.g., tip 3000) abuts the distal end (or slightly offset therefrom) of the sheath portion 1208, and also such that the transducer (if part of the device) is, by way of example only, in a rotational position such that the active surface points opposite the deflection direction of the sheath portion 1208. A mechanical stop (similar to the tool lock 1955) of the proximal central shaft 1240 (to which the proximal end of the medical tool is attached) abuts a feature in the handle shell 1206' or other component in the handle, providing a desired proximal retraction offset (e.g., 0.5 mm to 3.0 mm) between the proximal end of the tip of the medical tool and the distal end of the sheath 1208, as well as an extended distal travel limit for the tool 1212 and tip. The communication of the original position of the tool knob 1230 and the deflection knob 1220 relative to the fixed handle body (more specifically, the handle shell 1206') can be communicated with visual features, such as markings and / or raised or recessed features on each knob 1220 and 1230 and on the exterior of the handle shell 1206'. In an exemplary embodiment, these visual features are all aligned when in the original position. The raised or recessed markings also provide the user with tactile cues about the relative position of the knobs. As shown in Figure 45A and the highlighted views in Figure 45B, where the knob 1220 is segmented for clarity, a combination of an auditory cue feature 1525 and / or a tactile cue feature 1526 can be incorporated into the knob 1220 to signal the position of the knob 1220 relative to the neutral start position or stop position. For example, when the free end of the cantilever 1525 moves upward onto another feature structure 1526 that moves relative to it (or in other embodiments, moves downward into it), the cantilever can be allowed to flex or articulate relative to its attachment point. When the features 1525 and 1526 interact, the movement produces an audible and or vibratory "snap" or "click". The audible / tactile feature structure can be built into either the tool knob 1230 or the deflection actuator knob 1220. In another embodiment, the cantilever 1525 can also be coupled against a feature structure that moves within the handle shell, such as Fig.40A37B , or rotating gear teeth 1235, 1236, 1238, and / or 1239. The actuation speed of the auditory / tactile sense may be continuous, or engage only after a certain range of motion, or accelerate or decelerate as a limit is approached. In the latter example, an embodiment may include an increased density of features such as 1526 against which the cantilever 1525 contacts.

[0257] As described above, in a related embodiment, the medical tool is bonded within the proximal central shaft 1240. This is an embodiment similar to the functionality of the tool lock described herein. Specifically, it is beneficial to provide a way to reversibly attach the proximal central shaft 1240 (similar to the tool lock 1955) so that the tool portion 1212 can be released from the shaft 1240. This release allows the tool portion 1212 to be advanced beyond its normal operating advancement limit, or to be completely removed. Advancing beyond the normal limit can be beneficial for cleaning or repairing the tool portion 1212, especially for the distal end, without completely removing the shaft (which requires disconnecting the connection between the flexible bundle 2020 and the PCB 2030 as described herein). For example, the distal end of the tool portion 1212 may have a lubricating coating applied to the shaft over a certain length (for example, but not limited to, 3 cm to 15 cm, preferably 10 cm), which is worn away and / or contaminated by body fluids during the use of the device. In order to properly clean the shaft during the relocation process, it may be necessary to remove and reapply the coating. Advancing the shaft distally approximately 12 cm (preferably, in this example) will allow physical access to the exterior of the distal tool portion (previously inaccessible within the distal end of the outer shaft 1208) for cleaning and repair. Sufficient slack may be provided in the proximal conductor bundle to allow advancement of the tool portion 1212. In other examples, the distal portion of the tool 1212 may have other features attached thereto, such as an O-ring seal, a keyway, or a swellable hydrogel that occupies a lumen space between the tool 1212 and the interior lumen of the shaft 1208 that will not be accessible for cleaning and repair / replacement during the relocation process without the tool 1212 being advanced beyond its normal operating extension limit. Release of the tool 1212 from the central shaft 1240 also provides for complete removal of the inner shaft, provided that the flex bundle 2020 is disconnected from one or more PCBs 2030, as shown. FIG. 20A to FIG. 20C described.

[0258] In another embodiment, the proximal portion of the steerable shaft 1208 proximal to where it will enter the introducer sheath inserted into the patient can have an enlarged inner and outer diameters that will receive the enlarged outer diameter of the proximal end of the tool 1212 (particularly the portion that is enlarged to release it from the central shaft 1240, as described below). The enlarged proximal internal lumen of the shaft 1208 will allow the enlarged proximal shaft of the tool 1212 to be advanced forwardly sufficiently beyond its normal advancement limit for the cleaning and repair purposes described above.

[0259] Fig.46 Shows the display FIG. 40A to FIG. 44C An exploded view of many exemplary components of the illustrated embodiment. Components may be labeled with the same reference numerals as in the above-described embodiments. Components may be assembled and / or function as described in other embodiments herein. Fig.46 Also shown is a stopcock 1536 routed through an irrigation line tube 1537 formed in the handle body 1206 and coupled to an irrigation line port 1539 of the valve 1950 .

[0260] Fig.47 Shows such as Fig.46 An exemplary hemostatic valve 1950 is shown, which includes a valve body 1540 with an integrated flush port 1540' (to which a flush line such as line 1537 can be attached), a valve seal 1951, and a valve cover 1538, wherein the cover 1538 is designed to constrain the seal 1951 within the valve body 1540. The purge line can be used to purge air from the annular space between the tool 1212 and the internal lumen of the steerable sheath 1208. The proximal end of the shaft 1208 can be inserted into the distal end of the hemostatic valve body 1540, and the two can be irreversibly bonded with an adhesive. The hemostatic body can be overmolded onto the shaft 1208. The proximal end of the shaft 1208 can have a Luer fitting (preferably female) irreversibly bonded thereto. The distal end of the hemostasis body 1540 may also be fitted with a mating Luer fitting (preferably male in this case, such as fitting 1952 in FIG. 11A ) that reversibly attaches via a press fit (or irreversibly attaches by a press fit with an adhesive) to a female Luer fitting on the sheath 1208. In this embodiment, the reversible press fit Luer fitting would allow the hemostasis valve assembly to be removed from the fitting on the shaft 1208 during the relocation process.

