Medical device positioning equipment and systems

Abstract

A maneuverable medical device comprising one or more elongated shafts and medical instruments in the distal region. The medical device includes a handle portion for controlling one or more sides of the medical device.

Description

Technical Field

[0001] (Incorporation by Reference) This application claims priority to U.S. Provisional Patent Application No. 63 / 498,115, filed Apr. 25, 2023, which is hereby incorporated by reference in its entirety for all purposes. This application incorporates by reference in its entirety the disclosures of the following applications, which are hereby incorporated by reference in their entireties for all purposes: PCT / US2019 / 061228, filed Nov. 13, 2019; U.S. Provisional Patent Application No. 62 / 760,784, filed Nov. 13, 2018; International Publication No. WO 2018 / 017717, published Jan. 25, 2018; U.S. Patent Application Publication No. 20220401070(A1); and International Publication No. WO 2018 / 182836, published Oct. 4, 2018.

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

Background Art

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

Summary of the Invention

Problems to be Solved by the Invention

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

Means for Solving the Problems

[0005] This disclosure relates to medical devices and their use. Generally, this disclosure relates to flexible elongated members (e.g., flexible conductor bundles) that can extend along a portion of the length of a medical device. Some aspects of this disclosure describe methods for preventing deformation of flexible elongated members, or at least minimizing the degree of deformation. In some examples, this disclosure relates to attempts to minimize bending along a flexible elongated member at one or more locations. While bending is a type of deformation, this disclosure may also relate to attempts to minimize or prevent folding or other bundling of a flexible elongated member. In some examples, this disclosure relates to attempts to maintain the configuration of a flexible elongated member, or at least maintain a configuration as close as possible to a particular configuration, in order to prevent undesirable consequences from a large degree of deformation.

[0006] In some cases, a force is applied to the flexible elongated member at a position proximal to where it is fixed to the medical device. The applied force can help prevent undesirable deformation and / or maintain the desired configuration.

[0007] One aspect of this disclosure is a medical device configured and sized to be placed within an object such as a blood vessel, cardiac chamber, or other internal lumen or space.

[0008] The medical devices of this specification may include medical instruments such as ultrasonic transducers in the distal region of the medical device. The medical instruments may be fixed (directly or indirectly) in a first position to a flexible member such as a flexible electronic device (e.g., a flexible conductor bundle). The flexible member may extend proximal toward (and optionally toward) the handle assembly. In some examples, the disclosure relates to attempts to prevent the flexible electronic device from deforming to an undesirable extent and / or to attempts to maintain the configuration of the flexible electronic device (even if there is a slight degree of deformation).

[0009] A medical device may include one or more elongated shafts through which a flexible member passes. A medical device may include two or more elongated shafts through which a flexible member passes, such as an outer shaft and an inner shaft, the inner shaft passing through at least a portion of the outer shaft. The inner shaft may be movable relative to the outer shaft. The inner shaft may be deflectable independently of the outer shaft.

[0010] The flexible member (e.g., a flexible conductor bundle) may be movable axially within one or more elongated shafts, or it may be fixed to a shaft such as an outer shaft.

[0011] The medical device may include a tension member fixed to one or more surfaces of the flexible member (e.g., a flexible conductive bundle) at a second position proximal to the position where the medical device is fixed to the flexible member. The second position may be located within the handle assembly of the medical device, or distal to the handle assembly. The second position may be positioned so as to be within the object when the medical device is in use.

[0012] The tension member may be operably connected to (operably coupled to) a handle assembly actuator (e.g., a knob), so that the tension member moves with the operation of the handle actuator (e.g., rotation, axial movement). The actuator may also be operably connected to a medical device. In some embodiments, the tension member and the medical device are axially operably connected to the handle actuator, so that the ultrasonic transducer and the tension member move axially with the operation of the handle actuator. The axial movement of the tension can apply tension to the flexible conductive bundle at a second position within the handle assembly.

[0013] The tension member may be fixed axially to the flexible conductor bundle in a second position within the handle, thereby allowing the tension member and the flexible conductor bundle to move together axially in the second position when the handle actuator is operated.

[0014] The tensioning member may be fixed to the flexible conductor bundle, thereby maintaining the flexible conductor bundle in a substantially flat configuration at least in the position close to the medical device. The flexible conductor bundle can be maintained in a substantially flat configuration between the first and second positions when the medical device retracts proximally.

[0015] The flexible member may have flat or substantially flat first and second surfaces, and the tension member may be fixed to one or both of the flat or substantially flat first and second surfaces.

[0016] The actuator may also be adapted to rotate in order to cause rotation of a medical device, and the tension member and the actuator are operably connected so that the rotation of the actuator does not cause rotation of the tension member.

[0017] A flexible member (e.g., a flexible conductor bundle) may optionally be fixed to the printed circuit board ("printed circuit board, PCB") within the handle assembly at a position proximal to the printed circuit board.

[0018] The internal shaft of the medical device may be operably connected to the second handle actuator so that the internal shaft can be deflected when the second handle actuator is operated.

[0019] The medical device may include a flexible electronic device (e.g., a conductor bundle) planarizing member fixed to one or more surfaces of the flexible electronic device at a second position, the second position may be within a handle assembly. The flexible electronic device planarizing member and the medical device may be axially movably connected to a handle actuator, so that the medical device and the flexible electronic device planarizing member move axially upon operation of the handle actuator, thereby maintaining the flexible conductor bundle in a flat configuration between a first position and a second position, optionally.

[0020] Medical devices may also include flexible electronic equipment bending prevention members.

[0021] One aspect of the present disclosure is a method of using a medical device configured and sized to be disposed within a subject. The method includes disposing an ultrasonic transducer of an intravascular ultrasound catheter within the subject such that a flexible electronic device (e.g., a flexible conductor bundle) fixed to the ultrasonic probe at a first position extends proximally therefrom to a handle assembly, retracting the ultrasonic transducer proximally, and applying tension to the flexible electronic device at a second position proximal to the first position. The second position may be within the handle assembly.

[0022] The method may further include actuating a handle actuator, wherein actuating the handle actuator causes the ultrasonic transducer to retract proximally and tension to be applied to the flexible conductor bundle at the second position within the handle assembly.

[0023] Applying tension to the flexible electronic device can prevent folding of the flexible conductor bundle distal to the second position.

[0024] Applying tension to the flexible electronic device can include moving a tension member proximally within the handle assembly, the tension member being fixed to the flexible conductor bundle at the second position. The tension member may be operatively in communication with the handle actuator, and the method further includes actuating the actuator to move the tension member proximally and apply tension to the flexible conductor bundle.

[0025] The medical device may include a flexible electronic device having a twisted configuration along at least a portion of its length.

Brief Description of the Drawings

[0026] [Figure 1A] FIG. 1 is a diagram showing an exemplary embodiment of a system including a steering and a medical device. [Figure 1B] FIG. 2 is a diagram showing a cross-section A-A of the steering and device portion of the medical device of FIG. 1A. [Figure 2]A diagram showing an exemplary system including a handle assembly having a plurality of actuators, an operable sheath, and a medical instrument. [Figure 3Ai] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Aii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Aiii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Bi] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Bii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Ci] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Cii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Di] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Dii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Diii] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3Div] A diagram showing an exemplary operable shaft having a pull wire. [Figure 3E] A diagram showing an exemplary operable shaft in which one or more pull wires are woven circumferentially into the braided wires of the shaft. [Figure 4] A diagram showing an exemplary portion of an exemplary system including a bundle. [Figure 5] A diagram showing an exemplary proximal end of a medical instrument including a conductor bundle extending into a proximal connector housing a printed circuit board (PCB). [Figure 6A] A diagram showing a part of an exemplary medical instrument including a flexible circuit strip. [Figure 6B]This figure shows an exemplary proximal portion of the strip. [Figure 6C] This is a detailed view of an exemplary proximal portion of the strip. [Figure 6D] This is an example of an end view of a flex strip. [Figure 6E] This diagram shows an example stack of flex strips. [Figure 6F] This figure shows an exemplary stack of flex strips and grounding shield strips. [Figure 6G] This figure shows an exemplary bundle including tubing material around a stack of strips and grounding shield strips. [Figure 7] This figure shows an integrated system of a controllable sheath and medical device, with the system connected to a console via a connector cable. [Figure 8A] This figure shows an exemplary handle assembly that can be used with either the inner or outer elongated body or shaft as described herein. [Figure 8B] This figure shows an exemplary handle assembly that can be used with either the inner or outer elongated body or shaft as described herein. [Figure 9A] This diagram shows an example of an elongated inner body or a part of an inner shaft. [Figure 9B] This figure shows an example of an elongated outer body or a part of the outer shaft. [Figure 9C] Figures 9A and 9B show a part of an exemplary medical device, including an elongated body (or shaft). [Figure 9D] This figure shows a cross-section of the equipment in the deflection-possible portion, as seen from Figure 9C. [Figure 10A] This is a diagram showing a part of an exemplary handle assembly. [Figure 10B] This is an exploded view showing an example of an external, elongated body (or external shaft) moving part assembly. [Figure 10C] This is a side cross-sectional view of the handle assembly from Figure 10A. [Figure 11]This figure shows an exemplary handle assembly including rotation indicators for the first actuator and the second actuator. [Figure 12A] This figure shows the internal components of an exemplary handle assembly, including a tensioning member or a flattening member. [Figure 12B] This figure shows an exemplary internal component of a handle shell, including one or more guide features positioned to help stabilize tension members within the handle assembly. [Figure 12C] This is a side view of an exemplary handle shell. [Figure 12D] This figure shows (in a side view) the internal components of an exemplary handle assembly, including a tensioning member or a flattening member. [Figure 12E] This is a side view of an exemplary handle shell. [Figure 12F] This figure shows the internal components of an exemplary handle assembly, including a tensioning member or a flattening member, in a side view opposite to Figure 12D. [Figure 13A] This figure shows an exemplary flexible cable bundle in which at least a portion is twisted relative to its long axis. [Figure 13B] This figure shows an exemplary flexible cable bundle in which at least a portion is twisted relative to its long axis. [Figure 13C] This figure shows an exemplary flexible cable bundle in which at least a portion is twisted relative to its long axis. [Figure 13D] This figure shows an exemplary flexible cable bundle in which at least a portion is twisted relative to its long axis. [Figure 13E] This figure shows the details from Figure 13D. [Figure 14] This figure shows an exemplary medical device with a navigation interface. [Figure 15] This figure shows an exemplary medical device with a navigation interface. [Figure 16] This figure shows an exemplary medical device with a navigation interface. [Figure 17]This figure shows an exemplary medical device with a navigation interface. [Figure 18] This figure shows an exemplary medical device with a navigation interface. [Figure 19] This figure shows an exemplary transducer tip for a medical device. [Figure 20] This figure shows an exemplary transducer tip for a medical device. [Figure 21] This figure shows an exemplary transducer tip for a medical device. [Figure 22] This figure shows an exemplary transducer tip for a medical device. [Figure 23] This figure shows an exemplary transducer tip for a medical device. [Figure 24] This figure shows an exemplary transducer tip for a medical device. [Figure 25] This is a diagram illustrating an exemplary assembly for a medical device. [Figure 26] This diagram shows the arrangement of navigation sensors for medical devices. [Figure 27] This diagram shows various configurations of pull wires used to deflect a portion of the shaft or sheath of a medical device. [Figure 28] This diagram shows various configurations of pull wires used to deflect a portion of the shaft or sheath of a medical device. [Figure 29] This diagram shows various configurations of pull wires used to deflect a portion of the shaft or sheath of a medical device. [Figure 30] This diagram shows various arrangements of components within a medical device handle assembly. [Figure 31] This diagram shows various arrangements of components within a medical device handle assembly. [Figure 32A] This figure shows an example of a part of the shaft or sheath of a medical device. [Figure 32B] This figure shows an example of a part of the shaft or sheath of a medical device. [Figure 33A] This figure shows an example of a part of the shaft or sheath of a medical device. [Figure 33B] This figure shows an example of a part of the shaft or sheath of a medical device. [Figure 34] Exemplary deflection and tip length of medical devices are shown. [Figure 35] This is a diagram showing exemplary dimensions of medical devices. [Figure 36] This is a diagram showing exemplary dimensions of medical devices. [Figure 37A] This figure shows an exemplary folding pattern of a flexible strip at the tip of a medical device. [Figure 37B] This figure shows an exemplary folding pattern of a flexible strip at the tip of a medical device. [Figure 38] This figure shows an exemplary folding pattern of a flexible strip used in medical devices. [Figure 39] This figure shows an exemplary folding pattern of a flexible strip used in medical devices. [Figure 40] This figure shows an exemplary folding pattern of a flexible strip used in medical devices. [Figure 41] An example of the tip of a medical device equipped with a sensor is shown. [Figure 42] This is an illustrative diagram of the axis of a medical device as disclosed herein. [Figure 43] This is an illustrative diagram of the axis of a medical device as disclosed herein. [Modes for carrying out the invention]

[0027] Figure 1A shows an exemplary embodiment of a system integrating steering and medical equipment. System 1000 includes a steering assembly 1002 and a steering and medical equipment portion 1004. The steering and medical equipment portion 1004 includes a proximal portion 1006 and a steerable portion 1008. The system is adapted to allow the steering assembly 1002 to be actuated to steer the steerable portion 1008, and optionally to be further actuated to move the medical equipment 1010 relative to the steering and medical equipment portion 1004. In this exemplary embodiment, the steering assembly 1002 includes a first actuator 1001, a second actuator 1003, and a third actuator 1005. The first actuator 1001 is actuated (rotated in this example) relative to the steering body 1007 to steer the steerable portion 1008, specifically to steer the outer sheath 1102. The maneuverable portion 1008 in this embodiment can be steered or bent to configurations shown by solid lines in Figure 1A, and can be steered to configurations shown by dashed lines or to any position in between. In some embodiments, the opposite steer function is limited to simply straightening the shaft from the initial bent configuration, such as the solid-line bent configuration in Figure 1A. The term “maneuver” in this disclosure means deflecting or bending via the operation of at least one pull wire, but in some examples, the term may include rotation (torque) and axial movement of the shaft. The term “pull wire” in this specification refers to any element capable of transmitting tension from the proximal end to the distal end region of the device. The pull wire may consist of a metal wire such as stainless steel or nickel-titanium, which is either solid or twisted / braided, or a polymer such as aramid fiber (Kevlar®), polyethylene, PTFE, EPTE, preferably twisted / braided, but may also be in the form of a monofilament. In a preferred embodiment, the pull wire is composed of an aramid fiber bundle having four 50-denier multifilament (approximately 25 filaments) threads braided together with a high pick per inch.The cross-sectional diameter of the wire is typically in the range of 0.005 inches to 0.012 inches, more preferably 0.008 inches to 0.010 inches, although braided or twisted wires may be flattened or elliptical within the lumen of the instrument. A preferred structural embodiment is considered to provide optimized strength and wear resistance with respect to the size required to keep the shaft diameter to a minimum. An optional second actuator 1003 is actuated (rotating in this example) with respect to the handle body 1007 to rotate (indicated as rotational movement "R") the medical instrument 1010 relative to the shaft 1102, and an optional actuator 1005 is actuated (axially in this example) with respect to the handle body 1007 to move the medical instrument 1010 axially (distal-proximal) relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the maneuverable portion 1008 is maneuvered (bent / bent), but the proximal portion can bend and bend to conform to the anatomical structure used internally by the proximal portion. In many embodiments, this is achieved by constructing the maneuverable portion 1008 from a material and / or composite structure that is softer or less rigid than the proximal portion 1006.

