Cable routing and assembly for medical device handles

Abstract

A medical device comprising a medical implement, a handle, and a flexible cable bundle passing through the handle, the handle and the cable routing therein adapted to reduce noise in the cable.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 941,435, filed November 27, 2019, which is incorporated by reference in its entirety for all purposes.

[0002] The following applications are incorporated by reference herein for all purposes: WO 2018 / 017717, WO 2018 / 182836(A1), and International Application US2019 / 047930.

[0003] (Incorporated by reference) All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0004] Medical devices such as imaging catheters may include flexible cable bundles extending therethrough that may be susceptible to noise along the cable line(s) at certain frequencies. The cable routing and handle assembly through which the cables extend may be required to reduce noise in the cables. Summary of the Invention [Means for solving the problem]

[0005] One aspect of the disclosure is a medical instrument including an elongate shaft sized and configured for advancement within a patient. The medical instrument may include a handle sized and positioned to remain outside of the patient, and a flexible, elongate cable bundle extending through the elongate shaft and into the handle. Within the handle, one or more shielding layers of the cable bundle may be removed from the cable bundle before the remainder of the cable bundle passes through an electrical noise suppression member disposed within the handle.

[0006] In this embodiment, the medical device may include an ultrasound transducer in communication with a flexible cable bundle, optionally disposed at a distal tip of the medical device, and optionally used for medical imaging. The medical device may also be used with other energy modalities.

[0007] In this aspect, the electrical noise suppression member may optionally comprise a ferrite bead.

[0008] In this aspect, the flexible cable bundle may be folded in an organized manner within a fold area in the handle, and the shielding layer may be detached from the cable bundle prior to the fold area such that the shielding layer is not folded within the handle.

[0009] In this aspect, the flexible cable bundle may be folded accordion style within the folding area.

[0010] In this aspect, the shielding layer may be coupled to a receptacle at the proximal end of the handle.

[0011] In this aspect, the cable bundle may be coupled to multiple printed circuit boards secured within the handle, optionally after fanning out from a main cable bundle body.

[0012] In this aspect, the cable bundle may extend from a proximal end of an elongate shaft disposed within the handle.

[0013] In this manner, the cable bundle may pass by and extend radially outward from a number of printed circuit boards disposed within the handle.

[0014] In this embodiment, the cable bundle passes between a first printed circuit board and a second printed circuit board of a plurality of printed circuit boards disposed within the handle.

[0015] In this manner, the cable bundle may include a movable portion that is axially movable within the handle.

[0016] In this manner, the cable bundle does not have to be adapted to move axially within the handle after the handle is assembled.

[0017] In this aspect, the electrical noise suppression member may comprise one or both of a material or configuration adapted to suppress electromagnetic interference from the elongate cable bundle.

[0018] In this aspect, the electrical noise suppression member may comprise one or both of a material and / or configuration for suppressing electromagnetic interference to the elongate cable bundle.

[0019] One aspect of the present disclosure is a medical instrument that includes an elongate shaft sized and configured for advancement within a patient. The medical instrument may include a handle sized and positioned to remain outside of the patient, and a flexible, elongate cable bundle extending through the elongate shaft and into the handle.

[0020] In this aspect, the flexible elongated cable bundle may be folded in an organized manner within a folding area in the handle, and the shielding layer of the cable bundle is removed from the cable bundle prior to the folding area such that the shielding layer is not folded within the folding area.

[0021] This aspect may include any other suitable components, features, or functionality described herein, including any other feature of any other aspect in this summary section.

[0022] In this aspect, the medical instrument may include an ultrasound transducer in communication with the flexible cable bundle, optionally disposed at a distal tip of the medical instrument, optionally used for medical imaging. [Brief description of the drawings]

[0023] [Figure 1A] FIG. 1 illustrates an exemplary embodiment of a system including steering and a medical instrument. [Figure 1B] FIG. 1B shows cross section AA of the steering and instrument portion of the medical instrument of FIG. 1A. [Diagram 2] 1 illustrates an exemplary system including a handle assembly having multiple actuators, a steerable sheath, and a medical instrument. [Figure 3Ai] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Aii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Aiii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Bi] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Bii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Ci] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Cii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Di] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Dii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Diii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3Diiii] FIG. 1 illustrates an exemplary steerable shaft with pull wires. [Figure 3E] FIG. 1 illustrates an exemplary steerable shaft in which one or more pull wires are circumferentially woven into the braided wires of the shaft. [Figure 4] FIG. 2 illustrates an exemplary portion of an exemplary system including a bundle. [Diagram 5]1 illustrates an exemplary proximal end of a medical device including a conductor bundle extending into a proximal connector in which a printed circuit board (PCB) is housed. [Figure 6A] 1 illustrates a portion of an exemplary medical device including a flexible circuit strip. [Figure 6B] FIG. 13 illustrates an exemplary proximal portion of the strip. [Figure 6C] FIG. 13 is a detailed view of an exemplary proximal portion of the strip. [Figure 6D] FIG. 2 is an end view of an exemplary flex strip. [Figure 6E] FIG. 2 illustrates an example stack of flex strips. [Figure 6F] FIG. 2 illustrates an example stack of flex strips and ground shield strips. [Figure 6G] 1 illustrates an exemplary bundle including tubing around a stack of strips and ground shield strips. [Figure 7] FIG. 1 illustrates an integrated steerable sheath and medical instrument system, where the system is connected to a console via a connector cable. [Figure 8A] 1A-1C show an exemplary handle assembly that may be used with any of the inner and outer elongate bodies or shafts herein. [Figure 8B] 1A-1C show an exemplary handle assembly that may be used with any of the inner and outer elongate bodies or shafts herein. [Figure 9A] 1 illustrates a portion of an exemplary inner elongate body, or inner shaft. [Figure 9B] 1 illustrates a portion of an exemplary outer elongate body, or outer shaft. [Figure 9C] FIG. 9C illustrates a portion of an exemplary medical device including the elongated body (or shaft) from FIGS. 9A and 9B. [Figure 9D] FIG. 9D shows a cross section of the device at the deflectable portion from FIG. 9C. [Figure 10A]FIG. 2 illustrates a portion of an exemplary handle assembly. [Figure 10B] FIG. 2 is an exploded view showing an exemplary outer elongate body (or outer shaft) movement subassembly. [Figure 10C] FIG. 57B is a side cross-sectional view of the handle assembly from FIG. 57A. [Figure 11] 1 illustrates an exemplary handle assembly including rotation indicators for a first actuator and a second actuator. [Figure 12A] 1A-1C illustrate internal components of an exemplary handle assembly including a tensioning or flattening member. [Figure 12B] FIG. 1 illustrates (in side view) the internal components of an exemplary handle assembly, including a tensioning or flattening member. [Figure 12C] FIG. 12C shows the internal components of an exemplary handle assembly (in an opposite side view to FIG. 12B) including tensioning or flattening members. [Figure 12D] 1A-1C illustrate internal components of an exemplary handle shell including one or more guide features positioned to help stabilize the tension member within the handle assembly. [Figure 12E] FIG. 2 is a side view of an exemplary handle shell. [Figure 12F] FIG. 2 is a side view of an exemplary handle shell. [Figure 13A] 1A-1C illustrate an exemplary flexible cable bundle having at least a portion twisted about its longitudinal axis. [Figure 13B] 1A-1C illustrate an exemplary flexible cable bundle having at least a portion twisted about its longitudinal axis. [Figure 13C] 1A-1C illustrate an exemplary flexible cable bundle having at least a portion twisted about its longitudinal axis. [Figure 13D] 1A-1C illustrate an exemplary flexible cable bundle having at least a portion twisted about its longitudinal axis. [Figure 13E] FIG. 13D shows a detail from FIG. [Figure 14A]FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. [Figure 14B] FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. [Figure 15] FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. [Figure 16] FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. [Figure 17] FIG. 2 is an exemplary schematic diagram of cable routing. [Figure 18] FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. [Figure 19] 13A-13D illustrate folding of a flexible cable within the handle of a medical device. [Figure 20] FIG. 1 illustrates an exemplary handle including a cable bundle shielding layer removed before the bundle passes through a ferrite bead. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The present disclosure relates to medical device cable routing and handle assemblies configured and adapted to improve discharge and / or immunity performance. Figures 1-13E and their textual descriptions show exemplary features of imaging devices, systems, and methods of use, any of which may be incorporated into the cable routing concepts described herein with respect to Figures 14A-20.