[0261] Figure 49A to Fig.49CVarious adaptations for reversibly attaching a medical tool from a steerable shaft are shown. In one embodiment, as shown in FIG. 49A , an attachment tubular element 1519 is permanently attached to the proximal end of the tool 1212 in the region where it can be coupled to the shaft 1240. The attachment tube 1519 provides structural reinforcement to the proximal end of the shaft 2010 (of the tool 1212) and is preferably a thin-walled metal or rigid polymer tube (e.g., 0.005" to 0.010" wall) that is attached to the shaft 2010 (e.g., by bonding with an adhesive and / or constraining it on either end with a heat-laminated polymer tubing such as nylon or pebax). The OD of the attachment tube 1519 is designed so that it will pass through the interior lumen of the outer shaft 1208. The shaft 1240 can be constructed of machined or injection molded plastic or metal. One or more threaded set screw features 1518 can be used to reversibly secure the shaft 1240 against the attachment tube 1519. Grooves, notches, flats, protrusions, or other similar features may be provided on the attachment tube 1519 to facilitate compression and interlocking of the set screw 1518 against it. In another embodiment, the set screw 1518 may be replaced with a locating pin. These pins will be held in place by a radial clamp, which can be tightened to engage the pins against the attachment tube 1518, or can be loosened to release the attachment tube 1519 and the tool 1212 from the shaft 1240. In another embodiment, the attachment tube 1519 may be composed of two half tubes, such as a tube separated along its longitudinal axis, each half preferably having slightly less than half the circumference of the tube, and compressed against the tool shaft 2010 by any of the above-mentioned means. This will allow the attachment tube to be removed from the shaft 2010 as well. In another embodiment, only a single half of the attachment tube 1519 can be used to compress and secure it against the tool shaft 2010, which in turn is compressed against the interior of the central shaft 1240. Figures 49B and Fig.49C Another embodiment is shown having a snap collar 1520 that compresses against the tool 1212 (or, in a more specific embodiment, the tool shaft 2010) when inserted into the interior lumen of the central shaft 1240 to reversibly lock the tool 1212 to the shaft 1240. The snap collar 1520 has a feature 1521 that engages with a tapered channel feature 1523 on the shaft 1240, as shown in FIG. 49B. When these features are as shown in FIG. Fig.49C When engaged as shown, feature 1521 is compressed by feature 1523, and this compression forces feature 1521 to invade the inner lumen of snap collar 1520, which in turn clamps onto 1212, thereby locking tool 1212 to shaft 1240. In addition, when 1520 is fully engaged with 1240, as shown in FIG. Fig.49CAs shown, snap feature 1522 engages with receptacle feature 1524. When these features are engaged, snap collar 1520 cannot be rotated within or removed from shaft 1240. In order to disengage snap collar 1520 from shaft 1240, feature 1522 must be pressed to disengage 1522 from 1524, thereby allowing 1520 to be removed from the interior lumen of 1240, thereby releasing tool 1212 from snap collar 1520 and shaft 1240. In the above-described embodiment using snap collar 1520, attachment tube 1519 may also be bonded to tool 1212 such that collar 1520 engages attachment tube 1519.

[0262] The inner surface of the handle shell 1206' can be configured with one or more access ports to allow the central shaft 1240 to be attached or detached from the tool 1212 and / or the attachment tube 1519. In one embodiment, the access port can be a hole or channel in a structure that protrudes radially inward from the inner surface of the shell 1206', allowing it to terminate adjacent to the shaft 1240.

[0263] The handle shell 1206' has several features that are integral to the functionality of the handle assembly as a whole. Some of these features anchor the components in place, while others allow the components to rotate about a central axis and / or allow the components to translate longitudinally. Additionally, some of the features on 1206' are critical to constraining other components so that they remain engaged with mating components and movement of the tool and / or steerable shaft.

[0264] The following description relates to 1206' handle shell features associated with deflection of the catheter sheath. The handle shell features can generally be described as integral ribs (also referred to herein as "walls") that project and extend radially inward from a radial surface of the handle shell that acts as a bearing surface, rail, or guide that also constrains mating components. For example, referring to Fig.44A and Fig.44B , the components constrained by the handle shell 1206 ′ include those identified by the following reference numerals: 1950 , 1400 , 1220 , 1408 , 1406 , and 1402 . Fig.44A All deflection components are shown in their assembled state constrained by 1206'. Fig.44B The exploded view shows Fig.44AThe steering actuator 1220 and the deflection limiter 1408 are constrained by features 1501 and 1502 on the handle shell 1206', which in this embodiment are walls extending in the width dimension, orthogonal to the length dimension, with recessed areas formed in each. These features only allow the actuator 1220 and the limiter 1408 to rotate about their central axis. These components are free to rotate until the deflection limiter prevents further rotation, as described elsewhere herein. The washer 1406 creates friction between 1220 and 1501. The friction is achieved by slightly compressing 1406 against 1501, as described elsewhere herein. The spindle 1400, which cooperates with the steering actuator 1220 as described herein, is constrained between the 1206' handle shell features 1503, 1504, 1505, 1506, the wall 1507 with the recess formed therein, and the wall 1508 with the recess formed therein, and the steering actuator 1220 and the spindle support 1402. The spindle 1400 is constrained so that it can only rotate about its central axis. The spindle support 1402 is fixed in place by the wall features 1507 and 1508 of the handle shell 1206' with the recess formed herein, and has no freedom of movement. The walls 1507 and 1507 extending along the width dimension can at least partially define the guide of the spindle support 1402. The hemostatic valve assembly 1950 is secured in place by handle housing wall features 1509 and 1510 that extend in a width dimension and at least partially define guides for the hemostatic valve. The spindle support 1402 and hemostatic valve 1950 may additionally be permanently attached to their respective features of the handle housing 1206' with an adhesive to help facilitate complete closure of the handle housing. In this embodiment, the integrated handle body includes a central region that includes at least one guide (e.g., a guide for the hemostatic valve and / or a guide for the spindle support 1402), the at least one central guide including walls orthogonal to the guide walls in the proximal and distal regions of the handle body 1206 that support an axis 1237 and corresponding gears that facilitate movement of the medical tool.

[0265] This and other embodiments herein are examples of a handle body that includes integrated features that allow a medical tool control system to extend further proximally than the proximal end of the steerable shaft and be actuated by a distal actuator.

[0266] Fig.44D and Fig.44EA front perspective view and a rear perspective view of a spindle support 1402 are provided, respectively. The spindle support 1402 supports the spindle 1400 within the handle assembly. The spindle support 1402 includes a central lumen 1420 (and a tool for passing a steerable shaft), the size and configuration of which are designed to allow the steerable shaft to pass therethrough. The spindle support 1402 includes two bearing surfaces 1422 (e.g., a portion of the pin 1402' described herein), which may be a component separated from the rest of the support 1402 or may be integrally formed therein. In some embodiments, the surface 1422 may be a portion of a component of a generally cylindrical configuration disposed within a guide in the support 1402. For example, each cylindrical element (e.g., pin 1402') may have an axis orthogonal to the axis of the component around which the pull wire of the spindle 1400 is rolled up. The description herein of component 1402' is equally applicable to any of the supports 1402 herein. The support 1402 also includes two recessed areas 1421, each of which is configured to receive one of the spindles 1400 and provide stability thereto.

[0267] In some embodiments, the length L of support member 1420 is 0.4 inches to 0.6 inches, such as 0.5 inches. In some embodiments, the width W of the support member is 0.4 inches to 0.65 inches, such as 0.55 inches. In some embodiments, the height H of support member 1402 is 0.6 inches to 1.1 inches, such as 0.85 inches. In some embodiments, the diameter of the component including bearing surface 1422 is 0.15 inches to 0.35 inches, such as 0.22 inches.