[0028] The embodiment shown in Figure 1A is an example of a device including an integrated handle assembly that is operably in communication with both a steerable outer shaft and an inner medical device. The handle assembly is integrated in that it is assembled and constructed to be operably in communication with the outer shaft and the inner medical device before packaging and use. When the term “integrated” is used in the context of an integrated handle assembly, it refers to a handle assembly that requires at least a portion of the handle assembly to be destroyed or disassembled before it becomes possible to remove the medical device from inside the outer shaft.

[0029] Figure 1B shows an exemplary cross-section AA (shown in Figure 1A) of the steering and equipment portion 1004, specifically of the operable portion 1008. In this embodiment, the medical device 1010 is sized and configured to be housed within an operable sheath. The operable sheath includes an outer shaft 1102 and a pair of pull wires 1104 fixed axially in the distal region of the operable portion 1008.

[0030] The medical devices in Figures 1A and 1B may be any medical device as specified herein, such as an ultrasonic device. When “ultrasonic probe” is used herein, it generally refers to an elongated device comprising at least one ultrasonic transducer and one or more conductive elements electrically connecting at least one ultrasonic transducer to the proximal region of the elongated device. The proximal region of the ultrasonic probe includes, or is modified to include, at least one proximal contact that is electrically in communication with at least one ultrasonic transducer and can optionally be electrically in communication with electrical contacts on another device, cable, or connector via attachments thereto.

[0031] Figure 2 shows an exemplary system 10 adapted to function similarly to the systems in Figures 1A and 1B, and also shows exemplary internal components of the handle assembly 12 (internal components shown as dashed lines). The handle assembly 12 is integrated with the outer operable shaft 20 and the medical instrument 30 and is operably connected to the outer operable shaft 20 and the medical instrument 30. The handle assembly 12 includes an actuator 14 adapted to operate the operable shaft 20 when actuated against the handle body 15. The actuator 14 is operably connected to the operable shaft 20 via an operating control unit 16 located within the handle assembly 12. The medical instrument 30 is located within the handle assembly 12 and includes a proximal portion 18 incorporated into the handle assembly 12. An actuator 13 is operably connected to the medical instrument 30, and by acting the actuator 13 against the handle body 15 (rotating in this example), the medical instrument 30 is rotated relative to the outer shaft 20 via a rotation control unit 1215. The optional third actuator 17 is also operably connected to the medical instrument 30 and, in this embodiment, is adapted to act axially (relative to the handle body 15) to move the medical instrument 30 axially relative to the outer operable shaft 20 via the axial control unit 1217.

[0032] The medical device in Figure 2 may be any medical device as specified herein, such as an ultrasonic device.

[0033] Figures 3A to 3E represent exemplary embodiments of the distal region of the sheath portion 1208 of the maneuverable sheath 1202 within the system 1200. For simplification, the illustrated cross-sections show only the outer sheath 1208, and the inner instrument 1212 is not shown. The outer sheath 1208 preferably has a composite structure to improve torque transmission applied to the outside of the shaft from the proximal end, or to resist torque forces applied to the outer sheath 1208 from inside the shaft, such as from the instrument 1212. As shown in Figures 3Ai to 3Aiii, to form the composite, a plurality of braided elements 1250, preferably formed from metal wires (round, several pairs of round, or ribbon) and / or a plurality of fibers (e.g., aramid or nylon), may be braided directly onto a thin-walled (e.g., 0.0010 inches ± 0.0005 inches) lubricating liner tube 1251, such as PTFE or FEP material. A thermoplastic polymer 1252 (such as Pebax, nylon, or other common catheter materials in the durometer range of 25D to 72D) can be heat-laminated using heat-shrink tubing (such as FEP), and the polymer can be reflowed onto the braided element 1250 and liner tube 1251 to form a uniform component. The thermoplastic polymer 1252 may also have radiopaque compounds containing materials such as bismuth, barium sulfate, or tungsten, so that the tip of the sheath is visible to the user under fluoroscopy.

[0034] In the embodiments shown in Figures 3Ai to 3Aiii, the pull wire 1104 is preferably parallel to the central axis in a maneuverable (deflectable) portion 1222 of the sheath, and also preferably located within a lumen 1253 created within the wall of the maneuverable sheath 1208. This lumen can be fabricated during the extrusion process of the thermoplastic polymer tube or during a shaft thermal lamination fusion process using a removable mandrel. The pull wire lumen 1253 may be further fabricated by incorporating the pull wire tube 1254, which is preferably temporarily supported by a removable mandrel, into the wall. The removable mandrel may also be positioned along the pull line 1104 or 1104' during the fusion process, resulting in a somewhat elliptical lumen 1253, which allows the fibrous pull wire to be flattened and provides space for the pull wire to move freely. The tube 1254 may contain PTFE, FEP, polyimide, or other material that maintains the integrity of the tube 1254 walls during a heat lamination process up to about 500°F. The tube is preferably surrounded and supported by a thermoplastic polymer 1252, which is preferably heat-laminated to the tube.

[0035] In another embodiment, a pull wire lumen, preferably including a pull wire tube, is incorporated into the fabric of the braided element 1250. For example, a braided element 1250 extending in one direction would pass below the pull wire lumen, while a braided element 1250 extending in the opposite direction would pass above the pull wire lumen. The braided reinforcement provides a more dimensionally stable lumen during catheter manipulation and helps ensure the straightness of the lumen as needed. Proximal to the maneuverable portion, the pull wire may extend proximal parallel to the central axis on the same side of the outer sheath 1208, as shown in Figures 3Ai to 3Aiii. In this embodiment and other embodiments below, a further pull wire 1104' in a further pull wire lumen routed through the maneuverable portion 1222 within the wall of the sheath 1208 may be required to straighten the maneuverable portion of the device. The straightened pull wire 1104' is preferably routed within the maneuverable section 1222, on the opposite side from the pull wire(s) 1104 used for steering (deflection) within the maneuverable section 1222. In another embodiment not shown, two lumens and two straightened pull wires 1104' can be used, essentially reflecting a paired 1104 pull wire configuration. These straightened wires may also be configured to allow deflection in the opposite direction by applying tension over longer distances within the handle (beyond simply straightening them).

[0036] During use, the distal catheter portion 1223, located immediately proximal to the maneuverable (bendable) portion 1222, may be biased to conform to a curve based on the constraints of the anatomical structures used internally. In a particular embodiment where the device advances into the cardiac chambers from an inguinal access, the biased, curved portion 1223 is expected to be in the range of 5–25 cm in length. During rotation of the sheath shaft 1208 from the proximal end, torque is transmitted to the catheter tip through this distal curved region 1223. Non-uniform cross-section and / or tension of the device in this region 1223 may induce a tendency for the shaft to accumulate torque and suddenly release it, resulting in a "whip" or sudden rattle of rotation when torque is applied. To minimize the possibility of whipping, optionally, the tension and constituent material of the pull wire are distributed around the surface of the curved region 1223. In one embodiment, as shown in Figures 3Bi to 3Biii, the pull wire 1104 may be spirally wound around the central axis of the sheath in a curved region 1223 at least proximal to portion 1222. The pull wire in this embodiment may be wound around the entire circumference for a length of about 10 cm (this value is in the range of 5 to 15 cm). The spiral body only needs to be present in the curved region 1223 and then extend straight proximally through the proximal portion 1224 (similar to 1006), thereby minimizing friction within the pull wire lumen and the associated pull wire force required to steer (deflect) the maneuverable portion 1222. The spiral body may extend straight after at least one turn, or it may be spirally wound along the entire length of the shaft. In another embodiment to minimize whipping, the tension of the pull wire may simply be distributed to the opposite side of the shaft. As shown in Figures 3Ci to 3Cii, the deflection of the maneuverable section 1222 is achieved by two parallel pull wires 1104 positioned adjacent to each other on the same side of the sheath 1208. In the curved region 1223 and proximal section 1224 (similar to 1006) near the proximal part of the maneuverable section 1222, the pull wires are routed to the opposite side of the shaft at 90° from their positions in the maneuverable section 1222, respectively, to distribute the tension more evenly.It is preferable to actuate two parallel pull wires simultaneously with equal force by a handle actuator, but in other embodiments, the difference in force can be applied to maneuver the ends toward one or the other side of the plane formed when the two pull wires are actuated with equal force. In other embodiments, any multiple pull wires can be routed in the same configuration as shown in Figure 3B or Figure 3C, with multiple proximal pull wires evenly distributed around the circumference of the shaft. Also, as shown in Figures 3Ci to 3Cii, the pull wire 1104 can be routed proximal along the opposite side of the shaft for most of the length of the proximal portion 1124 of the shaft, but preferably they are brought together again adjacent to each other near the proximal end portion of the shaft so that the wires can exit together from the same side of the proximal shaft, facilitating their fixation together to the handle component for simultaneous acting tension.

[0037] Figures 3Di to 3Div show another embodiment of the distal region of a catheter having a similar structure to those described above, but instead configured to provide a distal maneuverable portion 1222 that can be deflected in two different directions. As shown, two pairs of pull wires 1105 / 1107 and 1106 / 1108 run along the proximal shaft region 1224 and the curved region 1223. This is similar to Figures 3Ai to 3Aiii, but differs in that the wires are paired on each side of the shaft. The routing may be a helical winding as shown in Figures 3Bi to 3Bii, or other configurations discussed. Within the distal maneuverable portion 1222, the wires are routed 90° from the proximal portion, but other angles are also conceivable. At joint 1225 within 1222, one or more of the pull wires (e.g., 1105 and 1107) may be terminated and fixed to the shaft, while the remaining pull wires (e.g., 1106 and 1108) extend to a more distal end location 1226, where they are fixed. This configuration allows for independent operation of the pull wires terminated at 1225 and 1226, enabling them to form different shapes during operation. Figure 3Dii shows tension applied to both wires 1107 and 1108 to create a variable curve in the same direction. Figure 3Diii shows tension applied to wires 1107 and 1106 to create an "S" curve. Other configurations are also possible.

[0038] To prevent the pull wires from breaking or being pulled freely when repeated tension is applied, the pull wires (such as 1104 and 1104') can be terminated at their distal ends so that the pull wires are securely fixed to the wall of the distal maneuverable shaft portion 1222. In a preferred embodiment shown in Figure 3E, the pull wires 1104 and 1104' are circumferentially woven into the braided wire 1250 of the distal shaft 1222 (shown without the thermoplastic polymer 1252) as they exit the distal pull wire lumen 1253. Alternatively, one or more of the pull wires 1104 or 1104' can be wrapped around and / or tied to the outside of the braided wire 1250 for further fastening. The braided wire 1250 can then be cut distal to the fixing point, and the woven and / or wrapped pull wires prevent the braided wire from expanding and / or fraying. Alternatively, the pull wire can be secured to the braided wire using UV curing or a further adhesive such as cyanoacrylate. The weave and / or winding of the pull wire and braided wire is then laminated with a thermoplastic polymer, which melts in the space around the wire and cools to fix the wire in place. The thermoplastic polymer may also have radiopaque compounds containing materials such as bismuth, barium sulfate, or tungsten, so that the tip of the sheath is visible to the user under X-ray fluoroscopy.

[0039] In further embodiments, the instrument 1212 may be constructed using one or more pull wires to deflect its tip in the same manner as in any of the above embodiments described for the outer sheath 1208. In addition to routing the pull wires within the walls of the tubular member of the instrument 1212, the pull wires may be routed alongside the conductors in the lumen of the tubular element 1212. The action of the pull wires may originate from an actuator located within the proximal handle 1206. The distal shaft of the instrument 1212 may be formed in a specific shape (e.g., arc-shaped) so as to bend into a specific shape when it exits the tip of the maneuverable portion 1222 of the outer sheath 1208. The stiffness of the distal shaft of the instrument 1212 is such that the distal shaft does not substantially deform the outer sheath 1208 while it is inside, but bends after it exits. The shape can be determined by any one or a combination of the following means: thermosetting of a polymer material; the use of a movable or fixed molded stylet in the inner lumen of the shaft 1212 or in the lumen within the wall of the shaft 1212. Such a stylet may have a round, elliptical, or rectangular cross-section and may be formed from stainless steel, nitinol, or a rigid polymer such as PEEK or Vestamid. Alternatively, the outer maneuverable sheath may be bent in a manner similar to that described above, with or without further deflection of the pull wire, and with or without further shaping or deflection of the distal portion of the instrument shaft 1212.