[0025] 1A shows an exemplary embodiment of an integrated steering and medical instrument system. The system 1000 includes a handle assembly 1002 and a steering and medical instrument portion 1004. The steering and medical instrument portion 1004 includes a proximal portion 1006 and a steerable portion 1008. The system is adapted to actuate the handle assembly 1002 to steer the steerable portion 1008, and optionally further to move the medical instrument 1010 relative to the steering and medical instrument portion 1004. In this exemplary embodiment, the handle assembly 1002 includes a first actuator 1001, a second actuator 1003, and a third actuator 1005. The first actuator 1001 is adapted to be actuated (rotated in this example) relative to the handle body 1007 to steer the steerable portion 1008, specifically to steer the outer sheath 1102. The steerable portion 1008 in this embodiment can be steered or bent to the configuration shown in solid lines in FIG. 1A, and to the configuration shown in dashed lines or any position in between, and in some embodiments, the opposite steering function is limited to simply straightening the shaft from an initial bent configuration, such as the bent configuration in solid lines in FIG. 1A. The term "steer" in this disclosure means to deflect or bend, optionally via actuation of at least one pull wire, although in some examples, the term can include rotation (torque) and axial translation of the shaft. The term "pull wire" in this specification refers to any element capable of transmitting tension from the proximal end of the device to the distal end region. The pull wire may be composed of a metal wire, such as stainless steel or nickel titanium, either solid or twisted / braided, or a polymer, such as aramid fiber (Kevlar®), polyethylene, ptfe, eptfe, etc., preferably twisted / braided, but also in the form of a monofilament. In a preferred embodiment, the pull wire is constructed from an aramid fiber bundle having four 50 denier multifilament (approximately 25 filaments) yarns braided together at a high pick per inch.The cross-sectional diameter of the wires is typically in the range of 0.005" to 0.012", more preferably 0.008" to 0.010", although braided or twisted wires may be flattened or ovalized within the lumen of the device. The preferred construction embodiment is believed to provide optimized strength and wear resistance with respect to the size required to keep the shaft diameter to a minimum. The optional second actuator 1003 is adapted to be actuated (rotating in this example) relative to the handle body 1007 to rotate (labeled rotational movement "R") the medical instrument 1010 relative to the shaft 1102, and the optional actuator 1005 is adapted to be actuated (axially in this example) relative to the handle body 1007 to move the medical instrument 1010 axially (distal-proximal) relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the steerable portion 1008 is steered (bent / deflected), but the proximal portion can bend and flex to conform to the anatomy it is used within. In many embodiments, this is accomplished by constructing the steerable portion 1008 from a softer or less stiff material and / or composite structure than the proximal portion 1006.

[0026] The embodiment shown in Figure 1A is an example of a device that includes an integrated handle assembly that is in operative communication with both a steerable outer shaft and an inner medical instrument. The handle assembly is integrated in that it is assembled and constructed to be in operative communication with the outer shaft and inner medical instrument prior to packaging and use. "Integrated," as the term is used in the context of an integrated handle assembly, refers to a handle assembly that requires at least a portion of the handle assembly to be destroyed or disassembled before a medical instrument can be removed from within the outer shaft.

[0027] 1B illustrates an exemplary cross section AA (shown in FIG. 1A) of the steering and instrument portion 1004, specifically the steerable portion 1008. In this embodiment, the medical instrument 1010 is sized and configured to be disposed within a steerable sheath. The steerable sheath includes an outer shaft 1102 and a set of pull wires 1104 that are axially fixed at a distal region of the steerable portion 1008.

[0028] The medical instrument of Figures 1A and 1B may be any medical instrument herein, such as, for example, an ultrasonic instrument. As used herein, "ultrasonic probe" generally refers to an elongated instrument that includes at least one ultrasonic transducer and one or more conductive elements that electrically connect the at least one ultrasonic transducer to a proximal region of the elongated instrument. The proximal region of the ultrasonic probe includes, or is modified to include, at least one proximal contact that is in electrical communication with the at least one ultrasonic transducer and that can be in electrical communication with electrical contacts on another instrument, cable, or connector, optionally via attachment thereto.

[0029] FIG. 2 illustrates an exemplary system 10 adapted to function similarly to the systems of FIGS. 1A and 1B, and also illustrates exemplary internal components of a handle assembly 12 (internal components shown as dashed lines). The handle assembly 12 is integrated with and in operative communication with an outer steerable shaft 20 and a medical instrument 30. The handle assembly 12 includes an actuator 14 adapted to manipulate the steerable shaft 20 upon actuation relative to a handle body 15. The actuator 14 is in operative communication with the steerable shaft 20 via a steering control 16 disposed within the handle assembly 12. The medical instrument 30 is disposed within the handle assembly 12 and includes a proximal portion 18 integrated therewith. The actuator 13 is in operative communication with the medical instrument 30, and actuation (rotation, in this example) of the actuator 13 relative to the handle body 15 rotates the medical instrument 30 relative to the outer shaft 20 via a rotation control 1215. The optional third actuator 17 is also in operative communication with the medical instrument 30 and, in this embodiment, is adapted to actuate axially (relative to the handle body 15) to move the medical instrument 30 axially relative to the outer steerable shaft 20 via the axial control section 1217.

[0030] The medical instrument of FIG. 2 can be any medical instrument herein, such as, for example, an ultrasound instrument.

[0031] 3A-3E depict an exemplary embodiment of a distal region of the sheath portion 1208 of the steerable sheath 1202 in the system 1200. For simplicity, the illustrated cross section shows only the outer sheath 1208, and not the inner instrument 1212. The outer sheath 1208 preferably has a composite structure to improve torque transmission applied to the outside of the shaft from the proximal end, or to resist torque forces applied to the outer sheath 1208 from within the shaft, such as from the instrument 1212. As shown in FIGS. 3Ai-3Aiii, a plurality of braided elements 1250, preferably formed from metal wires (round, pairs of rounds, or ribbon) and / or multiple fibers (e.g., aramid or nylon), may be braided directly onto a thin-walled (e.g., 0.0010 inches ± 0.0005 inches) lubricious liner tube 1251, such as PTFE or FEP material, to form a composite. A thermoplastic polymer 1252 (such as Pebax, or nylon, or other common catheter materials, in the durometer range of 25D-72D) can be thermally laminated using heat shrink tubing (such as FEP) to reflow the polymer onto the braided element 1250 and liner tube 1251 to form a homogenous member. The thermoplastic polymer 1252 can also have a radiopaque compound, including materials such as bismuth, barium sulfate, or tungsten, so that the tip of the sheath is visible to the user under fluoroscopy. In the embodiment of Figures 3Ai-3Aiii, the pull wire 1104 is preferably parallel to the central access in the steerable (deflectable) portion 1222 of the sheath, and is also preferably provided within a lumen 1253 created within the wall of the steerable sheath 1208. This lumen can be created during the extrusion process of the thermoplastic polymer tube or during the shaft heat laminate fusion process using a removable mandrel. A pullwire lumen 1253 may further be created by incorporating a pullwire tube 1254 within the wall, preferably temporarily supported by a removable mandrel.A removable mandrel may also be placed along the pull line 1104 or 1104' during the fusing process, resulting in a somewhat elliptical lumen 1253 within which the fibrous pull wires can be flattened and space for the pull wires to move freely. The tube 1254 may comprise PTFE, FEP, polyimide, or other material that maintains the integrity of the tube 1254 walls during the thermal lamination process up to about 500°F. The tube is preferably surrounded and supported by a thermoplastic polymer 1252, which is preferably thermally laminated to the tube. In another embodiment, a pull wire lumen, preferably including a pull wire tube, is incorporated within the weave of the braided element 1250. For example, the braided element 1250 extending in one direction will pass under the pull wire lumen while the braided element 1250 extending in the opposite direction will pass over the pull wire lumen. The braided reinforcement provides a dimensionally more stable lumen during manipulation of the catheter and also helps ensure lumen straightness, if necessary. Proximal to the steerable portion, the pull wires may run proximally parallel to the central axis on the same side of the outer sheath 1208, as shown in Figures 3Ai-3Aiii. In this embodiment and other embodiments below, an additional pull wire 1104' in an additional pull wire lumen routed within the wall of the sheath 1208 through the steerable portion 1222 may be required to straighten the steerable portion of the device. This straightening pull wire 1104' is preferably routed within the steerable portion 1222 on the opposite side from the pull wire(s) 1104 used for steering (deflection) at the steerable portion 1222. In another embodiment not shown, two lumens and two straightening pull wires 1104' may be used, essentially mirroring the paired 1104 pull wire configuration. These straightening wires may also be configured to allow deflection in the opposite direction by tensioning them a greater distance within the handle (beyond simply straightening).

[0032] During use, the portion 1223 of the distal catheter immediately proximal to the steerable (deflectable) portion 1222 may be biased to conform to a curve based on the constraints of the anatomy in which the portion 1223 is to be used. For certain embodiments in which the device is advanced into a heart chamber from a groin access, the biased to curve 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, resulting in a "whip" or sudden rattle of rotation when torque is applied. To minimize the possibility of whipping, the tension and construction material of the pull wires are optionally distributed around the surface of the curved region 1223. In one embodiment as shown in Figures 3Bi-3Biii, the pull wire 1104 may be helically wound around the central axis of the sheath at least in the curved region 1223 proximal to the portion 1222. The pull wire in this embodiment may be completely wrapped around for a length of about 10 cm (this value ranges from 5-15 cm). The helix need only be in the curved region 1223 and then run 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 steerable portion 1222. The helix may be straight after a minimum of one revolution or may be helically wound the entire length of the shaft. In another embodiment to minimize whip, it may be sufficient to distribute the pull wire tension to opposite sides of the shaft. 3Ci-3Cii, deflection of the steerable section 1222 is accomplished by two parallel pull wires 1104 positioned adjacent to each other on the same side of the sheath 1208. In a curved region 1223 proximal to the steerable section 1222 and in a proximal portion 1224 (similar to 1006), the pull wires are each routed 90° from their location in the steerable section 1222 on opposite sides of the shaft to distribute tension more evenly.While it is preferred that the two parallel pull wires are actuated simultaneously by the handle actuator with equal force, in other embodiments, a force differential can be applied to steer the tip to one side or the other of a plane formed when the two pull wires are actuated with equal force. In other embodiments, any of the multiple pull wires can be routed in the same configuration as shown in FIG. 3B or 3C, with multiple proximal pull wires evenly distributed around the circumference of the shaft. Also, as shown in FIG. 3Ci-Cii, the pull wires 1104 can be routed proximally along opposite sides of the shaft for most of the length of the shaft proximal portion 1124, but are preferably brought together adjacent to each other again near the proximal end portion of the shaft, allowing the wires to exit together from the same side of the proximal shaft, facilitating their fastening together to the handle components for simultaneous actuation tension.

