Medical tool comprising electrically conductive layer

Abstract

Medical devices configured and dimensioned to be positioned within a subject are disclosed herein. A medical device may include a flexible circuit including at least two conductive layers. A first conductive layer may be disposed on a first surface of the flexible circuit and a second conductive layer disposed on a second surface opposite the first surface such that electrical energy can be conducted through the flexible circuit to the first and second conductive layers. A medical device may include an electro-acoustic module (EAM) disposed at or near a distal region of the flexible circuit, the EAM coupled to the flexible circuit to define a distal tip of the medical device. The at least two conductive layers create a trace route to the EAM via the flex circuit.

Description

[0001] priority

[0002] This application claims priority and interest in U.S. Provisional Application No. 63 / 673,079, filed July 18, 2024.

[0003] Incorporate by reference

[0004] The entire disclosures of the following applications are also incorporated herein by reference for all purposes: U.S. Provisional Application No. 63 / 673,079, filed July 18, 2024; U.S. Patent Application Serial No. 18 / 608,646, filed March 18, 2024; PCT / US2019 / 061228, filed November 13, 2019; U.S. Provisional Application No. 62 / 760,784, filed November 13, 2018; WO2018 / 017717, published January 25, 2018; US20220401070A1; and WO 2018 / 182836, published October 4, 2018.

[0005] All publications and patent applications mentioned in this specification are incorporated herein by reference as if each individual publication or patent application were explicitly and independently incorporated by reference. Background Technology

[0006] Various endovascular medical devices are known. These devices use conductive traces to transmit data sensed inside the body to a computing device outside the body. However, conductive traces can be easily broken and difficult to repair and / or replace. When a conductive trace breaks, the medical device may become unusable and must be replaced, which can be time-consuming and expensive. Improvements are still needed. Summary of the Invention

[0007] It should be understood that the following general description and detailed description are exemplary and illustrative only, and do not constitute a limitation.

[0008] The medical device may include a flexible circuit having at least two conductive layers. A first conductive layer may be disposed on a first surface of the flexible circuit, and a second conductive layer may be disposed on a second surface opposite the first surface, such that electrical energy can be conducted through the flexible circuit to the first and second conductive layers. The medical device may include an electroacoustic module (EAM) disposed in or near a distal region of the flexible circuit, the EAM being coupled to the flexible circuit to define a distal end of the medical device. The medical device may include a route in which the at least two conductive layers create a trace from the flexible circuit to the EAM.

[0009] The medical device may include an electroacoustic module (EAM) disposed in or near a distal region of the medical device, the EAM being at least partially enclosed in material to define the distal end of the medical device. The medical device may include a handle disposed in or near a proximal region of the medical device and spaced apart from the EAM. The medical device may include a flexible circuit connecting the EAM and the handle, the flexible circuit having at least two conductive layers. A first conductive layer may be disposed on a first surface of the flexible circuit, and a second conductive layer may be disposed on a second surface opposite the first surface, such that electrical energy can be conducted through the flexible circuit to the first conductive layer and the second conductive layer. The at least two conductive layers can create a route through the flexible circuit to the EAM.

[0010] The medical device may include a flexible circuit having at least two conductive layers. The at least two conductive layers may include a printed circuit board assembly (PCBA). The medical device may include an electroacoustic module (EAM) disposed in or near a distal region of the flexible circuit, the EAM being material-bonded to a first side of the flexible circuit to define a distal end of the medical device. The medical device may include an application-specific integrated circuit (ASIC) disposed in or near a distal region of the flexible circuit, the ASIC being bonded to a second side of the flexible circuit opposite to the first side.

[0011] This disclosure relates to medical devices and their uses. The disclosure generally relates to a flexible, elongated member (e.g., a flexible conductor bundle) that can extend along a certain length of a medical device. Some aspects of this disclosure describe ways to prevent deformation of the flexible, elongated member, or at least minimize the degree of deformation. In some examples, the disclosure relates to attempting to minimize bending along the flexible, elongated member at one or more locations. While bending is a form of deformation, the disclosure may also relate to attempting to minimize or prevent folding or otherwise convergence of the flexible, elongated member. In some examples, the disclosure relates to attempting to maintain the configuration of the flexible, elongated member, or at least keep that configuration as close as possible to a particular configuration in an attempt to prevent the undesirable consequences of excessive deformation.

[0012] In some examples, forces are applied to the flexible elongated member at a location proximal to where it is fixed to the medical instrument. The applied forces can help prevent undesirable deformation and / or maintain the desired configuration.

[0013] One aspect of this disclosure is a medical device whose dimensions are set and configured to be positioned within a subject's body, such as within a blood vessel, heart chamber, or other body cavity or space.

[0014] The medical device described herein may include a medical tool, such as an ultrasound transducer in a distal region of the medical device. The medical tool may be attached at a first location (directly or indirectly) to a flexible member, such as flexible electronics (e.g., a flexible conductor bundle). The flexible member may extend proximally toward a handle assembly (and optionally into the handle assembly). In some examples, this disclosure relates to attempting to prevent the flexible electronics from deforming to an undesirable degree and / or attempting to maintain the configuration of the flexible electronics (even if some degree of deformation is present).