[0040] One aspect of the present disclosure includes a method for selectively separating at least a portion of a system from other components as part of a rearrangement process. In some embodiments, a medical device includes one or more electrical contacts connected to other electrical contacts that are electrically in communication with an energy console, examples of which are known in the field of ultrasound.

[0041] In one embodiment, the pull wires shown in Figures 3Ai-3E may be present in a symmetrical design, or they may branch to change their relative positions to each other in various sections of the shaft. By controlling the stiffness of the shaft and the positioning of the pull lines (e.g., moving the branching point further distally), off-axis curl can be reduced, while providing more precise control of the deflection of the distal end of the shaft. The associated shaft may have multiple bobbins (e.g., 16 bobbins), which may be tuned to increase torque response. The associated shaft may have multiple (e.g., 4) pull lines for balanced braided wire, which can reduce deflection and orientation changes due to annealing and sterilization. The associated shaft may have a more optimized non-deflected tip length as described herein. As a further example, the associated shaft may have a flared inner diameter at the tip so as not to bond to the bundle very close to the post.

[0042] Figure 4 shows some exemplary medical devices, such as ultrasound probes, that can be electrically coupled directly or indirectly to an energy console, such as an ultrasound console.

[0043] Repositioning the device may involve disconnecting one or more proximal electrical contacts and moving the device portion distally from the distal end of the sheath portion. In this embodiment, the device portion 1212 includes at least an outer sheath or outer 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 outer member 2010 to the proximal connector (for clarity, the connector and handle mechanism are not shown in Figure 18). In some embodiments, the medical device is used for ultrasonic imaging, and optionally, the distal working end 1821 includes a two-dimensional (2D) array of piezoelectric elements mounted on an application-specific integrated circuit (ASIC).

[0044] Figure 5 shows a merely exemplary proximal end of a medical device (the medical device is shown on the right), 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 which is adapted to be electrically coupled directly to an energy console, such as an ultrasound energy console, or indirectly to an energy console. As shown in Figure 5, the flexible conductor bundle 2020 extends from the distal region of the medical device (the distal region is not shown) into the proximal connector 2015 which houses a rigid or flexible printed circuit board ("PCB") 2030. The connector bundle 2020 includes a number of contacts 2024 attached to PCB board contacts 2031 (an example of which is described later). Each individual wire from each contact 2031 is coupled to an individual exposed contact 2050, optionally more proximal, in another part of the PCB. Individual PCB wires may also pass through other useful circuits on the PCB. The exposed contact 2050 is configured for mechanical meshing for electrical conduction to a similar contact 2060 on the interlocking connector cable 2070, in a similar manner to the aforementioned proximal device connector 1990, connecting the device 1204 to the user interface console. The proximal connector 2015 may be incorporated into any of the systems, handles, maneuverable sheaths, medical devices, etc., as described herein.

[0045] As used herein, the term “conducting bundle” may be used interchangeably with “flexible conducting bundle” unless otherwise specified herein.

[0046] Figures 6A and 6B show exemplary conductor strips (also referred to herein as flexible circuit strips) 2021 that may be included in any of the conductor bundles described herein. Embodiments of Figures 6A and 6B are examples of conductor strips that may be included in the bundle 2020 of Figures 4 and 5. Embodiments of Figures 6A and 6B may be incorporated into any other system described herein.

[0047] As shown in Figures 6A, 6B, and 6G, the conductor bundle 2020 includes multiple wiring strips 2021, as well as several flexible circuit strips, including conductive strips for grounding 2022 and shielding 2023 (only a portion of which is illustrated). Each multiple wiring strip includes several conductive traces 2025, which can be clearly seen in Figures 6B, 6C, and 6D. The number of traces 2025 in Figures 6D–6G is 12, and the number of traces in Figures 6A–6C is 16; these are both illustrative with respect to the number of traces 2025 that can be used. Each strip 2021 may be approximately 0.072 inches wide and 0.0022 inches thick, and may optionally include 16 conductive (e.g., copper) wires spaced approximately 0.0022 inches apart, each measuring approximately 0.0022 inches wide × approximately 0.0007 inches thick. The wiring is arranged on an insulating substrate layer 2027, such as a polyimide substrate, and the wiring may be at least partially covered by a cover layer 2026, such as a photosensitive film cover ("PIC") layer or other dry film solder mask (DFSM), or other similar material. The cover layer extends generally along most of the bundle, except for separate locations in the proximal and distal regions for electrical coupling. In other embodiments, strip 2021 is approximately 0.055 inches wide and contains 12 conductive wires (see Figures 6D–6G). In other embodiments, strip 2021 is approximately 0.037 inches wide and contains 8 copper conductive wires. Outer strips 2022 and 2023 used for grounding and shielding may have similar configurations and dimensions, except that they may include a single full-width strip of copper. To optimize for a 2D piezoelectric array, approximately seven stacks of 16-wire strips 2021 (or nine 12-wire strips, or fourteen 8-wire strips) will be required along one strip each of strips 2022 and 2023 on each side of the multi-wire strip stack. Figure 6E shows a portion of an exemplary bundle 2020 with nine strips 2021 stacked on top of each other.Figure 6F shows a portion of the bundle, including nine stacked strips 2021, as well as the ground strip 2022 and the shield strip 2023 (only the top strip is labeled). The complete bundle may optionally be held together with heat-shrink tubing with a wall thickness of approximately 0.001 inches, such as tube 2028 in Figure 6G, for example, but not limited to these. The dimensions and number of wires of the flex circuit described above are for a particular configuration of the piezoelectric array (and / or its ASIC controller) and may vary depending on how the number and size of array elements are optimized for a particular application.

[0048] The proximal end of each flex circuit strip has a conductive material (e.g., gold-plated copper) exposed over a length of, for example, about 3 mm by removing the cover layer 2026 at location 2024. Location 2024 and other exposed locations described herein are broadly referred to as “contacts”. In this context, it is understood that contacts actually include multiple separate conductive traces (such as those indicated in the location of the region), and each of these traces is adapted to be electrically in communication with a corresponding conductive element. Thus, “contacts” is not limited to meaning only a single electrical connection between two conductive elements. Figure 6A shows multiple exposed regions 2024, but the embodiment of Figure 6A is initially described herein as if only one exposed region (i.e., the proximal end region 2024) exists. Strip 2021 can be manufactured to produce electrical connections to matching exposed contacts 2031 for conductive traces on PCB 2030, as shown in Figures 6A–6C. In some embodiments, 16 individual wires, sized to match and spaced apart to match 16 wires within a multi-wire strip 2021, are provided within a given contact 2031. A suitable electrical connection (electrical coupling) between the strip wires and the PCB contact may be achieved using an anisotropic conductive film (ACF), soldering, conductive adhesive, mechanical connection, or any combination thereof.

[0049] The flexible strips shown in Figures 6A to 6G may include a variety of configurations. A modified M-shaped folding configuration, which pulls the wider portion of the application-specific integrated circuit (ASIC) flex further distally, may allow for more distal positioning of the inner shaft 132. A Z-shaped folding configuration may have two bends. As an exemplary example, a stacked configuration of a flexible circuit board may be used. The Z-shaped folding is shown, for example, in Figure 38 and shows stacked components J, H, and G as referenced in Figure 37. A first version of the M-shaped folding configuration may allow for a shorter length associated with the tip, as shown in Figure 39. A modified M-shaped folding configuration may allow for a shorter length associated with the tip than the other two configurations described, as shown in Figure 40.

[0050] The modified M-shaped folding configuration may have a series of folds within the flex so that the proximal broad portion of the flex is brought as distal as possible. The optimal number of fold points is four; beyond this, the stack is too thick to fit the outer shaft. The broad portion in question is located immediately distal to pad G, which is too wide for the inner diameter of the inner shaft to advance. Some fold positions, particularly those involving folds of long flexes (e.g., connecting to pad H), may need reinforcement to prevent the folds from becoming too tight and damaging the cover layer and / or copper traces. Reinforcement across fold positions can be achieved using various materials such as adhesives, tapes, or thin-walled heat-shrink tubing (e.g., PET) to limit the bending radius of the flexibility to an acceptable level.

[0051] Figure 7 shows an integrated system 1200 comprising a controllable sheath 1202 and a medical instrument 1204, the system 1200 being connected to a console 4000 via a connector cable 2070. As previously mentioned, such as with respect to Figure 5, the instrument 1204 includes a proximal connector 2015 that forms a mating connection to the cable 2070. As previously mentioned, it is desirable to relocate (e.g., reprocess and reuse) the system 1200. It is further desirable to ensure that the system is relocated only by authorized manufacturers and not by unrelated third parties, and that the device is reused only a certain number of times. To control the relocating process, a cryptographic authentication chip (encryption chip) is preferably incorporated into the instrument 1204 on the PCB 2030, but other locations such as within the controllable handle 1206 or within the tip 3000 are conceivable. The encryption chip is programmable only by authorized manufacturers who control the authentication key. The console 4000 to which the system 1200 is connected has a Trusted Platform Module (TPM) which also has the authentication key. While system 1200 is in use, console 4000 can authenticate system 1200 via an encryption chip and, if desired, read information (e.g., via an EEPROM mechanism) and write information to the chip. In any of the scenarios considered, an RFID chip, preferably an encrypted RFID chip, can be used to read and transmit data between the console, connector, and device.

[0052] As used herein, “cleaning” can refer to any type of cleaning, including, but is not limited to, cleaning the inside of an outer shaft using a cleaning system of cleaners and / or disinfectants, optionally mechanically scrubbing with a small brush, mechanically cleaning (e.g., wiping, brushing) the outer portion of the outer shaft and / or the outer portion of a medical device shaft (e.g., an ultrasonic probe) with a cleaner / disinfectant, optionally immersing the shaft in an ultrasonic bath of the cleaner / disinfectant for a specific period of time, and optical cleaning methods, 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.

[0053] The disclosures herein also include methods for assembling or reassembling any of the subassemblies or assemblies herein, including any of the internal subassemblies of any of the handle assemblies herein. For example, but not limited to, the disclosures herein include methods for winding one or more pull wires onto the bearing surface of a spindle support and then around the spindle.

[0054] The methods described herein also include manufacturing or constructing any of the individual components of any subassemblies or assemblies described herein. For example, the disclosure includes a method for manufacturing a component of a handle shell having certain configurations (e.g., guides, walls, etc.) that can accommodate internal components that enable the assemblies or subassemblies described herein to function as intended.

[0055] Regardless of the reference numerals, any of the handle assemblies, medical devices, operable sheaths, and electrical connections described herein can be used together in any combination within a system.

[0056] Any technique, including ultrasonic and manipulative techniques, found in any of the following U.S. patent references may be incorporated herein into any medical device, apparatus, system, or method of use thereof, and such disclosures are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833 ,7783339,7791252,7791252,7819802,7824335,7966058,8057397,8096951,8207652,8207652,8213693,8364242,8428690,8451155,8527032,86 59212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

[0057] Any preferred disclosure described above may be incorporated into any of the following embodiments. For example, embodiments of equipment, systems, and methods of manufacture and use are incorporated herein and, unless otherwise specified, may be incorporated into any of the following embodiments.

[0058] Figures 8A and 8B show a purely exemplary handle assembly that can operably communicate with an outer shaft 131 and an inner shaft 132. In this embodiment, the handle assembly 120 includes a handle body 123 having an outer surface that can be grasped by a user, a first actuator 121, and a second actuator 122. The actuator 121 can operably communicate with the outer shaft 131, and the actuator 122 can operably communicate with the inner shaft 132. The actuator 121 is adapted to rotate and move axially relative to the handle body 123 (and the second actuator 122). This allows the actuator 121 to cause axial movement and rotation of the medical instrument 103 relative to the distal end of the inner shaft 132. The second actuator 122 is adapted to be actuated (e.g., rotated in this embodiment) relative to the handle body 123 to cause deflection of the inner shaft 132. For example, the handle assembly may have internal components that interface with the proximal ends of the pull wires such that the operation of actuator 122 applies tension to one or more pull wires, causing the inner shaft to deflect. In this embodiment, actuator 121 is distal to actuator 122, but in other designs, their relative positions can be reversed. Figure 8B shows the handle assembly 120 after actuator 121 has advanced distally relative to its position in Figure 8A. This distal advance causes the outer shaft 131 to advance distally, and therefore the medical device to advance distally. Actuator 121 can also be retracted proximal to its position in Figure 8B. With regard to actuator 121 retracting proximal, refer to the tension members described further below.

[0059] In other designs, actuator 121 can be operably communicated with the inner shaft, and actuator 122 can be operably communicated with the outer shaft.

[0060] As described herein, the outer shaft can be moved axially relative to the inner deflectable shaft. The outer shaft may consist of portions of material in which the stiffness (e.g., durometer) varies along at least a portion of the length of the outer shaft. For example, the first portion distal to the second portion may have a lower durometer than the second portion. Because the outer shaft can be moved axially relative to the deflectable inner shaft, and the stiffness of the outer shaft can vary along the length of the outer shaft, the deflection of the entire instrument, including its degree (or amount), can be selectively controlled by controlling the axial position of the outer shaft (relative to the inner shaft). Thus, the deflection of the instrument can be selectively controlled by the axial movement of the outer shaft. For example, a user (e.g., a physician) can change or control where bending occurs along the length of the instrument (measured from the distal end) by moving the outer shaft axially relative to the inner shaft. In addition, for example, sections of varying stiffness in the outer shaft can allow for more or less deflection depending on the relative position of the outer shaft to the deflectable inner shaft. For example, by deflecting the inner shaft in a region where the outer shaft has relatively high rigidity, the deflection of the inner shaft may be smaller than when the outer shaft is deflected in a region where it has lower rigidity. A distinction in the characteristics and control of the inner and outer shafts is referred to, but such control of the inner and outer shafts may be reversed, with the inner shaft configured for rotation and the outer shaft configured for deflection.

[0061] Figure 9C shows an exemplary medical device 130 including an elongated inner shaft 132 (see Figure 9A) and an elongated outer shaft 131 (see Figure 9B). The medical device 130 may be referred to herein as a “catheter” or other medical devices including at least one elongated shaft.