[0033] Figures 3Di-3Div show another embodiment of a distal region of a catheter having a similar structure to that previously described, but instead configured to provide a distal steerable 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 curved region 1223. This is similar to Figures 3Ai-3Aiii, except that the wires are paired on each side of the shaft. The routing may be helical, as in Figures 3Bi-3Bii, or other configurations as discussed. Within the distal steerable portion 1222, the wires are routed 90° from the proximal portion, although other angles are contemplated. At junction 1225 in 1222, one or more of the pull wires (e.g., 1105 and 1107) may terminate and be fixed to the shaft, while the remaining pull wires (e.g., 1106 and 1108) extend to a more distal tip location 1226 where they are fixed. This configuration allows for independent actuation of the pull wires terminating at 1225 and 1226, allowing different shapes to be formed during actuation. FIG. 3Dii shows both lines 1107 and 1108 being tensioned to create variable curves in the same direction. FIG. 3Diii shows lines 1107 and 1106 being tensioned to create an "S" curve. Other configurations are possible.

[0034] To prevent the pull wires from breaking or pulling free when repeatedly tensioned, the pull wires (such as 1104 and 1104') should be terminated at their distal ends such that they are securely anchored to the wall of the distal steerable shaft section 1222. In a preferred embodiment shown in FIG. 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. Additionally or alternatively, one or more of the pull wires 1104 or 1104' can be wrapped and / or tied around the outside of the braided wire 1250 for further fixation. The braided wire 1250 can then be trimmed distal to the fixation point, with the woven and / or wrapped pull wires preventing the braided wire from expanding and / or fraying. An additional adhesive, such as a UV cure or cyanoacrylate, may also be used to secure the pull wire to the braided wire. The weave and / or wrap of the pull wire and braided wire is then laminated with a thermoplastic polymer that melts in the space around the wires and cools to secure the wires in place. The thermoplastic polymer may also have a radiopaque compound, including materials such as bismuth, barium sulfate, or tungsten, so that the tip of the sheath is visible to the user under fluoroscopy.

[0035] In further embodiments, the instrument 1212 may also or alternatively be constructed with one or more pull wires to deflect the tip in the same manner as any of the previous embodiments described for the outer sheath 1208. In addition to routing the pull wires within the wall of the tubular member of the instrument 1212, the pull wires may be routed alongside conductors within the lumen of the tubular element 1212. Actuation of the pull wires may come from an actuator located within the proximal handle 1206. The distal shaft of the instrument 1212 may be formed with a particular shape (e.g., an arc) so that it bends into a particular shape as it exits the tip of the steerable portion 1222 of the outer sheath 1208. The stiffness of the distal shaft of the instrument 1212 is such that it does not substantially deform the outer sheath 1208 while inside, but bends after exiting. The shape may be defined by any one or combination of the following means: heat setting of a polymeric material, use of a movable or fixed shaped stylet within the inner lumen of the shaft 1212 or within a lumen in the wall of the shaft 1212. Such a stylet may be round, oval, or rectangular in cross section and formed from stainless steel, Nitinol, or rigid polymers such as PEEK, Vestamid, etc. Alternatively, the outer steerable sheath may be bent by methods similar to those described above, with or without further pullwire deflection, and with or without further shaping or deflection of the distal portion of the instrument shaft 1212.

[0036] An aspect of the present disclosure includes a method for disconnecting at least a portion of the system from other components, optionally as part of a repositioning process. In some embodiments, the medical instrument includes one or more electrical contacts coupled to other electrical contacts in electrical communication with an energy console, examples of which are known in the ultrasound field.

[0037] FIG. 4 illustrates only a portion of an exemplary medical instrument, such as an ultrasound probe, that may be electrically coupled directly or indirectly to an energy console, such as an ultrasound console.

[0038] Repositioning the instrument may include severing one or more proximal electrical contacts and moving the instrument portion distally from the distal end of the sheath portion. In this embodiment, the instrument portion 1212 includes at least an instrument outer sheath or instrument 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 instrument outer member 2010 to a proximal connector (for clarity, the connector and handle mechanism are not shown in FIG. 18). In some embodiments, the medical instrument is used for ultrasound 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).

[0039] FIG. 5 shows merely an exemplary proximal end of a medical device (the medical device is shown on the right), which in this embodiment is an ultrasound probe. The proximal end 2015 of the medical device is adapted to be electrically coupled to a connector cable 270, which is adapted to be electrically coupled directly or indirectly to an energy console, such as an ultrasound energy console. As shown in FIG. 5, a flexible conductor bundle 2020 extends from a distal region of the medical device (distal region not shown) into a proximal connector 2015 that houses a rigid or flexible printed circuit board ("PCB") 2030. The connector bundle 2020 includes a number of contacts 2024 that are attached to PCB board contacts 2031 (examples of which are described below). Each individual trace from each contact 2031 is coupled to another portion of the PCB, optionally more proximally, an individual exposed contact 2050. The individual PCB traces may also pass through other useful circuitry on the PCB. The exposed contacts 2050 are configured for mechanical engagement for electrical conduction to similar contacts 2060 on a mating connector cable 2070, similar in concept to the proximal instrument connector 1990 described above, connecting the instrument 1204 to a user interface console. The proximal connector 2015 may be incorporated into any of the systems, handles, steerable sheaths, medical instruments, etc. herein.

[0040] As used herein, the term "conductor bundle" may be used interchangeably with "flexible conductor bundle" unless otherwise specified herein.

[0041] Figures 6A and 6B show an exemplary conductor strip (also referred to herein as a flexible circuit strip) 2021 that may be included in any of the conductor bundles herein. The embodiment of Figures 6A and 6B is an example of a conductor strip that may be included in the bundle 2020 of Figures 4 and 5. The embodiment of Figures 6A and 6B may be incorporated into any of the other systems herein.

[0042] As shown in Figures 6A, 6B, and 6G, the conductor bundle 2020 includes multiple flex circuit strips including a multi-wire strip 2021 and conductive strips (only portions of which are shown) for ground 2022 and shield 2023. Each multi-wire strip includes multiple 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, both of which are exemplary with respect to the number of traces 2025 that may be used. Each strip 2021 may be approximately 0.072 inches wide and 0.0022 inches thick, and may optionally include 16 0.0022 inch wide by approximately 0.0007 inch thick conductive (e.g., copper) traces, each spaced apart by approximately 0.0022 inches. The traces are disposed on an insulating substrate layer 2027, such as a polyimide substrate, and the traces may be at least partially covered by a cover layer 2026, such as a photosensitive film cover ("PIC") layer or other dry film solder mask (DFSM), or other similar material. The cover layer generally extends along most of the bundle, except for separate locations in the proximal and distal regions for electrical coupling. In other embodiments, the strip 2021 is approximately 0.055 inches wide and includes 12 conductive traces (see Figures 6D-6G). In other embodiments, the strip 2021 is approximately 0.037 inches wide and includes 8 copper conductive traces. The 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. As optimized for a 2D piezoelectric array, approximately seven stacks of 16-wire strips 2021 (or nine 12-wire, or fourteen 8-wire) would be required along each one of the strips 2022 and 2023 on each side of the stack of multi-wire strips. Figure 6E shows a portion of an example bundle 2020 having nine strips 2021 stacked on top of each other.Figure 6F shows a portion of a bundle including nine stacked strips 2021 as well as ground strip 2022 and shield strip 2023 (only the top strip is labeled). The complete bundle may optionally be held together with shrink tubing of approximately 0.001 inch wall thickness, such as, but not limited to, tube 2028 of Figure 6G. The flex circuit dimensions and number of wires described above are for a particular configuration of the piezoelectric array (and / or its ASIC controller) and may be varied depending on how the number and size of the array elements are optimized for a particular application.

[0043] The proximal end of each flex circuit strip has conductive material (e.g., gold-plated copper) exposed by removing cover layer 2026 at location 2024, for example, over a length of approximately 3 mm. Location 2024 and other exposed locations described herein are generally referred to as "contacts." As used in this context, it is understood that contacts actually include multiple separated conductive traces (such as shown in the area locations), each of which is adapted to electrically communicate with its own corresponding conductive element. Thus, "contact" is not limited to mean only a single electrical connection between two conductive elements. Although FIG. 6A shows multiple exposed regions 2024, the embodiment of FIG. 6A is initially described herein as if there was only one exposed region (i.e., region 2024 at the proximal end). Strip 2021 can be manufactured to create electrical connections for conductive traces on PCB 2030 to matching exposed contacts 2031, shown in FIGS. 6A-6C. In some embodiments, 16 individual wires will be provided within a given contact 2031, sized and spaced to match the 16 wires in the multi-wire strip 2021. A suitable electrical connection between the strip wires and the PCB contacts may be achieved using anisotropic conductive film (ACF), soldering, conductive adhesives, mechanical connections, or any combination thereof.

[0044] FIG. 7 shows an integrated system 1200 of a steerable sheath 1202 and a medical instrument 1204, the system 1200 being connected to a console 4000 via a connector cable 2070. As previously described, such as with respect to FIG. 5, the instrument 1204 includes a proximal connector 2015 that forms a mating connection to the cable 2070. As previously described, it is desirable to reconfigure (e.g., reprocess and reuse) the system 1200. It is further desirable to ensure that the system is reconfigured only by the original manufacturer and not by unrelated third parties, and that the device is reused only a certain number of times. To control the reconfiguration process, a cryptographic authentication chip (encryption chip) is preferably incorporated into the instrument 1204 on the PCB 2030, although other locations are envisioned, such as in the steerable handle 1206 or in the tip 3000. The encryption chip is programmable only by the original manufacturer, which controls the authentication key. The console 4000 to which the system 1200 is connected has a Trusted Platform Module (TPM) that also has the authentication key. During use of the system 1200, the console 4000 can authenticate the system 1200 via the encryption chip and, if desired, can 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, connectors, and devices.