[0015] A medical device may include one or more elongated shafts through which a flexible member extends. The medical device may include more than one elongated shaft, such as an outer shaft and an inner shaft, through which the flexible member extends, with the inner shaft extending through at least a portion of the outer shaft. The inner shaft may be movable relative to the outer shaft. The inner shaft may deflect independently relative to the outer shaft.

[0016] Flexible components (e.g., flexible conductor bundles) can move axially within one or more elongated shafts and can be fixed to a shaft (such as an outer shaft).

[0017] The medical device may include a tensioning member secured at a second location to one or more surfaces of a flexible member (e.g., a flexible conductor bundle), adjacent to the location where the medical instrument is secured to the flexible member. The second location may be within the handle assembly of the medical device, but may be distal to the handle assembly. The second location may be positioned such that it is located within the subject's body during use of the medical device.

[0018] The tensioning member may be operatively connected (operably coupled) to a handle assembly actuator (e.g., a knob, etc.) such that actuation of the handle actuator (e.g., rotation, axial movement) causes movement of the tensioning member. The actuator may also be operatively connected to a medical instrument. In some embodiments, the tensioning member and the medical instrument are operatively axially connected to the handle actuator such that actuation of the handle actuator causes axial movement of the ultrasonic transducer and the tensioning member. This axial movement of the tensioning member can apply tension to the flexible conductor bundle at a second position within the handle assembly.

[0019] The tensioning member can be axially fixed to the flexible conductor bundle at a second position within the handle, such that when the handle actuator is actuated, the tensioning member and the flexible conductor bundle move together axially at the second position.

[0020] The tensioning member can be fixed to the flexible conductor bundle such that the flexible conductor bundle maintains a substantially flattened configuration at least in the vicinity of the medical instrument. When the medical instrument retracts proximally, the flexible conductor bundle maintains a substantially flattened configuration between the first and second positions.

[0021] The flexible member may have a flat or substantially flat first surface and a second surface, and the tensioning member may be fixed to one or both of the flat or substantially flat first surface and the second surface.

[0022] The actuator may also be adapted to rotate to cause rotation of the medical instrument, and wherein the tensioning member and the actuator are operatively connected such that rotation of the actuator does not cause rotation of the tensioning member.

[0023] Flexible components (e.g., flexible conductor bundles) may be secured to a printed circuit board (“PCB”) in the handle assembly, and optionally at a location proximal to the printed circuit board.

[0024] The inner shaft of the medical device can be operatively connected to the second handle actuator, so that the inner shaft can deflect when the second handle actuator is actuated.

[0025] The medical device may include a flexible electronics (e.g., conductor bundle) flattening member fixed to one or more surfaces of a flexible electronics at a second location, wherein the second location may be within a handle assembly. The flexible electronics flattening member and the medical tool may be operatively axially connected to a handle actuator such that actuation of the handle actuator causes axial movement of the medical tool and the flexible electronics flattening member, thereby optionally maintaining the flexible electronics bundle in a flattened configuration between the first and second locations.

[0026] Medical devices may also include flexible electronic components to prevent bending.

[0027] One aspect of this disclosure is a method of using a medical device configured and sized for positioning within a subject. The method may include positioning an ultrasound transducer of an intravascular ultrasound catheter within the subject, wherein flexible electronics (e.g., a flexible conductor bundle) secured to an ultrasound probe at a first location extends proximally from the ultrasound transducer to a handle assembly; retracting the ultrasound transducer proximally; and applying tension to the flexible electronics at a second location adjacent to the first location. The second location may be within the handle assembly.

[0028] The method also includes an actuating shank actuator, wherein the actuating shank actuator causes proximal retraction of the ultrasonic transducer and causes tension to be applied to the flexible conductor bundle at a second position within the shank assembly.

[0029] Applying tension to flexible electronic devices can prevent the flexible conductor bundle from folding on the far side of the second location.

[0030] Applying tension to a flexible electronic device may include moving a tensioning member proximally within a handle assembly, the tensioning member being secured to a flexible conductor bundle in a second position. The tensioning member may be operatively connected to a handle actuator, and the method may further include actuating the actuator to cause proximal movement of the tensioning member and applying tension to the flexible conductor bundle.

[0031] Medical devices may include flexible electronics having a torsion configuration along at least a portion of their length in a torsion region.

[0032] These and other features and advantages will be described in more detail below. Attached Figure Description

[0033] Refer to the following figures to describe non-restrictive and non-exhaustive examples.

[0034] Figure 1A An example implementation of a system including steering and medical devices is shown.

[0035] Figure 1B It shows Figure 1A The direction of the medical device and the cross-section of the device part AA.

[0036] Figure 2 An example system is shown, including a handle assembly with multiple actuators, a steerable sheath, and a medical tool.

[0037] Figures 3Ai to 3Aiii An example of a steerable shaft with a pull cord is shown.

