Ultrasound imaging tool

Abstract

To provide an ultrasound imaging tool controllable in a rotational direction and a deflection direction.SOLUTION: An ultrasound probe disposed in a distal region of a rotatable shaft comprises an ultrasonic transducer and a flexible circuit strip. The flexible circuit strip comprising an insulating substrate and a plurality of conductive traces, comprises a deflectable shaft disposed so as to cause deflection of the rotatable shaft, and a handle assembly comprising a handle body, a first actuator configured to be moved, and a second actuator configured to be moved. The first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body. Actuation of the first actuator causes rotational movement of the rotatable shaft and actuation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft.SELECTED DRAWING: Figure 11A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 62 / 364,268, filed July 19, 2016, and U.S. Provisional Application No. 62 / 404,711, filed October 5, 2016, which applications are incorporated herein by reference.

[0002] Incorporation by Reference

[0002] 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]

[0003]

[0003] A wide variety of intravascular medical devices are known. After a medical device has been used in a subject's body, it may be desirable to reuse said medical device, or at least a portion of said medical device, on another subject, rather than using an entirely new medical device, or an entirely new portion of said medical device. One reason for desirability in reusing at least a portion of a medical device may be the cost of at least a portion of the medical device. It may be cheaper to reuse a device, or a portion of it, rather than purchasing a new medical device, or a portion of it. If the device, or a portion of it, has been exposed to bodily fluids (e.g., in a blood environment), it is generally necessary to clean and resterilize (and perhaps to some extent degrade) the medical device before it can be used again on another subject. Some non-sellers of devices attempt to clean the device and then resell it for later use. A drawback of this approach is that the device is handled and cleaned by unskilled individuals who may damage the device, making it unsafe for later use. There is a need for alternative, more reliable, safe and / or predictable techniques for reusing medical devices that have been exposed to bodily fluids (eg, in a blood environment).

[0004]

[0004] Additionally, there are limitations to the use of some medical devices, such as, but not limited to, ultrasound imaging devices. There is also a need for improved systems, devices, and methods that facilitate better control and availability of medical devices. Summary of the Invention [Means for solving the problem]

[0005] One aspect of the present disclosure is a method of disassembling a system exposed to a bodily fluid of a subject, the system including a medical tool (optionally an ultrasound probe), a steerable shaft, and a handle assembly.The method includes providing a handle assembly, a steerable sheath that has been exposed to a bodily fluid environment of a subject, and a medical tool (optionally an ultrasound probe) that has been exposed to the bodily fluid environment of the subject, the handle assembly in operative communication with the steerable sheath and the medical tool, the handle assembly including a handle body having an outer surface that can be grasped by a user, a first actuator adapted to be moved relative to the handle body, and a second actuator adapted to be moved relative to the handle body, the steerable sheath having a distal deflectable region in operative communication with at least one pull wire, the first actuator in operative communication with the pull wire such that actuation of the first actuator relative to the handle body deflects the distal deflectable region, the second actuator adapted to be rotated relative to the handle body and adapted to be moved axially relative to the handle body, the second actuator adapted to be moved axially relative to the handle body such that axial movement of the second actuator relative to the handle body causes the medical tool to move axially relative to a distal end of the steerable sheath. and a second actuator in operative communication with the medical tool such that rotation relative to the handle body rotates the medical tool relative to the distal end of the maneuverable sheath, the medical tool having a distal portion that may include an ultrasonic transducer, the distal portion extending distally beyond the distal end of the maneuverable sheath and having an outer dimension that is greater than a dimension of a lumen of the maneuverable sheath in which the medical tool is disposed, the medical tool further including a flexible circuit strip, the flexible circuit strip comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of each of the plurality of conductive traces being covered by an insulating member, a portion of the plurality of conductive traces not covered by the insulating member, and a portion of the plurality of conductive traces not covered by the second insulating layer defining contacts, the contacts being electrically coupled to electrical contacts on the printed circuit board.

[0006] The method may further include the step of electrically isolating the contacts from electrical contacts on the printed circuit board.

[0007] The method may further include moving the medical tool distally of the steerable sheath until the medical tool clears the distal end of the steerable sheath.

[0007]

[0008] The method may optionally further include cleaning at least a portion of the medical tool, the portion including a region of the medical tool that did not extend out of the steerable shaft prior to the moving step, and optionally including a region that was disposed within the handle assembly prior to the moving step. The method may optionally further include electrically coupling the contacts to either the printed circuit board or another printed circuit board at some point after the cleaning step.

[0008]

[0009] In some embodiments of the method, the medical tool comprises a plurality of flexible circuit strips, each of the plurality of flexible circuit strips comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of each of the plurality of conductive traces being covered by an insulating member, a portion of the plurality of conductive traces not being covered by the insulating member, and a portion of the plurality of conductive traces not covered by the insulating member defining a probe contact.

[0009]

[0010] The method may further include releasing the medical tool from releasably secured engagement with the handle assembly component at some point prior to the moving step. Releasing the medical tool from releasably secured engagement with the handle assembly component may include releasing the probe from releasably secured engagement with a handle assembly component that is in direct or indirect operative communication with the second actuator.

[0010]

[0011] One aspect of the present disclosure is a method of removing used electrical contacts from a flexible circuit. The method may further include creating or preparing new electrical contacts on the flexible circuit from which the used electrical contacts have been removed.

[0011]

[0012] One aspect of the present disclosure is the reuse of the flexible circuit after the first electrical contacts have been used and are no longer being used to make an electrical connection. The first electrical contacts can optionally be removed after use.

[0012]

[0013] One aspect of the present disclosure is a method of removing electrical contacts from an ultrasonic probe for reusing the ultrasonic probe, comprising the steps of providing an ultrasonic probe having an ultrasonic transducer at a distal region, the ultrasonic probe including at least one exposed region of a plurality of conductive traces, the exposed region defining a probe contact, and isolating the probe contact from the ultrasonic probe.

[0013]

[0014] The step of isolating the probe contact from the ultrasonic probe may include disconnecting the probe contact from the ultrasonic probe. The method may further include exposing the plurality of conductive traces in new areas that were not previously exposed and define new probe contacts. The step of exposing the plurality of conductive traces in new areas may include any of the steps of removing an adhesive layer from the ultrasonic probe contacts, ablating a portion of an insulator covering the conductive traces, ablating using a laser to remove areas on the insulating material, and dissolving at least a portion of the insulating material using a solvent. The method may further include electrically coupling the new probe contact to an electrical contact on the printed circuit board.

[0014]

[0015] One aspect of the present disclosure is a flexible circuit that includes a first electrical contact and at least one additional electrical contact that can be created or prepared on the flexible circuit for use after the first electrical contact is used and is no longer used to make an electrical connection.

[0015]

[0016] One aspect of the disclosure is a flexible circuit strip comprising an elongated substrate, a plurality of elongated conductive traces disposed on and extending along the substrate, first and second covering elements disposed on and covering the plurality of conductive traces, the first and second covering elements being axially separated from one another and defining a new probe contact therebetween comprising the plurality of conductive traces, and a removable covering element disposed over the new probe contacts and adapted to be removed from the plurality of conductive traces to expose the plurality of conductive traces at the location of the new probe contact.

[0016]

[0017] The strip may further include at least a third covering element disposed over and covering the plurality of conductive traces and axially spaced from the second covering element, the second and third covering elements defining a second new probe contact therebetween, and a second removable covering element disposed over the second new probe contact and adapted to be removed from the plurality of conductive traces to expose the plurality of conductive traces at the location of the second new probe contact.

[0017]

[0018] One aspect of the present disclosure is an integrated medical tool comprising a handle assembly, a steerable sheath, and a medical tool (optionally an ultrasound probe), the handle assembly being in operative communication with the steerable sheath and the medical tool, the handle assembly including a handle body having an outer surface that can be grasped by a user, a first actuator adapted to be moved relative to the handle body, and a second actuator adapted to be moved relative to the handle body, the steerable sheath having a distal deflectable region in operative communication with at least one pull wire, the elongated medical tool having a distal portion with a working end (optionally an ultrasound transducer), at least a portion of the elongated medical tool being disposed within the steerable sheath, the elongated medical tool having a second actuator adapted to be moved relative to the handle body, the steerable sheath having a distal deflectable region in operative communication with at least one pull wire, the elongated medical tool having a distal portion with a working end (optionally an ultrasound transducer), The actuators are in operative communication with the first actuator, the first actuator being in operative communication with the at least one pull wire such that actuation of the first actuator relative to the handle body deflects the distal deflectable region, and the second actuator is adapted to be rotated relative to the handle body and adapted to be moved axially relative to the handle body, the second actuator being in operative communication with the elongated medical tool such that axial movement of the second actuator relative to the handle body causes the elongated medical tool to move axially relative to the distal end of the manipulable sheath and such that rotation of the second actuator relative to the handle body causes the elongated medical tool to rotate relative to the distal end of the manipulable sheath.

[0018]

[0019] The second actuator can be interfaced with the handle assembly such that the interface with the handle assembly limits at least one of axial movement of the second actuator in both proximal and distal directions within a fixed range of motion, and rotational movement of the second actuator in both rotational directions within a fixed range of motion.

[0019]

[0020] The first actuator may be adapted to be rotated relative to the handle body such that rotation of the first actuator relative to the handle body deflects the distal deflectable region.

[0020]

[0021] The medical tool can extend further proximally than the proximal end of the steerable sheath, and optionally, further proximally than the handle body.

[0022] In some aspects, the present disclosure relates to medical devices, systems, apparatus, and methods of use, assembly, and disassembly thereof. In some embodiments, the present disclosure relates to steerable medical devices, or at least medical devices that are steered via a separate steerable shaft. Steerable devices, as that term and its derivatives are used herein, include any type of medical device that can benefit from being directly or indirectly steered, bent, or deflected.

[0021]

[0023] In some aspects, the present disclosure relates to steerable medical tools. When steerable medical tools are described herein, they are merely examples of steerable medical devices described herein. The steerable delivery device can be used to deliver or guide any type of suitable medical device therethrough to a target location within a patient's body. For example, the steerable delivery device can be used to deliver or guide a medical device into a body lumen or cavity, such as, but not limited to, blood vessels, esophagus, trachea and possibly adjacent bronchi, any part of the gastrointestinal tract, abdominal cavity, thorax, various other body vessels, lymphatic vessels, one or more chambers of the heart, etc. Once the steerable medical device has gained access to a target location within a subject, the tool can be used to perform one or more medical interventions. In some methods of use, the steerable devices described herein are tracked along a pre-positioned guidewire, the positioning of which is known in the art. In some embodiments, the steerable concept described herein can be applied to steerable medical tools, such as catheters, that have some diagnostic and / or therapeutic functionality.