[0045] As used herein, "cleaning" can refer to any type of cleaning, such as, but not limited to, cleaning the inside of an outer shaft using a cleaning system of cleaners and / or disinfectants, optionally mechanically scrubbing with small brushes, 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 ultrasound probe) with a cleaner / disinfectant, optionally immersing the shaft in an ultrasonic bath of cleaner / disinfectant for a certain period of time, and optical cleaning methods such as including the use of UV light. As used herein, "cleaning" does not refer to a specific cleaning process, but rather to the general concept of cleaning an object.

[0046] The disclosure herein also includes methods of assembling or reassembling any of the subassemblies or assemblies herein, including any of the subassemblies within any of the handle assemblies herein. For example, but not by way of limitation, the disclosure herein includes a method of winding one or more pull wires over a bearing surface of a spindle support and then around a spindle.

[0047] Methods herein also include manufacturing or constructing any of the individual components of any of the subassemblies or assemblies herein. For example, the present disclosure includes methods of manufacturing components of a handle shell having specific configurations (e.g., guides, walls, etc.) that can accommodate internal parts that enable the assemblies or subassemblies herein to function as intended.

[0048] Regardless of labeled reference numbers, any of the handle assemblies, medical instruments, steerable sheaths, and electrical connections herein may be used together in a system in any combination with one another.

[0049] Any of the techniques involving ultrasound and manipulation techniques in any of the following U.S. patent references may be incorporated into any of the medical instruments, devices, systems, or methods of use herein, the disclosures of which are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833 , 7783339, 7791252, 7791252, 7819802, 7824335, 7966058, 8057397, 8096951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 86 59212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

[0050] Any suitable disclosure above may be incorporated into any of the following embodiments, for example, aspects of the devices, systems, and methods of making and using are incorporated herein and may be incorporated into any of the following embodiments, unless otherwise indicated.

[0051] 8A and 8B show merely an exemplary handle assembly that may be in operative communication with the outer shaft 131 and the inner shaft 132. In this exemplary implementation, the handle assembly 120 includes a handle body 123 having an outer surface that may be gripped by a user, a first actuator 121, and a second actuator 122. The actuator 121 may be in operative communication with the outer shaft 131, and the actuator 122 may be in operative communication with the inner shaft 132. The actuator 121 is adapted to rotate and move axially relative to the handle body 123 (and relative to the second actuator 122). This allows the actuator 121 to cause axial movement of the medical instrument 103 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 can have internal components that interface with the proximal ends of the pull wires such that actuation of the actuator 122 tensions one or more pull wires causing deflection of the inner shaft. In this embodiment, the actuator 121 is distal to the actuator 122, although in other designs their relative positions can be reversed. FIG. 8B shows the handle assembly 120 after the actuator 121 has been advanced distally relative to its position in FIG. 8A. This distal advancement advances the outer shaft 131 distally and therefore the medical instrument distally. The actuator 121 can similarly be retracted proximally relative to its position in FIG. 8B. With regard to the proximal retraction of the actuator 121, reference is made to the tensioning members, which are further described below.

[0052] In other designs, actuator 121 can be in operative communication with the inner shaft and actuator 122 can be in operative communication with the outer shaft.

[0053] As described herein, the outer shaft can move axially relative to the inner deflectable shaft. The outer shaft can be constructed of a section of material that varies in stiffness (e.g., durometer) along at least a portion of the length of the outer shaft. For example, a first section distal to a second section can have a lower durometer than the second section. Because the outer shaft can move axially relative to the deflectable inner shaft and the stiffness of the outer shaft can vary along the length of the outer shaft, the deflection, including the degree (or amount), of the entire instrument can be selectively controlled by controlling the axial position of the outer shaft (relative to the inner shaft). Thus, the axial movement of the outer shaft can selectively control the deflection of the instrument. For example, a user (e.g., 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. Additionally, for example, sections of varying stiffness in the outer shaft can allow 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 a relatively high stiffness, the inner shaft may deflect less than when the outer shaft is deflected in a region having a lower stiffness.

[0054] 9C illustrates an exemplary device medical device 130 that includes an elongate inner shaft 132 (see FIG. 9A) and an elongate outer shaft 131 (see FIG. 9B). Medical device 130 may also be referred to herein as a "catheter" or other medical instrument that includes at least one elongate shaft.

[0055] Figure 9D shows cross section AA shown in the assembly of Figure 9C, which is a cross section at the deflectable portion of the device. Parts in Figures 9A-9C are similarly labeled. As can be seen in Figure 9D, pull wires 111 and 112 are very close to each other and approximately 180 degrees away from straightened pull wire 116.

[0056] Also shown in FIG. 9D, the elongated inner shaft 132 includes two layers of braided material 119, with the pull wire essentially sandwiched between the two layers of braided material at least at this portion. The annular space 118 allows for freedom of movement and room for optional lubrication. The inner shaft 132 can be manufactured from a polymeric material, such as, for example, but not limited to, Pebax, optionally with a lubricious additive. The inner shaft 132 can include a liner 125, such as a PTFE liner. The flexible cable bundle 105 can be surrounded by one or more layers of insulation 126, such as a PTFE insulation. The outer shaft 131 can include a polymeric material 127, such as Pebax. The outer shaft 131 can also include a radially inner liner 128, such as a PTFE liner. Any of the pull wires (e.g., 111, 112, 116) can be disposed within a lumen having a liner, such as a PTFE liner 129.

[0057] Medical device 130 (or, individually, either elongate shaft 132 or elongate shaft 131) may be in operative communication with any of the handle assemblies herein, including handle assembly 120 shown in Figures 8A and 8B.

[0058] Figures 10A-10C and 11 show additional exemplary handle assemblies that may be in operative communication with any medical device herein, including an ultrasound probe. For example, the exemplary handle assemblies shown in Figures 10A-10C may be coupled (directly or indirectly) to and in operative communication 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 in operative communication with the handle assemblies shown in Figures 10A-10C.

[0059] The handle assembly of Figures 10A-10C and 11 has several similarities to the handle assembly, individual components, and subassemblies shown in Figures 8A and 8BB. Unless otherwise noted, the concepts, features, and methods of use of Figures 8A and 8B that may be incorporated into the handle assembly of Figures 10A-10C are incorporated by reference for all purposes into the disclosure of the handle assembly shown in and described with respect to Figures 10A-10C. Similarly, the concepts, features, and methods of use of Figures 10A-10C that may be incorporated into other handle assemblies herein are incorporated by reference for all purposes into the disclosure of any of the handle assemblies described herein.

[0060] FIG. 10A is a side view of a handle assembly 140 with a portion of the handle body 141 removed to expose some internal components of the handle assembly. The handle assembly 140 includes a first actuator 143 and a second actuator 142, where in this embodiment the first actuator 143 is distal to the second actuator 142. The first actuator 143 can move axially and rotate relative to the handle body and relative to the second actuator (actuator 142 in this embodiment). The first actuator 143 is in operative communication with an outer elongate body, such as the outer shaft 131 (see FIG. 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 in operative communication with an inner shaft, such as the inner shaft 132 (FIG. 9A). Actuation of the second actuator 142, which in this embodiment is rotation, causes deflection of the inner shaft. In this embodiment, a rotatable, axially movable actuator (ie, first actuator 143) is in operative communication with the outer shaft.

[0061] The first actuator 143 is coupled to an elongated outer shaft moving assembly 150, shown in an exploded view in FIG. 10B, such that movement of the first actuator 143 causes movement of the assembly 150. The elongated outer shaft moving assembly 150 is similarly coupled to an elongated outer shaft, such that movement of the first actuator also causes movement of the elongated outer shaft. In this embodiment, the outer elongated shaft is attached to a removable part 153 after being inserted into a channel 156. The removable part 153 and the channel 156 are configured such that the removable part 153 is constrained by at least one inner surface of the channel when inserted into the channel 156. The elongated outer shaft moving assembly 150 also includes a distal head portion 151 secured to the first actuator. The elongated outer shaft moving assembly 150 also includes a rotation limiting mechanism, similar to those described herein, that limits rotation of the first actuator 143, and thereby the outer elongated shaft. Any of the above disclosures regarding rotation limiting subassemblies, functionality, and use are incorporated into this embodiment for all purposes and may be incorporated into this and similar designs. During rotation, part 157 (see FIG. 10B) interacts with part 161, and part 162 interacts with part 158. The physical interaction of these two sets of parts limits rotation to a desired rotation limit, such as, for example, limiting rotation to a maximum of 630 degrees of rotation of the outer body (in other embodiments, the permitted rotation may be greater than 630 degrees, such as, for example, 720 degrees or less).

[0062] For example, if it is desired to clean the outer shaft after use, the removable part 153 can be detached from the outer shaft, the outer shaft can be removed from the handle assembly and cleaned, and then reinserted and reinstalled into the removable part 153, or a new removable part if part 153 is damaged or broken.

[0063] The handle assembly 140 also includes an inner shaft deflection assembly 146 in operative communication with the second actuator 142. The inner shaft deflection assembly 146 includes a central gear 147 adapted and configured to rotate when the second actuator 142 rotates. The central gear 147 interfaces with a first spindle 148 and a second spindle 149 via a geared interface such that rotation of the central gear 147 causes rotation of the spindles in opposite directions. The inner shaft deflection assembly 146, including the spindles, extends further proximally than an elongated outer body movement assembly 150. The inner shaft extends through the outer shaft and also extends further proximally than the outer shaft within the handle assembly 150. This allows one or more pull wires that are part of the inner shaft to extend radially outward and interface with a reel 160.