[0038] Figure 3Bi and Figure 3 Bii An example of a steerable shaft with a pull cord is shown.

[0039] Figure 3 Ci and Figure 3Cii An example of a steerable shaft with a pull cord is shown.

[0040] Figures 3Di to 3Div An example of a steerable shaft with a pull cord is shown.

[0041] Figure 3E An example of a directional axis is shown, featuring one or more draw wires in a braided yarn that is circumferentially interwoven to the axis.

[0042] Figure 4 An example section of an example system including a bundle is shown.

[0043] Figure 5 An example proximal end of a medical tool is shown, which includes a conductor bundle extending into a proximal connector, within which a printed circuit board (PCB) is housed.

[0044] Figure 6AA portion of an example medical tool, including flexible circuit strips, is shown.

[0045] Figure 6B An example of the proximal portion of the bar is shown.

[0046] Figure 6C A detailed view of an example proximal portion of the bar is shown.

[0047] Figure 6D An end view of an example flexible strip is shown.

[0048] Figure 6E An example stack of flexible strips is shown.

[0049] Figure 6F An example stack of flexible strips, grounding strips, and shielding strips is shown.

[0050] Figure 6G An example bundle is shown, which comprises stacked tubular material surrounding the bar, as well as shielding and grounding bars.

[0051] Figure 7 An integrated system of steerable sheaths and medical tools is shown, which is connected to a console via connector cables.

[0052] Figure 8A and Figure 8B An example shank assembly is shown that can be used with either the internal elongated body or the external elongated body or shaft described herein.

[0053] Figure 9A The example shows a portion of the slender inner body or inner shaft.

[0054] Figure 9B An example of an elongated outer body or part of an outer shaft is shown.

[0055] Figure 9C It shows including Figure 9A and Figure 9B A part of an example medical device with a slender body (or shaft).

[0056] Figure 9D It shows Figure 9C A cross-section of the device in the deflectable part.

[0057] Figure 10A A portion of an example handle component is shown.

[0058] Figure 10B An exploded view of an example external elongated body (or external shaft) motion sub-assembly is shown.

[0059] Figure 10C Showing from Figure 10A A side sectional view of the handle assembly.

[0060] Figure 11 An example handle assembly is shown, including a rotation indicator for the first actuator and the second actuator.

[0061] Figure 12A The internal components of an example handle assembly, including a tensioning member or a flattening member, are shown.

[0062] Figure 12B An example of the internal components of the handle housing is shown, which includes one or more guide features positioned to help stabilize the tensioning member in the handle assembly.

[0063] Figure 12C A side view of an example handle housing is shown.

[0064] Figure 12D The internal components of an example handle assembly, including a tensioning member or a flattening member, are shown (in a side view).

[0065] Figure 12E A side view of an example handle housing is shown.

[0066] Figure 12F It is shown (in relation to) Figure 12D The side view on the other side includes an example of the internal components of the handle assembly, which is a tensioning or flattening member.

[0067] Figure 13A An example flexible cable bundle is shown, with at least a portion twisted relative to its long axis.

[0068] Figure 13B An example flexible cable bundle is shown, with at least a portion twisted relative to its long axis.

[0069] Figure 13C An example flexible cable bundle is shown, with at least a portion twisted relative to its long axis.

[0070] Figure 13D An example flexible cable bundle is shown, with at least a portion twisted relative to its long axis.

[0071] Figure 13E Showing from Figure 13D Details.

[0072] Figures 14 to 18 An example medical device with a navigation interface is shown.

[0073] Figures 19 to 24 An example transducer end for use in a medical device is shown.

[0074] Figure 25 An example component for a medical device is shown.

[0075] Figure 26 The arrangement of navigation sensors for a medical device is shown.

[0076] Figures 27A to 27C as well as Figures 28 to 29 Various configurations of draw wires for deflecting a portion of a shaft or sheath of a medical device are shown.

[0077] Figures 30 to 31 Various arrangements of components in the handle assembly of a medical device are shown.

[0078] Figures 32A to 32B Examples of various aspects of a portion of a shaft or sheath of a medical device are shown.

[0079] Figures 33A to 33B An example of the deflection and end length of the medical device is shown.

[0080] Figure 34 An example of the deflection and end length of the medical device is shown.

[0081] Figure 35 Example dimensions of a medical device are shown.

[0082] Figure 36 Example dimensions of a medical device are shown.

[0083] Figure 37A An example folded pattern of a flexible strip at the end of a medical device is shown.

[0084] Figure 37B An example folded pattern of a flexible strip at the end of a medical device is shown.

[0085] Figure 38 An example folded pattern of a flexible strip in a medical device is shown.

[0086] Figure 39 An example folded pattern of a flexible strip in a medical device is shown.

[0087] Figure 40 An example folded pattern of a flexible strip in a medical device is shown.

[0088] Figure 41 An example end of a medical device with sensors is shown.

[0089] Figure 42 An example diagram of the axis of a medical device according to this disclosure is shown.