[0268] Fig.50 An integrated system 1200 of a steerable sheath 1202 and a medical tool 1204 is shown, wherein the system 1200 is connected to a console 4000 via a connector cable 2070. As previously described, such as for Fig.19, tool 1204 includes a proximal connector 2015 that forms a mating connection with cable 2070. As previously described, it is desirable to relocate (e.g., reprocess and reuse) system 1200. It is further desirable to ensure that the system is only relocated by the original manufacturer rather than an unaffiliated third party, and that the device is only reused a specified number of times. In order to control the relocation process, a cryptographic authentication chip (cryptochip) is incorporated into tool 1204, preferably on PCB 2030, but other locations, such as within the turnable handle 1206 or within the end 3000, are also conceivable. The cryptographic chip can only be programmed by the original manufacturer who controls the authentication key. The console 4000 to which system 1200 is connected has a trusted platform module (TPM) that also has an authentication key. During use of system 1200, console 4000 is able to authenticate system 1200 via the cryptographic chip, and can read and write information to the chip as needed (e.g., via EEPROM features). In any of the scenarios discussed, an RFID chip (preferably encrypted) can be used to read and transmit data between the console, connector, and device. Fig.51 A more detailed description of how the system 1200 and console 4000 can communicate to control the use and reuse of the system 1200 is described in Fig.33 and Fig.34 In embodiments related to a mechanical key, console authentication may be required to unlock the tool tip from the steerable catheter tip.

[0269] Since the relocation process relies on the return of the device in order to relocate, the reliable collection of the device is of vital importance. In order to motivate the collection, stakeholders (e.g., doctors, hospital laboratory staff, hospital purchasers, manufacturer sales staff) should be motivated to return the device. The method includes reminding the laboratory staff that the device needs to be returned intact. It is conceivable that the collection box of the automatic recording device return provided by the manufacturer. The box may have one or more receptacles or containers to place one or more devices (e.g., ICE catheters). The container may have or include a sealable liquid-resistant bag to provide a biohazard barrier for the device. Alternatively or in addition, the container may have a hollow shape, such as a rigid tube, to protect the device. The hollow shape may be configured to accept a lid that forms a seal with the hollow shape, and may be further configured to insert a device connector to communicate with a container and / or a collection box. The hollow shape may be configured to have a device that provides a sterile seal that is permeable to ethylene oxide sterilants. The receptacle or container may have a one-way lock that prevents the device from being removed once it is fixed in the box, preferably so that once it is engaged to record and / or authorize return, it cannot be removed. Alternatively, if removed, the box erases or modifies the returned record to indicate removal. The box itself can be shipped back to the manufacturer or other authorized third party for reprocessing, or it can be placed in a secondary protection transport box for transportation. The box can include an RFID reader that reads information (e.g., serial number, sale date, use date, use location, etc.) from the device. Some of this information may have just been written to the device from the console. A reusable connector in a collection box or container can also be provided that provides a direct connection to the device to read information and, if necessary, writes to the device to record the returned record. The connector can be built into the sealable cover of the above-mentioned container. Like the console, the box itself can be constructed to have encryption technology, including a TPM unit in the box itself. The box can be powered by a battery and / or plugged into a wall outlet. The battery can be durable by being preferably removable, rechargeable and / or replaceable to maintain power. A manufacturer representative or local laboratory staff can provide this service. The collection box can be configured to provide a wireless (e.g., WIFI, Bluetooth) or wired (e.g., Ethernet) connection between the console and / or a direct hospital and / or cloud server (accessible by the manufacturer or an authorized third party) to transmit and / or receive information about the return of the device. Such communication may include information about the presence and quantity of the device to be returned to signal the manufacturer or other third party to collect and return the box. In order to allow the collection box to be stored in any desired area of ​​the hospital, and to prevent access during transportation, the exterior of the collection box can be designed to have an airtight and / or liquid-tight seal so that when closed, biohazard contamination is not possible. A lockable door, cover or other suitable access point may be provided.The collection box can be configured with attachment points to facilitate physical attachment to and / or electronic communication with a console used by the device.The collection box can be the same box in which the sterile product is initially delivered to the hospital.

[0270] The device connector may be equipped with a battery and circuitry that provides an audible and or flashing visual alarm when the device connector is initially unplugged from the plug-in connector with the console. The alarm may continue until the device is plugged back into the connector or is recognized by the collection box by placing it in close proximity to the collection box RFID sensor or directly inserted into the collection box receptacle or container.

[0271] In another embodiment, the device may be equipped with a removable or separable component that must be removed to fit the device into a collection cassette receptacle or container. The component may be placed in a separate location in the collection cassette, or it may be discarded. Removal of the component may render the device unusable until replaced by the manufacturer.

[0272] During manipulation of the catheter system 1200, the imaging tip may contact cardiac structures. In order to minimize potential damage to delicate structures (e.g., thin heart walls, valve leaflets), it may be advantageous to provide a more atraumatic feature on the distal tip of the tool (or in a particular embodiment, the ultrasound probe tip). Specifically, the feature preferably distributes the contact force over a larger surface area of ​​the tip and / or allows bending or deflection to buffer the force of the tip against the tissue. The atraumatic feature is preferably placed distal to the tip where it can expand to a larger size and surface area and does not interfere with ultrasound imaging. Fig.52A variety of expandable non-traumatic terminal feature structures are shown. Expansion can be accomplished with an inflatable balloon or using a spring-like structure. The inflatable balloon can be composed of a compliant material (such as silicone or polyurethane), or a relatively non-compliant material (such as nylon or polyester), or a material with compliance between the two. The spring-like structure is preferably composed of nickel-titanium or cold-worked stainless steel, but can also be made of polymers such as nylon, polyester, polypropylene or ePTFE. The spring-like structure can be constructed as a J-shaped or "pigtail" curl of a given element, a basket-shaped spline group (straight or spiral), a braid of a wire element, a coil, a ring or a ring group, or a laser cut sheet or a hypotube. The elements of these structures can be formed by round wire or a band or sheet with a rectangular cross section. In other embodiments, the given element of the structure itself can be a coil or braid of a smaller element. In other embodiments, the feature structure can be an annular complex of the above-mentioned elements, which is surrounded or coated by an elastic polymer matrix (such as silicone or polyurethane). In another embodiment, an annular array of curved petal-shaped surfaces may be provided, such that the surfaces slide against each other to expand and collapse.Some embodiments may be configured to be self-expanding, either by actuation of an element or by inflation with a fluid or gas.

[0273] For the first entry into the body, the self-expanding element can be constrained to a collapsed shape by a tubular sheath element mounted on the outer top of the catheter end. Once the device enters a blood vessel (or more generally, a body cavity) from an introducer, or after the device reaches a target position (e.g., a cardiac chamber), the tubular sheath element can be retracted. The introducer sheath itself may be sufficient to constrain the expandable element for a sufficiently long time to allow entry into a blood vessel or body cavity. For example, the leading edge of a J-shaped, pigtail, or braided fabric can be artificially straightened long enough to advance forward through the hemostatic valve of the introducer sheath and constrained in the sheath until it leaves the sheath end. In most examples, such as when the feature structure is attached to the device end at the proximal end of the feature structure, but the distal end is unconstrained, the feature structure is self-straightened and / or collapsed when being stretched and / or radially compressed during the withdrawal of the feature structure by a blood vessel, a body cavity, or an introducer sheath. The attachment of the atraumatic feature structure to the end can be achieved by combining a metal ring or disc into the distal end of the catheter, and the structure is welded or soldered to the metal ring or disc. The ring or disc can also be a feature structure continuous with the spline extending away from it, such as a spline cut by a nitinol hypotube laser and then heat-set into an expanded shape. As needed, removing material from the ring portion can also be beneficial for encapsulation in the polymer of the catheter end. As described above, the surface of such a structure can be overmolded with silicone or polyurethane, including the round end of the polymer to form a self-expanding and collapsible volume. The support structure for the atraumatic end can be insert molded in a mold in which the polymer end of the transducer is assembled. The atraumatic end feature structure can also include elements extending proximally behind the transducer (non-imaging side), which are fixed in the end by bonding, welding, soldering, heat-melting polymers or any combination thereof.