[0064] 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 independently controlled by the first actuator 143 and the second actuator 142.

[0065] The handle assembly 140 also includes a printed circuit board ("PCB") 170 disposed within the handle body 141 which is in electrical communication with a cable bundle, such as the flexible cable bundle 105 of FIG. 53, or any of the cable bundles herein which communicate with a medical instrument, such as an ultrasound transducer.

[0066] The handle assembly 140 also includes a rotation indicator 180 that can be used to indicate to a user the degree to which at least one of the first and second actuators has rotated relative to a home or neutral position. The first actuator 143 can include a rotation indicator 181 that is aligned along an axis with the rotation indicator 180 when the first actuator 143 is in the neutral position, as shown in FIG. 11. As the first actuator 143 rotates, the rotation indicator 181 rotates about the axis along which the rotation indicator 180 extends, allowing a user to visually understand that the first actuator 143, and thus the outer shaft, has rotated to a certain degree relative to the neutral position. Similarly, the second actuator 142 can also have a rotation indicator 182 that is aligned along an axis with the rotation indicator 180 when the second actuator 142 is in the neutral position, as shown in FIG. 11. As the second actuator 143 rotates, the rotation indicator 182 rotates about the axis along which the rotation indicator 180 extends, thereby allowing a user to visually understand that the second actuator 143, and therefore the inner shaft, is deflected to a certain extent relative to its neutral position.

[0067] In some alternative embodiments, the handle assembly can include one or more sensors to track how much rotation occurs in the outer shaft or how much deflection occurs in the inner shaft, hi some embodiments, the handle assembly can include an encoder for each actuator.

[0068] In any of the embodiments herein that include an outer shaft and an inner shaft, the device can include one or more lubricants between the inner and outer shafts, which makes it easier to move the inner and outer shafts relative to one another by reducing friction between the two shafts. If the medical device needs to be cleaned for reuse, additional lubricant can be added between the inner and outer shafts after the cleaning process.

[0069] In some embodiments herein, the medical device may include a flexible member such as a flexible conductor bundle (which may be referred to herein as a conductor bundle, flex bundle, or other similar derivatives thereof) coupled to a distal region (e.g., a probe tip) of the medical device and extending therefrom toward a proximal region (see, e.g., conductor bundle 2020 shown in exemplary FIGS. 4-6G, or bundle 105 in FIG. 9B). The probe tip may include an ultrasound transducer in electrical communication with the flexible conductor bundle. In some embodiments herein (e.g., FIGS. 9A-11), the probe tip and conductor bundle may be displaced axially (proximally and / or distally) by actuation of a handle actuator (e.g., actuator 143 shown in FIG. 10A). In some cases, the conductor bundle is disposed within an elongate member (e.g., steerable inner elongate body 132, or elongate member 131) and moves axially relative thereto as the probe tip advances distally or retracts proximally. As the distal region (e.g., the ultrasound probe) and the conductor bundle retract proximally (after advancing distally), the conductor bundle tends to fold, bunch, or otherwise bend near or adjacent its distal end due to friction between the bundle and, for example, the elongate member on which the conductor bundle is disposed (e.g., the steerable inner shaft 132). Bunching can occur when the medical device is in a straight configuration as well as when there is some degree of bending of the medical device (e.g., after being deflected from a straight or linear configuration).

[0070] To reduce the degree of or even completely prevent the tendency to bunch or bend, any of the medical devices herein may include a structural tension member adapted and configured to apply or maintain tension to a flexible member, such as a flexible conductor bundle, at a location proximal to where the conductor bundle is coupled to the distal medical instrument. Tensioning the flexible member can minimize or even prevent folding or bunching of the flexible member. As used in this context, a "tension" member is adapted and configured to reduce bunching of the distal region of the flexible conductors (compared to devices without a tension member) by moving at least a distal portion of the flexible conductor bundle proximally when the distal probe is retracted proximally. In some embodiments, the structural tension member (e.g., a tension bar) may be physically secured (e.g., directly or indirectly attached) to the flexible conductor bundle. Generally, the tension members herein are in operative communication with a flexible member (e.g., a flexible conductor bundle) such that movement or actuation of the tension member applies a degree of force to the flexible member, causing the flexible member to move (e.g., proximally). In some exemplary embodiments, the structural tension member may be disposed within or supported by a handle assembly of a medical device. A structural tension member in this context may be a single component or an assembly of separate components.

[0071] 12A-12F illustrate a handle assembly portion of an exemplary medical device, which may be incorporated into any suitable medical device herein. For example, the handle assembly of FIGs. 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 assembly shown in FIGs. 12A-12F.

[0072] The exemplary handle assembly 310 includes a first actuator 314 and a second actuator 322, with the first actuator 314 distal to the proximal actuator 322. The first actuator 314 is adapted and configured to move axially (distally and proximally) relative to the second actuator 322 (and optionally rotatable relative to the second actuator 322), and may be in operative communication with an elongate body (e.g., 131 or 132) that may include a medical instrument (e.g., 103) in a distal region. The handle assembly 310 (including the actuators) may incorporate any of the relevant disclosures from any other handle assemblies herein. The medical device of which the handle assembly 310 is a part also includes a flexible member (e.g., flexible conductor bundle 105 in FIG. 9B) that is securely coupled (directly or indirectly) to the medical device at a first distal location (e.g., as shown in FIGS. 9B and 9C where the medical device 103 is secured to the flexible member 105) and extends proximally from the medical device towards the handle assembly 310. The flexible member may be a flexible conductor bundle as shown and may extend within the handle assembly 310. A portion of the flexible member is disposed within the outer surface of the elongate body (e.g., within 131 and / or 132). The medical device also includes a tension member secured to the flexible member at a second location 316 proximal to the first location (the "first location" in this context may be referred to as the first distal location or derivatives thereof). FIG. 12A illustrates an exemplary tension member 312, where reference number 312 also refers to the 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 tension the flexible member as the medical instrument is retracted proximally. This may also be referred to herein as tensioning the flexible member, or tensioning the flexible member, or maintaining tension in the flexible member. In this exemplary embodiment, the tension member 312 is adapted and configured to tension the flexible member as the medical instrument is retracted proximally, which in this embodiment occurs when the first actuator 314 is retracted proximally from its position shown in FIGS. 12A-12C.The tensioning members herein can apply tension when the medical device is in a straight configuration and also when the medical device is in a non-straight (linear) configuration, for example, when the medical device may deflect or bend.

[0073] In this embodiment, the tension member 312 (which may include a tension bar shown in FIG. 12A) is fixed (e.g., directly attached) to the flexible conductor bundle at location 316, which in this embodiment is inside the handle assembly. Alternatively, the tension member may be fixed to the flexible member at a location not within the handle, such as outside the handle, inside one or both of the outer and inner shafts, etc. In this embodiment, the tension member is also fixed axially relative to the first actuator 314, such that axial movement of the first actuator 314 causes axial movement of the tension member 312 (which may be a 1:1 movement ratio). Because the tension member 312 is also fixed to the flexible member (e.g., at location 316), axial movement of the tension member 312 also causes axial movement of the flexible member at location 316. By fixing the tensioning member 312 to the flexible member, when the first actuator 314 retracts proximally, the flexible member is tensioned distal to the location where the tensioning member is fixed to the flexible member, which prevents the flexible member from folding or bunching in its distal region near or adjacent the medical device (or at least reduces the extent to which it folds / bundles compared to a device without the tensioning member).

[0074] The flexible member may include a flexible conductor bundle, such as any of the flexible conductor bundles herein. In Figures 12A-F, the tension member includes a rigid elongated member (generally referred to as 312 in Figure 12A) having a fixed length. The rigid tension member shown has a common longitudinal axis, which in this embodiment is parallel to the longitudinal axis of the medical device and / or the longitudinal axis of the handle assembly. The rigid tension member may be made of a variety of materials, such as a rigid plastic member.

[0075] The tensioning members herein can ensure that the distance traveled by the medical device is the same as the distance traveled by any point on the flexible member between a first position and a second position. The tensioning members herein can ensure that the distance traveled by the medical device is the same as the distance traveled by the position where the tensioning member is fixed to the flexible member (e.g., position 316 in FIG. 12A).

[0076] The fixed relationship between the tension member and the flexible member maintains the flexible member in a substantially flat or straight configuration between the first and second positions when the medical instrument is retracted proximally (when the medical instrument is in a straight configuration). A flat configuration in this context can include embodiments in which the flexible member may twist (i.e., the flexible member may be flat and still twist, but is not bunched / folded). A flat configuration as used herein indicates that the flexible member is not folded or bunched.

[0077] A medical device incorporating a tensioning member may also be steerable or deflectable. The tensioning members herein may be adapted and configured to apply tension to a flexible member even when the medical device including the flexible member is in a non-linear (e.g., deflected, steered, bent) configuration. When the present disclosure refers to maintaining a substantially flat configuration in a flexible member, this does not necessarily refer to the case when the medical device is steered, bent, or deflected, but rather when the medical device may be in a linear configuration.

[0078] The fixed relationship between the tension members and the flexible members herein prevents the flexible member from forming a crease (i.e., bending or bunching) between a first position and a second position as the medical device is retracted proximally. Folding, bending, and bunching in this context includes a first region of the flexible member axially overlapping a second region of the flexible member, and also includes general bending and bunching of the flexible member, such as regions of the flexible member that are not flat, e.g., form curved, bent regions, and / or meander back and forth.