[0090] Figure 43 An example diagram of the axis of a medical device according to this disclosure is shown.

[0091] Figure 44 An example medical device construction is shown.

[0092] Figure 45 An example medical device structure is shown.

[0093] Figure 46 An example medical device structure is shown.

[0094] Figure 47 An example medical device construction according to this disclosure is shown.

[0095] Figure 48 An example medical device construction according to this disclosure is shown.

[0096] Figure 49 An example medical device construction according to this disclosure is shown.

[0097] Figure 50 An example medical device structure is shown.

[0098] Figure 51 An example medical device construction according to this disclosure is shown.

[0099] Figure 52 An example medical device structure is shown.

[0100] Figure 53 An example medical device construction according to this disclosure is shown.

[0101] Figure 54 An example medical device structure is shown.

[0102] Figure 55 An example medical device construction according to this disclosure is shown.

[0103] Figure 56 An example medical device construction according to this disclosure is shown.

[0104] The accompanying drawings illustrate examples of this disclosure. It should be understood that the examples shown in the drawings and / or discussed herein are non-exclusive, and there are other examples of how this disclosure can be practiced. Detailed Implementation

[0105] Figure 1AAn example embodiment of a system integrating steering and a medical device is shown. System 1000 includes a handle assembly 1002 and a steering and medical device portion 1004. The steering and medical device portion 1004 includes a proximal portion 1006 and a steerable portion 1008. The system is adapted such that the handle assembly 1002 can be actuated to cause steering of the steerable portion 1008, and optionally can be further actuated to cause movement of the medical device 1010 relative to the steering and medical device portion 1004. In this example embodiment, the handle assembly 1002 includes a first actuator 1001, a second actuator 1003, and a third actuator 1005. The first actuator 1001 is adapted to be actuated (in this example, rotated) relative to the handle body 1007 to cause steering of the steerable portion 1008, and specifically, to cause steering of the outer sheath 1102. In this embodiment, the steerable portion 1008 can be steered or bent to... Figure 1A The configuration shown in solid lines can also be turned to the configuration shown in dashed lines, or anywhere in between, and in some embodiments, the reverse turning function is limited to merely causing the axis to move from the initial bending configuration (such as...). Figure 1A (Solid line bending configuration in the image) straightened. The term "direction" in this disclosure means deflection or bending optionally via actuation of at least one draw wire, but in some cases, the term may include shaft rotation (torsion) and axial movement. The term "draw wire" herein refers to any element that can transmit tension from the proximal end region of the device to the distal end region. The draw wire may be made of solid or stranded / braided metal wire (such as stainless steel or nickel-titanium), or it may be made of preferably stranded / braided polymer (such as aramid fibers). It is constructed of polyethylene, PTFE, eptfe, etc., but can also be in monofilament form. In a preferred embodiment, the drawwire is composed of an aramid fiber bundle having four 50-denier multifilaments (approximately 25 filaments) woven together at a high weft per inch. The cross-sectional diameter of the wire is typically in the range of 0.005” to 0.012”, more preferably 0.008” to 0.010”, but the braided or stranded wire can be flattened or elliptical within the device lumen. It is believed that the preferred construction embodiment provides optimized strength and abrasion resistance while keeping the shaft diameter to a minimum required size. An optional second actuator 1003 is adapted to actuate (in this example, rotate) relative to the handle body 1007 to cause rotation of the medical device 1010 relative to the axis 1102 (labeled as rotational motion "R"), and an optional actuator 1005 is adapted to actuate relative to the handle body 1007 (in this example, axially) to cause axial (distal-proximal) movement of the medical device 1010 relative to the outer sheath 1102. The proximal portion 1006 is not configured to bend significantly when the steerable portion 1008 is turned (bent / deflected), but the proximal portion is flexible and bendable to conform to the anatomy in which the proximal portion is used. In many embodiments, this is achieved by constructing the steerable portion 1008 from materials and / or composite structures that are less soft or less rigid than the proximal portion 1006.

[0106] Figure 1A The illustrated embodiment is an example of a device including an integrated handle assembly that is operatively connected to both a steerable outer shaft and an internal medical tool. The handle assembly is integrated because it is assembled and configured to be operatively connected to both the outer shaft and the internal medical tool prior to encapsulation and use. The term "integrated" as used in the context of an integrated handle assembly refers to a handle assembly in which at least a portion must be broken or separated before the medical tool can be removed from within the outer shaft.

[0107] Figure 1B An example cross-section AA (shown in the steering and device portion 1004, and specifically in the steerable portion 1008) is shown. Figure 1A (in the middle). In this embodiment, the size and configuration of the medical device 1010 are configured to be housed within a steerable sheath. The steerable sheath includes an outer shaft 1102 and a set of draw cables 1104, which are axially fixed in the distal region of the steerable portion 1008.