[0022]

[0024] In some embodiments herein, the medical device (sometimes referred to herein as a medical tool or tool) is integrated with a steerable sheath prior to delivery of the medical device to a target tissue. For example, the medical device may be integrated with any of the steerable sheaths herein.

[0023]

[0025] As used herein, a medical device or tool can be any type of medical device, including devices with diagnostic and / or therapeutic functionality. An integrated medical device includes a catheter configured to provide functionality using at least a distal working region. A catheter with a distal tip electrode and associated components extending along its length is just one example of a medical device that can be integrated with the manipulation capabilities of the present specification. A device with one or more ultrasound transducers, optionally for ultrasound imaging, can be any of the medical tools of the present specification.

[0024]

[0026] Another aspect of the present disclosure relates to the electrical connection between the connector and contacts, optionally at the distal end, that are in electrical communication with the working area of ​​the medical device. [Brief description of the drawings]

[0025] [Figure 1A]

[0027] FIG. 1A illustrates an exemplary embodiment of an integrated manipulation and medical device system. [Figure 1B]

[0028] FIG. 1B illustrates the operation of the medical device of FIG. 1A and cross section AA of the device portion. [Diagram 2]

[0029] 1A-1C illustrate an exemplary integrated system including a handle assembly with multiple actuators, a steerable sheath, and a medical tool. [Diagram 3]

[0030] FIG. 3 shows an exemplary embodiment of the system in which the operable portion can have a cross section equal to that shown in FIG. 2. [Figure 4] FIG. 3 shows an exemplary embodiment of the system in which the operable portion can have a cross section equal to that shown in FIG. 2. [Diagram 5]

[0031] FIG. 1C illustrates an exemplary distal region of the system, where the operable portion may include a cross-section as shown in FIG. 1B. [Figure 6]FIG. 1C illustrates an exemplary distal region of the system, where the operable portion may include a cross-section as shown in FIG. 1B. [Figure 7]

[0032] FIG. 1 illustrates a system with a medical tool inside a steerable sheath designed with modular components that are presented to the user in an integrated manner. [Figure 8A]

[0033] FIG. 8A illustrates an embodiment in which the sheath handle includes a removable or breakable handle portion. [Figure 8B] FIG. 8B illustrates an embodiment in which the sheath handle includes a removable or breakable handle portion. [Figure 9A]

[0034] FIG. 9A illustrates a portion of an exemplary system in which a tool lock and handle are configured to limit the range of rotation of a medical device. [Figure 9B] FIG. 9B illustrates a portion of an exemplary system in which a tool lock and handle are configured to limit the range of rotation of a medical device. [Figure 10A-10B]

[0035] 10A and 10B illustrate an embodiment of a system including a steerable sheath having an exemplary modular mechanism for aiding in device repositioning. [Figure 11A]

[0036] FIG. 11A illustrates an alternative embodiment of the system in which the tool lock is contained within the sheath handle but is coupled to an external control. [Figure 11B] FIG. 11B illustrates an alternative embodiment of the system in which the tool lock is contained within the sheath handle but is coupled to an external control. [Fig. 12Ai-12Aii]

[0037] 12Ai and 12Aii illustrate the concept of a medical tool including a proximal electrical connector that includes a plurality of electrical contacts. [Figure 12Bi] FIG. 12Bi illustrates the concept where a medical tool includes a proximal electrical connector that includes a number of electrical contacts. [Figure 12Bii] FIG. 12Bii illustrates the concept where a medical tool includes a proximal electrical connector that includes multiple electrical contacts. [Figure 12C] FIG. 12C illustrates the concept where the medical tool includes a proximal electrical connector that includes multiple electrical contacts. [Figure 13A]

[0038] FIG. 13A illustrates an exemplary proximal coupling between a medical tool and a connector. [Figure 13B] FIG. 13B illustrates an exemplary proximal coupling between a medical tool and a connector. [Figure 13C] FIG. 13C illustrates an exemplary proximal coupling between a medical tool and a connector. [Figure 14A]

[0039] FIG. 14A illustrates an exemplary system with a connector that includes an internal mechanism designed to encapsulate a tool lock attached to a tool portion. [Figure 14B] FIG. 14B illustrates an exemplary system with a connector that includes an internal mechanism designed to encapsulate a tool lock attached to the tool portion. [Figure 15]

[0040] FIG. 1 illustrates an exemplary system including a separate torque device that can be attached to a medical tool to provide the ability to translate and torque the tool relative to a steerable sheath. [Figure 16A]

[0041] FIG. 16A illustrates an exemplary tool including an outer member and an inner lead assembly. [Figure 16B]FIG. 16B illustrates an exemplary tool including an outer member and an inner lead assembly. [Figure 16C] FIG. 16C illustrates an exemplary tool including an outer member and an inner lead assembly. [Figure 17]

[0042] FIG. 2 illustrates an example portion of an example system including a bundle. [Figure 18]

[0043] FIG. 1 illustrates an exemplary proximal end of a medical tool including a conductor bundle that extends into a proximal connector in which a printed circuit board (PCB) is housed. [Figure 19A-19B]

[0044] FIG. 19A illustrates a portion of an exemplary medical tool including a flexible circuit strip.

[0045] FIG. 19B illustrates an exemplary proximal portion of the strip. [Figure 19C]

[0046] FIG. 13 is a detailed view showing an exemplary proximal portion of the strip. [Figure 19D]

[0047] FIG. 2 is an end view of an exemplary flexible strip. [Figure 19E]

[0048] FIG. 1 illustrates an exemplary stack of flexible strips. [Figure 19F]

[0049] FIG. 2 illustrates an exemplary stack of flexible strips and ground and shield strips. [Figure 19G]

[0050] FIG. 1 illustrates an exemplary bundle including tubing around a stack of strips and shield and ground strips. [Figure 20A]

[0051] FIG. 20A illustrates an embodiment in which multiple flexible circuit strips have staggered lengths and are attached to a PCB with contacts provided at exposed locations that are also staggered lengths. [Figure 20B]FIG. 20B illustrates an embodiment in which multiple flexible circuit strips have staggered lengths and are attached to a PCB with contacts provided at exposed locations that are also staggered in length. [Figure 20C]

[0052] FIG. 20C illustrates an exemplary method of moving the tool distally and out of the sheath until it is free of the optionally steerable sheath. [Figure 21]

[0053] FIG. 1 illustrates an exemplary embodiment in which a conductor bundle may be reversibly wound on or wrapped around a spool that comprises a rod, tube, spindle, or similar rotatable structure. [Figure 22]

[0054] FIG. 1 illustrates a portion of an exemplary embodiment in which an exposed flexible circuit end is attached to a disposable, small PCB element with the same sized connection on one side, but a larger exposed connection on the other side. [Figure 23]

[0055] 13A-13C show exemplary alternative embodiments of cross-sections of intraluminal bundled stacks that may be incorporated into any of the systems herein. [Figure 24] 13A-13C show exemplary alternative embodiments of cross-sections of intraluminal bundled stacks that may be incorporated into any of the systems herein. [Diagram 25] 13A-13C show exemplary alternative embodiments of cross-sections of intraluminal bundled stacks that may be incorporated into any of the systems herein. [Figure 26] 13A-13C show exemplary alternative embodiments of cross-sections of intraluminal bundled stacks that may be incorporated into any of the systems herein. [Figure 27] 13A-13C show exemplary alternative embodiments of cross-sections of intraluminal bundled stacks that may be incorporated into any of the systems herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026]

[0056] FIG. 1A illustrates an exemplary embodiment of an integrated manipulation and medical device system. The system 1000 includes a handle assembly 1002 and a manipulation and medical device portion 1004. The manipulation and medical device portion 1004 includes a proximal portion 1006 and a manipulable portion 1008. The system is adapted to actuate the handle assembly 1002 to manipulate the manipulable portion 1008, and optionally further actuate to move the medical device 1010 relative to the manipulation and medical device 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 actuate (rotate, in this example) the handle body 1007 to manipulate the manipulable portion 1008, specifically to manipulate the outer sheath 1102. The steerable portion 1008 of this embodiment can be steered or bent into the configuration shown in solid lines in FIG. 1A, and can also be steered into the configuration shown in dashed lines or any position therebetween, 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 (torquing) and axial movement of the shaft. The term "pull wire" as used herein refers to any element that may transmit a pulling force 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 stranded / braided, or a polymer, such as Kevlar, polyethylene, PTFE, ePTFE, etc., preferably stranded / braided, but also in monofilament form. The cross-sectional diameter of the wire can range from .013 to .030 cm (.005 to .012 inches), although braided or stranded wires may be flattened or ovalized within the device lumen.The optional second actuator 1003 is adapted to be actuated (in this example, rotated) relative to the handle body 1007 to rotate the medical tool 1010 relative to the shaft 1102 (shown as rotational movement "R"), and the optional actuator 1005 is adapted to be actuated (in this example, axially) relative to the handle body 1007 to move the medical device 1010 axially (distal-proximal direction) relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the steerable portion 1008 is manipulated (bended / deflected), although the proximal portion may flex and bend to accommodate the shape of the anatomical structure in which it is used. In many embodiments, this is accomplished by constructing the steerable portion 1008 from a softer or less stiff material and / or composite than the proximal portion 1006.

[0027]

[0057] 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 manipulable outer shaft and an internal medical tool. The handle assembly is integrated in the sense that it is assembled and constructed such that it is in operative communication with the outer shaft and the internal medical tool prior to packaging and use. The term "integrated," when used in the context of an integrated handle assembly, refers to a handle assembly in which at least a portion of the handle assembly must be disrupted or disassembled before the medical tool can be removed from within the outer shaft.

[0028]

[0058] 1B shows an exemplary cross section AA (shown in FIG. 1A) of the manipulation and device portion 1004, specifically the steerable portion 1008. In this embodiment, the medical device 1010 is sized and configured to be disposed within a steerable sheath. The steerable sheath includes an outer shaft 1102 and a set of pull wires 1104 axially secured to a distal region of the steerable portion 1008.

[0029]

[0059] The medical tool of Figures 1A and 1B can be any medical tool herein, such as, for example, an ultrasonic tool. "Ultrasonic probe" as used herein generally refers to an elongated tool that includes at least one ultrasonic transducer and one or more conductive elements that electrically connect the at least one ultrasonic transducer to a proximal region of the elongated tool. 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 an electrical contact on another device, cable, or connector, or optionally through an attachment.