[0062] Figure 9D shows cross-section AA of the assembly in Figure 9C, which is a cross-section of the deflectable portion of the equipment. The parts in Figures 9A to 9C are similarly referenced. As seen in Figure 9D, pull wires 111 and 112 are very close to each other and about 180 degrees away from the straightened pull wire 116.

[0063] Furthermore, as shown in Figure 9D, the elongated inner shaft 132 includes two layers of braided material 119, and the pull wire is essentially sandwiched between the two layers of braided material, at least in this portion of the shaft. The annular space 118 allows for freedom of movement and space for an optional lubricant. The inner shaft 132 can be manufactured from a polymer material such as Pebax, for example, but not limited to, and optionally with a lubricating additive. The inner shaft 132 may include a liner 125 such as a PTFE liner. The flexible cable bundle 105 may be surrounded by one or more layers of insulator 126 such as a PTFE insulator. The outer shaft 131 may include a polymer material 127 such as Pebax. The outer shaft 131 may also include a radial inner liner 128 such as a PTFE liner. Any of the pull wires (e.g., 111, 112, 116) may be placed in a lumen having a liner such as a PTFE liner 129.

[0064] The medical device 130 (or, individually, either the elongated shaft 132 or the elongated shaft 131) can be operably connected to any of the handle assemblies of this specification, including the handle assembly 120 shown in Figures 8A and 8B.

[0065] Figures 10A–10C and 11 show additional exemplary handle assemblies that can operably communicate with any medical device, including an ultrasound probe, as described herein. For example, the exemplary handle assemblies shown in Figures 10A–10C can be coupled (directly or indirectly) to and operably communicate with the medical device 130 shown in Figures 9A–9D. In certain embodiments, both the elongated outer shaft 131 and the elongated inner shaft 132 are coupled to and operably communicate with the handle assemblies shown in Figures 10A–10C.

[0066] The handle assemblies in Figures 10A–10C and Figure 11 have some similarities to the handle assemblies, individual components, and subassemblies shown in Figures 8A and 8BB. Unless otherwise noted, the concepts, features, and uses of Figures 8A and 8B that can be incorporated into the handle assemblies of Figures 10A–10C are incorporated by reference for all purposes into the disclosures of handle assemblies shown and described herein. Similarly, the concepts, features, and uses shown and described in Figures 10A–10C that can be incorporated into other handle assemblies described herein are incorporated by reference for all purposes into any disclosure of handle assemblies described herein.

[0067] Figure 10A is a side view of the handle assembly 140 with a portion of the handle body 141 removed so that some internal components of the handle assembly are visible. The handle assembly 140 includes a first actuator 143 and a second actuator 142, the first actuator 143 being distal to the second actuator 142 in this embodiment. The first actuator 143 can move and rotate axially relative to the handle body and the second actuator (actuator 142 in this embodiment). The first actuator 143 is operably connected to an outer elongated body such as an outer shaft 131 (see Figure 9B). Axial movement (distal or proximal) of the actuator 143 causes axial movement of the outer shaft 131, while rotation of the actuator 143 causes rotation of the outer shaft. The second actuator 142 is operably connected to an inner shaft such as an inner shaft 132 (Figure 9A). The operation of the second actuator 142, in this embodiment, rotation, causes deflection of the inner shaft. In this embodiment, a rotatable and axially movable actuator (i.e., the first actuator 143) is operably in communication with the outer shaft. While it is referenced that the operation of the second actuator 142 may cause deflection of the inner shaft, alternatively, the operation of the second actuator 142 may cause rotation of the inner shaft. Similarly, alternatively, the operation of actuator 143 may cause deflection of the outer shaft.

[0068] The first actuator 143 is coupled to an elongated outer shaft moving assembly 150, as shown in the exploded view of Figure 10B, so that movement of the first actuator 143 causes movement of the assembly 150. The elongated outer shaft moving assembly 150 is similarly coupled to the elongated outer shaft, so that movement of the first actuator also causes movement of the elongated outer shaft. In this embodiment, the outer elongated shaft is inserted into a channel 156 and then attached to a removable component 153. The removable component 153 and the channel 156 are configured such that the removable component 153 is constrained by at least one inner surface of the channel when it is inserted into the channel 156. The elongated outer shaft moving assembly 150 also includes a distal head portion 151 fixed to the first actuator. The elongated outer shaft moving assembly 150 also includes a rotation limiting mechanism similar to those described herein, which limits the rotation of the first actuator 143, thereby limiting the rotation of the outer elongated shaft. Any of the above disclosures relating to the rotation-limiting subassemblies, functionality, and use are incorporated into this embodiment for all purposes and may be incorporated into this design and similar designs. During rotation, part 157 (see Figure 10B) interacts with part 161, and part 162 interacts with part 158. The physical interaction of these two sets of parts limits the rotation to a desired limit, for example, limiting the rotation of the outer body to a maximum of 630 degrees (in other embodiments, the allowable rotation may be greater than 630 degrees, for example, 720 degrees or less).

[0069] For example, if it is desired to clean the outer shaft after use, the removable part 153 can be removed from the outer shaft, the outer shaft can be removed from the handle assembly and cleaned, and then the removable part 153, or a new removable part if part 153 is damaged or broken, can be reinserted and reinstalled.

[0070] The handle assembly 140 also includes an inner shaft deflection assembly 146 which is operably in communication with a second actuator 142. The inner shaft deflection assembly 146 includes a central gear 147 which is adapted and configured to rotate when the second actuator 142 rotates. The central gear 147 interfaces with the first spindle 148 and the second spindle 149 via a geared interface, so that the rotation of the central gear 147 causes the spindles to rotate in the opposite direction. The inner shaft deflection assembly 146, including the spindles, extends further proximal to the elongated outer body moving assembly 150. The inner shaft extends through the outer shaft and also extends further proximal to the outer shaft within the handle assembly 150. This allows one or more pull wires, which are part of the inner shaft, to extend radially outward and interface with the reel 160.

[0071] The central gear 147 and the geared interface are shown using spur gears, but in other embodiments, helical gears may be used. Helical gears can provide smoother control and reduced tilt of the first actuator 143 and the second actuator 142. Helical gear designs can provide smoother operating performance than spur gears. Helical gears may have more "virtual teeth" compared to physical teeth. Helical gears may have the same number of "virtual teeth" as spur gears, while having fewer physical teeth than spur gears, allowing the device to have the same or better functionality while using a smaller area. Helical gears may have stronger teeth, as measured by bending and surface fatigue, compared to spur gears with the same number of physical teeth. Helical gears can reduce undercuts and have fewer physical teeth compared to the minimum number of physical teeth required for spur gears. An exemplary helical gear configuration may include 26 gear teeth, 17 pinion teeth, a gear ratio of 26:17, a pressure angle of 20 degrees, and a helical angle of 20 degrees. The exemplary helical gear configuration may also include 1.0 degree gears meshed in alignment to allow for easy manufacturability. The helical gear may be molded. The helical gear may have a configuration similar to that of a spur gear. The helical gear configuration may include spindles such as a first spindle 148 and a second spindle 149 having through holes, as the spindles have in a spur gear configuration.

[0072] The lack of interaction between the elongated outer shaft moving assembly 150 and the elongated inner shaft moving assembly 146 allows the inner and outer elongated shafts to be controlled independently by the first actuator 143 and the second actuator 142.

[0073] The handle assembly 140 also includes a printed circuit board ("PCB") 170 located within the handle body 141, the PCB being electrically connected to either a cable bundle such as the flexible cable bundle 105 in Figure 53, or a cable bundle of this specification communicating with a medical device such as an ultrasonic transducer.

[0074] The handle assembly 140 also includes a rotation indicator 180 that can be used to indicate to the user the degree to which at least one of the first actuator and the second actuator rotates relative to the home or neutral position. The first actuator 143 may include a rotation indicator 181 that is aligned along the axis with the rotation indicator 180 when the first actuator 143 is in the neutral position, as shown in Figure 11. As the first actuator 143 rotates, the rotation indicator 181 rotates relative to the axis from which the rotation indicator 180 extends, thereby allowing the user to visually understand that the first actuator 143, and therefore the outer shaft, rotates to some extent relative to the neutral position. Similarly, the second actuator 142 may also have a rotation indicator 182 that is aligned along the axis with the rotation indicator 180 when the second actuator 142 is in the neutral position, as shown in Figure 11. When the second actuator 143 rotates, the rotation indicator 182 rotates with respect to the axis from which the rotation indicator 180 extends, thereby allowing the user to visually understand that the second actuator 143, and therefore the inner shaft, is deflected to some extent relative to its neutral position.

[0075] In some alternative embodiments, the handle assembly may include one or more sensors to track how much rotation occurs on the outer shaft or how much deflection occurs on the inner shaft. In some embodiments, the handle assembly may include encoders for each actuator.

[0076] In any embodiment of this specification, including an outer shaft and an inner shaft, the device may include one or more lubricants between the inner and outer shafts, thereby facilitating the movement of the inner and outer shafts relative to each other by reducing friction between the two shafts. If the medical device needs to be cleaned for reuse, additional lubricants may be added between the inner and outer shafts after the cleaning process.

[0077] In some embodiments of this specification, the medical device may include a flexible member, such as a flexible conductive bundle (which may be referred to herein as a conductive bundle, flex bundle, or other similar derivatives thereof), coupled to the distal region of the medical device (e.g., the probe tip) and extending thereto toward the proximal region (see, for example, conductive bundle 2020 shown in exemplary Figures 4–6G, or bundle 105 in Figure 9B). The probe tip may include an ultrasonic transducer electrically communicating with the flexible conductive bundle. In some embodiments of this specification (e.g., Figures 9A–11), the probe tip and conductive bundle may be displaced axially (proximal and / or distally) by the operation of a handle actuator (e.g., actuator 143 shown in Figure 10A). In some cases, the conductive bundle is located within an elongated member (e.g., a maneuverable inner elongated body 132, or elongated member 131) and moves axially relative to it as the probe tip advances distally or retracts proximal. When the distal region (e.g., ultrasound probe) and the conductor bundle retract proximally (after advancing distally), the conductor bundle tends to fold, bundle, or bend in other ways due to friction between the bundle and, for example, the elongated member (e.g., the maneuverable inner shaft 132) on which the conductor bundle is positioned, near or adjacent to its distal end. Bundling can occur when the medical device has a linear configuration, and when the medical device has some degree of bending (e.g., after being deflected from a linear or linear configuration).

[0078] To reduce, or even completely prevent, the tendency to bundle or bend, any medical device according to this specification may include a structural tension member fitted and configured to apply or maintain tension to a flexible member, such as a flexible conductor bundle, at a position proximal to where the conductor bundle is attached to the distal medical device. By applying tension to the flexible member, folding or bundlening of the flexible member can be minimized or even prevented. As used in this context, the “tension” member is fitted and configured to reduce the bundling of the distal region of the flexible conductor (compared to a device without a tension member) by moving at least the distal portion of the flexible conductor bundle proximal as the distal probe retracts proximal. In some embodiments, the structural tension member (e.g., a tension bar) may be physically fixed to the flexible conductor bundle (e.g., directly or indirectly attached). Generally, the tension members described herein are operably connected to a flexible member (e.g., a flexible conductor bundle), so that the movement or operation of the tension member applies a certain force to the flexible member, causing movement of the flexible member (e.g., proximal). In some exemplary embodiments, the structural tension member may be located within or supported by a handle assembly of a medical device. The structural tension member in this context may be a single component or an assembly of separate components.

[0079] Figures 12A–12F show exemplary handle assemblies of medical devices, which can be incorporated into any suitable medical device herein. For example, the handle assemblies of Figures 12A–12F may be part of a medical device that includes a medical instrument (e.g., an ultrasound imaging probe) at or near its distal end, examples of which are described herein. Other embodiments or features herein are incorporated by reference into the exemplary handle assemblies shown in Figures 12A–12F.

[0080] An exemplary handle assembly 310 includes a first actuator 314 and a second actuator 322, the first actuator 314 being distal to the proximal actuator 322. The first actuator 314 is adapted and configured to move axially (distally and proximal) relative to the second actuator 322 (and optionally rotatable relative to the second actuator 322), and can operably communicate with an elongated body (e.g., 131 or 132) which may include a medical device (e.g., 103) in the distal region. The handle assembly 310 (including the actuators) may incorporate any relevant disclosures from any other handle assemblies of this specification. The medical device, of which the handle assembly 310 is part, also includes a flexible member (e.g., a flexible conductor bundle 105 in Figure 9B) that is firmly coupled (directly or indirectly) to the medical device at a first distal position (e.g., as shown in Figures 9B and 9C, where the medical device 103 is fixed to the flexible member 105) and extends proximal to the handle assembly 310 from the medical device. The flexible member may be a flexible conductor bundle, as shown, and may extend into the handle assembly 310. Part of the flexible member is located within the outer surface of an elongated body (e.g., within 131 and / or 132). The medical device also includes a tension member fixed to the flexible member at a second position 316 proximal to the first position (in this context, “first position” may be called the first distal position or a derivative thereof). Figure 12A shows an exemplary tension member 312, where reference numeral 312 also refers to an optional elongated rigid member of the tension member (in this embodiment, the elongated rigid member is linear and extends axially). The tension member 312 is adapted and configured to apply tension to the flexible member when the medical device retracts proximally. This may be referred to herein as applying tension to the flexible member, or applying tension to the flexible member, or maintaining tension in the flexible member. In this exemplary embodiment, the tension member 312 is adapted and configured to apply tension to the flexible member when the medical device retracts proximally, which in this embodiment occurs when the first actuator 314 retracts proximally from its position shown in Figures 12A, 12D, and 12F.The tensioning members described herein can apply tension when the medical device has a linear configuration, or when the medical device has a non-linear (linear) configuration, for example, when the medical device may deflect or bend.