[0079] The flexible member may have planar upper and lower surfaces (e.g., a conductor bundle having one or more planar surfaces), and optionally, the tension member may be secured to at least one of the upper and lower surfaces. For example, Figures 6A-6G show flexible members having first and second surfaces (e.g., upper and lower surfaces) that are planar or substantially planar, and the tension member may be secured to one or both of the planar or substantially planar surfaces (e.g., at location 316). They may be secured using a variety of techniques, such as using adhesives, welding, or other joining techniques.

[0080] The tension member may be in operative communication (directly or indirectly) with a handle actuator, such that axial movement of the actuator causes axial movement of the tension member. The handle actuator may be further adapted and configured to rotate to cause rotation of the medical instrument (e.g., actuator 314), and optionally, rotation of the actuator does not cause rotation of the tension member. Thus, the tension member may be adapted to move axially when the actuator moves axially, but not rotate when the actuator rotates. This may be accomplished by any method of placing the tension member in operative communication (directly or indirectly) with the actuator.

[0081] The medical instrument may include an inner elongate body (e.g., 132) that includes a lumen in which at least a portion of the flexible member is disposed. The inner elongate body may be independently steerable, such as with a separate, independently actuable handle actuator (e.g., actuator 322). Aspects of other embodiments herein in which the medical instrument includes an inner member and an outer member, and in which the inner member is independently controllable (e.g., axially and rotationally), are fully incorporated into any embodiment herein.

[0082] The flexible member may be coupled to a printed circuit board (e.g., 321 "board" shown in FIG. 12A) within the handle assembly. The tension member may be coupled to the flexible member proximal to the printed circuit board. In an alternative embodiment, the tension member may be coupled to the flexible member distal to the printed circuit board.

[0083] 12A-12F show an example of a portion of a medical instrument that includes an elongated outer body (e.g., 131) including a probe tip at a distal region of the elongated body, a flexible conductor bundle (e.g., 105) that is securely coupled to the probe tip at a first location (shown in FIGS. 9B and 9C) and extends proximally from the medical instrument into a handle assembly, the flexible conductor bundle being disposed within an outer surface of the elongated body, an inner elongated body (e.g., 131) at least a portion of which is disposed within the elongated outer body, the inner elongated body being optionally steerable, at least a portion of the flexible conductor bundle being disposed within the inner elongated body and configured to be axially movable relative to the inner elongated body, and a tensioning member secured to the flexible member at a second location within the handle assembly and adapted and configured to apply tension to the flexible member as the probe tip retracts proximally. As used herein, a probe tip may include one or more ultrasound transducers.

[0084] 12E-F show halves of a handle outer shell 320, two of which form a portion of the exterior surface of the handle assembly 310. The handle shell 320 includes radially inwardly extending features 315 adapted to interface with a control that controls the movement of the tension member 312. The features 315 can include guides configured to interface with the tension member at one or more locations and help stabilize the tension member.

[0085] Any other handle assembly components in any other embodiment herein that may be suitably integrated into the handle assembly 310 are hereby incorporated by reference.

[0086] In any embodiment and claim herein, the phrase "tensioning member" may be replaced with "straightening member", "flattening member", or their derivatives. As described herein, straightening member or flattening member refers to maintaining a substantially straight or flat configuration in the flexible member when the medical device is in a straight configuration, and does not require the device to always have a straight configuration. Thus, even if the flexible member is not necessarily under tension, it may still be maintained in a straight (i.e., unfolded) configuration along at least a portion of its length due to the straightening member. For example, member 312 in FIG. 12A is an example of a straightening member, even though it also functions as a tensioning member. This applies to all tensioning members described, shown, and claimed herein. In some embodiments herein, the "member" may be a straightening member (or flattening member) and may also function as a tensioning member. Alternatively, the term "tension member" herein may be replaced with "anti-fold member," "anti-bend member," "anti-bundle member," or derivatives thereof.

[0087] The disclosure above describes that in some embodiments, a flexible member such as the conductor bundle 2010 may be twisted along a portion of its length. For example, the conductor bundle may be twisted to provide a more balanced cross-section along a portion of the length of the medical device. The conductor bundle may be twisted only in the portion of the medical device that undergoes deflection.

[0088] 13A-13E illustrate portions of an exemplary medical device including a twisted flexible member, such as a flexible conductor bundle. The embodiments of FIG. 13A-E may be incorporated with any other suitable features and / or medical devices described herein.

[0089] The portion 330 of the medical device shown in Figures 13A-E includes a medical implement 332 at a distal region, a flexible member 331 coupled thereto and extending proximally therefrom, and a proximal end region 333 including a plurality of electrical connectors. The flexible member 331 may be a flexible conductor bundle such as any bundle herein. The medical implement 332 may include an ultrasound imaging transducer 339. The flexible conductor bundle 331 has a region 338 where the conductor bundle is twisted, 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 implement 332 may be coupled to an outer shaft such as the outer shaft 131 shown in Figure 9B.

[0090] The length of the twisted region 338 from its distal end to its proximal end can vary, and in some embodiments is between 5 and 15 cm, such as between 8 and 15 cm, such as 11 cm, etc. The length over which a complete turn is made can vary substantially, such as between 1 and 5 cm, such as 3 cm.

[0091] The number of twists over the length of the twisted region can also vary, for example, but not limited to, between 7 and 9 full twists.

[0092] An exemplary method for forming a twisted region of a flexible member (e.g., a flexible conductor bundle) is to couple the flexible member to a medical device at a distal end (e.g., a probe tip). A thin section of PET heat shrink can then be advanced over the flexible conductor bundle. While holding one portion of the device in place, another portion can be twisted to a desired number of turns to form the twisted region. PET can then be heat shrunk over the twisted bundle region while maintaining the twisted structure. Additional layers of PET can then be added. An elongated member (e.g., shaft 131) can then be placed over the bundle containing the twisted region, and the elongated member can be coupled to the medical device.

[0093] The following concepts may be applied to any suitable device, system, and / or method of use described above. Although the following disclosure is generally described in the context of imaging catheters, and particularly ultrasound imaging catheters, the following concepts may be applied to any type of suitable medical device that includes a cable through which electrical signals are transmitted. One merely exemplary and illustrative medical device is an ultrasound imaging catheter that includes a cable bundle in electrical communication with one or more ultrasound transducers, the cable bundle transmitting signals to and / or from the ultrasound transducers. An exemplary ultrasound imaging device including its handle is shown and described with respect to Figures 1-13E herein, the disclosure of which is fully incorporated by reference in the following disclosure. For example, the handle assembly shown in Figures 14-20 and the description thereof may incorporate any of the disclosures herein relating to the handle assemblies of any of Figures 1-13E herein.

[0094] 14A and 14B show an exemplary handle 1400 of a medical instrument with half of the handle shell removed to reveal the internal handle components. Any of the components of the handle assembly herein can have the exemplary designs described in more detail with respect to the embodiments of FIGS. 1-13E. For example, the flexible bundle 1402 of FIGS. 14A and 14B can include any of the electrical flexible bundle disclosures herein. Additionally, for example, the push arm 1404 of FIG. 1 can include any of the tensioning members disclosed herein adapted to maintain tension in a cable bundle. Additionally, the inner shaft 1406 of FIGS. 14A and 14B can be any of the inner members (or any derivatives thereof) herein. Additionally, the medical instrument extending distally from the handle 1400 of FIGS. 14A-20 can also include an outer member or outer shaft, such as any of those described herein. It is further understood that the "inner" shaft is illustrative and that the medical instrument shaft does not necessarily require an inner shaft and an outer shaft. In embodiments including an inner shaft and an outer shaft, the two shafts may be axially movable relative to one another to allow for a telescoping probe tip, although in any embodiment herein the inner shaft and outer shaft may be non-movable relative to one another, such as the example shown in FIG.

[0095] Some medical device cables may be susceptible to noise along the cable line(s) at frequencies in the subject. One aspect of the present disclosure relates to immunity performance to reduce noise. FIG. 14A shows an exemplary handle including an exemplary electrical noise suppression member 1408 including a lumen through which a flexible cable bundle 1402 passes. By way of example only, any of the electrical noise suppression members herein may comprise ferrite beads, a common example of which is known. While the present disclosure may refer to ferrite beads in the context of certain embodiments, it is understood that this is merely illustrative and other materials and / or configurations of electrical noise suppression members may be used. The noise suppression members herein may include one or both of a material or configuration to be adapted to increase the impedance to any RF noise coupled into sensitive analog lines. It is noted that the cable bundle shield 1410, an example of which is shown in FIG. 18, is removed from the cable bundle 1402 in the handle before the cable bundle 1402 passes through the electrical noise suppression member 1408 so as not to cause a reduction in the impedance of the shield 1410.

[0096] Although ferrite beads are described in the examples herein, it is understood that these are examples and other materials and / or configurations may be used. In general, the noise suppression members herein include materials configured to surround one or more signal line conductors such that the surrounding material provides a high impedance path intended to dissipate frequencies within a target range induced from the signal line to the surrounding material. Dissipation of frequencies provides a filtering or noise suppression effect. The surrounding material may include sintered powder and may be formed into a hollow cylinder or similar extruded polygon. The material may be formed integrally with the signal line running through the center, and in some embodiments may include two halves clamped together over the signal line conductor. The impedance and filtering effect of the surrounding material may be optimized based on the selection, size, and relative amount of sintered powder. The powder is typically formed into a ceramic compound that includes a mixture of iron oxide and other materials such as cobalt, copper, manganese, magnesium, nickel, and zinc. The perimeter, thickness, and length of the surrounding material may also be optimized for the desired effect. The signal wire (e.g., cable bundle herein) may pass once through the center, or may pass once and then be routed multiple times around the outside of the surrounding material and back through the center in the same direction as the first pass (forming a winding). Various structures and configurations allow for optimization of impedance in a given frequency range. In some applications of intracardiac ultrasound imaging, a ferrite structure may be selected to provide enhanced immunity from frequencies below 10 MHz and suppress radiation of frequencies above 100 MHz. Different surrounding material embodiments may be employed at different locations along the path of the signal wire conductor (cable bundle herein) to achieve different noise suppression effects.