[0274] Fig.52 Selection of such termini is shown.

[0275] As used herein, "cleaning" may refer to any type of cleaning, such as, but not limited to: using a flushing system of a detergent and / or disinfectant to clean the interior of an outer shaft, and optionally mechanical scrubbing with a small brush; mechanically cleaning (e.g., wipes, brushes) the exterior portion of an outer shaft and / or the exterior portion of a medical device shaft (e.g., ultrasound probe) with a detergent / disinfectant, and optionally immersing the shaft in an ultrasonic bath of the detergent / 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 general concept of cleaning an object.

[0276] 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 herein. For example, but not limited to, the disclosure herein includes methods of winding one or more pull wires onto a bearing surface in a spindle support and then winding around the spindle.

[0277] The methods herein also include making or constructing any individual component of any of the subassemblies or assemblies herein. For example, the present disclosure includes methods of making a handle shell component having a specific configuration (e.g., guides, walls, etc.) that can accommodate internal components that allow the assembly or subassembly herein to function as intended.

[0278] Regardless of the reference numbers labeled, the handle assemblies, medical tools, steerable sheaths, and electrical connectors herein may be used in any combination with one another in a system.

[0279] Any technology in any of the following U.S. patent references (including ultrasound and steering technology) can be incorporated into any of the medical tools, devices, systems or methods of use thereof, and the disclosures of these patent references are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833, 7783339, 779125 2. 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.

[0280] Any suitable disclosure above can be incorporated into any one of the following embodiments.For example, unless specifically stated otherwise, various aspects of the apparatus, system, and methods of manufacture and use are incorporated herein and can be incorporated into any one of the following embodiments.

[0281] Fig.53 , Fig.54A , Fig.54B , Fig.55A , FIG. 55B, FIG. 55C and Fig.56 A portion of an exemplary medical device is shown. In the exemplary embodiment, the medical device is an ultrasound imaging catheter, but it should be understood that the invention described herein is equally applicable to other types of medical devices. Fig.53 A portion of an elongated body of an exemplary medical device is shown. Fig.54A and Fig.54B Various views of a portion of an elongated inner body of an exemplary medical device are shown. Fig.55A Shows Fig.53 The slender body and Fig.54A and Fig.54B A component of an elongated inner body. Fig.56 Shows Fig.55A The assembly is shown in section AA. Fig.57A and Fig.57B Only exemplary handle assemblies are shown that may be coupled to and used to control Fig.53 The slender body and Fig.54A and Fig.54B The elongated inner body (and thus also connected to Fig.55A ). Similar to Fig.57A and Fig.57B Figures similar to those in the embodiments are shown in Figures 36A and 36B, and unless specifically stated to the contrary, any suitable aspects of these embodiments (including devices, components, manufacturing methods and / or methods of use) may be incorporated herein by reference.

[0282] Exemplary medical devices 117 include Fig.53 1. The exemplary elongated outer body 100 shown. In this embodiment, the elongated outer body 100 includes an outer shaft 101 coupled to a distal segment 102 at an interface 106. The shaft 101 can be a flexible shaft (e.g., a polymer shaft, such as PEBAX), and optionally includes a braided material embedded in the flexible material, as shown. The distal segment 102 can be coupled to the shaft 101 using any type of known coupling technology in the catheter field. The shaft 101 and the distal segment 102 can have the same outer dimensions at the interface 106, and can also have the same maximum diameter.

[0283] The distal segment 102 includes a medical tool 103, which may include at least one ultrasonic transducer and, optionally, an ultrasonic imaging transducer. The medical tool 103 is surrounded by a member 104, which may be composed of one or more materials and / or one or more discrete material segments. The member 104 may encapsulate the medical tool 103 such that the material of the member 104 engages the medical tool 103 and surrounds the medical tool 103. An exemplary material for the member 104 is a flexible polymer material, such as PEBAX.

[0284] The medical tool 103 may include an electrical connector 105, which may be, for example, but not limited to, an electrical connector (such as an electrical bundle of electrical conductors) in electrical communication with the medical tool 103. For example, but not limited to, the electrical connector 105 may be a cable bundle extending from a medical tool including an ultrasound probe. The electrical connector 105 extends radially within the shaft 101 (i.e., the shaft 101 is radially outside the connector 105) and extends axially through at least a portion of the shaft 101.

[0285] The outer shaft 101 and the distal section 102 (and the medical tool 103) are attached so that axial movement of the shaft 101 also causes axial movement of the distal section 102 and the medical tool 103. Rotation of the shaft 101 similarly causes rotation of the distal section 102.

[0286] Fig.54A and Fig.54B An exemplary elongated inner body 110 is shown, which may also be Fig.55A 1. The elongated inner body 110 is radially disposed within at least the shaft portion 101 of the elongated outer body. The elongated outer body 100 is adapted to move axially and rotationally relative to the elongated inner body. This allows the medical tool to be independently moved axially and rotationally relative to the elongated inner body, which may help allow a physician to more finely control the axial and rotational position of the medical tool during use.

[0287] Fig.54B Shown relative to Fig.54A The view shown is of the inner elongate body 110 rotated 90 degrees.

[0288] The elongated inner body 110 includes an inner shaft 114, which in this embodiment includes a deflectable segment 113, a first tensioning element 111 (e.g., a pull wire) and a second tensioning element 112 (e.g., a pull wire), and an optional straightening tensioning element 116. In this embodiment, the tensioning elements 111 and 112 are used in conjunction with a handle assembly (described below) to deflect the deflectable segment 113. Deflection of the deflection segment 113 also causes deflection of the elongated outer body 100 (including the tool 103) due to the relative position of the elongated body 100 and the inner body 110. Therefore, the inner elongated body can be used to deflect the outer elongated body, while the outer elongated body can be moved axially and rotationally relative to the inner elongated body. Therefore, the axial, rotational, and deflectable position of a medical tool can be independently controlled using the outer elongated body and the inner elongated body of the present invention. Therefore, the device of the present invention allows fine control of a medical tool such as an ultrasound imaging transducer.

[0289] In the deflectable segment 113, the first axial tensioning member and the second axial tensioning member extend parallel to the longitudinal axis of the elongated inner body 110. In the deflectable segment 113, the first axial tensioning member and the second axial tensioning member are spaced less than 180 degrees around the elongated inner body, and are spaced less than 135 degrees, less than 90 degrees, less than 45 degrees, less than 30 degrees, less than 25 degrees, less than 20 degrees, and less than 10 degrees from each other. In this embodiment, they are quite close to each other, but can generally be spaced less than 180 degrees apart. Being closely together makes deflection of the deflectable segment 113 easier to achieve because the tension applied via the tensioning members is more closely aligned.