[0081] In this embodiment, the tension member 312 (which may include the tension bar shown in Figure 12A) is fixed to the flexible conductor bundle at position 316 (e.g., directly attached), and its position is inside the handle assembly in this embodiment. Alternatively, the tension member may be fixed to the flexible member at a position not inside the handle, e.g., outside the handle, inside one or both of the outer and inner shafts. In this embodiment, the tension member is also fixed axially to the first actuator 314, so that axial movement of the first actuator 314 causes axial movement of the tension member 312 (which may be a 1:1 movement ratio). Since the tension member 312 is also fixed to the flexible member (e.g., at position 316), axial movement of the tension member 312 also causes axial movement of the flexible member at position 316. By fixing the tension member 312 to the flexible member, when the first actuator 314 retracts proximally, tension is applied to the flexible member distal to the position where the tension member is fixed, which prevents the flexible member from folding or bundling in its distal region near or adjacent to the medical device (or at least reduces the degree of folding / bundling compared to a device without the tension member).

[0082] Flexible members may include flexible conductor bundles, such as any flexible conductor bundle as described herein. In Figures 12A to 12F, tension members include rigid, elongated members with a fixed length (generally referred to as 312 in Figure 12A). The illustrated rigid tension members have a general longitudinal axis, which in this embodiment is parallel to the longitudinal axis of the medical device and / or the longitudinal axis of the handle assembly. Rigid tension members can be made from a variety of materials, such as rigid plastic members.

[0083] The tension members described herein can ensure that the distance a medical device moves is the same as the distance any point on the flexible member moves between the first and second positions. The tension members described herein can ensure that the distance a medical device moves is the same as the distance the position to which the tension member is fixed to the flexible member (for example, position 316 in Figure 12A) moves.

[0084] The fixed relationship between the tension member and the flexible member maintains the flexible member in a substantially flat or linear configuration between the first and second positions when the medical device retracts proximal (if the medical device has a linear configuration). In this context, a flat configuration may include embodiments in which the flexible member may be twisted (i.e., the flexible member may still be twisted even when flat, but not bundled / folded). As used herein, a flat configuration indicates that the flexible member is not folded or bundled.

[0085] Medical devices incorporating tension members may also be maneuverable or deflectable. The tension members described herein can be adapted and configured to apply tension to a flexible member even when the medical device including the flexible member has a non-linear configuration (e.g., deflected, maneuvered, or curved). When this disclosure refers to maintaining a substantially flat configuration in a flexible member, it means that the medical device may have a linear configuration, and does not necessarily have to be such as when the medical device is maneuvered, curved, or deflected.

[0086] The fixed relationship between the tension member and the flexible member described herein prevents the flexible member from forming a fold (i.e., bending or bundling) between the first and second positions when the medical device retracts proximal. Folding, bending, and bundling in this context include the axial overlap of a first region of the flexible member with a second region of the flexible member, and also includes general bending and bundling of the flexible member, such as forming a curved region rather than a flat one, and / or a region of the flexible member that meanders back and forth.

[0087] The flexible members may have flat top and bottom surfaces (e.g., a bundle of conductors having one or more flat surfaces), and optionally, tension members may be fixed to at least one of the top and bottom surfaces. For example, Figures 6A to 6G show flexible members having flat or substantially flat first and second surfaces (e.g., top and bottom surfaces), and tension members may be fixed to one or both of the flat or substantially flat surfaces (e.g., at position 316). They can be fixed using a variety of techniques, such as using adhesives, welding, or other joining techniques.

[0088] The tension member may be operably connected (directly or indirectly) to the handle actuator, so that the tension member moves axially with the axial movement of the actuator. The handle actuator may be further adapted and configured to rotate to cause rotation of the medical device (e.g., actuator 314), and optionally, the rotation of the actuator does not cause rotation of the tension member. Thus, the tension member can be adapted to move axially when the actuator moves axially, but not to rotate when the actuator rotates. This can be achieved by operably connecting the tension member to the actuator (directly or indirectly).

[0089] The medical device may include an inner elongated body (e.g., 132) which includes a lumen in which at least a portion of the flexible member is located. The inner elongated body may be independently maneuverable, for example, by using a separate, independently operable handle actuator (e.g., actuator 322). The medical device includes internal and external members, and the internal members are independently controllable (e.g., in the axial and rotational directions). Aspects of other embodiments of this specification are fully incorporated into any embodiment of this specification.

[0090] The flexible member may be coupled to a printed circuit board within the handle assembly (for example, 321 “Surface” shown in Figure 12A). The tension member may be coupled to a flexible member located proximal to the printed circuit board. In an alternative embodiment, the tension member may be coupled to a flexible member located distal to the printed circuit board.

[0091] Figures 12A to 12F show an example of a part of a medical device, which includes an elongated outer body (e.g., 131) with a probe tip in the distal region of the elongated body; a flexible conductive bundle (e.g., 105) that is firmly coupled to the probe tip at a first position (shown in Figures 9B and 9C) and extends proximal from the medical device into a handle assembly, wherein the flexible member is located within the outer surface of the elongated body; an inner elongated body (e.g., 131) in which at least a portion is located within the elongated outer body, and the inner elongated body is optionally maneuverable, wherein at least a portion of the flexible conductive bundle is located within the inner elongated body and is configured to be axially movable relative to the inner elongated body; and a tension member fixed to the flexible member at a second position within the handle assembly and adapted and configured to apply tension to the flexible member when the probe tip retracts proximal. The probe tip used herein may include one or more ultrasonic transducers.

[0092] Figures 12C and 12E show halves of the handle outer shell 320, the two of which form part of the outer surface of the handle assembly 310. The handle shell 320 includes radially inwardly extending feature 315 adapted to interface with a control unit that controls the movement of the tension member 312. Feature 315 may include guides configured to interface with the tension member at one or more positions and to help stabilize the tension member.

[0093] Any other handle assembly components in any other embodiment of this specification that can be appropriately integrated into the handle assembly 310 are incorporated herein by reference.

[0094] In any embodiment and claim of this specification, the term “tension member” may be replaced with “straightening member,” “flattening member,” or a derivative thereof. As described herein, a straightening member or flattening member means maintaining a substantially straight or flat configuration in a flexible member when the medical device is in a linear configuration, and it is not necessary for the device to always have a linear configuration. Thus, even if a flexible member is not necessarily under tension, it can still be maintained straight (i.e., in an unfolded configuration) along at least a portion of its length for the sake of a straightening member. For example, member 312 in Figure 12A is an example of a straightening member, even though it also functions as a tension member. This applies to all tension members described, shown and claimed herein. In some embodiments of this specification, “member” may be a straightening member (or flattening member) and may also function as a tension member. Furthermore, the term "tension member" in this specification may be replaced with "folding prevention member," "bending prevention member," "bundling prevention member," or derived terms thereof.

[0095] The above disclosure describes that in some embodiments, a flexible member such as a conductor bundle 2010 may be twisted along a portion of its length. For example, the conductor bundle may be twisted to provide a more balanced cross-section along a portion of the length of the medical device. The conductor bundle may be twisted only in the portion of the medical device that is subjected to deflection.

[0096] Figures 13A–13E show some exemplary medical devices that include twisted flexible members such as flexible conductor bundles. Embodiments of Figures 13A–13E can be incorporated with any other suitable features and / or medical devices described herein.

[0097] The portion 330 of the medical device shown in Figures 13A to 13E includes a distal medical instrument 332, a flexible member 331 coupled thereto and extending proximal therefrom, and a proximal end region 333 including a plurality of electrical connectors. The flexible member 331 may be a flexible conductor bundle, such as any bundle as specified herein. The medical instrument 332 may include an ultrasound imaging transducer 339. The flexible conductor bundle 331 has a twisted region 338, the twisted region 338 having a distal end and a proximal end. The flexible conductor bundle 331 also includes an untwisted region 336 distal to the twisted region 334 and an untwisted region 340 proximal to the twisted region 336. The medical instrument 332 may be coupled to an outer shaft, such as the outer shaft 131 shown in Figure 9B.

[0098] The length of the twisted region 338 from its distal end to its proximal end can vary, and in some embodiments, it is 5 to 15 cm, for example 8 to 15 cm, for example 11 cm, etc. The length at which a complete turn is formed can vary considerably, for example 1 to 5 cm, for example 3 cm, etc.

[0099] The number of twists over the length of the twisted region can also vary, for example, not limited to 7 to 9 complete twists.

[0100] An exemplary method for forming a twisted region of a flexible member (e.g., a flexible conductor bundle) is to attach the flexible member to a medical device at its distal end (e.g., the tip of a probe). Next, a thin portion of PET heat shrinkage can be advanced onto the flexible conductor bundle. While holding a portion of the device in place, another portion can be twisted to a desired number of turns to form a twisted region. The PET can then be heat-shrinked on the twisted bundle region while maintaining the twisted structure. Additional PET layers can then be added. Next, an elongated member (e.g., a shaft 131) can be placed on the bundle containing the twisted region, and the elongated member can be attached to the medical device.

[0101] Referring to Figures 14 to 18, the system 2800 includes a handle assembly 2802 and a steering and medical device portion 2810 (for example, shown as an outer sheath similar to sheath 1208 (Figure 4), which may further enclose an inner shaft and instrument). The system is adapted so that the handle assembly 2802 can be actuated to steer the operable portion of the steering and medical device portion 2810, and optionally so that the handle assembly 2802 can be further actuated to cause movement of the medical device coupled thereto. In exemplary cases, the handle assembly 2802 includes a first actuator 2806 and a second actuator 2808. One or more of the first actuator 2806 or the second actuator 2808 are actuated (rotated in this embodiment) on the handle body of the handle assembly 2802 to steer (e.g., configured to steer) the operable portion 2810, such as steering the outer sheath. Steering may include rotation or deflection. As an example, one of actuators 2806 and 2808 controls rotation, and the other actuator controls deflection. In a further embodiment, one of actuators 2806 and 2808 controls the rotation of one or more of the inner shaft or outer shaft, and the other actuator 2806 and 2808 controls the deflection of one or more of the inner shaft or outer shaft.

[0102] As clearly shown in Figure 17, the neutral position marker 3102 may be positioned on the body of the handle assembly 2802 to indicate a fixed reference point (e.g., visually, tactilely, etc.). One or more of the actuators 2806, 2808 may further include markers 3104, 3106 indicating the alignment or position of the actuator 2806, 2808 relative to the neutral position marker 3102. For example, marker 3104 may indicate the deflection of the shaft relative to the neutral position marker 3102, and marker 3106 may indicate the rotation of a component (e.g., a transducer surface located within the sheath 2810) relative to the neutral position marker 3102, or vice versa. Markers 3104, 3106 may indicate other positions. Additionally or alternatively, a mechanical alignment mechanism, such as a stopper, may be used to provide haptic feedback to the user to indicate a specific position of actuators 2806, 2808, such as when actuators 2806, 2808 are in the neutral position.

[0103] The handle assembly 2802 may include any other handle components or functionalities described in any of the other handles described herein. For example, the receptacle 2804 may be located at the proximal end of the handle assembly 2802 and adapted to receive a plug such as an umbilical plug. As clearly shown in Figure 16, the receptacle 2804 may include visual and / or tactile orientation markers for the alignment and positioning of the umbilical plug and the receptacle 2804.

[0104] The navigation connector 2812 may be coupled to the handle assembly 2802 via a navigation conduit 2814 (e.g., a navigation cable sleeve). The navigation connector 2812 may be configured to interface with a navigation system so that the system 2800 can communicate with the navigation system. For example, the navigation system may provide tracking and navigation of a part of the system (e.g., a medical device) during use. As shown, for example, the navigation conduit 2814 may be coupled to the body of the handle assembly 2802 to provide access for one or more cables to pass from the navigation connector 2812 to components within the housing of the handle assembly 2802. As clearly shown in Figure 18, the navigation connector 2812 may be configured to interface with a navigation system connector 3204 (e.g., a receptacle), which may be the property of the navigation system manufacturer. Other configurations may be used.

[0105] Figures 19–24 show exemplary distal regions of a maneuverable system including a medical device. As an exemplary example, Figure 19 shows that the medical device may comprise a maneuverable tip 3300 located at the distal end of a sheath. The maneuverable tip 3300 may include a transducer 3304 (e.g., an ultrasonic transducer) at least partially enclosed by a material 3302 (e.g., a polymer). The tip 3300 may comprise an electronic module 3306, which may include sensors, a control panel, a thermistor, etc. As an example, a triaxial sensor (TAS) 3308 may be arranged to communicate with module 3306. As a further example, a sensor cable bundle 3310 may be arranged to provide electrical communication to one or more components coupled to module 3306.

[0106] As an exemplary example, Figure 20 shows that a medical device may have a maneuverable tip 3400 positioned at the distal end of a sheath. The maneuverable tip 3400 may include a transducer 3404 (e.g., an ultrasonic transducer, a collapsible transducer) at least partially enclosed by a material 3402 (e.g., a polymer). The tip 3400 may also include sensors, control panels, thermistors, etc. As an example, a triaxial sensor (TAS) 3408 may be positioned closer to the distal end of the tip 3400 compared to the configuration of the tip 3300 in Figure 19. Moving the sensor 3406 increases the proportion of the tip 3400 that can be deflected.

[0107] Figures 19 and 20 show the TAS sensor 3308, but in other embodiments, a single-axis sensor (SAS) or a dual-axis sensor (DAS) may be used. By replacing the TAS sensor 3308 with a SAS or DAS, the length associated with the tip 3300 and the post length can be reduced, allowing for more distal deflection. As exemplary examples, Figures 41 to 43 show how the projections for tip rotation and shaft curvature can be calculated using a DAS 4402 at or adjacent to the tip portion 4400 (e.g., 17 mm from the distal range of the tip) and a SAS 4404 at a distance from the distal end of the inner shaft terminating within the tip portion 4400 (e.g., 105 mm from DAS 4402), the tip rotation and shaft curvature. Figure 42 is a cross-sectional view along line A in Figure 41, and Figure 43 is a cross-sectional view along line B in Figure 41. For example, an independent tip rotation can be projected using the angle between X1 and X2 around Z. As a further example, the angle between Z1 and Z2 can be used to project the shaft curve. DAS 4402 is preferably coupled to the proximal extension of the transducer tip (e.g., the end of tip portion 4400), and the proximal extension of the transducer tip is also coupled to the outer shaft so that DAS 4402 moves with the outer shaft and tip. SAS 4404 is preferably coupled to the inner shaft. Thus, DAS can move independently of SAS 4404. The position of SAS 4404 on the inner shaft is preferably proximal to the deflection position. This position can also preferably be located in the more rigid portion of the inner shaft proximal to both the deflection region and the more flexible portion of the shaft immediately proximal to the deflection region. The position of SAS 4404 may be within a range of 5 to 15 cm from the distal end of the inner shaft.