[0108] Figure 1A and Figure 1BThe medical tool described herein can be any medical tool, such as an ultrasound tool. When used herein as an "ultrasound probe," it generally refers to an elongated tool comprising at least one ultrasound transducer and one or more conductive elements electrically connecting the at least one ultrasound transducer to a proximal region of the elongated tool. The proximal region of the ultrasound probe includes, or is modified to include, at least one proximal contact electrically connected to at least one ultrasound transducer, and optionally may be placed in electrical communication with an electrical contact on another device, cable, or connector via an electrical contact attached to another device, cable, or connector.

[0109] Figure 2 It shows that it is suitable for use with Figure 1A and Figure 1B The system described in the example 10 functions similarly to the system described above, and example internal components of the handle assembly 12 (shown in dashed lines) are also shown. The handle assembly 12 is integrated with and operatively communicates with the external steerable shaft 20 and the medical tool 30. The handle assembly 12 includes an actuator 14 adapted to cause steering of the steerable shaft 20 when actuated relative to the handle body 15. The actuator 14 is operatively communicated with the steerable shaft 20 via a steering control 16 disposed in the handle assembly 12. The medical tool 30 includes a proximal portion 18 disposed within and incorporated into the handle assembly 12. An actuator 13 is operatively communicated with the medical tool 30, and actuation of the actuator 13 relative to the handle body 15 (in this example, rotation) causes rotation of the medical tool 30 relative to the external shaft 20 via a rotation control 1215. An optional third actuator 17 is also operatively connected to the medical tool 30 and, in this embodiment, is adapted to be axially (relative to the handle body 15) actuated to cause axial movement of the medical tool 30 relative to the external steerable shaft 20 via the axial control 1217.

[0110] Figure 2 The medical tools mentioned can be any medical tool, such as ultrasound tools, as described in this article.

[0111] Figure 3A to Figure 3E An example embodiment shows the distal region of the sleeve portion 1208 of the steerable sleeve 1202 in system 1200. For simplicity, the cross-section shown only shows the outer sleeve 1208 and not the inner tool 1212. The outer sleeve 1208 preferably has a composite construction to improve torque transmission from the proximal end to the outside of the shaft, or to resist torque forces applied to it from inside the shaft (such as from tool 1212). Figures 3Ai to 3AiiiAs shown, to form the composite, multiple braided elements 1250, preferably formed of metal wires (circular, paired circular, or strip-shaped) and / or multiple fibers (e.g., aramid or nylon), can be directly braided over a thin-walled (e.g., 0.0010” ± 0.0005”) lubricated lining tube 1251 (such as PTFE or FEP material). A thermoplastic polymer 1252 (such as Pebax with a hardness in the range of 25D to 72D, or nylon, or other common conduit materials) can be laminated using heat-shrinkable tubing (such as FEP) to allow the polymer to reflow over the braided elements 1250 and the lining tube 1251 to form a uniform component. The thermoplastic polymer 1252 may also have a radiopaque compound, including materials such as bismuth, barium sulfate, or tungsten, so that the end of the sheath is visible to the user under fluoroscopic examination.

[0112] exist Figures 3Ai to 3Aiii In one embodiment, the draw cord 1104 is preferably parallel to the central axis in the steerable (deflectable) portion 1222 of the sheath, and is also preferably disposed in a cavity 1253 formed within the wall of the steerable sheath 1208. This cavity may be formed by means of a removable mandrel during the thermoplastic polymer tubing extrusion process or during the axial thermal lamination fusion process. The draw cord cavity 1253 may be further formed by incorporating a draw cord tube 1254, preferably temporarily supported by a removable mandrel, within the wall. During the fusion process, the removable mandrel may also be placed alongside the draw cord 1104 or 1104', thereby creating a partially elliptical cavity 1253 within which the fiber draw cord can be flattened, thus allowing space for free movement of the draw cord. The tube 1254 may comprise PTFE, FEP, polyimide, or another material that maintains its wall integrity during thermal lamination processes up to approximately 500°F. The tube is preferably surrounded and supported by a thermoplastic polymer 1252, which is preferably thermally laminated against the tube.

[0113] In another embodiment, the draw-line lumen (preferably comprising a draw-line tube) is incorporated within the braid of the braided element 1250. For example, braided elements 1250 extending in one direction will pass beneath the draw-line lumen, while those extending in the opposite direction will pass above it. The braid reinforcement provides a dimensionally more stable lumen during catheter manipulation and also helps ensure lumen straightness as needed. Proximal to the swivel portion, the draw-line may continue proximal to the same side of the outer sheath 1208 parallel to the central axis, such as... Figures 3Ai to 3AiiiAs shown. In this embodiment and subsequent embodiments, it may be necessary to pass an additional pull wire 1104' within an additional pull wire lumen that is routed within the wall of the sheath 1208 upward through the steerable portion 1222 to straighten the steerable portion of the device. This straightening pull wire 1104' is preferably routed within the steerable portion 1222 on the side opposite to the pull wire 1104 used for turning (deflecting) in the steerable portion 1222. In another embodiment (not shown), two lumens and two straightening pull wires 1104' may be used, essentially making the paired pull wires 1104 configured as mirror images. These straightened wires may also be configured to allow deflection in opposite directions by tensioning a larger distance (more than just straightened) within the handle.