[0290] As in Fig.54A 1, the first and second axial tensioning members are separated relative to each other in the transition region proximal to the deflectable segment 113 and then spaced 180 degrees apart from each other in the segment proximal to the steerable portion. In this embodiment, the transition segment is shorter than the steerable segment and the segment in which the tensioning elements are spaced 180 degrees apart.

[0291] In the segment where the tensioning members are on opposite sides of the elongated inner body (spaced 180 degrees apart), when the tensioning members are tensioned (e.g., via a handle assembly as described below), tension is applied on the opposite sides of the elongated inner body. Having the tensioning members on opposite sides reduces or prevents undesirable reverse deflection from occurring, which advantageously provides less jitter.

[0292] There is another transition region proximal to the position where the tension members are spaced 180 degrees apart, where the tension members move closer relative to each other, such as Fig.54A Bringing them closer together in this area, and optionally all the way back to the handle assembly, can make it easier to tension them together at the handle assembly, but they do not need to be close together. In this proximal-most area, the first and second tensioning members can be spaced less than 180 degrees apart, less than 135 degrees apart, less than 90 degrees apart, less than 45 degrees apart, less than 35 degrees apart, less than 25 degrees apart, less than 20 degrees apart, and less than 15 degrees apart. In this embodiment, they are very close to each other, such as less than 10 degrees apart.

[0293] In this embodiment, the tensioning members 111, 112, and 116 have a distal region, generally indicated by reference numeral 115, where the tensioning members are interwoven with the braided material in the elongated inner body 110 (e.g., interwoven above and below, etc.). Interweaving the tensioning members with the braided material can be a way to secure the distal ends of the tensioning members without requiring, for example, a marker band that is commonly used. This can also eliminate the need for adhesive to secure the distal ends of the tensioning members. In the securement region 115, the tensioning members are oriented more orthogonally to the longitudinal axis (as that term is commonly used in the medical device field) of the inner elongated body, which is in the deflection segment 113. In the securement region 115, any of the tensioning members can be wrapped around the elongated body at least one or more turns, such as at least one turn, at least one and a half turns, at least two turns, at least two and a half turns, at least three turns, or more turns. The one or more tension members need not be oriented completely orthogonal (i.e., 90 degrees) relative to the longitudinal axis, but may, for example, be oriented at an angle closer to orthogonal than their orientation in the deflection segment 113. For example, they may be oriented at an angle between 0 and 90 degrees relative to the longitudinal axis, such as at least 5 degrees, at least 10 degrees, at least 15 degrees, at least 20 degrees, at least 25 degrees, at least 30 degrees, etc. (continuing in increments of 5 degrees and up to 90 degrees) . In some embodiments, the one or more tension members may be oriented at an angle greater than 90 degrees relative to the longitudinal axis, as measured from the proximal end of the handle.

[0294] By interweaving one or more tensioning members to help secure the distal end thereof in place, it may not be necessary to use adhesives and / or marker bands, for example, to secure the distal end thereof in place. This may reduce the outer dimensions of the elongated body by eliminating additional components such as marker bands having a certain thickness, thereby providing a smaller overall profile of the elongated body. This may provide additional free space between the elongated inner body and the outer elongated body, which may allow the relative axial movement therebetween to be less constrained, as will be discussed in greater detail herein.

[0295] The elongated inner body 110 also includes a third tensioning element 116, which in this exemplary embodiment is adapted to be used as a straightening element to straighten the inner elongated body 110 after it has been deflected. In the deflectable segment 113 of this embodiment, the straightening element 116 is approximately 180 degrees away from the tensioning members 111 and 112, which can be Fig.54B Proximal to the deflectable section 113, in this embodiment, the straightening element 116 is 90 degrees away from each of the tensioning elements 111 and 112. The straightening element 116 can be straight (ie, not diverging) along its length, as in this embodiment.

[0296] In some cases, a device 117 having rotational control in an outer elongated body opposite an inner body can provide better rotational control for the device. This can provide better rotational control of a medical tool such as an ultrasonic transducer. Having rotational control in the outer elongated body rather than in the inner elongated body can minimize or prevent twisting of the device. In some cases, a relatively small inner shaft can be more difficult to twist and thus provide rotation to the medical tool. Incorporating rotational control into an outer relatively larger shaft can make it easier to twist the medical tool and thus provide better rotational control of the medical tool.

[0297] As discussed herein, in this embodiment, the outer elongated body is adapted to move axially (and rotationally) relative to the elongated inner body. In this type of design, bodily fluids (e.g., blood) contact the outer elongated body but cannot contact the deflectable elongated inner body. This is in contrast to device designs in which distal movement of the inner shaft relative to the outer elongated body can occur, which can allow bodily fluids to enter the space between the inner elongated body and the outer elongated body, where the bodily fluids can travel as far as a handle assembly disposed outside the patient's body. For example, in Fig.53 55C, there is therefore no need for a flush line to flush fluid solution distally during use. This can be considered an advantage of this embodiment and other designs of similar construction.

[0298] Fig.56 Shows Fig.55A Section AA shown in the component in, which is a segment in the deflectable segment 113. Fig.53 , Fig.54A , Fig.54B and Fig.55A The components are labeled similarly. Fig.56 As can be seen in FIG. 1 , tension members 111 and 112 are very close to each other and are approximately 180 degrees away from straightening tension member 116 .

[0299] Also like Fig.56 As shown, the elongated inner body 110 includes two layers of braided material 119, and the tensioning member is substantially sandwiched between the two layers of braided material at least at the location of the segment. The annular space 118 allows freedom of movement and space for an optional lubricant. The inner body 110 can be made of, for example, but not limited to, a polymer material such as Pebax, optionally with a lubricating additive. The inner body 110 can include a liner 125, such as a PTFE liner. The cable bundle can be surrounded by one or more layers of an insulator 126 (such as a PTFE insulator). The outer member 100 can include a polymer material 127, such as Pebax. The outer member 100 can also include a radial inner liner 128, such as a PTFE liner. Any of the pull wires (e.g., 111, 112, 116) can be set in a lumen having a liner such as a PTFE liner 129.

[0300] Fig.57A and Fig.57B A merely exemplary handle assembly is shown that can be operably connected to the elongated outer body 100 and the elongated inner body 110. In this exemplary implementation, the handle assembly 120 includes a handle body 123, a first actuator 121, and a second actuator 122, the handle body having an outer surface that is designed to be held by a user in size and configuration. The actuator 121 can be operably connected to the elongated outer body 100, and the actuator 122 can be operably connected to the elongated inner body 110. The actuator 121 is adapted to rotate and move axially relative to the handle body 123 (and relative to the second actuator 122). This allows the actuator 121 to cause axial movement of the medical tool 103 and rotation of the distal end of the medical tool 103 relative to the elongated inner body 110. The second actuator 122 is adapted to actuate (e.g., rotate in this embodiment) relative to the handle body 123, which causes the elongated inner body 110 to deflect in the steerable segment. For example, the handle assembly can have an internal component that interfaces with the proximal ends of the tension members (e.g., tension members 111, 112, and 116) such that actuation of the actuator 122 tensions one or more of the tension members to cause deflection of the elongated inner body, and thus also of the medical tool due to the relative positions of the inner and outer shafts. In this embodiment, the actuator 121 is located distal to the actuator 122, but in other designs, their relative positions may be reversed. Fig.57B The actuator 121 is shown to have been moved relative to its Fig.57A The handle assembly 120 after being advanced distally from the position in the distal end. This distal advancement causes the outer elongated body 100 to be advanced distally, and thus causes the medical tool to be advanced distally. The actuator 121 can be similarly moved relative to its position in the distal end. Fig.57B The position in the middle is retracted proximally, thereby causing proximal movement of the medical tool.