[0030]

[0060] FIG. 2 illustrates an exemplary system 10 adapted to function similarly to the system of FIGS. 1A and 1B and illustrates exemplary internal components of a handle assembly 12 (internal components shown in dashed lines). The handle assembly 12 is integrated with and in operative communication with an outer steerable shaft 20 and a medical tool 30. The handle assembly 12 includes an actuator 14 adapted to operate the steerable shaft 20 when actuated relative to a handle body 15. The actuator 14 is in operative communication with the steerable shaft 20 via an actuation control 16 disposed within the handle assembly 12. The medical tool 30 includes a proximal portion 18 disposed within and integrated therewith. The actuator 13 is in operative communication with the medical tool 30, and actuating (rotating, in this example) the actuator 13 relative to the handle body 15 rotates the medical tool 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 tool 30 and, in this embodiment, is adapted to be actuated axially (relative to the handle body 15) to move the medical tool 30 axially relative to the external operable shaft 20 via the axial control section 1217.

[0031]

[0061] The medical tool of FIG. 2 can be any medical tool described herein, such as, for example, an ultrasound tool.

[0062] 3 and 4 show an exemplary embodiment of a system 1200 in which the manipulable portion can have a cross-section as shown in FIG. 1B. The system 1200 can include a manipulable portion 1202 and a medical tool 1204, both of which are configured to interface with each other. The manipulable portion 1202 includes a handle portion 1206 and a sheath portion 1208 including a manipulable portion 1222. The sheath portion 1208 includes an outer tubular member 1207. The medical tool 1204 includes a handle portion 1210 and a tool portion 1212 including at least one shaft and a distal working region at its distal end. The handle portion 1206 includes a manipulation actuator 1220, which in this embodiment is adapted to rotate relative to the handle body 1209 to manipulate the manipulable portion 1222.

[0032]

[0063] The medical tool 1204 is configured to be advanced through the manipulable portion 1202, both of which are configured to interface with one another. When advanced, the tool portion 1212 of the medical tool 1204 is advanced through the sheath portion 1208 until its distal end is near the distal end of the sheath portion 1208, and a portion of the handle portion 1210 is advanced distally within the handle portion 1206. The handle portion 1210 of the medical tool 1204 includes a handle 1214 and a stabilizer 1218. The stabilizer 1218 is configured with an interior portion of the handle portion 1206 to interface with one another in a stable relationship to prevent relative movement therebetween in at least one direction. The handle portion 1210 also includes a nut 1216 configured to interface with a proximal end of the handle portion 1206. The stabilizer 1218 acts to axially restrain the medical tool 1204 relative to the steerable sheath 1202 .

[0033]

[0064] 4, the distal working area of ​​the tool portion 1212 extends distally out of the sheath portion 1208 when the medical tool 1204 and the steerable sheath 1202 are stably interfaced with one another. In this embodiment, the distal end of the tool portion 1212 is not axially fixed relative to the distal end of the sheath portion 1208.

[0034]

[0065] The medical tool of Figures 3 and 4 can be any medical tool herein, such as, for example, an ultrasound tool.

[0066] The handle 1214 can optionally include at least one actuator that can cause axial and / or rotational movement of the medical device relative to the steerable sheath. Thus, once the tool and sheath are stably interfaced, one or more tool handle actuators can control (e.g., rotational or axial) movement of the medical tool. The tool and sheath can be interfaced after packaging and immediately prior to use, or can be integrated prior to packaging. The handle 1214 can also include other controls that control the functionality of the medical tool.

[0035]

[0067] 5 and 6 show an exemplary distal region of a steerable system, including an internal medical tool. The system 1300 includes a steerable sheath 1302 and a medical tool portion 1304. The steerable sheath 1302 includes an outer member 1308 and one or more pull wires 1306, which are secured distally to the steerable portion and configured to be moved axially proximally relative to the steerable portion upon actuation of a handle actuator, thereby causing axial relative movement with the steerable portion, thereby steering the steerable portion (as described above). The pull wires 1306 can be parallel to a central axis of the steerable portion of the sheath.

[0036]

[0068] In this merely exemplary embodiment, the tool portion 1304 includes an elongated medical tool 1310 including an RF tip electrode at its distal end, and a guidewire lumen 1312, although the medical tool can be any other medical tool described herein. In this embodiment, the tool 1310 and steerable sheath 1302 are configured such that the distal end of the tool (including the area very close to the distal end) is axially immobile but rotationally movable relative to the distal end of the steerable sheath 1302 (including the area very close to the distal end). To make the parts axially immobile but rotationally movable, the outer member 1308 includes an extension 1314 that extends radially inward relative to an inner surface of the outer member 1308 proximal to the extension 1314. The tool 1310 includes a region with an outer configuration 1315 (shaped radially inward) that corresponds to the extension 1314. The two components have similarly shaped elements 1317 and 1318 distal to elements 1314 and 1315. Thus, the configuration of the tool and outer member prevents distal and proximal movement of the tool relative to the outer member, and thus relative to the steerable sheath, when the tool and sheath are interfaced as shown. In this embodiment, the tool 1310 is rotationally free and therefore movable relative to the steerable sheath. That is, the tool 1310 cannot move axially in a fixed position (distal to the steerable portion), but can be rotated. Rotational freedom can be beneficial when a medical tool with one or more instruments installed is oriented or faces in a particular direction.

[0037]

[0069] Because the tool and sheath are axially fixed distal to the steerable portion, the proximal end of the tool is configured to be able to move axially slightly during operation. For example, a spring built into the handle may allow the tool shaft to move slightly relative to the steerable sheath. Other methods of allowing proximal axial movement may be incorporated as well.

[0038]

[0070] The proximal end of system 1300 can include two handle components, such as those shown in the embodiment of Figures 3 and 4, and can be interfaced similarly, except for modest axial movement of the tools at the proximal end.

[0039]

[0071] In other embodiments, the distal region shown in FIGS. 5 and 6 can be combined with the handle assembly shown in FIG.

[0072] One aspect of the disclosure is a method of axially immobilizing (axially fixing) two coaxial components that were previously axially movable. This aspect also includes a method of removing the axial fixation so that the components can again be axially moved. This can be considered a releasable axial fixation. The axial fixation is generally created prior to advancing the system into the patient's body, and in some embodiments, the axial fixation is created during manufacturing. Release of the axial fixation can occur during a refinishing process, and the axial fixation can be recreated during the refinishing process.

[0040]

[0073] In some embodiments, the system can be modified to include a component that can modify (increase or decrease) its volume to axially fix the medical tool, hi some embodiments, the component has a configuration that changes to axially fix the medical tool.

[0041]

[0074] In some embodiments, the system 1300 is adapted to configure the extension 1314 such that the volume of the extension can be modified to effect or release axial fixation. In this particular modification, the fillable annular volume 1319 (shown and labeled only once in the cross-sectional view, but understood to be present on the other side due to the annular configuration) is adapted to be filled with fill material and also to allow the fill material to be removed. In these alternative embodiments, the outer member includes an annular fill volume 1319 defined by the radially outer dotted surface and by the radially inner portion of the extension 1314 described above. That is, the extension 1314 is modified to include a fillable annular chamber or volume 1319, but the outer surface of the extension 1314 remains and defines the annular fillable volume 1319.

[0042]

[0075] When it is desired to allow relative axial movement of the tool 1310 and sheath 1302, such as during manufacture of the system, the fillable volume 1319 remains at least partially unfilled, allowing the tool 1310 to be easily advanced or retracted axially within the sheath 1302. When it is desired to make the tools 1310 and 1302 axially immobile or fixed (after being placed in a desired relative axial position, such as during manufacture or refinishing), the fillable volume 1319 is filled with filler material such that the extension extends radially inward and becomes more rigid to prevent axial movement of the tool 1310 relative to the sheath 1302. Thus, the extension in this embodiment is a reconfigurable axial constraint.

[0043]

[0076] If it is desired to move the tool 1310 and sheath 1302 axially at a later time (such as during refinishing, e.g., at least one of cleaning and sterilization), the fillable material can be removed from the volume (or chamber) 1319 to make the extension less stiff so that the tool 1310 can be moved axially relative to the sheath 1302.

[0044]

[0077] In these alternative embodiments, the extension 1314 can be considered to be expandable and non-expandable, fillable and non-fillable, reconfigurable, configured and adapted to have modifiable stiffness, configured such that stiffness can be modified, and to have a modifiable volume.

[0045]

[0078] In some embodiments, the fillable material can be inserted into and removed from the annular fill volume 1319 using a filling device, such as a needle.

[0079] 6 position, after which the fill volume 1319 is filled with fill material to axially secure the tool 1310 and the sheath 1302 (e.g., during manufacturing or refinishing). The method can also include removing the fill material and axially moving at least one of the tool 1301 and the sheath 1302 (e.g., during refinishing).

[0046]

[0080] In an exemplary embodiment, the filler material can be modified from a solid to a liquid and vice versa by changing its temperature. In some embodiments, the fillable material (also referred to herein as "filler material") is solid at operating temperatures, increasing the volume or stiffness of the extension 1314, but melts (or becomes less viscous) to allow it to be removed from the annular volume 1319.

[0047]

[0081] In some embodiments, the filler material is a wax, which in some embodiments can have a lower melting point than the polymeric material of the adjacent components, such as the inner or outer members.

[0048]

[0082] For example, this concept of providing axial fixation (and allowing for removal of axial fixation) by addition and removal of filler material may be used to axially fix any two components herein, including the outer sheath of a steerable sheath and a medical tool therein.

[0049]

[0083] 7 shows a system 1400 that includes a medical tool 1204 partially disposed within a steerable sheath 1202. The medical tool 1204 and sheath 1202 are labeled 1204 and 1202, but can be any of the medical tools or sheaths described herein. The steerable sheath 1202 is preferably "steerable," for example, by using a pull wire or other functional deflection mechanism (any of those described herein), although it is understood that this "steerable" sheath (or any steerable sheath herein) can also be non-steerable in that it is simply a straight tubular element or has a fixed, non-deflectable distal curved shape. Steering may also be accomplished by applying a torque to the sheath, with or without the use of a deflection mechanism.

[0050]

[0084] The system 1400 shown in FIG. 7 is designed to have modular components that are provided to the user in an integrated form, but can be disassembled after the procedure using a specialized process to clean, repair, and / or replace any of the modular components of the system. The system 1400 may then be reassembled, sterilized, and repackaged. This process, or possibly a portion of this process, may be referred to herein as "repositioning" or "refinishing," and any of the methods herein may be used to reposition or refinish any of the systems herein. The performance of the system 1400 is optimized such that the medical tool 1204 and the sheath 1202 only work with each other and are not replaced with other devices on the market that may have similar functions. Also, special care must be taken with repositioning the devices to ensure the continued safety and quality of performance of the system.