[0114] During use, the distal catheter's portion 1223, just proximal to the steerable (deflectable) portion 1222, is forced to conform to a curve based on the constraints of its anatomical structure. For a specific embodiment advancing the device from the inguinal canal into the ventricle, the length of the portion 1223 forced into the curve is expected to be in the range of 5 cm to 25 cm. During rotation of the sheath shaft 1208 from the proximal end, torque is transmitted to the catheter tip through this distal curved region 1223. Uneven cross-section and / or tension of the device in this region 1223 can cause a tendency for shaft torque to accumulate and be released abruptly, resulting in rotational "jitter" or sudden jerking during torsion. To minimize the possibility of jitter, it is optional to distribute the tension and construction material around the surface of the curved region 1223. In one embodiment, such as Figure 3Bi to Figure 3Bii As shown in figure i, the drawstring 1104 may be spiraled around the central axis of the sheath in at least the bend 1223 proximal to portion 1222. In this embodiment, the drawstring may form a complete circumferential wrap over a length of approximately 10 cm, where this value ranges from 5 cm to 15 cm. The spiral may only need to exist in the bend 1223, and then continue to be straightened proximally through the proximal portion 1224 (similar to 1006), which minimizes friction in the drawstring lumen and the associated drawstring force required to turn (deflect) the steerable portion 1222. The spiral may also be made at least one turn before continuing to be straightened, or the entire length of the shaft may be spiraled. In another embodiment that minimizes jitter, it may only be necessary to distribute the drawstring tension to opposite sides of the shaft. Figures 3Ci to 3CiiAs shown, the deflection of the steerable segment 1222 is achieved using two parallel draw wires 1104 positioned adjacent to each other on the same side of the sheath 1208. In the bend region 1223 and proximal portion 1224 (similar to 1006) of the steerable segment 1222, the draw wires are routed to opposite sides of the shaft, each side at 90° to its position within the steerable segment 1222, to distribute tension more evenly. While it is preferred to simultaneously actuate the two parallel draw wires with equal force using a shank actuator, in other embodiments, different forces can be applied when actuating the two parallel draw wires with equal force to steer the ends to one side or the other side of the formed plane. In other embodiments, any plurality of draw wires can be routed in the same configuration as shown in Figure 3B or Figure 3C, wherein the plurality of proximal draw wires are evenly distributed around the circumference of the shaft. Additionally, as... Figures 3Ci to 3Cii As shown, the pull wire 1104 may be routed proximally along the opposite side of the shaft for most of the length of the proximal portion 1124 of the shaft, but preferably pulled back together adjacent to each other near the proximal end portion of the shaft to allow the wires to leave the same side of the proximal shaft together so as to secure them together to the shank member for simultaneous actuation of tension.

[0115] Figure 3Di to Figure 3Div Another embodiment of the distal region of the catheter is shown, which is constructed similarly to the previously described construction, but instead is configured to provide a distally steerable portion 1222 that can be deflected in two different directions. As shown, two pairs of drawstrings 1105 / 1107 and 1106 / 1108 run along the proximal axial region 1224 and the bend region 1223. This is similar to... Figures 3Ai to 3Aiii The difference is that the lines are paired on each side of the axis. Wiring can also be done as follows: Figure 3Bi to Figure 3Bii The configuration can be either spiral or other configurations as discussed. Within the distal steerable portion 1222, the wires are routed at 90° to the proximal portion, but other angles are also conceivable. At the junction 1225 within 1222, one or more of the drawwires (e.g., 1105 and 1107) can terminate and anchor to the shaft, with the remaining drawwires (e.g., 1106 and 1108) continuing to their more distal end positions 1226 where they are anchored. This configuration allows for independent actuation of the drawwires terminating at 1225 and 1226, enabling the formation of different shapes during actuation. Figure 3Dii Lines 1107 and 1108 are shown being tensioned to form a variable curve in the same direction. Figure 3Diii Lines 1107 and 1106 are shown being tensioned to form an "S" curve. Other configurations are also possible.

[0116] The drawstrings (such as 1104 and 1104') can be securely attached to the wall of the distal steerable shaft portion 1222 in a manner that terminates at their distal ends, ensuring they do not break or detach under repeated tension. Figure 3E In the preferred embodiment shown, drawstrings 1104 and 1104' are circumferentially interwoven into the braided wire 1250 (shown without thermoplastic polymer 1252) of the distal drawstring lumen 1253 as they exit the distal drawstring lumen 1253. One or more of drawstrings 1104 or 1104' may also be additionally or alternatively wound and / or tied around the outside of the braided wire 1250 for additional fixation. The braided wire 1250 may then be trimmed distal to the fixation point, wherein the interwoven and / or wound drawstrings prevent the braided wire from expanding and / or unraveling. Additional adhesives such as UV-curing or cyanoacrylate may also be used to secure the drawstrings to the braided wire. The braid and / or wrapping of the drawstrings and braided wires are then laminated with a thermoplastic polymer that melts and cools within the space around the wire to hold the wire in place. The thermoplastic polymer may also have a radiopaque compound, including materials such as bismuth, barium sulfate, or tungsten, so that the end of the sheath is visible to the user under fluoroscopic examination.