[0108] As an exemplary example, Figure 21 shows that a medical device may have a operable tip 3500 located at the distal end of a sheath. The operable tip 3500 may include a transducer 3502 (e.g., an ultrasonic transducer, a collapsible transducer). As an example, an ASIC 3504 may be located adjacent to the transducer 3502. As a further example, an inactive piezoelectric element may be located adjacent to the transducer 3502. The tip 3500 may include various sensors, control panels, thermistors, etc. As shown, the tip 3500 includes a thermistor 3506 located proximal to the transducer 3502. As clearly shown in Figure 23, at least a portion of the tip 3500 may be at least partially surrounded by a first material 3700 (e.g., a polymer), and at least a portion of the tip 3500 may be at least partially surrounded by a second material 3704. The first material 3700 and the second material 3704 may be configured to have the same or different stiffness (e.g., durometer) and other different properties. As an exemplary example, as further illustrated in Figure 23, the navigation sensor 3702 may be positioned at or adjacent to the proximal end of the tip 3500. The navigation sensor 3702 may communicate with a navigation system to provide tracking and position of the tip 3500 and to provide feedback to the user.

[0109] As an exemplary example, Figure 22 shows that a medical device may have a operable tip 3600 located at the distal end of a sheath. The operable tip 3600 may include a transducer 3602 (e.g., an ultrasonic transducer, a foldable transducer). Compared to tip 3500, tip 3600 may include a shortened folded end 3601. Inactive piezoelectric material may be minimized adjacent to the transducer 3602. As an example, an ASIC 3604 may be located adjacent to the transducer 3602. Tip 3600 may include various sensors, control panels, thermistors, etc. As shown, tip 3600 includes a thermistor 3606 located proximal to the transducer 3602. Circuits such as flex circuits may be electrically connected to one or more components within tip 3600. As an example, a flex circuit may be divided into layers and selectively communicate with components. As clearly shown in Figure 24, at least a portion of the tip 3600 may be at least partially surrounded by a first material 3800 (e.g., a polymer), and at least a portion of the tip 3600 may be at least partially surrounded by a second material 3804. The first material 3800 and the second material 3804 may be made to have the same or different properties, such as different stiffness (e.g., durometer). As further shown in Figure 24, the navigation sensor 3802 may be positioned adjacent to the transducer 3602. The navigation sensor 3802 may communicate with a navigation system to provide tracking and position of the tip 3600 and to provide feedback to the user.

[0110] Figure 25 shows a medical device that may have a maneuverable tip 3902 located at the distal end of a sheath 3906. As shown, a biaxial sensor (DAS) 3908 may be located at or adjacent to the proximal end of the tip 3902. The inner sheath 3904 may have a section configured for deflection 3912 and may be located within the sheath 3906 adjacent to the tip 3902. One or more DAS sensors 3910, 3910' may be arranged along the length of the sheath 3904. One or more of the DAS sensors 3910, 3910' may alternatively be configured as a SAS sensor.

[0111] Figure 26 shows an exemplary configuration of a triaxial (TAS) navigation sensor 4000 comprising an x-axis coil 4000A, a y-axis coil 4000B, and a z-axis coil 4000C. The TAS sensor position can be facilitated by an extra cavity in a molded tip 4010 into which the TAS sensor 4000 can be bonded. A TAS position directly below the transducer 4112 provides closer alignment to the transducer, which can improve the accuracy of the ultrasonic volume relative to the catheter tip when displayed in the CARTO system. For example, the distance from the tip of the device to the center of the y-coil may be measured at a first length 4002. The distance from the center of the active transducer 4002 to the y-coil may be a second length 4004. The distance from the sensor axis to the tip axis may be a third length 4006. The distance from the sensor axis to the surface of the ultrasonic transducer may be a fourth length 4008. The lengths may be programmed into the EEPROM within the catheter as calibration parameters read by the CARTO system to ensure the accurate position of the catheter within the CARTO system. The TAS sensor 4000 can be replaced by a DAS sensor having alternative calibration parameters.

[0112] Figures 27A to 27C show various arrangements of pull wires, illustrating a first embodiment 4130 and a second embodiment 4140 in a vertically paired configuration for comparison. For example, a handle assembly may have internal components that interface with the proximal ends of the pull wires such that the operation of one or more actuators tensions such one or more pull wires, causing deflection of the inner shaft. As shown, for example, wire 4102 may have a relative configuration within the inner shaft 4100. Wire 4106 may have a relative configuration within the inner shaft 4104. Wire 4110 may have a relative configuration within the inner shaft 4108. Wire 4114 may have a relative configuration within the inner shaft 4112. Wire 4118 may have a relative configuration within the inner shaft 4116. Wire 4122 may have a relative configuration within the inner shaft 4120.

[0113] Referring to Figures 28-29, for example, the configuration of the inner shaft 4150 and wire 4160 (showing a first embodiment 4130 and a second embodiment 4140 in a vertical pair for comparison) from left to right may represent a distal portion 4170, an intermediate portion 4180, and a proximal portion 4190 along the length of the inner shaft. Figures 28-29 show that the pull wire 4160 may have varying spacing and configuration along the length of one or more shafts or sheaths. As illustrated, for example, the distal portion 4170, intermediate portion 4180, and proximal portion 4190 along the length of the inner shaft 4150 may have varying stiffnesses, as shown for illustrative purposes only. Stiffness can be achieved based on material selection, such as by using various durometer materials (e.g., 35D Pebax, 40D Pebax, 55D Pebax, 63D Pebax, 72D Pebax, nylon 12, etc.). As a further example, the selection of the stiffness (or other properties) of one or more parts of the shaft may be based on the desired bending, straightness, and / or shaping of the shaft to provide various control modes.

[0114] Given a pair of pull wires 4160, this pair may be close to each other within the handle assembly, branch further apart over most of the shaft length, and then return together distally, where the shaft is intended to deflect. As an exemplary example, as shown in Figures 28-29, at least one pair of a plurality of pull wires 4160 is arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft, from the handle assembly (not shown, adjacent to the proximal portion 4190) to a selected branching region (e.g., 4180) located distal to the handle assembly, wherein at least one pair of the plurality of pull wires is further apart from each other in the branching region than in the handle assembly, and at least one pair of the plurality of pull wires is closer to each other in a second region (e.g., 4170) located distal to the branching region compared to the branching region. As a further example, at least a portion of the second region exhibits lower stiffness than the stiffness of the branching region.

[0115] Extending to a non-restrictive example, at least a first pair of pull wires 4160 may be arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft within a first region (e.g., 4190) of the deflectable shaft, up to a selected first branching position located distal to the handle assembly, and at least a second pair of pull wires 4160 may be arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft within a second region of the deflectable shaft, up to a selected second branching position located distal to the handle assembly. Thus, at least a first pair of pull wires 4160 may be further spaced apart from each other in a third region located distal to the first branching point, and a second pair of pull wires 4160 may be further spaced apart from each other in a fourth region located distal to the second branching point.

[0116] Additionally or alternatively, the pull wires discussed herein may be configured such that the branching point of the pull wire is located within a more rigid region (e.g., the 72D region), which may provide desired control of deflection (e.g., deflection of a portion of the shaft distal to the branching point). Other configurations may be used. Additionally or alternatively, the pull line convergence and branching positions may be configured to be the same or different on both sides of the inner shaft. As an example, if the pull lines on opposite sides of the inner shaft converge or branch at the same longitudinal position on each side, the deflection of the shaft may be symmetrical in either direction. However, if the pull lines on opposite sides of the inner shaft converge or branch at different longitudinal positions, the deflection of the shaft in one direction may have a larger or smaller radius of curvature, which may provide asymmetric deflection control.

[0117] As a further example, Figures 32-33 show how comparative changes in stiffness and length between the first and second embodiments can affect the bending and straight-end length of the shaft. As shown in Figures 32-33, for example, the second embodiment exhibits a straight-end length of 33 mm, while the first embodiment exhibits a straight-end length of 40 mm. Furthermore, branching of wires (e.g., pull lines) can provide further control over the inner shaft, as shown in Figure 34.

[0118] Figure 34 illustrates, for example, how the configuration of the second embodiment shown in Figures 28-29 and 32-34 allows the catheter to bend at point 4200. Furthermore, the transition from a more flexible region 4202 to a more rigid region 4204 in the region proximal to the deflection region improves the maneuverability of the catheter. Such a configuration may be useful in various applications, such as navigation to more distal regions of the heart. As an example, the catheter may need to traverse the tricuspid valve and bend upward and transversely relative to the PA valve. As the catheter traverses the heart, it may need to bend through an "S" curve to reduce the transmission of excessive force. The rigidity transition proximal to the deflection region may also assist the catheter as it is advanced forward within the heart. As illustrated, the configuration of the second embodiment allows the catheter to bend from the right ventricular outflow tract into the right atrium. Furthermore, the configuration of the second embodiment may allow the catheter to be manipulated within the right atrium when the tip of the catheter is in the pulmonary artery or deeper within the left atrium.

[0119] Furthermore, Figures 35-36 show a comparative change in stiffness and length of the first and second embodiments of the inner shaft with respect to the wire branching point. Using other variations of the combination of inner and outer shaft durometers, the stiffness transition along the approximately 15 cm distal portion of the catheter can be optimized.

[0120] An exemplary example is a symmetrical design in which the pull wire branches, changing its relative position to each other across different sections of the shaft. By controlling the shaft's stiffness and the positioning of the pull line (e.g., moving the branching point further distally), it is possible to reduce off-axis curl while providing more precise control over the deflection of the distal end of the shaft.

[0121] Regardless of the reference numerals, any of the handle assemblies, medical devices, operable sheaths, and electrical connections described herein can be used together in any combination within a system.

[0122] This disclosure includes at least the following aspects: Embodiment 1: An ultrasonic imaging device configured to have rotation and deflection control, comprising: an ultrasonic probe positioned adjacent to the distal region of a rotatable shaft; a deflectable shaft positioned relative to the rotatable shaft such that the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft; a handle body having an outer surface that can be grasped by a user; a first actuator configured to move relative to the handle body; and a second actuator configured to move relative to the handle body, wherein the first and second actuators are circumferentially arranged around the longitudinal axis of the handle body, and the rotatable shaft is controlled by the first actuator Ultrasonic imaging apparatus comprising: a handle assembly operably communicating with a first actuator of a handle assembly such that the operation of the ethometer causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft, and the deflectable shaft operably communicating with a second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft; and a plurality of pull wires communicating with at least the second actuator and arranged along the longitudinal length of the deflectable shaft, the plurality of pull wires configured to converge or separate from each other one or more in order to provide control over the deflection of the deflectable shaft.

[0123] Embodiment 2: The ultrasound imaging apparatus according to Embodiment 1, wherein the plurality of pull wires includes four pull wires.

[0124] Embodiment 3: The ultrasonic imaging apparatus according to Embodiment 1 or 2, wherein the plurality of pull wires are configured to provide symmetric deflection of the deflectable shaft in at least two opposite curves.

[0125] Embodiment 4: The ultrasonic imaging apparatus according to Embodiment 1 or 2, wherein a plurality of pull wires are configured to provide asymmetric deflection of a deflectable shaft in a curve in a first direction and a curve in a second direction opposite to the curve in the first direction, and the first direct curve has a different radius of curvature than the curve in the second direction.

[0126] Embodiment 5: An ultrasonic imaging device according to any one of Embodiments 1 to 4, wherein at least one pair of a plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of a deflectable shaft, from the handle assembly to a selected branching region located distal to the handle assembly, the at least one pair of the plurality of pull wires is further apart from one another in the branching region than from the handle assembly, and the at least one pair of the plurality of pull wires is closer together in a second region of the deflectable shaft located distal to the branching region compared to the branching region.

[0127] Embodiment 6: The ultrasonic imaging apparatus according to Embodiment 5, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region.

[0128] Embodiment 7: An ultrasonic imaging device according to any one of Embodiments 1 to 4, wherein at least a first pair of a plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly; at least a second pair of a plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft to a selected second branching position located distal to the handle assembly in a second region of the deflectable shaft; at least a first pair of a plurality of pull wires are further spaced apart from each other in a third region located distal to the first branching point; and a second pair of a plurality of pull wires are further spaced apart from each other in a fourth region located distal to the second branching point.

[0129] Embodiment 8: The ultrasonic imaging apparatus according to Embodiment 7, wherein the rigidity of the first region is different from the rigidity of the third region.

[0130] Embodiment 9: The ultrasonic imaging apparatus according to Embodiment 7, wherein the rigidity of the second region is different from the rigidity of the fourth region.

[0131] Embodiment 10: An ultrasonic imaging apparatus according to any one of embodiments 1 to 9, further comprising a biaxial sensor and a monoaxial sensor arranged at a distance from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of the ultrasonic probe.

[0132] Embodiment 11: The ultrasonic imaging apparatus according to Embodiment 10, wherein a biaxial sensor is positioned adjacent to the ultrasonic probe, and a uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of a deflectable shaft.

[0133] Embodiment 12: An ultrasound imaging apparatus according to any one of embodiments 1 to 11, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material that defines the distal tip of the ultrasound imaging apparatus.

[0134] Embodiment 13: The ultrasonic imaging apparatus according to Embodiment 12, further comprising a flexible circuit board positioned adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads arranged thereon, and the flexible circuit board is configured in a folded arrangement on itself.