[0051]

[0085] In the following disclosure, there are many references to techniques for separating the various modular components of the system, either by breaking or by using a controlled process. Depending on the embodiment, the handle portion 1960 (see FIGS. 8A and 8B), the rear handle 1961 (see FIG. 10), and the handle lip 1962 (see FIG. 11A) can be separated from the handle assembly. For example, the tool lock 1955 can be separated from the tool portion 1212 of the medical tool 1204 or from the handle assembly 1206. For example, the tool connector 1210 (see FIG. 7) or 1990 (see FIG. 12A) can be separated from the tool portion 1212. The hemostasis valve 1950 assembly (see FIG. 7) can be separated from the handle assembly 1206. The sheath portion 1208 can be separated from the handle assembly 1206. The outer member 2010 (see FIG. 16B) of the tool portion 1212 can be separated from the inner lead assembly 2011 and its internal electrical connections. Many similarly controlled processes and materials can be used to enable the initial assembly and subsequent disassembly and reassembly of the components in any of the embodiments herein.

[0052]

[0086] Any given process or combination of processes can be used at any one or all of the points in the module separation described above. Processes include, but are not limited to, the following examples: Components can be bonded using materials that act like adhesives or mechanical locks, but can be deformed with heat to remove the components. This includes materials such as waxes and thermoplastic elastomers (e.g., polyurethane, polyethylene, polyamide, etc.). Materials such as hydrogels (such as those described herein above) can be expanded with an aqueous solution to change their properties so that they become soft or slippery enough to separate the components. Crystal or powder forms of sugars, salts, starches, or other similar materials can be used that create a mechanical interference fit between the components, but dissolve easily in an aqueous solution to separate the components. These materials can also be used as a matrix of non-degradable materials that compress like a foam when the crystalline structure dissolves. Other polymers, including those known in the art to be biodegradable, that are known to disintegrate over time after contact with fluids (such as those introduced during use) may be used in the system, but their properties are weakened and need to be replaced. Other materials can be used that lose retention strength in the presence of chemical solvents. Strong acids or bases can be used to dissolve certain metals and plastics. For example, silicones swell and easily fracture in the presence of heptane, hexane, or isopropyl alcohol. If a liquid material is dispensed to alter the seal, the seal can be protected in a protected space during use that can only be accessed with a specialized tool (such as a needle puncture septum or Luer actuated valve).

[0053]

[0087] Certain components may be joined using solder or solder-like processes, where the components are separated by reheating the solder. In some embodiments, electrolytic methods may be used to separate metallic bonds. Mechanical interference may also be used to hold the components together (e.g., nails, pins, screws, wedges, etc.). Indexing mechanisms (e.g., zip ties, belt loop methods, roller wedges, cam-activated grips) may also be used to hold the components together, but require the manufacturer to access, break and replace the parts, or use tools to temporarily separate the components. Components may be held in place by magnetic attraction (between magnets or between magnet and iron). In certain embodiments, the magnetic hold may be released without demagnetizing the magnet. This may be accomplished by physical breaking or mechanical fatigue of the magnet, by raising the temperature of the magnet above its Curie temperature (e.g., 80° C. for neodymium magnets), or by applying an alternating current to the magnet to break the bipoles. In another embodiment, the parts can be engaged and held in place using a lock such as a bar (similar to a door lock) that fits into a hole or other capture mechanism. The bar can be heat set in a curved or hinged configuration that is normally engaged in the hole, but changes shape and moves out of the hole (allowing the parts to be disassembled) when exposed to heat above a transition temperature. In a similar approach, the bar can be magnetized so that it is pushed out of the hole when exposed to a magnetic field. Other similar mechanisms can use coils or other springs or spring-activated devices that change shape and unlock in the presence of heat or a magnetic field. In another embodiment, the components can be held together under hydraulic pressure (e.g., water or oil such as mineral oil or silicone oil), such as a sealed cylinder with a piston, bellows, diaphragm, balloon, etc. To separate the components, the pressure can be vented by piercing or otherwise breaking a seal to a pressurized chamber. Valve opening or relieving pressure relief approaches can also be used.Often times, the processes used to separate the parts also contaminate or damage the parts to an extent that requires replacement, further repair, and / or additional cleaning prior to reassembly and other subsequent processing steps.

[0054]

[0088] Any combination of the above exemplary processes may also be used.

[0089] In any of the embodiments herein, the medical tool can be an ultrasound device with one or more ultrasound transducers disposed at a distal region. For example, the ultrasound device can be an ultrasound imaging device, such as a 4D-ICE (intracardiac echocardiography) imaging tool.

[0055]

[0090] 7 shows that the tool portion 1212 of the medical tool 1204 may be rotatable within and relative to the steerable sheath 1202, and may optionally be axially translatable within the sheath. A tool lock 1955, in FIG. 7, is disposed within the body of the handle 1206 and is fixed to the tool portion 1212, and may have one or more functions to constrain movement within the sheath 1202 and / or control functionality of the medical tool 1204. FIG. 7 also shows a hemostatic valve assembly 1950 within the handle portion 1206, useful for keeping blood or other fluids from leaking out of the proximal end of the steerable sheath 1202 and allowing flushing of the luminal space between the tool 1204 and the internal lumen of the sheath 1202.

[0056]

[0091] 8A and 8B show another embodiment of the system in which the handle assembly 1206 includes a removable or breakable handle portion 1960 that can be removed or broken from the handle assembly 1206 to allow access to the interior space of the handle assembly 1206. Once removed or broken, access is available to a tool lock 1955 disposed within the handle assembly 1206, as shown in FIG. 8A. The tool lock 1955 can then be disengaged from the tool portion 1212, as shown in FIG. 8A. Once the tool lock 1955 is removed, the tool 1204 can then be removed from the sheath 1202, as shown in FIG. 8B.

[0057]

[0092] In some embodiments, handle portion 1960 (and any other handle portion herein that can be removed or broken from the handle assembly) can be configured to interface with a corresponding component of handle assembly 1206 so that it can be stabilized relative to 1206 in use, but can be removed from handle 1206 in a controlled manner without breaking the interface between handle 1206 and portion 1960. For example, and without limitation, the two parts can have a threaded interface. Alternatively, for example, portion 1960 can be configured such that the interface between it and handle assembly 1206 must be broken, but the interface is one that allows for breaking in a relatively easy and predictable manner.

[0058]

[0093] One function of the tool lock 1955 is to prevent the medical tool 1204 from being removed from the sheath 1202 to ensure system integrity as described above. The tool lock also limits the axial translation of the medical tool within the handle assembly by being physically constrained within the handle assembly. This may be desirable to ensure that the medical tool does not move axially or that movement is constrained to a safe and functional range of the medical tool beyond the tip of the sheath. In another embodiment shown in FIGS. 9A and 9B, the tool lock 1955 and the handle assembly 1206 may both be configured to limit the rotational range of the medical tool. This may be desirable to prevent torque buildup in one direction that may twist and damage portions of the outer member 2010 or inner lead assembly 2011 (see FIG. 16).

[0059]

[0094] As shown in Figures 9A and 9B, the tool lock 1955 has a mechanism 1956, in this embodiment a radial protrusion, that allows it to rotate less than 360° in either direction. The handle assembly 1206 has a radially inward extending protrusion positioned and configured to engage the mechanism 1956 and thus the tool lock 1955, stopping its movement. Other torque limiters known in the art can also be used, including those that limit the torque to a finite number of rotations in a given direction. Axial movement and torque can also be limited by a counter magnet. When the magnet of the tool lock approaches (through axial or rotational movement) a counter magnet positioned in the handle portion is resisted. The rotation limiting illustrated in Figures 9A and 9B can be incorporated into any of the systems herein.

[0060]

[0095] In embodiments including a tool lock, the rotational and / or axial movement of the tool lock may also have a friction fit with features in the handle so that it can move but not rotate or slide back to its original position except by the action of the user. For example, either or both of the outer surface of the tool lock and the inner surface of the handle portion (such as handle portion 1960) may include a lubricating material such as PTFE, FEP, Delrin (Acetal), etc. The mating material can be a smoothly polished polymer or metal, unless formed from the same material. The two parts can have a precise play or interference, for example, .0005 cm (.0002 inches) or less. Friction can also be controlled by slight interference from only a portion of the surface of the tool lock and a portion of the handle portion (portion 1960). The interference can be a small integrated feature and / or a separate component resting on a spring of metal or rigid polymer in solid or foam form, or a resilient material such as compressible polymer (silicone, polyurethane, etc.), or formed from a coil or flattened ribbon. A slidable wedge can also be used to adjust the compression. A lead screw or pressurized chamber driving the interference mechanism together can also be used to adjust the amount of compression interference at the time of manufacture. During the repositioning process, this compression friction interference would need to be disassembled and then reassembled and returned to the manufacturer settings. In another embodiment, the compression mechanism can be incorporated into the handle portion (such as portion 1960) and acted directly on the tool portion 1212 without the need for a tool lock mechanism. Although the tool lock is illustrated as being integrated into the tool portion 1212, it can also be integrated directly into the tool handle portion 1210, which would be engaged by the sheath handle portion 1960. This is particularly applicable when axial translation of the medical tool 1204 relative to the sheath 1202 is not required.

[0061]

[0096] The tool lock 1955 may also have an electronic or electromagnetic mechanism that senses the presence of the handle portion 1960 (or other handle portion). When a handle portion (such as portion 1960) is removed, the tool lock may disable the functionality of the medical tool 1204. For example, the handle portion may include a magnet mounted in proximity to the tool lock. The magnet may hold a closed reed switch within the tool lock that completes the functional circuit of the medical tool. When the magnet is removed by the handle portion (such as portion 1960), the reed switch is opened and the medical tool is disabled. Other proximity switches that perform the same function may also be used. The tool lock may also disable the functionality of the medical tool, or may disable the functionality of the medical tool when the tool lock is removed from the medical tool (such as is necessary to remove the medical tool from a sheath). For example, the tool lock may have a direct wired connection to the medical tool (e.g., within the tool portion 1212) that is disconnected from the medical tool when the tool is removed. The medical tool may also include a proximity sensor in the tool portion 1212 that is disabled when the medical tool is removed from the sheath. For example, a reed switch completing the functional circuit of the medical tool may be held closed by a magnet in the tool lock, similar to that described above. Removal of the tool lock then opens the reed switch and disables the medical tool. Other proximity sensors known in the art may also be utilized. Replacement of the tool lock may re-enable functionality, but may also require additional reprogramming of the control tool software to reset the functionality of the medical tool once the software detects an interruption in the circuit. In a related scenario, removal or breakage of a handle portion (such as portion 1960) may interrupt the circuit of the tool lock as sensed by the medical tool and / or more specifically the control tool software. Functionality of the tool may then be restored by repairing, replacing, or reprogramming the tool lock and replacing and / or repairing the handle portion (such as portion 1960).