[0117] In an additional embodiment, tool 1212 may also be configured to have one or more draw wires, such that the ends deflect in a manner similar to any of the foregoing embodiments described for the outer sheath 1208. In addition to wiring the draw wires within the wall of the tubular member of tool 1212, the draw wires may also be wired near a conductor within the lumen of the tubular element 1212. Actuation of the draw wires may be derived from an actuator located in the proximal shank 1206. The distal shaft of tool 1212 may also be formed in a specific shape (e.g., arcuate) such that it bends into this shape as it exits the end of the steerable portion 1222 of the outer sheath 1208. The stiffness of the distal shaft of tool 1212 is such that it substantially does not deform the outer sheath 1208 when inside, but allows the outer sheath to bend upon exiting. The shape can be set by any or a combination of the following methods: heat-setting the polymer material; using a movable or fixed-shape mandrel within a cavity inside the internal tube of the shaft 1212 or within a cavity in the wall of the shaft 1212. Such a mandrel can have a circular, elliptical, or rectangular cross-section and is formed of stainless steel, nitinol, or a rigid polymer such as PEEK, Vestamid, or the like. Alternatively, the external steerable sheath can be made curved using a method similar to that described above, with or without additional draw wire deflection, and with or without additional shape or deflection of the distal portion of the tool shaft 1212.

[0118] One aspect of this disclosure includes a method for separating at least a portion of a system from other components, optionally as part of a relocation process. In some embodiments, the medical tool includes one or more electrical contacts coupled to other electrical contacts that are electrically connected to an energy control console, and examples of such consoles are known in the field of ultrasound.

[0119] In one implementation scheme Figures 3Ai to 3E The drawstrings described herein can be symmetrically designed and can branch and change their relative positions to each other in the various segments of the respective shaft. By controlling the stiffness of the shaft and the positioning of the drawstrings (e.g., moving the branching point to the more distant side), off-axis curling can be reduced, while providing more precise control over the deflection of the distal end of the shaft. The associated shaft may include multiple spools (e.g., sixteen (16) spools) that can be tuned to improve torque response. The associated shaft may include multiple (e.g., four (4)) drawstrings for balancing the braided yarn, which reduces changes in deflection orientation due to annealing and sterilization. As described herein, the associated shaft may include a more optimized non-deflection end length. As another example, the associated shaft may include an inner diameter tapering structure at the end near the post to prevent entanglement with the yarn bundle.

[0120] Figure 4 A portion of an example medical tool, such as an ultrasound probe, is shown, which can be electrically connected directly or indirectly to an energy control console, such as an ultrasound console.

[0121] The repositioning device may involve disconnecting one or more proximal electrical contacts and moving the tool portion distally away from the distal end of the sheath portion. In this embodiment, the tool portion 1212 includes at least a tool outer sheath or member 2010, a distal working end 1821 (which may include at least one ultrasonic transducer), and a conductor bundle 2020. The conductor bundle 2020 extends from the distal working end 1821 through the tool outer member 2010 to the proximal connector (for clarity, the connector and shank mechanism are...). Figure 18 (Not shown in the image). In some embodiments, the medical instrument is used for ultrasound imaging, optionally wherein the distal working end 1821 includes a two-dimensional (2D) array of piezoelectric components mounted on an ASIC (Application-Specific Integrated Circuit).

[0122] Figure 5 The image shows only an example of the proximal end of a medical device (the medical device is shown on the right), and in this embodiment, the medical device is an ultrasound probe. The proximal end 2015 of the medical device is adapted for electrical connection to a connector cable 270, which is adapted for direct or indirect electrical connection to a power control console, such as an ultrasound power control console. Figure 5As shown, a flexible conductor bundle 2020 extends from a distal region (not shown) of the medical tool into a proximal connector 2015, within which a rigid or flexible printed circuit board (“PCB”) 2030 is housed. The connector bundle 2020 includes a plurality of contacts 2024 (examples of which are described below) attached to PCB contacts 2031. Each individual trace from each contact 2031 connects to a separate exposed contact 2050 on another portion of the PCB (optionally closer to the PCB). Individual PCB traces may also pass through other available circuitry on the PCB. The exposed contacts 2050 are configured to mechanically engage with similar contacts 2060 on mating connector cables 2070 for electrical conductivity, conceptually similar to the previously described proximal tool connector 1990 that connects tool 1204 to a user interface console. The proximal connector 2015 can be incorporated into any of the systems, handles, steerable sheaths, medical tools, etc., described herein.

[0123] Unless otherwise stated herein, the term “conductor bundle” is used interchangeably with “flexible conductor bundle” as used herein.