[0301] In other designs, actuator 121 may be in operable communication with elongated inner body 110 , and actuator 122 may be in operable communication with elongated body 100 .

[0302] Slack may be added to one or more tensioning members (eg, pull wires) in the handle assembly to better allow the outer elongate body to translate relative to the elongate inner body.

[0303] Figures 55B and 55C show rotation ("R") and axial movement (L1 and L2) of the outer elongated body. Deflection of the inner elongated body causes deflection of the outer elongated body as shown. Different types of movement may occur at any time relative to other types of movement.

[0304] As described herein, the outer shaft can be axially movable relative to the deflectable inner shaft. The outer shaft can be composed of material segments that vary in stiffness (e.g., hardness) along the length of at least a portion of the outer shaft. For example, the first portion distal to the second portion may have a lower hardness than the second portion. Since the outer shaft can be axially movable 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 can be selectively controlled by controlling the axial position of the outer shaft (relative to the inner shaft), including the degree (or amount). Therefore, 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 position where the bending occurs along the length of the device (measured from the distal end) by axially moving the outer shaft relative to the inner shaft. In addition, for example, depending on the relative position of the outer shaft relative to the deflectable inner shaft, the segments of the outer shaft with varying stiffness can allow more or less deflection. For example, the inner shaft deflecting at an area where the outer shaft has relatively high stiffness can result in a smaller deflection than when the inner shaft deflects at an area where the outer shaft has less stiffness.

[0305] Fig.58C An exemplary device medical device 130 is shown, which includes an elongated inner body 132 (shown in FIG. Fig.58A ) and an elongated outer body 131 (shown in Fig.58B In other respects, the elongated inner body 132 and the elongated outer body 131 may be similar to Fig.53 , Fig.54A , Fig.54B and Fig.55A The elongated inner body and the elongated outer body are the same or similar to those shown in Figure 55C. Fig.53 , Fig.54A , Fig.54B and Fig.55A Any of the aspects of the embodiments in Figure 55C may be incorporated into 58A, Fig.58B and Fig.58C In the implementation scheme of Fig.53 Some individual components of the embodiment in FIG. 55C are Fig.58A , Fig.58B and Fig.58C The individual components in FIG. 1 are the same, such as shaft 114 , shaft 101 , tensioning members 111 and 112 , and medical tool 103 .

[0306] The medical device 130 (or either of the elongated inner body 132 and the elongated outer body 131, individually) can be used with any of the handle assemblies described herein (including Fig.57A and Fig.57B The handle assembly 120 shown is capable of being operably connected.

[0307] Fig.59A , Fig.59B , Fig.59C 59D and 59E illustrate additional exemplary handle assemblies that may be operably connected to any of the medical devices described herein, including an ultrasound probe. For example, Fig.59A The exemplary handle assembly shown in FIG. 59E may be coupled (directly or indirectly) to FIG. 58A to FIG. 58C The medical device 130 shown or Fig.53 , Fig.54A , Fig.54B and Fig.55A 55C and is operably connected thereto. In certain embodiments, both the elongated outer body (e.g., 100, 131) and the elongated inner body (e.g., 110) 132 are coupled to Fig.59A To the handle assembly shown in Figure 59E and operably connected thereto.

[0308] Fig.59A The handle assembly in Figure 59E is similar to that in Figures 36A to Fig.48 and FIG. 57A to FIG. 57B The handle assemblies, individual components and subassemblies shown in FIG. have some similarities. Unless otherwise indicated, they may be combined with Fig.59A 36A to 59E of the handle assembly Fig.48 and / or FIG. 57A to FIG. 57B The concepts, features, structures, and methods of use of any of Fig.59A 59E. Similarly, the handle assembly that can be incorporated into other handle assemblies herein Fig.59A The concepts, features, and methods of use illustrated in and described with respect to FIG. 59E are hereby incorporated by reference into the disclosure of any of the handle assemblies set forth herein for all purposes.

[0309] Fig.59A 36A is a side view of the handle assembly 140 with a portion of the handle body 141 removed so that some of the internal components of the handle assembly can be seen. The handle assembly 140 includes a first actuator 143 and a second actuator 142, and in this embodiment, the first actuator 143 is distal to the second actuator 142. Similar to the actuator 1230 shown in FIG. 36A, the first actuator 143 can move axially and rotate relative to the handle body and relative to the second actuator (in this embodiment, the actuator 142). The first actuator 143 is connected to an outer slender body such as the outer slender body 100 (see Fig.53 ) or the outer elongated body 131 (see Fig.58B) is operably connected. Axial movement of actuator 143 (distal or proximal) causes axial movement of the outer elongated body, and rotation of actuator 143 causes rotation of the outer elongated body. Second actuator 142 is operably connected to an inner elongated body, such as inner elongated body 110 (see Fig.54A ) or the inner elongated body 132 (see Fig.58A ). In this rotational embodiment, actuation of the second actuator 142 causes deflection (or bending) of the inner elongated body. An exemplary difference between this embodiment and the embodiment shown in FIGS. 37A and 37B is that in this embodiment, the rotatable and axially movable actuator (i.e., first actuator 143) is in operative communication with the outer elongated body, whereas in FIGS. 37A-37B , the rotatable and axially movable actuator 1230 is in operative communication with the inner elongated body.

[0310] The first actuator 143 is operatively coupled to Fig.59B 143, so that the movement of the first actuator 143 causes the movement of the assembly 150. The slender outer body moving assembly 150 is similarly connected to the slender outer body so that the movement of the first actuator also causes the movement of the slender outer body. In this embodiment, the outer slender body can be attached to the removable component 153 after it is inserted into the channel 156. The removable component 153 and the channel 156 can be configured so that the removable component 153 is constrained by at least one inner surface of the channel when inserted into the channel 156. The slender outer body moving assembly 150 also includes a distal head portion 151 fixed to the first actuator 143. The slender outer body moving assembly 150 also includes a rotation limiting mechanism similar to the rotation limiting mechanism described herein, which limits the rotation of the first actuator 143 and thereby limits the rotation of the outer slender body. Any disclosure above relating to the rotation limiting subassembly, function and use is incorporated into this embodiment for all purposes and may be incorporated into this design and similar designs. During rotation, component 157 (in Fig.59B ) interacts with component 161, and component 162 interacts with component 158. The physical interaction of these two sets of components limits the rotation to the desired rotation limit, for example, limiting the rotation to at most 630 degrees of rotation of the outer body (in other embodiments, the allowed rotation may be greater than 630 degrees, such as up to and including 720 degrees).