[0097] One aspect of the disclosure relates to improving emissions within the handle of a medical device. Figures 14A and 18 show an example where an excess flex cable bundle 1402 is disposed within a handle and folded within a folding region 1412 in an organized manner within the handle, in this embodiment folded in an accordion-style configuration as shown against the inner surface of the shell of the handle 1400. As shown, the cable bundle shield 1410 is pulled out of the cable bundle 1402 before the bundle assumes its folded configuration within region 1412 as shown. Isolating the shield layer 1410 from the rest of the bundle 1402 before folding in region 1412 minimizes the inductance of the shield layer 1410 while increasing the impedance of the signal cable at the frequency of interest. Folding the excess cable length in an accordion-style fold as shown can reduce variations around the unit, which can help minimize the self-inductance of the signal cable and reduce radiated emissions. However, in some embodiments, the cable bundle may not be folded within the handle, one example of which is shown in the exemplary embodiment of FIG.

[0098] The ferrite bead 1408 of FIG. 14A disposed within the handle 1400 is positioned around or around the portion of the flex cable bundle 1402 that includes the signal lines and ground, rather than the shield 1410 as shown. An exemplary advantage to this structure is that it may increase the impedance to the RF entering the cable bundle (for noise reduction) without increasing the impedance to the shield 1410. The shield impedance should be as low as possible to shunt any RF currents that are picked up. By removing the shield 1410 from the cable bundle 1402 within the handle before passing through the ferrite bead 1408, the ferrite bead 1408 does not increase the impedance of the cable bundle shield 1410. A section of the cable bundle 1402' is shown to fan out at the attachment location of the printed circuit board ("PCB") with the handle. A receptacle flex 1414 is also shown coupled to a receptacle at the handle proximal end. FIG. 14B shows the handle and labels the noise suppression member 1410 without showing the cable bundle for clarity.

[0099] The ferrite (or other suitable noise suppression member / material) can improve immunity to external noise, such as imaging frequencies of 5-10 MHz, if the system is so configured. The ferrite bead can be selected to maximize impedance within the desired frequency range (e.g., 5-10 MHz) while allowing for mating within the handle shell. An exemplary impedance obtained is approximately 90-102 ohms within the range of interest. The impedance can be increased by increasing the number of "turns" or "T", defined as the number of times the cable passes inside the ferrite. Impedance increases with the square of the number of turns. The cable can pass only 1 T through the ferrite, but can also go 2, 3, or 4 up to the limit of the ferrite ID. An alternative to a solid ferrite is to have a "split" ferrite clamped around the cable. This can allow for ACF crimping and then wrapping of the cable. 1 T in a solid ferrite may be sufficient to adequately improve noise immunity. Additionally, with a solid core, there may not be enough slack for the ACF crimping process when the cable is wrapped around the ferrite. In an exemplary implementation, too much impedance at a desired frequency can have a detrimental effect on image quality, for example.

[0100] As shown in FIG. 14A, the excess cable bundle may be folded in a controlled and organized manner or configuration within the handle. For example, an "accordion" style fold as shown in FIG. 14A can minimize loops and any RF that is returned to the flexible bundle. Ribs or other protruding members may be added (e.g., integrally formed) directly to the inner surface of the handle shell to facilitate folding of the flex cable bundle. An alternative embodiment is a separate, non-integral handle component to facilitate flex cable folding.

[0101] As mentioned above, the shield is pulled or removed from the cable bundle as shown in exemplary Figures 14A and 17. Both the top and bottom shield strips are shorted to a single wire, which is soldered to a plated surface of the receptacle as shown in Figures 14A and 15 (position 1511). This plating makes the shield connection to the umbilical cable plug. Exemplary benefits of this approach can include one or more of the following: sending RF out of the equipment with the lowest possible impedance path, preventing the shield from getting into the ferrite, or minimizing loops of the shield near other conductors that would provide more noise inductance in the conductor.

[0102] 14A and 15 show exemplary embodiments of imaging catheters with an optional tension-controlled push arm that may include any of the tensioning member disclosures described herein (e.g., with respect to any of FIGS. 1-13). The push arm may be present in catheter designs where the inner and outer shafts are movable relative to one another. In these embodiments, the cable bundle may remain intact (shield and flex remainder) between the exit from the inner shaft and the push arm attachment to allow the bundle to extend and retract back and forth, along with a distal tip (2.5-3.0 cm) that may have an ultrasound transducer therein. Tension on the bundle is provided from the tip during advancement and tension during retraction is provided from the push arm attachment point. An additional intact portion (another 2-3 cm) proximal to the push arm attachment may be provided to allow for changes in bundle radius during advancement and retraction. The shield may be withdrawn from the bundle at the push arm attachment, but it may be preferable to withdraw it after the additional 2-3 cm so that it does not need to be moved. The shield exit can be fixed and the remainder of the cable is immediately routed into the noise suppression member.

[0103] The distal tip of a medical device, such as any of the distal tips herein including an ultrasonic probe, may include shielding. For example, some medical device tips may include an ultrasonic transducer. The shielding strip may extend around the tip (along with an existing short flex strip) except where the acoustic window is. The shielding may also be wrapped around the sides of the transducer. The tip flex strip may also be plated or coated with a conductive material that is connected to the shielding conductor. A very thin shielding coating may be provided over the transducer at least ¼ to ⅛ of the ultrasonic wavelength.

[0104] Some embodiments may include an additional shielding layer incorporated into the PCB and layers of the flex circuit that extend between the PCB and the catheter connector. Shielding may also be applied to the outside of the PCB and flex circuit using copper tape or other similar structures. The additional shielding layer may be connected to the catheter connector shield directly or via a low impedance shielding connection wire (FIG. 18). In another embodiment, the low impedance shielding connection wire may terminate on the distal side of the additional shielding layer, with the proximal end of the additional shielding layer terminating in the connector shielding layer. Termination may be done, for example, through the use of solder, welding, mechanical contact, or other conventional techniques.

[0105] Some embodiments may include an umbilical connector shield. The connection may be made between the catheter and the cable shield through plated surfaces of the catheter receptacle and umbilical plug. It may be preferable to provide a low impedance connection in addition to or instead of an existing plated connection. For example, the central cores of the receptacle and plug may be adapted to provide a direct electrical connection to each other. A "banana style" connection may be made, or other pogo pin, c-pin, or lever arm metal-to-metal mechanical connection may be made. Instead of or in addition to the shield plating, a directional braided wire (preferably a flat shield wire) may be electrically attached (solder, crimp, etc.) between the connector pins and the shield in the umbilical cable and catheter. The umbilical cable plug may have a recessed touch-proof receptacle for the male pins from the catheter receptacle connector. This may be located on the central axis, but may also be on the inner circumference or built into the cable.

[0106] Some embodiments may include an umbilical ferrite. A clamp on ferrite may be used over the outside of the umbilical cable to improve noise immunity. A 3T or 4T may be used on the cable. This use is common in the art. However, a ferrite of appropriate size may be used under the shield and this may be incorporated into the design. This may be located on the DLP (console connector) side, on the outside of the DLP, or indeed inside the housing of the DLP (and inside the shielding cage). This may be incorporated closer to the plug (catheter connector) side, although the extra weight in this location may not be desirable and should be taken into consideration.

[0107] 15 and 16 show photographs of a portion of the example handle shown in FIG. 14A, with FIG. 16 further highlighting the example cable bundle 1602 routing within the handle, with components similarly numbered with respect to FIGS. 14A, 15, 17, 18, and 19.

[0108] FIG. 17 illustrates diagrammatically the routing of an exemplary cable bundle 1702 within the handle (handle housing not shown) illustrated in FIGS. 14A-16. FIG. 17 excludes the handle housing to provide a clearer routing path. The shield 1710 is removed from the cable bundle 1702 before passing through the noise suppression member 1708 (e.g., ferrite bead), and the cable bundle is shown folded at a fold region 1712. Sections of the cable bundle are fanned out at the mounting location on the printed circuit board 711, as shown. Receptacles 1713 are also shown.

[0109] 18 illustrates an exemplary embodiment of an imaging catheter in which the handle 1800 does not include a noise suppression member (e.g., ferrite beads). The handle 1800 may include any other handle components or functionality described in any of the other handles herein. For example, an exemplary inner shaft 1806 is shown. In this example, the shielding layer 1810 is routed directly from the cable bundle to a receptacle 1813 as shown. The cable bundle is folded accordion style within a fold region 1812. After the shielding layer is removed from the bundle, the cable bundle 1802 is routed directly to the PCB as shown and fanned out to a PCB attachment point at location 1803.

[0110] Additional exemplary details and parts are shown that may be the same or similar to the handle components shown in the embodiments of Figures 14A-17. Any suitable disclosure from the embodiments from Figures 14A-17 may be incorporated by reference into the disclosure of the embodiment shown in Figure 18. Figure 18 also shows an exemplary cable bundle cross-section, and any of the embodiments herein may include such a cable bundle. However, in this or any other embodiment, the cable bundle is exemplary and not all layers need to be included.