[0062]

[0097] 10A and 10B show another embodiment of the system with a modular mechanism to aid in repositioning of the device. In this embodiment, the handle assembly 1506 may be disassembled by removing or breaking the rear component 1961 from the remainder of the handle assembly 1506. This allows access to the tool lock (not shown, but can be any tool lock described herein) as well as the hemostatic valve assembly 1950. Depending on the configuration of the tool handle, the handle rear portion 1961 may be removed from the tool in a proximal direction (without removing the tool lock) or the tool lock may be accessed and removed more easily than in the previous embodiment where only the handle portion 1955 is removed. In this configuration, the hemostatic valve assembly 1950 may be accessed to remove and replace the valve assembly. Alternatively, the valve assembly including any of the individual components may be removed, disassembled, cleaned, repaired, and replaced. Repair may involve only replacement of the hemostatic seal 1951 of the assembly 1950. The seal may be slit silicone or other soft polymeric compounds known in the art or any of the seals of the present disclosure. The hemostasis valve assembly preferably includes a luer fitting 1952 at its distal end so that it can simply be pressed into and out of a mating luer fitting on the handle. Alternative fittings may also be used.

[0063]

[0098] The steerable sheath 1202 may also be adapted to allow the sheath portion 1208 to be separated from the handle assembly 1506. As with other modular components, this may allow removal for cleaning, repair, or replacement. The sheath 1202 may be mated with an elongated element to deflect the catheter tip. An elongated element similar to these is shown in FIG. 10B as element 1970. One or more elongated elements 1970 are preferably permanently secured to fasteners 1971, such as by welding, soldering, crimping, swaging, or an adhesive / epoxy bonding process. When the ends are placed in the adhesive / epoxy, the ends of the elongated elements are preferably formed into an enlarged ball, coil, loop, or other similar mechanism that is larger in cross section than the elongated element itself. Alternatively, the elongated elements may be releasably secured using set screws or other mechanical fasteners. An enlarged weld ball end or a separate tube crimped to the proximal end of the extension element may help mechanically capture the extension element 1970 within the fastener 1971. The fastener 1971 is configured to be actuated by an engagement mechanism 1972 and linked to the manipulable actuator 1520. The engagement mechanism 1972 includes portions 1972' and 1972'', each with opposing threads. The actuator 1520 includes dual opposing threads, so that rotation of the actuator 1520 drives the engagement mechanism portions 1972' and 1972'' in opposite directions, thereby deflecting the manipulable section in one direction or another. The fastener may be designed to be easily disconnected and reconnected to the actuator for quick and cost-effective handling during repositioning. Alternatively, the extension element may be removably connected directly to the engagement mechanism without the use of fasteners.

[0064]

[0099] 11A and 11B show an alternative embodiment of a medical device (e.g., ultrasound) or system 1700 that includes an integrated handle assembly, steerable sheath, and medical tool, and that can be repurposed using any of the methods herein. In the system 1700, a handle assembly 1703 is in operative communication with a steerable sheath 1702 and a medical tool 1704, the handle assembly 1703 includes a handle body 1705 having an outer surface positioned for gripping by a user, a first actuator 1720 adapted to be moved relative to the handle body 1705, and a second actuator 1780 adapted to be moved relative to the handle body 1705. The steerable sheath 1702 has a distal deflectable region (not numbered) in operative communication with at least one pull wire. In some embodiments, the medical tool 1704 is an elongated ultrasonic device having a distal portion comprising an ultrasonic transducer, at least a portion of the elongated ultrasonic device disposed within the steerable sheath 1702, the elongated ultrasonic device in operative communication with a second actuator 1780. The first actuator 1720 is in operative communication with at least one pull wire such that actuation of the first actuator 1720 relative to the handle body 1705 deflects a distal deflectable region of the steerable sheath 1702.

[0065] [000100] The second actuator 1780 is adapted to rotate relative to the handle body 1705 and to move axially relative to the handle body 1705. The second actuator 1780 is in operative communication with the elongated medical device 1704 such that axial movement of the second actuator relative to the handle body 1705 causes the elongated medical device 1704 to move axially (distal and proximal) relative to the distal end of the steerable sheath, and such that rotation of the second actuator 1780 relative to the handle body 1705 causes the elongated medical device 1704 to rotate relative to the distal end of the steerable sheath, as shown as rotational movement "R" in FIGS.

[0066] [000101] Axial movement of the tool relative to the sheath, when the tool is an ultrasound imaging tool, is generally desirable in that it improves the ability of the probe to image larger areas of the body after the probe has been manipulated to a particular position, and also allows the operator to more easily refine the field of view after the probe has been manipulated to a generally achievable position.

[0067] [000102] The system 1700 also includes an optional tool lock 1755. The tool lock 1755 is housed within the handle assembly 1703, but is coupled to a second actuator 1780. The tool lock 1755 and the second actuator 1780 may be fitted to engage one another, for example, by magnets. Alternatively, one of the components may include iron and the other may include a magnet. The tool lock 1755 is securely and releasably coupled to the tool portion 1712 of the medical tool 1704. Advancing the second actuator 1780 distally or retracting it proximally moves the tool lock 1755 distally or proximally, respectively. The resulting axial movement of the actuator tool 1755 axially moves the medical tool 1704. Similarly, rotation of the second actuator 1780 relative to the handle body 1705 rotates the tool lock 1755, which in turn rotates the medical tool 1704 (shown as rotation "R" in FIGS. 11A and 11B). In this embodiment, the tool's axial (relative to the sheath) movement as well as its rotational (relative to the sheath) movement are restricted within a fixed range of motion. In one embodiment, to remove the medical tool 1704 from the steerable sheath 1702 (such as during refinishing), the handle rear lip 1762 can be removed or broken to remove the tool lock 1755 (and the remainder of the tool portion 1712) from the handle 1706. Additionally, the second actuator 1780 can be decoupled from the tool lock 1755. This may require the use of a custom fastener that pulls the coupled units apart, or a dedicated tool that demagnetizes or otherwise polarizes either the external coupling or the tool lock. As mentioned above, the tool lock may include a mechanism that disables the tool function when a magnet or other proximity controller is removed. The rear lip 1762 is an exemplary and optional component, and the handle assembly may have different parts.

[0068] [000103] Figures 12A-12C show an embodiment of the system in which a medical tool 1204 (which may be any other medical tool herein) includes a plurality of electrical contacts 1992. Figures 12Ai and 12Aii show disassembled components. Figures 12Bi and 12Bii show a tool portion 1212 reloaded into a sheath portion 1208. Figure 12C shows a proximal tool connector 1990 (which may be directly or indirectly attached to an energy console) connected to the tool portion 1212 such that the tool portion 1212 is in electrical communication with the connector 1990. The tool portion 1212 is mated at a proximal end with a plurality of mating electrical contacts 1992. The tool 1204 includes a distal working end 1821 (e.g., an ultrasound imaging tool) that is larger in diameter than the lumen of the tool portion 1212, as shown in Figure 12Bii. In this embodiment, the outer dimensions of the tool portion 1212 and electrical contacts 1992 are sized to fit through the lumen of the sheath portion 1208 or the distal working end 1821 is too large to fit through the lumen. As a result, assembly of the tool through the sheath portion 1208 requires advancing the proximal end of the tool portion 1212 through the distal tip of the sheath and advancing proximally until the electrode exits the proximal end of the sheath handle 1206. This configuration helps minimize the outer dimensions of the sheath portion 1208 so that it is not necessarily larger than the distal working end 1821. In certain applications, the distal working end may need to be the largest possible size to accommodate electronic components and their connections or, in certain applications, to minimize the density of electrical current or sonic energy to minimize overheating or cavitation of tissue. The proximal electrical contacts 1992 may be discrete conductive surfaces (e.g., disks, bars, strips, spheres, etc.) or circumferential or partially circumferential rings. In a preferred embodiment, the contacts are formed from exposed conductive material of the flexible circuit that is otherwise insulated (e.g., no insulation is placed over the exposed conductive material). The mating contacts 1991 of the connector may be similarly designed to make contact.The contact surface may be annular or planar, and is preferably spring loaded or otherwise mechanically compressed to provide firm contact. The handle assembly of Figures 12A-C can be any of the handle assemblies herein, the steerable sheath can be any of the steerable sheaths herein, and the medical tool can be any of the medical tools herein. The forward load assembly can be used during assembly of any of the systems herein.

[0069] [000104] Figures 13A-13C show an exemplary proximal portion of the present disclosure and can be any proximal portion of the system of the present disclosure. As shown in Figure 13A, the proximal contacts 1992 of the medical tool can be press-fitted into the connector 1990 against the contacts 1991. Alternatively, as shown in Figure 13B, the connector 1990' can be adapted to open and receive the contacts 1991 before being clamped over the contacts 1991 as shown in the closed configuration of Figure 13C. The connector 1990' can be sealed with a seal 1995 during manufacture. The seal 1995 can include, but is not limited to, hydrogel, wax, silicone ring or gasket, or other means and combinations as described above in this disclosure. To reposition the device, the contacts of the connector 1990' must be broken or carefully disassembled and the shaft of the tool 1212 removed distally through a sheath (such as a steerable sheath). Dissolution of the seal 1995 may be accomplished by heating and melting the wax or other meltable substance, dissolving the dried material in an aqueous solution, and / or expanding the silicone with heptane or a similar chemical compound.

[0070] 14A-14B show an exemplary system similar to FIGS. 13A-13C, except that the connector 1990″ includes an internal mechanism 2000 designed to stably interface with and encapsulate a tool lock 1995 attached to the tool portion 1212. FIG. 14A shows the system immediately prior to connecting the connector 1990″ to the tool portion 1212, and FIG. 14B shows the completed connection. The tool lock 1955 is shown just distal to the proximal tool contacts 1992, but could also be configured proximal to the contacts, with a corresponding internal mechanism 2000 located proximal to the connector contacts 1991. As discussed above, the tool lock may include a mechanism to disable tool function when a magnet or other proximity controller is removed. In this embodiment, the disabling mechanism may alternatively be built into the connector 1990″, specifically the internal mechanism 2000, with the circuit connection of the cable back to the control console dependent on the state of the disabling mechanism. Assembly and disassembly of the portion of the connector including mechanism 2000 can be accomplished by the means described above with respect to the connector 1990 of Figure 13, the handle portion of Figure 8, or the rear handle of Figure 10. The handle assembly of Figures 14A-B can be any of the handle assemblies herein, the steerable sheath can be any of the steerable sheaths herein, and the medical tool can be any of the medical tools herein.