[0311] If it is desired to clean the outer elongated body, for example after use, the removable component 153 can be separated from the outer elongated body to allow the outer elongated body to be removed from the handle assembly and cleaned prior to reinsertion and reattachment to the removable component 153 or a new removable component if the component 153 is damaged or broken.

[0312] The handle assembly 140 also includes an inner elongated body deflection assembly 146 that is in operative communication with the second actuator 142. The inner elongated body 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 with gears on each of the first spindle 148 and the second spindle 149 via respective gear interfaces, such that rotation of the central gear 147 causes rotation of the spindles in opposite directions. The spindles 148 and 149 are similar to those described with reference to FIG. Figure 39C to Figure 41 The spindle 1400 described in the embodiment may be referred to Figure 39C to Figure 41 Any disclosure of the spindles in the embodiments is incorporated into the spindles of this embodiment, including how they interface with one or more pull wires to cause deflection of the inner elongated body. The inner elongated body deflection assembly 146 (including the spindle) extends further proximally than the elongated outer body movement assembly 150. The inner elongated body extends through the outer elongated body and extends further proximally within the handle assembly 150 than the outer elongated body and the outer elongated body movement assembly 150. This allows one or more pull wires that are part of the inner elongated body to extend radially outward and interface with the reel 160, which forms an operable connection between the pull wires and the spindle. The reel 160 can be coupled to Figure 39C to Figure 41 The reel 1407 in the embodiment of FIG. 1 is similar or identical to, and any suitable disclosure related to reel 1407 may be incorporated into reel 160 .

[0313] The absence of interaction between the elongated outer body movement assembly 150 and the elongated inner body movement assembly 146 allows the inner and outer elongated bodies to be independently controlled by the first and second actuators 143 , 142 .

[0314] The handle assembly 150 also includes a printed circuit board ("PCB") 170 disposed within the handle body 141 that is in electrical communication with a cable harness or other electrical connector, such as Fig.53 The cable bundle 105 in the apparatus or any of the cable bundles herein that are connected to a medical tool such as an ultrasonic transducer.

[0315] The handle assembly 150 also includes an optional rotation indicator 180 that can be used to display or indicate to a user the extent to which at least one of the first actuator and the second actuator has been rotated relative to an original or neutral position. The first actuator 143 may include a rotation indicator 181 that is aligned along an axis with the rotation indicator 180 when the first actuator 143 is in the neutral position, such as Fig.60 As 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 that the first actuator 143 and thus the elongated outer body and the medical tool are rotated to a certain extent relative to the neutral position. Similarly, the second actuator 142 may also have a rotation indicator 182, which is aligned with the rotation indicator 180 along the axis when the second actuator 142 is in the neutral position, as shown. Fig.60 When the second actuator 143 rotates, the rotation indicator 182 rotates relative to the axis along which the rotation indicator 180 extends, which enables the user to visually understand that the second actuator 143 and thus the elongated inner body are deflected to some extent relative to their neutral position.

[0316] In some alternative embodiments, the handle assembly may include one or more sensors to track how much rotation of the outer elongated body has occurred, or how much deflection of the inner elongated body has occurred. In some embodiments, the handle assembly may include an encoder for each actuator.

[0317] In any of the embodiments herein that include an outer elongated body and an inner elongated body, the device may include one or more lubricants between the inner elongated body and the outer elongated body to make it easier to move the inner elongated body and the outer elongated body relative to each other by reducing the friction between the inner elongated body and the outer elongated body. If the medical device needs to be cleaned for reuse, additional lubricant may be added between the inner elongated body and the outer elongated body after the cleaning process.

[0318] It may be beneficial to be able to stabilize, minimize, or maintain the position of the handle of a medical device while it is in use. For example, a physician may not wish to hold the handle at all times, but may wish to keep the handle in a particular position relative to the patient. Now, the physician may simply place the handle on a portion of the patient's body, but once placed on the patient, the handle may move. In addition, for example, it may be desirable for a particular medical device to be stable while in use to avoid unwanted movement of one or more distal portions of the medical device. In addition, for example, a physician may wish to hold the handle with only one hand and use the other hand for other things, and may not wish for the handle to move. Figure 61A shows an exemplary handle stabilizing member 190 that may provide any of the previously listed functions or benefits, such as at least one of the following: stabilizing the handle of the medical device relative to a portion of the patient, minimizing movement of the handle relative to a portion of the patient, etc. The handle stabilizing member 190 includes a handle receiving guide 191 and a patient interface 192 and an optional stabilization aid 193. The guide 191 may be constructed with any configuration to allow it to stably interface with a portion of the handle to help stabilize or minimize movement of the handle, such as only the exemplary handle portion 195 in the exemplary handle assembly shown in FIG. 61B. For example, in this embodiment, the guide 191 has a curved configuration to interface with the curved configuration of the handle portion 195. In this embodiment, the curved configuration has a generally U-shape, but it may be any other curved shape, such as a generally C-shape, or any other shape that is difficult to define a curved configuration. The guide may also be constructed with any curved configuration that can stably interface with a portion of the handle. Alternatively, the guide may have only a flat surface (e.g., a partial square or partial rectangle).

[0319] The guide may be configured to prevent the handle from moving in at least one direction (e.g., from side to side, proximally-distally, etc.). The restriction on the movement of the handle may also depend on the configuration of the handle. For example, the guide 191 is configured as a channel and is adapted to prevent movement from side to side while allowing the handle to be lifted upward out of the open area. If a true cylindrical handle is placed in the guide 191, the cylinder may also move proximally or distally in the guide 191. A handle portion (such as the handle portion 195 in FIG. 61B ) may be configured with one or more movement limiting regions 196 and 197 that may further limit or minimize the movement of the handle when interfacing with the guide 191. For example, the movement limiting regions 196 and 197 have larger outer dimensions than the central region therebetween, such that when the handle portion 195 is placed in the guide 191 from above, the region 197 prevents full distal movement of the handle, and the region 196 prevents full proximal movement due to their relatively large size. Alternatively, the handle may have only one movement limiting region or more than one movement limiting region.The central region between regions 196 and 197 and guide 191 may be sized so that handle portion 195 and guide 191 interface with an interference fit.

[0320] Stabilizing member 190 includes a patient interface 192, which is configured to interface with a portion of the patient and optionally conform to the portion. In this embodiment, it is envisioned that interface 192 interfaces with the patient's legs and conforms to the patient's legs, but it may have any other configuration so that it interfaces with any other surface (e.g., arm, torso, wrist, etc.) and conforms to any other surface. Portion 192 may be a rigid or semi-rigid material manufactured in the configuration shown, or it may be a flexible material that can be more easily conformed to a variety of patients. For example, portion 92 may be a polymer material that has sufficient rigidity to maintain the position of stabilizing member 190 when placed on the patient, but has sufficient flexibility to deform when not in use, such as rolling up to save space in packaging and / or storage devices. Even if flexible, portion 192 may also be manufactured so that it more naturally presents the configuration of the portion of the patient where it will be placed. For example, portion 192 may be flexible / foldable, but may have a natural tendency to return to or assume a more curved configuration, such as the curved configuration shown in FIG. 61A. Exemplary configurations of portion 192 include generally U-shaped, C-shaped, etc., which may facilitate better conformity to a leg and arm or other portion of the body. Patient interface member 192 may also be rigid and non-deformable, and may be manufactured to have any desired configuration.