[0111] 19 illustrates an exemplary embodiment of an imaging catheter in which the handle 1900 does not include ferrite beads and the excess cable bundle 1902 is bundled in a loop region 1905. The handle illustrated in FIG. 19 may incorporate any suitable features of any of the other handles and imaging catheters herein. The handle 1900 has an inner shaft 1906 extending therethrough from which the cable bundle 1902 extends as shown. The cable bundle is fanned out at location 1903 for attachment to a PCB as shown. The handle 1900 may include any other suitable components or functionality described or illustrated with respect to other handles herein.

[0112] FIG. 20 illustrates an exemplary handle 2000 with half of the handle housing 2005 removed to show the internal components therein. The handle includes a catheter shaft control system 2010, which may include any suitable components herein to cause deflection of the deflectable shaft herein, such as one or more pull wires routed through the elongated deflectable shaft. In this example, a flexible cable bundle 2002 extends around a plurality of printed circuit boards 2004. This is in contrast to FIGS. 14A-19 herein, where the flexible cable bundle passes between a first printed circuit board and a second printed circuit board of a plurality of printed circuit boards. In this example, the shield 2002 is removed from the cable bundle within the handle before the remainder of the cable bundle passes through the ferrite bead 2006, as shown. The unshielded bundle 2007 then extends proximally and is coupled to the printed circuit board 2004, as shown. In the example of Fig. 20, the inner and outer catheter shafts are not axially movable (not telescopic) relative to each other, and the cable bundle is not axially movable within the handle after the handle is assembled. Since the flexible cable bundle does not need to follow a straight axial path for easy axial movement, as may be beneficial in some examples involving a telescoping probe tip, the flexible bundle may be routed around the printed circuit board 2004 as shown. Routing the flexible cable bundle around the printed circuit board 2004 may help increase the distance between the signal lines of the cable bundle 2002 and the signal lines (especially the analog signal lines) of the printed circuit board 2004 so as to minimize noise pickup.

[0113] [Embodiment] (1) An ultrasound imaging catheter, comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing through the elongated shaft and extending into the handle; Equipped with An ultrasound imaging catheter, wherein the elongated cable bundle passes through a ferrite bead secured within the handle, and a shielding layer of the cable bundle is detached from the elongated cable bundle at a position such that the shielding layer does not pass through the ferrite bead secured within the handle. (2) An ultrasound imaging catheter as described in embodiment 1, wherein the elongated cable bundle is folded in an organized manner within a folding area in the handle, and the shielding layer is detached from the cable bundle prior to the folding area such that the shielding layer is not folded within the handle. (3) An ultrasound imaging catheter as described in embodiment 1, wherein the elongated cable bundle is folded in an accordion-style fold within the folding region. (4) An ultrasound imaging catheter as described in embodiment 1, wherein the shielding layer is coupled to a receptacle in the handle. (5) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle is coupled to a plurality of printed circuit boards fixed within the handle.

[0114] (6) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle extends from a proximal end of an elongated shaft disposed within the handle. (7) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle extends radially outwardly of a plurality of printed circuit boards disposed within the handle. (8) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle passes between a first printed circuit board and a second printed circuit board among a plurality of printed circuit boards disposed within the handle. (9) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle includes a movable part that is axially movable within the handle. (10) An ultrasound imaging catheter as described in embodiment 1, wherein the cable bundle is not adapted to be moved axially within the handle after the handle is assembled.

[0115] (11) An ultrasound imaging catheter, comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing proximally through the elongated shaft and extending into the handle; Equipped with An ultrasound imaging catheter, wherein the elongated cable bundle is folded in an organized manner within a fold area in the handle, and a shielding layer of the cables is removed from the cable bundle prior to the fold area such that the shielding layer is not disposed within the fold area. (12) The ultrasound imaging catheter of embodiment 11, wherein the elongated cable bundle is folded in an accordion-style fold within the folding region. (13) An ultrasound imaging catheter as described in embodiment 11, wherein the shielding layer is coupled to a receptacle in the handle. (14) An ultrasound imaging catheter as described in embodiment 11, wherein the cable bundle is coupled to a plurality of printed circuit boards disposed within the handle. (15) The ultrasound imaging catheter of claim 11, wherein the cable bundle extends from a proximal end of the elongate shaft within the handle.

[0116] (16) An ultrasound imaging catheter as described in embodiment 15, wherein the cable bundle extends radially outwardly of a plurality of printed circuit boards disposed within the handle. (17) An ultrasound imaging catheter as described in embodiment 15, wherein the cable bundle passes between a first printed circuit board and a second printed circuit board among a plurality of printed circuit boards disposed within the handle. (18) An ultrasound imaging catheter as described in embodiment 11, wherein the cable bundle is axially movable within the handle. (19) An ultrasound imaging catheter as described in embodiment 11, wherein the cable bundle is not axially movable within the handle. (20) An ultrasound imaging catheter, comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing through the elongated shaft and extending into the handle; Equipped with an ultrasound imaging catheter, wherein the elongated cable bundle passes through a lumen of an electrical noise suppression member secured within the handle, and a shielding layer of the cable bundle is detached from the elongated cable bundle at a position such that the shielding layer does not pass through the lumen of the electrical noise suppression member secured within the handle.

[0117] (21) The catheter of claim 20, wherein the electrical noise suppression member comprises one or both of a material or configuration for suppressing electromagnetic interference from the elongated cable bundle. (22) The catheter of claim 20, wherein the electrical noise suppression member comprises one or both of a material or configuration for suppressing electromagnetic interference to the elongated cable bundle. (23) The catheter of claim 20, wherein the electrical noise suppression member comprises a ferrite bead. (24) The catheter of embodiment 20, further comprising any suitable feature or component of any of embodiments 1 to 19.

Claims

1. 1. An ultrasound imaging catheter comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing through the elongated shaft and extending into the handle, the elongated cable bundle being axially movable within the handle; Equipped with An ultrasound imaging catheter, wherein the elongated cable bundle passes through a ferrite bead secured within the handle, and a shielding layer of the elongated cable bundle is detached from the elongated cable bundle at a position such that the shielding layer does not pass through the ferrite bead secured within the handle.

2. 2. The ultrasound imaging catheter of claim 1, wherein the elongated cable bundle is folded in an organized manner within a fold area in the handle, and the shielding layer is detached from the elongated cable bundle prior to the fold area such that the shielding layer is not folded within the handle.

3. The ultrasound imaging catheter of claim 2 , wherein the elongated cable bundle is folded in an accordion-style fold within the folding region.

4. The ultrasound imaging catheter of claim 1 , wherein the shielding layer is coupled to a receptacle in the handle.

5. The ultrasound imaging catheter of claim 1 , wherein the elongated cable bundle is coupled to a plurality of printed circuit boards secured within the handle.

6. The ultrasound imaging catheter of claim 1 , wherein the elongate cable bundle extends from a proximal end of the elongate shaft disposed within the handle.

7. The ultrasound imaging catheter of claim 1 , wherein the elongated cable bundle extends radially outwardly of a plurality of printed circuit boards disposed within the handle.

8. The ultrasound imaging catheter of claim 1 , wherein the elongated cable bundle passes between a first printed circuit board and a second printed circuit board of a plurality of printed circuit boards disposed within the handle.

9. 1. An ultrasound imaging catheter comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing proximally through the elongated shaft and extending into the handle, the elongated cable bundle being axially movable within the handle; Equipped with An ultrasound imaging catheter, wherein the elongated cable bundle is folded in an organized manner within a fold area in the handle, and a shielding layer of the elongated cable bundle is detached from the elongated cable bundle prior to the fold area such that the shielding layer is not disposed within the fold area.

10. The ultrasound imaging catheter of claim 9 , wherein the elongated cable bundle is folded in an accordion-style fold within the folding region.

11. The ultrasound imaging catheter of claim 9 , wherein the shielding layer is coupled to a receptacle in the handle.

12. The ultrasound imaging catheter of claim 9 , wherein the elongated cable bundle is coupled to a plurality of printed circuit boards disposed within the handle.

13. The ultrasound imaging catheter of claim 9 , wherein the elongate cable bundle extends from a proximal end of the elongate shaft within the handle.

14. The ultrasound imaging catheter of claim 13 , wherein the elongated cable bundle extends radially outwardly of a plurality of printed circuit boards disposed within the handle.

15. The ultrasound imaging catheter of claim 13 , wherein the elongated cable bundle passes between a first printed circuit board and a second printed circuit board of a plurality of printed circuit boards disposed within the handle.

16. 1. An ultrasound imaging catheter comprising: an elongate shaft sized and configured for advancement within a patient; a handle sized and positioned to remain outside the patient; a distal tip including an ultrasound transducer; an elongated cable bundle in communication with the ultrasonic transducer, the elongated cable bundle passing through the elongated shaft and extending into the handle, the elongated cable bundle being axially movable within the handle; Equipped with an ultrasound imaging catheter, wherein the elongated cable bundle passes through a lumen of an electrical noise suppression member secured within the handle, and a shielding layer of the elongated cable bundle is detached from the elongated cable bundle at a position such that the shielding layer does not pass through the lumen of the electrical noise suppression member secured within the handle.

17. The catheter of claim 16, wherein the electrical noise suppression member comprises one or both of a material and a configuration for suppressing electromagnetic interference from the elongate cable bundle.

18. The catheter of claim 16, wherein the electrical noise suppression member comprises one or both of a material and a configuration for suppressing electromagnetic interference to the elongate cable bundle.

19. The catheter of claim 16 , wherein the electrical noise suppression member comprises a ferrite bead.

Images