[0135] Embodiment 14: The ultrasonic imaging apparatus according to Embodiment 13, wherein a flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflection shaft.

[0136] Embodiment 15: The ultrasonic imaging apparatus according to Embodiment 13, wherein the folded arrangement of the flexible circuit board includes at least four folds.

[0137] Embodiment 16: The ultrasonic imaging apparatus according to Embodiment 15, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

[0138] Embodiment 17: An ultrasonic imaging apparatus configured to have rotation and deflection control, comprising: an ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft such that the rotation of the rotatable shaft causes the tip region and the ultrasonic probe to rotate; a deflectable shaft positioned relative to the rotatable shaft such that the deflection of the deflectable shaft causes the deflection of at least a portion of the rotatable shaft to control the position of the distal tip and the ultrasonic probe; and a biaxial sensor and a monoaxial sensor positioned spaced apart from each other and configured to provide positional feedback indicating the deflection and rotation of the ultrasonic probe.

[0139] Embodiment 18: The ultrasonic imaging apparatus according to Embodiment 17, wherein a biaxial sensor is positioned adjacent to the ultrasonic probe, and a uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of a deflectable shaft.

[0140] Embodiment 19: The ultrasonic imaging apparatus according to claim 17, wherein a biaxial sensor is positioned within or adjacent to the distal tip region, and a uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft.

[0141] Embodiment 20: An ultrasonic imaging apparatus according to any one of embodiments 17 to 19, further comprising a handle assembly having a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, wherein the first actuator and the second actuator are arranged circumferentially around the longitudinal axis of the handle body, a rotatable shaft operably communicates with the first actuator of the handle assembly such that the operation of the first actuator causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft, and a deflectable shaft operably communicates with the second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft.

[0142] Embodiment 21: An ultrasonic imaging apparatus according to any one of embodiments 17 to 20, further comprising a plurality of pull wires communicating with at least a second actuator and arranged along the longitudinal length of a deflectable shaft, wherein the plurality of pull wires are configured to converge or separate from one another in order to provide control over the deflection of the deflectable shaft.

[0143] Embodiment 22: An ultrasound imaging apparatus according to any one of embodiments 17 to 21, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material that defines the distal tip of the ultrasound imaging apparatus.

[0144] Embodiment 23: The ultrasonic imaging apparatus according to Embodiment 22, further comprising a flexible circuit board positioned adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads arranged thereon, and the flexible circuit board is configured in a folded arrangement on itself.

[0145] Embodiment 24: The ultrasonic imaging apparatus according to Embodiment 23, wherein a flexible circuit board is interposed between the ultrasonic transducer and the biaxial sensor.

[0146] Embodiment 25: The ultrasonic imaging apparatus according to Embodiment 23, wherein the folded arrangement of the flexible circuit board includes at least four folds.

[0147] Embodiment 26: The ultrasonic imaging apparatus according to Embodiment 25, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

[0148] Embodiment 27: An ultrasonic imaging apparatus configured to have rotation and deflection control, comprising: an ultrasonic probe positioned adjacent to the distal region of a rotatable shaft; a deflectable shaft positioned relative to the rotatable shaft such that the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft; a handle assembly comprising: a handle body having an outer surface that can be grasped by a user; a first actuator configured to move relative to the handle body; and a second actuator configured to move relative to the handle body; and a plurality of pull wires communicating with one or more of the first actuators or the second actuators, wherein the plurality of pull wires are arranged along the longitudinal length of the deflectable shaft and the rotatable shaft, and the rotatable shaft is operably connected to a first actuator of the handle assembly via one or more of the plurality of first pull wires, thereby controlling the first actuator Ultrasonic imaging instrument, wherein the operation of a diode causes rotational motion of at least a portion of a rotatable shaft relative to a deflectable shaft, the deflectable shaft operably communicates with a second actuator via one or more second pull wires of a plurality of pull wires, thereby causing the rotation of the second actuator to cause deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft, and one or more of the first actuator or second actuators includes a first helical gear arranged to rotate in response to the rotation of one or more of the first actuator or second actuators, one or more of the first pull wire or second pull wires are coupled to a spindle having the second helical gear, the second helical gear is configured to engage with the first helical gear such that the rotation of the first helical gear causes the spindle to rotate, thereby winding or unwinding one or more of the first pull wire or second pull wire.

[0149] Embodiment 28: The ultrasonic imaging apparatus according to Embodiment 27, wherein the plurality of pull wires includes four pull wires.

[0150] Embodiment 29: The ultrasonic imaging apparatus according to Embodiment 27 or 28, wherein a plurality of pull wires are configured to provide symmetric deflection of a deflectable shaft in at least two opposite curves.

[0151] Embodiment 30: The ultrasonic imaging apparatus according to Embodiment 27 or 28, wherein a plurality of pull wires are configured to provide asymmetric deflection of a deflectable shaft in a curve in a first direction and in a curve in a second direction opposite to the curve in the first direction, and the first direct curve has a different radius of curvature than the radius of curvature of the curve in the second direction.

[0152] Embodiment 31: An ultrasonic imaging device of any one of Embodiments 27 to 30, wherein at least one pair of a plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of a deflectable shaft, from a handle assembly to a selected branching region located distal to the handle assembly, the at least one pair of the plurality of pull wires is further apart from one another in the branching region than from the handle assembly, and the at least one pair of the plurality of pull wires is closer apart from one another in a second region of the deflectable shaft located distal to the branching region compared to the branching region.

[0153] Embodiment 32: The ultrasonic imaging apparatus according to Embodiment 31, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region.

[0154] Embodiment 33: An ultrasonic imaging device according to any one of Embodiments 27 to 30, wherein at least a first pair of a plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly; at least a second pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft to a selected second branching position located distal to the handle assembly in a second region of the deflectable shaft; at least a first pair of the plurality of pull wires are further spaced apart from each other in a third region located distal to the first branching point; and a second pair of the plurality of pull wires are further spaced apart from each other in a fourth region located distal to the second branching point.

[0155] Embodiment 34: The ultrasonic imaging apparatus according to Embodiment 33, wherein the rigidity of the first region is different from the rigidity of the third region.

[0156] Embodiment 35: The ultrasonic imaging apparatus according to Embodiment 33, wherein the rigidity of the second region is different from the rigidity of the fourth region.

[0157] Embodiment 36: An ultrasonic imaging apparatus according to any one of embodiments 27 to 35, further comprising a biaxial sensor and a monoaxial sensor arranged spaced apart from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of an ultrasonic probe.

[0158] Embodiment 37: The ultrasonic imaging apparatus according to Embodiment 36, wherein a biaxial sensor is positioned adjacent to the ultrasonic probe, and a uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of a deflectable shaft.

[0159] Embodiment 38: An ultrasound imaging apparatus according to any one of embodiments 27 to 37, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material defining the distal tip of the ultrasound imaging apparatus.

[0160] Embodiment 39: The ultrasonic imaging apparatus according to Embodiment 38, further comprising a flexible circuit board positioned adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads arranged thereon, and the flexible circuit board is configured in a folded arrangement on itself.

[0161] Embodiment 40: The ultrasonic imaging apparatus according to Embodiment 39, wherein a flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflection shaft.

[0162] Embodiment 41: The ultrasonic imaging apparatus according to Embodiment 39, wherein the folded arrangement of the flexible circuit board includes at least four folds.

[0163] Embodiment 42: The ultrasonic imaging apparatus according to Embodiment 41, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

[0164] Embodiment 43: An ultrasonic imaging apparatus configured to have rotation and deflection control, comprising: an ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft such that rotation of the rotatable shaft causes rotation of the tip region and the ultrasonic probe, the ultrasonic probe comprising an ultrasonic transducer at least partially surrounded by a material defining the distal tip of the ultrasonic imaging apparatus; a deflectable shaft positioned relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft in order to control the position of the distal tip and the ultrasonic probe; and a flexible circuit board positioned adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, the flexible circuit board comprising a plurality of electrical component pads, wherein the flexible circuit board is configured in a folded arrangement on itself, the flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft, and the folded arrangement of the flexible circuit board includes at least four folds.

[0165] Any technique, including ultrasonic and manipulative techniques, found in any of the following U.S. patent references may be incorporated herein into any medical device, apparatus, system, or method of use thereof, and such disclosures are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833 ,7783339,7791252,7791252,7819802,7824335,7966058,8057397,8096951,8207652,8207652,8213693,8364242,8428690,8451155,8527032,86 59212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

[0166] [Implementation Method] (1) An ultrasonic imaging device configured to have rotation and deflection control, An ultrasound probe positioned adjacent to the distal region of the rotatable shaft, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft, A handle assembly comprising a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, The first actuator and the second actuator are arranged circumferentially around the longitudinal axis of the handle body. The rotatable shaft is operably communicated with the first actuator of the handle assembly such that the operation of the first actuator causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The deflectable shaft is operably communicated with the second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft, and a handle assembly is also operably connected to the second actuator. An ultrasonic imaging apparatus comprising: a plurality of pull wires, each communicating with at least the second actuator and arranged along the longitudinal length of the deflectable shaft, wherein the plurality of pull wires are configured to converge or separate from one another in order to provide control over the deflection of the deflectable shaft. (2) The ultrasonic imaging apparatus according to Embodiment 1, wherein the plurality of pull wires include four pull wires. (3) The ultrasonic imaging apparatus according to Embodiment 1, wherein the plurality of pull wires are configured to provide symmetric deflection of the deflectable shaft in at least two opposite curves. (4) The ultrasonic imaging apparatus according to Embodiment 1, wherein the plurality of pull wires are configured to provide asymmetric deflection of the deflectable shaft in a curve in a first direction and in a curve in a second direction opposite to the curve in the first direction, and the curve in the first direction has a different radius of curvature from the radius of curvature of the curve in the second direction. (5) The ultrasonic imaging apparatus according to Embodiment 1, wherein at least one pair of the plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a selected branching region located distal to the handle assembly, and at least one pair of the plurality of pull wires is further apart from one another in the branching region than from the handle assembly, and at least one pair of the plurality of pull wires is closer to one another in a second region of the deflectable shaft located distal to the branching region compared to the branching region.

[0167] (6) The ultrasonic imaging apparatus according to Embodiment 5, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region. (7) The ultrasonic imaging apparatus according to Embodiment 1, wherein at least a first pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly; at least a second pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft to a selected second branching position located distal to the handle assembly; at least the first pair of the plurality of pull wires are further spaced apart in a third region located distal to the first branching point; and the second pair of the plurality of pull wires are further spaced apart in a fourth region located distal to the second branching point. (8) The ultrasonic imaging apparatus according to Embodiment 7, wherein the rigidity of the first region is different from the rigidity of the third region. (9) The ultrasonic imaging apparatus according to Embodiment 7, wherein the rigidity of the second region is different from the rigidity of the fourth region. (10) The ultrasonic imaging apparatus according to Embodiment 1, further comprising a biaxial sensor and a monoaxial sensor, which are arranged spaced apart from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of the ultrasonic probe.

[0168] (11) The ultrasonic imaging apparatus according to Embodiment 10, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft. (12) The ultrasound imaging device according to Embodiment 1, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material that defines the distal tip of the ultrasound imaging device. (13) The ultrasonic imaging apparatus according to Embodiment 12, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself. (14) The ultrasonic imaging apparatus according to Embodiment 13, wherein the flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft. (15) The ultrasonic imaging apparatus according to Embodiment 13, wherein the folded arrangement of the flexible circuit board includes at least four folds.

[0169] (16) The ultrasonic imaging apparatus according to embodiment 15, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration. (17) An ultrasonic imaging device configured to have rotation and deflection control, An ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft, wherein rotation of the rotatable shaft causes rotation of the tip region and the ultrasonic probe; A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft in order to control the position of the distal tip and the ultrasound probe, An ultrasonic imaging apparatus comprising a biaxial sensor and a uniaxial sensor, which are arranged at a distance from each other and configured to provide positional feedback indicating the deflection and rotation of the ultrasonic probe. (18) The ultrasonic imaging apparatus according to embodiment 17, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft. (19) The ultrasonic imaging apparatus according to Embodiment 17, wherein the biaxial sensor is located within or adjacent to the distal tip region, and the uniaxial sensor is located proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft. (20) A handle assembly further comprising a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, The first actuator and the second actuator are arranged circumferentially around the longitudinal axis of the handle body. The rotatable shaft is operably communicated with the first actuator of the handle assembly such that the operation of the first actuator causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The ultrasonic imaging apparatus according to Embodiment 17, wherein the deflectable shaft is operably communicated with the second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft.

[0170] (21) The ultrasonic imaging apparatus according to Embodiment 17, further comprising a plurality of pull wires communicating with at least the second actuator and arranged along the longitudinal length of the deflectable shaft, wherein the plurality of pull wires are configured to converge or separate from one another in order to provide control over the deflection of the deflectable shaft. (22) The ultrasound imaging apparatus according to embodiment 17, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material that defines the distal tip of the ultrasound imaging apparatus. (23) The ultrasonic imaging apparatus according to embodiment 22, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself. (24) The ultrasonic imaging apparatus according to embodiment 23, wherein the flexible circuit board is interposed between the ultrasonic transducer and the biaxial sensor. (25) The ultrasonic imaging apparatus according to Embodiment 23, wherein the folded arrangement of the flexible circuit board includes at least four folds.