[0321] Stabilizing member 190 also includes an optional additional stabilizing aid member 193, which in this exemplary embodiment can act as a counterweight for guide segment 191 in which the handle will be placed. Stabilizing aid portion 193 can have any desired shape, configuration, and / or material that provides the desired weight to offset the weight of the handle in the guide. Portion 193 is optional and may not be required. In some embodiments, portion 193 can be made of a different material that provides a counterweight function.

[0322] In this embodiment, a stabilization assist member 193 is shown on one end of the stabilization member 190, a guide 191 on the other end, and a patient interface / conformable portion in between.

[0323] FIG. 61B illustrates an exemplary handle assembly configured for use with the exemplary handle stabilization member of FIG. 61A . The handle assembly of FIG. 61B may be the same or similar to any of the handle assemblies herein. Other handle assemblies may be used with stabilization member 190 .

Claims

1. An intravascular catheter, comprising: an outer shaft having a proximal region secured to the handle assembly; a medical tool axially secured to the distal end of the outer shaft; as well as an inner shaft disposed within the outer shaft, the inner shaft having a proximal region secured to the handle assembly, The handle assembly includes a first handle actuator in operative communication with the outer shaft such that actuation of the first handle actuator relative to a second handle actuator rotates the outer shaft and the medical tool relative to the inner shaft, the second handle actuator being in operative communication with the inner shaft such that actuation of the second handle actuator deflects the inner shaft and thereby causes deflection of the outer shaft, Wherein, the first handle actuator and the second handle actuator are coaxially positioned on the handle assembly.

2. The catheter of claim 1, wherein the second handle actuator is operatively connected to the inner shaft via one or more tensioning elements extending along the inner shaft and fixed at a distal end of the deflection section of the inner shaft.

3. The catheter of claim 2, wherein actuation of the second handle actuator results in applying tension to the one or more tensioning elements, thereby causing deflection of the inner shaft.

4. The catheter of claim 1, wherein the second handle actuator is fixed to the handle assembly such that the second handle actuator is adapted to rotate but not move axially.

5. The catheter of claim 1, wherein the second handle actuator is in rotational communication with a central gear within the handle assembly, the outer shaft and the inner shaft extending through the central gear.

6. The catheter of claim 5, wherein the sun gear is in rotational communication with a spindle gear, the spindle gear being further radially away from a handle assembly axis than the sun gear.

7. The catheter of claim 6, wherein the inner shaft tensioning element is wrapped around the main shaft.

8. The catheter of claim 6, wherein the main shaft extends further proximally than a proximal end of the outer shaft.

9. A catheter according to claim 1, wherein the inner shaft includes a deflection portion, in which the inner shaft is suitable for deflecting when the second handle actuator is actuated, wherein the deflection portion is more flexible than a proximal region of the inner shaft disposed proximal to the deflection portion.

10. A catheter according to claim 1, wherein the first handle actuator is fixed relative to the handle assembly so that the first handle actuator is suitable for rotating and moving axially relative to the second handle actuator, wherein the axial movement of the first handle actuator causes the outer shaft and the medical tool to move axially relative to the inner shaft.

11. The catheter of claim 1, wherein the inner shaft comprises a first axially extending pull wire and a second axially extending pull wire, wherein in a deflection section of the inner shaft, the first axially extending pull wire and the second axially extending pull wire are spaced less than 180 degrees around the inner shaft.

12. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 135 degrees apart around the inner shaft.

13. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 90 degrees apart around the inner shaft.

14. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 45 degrees apart around the inner shaft.

15. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 30 degrees apart around the inner shaft.

16. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 20 degrees apart around the inner shaft.

17. The catheter of claim 11, wherein in the deflection section of the inner shaft, the first axially extending puller wire and the second axially extending puller wire are spaced less than 10 degrees apart around the inner shaft.

18. The catheter of claim 11, wherein the first axially extending puller wire and the second axially extending puller wire are separated from each other about the inner shaft and spaced approximately 180 degrees apart from each other in a portion of the inner shaft proximal to the deflection segment.

19. The catheter of claim 11, wherein the inner shaft further comprises a third axially extending puller wire positioned relative to the first and second axially extending puller wires to straighten the inner shaft after the inner shaft has been deflected.

20. The catheter of claim 11, wherein the first axially extending puller wire and the second axially extending puller wire are each interwoven within a braided material in the inner shaft.

21. The catheter of claim 11, wherein the first axially extending pull wire and the second axially extending pull wire each have a distal region, the distal region being interwoven within a braided material in the inner shaft to secure the distal regions of the first axially extending pull wire and the second axially extending pull wire to the shaft, and wherein the distal regions of the first axially extending pull wire and the second axially extending pull wire each extend closer to orthogonal to the longitudinal axis than regions of the first axially extending pull wire and the second axially extending pull wire in a deflection segment of the inner shaft.

22. The catheter of claim 21, wherein the distal regions each wrap around the inner shaft at least one turn.

23. The catheter of claim 1, wherein the outer shaft and the inner shaft are coaxial.

24. The catheter of claim 1, wherein one or more of the inner shaft and the outer shaft comprises a braided material.

25. The catheter of claim 1, wherein the inner shaft comprises an inner layer of braided material and an outer layer of braided material.

26. The catheter of claim 25, wherein the inner layer of braided material and the outer layer of braided material vary in one or more of a density of braid construction and a pattern of the braid construction.

27. The catheter of claim 1, wherein the medical tool comprises an imaging element.

28. The catheter of claim 1, wherein the medical implement comprises an ultrasonic transducer.

29. The catheter of claim 1, wherein the medical implement comprises an ablation element.

30. A catheter according to claim 1, wherein the outer shaft has at least a first segment and a second segment axially spaced apart, the first segment and the second segment having different stiffnesses, and the different stiffnesses are used to selectively control one or more of the following: the position of the deflection segment of the catheter relative to the distal end of the catheter, or the curvature of the catheter when the catheter is deflected.

31. The catheter of claim 1, wherein the medical implement is encapsulated within a polymer body comprising one or more polymer materials.

32. The catheter of Claim 1, further comprising a cable harness electrically coupled to the medical implement, the cable harness extending through the inner shaft and axially movable relative to the inner shaft.

33. The catheter of claim 1, wherein the distal end of the outer shaft extends further distally than the distal end of the inner shaft.

34. The catheter of claim 1, wherein the catheter does not include a flushing line.

35. The catheter of Claim 1, wherein the first handle actuator is located distal to the second handle actuator.

36. The catheter of Claim 1, wherein the first handle actuator and the second handle actuator are disposed at a distal end of the handle assembly.

37. The catheter of Claim 1, wherein the first handle actuator is directly adjacent to the second handle actuator when the first handle actuator is in a neutral position.

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