[0071] [000106] In a variation of the embodiment of Figures 14A and 14B, assembly of the tool 1212 may require "backloading" the tool 1212 through the distal end of the steerable sheath portion 1208 as described in the embodiment of Figures 12A-12C where the outer dimensions of the tool and electrical contacts are sized to pass through the lumen of the sheath portion but not through the distal working end. In this embodiment of Figures 14A and 14B, the tool lock must be assembled after backloading the tool. After repositioning, the tool lock would need to be removed to remove the tool 1212 from the sheath portion 1208, and the tool 1212 would need to be cleaned and backloaded again through the sheath portion 1208 before repair and / or replacement. In an alternative embodiment, the tool 1212 may be assembled by "front loading" the distal tip insert through the proximal handle end of the sheath 1202. In this alternative embodiment of FIGS. 14A and 14B, the tool lock 1955 does not necessarily need to be removable from the tool 1212.

[0072] 14A-B, the clamping action of internal feature 2000 through tool lock 1950 provides a mechanical engagement of the two features so that axial translation and torque can be transferred from connector 1990'' to tool 1212. This can provide the user with a more convenient means of grasping tool 1212 and manipulating its position relative to sheath 1202.

[0073] [000108] As shown in the exemplary system of FIG. 15, a separate torque device 2005 can be attached to the tool 1212 to provide similar capabilities and torque as described above to translate the tool 1212 relative to the sheath 1202, but without the need to connect to the connector 1990 as described above in FIGS. 14A and 14B. The torque device 2005 can also be engaged through a tool lock 1950 to provide an extended mechanical engagement. The torque device 2005 can also serve a similar purpose to the internal mechanism 2000 in that tool function is dependent on the presence of the torque device 2005. As described above in the embodiment of FIGS. 12A-12C, the torque device can be assembled onto the tool 1212 such that the tool 1212 cannot be removed from the sheath 1202 without breaking the torque device and / or the tool 1212 or using a custom repositioning process to remove the torque device. The handle assembly of FIG. 15 can be any of the handle assemblies herein, the steerable sheath can be any of the steerable sheaths herein, and the medical tool can be any of the medical tools herein.

[0074] [000109] The embodiment of Figures 16A-C illustrates an exemplary medical tool in which the tool portion 1212 includes an outer member 2010 and an inner lead assembly 2011. The inner lead assembly further includes a distal working end 1821 and a proximal electrical contact 1992. The outer member 2010 may be assembled and disassembled from the inner lead assembly as part of the repositioning process. The outer member 2010 can be a tubular structure capable of transmitting torque, for example, via a braided composite structure. The outer member 2010 is reversibly sealed and secured to the inner lead assembly at locations 2015 and 2013 using the process described above in this disclosure. Figure 16B illustrates an enlarged view of the enclosed area of ​​Figure 16A. Figure 16C illustrates the inner lead assembly 2011, the distal working end, and the proximal end removed from the outer member 2010. The handle assembly of Figures 16A-C can be any of the handle assemblies herein, the steerable sheath can be any of the steerable sheaths herein, and the medical tool can be any of the medical tools herein.

[0075] [000110] The following disclosure generally relates to electrical connections and contacts of medical devices, optionally ultrasound probes unless otherwise specified. The following disclosure may be applied to any of the systems or system aspects herein. The electrical connections, contacts, devices, and methods may be integrated into any of the systems described above, including but not limited to the handle assembly of FIG.

[0076] [000111] An aspect of the disclosure includes a method for dissociating at least a portion of the system from other components, optionally as part of a repositioning process. In some embodiments, the medical tool 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.

[0077] [000112] FIG. 17 illustrates only a portion of an exemplary medical tool, such as an ultrasound probe, that can be electrically coupled directly or indirectly to an energy console, such as an ultrasound console.

[0078] [000113] The embodiment shown in Figure 17 can be used in a similar manner to the concept of the embodiment shown in Figures 12A-C in that repositioning the device involves breaking one or more proximal electrical contacts and moving the tool portion distal to the distal end of the sheath portion. In this embodiment, the tool portion 1212 comprises at least a tool outer sheath or member 2010, a distal working end 1821 (which may include at least one ultrasonic transducer), and a conductor bundle 2020. The conductor bundle 2020 extends from the distal working end 1821 through the tool outer member 2010 to a proximal connector (the connector and handle mechanism are not shown in Figure 17 for clarity). In some embodiments, the medical tool is used for ultrasound imaging, optionally with the distal working end 1821 comprising a two-dimensional (2D) array of piezoelectric components on an ASIC (application specific integrated circuit).

[0079] [000114] FIG. 18 shows only an exemplary proximal end of a medical device (the medical device is illustrated on the right), in this embodiment, the medical device is an ultrasound probe. The proximal end 2015 of the medical device is adapted to be electrically coupled to a connector cable 270, which is adapted to be electrically coupled directly or indirectly to an energy console, such as an ultrasound energy console. As shown in FIG. 18, a conductor bundle 2020 extends from a distal region of the medical tool (distal region not shown) into a proximal connector 2015 in which a rigid or flexible printed circuit board ("PCB") 2030 is housed. The connector bundle 2020 includes a number of contacts 2024 (examples of which are described below) that are attached to PCB board contacts 2031. Each individual trace from each contact 2031 is linked to an individual exposed contact 2050 on another portion of the PCB, optionally on the proximal side. The individual PCB traces may also run through other useful circuitry on the PCB. The exposed contacts 2050 are configured to mechanically mate for electrical conductivity to similar contacts 2060 on a mating connector cable 2070, similar in concept to the proximal tool connector 1990 described above that links the tool 1204 to the user interface console. The proximal connector 2015 can be incorporated into any of the systems, handles, steerable sheaths, medical tools, etc. herein, such as those shown in Figures 11A and 11B.

[0080] [000115] Figures 19A and 19B 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 19A and 19B is one example of a conductor strip that may be included in the bundle 2020 of Figures 17 and 18. The embodiment of Figures 19A and 19B may be incorporated into any of the other systems herein.

[0081] [000116] As shown in Figures 19A, 19B, and 19G, conductor bundle 2020 comprises a plurality of flexible circuit strips including multi-trace strip 2021, as well as conductive strips (only portions of which are shown) for ground 2022 and shield 2023. Each multi-trace strip comprises a plurality of conductive traces 2025, which can be clearly seen in Figures 19B, 19C, and 19D. The number of traces 2025 in Figures 19D-19G is 12, while the number of traces in Figures 19A-19C is 16, both of which are illustrative of the number of traces 2025 that may be used. Each strip 2021 may be approximately .072 inches wide and .0022 inches thick, and may optionally comprise sixteen conductive (e.g., copper) traces, each .0022 inches wide by .0007 inches thick, spaced approximately .0022 inches apart. The traces may be disposed on an insulating substrate layer 2027, such as a polyimide substrate, and the traces may be at least partially covered with a cover layer 2026, such as a photoimageable film cover ("PIC") layer or other dry film solder mask (DFSM) or other similar material. The cover layer generally extends along most of the bundle, except for discrete locations in the proximal and distal regions for electrical coupling. In another embodiment, strip 2021 is about .055 inches wide and includes 12 conductive traces (see FIGS. 19D-19G). In another embodiment, strip 2021 is about .037 inches wide and includes 8 copper conductive traces. The outer strips 2022 and 2023 used for grounding and shielding may have a similar structure and dimensions, except that they may include a single full width copper strip. When optimizing for a 2D piezoelectric array, it may be necessary to have about 7 stacks of 16 trace strips 2021 (or 9 of 12 traces, or 14 of 8 traces), with strips 2022 and 2023 on each side of the stack of multi-trace strips.FIG. 19E shows a portion of an example bundle 2020 with nine strips 2021 stacked together. FIG. 19F shows a portion of a bundle including nine stacked strips 2021 as well as ground strip 2022 and shielding strip 2023 (only the top one is labeled). The complete bundle may optionally be held together using shrink tubing with a wall thickness of about .003 cm (.001 inch), such as, but not limited to, tubing 2028 of FIG. 19G. The dimensions of the flexible circuit and number of traces described above are for a particular configuration of the piezoelectric array (and / or its ASIC controller) and may vary depending on how the number and size of the array elements are optimized for a particular application.

[0082] [000117] The proximal end of each flexible circuit strip has a conductive material (e.g., gold-plated copper) exposed by removing the cover layer 2026 at location 2024, for example, over a length of about 3 mm. Location 2024, and other exposed locations described herein, are generally referred to as "contacts." As used in this context, a contact actually includes multiple separated conductive traces (such as those shown in the region locations), each of which is adapted to electrically communicate with its corresponding conductive element. Thus, a "contact" is limited to mean only a single electrical connection between two conductive elements. Although FIG. 19A shows multiple exposed regions 2024, the embodiment of FIG. 19A is described herein initially as having only one exposed region (i.e., region 2024 at the proximal end). The strip 2021 can be adapted to make an electrical connection to the exposed contacts 2031 shown in FIGS. 20A-C, which match the conductive traces on the PCB 2030. In some embodiments, 16 individual traces will be provided within a given contact 2031, sized and spaced to fit the 16 traces of the multi-trace strip 2021. ACF (anisotropic conductive film), solder, conductive adhesive, mechanical connection, or any combination of these may be used to achieve a suitable electrical connection (electrical bond) between the strip traces and the PCB contact.

[0083] [000118] As shown in Figures 20A and 20B, multiple flexible circuit strips (not all of which are shown) preferably have staggered lengths such that the exposed locations 2024 (each strip has an exposed location 2024 at its proximal end) are attached to a PCB 2030 with contacts 2031 provided at similarly staggered lengths. One or more of the arrays (preferably linear arrays) of contacts 2031 can all be on one side of the PCB, or a second array (or arrays) 2031' (see Figure 20B) can be provided on the underside of the PCB. One on the other side of the PCB allows the exposed areas 2024 of other strips to be attached to the other side of the PCB to create more room and connection options.