[0171] (26) The ultrasonic imaging apparatus according to embodiment 25, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration. (27) An ultrasonic imaging device configured to have rotation and deflection control, An ultrasound probe positioned adjacent to the distal region of the rotatable shaft, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft, A handle assembly comprising a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, A plurality of pull wires communicating with one or more of the first actuator or the second actuator, the plurality of pull wires arranged along the longitudinal length of the deflectable shaft and the rotatable shaft, The rotatable shaft is operably connected to the first actuator of the handle assembly via one or more first pull wires from the plurality of pull wires, thereby causing the operation of the first actuator to cause rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The deflectable shaft is operably connected to the second actuator via one or more second pull wires from the plurality of pull wires, so that the rotation of the second actuator causes deflection of the deflectable shaft, which in turn causes deflection of the rotatable shaft. One or more of the first actuator or the second actuator comprises a first helical gear arranged to rotate in response to the rotation of one or more of the first actuator or the second actuator, An ultrasonic imaging device, wherein one or more of the first pull wire or the second pull wires are coupled to a spindle having a second helical gear, the second helical gear being configured to engage with the first helical gear such that the rotation of the first helical gear causes the spindle to rotate, thereby winding or unwinding the first pull wire or the second pull wire. (28) The ultrasonic imaging apparatus according to embodiment 27, wherein the plurality of pull wires include four pull wires. (29) The ultrasonic imaging apparatus according to embodiment 27, wherein the plurality of pull wires are configured to provide symmetric deflection of the deflectable shaft in at least two opposite curves. (30) The ultrasonic imaging apparatus according to Embodiment 27, wherein the plurality of pull wires are configured to provide asymmetric deflection of the deflectable shaft in a curve in a first direction and in a curve in a second direction opposite to the curve in the first direction, and the curve in the first direction has a different radius of curvature from the radius of curvature of the curve in the second direction.

[0172] (31) The ultrasonic imaging apparatus according to Embodiment 27, wherein at least one pair of the plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a selected branching region located distal to the handle assembly, and at least one pair of the plurality of pull wires is further apart from one another in the branching region than from the handle assembly, and at least one pair of the plurality of pull wires is closer to one another in a second region of the deflectable shaft located distal to the branching region compared to the branching region. (32) The ultrasonic imaging apparatus according to embodiment 31, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region. (33) The ultrasonic imaging apparatus according to Embodiment 27, wherein at least a first pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly, at least a second pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft to a selected second branching position located distal to the handle assembly, at least the first pair of the plurality of pull wires are further spaced apart in a third region located distal to the first branching point, and the second pair of the plurality of pull wires are further spaced apart in a fourth region located distal to the second branching point. (34) The ultrasonic imaging apparatus according to embodiment 33, wherein the rigidity of the first region is different from the rigidity of the third region. (35) The ultrasonic imaging apparatus according to embodiment 33, wherein the rigidity of the second region is different from the rigidity of the fourth region.

[0173] (36) The ultrasonic imaging apparatus according to embodiment 27, further comprising a biaxial sensor and a monoaxial sensor, which are arranged spaced apart from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of the ultrasonic probe. (37) The ultrasonic imaging apparatus according to embodiment 36, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft. (38) The ultrasound imaging apparatus according to embodiment 27, wherein the ultrasound probe comprises an ultrasound transducer at least partially surrounded by a material that defines the distal tip of the ultrasound imaging apparatus. (39) The ultrasonic imaging apparatus according to embodiment 38, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself. (40) The ultrasonic imaging apparatus according to embodiment 39, wherein the flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft.

[0174] (41) The ultrasonic imaging apparatus according to embodiment 39, wherein the folded arrangement of the flexible circuit board includes at least four folds. (42) The ultrasonic imaging apparatus according to embodiment 41, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration. (43) An ultrasonic imaging device configured to have rotation and deflection control, An ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft, wherein rotation of the rotatable shaft causes rotation of the tip region and the ultrasonic probe, and the ultrasonic probe comprises an ultrasonic transducer at least partially surrounded by a material defining the distal tip of an ultrasonic imaging device, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft in order to control the position of the distal tip and the ultrasound probe, A flexible circuit board is disposed adjacent to the ultrasonic transducer and electrically communicates with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself, The flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft. An ultrasonic imaging device wherein the folded arrangement of the flexible circuit board includes at least four folds.

Claims

1. An ultrasonic imaging device configured to have rotation and deflection control, An ultrasound probe positioned adjacent to the distal region of the rotatable shaft, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft, A handle assembly comprising a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, The first actuator and the second actuator are arranged circumferentially around the longitudinal axis of the handle body. The rotatable shaft is operably connected to the first actuator of the handle assembly such that the operation of the first actuator causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The deflectable shaft is operably communicated with the second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft, and a handle assembly is also in operation with the second actuator. An ultrasonic imaging apparatus comprising: a plurality of pull wires, each communicating with at least the second actuator and arranged along the longitudinal length of the deflectable shaft, wherein the plurality of pull wires are configured to converge or separate from one another in order to provide control over the deflection of the deflectable shaft.

2. The ultrasonic imaging apparatus according to claim 1, wherein the plurality of pull wires include four pull wires.

3. The ultrasonic imaging apparatus according to claim 1, wherein the plurality of pull wires are configured to provide symmetric deflection of the deflectable shaft in at least two opposite curves.

4. The plurality of pull wires are configured to provide asymmetric deflection of the deflectable shaft in a curve in a first direction and in a curve in a second direction opposite to the curve in the first direction, wherein the curve in the first direction has a radius of curvature different from the radius of curvature of the curve in the second direction, as described in claim 1.

5. The ultrasonic imaging apparatus according to claim 1, wherein at least one pair of the plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a selected branching region located distal to the handle assembly, and at least one pair of the plurality of pull wires is further apart from one another in the branching region than from the handle assembly, and at least one pair of the plurality of pull wires is closer to one another in a second region of the deflectable shaft located distal to the branching region compared to the branching region.

6. The ultrasonic imaging apparatus according to claim 5, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region.

7. The ultrasonic imaging apparatus according to claim 1, wherein at least a first pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly; at least a second pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft to a selected second branching position located distal to the handle assembly in a second region of the deflectable shaft; at least the first pair of the plurality of pull wires are further spaced apart from each other in a third region located distal to the first branching point; and the second pair of the plurality of pull wires are further spaced apart from each other in a fourth region located distal to the second branching point.

8. The ultrasonic imaging apparatus according to claim 7, wherein the rigidity of the first region is different from the rigidity of the third region.

9. The ultrasonic imaging apparatus according to claim 7, wherein the rigidity of the second region is different from the rigidity of the fourth region.

10. The ultrasonic imaging apparatus according to claim 1, further comprising a biaxial sensor and a uniaxial sensor, which are arranged at a distance from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of the ultrasonic probe.

11. The ultrasonic imaging apparatus according to claim 10, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft.

12. The ultrasonic imaging device according to claim 1, wherein the ultrasonic probe comprises an ultrasonic transducer at least partially surrounded by a material that defines the distal tip of the ultrasonic imaging device.

13. The ultrasonic imaging apparatus according to claim 12, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself.

14. The ultrasonic imaging apparatus according to claim 13, wherein the flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft.

15. The ultrasonic imaging apparatus according to claim 13, wherein the folded arrangement of the flexible circuit board includes at least four folds.

16. The ultrasonic imaging apparatus according to claim 15, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

17. An ultrasonic imaging device configured to have rotation and deflection control, An ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft, wherein rotation of the rotatable shaft causes rotation of the tip region and the ultrasonic probe, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft in order to control the position of the distal tip and the ultrasound probe, and the deflectable shaft is positioned relative to the rotatable shaft. An ultrasonic imaging apparatus comprising a biaxial sensor and a uniaxial sensor, which are arranged at a distance from each other and configured to provide positional feedback indicating the deflection and rotation of the ultrasonic probe.

18. The ultrasonic imaging apparatus according to claim 17, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft.

19. The ultrasonic imaging apparatus according to claim 17, wherein the biaxial sensor is positioned within or adjacent to the distal tip region, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft.

20. The handle assembly further comprises a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body. The first actuator and the second actuator are arranged circumferentially around the longitudinal axis of the handle body. The rotatable shaft is operably connected to the first actuator of the handle assembly such that the operation of the first actuator causes rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The ultrasonic imaging apparatus according to claim 17, wherein the deflectable shaft is operably communicated with the second actuator such that the rotation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft.

21. The ultrasonic imaging apparatus according to claim 17, further comprising a plurality of pull wires, which communicate with at least the second actuator and are arranged along the longitudinal length of the deflectable shaft, wherein the plurality of pull wires are configured to converge or separate from one another in order to provide control over the deflection of the deflectable shaft.

22. The ultrasonic imaging device according to claim 17, wherein the ultrasonic probe comprises an ultrasonic transducer at least partially surrounded by a material that defines the distal tip of the ultrasonic imaging device.

23. The ultrasonic imaging apparatus according to claim 22, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself.

24. The ultrasonic imaging apparatus according to claim 23, wherein the flexible circuit board is interposed between the ultrasonic transducer and the biaxial sensor.

25. The ultrasonic imaging apparatus according to claim 23, wherein the folded arrangement of the flexible circuit board includes at least four folds.

26. The ultrasonic imaging apparatus according to claim 25, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

27. An ultrasonic imaging device configured to have rotation and deflection control, An ultrasound probe positioned adjacent to the distal region of the rotatable shaft, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft, A handle assembly comprising a handle body having an outer surface that can be grasped by a user, a first actuator configured to move relative to the handle body, and a second actuator configured to move relative to the handle body, A plurality of pull wires communicating with one or more of the first actuator or the second actuator, the plurality of pull wires arranged along the longitudinal length of the deflectable shaft and the rotatable shaft, The rotatable shaft is operably connected to the first actuator of the handle assembly via one or more first pull wires from the plurality of pull wires, thereby causing the operation of the first actuator to cause rotational motion of at least a portion of the rotatable shaft relative to the deflectable shaft. The deflectable shaft is operably connected to the second actuator via one or more second pull wires from the plurality of pull wires, so that the rotation of the second actuator causes deflection of the deflectable shaft, which in turn causes deflection of the rotatable shaft. One or more of the first actuator or the second actuators comprises a first helical gear arranged to rotate in response to the rotation of one or more of the first actuator or the second actuators. An ultrasonic imaging device, wherein one or more of the first pull wire or the second pull wires are coupled to a spindle having a second helical gear, the second helical gear being configured to engage with the first helical gear such that the rotation of the first helical gear causes the spindle to rotate, thereby winding or unwinding the first pull wire or the one or more of the second pull wires.

28. The ultrasonic imaging apparatus according to claim 27, wherein the plurality of pull wires include four pull wires.

29. The ultrasonic imaging apparatus according to claim 27, wherein the plurality of pull wires are configured to provide symmetric deflection of the deflectable shaft in at least two opposite curves.

30. The ultrasonic imaging apparatus according to claim 27, wherein the plurality of pull wires are configured to provide asymmetric deflection of the deflectable shaft in a curve in a first direction and in a curve in a second direction opposite to the curve in the first direction, and the curve in the first direction has a different radius of curvature from the radius of curvature of the curve in the second direction.

31. The ultrasonic imaging apparatus according to claim 27, wherein at least one pair of the plurality of pull wires is arranged adjacent to one another in a parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a selected branching region located distal to the handle assembly, and at least one pair of the plurality of pull wires is spaced further apart from one another in the branching region than from the handle assembly, and at least one pair of the plurality of pull wires is spaced closer together in a second region of the deflectable shaft located distal to the branching region compared to the branching region.

32. The ultrasonic imaging apparatus according to claim 31, wherein at least a portion of the second region exhibits a stiffness lower than that of the branched region.

33. Ultrasonic imaging apparatus according to claim 27, wherein at least a first pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a selected first branching position located distal to the handle assembly; at least a second pair of the plurality of pull wires are arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a second region of the deflectable shaft to a selected second branching position located distal to the handle assembly; at least the first pair of the plurality of pull wires are further spaced apart from each other in a third region located distal to the first branching point; and the second pair of the plurality of pull wires are further spaced apart from each other in a fourth region located distal to the second branching point.

34. The ultrasonic imaging apparatus according to claim 33, wherein the rigidity of the first region is different from the rigidity of the third region.

35. The ultrasonic imaging apparatus according to claim 33, wherein the rigidity of the second region is different from the rigidity of the fourth region.

36. The ultrasonic imaging apparatus according to claim 27, further comprising a biaxial sensor and a uniaxial sensor, which are arranged at a distance from each other and configured to provide positional feedback indicating one or more of the deflection or rotation of the ultrasonic probe.

37. The ultrasonic imaging apparatus according to claim 36, wherein the biaxial sensor is positioned adjacent to the ultrasonic probe, and the uniaxial sensor is positioned proximal to the biaxial sensor along the longitudinal axis of the deflectable shaft.

38. The ultrasonic imaging device according to claim 27, wherein the ultrasonic probe comprises an ultrasonic transducer at least partially surrounded by a material that defines the distal tip of the ultrasonic imaging device.

39. The ultrasonic imaging apparatus according to claim 38, further comprising a flexible circuit board disposed adjacent to the ultrasonic transducer and electrically communicating with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself.

40. The ultrasonic imaging apparatus according to claim 39, wherein the flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft.

41. The ultrasonic imaging apparatus according to claim 39, wherein the folded arrangement of the flexible circuit board includes at least four folds.

42. The ultrasonic imaging apparatus according to claim 41, wherein the folded arrangement of the flexible circuit board includes an M-shaped folding configuration.

43. An ultrasonic imaging device configured to have rotation and deflection control, An ultrasonic probe positioned adjacent to the distal tip region of a rotatable shaft, wherein rotation of the rotatable shaft causes rotation of the tip region and the ultrasonic probe, and the ultrasonic probe comprises an ultrasonic transducer at least partially surrounded by a material defining the distal tip of an ultrasonic imaging device, A deflectable shaft, wherein the deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft in order to control the position of the distal tip and the ultrasound probe, and the deflectable shaft is positioned relative to the rotatable shaft. A flexible circuit board is disposed adjacent to the ultrasonic transducer and electrically communicates with the ultrasonic transducer, wherein the flexible circuit board has a plurality of electrical component pads disposed thereon, and the flexible circuit board is configured in a folded arrangement on itself, The flexible circuit board is interposed between the ultrasonic transducer and the distal end of the deflectable shaft. An ultrasonic imaging device wherein the folded arrangement of the flexible circuit board includes at least four folds.

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