[0084] [000119] As part of any of the repositioning processes described herein, the strip-to-PCB connection may be interrupted to allow the entire tool portion 1212, including the now-disconnected conductor bundle 2020 (disconnected from the PCB), to be slidably removed from the distal end of the sheath portion 1208, as indicated by the direction of the arrow shown in FIG. 20C. Once removed, the exterior of the tool portion 1212, as well as at least the inner and outer surfaces of the sheath portion 1208, may be washed and cleaned. The tool portion 1212 may then be backloaded proximally through the sheath portion 1208 until the distal working end 1821 fits properly against the distal end of the sheath portion 1208, as described in more detail herein. The proximal ends of the strips 2021, 2022, and 2023 are then reattached to the exposed contacts 2031 and 2031', which may be the same or different contacts. For ACF bonding, the same ACF material may be used and / or cleaned and new ACF material may be applied prior to bonding. The integrity and ultrasonic performance of the connection may then be tested to verify acceptable performance. This repositioning process may be used for any of the systems herein.

[0085] [000120] One aspect of the present disclosure is a method of disassembling a system that has been exposed to a subject's bodily fluids (e.g., exposed to a blood environment, esophagus, etc.), including a medical tool, such as an ultrasound probe, a maneuverable shaft, and a handle assembly.The method may include providing a handle assembly, a steerable sheath that has been exposed to a bodily fluid environment of a subject, and an ultrasound probe that has been exposed to the bodily fluid environment of the subject, the handle assembly in operative communication with the steerable sheath and the ultrasound probe, the handle assembly including a handle body having an outer surface that can be grasped by a user, a first actuator adapted to be moved relative to the handle body, and a second actuator adapted to be moved relative to the handle body, the steerable sheath having a distal deflectable region in operative communication with at least one pull wire, the first actuator in operative communication with the pull wire such that actuation of the first actuator relative to the handle body deflects the distal deflectable region, the second actuator adapted to be rotated relative to the handle body and moved axially relative to the handle body, the second actuator adapted to rotate relative to the handle body and move axially relative to the handle body, the second actuator adapted to move axially relative to the handle body to deflect the ultrasound probe. the ultrasonic probe is in operative communication with the ultrasonic probe such that the ultrasonic probe moves axially relative to the distal end of the steerable sheath and such that the second actuator rotates relative to the handle body such that the ultrasonic probe rotates relative to the distal end of the steerable sheath, the ultrasonic probe having a distal portion including an ultrasonic transducer, the distal portion extending distally beyond the distal end of the steerable sheath and having an outer dimension greater than a dimension of a lumen of the steerable sheath in which the probe is disposed, the ultrasonic probe further including a flexible circuit strip, the flexible circuit strip comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of each of the plurality of conductive traces being covered by an insulating member, a portion of the plurality of conductive traces not covered by the insulating member, a portion of the plurality of conductive traces not covered by the second insulating layer defining a probe contact, the probe contacts being electrically coupled to electrical contacts on the printed circuit board, and either the printed circuit board or the printed circuit board herein can be a flexible circuit board.An exemplary system that can be used in this method is shown in Figures 11A and 11B. The "providing" step above (or in any other method herein) merely requires that the system be available for the following method steps, and does not require the act of providing or bestowing the system to another person or entity. Thus, in this context, a system that simply sits on a tabletop is "provided."

[0086] [000121] The method of disassembly further includes electrically isolating the probe contacts from the electrical contacts on the printed circuit board described herein. [000122] The method of disassembly optionally further includes moving the ultrasonic probe distally of the steerable sheath until it clears the distal end of the steerable sheath as shown in FIG. 20C.

[0087] [000123] The method of disassembly can optionally, but need not, further include the step of cleaning at least a portion of the ultrasonic probe, including a region of the ultrasonic probe that did not extend outside the sheath prior to the moving step, and that was optionally disposed within the handle assembly. For example, in Figures 11A and 11B, a portion of the medical device is disposed within the handle assembly.

[0088] [000124] The method of disassembly can, optionally, but need not, further include the step of electrically coupling the probe contacts to either the printed circuit board or another printed circuit board at some point after any cleaning step.

[0089] [000125] The method of disassembly may further include (and may in fact require) releasing the ultrasonic probe from releasably secured engagement with a handle assembly component at some point prior to the moving step. In some embodiments, the ultrasonic probe cannot be removed from the handle assembly without first doing so. Releasing the ultrasonic probe from releasably secured engagement with a handle assembly component may include releasing the probe from releasably secured engagement with a handle assembly component that is in direct or indirect operative communication with a second actuator. For example, FIG. 11A shows a medical device releasably secured to a handle assembly component 1755, which in this embodiment is described as a tool lock. The method of disassembly may include releasing the ultrasonic probe from releasably secured engagement with a tool lock 1755, which in this embodiment is also an example of a handle assembly component in direct or indirect operative communication with a second actuator 1780, prior to the moving step.

[0090] [000126] In some embodiments herein, the ultrasonic probe and handle assembly are adapted to allow the probe to be moved axially (distally and proximally) relative to the sheath. Bodily fluids such as blood may enter the space between the probe and the sheath, necessitating cleaning of the probe, which is usually relatively expensive, before reuse. In some embodiments, the distal tip of the ultrasonic probe has a larger outer dimension than the distal end of the steerable sheath. This may be desirable as a way of minimizing the footprint of the sheath within the patient's body. Therefore, after the probe has been used and exposed to bodily fluids, it cannot be disassembled from the sheath by retracting the probe proximally within the sheath. Thus, in order to reuse the probe for another purpose, the probe must be removed from the sheath distally relative to the sheath. The probe is attached at its proximal end to some type of connector (directly or indirectly to the ultrasound console), and therefore the probe must first be put out of electrical communication with the connector before it can be moved distally relative to the sheath.

[0091] [000127] In an alternative embodiment, it may be more efficient and / or reliable not to redeposit the original exposed locations 2024 of the conductive strip 2021 (and 2022 and 2023, if desired) during the repositioning process. In this case, as shown in Figs. 19A and 19B, each strip 2021 may comprise a plurality of exposed locations 2024, 2024', 2024'', etc. (each optionally about 3 mm in length) staggered in a distal direction along the strip length. Thus, the original locations 2024, as well as a section of layer 2026, may be resected or removed using other techniques, leaving the second most proximal location 2024' available for a new connection attachment. This process may be repeated for subsequent repositioning processes until all exposed locations have been used. This may also help limit the number of times the device is reused. The exposed but unused locations on the strip may be protected, for example with a peel-off insulating low tack adhesive strip, until ready for use. In other embodiments, the protective layer can be a paste, adhesive, or cured polymer with sufficient dielectric and conformal properties to insulate adjacent exposed conductors in a given strip. The material is preferably reversibly adhered so that it can be easily peeled or dissolved away from the exposed conductors without damaging the conductors. In some embodiments, the cover layer disposed over the traces can be removed by ablation (e.g., using a laser, sandblasting, or sanding) to expose exposed areas of the traces, which can then be used as contact locations.

[0092] [000128] In some embodiments, alternative to those shown in Figures 19A and 19B, the strip can be initially attached to only one exposed area, the proximal-most region 2024, with the covering layer 2026 extending distally without any discontinuities in layer 2026. After the first use, region 2024 can be removed. To expose another conductive region, a portion of the new proximal end of layer 2026 can be removed, such as by ablation, or peeled off if layer 2026 is a peel-off section. This process can be repeated as necessary to create a new conductive exposed area after each use.

[0093] [000129] In embodiments where the flexible circuit strip is cut or removed using any suitable technique to attach the next exposed element of the flexible circuit strip to the PCB, it may be necessary to advance the strip forward to establish electrical connections. This may be difficult or impossible if the strip is constrained in a tube and cannot be moved to the PCB, or is otherwise securely housed. As shown in the exemplary embodiment of FIG. 21, to allow the extra length to be advanced relative to the tube, the conductor bundle 2020 (which may be the same or a different bundle as bundle 2020 herein) may be reversibly wound on or around a spool 2035 comprising a rod, tube, spindle, or similar rotatable structure for a length appropriate for advancing out of all exposed elements. Prior to winding, the conductor bundle may first be passed through a slot that traverses through a central axis, or the bundle may be wound from one end to the other end of the outer surface of the spool. Thus, after cutting off one set of contacts, the conductors are unwound from the spool to create the next set of connections on the PCB 2030. The spool preferably has a central axis that can be mounted on the distal end of the PCB or in a mechanism just distal to the board and secured in the proximal connector 2015. The spool may also serve to protect the connection to the PCB from distortion due to pulling or twisting forces applied to the flexible conductor handle. To prevent premature unwinding, the spool can be fitted with a keyed mechanism reversibly connected to the PCB or elsewhere on the proximal connector or connector housing itself.

[0094] [000130] If removing the original connections to the PCB at connector 2031 would compromise the integrity of those connections, the PCB may include multiple arrays of redundant connectors 2031', 2031'', etc. that can make connections with each repositioning cycle of the device.

[0095] [000131] In another embodiment, the PCB can simply be replaced with a new identical PCB to which the exposed end 2024 (or 2024' etc.) of the flexible circuit strip can be attached.

[0096] [000132] Figure 22 shows another embodiment in which an exposed flexible circuit end (2024 or 2024') can be attached to a disposable miniature PCB element 2040 with the same connection 2031 on one side, but a larger exposed connection 2041 on the other side that is linked through a trace of the miniature PCB that is suitable for a reusable mechanical connection to the PCB 2030. A mechanical connection from the connection 2041 on the miniature PCB 2040 is made to a matching exposed mechanical connection 2042 on the PCB 2030. Spring clips or other suitable retention mechanisms can be integrated into the PCB to hold the contacts of the miniature PCB to the contacts on the PCB. Each individual trace from each contact 2042 is linked to an individual exposed contact 2050 on another part of the PCB, preferably more proximal. The individual PCB traces may also run through other useful circuitry on the PCB. The exposed contacts 2050 are configured to mechanically mate for electrical conductivity with similar contacts 2060 on a mating connector cable (e.g., cable 2070) that links the medical tool to the console. During the relocation process, the mini-PCB is lifted off the PCB and the flex circuit may be disconnected or cut off (as described above) from the mini-PCB. After the tool is removed, cleaned, and reassembled into the sheath, the flex circuit may be reattached to a new mini-PCB that is reconnected to the original PCB.

[0097] [000133] To allow access to the PCB 2030 and, if applicable, the spool 2035, the proximal connector (e.g., proximal connector 2015) may be mated with a removable housing having a custom design to mate with other portions of the connector and / or PCB 2030 and / or spool 2035. Optionally, complete removal of this housing may be required to render it non-functional by fracturing it, and replacement is required prior to continued use.

[0098] [000134] Distal to the spool, the conductor bundle 2020 is optionally irreversibly secured within the tool exterior member 2010. The tool exterior member 2010 preferably also extends proximally to the handle 1206. To allow the assembly of the tool exterior member 2010 and conductor bundle to be removed from the handle 1206 and sheath portion 1208 after disconnecting the flexible circuit from the PCB, the assembly is preferably slidable within any tubular connection lines between the handle 1206 and the proximal connector 2015. A reversible seal similar to that described herein above may also be used between the tool exterior member 2010 and the tubular connection lines.

[0099] [000135] The structure of the medical tool 1212 may be optimized to minimize diameter while providing optimal torque response at the distal working end (e.g., working end 1812). In some embodiments, a flexible circuit is routed through the internal lumen of the tool member 2010, similar to that shown in FIG. 16B.

[0100] [000136] Figure 23 shows a cross section of the bundled stack 2020 inside the member 2010. In this embodiment, the width of the flexible circuit bundle, .072 inches, is optimized for the width of the ASIC on which the piezoelectric components are mounted. Taking into account the shrink tubing around the stack, the dimensions of the stack are approximately .028 inches thick by .085 inches wide. The internal lumen of the tool member 2010 would require an internal dimension of approximately .089 inches in at least one dimension. This dimension drives the external dimension of the member 2010, which in turn dictates the internal and external dimensions of the sheath portion 1208.

[0101] [000137] The conductor bundle 2020 may simply be routed through a circular internal lumen of the tool member 2010, as shown in Figure 23, or alternatively may be constrained within a non-circular lumen, such as that shown in Figure 24. In this configuration, an additional stiffening member 2100 is added to ensure that the stiffness along the long axis of the conductor bundle 2020 does not dominate the shaft stiffness, and an additional "D-shaped" lumen is also provided to create a more uniform bending stiffness in various directions. This serves to minimize "whipping" or jerking of the torque response when the tool member 2010 is torqued.

[0102] [000138] Figure 25 shows an embodiment similar to that shown in Figure 24 in which different sized lumens are provided to receive stiffening members 2101 and 2102. These may also play a role in creating uniform bending stiffness. The tool member 2010 is preferably constructed using an outer braid of wire and / or fiber that is heat laminated with a jacket of thermoplastic polymer (e.g., Pebax with a durometer hardness of 25D to 72D, or other suitable catheter material known in the art).

[0103] [000139] The embodiment of FIG. 26 shows "D-shaped" members 2103 applied to either side of the flexible circuit bundle 2020. This creates a uniform circular member that can be held in place using thin-walled (.001 inch thick) heat shrink tubing. In one embodiment, the assembly may then be inserted into the tool member shaft 2010. In another embodiment, the tool member shaft may be constructed directly around the conductor bundle. For example, to improve torque response and minimize the size of the tool 1212, multiple fibers and / or metal wires (round or ribbon-like) may be braided directly onto the conductor bundle 2020. A jacket of polymer (such as Pebax with a durometer hardness of 25D to 72D, or other common catheter material) may be heat laminated to backflow the polymer over the entire braid to form a uniform member. A polymer layer similar to the jacket may also be laminated onto the conductor bundle before braiding to improve polymer backflow and penetration into the braid during heat lamination.

[0104] [000140] For the embodiment of Figures 23-26, the luminal space between the conductor bundle and the inner diameter of the shaft 2010 can be used to route a pull wire that is used to steer the tool 1212 independent of the steerable sheath 1202. The stiffener itself can be used as the pull wire or can be replaced with a more traditional pull wire (e.g., round and / or flattened stainless steel or nitinol, or cable braids of these materials). The pull wire can be anchored at the distal end of the shaft 2010 and actuated in a manner similar to other embodiments described herein.

[0105] [000141] In an alternative embodiment, shown in FIG. 27 and illustrating an exemplary bundle 2020, each flexible circuit strip can be made with about half the number of traces and therefore about half the width (~.037 inches wide). For the particular embodiment described herein, this requires doubling the number of multi-trace circuits to about 14. This, combined with the ground and shield flexible circuits, is made into a stack of about 17 flexible circuits. The resulting width and height are more uniform, each about .042 inches including heat shrink. This allows for more efficient use of the space within the lumen of the member 2010 and improves uniformity of torque response. As described with respect to FIG. 26, the stack can be inserted into a tubular shaft or into a shaft around which a braid and jacket are constructed. Other configurations between those shown in FIG. 23 and FIG. 27 are envisioned for optimization with the transducer assembly. For example, the width of a flexible bundle including heat shrink is limited to approximately .068 inches, and a stack of 13 flexible circuits is approximately .031 inches thick.

[0106] [000142] In another embodiment, the ground and / or shield strips are replaced with separate braids or windings of conductor wires (individually insulated or not) around the bundle of multi-trace flexible circuits. If the ground and shield conductors are not insulated, an insulating polymer layer may be added between the braids of the ground and shield conductors. This conductor braid may be provided in addition to or instead of the fiber and / or metal wire / ribbon braids. To optimize the torque response of the tool 1212 and minimize the number of braid layers, the insulated conductors may also be braided into the fiber and / or metal wire / ribbon braids.

[0107] [000143] In another embodiment, the conductor bundle 2010 may be twisted to provide a more uniform cross-section along most of the length of the tool 1212. The conductor bundle may be straight for the distal few centimeters to facilitate connection to the distal working end 1821.

[0108] [000144] In another embodiment, the individual flexible circuit strips may be wrapped around the outside dimension of an elongated central core member. The core may be a polymeric or metallic solid or tubular structure, or a composite braid. The wrap may be a single layer of parallel strips, but may be wrapped in multiple layers. Preferably, the layers are wrapped in alternating directions to optimize the torque of the unit. The wrapped strips are preferably laminated with a polymeric jacket against the central core. In other embodiments, the interior of the jacket may have loose play with the conductor strips to allow some bending movement to relieve strain on the strips. A braid may be provided over this jacket, and then a second jacket may be laminated over the braid. As in the above embodiment, the ground and / or shield conductors may also be replaced with braided or wound conductors.

[0109] [000145] As used herein, "cleaning" can refer to any type of cleaning, including, but not limited to, cleaning the inside of an external shaft with a cleaning and / or disinfectant flushing system and optionally mechanical scrubbing with small brushes, mechanically cleaning (e.g., wipes, brushes) the external portion of an external shaft and / or the external portion of a medical device shaft (e.g., an ultrasound probe) with a cleaning / disinfectant, and optionally immersing the shaft in an ultrasonic bath of a cleaning / disinfectant for a specified period of time. "Cleaning" as used herein does not refer to a specific cleaning process, but rather to the general idea of ​​cleaning an object.

[0110] [000146] Regardless of the reference numbers given, any of the handle assemblies, medical tools, steerable sheaths, and electrical connections herein may be used together in a system in any combination with one another.

[0111] [000147] Any of the techniques involving ultrasound and manipulation techniques in any of the following U.S. patent documents, the disclosures of which are incorporated herein by reference, may be incorporated into any of the medical tools, devices, systems, or methods of use thereof herein: No. 6100626, No. 6537217, No. 6559389, No. 7257051, No. 7297118, No. 7331927, No. 7338450, No. 7451650, No. 7451650, No. 7527591, No. 7527592, No. 75690 No. 15, No. 7621028, No. 7731516, No. 7740584, No. 7766833, No. 7783339, No. 779 No. 1252, No. 7791252, No. 7819802, No. 7824335, No. 7966058, No. 8057397, No. 80 Nos. 96951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 8659212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056, and 20080287783.

Claims

1. 1. An ultrasound imaging tool configured to be controllable in a rotational and deflection direction, comprising: an ultrasonic probe disposed adjacent a distal region of a rotatable shaft, the ultrasonic probe comprising an ultrasonic transducer and a flexible circuit strip in electrical communication with the ultrasonic transducer, the flexible circuit strip further comprising an insulating substrate and a plurality of conductive traces disposed on and extending along the insulating substrate, one or more of the plurality of conductive traces being partially covered by an insulating member; a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft; a handle assembly comprising a handle body having an outer surface that can be gripped by a user, a first actuator configured to be moved relative to the handle body, and a second actuator configured to be moved relative to the handle body; the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body; the rotatable shaft is in operative communication with the first actuator of the handle assembly, such that actuation of the first actuator causes rotational movement of at least a portion of the rotatable shaft relative to the deflectable shaft; The deflectable shaft is in operative communication with the second actuator, such that actuation of the second actuator causes deflection of the deflectable shaft, thereby causing deflection of the rotatable shaft.

2. 2. The ultrasound imaging tool of claim 1, wherein the deflectable shaft comprises a distal deflection region in operative communication with at least one pull wire, the first actuator being in operative communication with the at least one pull wire, and actuation of the second actuator relative to the handle body causes deflection of the distal deflection region.

3. The ultrasound imaging tool of claim 1 , wherein the rotatable shaft and the deflectable shaft are in independent operative communication with the handle assembly.

4. The ultrasound imaging tool of claim 1 , wherein the rotatable shaft and the deflectable shaft are in independent operative communication with each other.

5. The ultrasound imaging tool of claim 1 , wherein the first actuator is positioned relative to the handle assembly such that rotational motion of the first actuator is in a direction perpendicular to a longitudinal axis of the rotatable shaft.

6. The ultrasound imaging tool of claim 1 , wherein the second actuator is disposed relative to the handle assembly such that rotational motion of the second actuator is in a direction perpendicular to a longitudinal axis of the deflectable shaft.

7. 2. The ultrasound imaging tool of claim 1, wherein the rotatable shaft is in operative communication with the first actuator of the handle assembly, and actuation of the first actuator causes rotational movement of at least a portion of the ultrasound transducer relative to a distal end of the deflectable shaft.

8. 2. The ultrasound imaging tool of claim 1, wherein the rotatable shaft is in operative communication with the first actuator of the handle assembly, and actuation of the first actuator causes a displacement of a field of view of the ultrasound transducer relative to a distal end of the deflectable shaft.

9. The ultrasound imaging tool of claim 1 , wherein the first actuator is proximal to the second actuator.

10. The ultrasound imaging tool of claim 1 , further comprising an elongated electrical connector electrically connected to the ultrasound transducer, the elongated electrical connector extending axially within the deflectable shaft and the rotatable shaft.

11. 11. The ultrasound imaging tool of claim 10, wherein the elongated electrical connector is part of a flexible electrical bundle in electrical communication with the ultrasound transducer, the flexible electrical bundle extending axially within the deflectable shaft and the rotatable shaft.

12. The ultrasound imaging tool of claim 1 , wherein the rotatable shaft and the deflectable shaft are coaxial.

13. The ultrasound imaging tool of claim 1 , wherein the first actuator and the second actuator are coaxial with one another about the longitudinal axis of the handle body.

Images