[0124] Figure 6A and Figure 6B An example conductor strip (also referred to herein as a flexible circuit strip) 2021 that may be included in any of the conductor bundles herein is shown. Figure 6A and Figure 6B The implementation scheme can be included in Figure 4 and Figure 5 Example of conductor strips in the bundle 2020. Figure 6A and Figure 6B The implementation scheme described herein can be incorporated into any other system described herein.

[0125] like Figure 6A , Figure 6B and Figure 6G As shown, the conductor bundle 2020 includes multiple flexible circuit strips, including multi-trace lines 2021, conductive strips 2022 for grounding, and conductive strips 2023 for shielding (only a portion of which is shown). Each multi-trace line includes multiple conductive traces 2025, which can... Figure 6B , Figure 6C and Figure 6D It can be clearly seen in the middle. Figures 6D to 6G The number of traces in 2025 is twelve, and Figures 6A to 6CThe number of traces in the bundle is sixteen, and both are illustrative of the number of traces 2025 that can be used. Each strip 2021 may be approximately 0.072” wide and 0.0022” thick, and may optionally include sixteen conductive (e.g., copper) traces, each 0.0022” wide × approximately 0.0007” thick, spaced apart by approximately 0.0022”. The traces are disposed on an insulating substrate layer 2027, such as a polyimide substrate, and the traces may be at least partially covered by a capping layer 2026, such as a photoimageable film capping (“PIC”) layer or other dry film bonding mask (DFSM) or other similar material. The capping layer typically extends along most of the bundle, except at discrete locations in the proximal and distal regions for electrical connection. In other embodiments, the strip 2021 is approximately 0.055” wide and includes twelve conductive traces (see [link to other embodiments]). Figures 6D to 6G In other embodiments, strip 2021 is approximately 0.037” wide and comprises eight copper conductive traces. The outer strip 2022 for grounding and the outer strip 2023 for shielding may have similar construction and dimensions, except that they may comprise a single full-width copper strip. For optimization for a 2D piezoelectric array, approximately seven stacks of 16-trace strips 2021 (or nine 12-trace strips, or fourteen 8-trace strips) would be required, along with each of strips 2022 and 2023 located on each side of the multi-trace strip stack. Figure 6E A portion of an example bundle 2020 with nine bars stacked together is shown. Figure 6F A portion of the bundle is shown, comprising nine stacked strips 2021, a grounding strip 2022, and a shielding strip 2023 (only the top ones are labeled). The complete bundle may optionally be coupled (e.g., but not limited to) a shrinkage tube with a wall thickness of approximately 0.001” (such as...). Figure 6G The tubes in the 2028 are held together. The flexible circuit dimensions and number of traces discussed above are used for specific configurations of the piezoelectric array (and / or its ASIC controller) and can be varied depending on the number and size of the array elements optimized for a particular application.

[0126] Each flexible circuit strip has a conductive material (e.g., gold-plated copper) exposed for approximately 3 mm in length by removing the cover layer 2026 at location 2024. Location 2024 and other exposed locations described herein are generally referred to as “contacts.” It should be understood that, when used in this context, a contact actually comprises multiple separate conductive traces (such as those shown in the area locations), each conductive trace adapted to be electrically connected to its corresponding conductive element. Therefore, “contact” is not limited to meaning a single electrical connection between two conductive elements. Although Figure 6A Multiple exposed areas were shown in 2024, but Figure 6AThe implementation described herein will first be described as if only one exposed area exists (i.e., region 2024 at the proximal end). Strip 2021 may be made to form an electrical connection with mating exposed contacts 2031 for conductive traces on the PCB 2030, which in Figures 6A to 6C As shown in the diagram. In some embodiments, the size and spacing are set such that sixteen individual traces, which mate with the sixteen traces in the multi-trace line 2021, are positioned within a given contact 2031. ACF (Anisotropic Conductive Film), soldering, conductive adhesive, mechanical connection, or any combination thereof can be used to achieve a suitable electrical connection (electrical coupling) between the trace and the PCB contact.

[0127] Figure 6A-6G The flexible strip shown can include various configurations. A modified M-shaped folding configuration, which pulls the wider portion of the application-specific integrated circuit (ASIC) further to the side, allows the inner axis 132 to be positioned further to the side. A Z-shaped folding configuration can include two bends. As an illustrative example, a stacked configuration of flexible circuit boards can be used. For example, a Z-shaped fold in... Figure 38 The diagram shows, and illustrates, the stacked components J, H, and G referenced in Figure 37. The first form of the M-shaped folding configuration allows for short lengths associated with the ends, such as... Figure 39 As shown. Compared to the other two configurations described, the modified M-shaped fold configuration allows for a shorter length associated with the end, such as... Figure 40 As shown.

[0128] The modified M-shaped fold configuration includes a series of folds within the flexible element, such that the proximal wide portion of the flexible element moves as far to the distal end as possible. The optimal number of fold points is four; if this number is exceeded, the stack becomes too thick to accommodate the outer axis. The wide portion of interest is located precisely on the distal side of pad G, which is too wide to allow the inner diameter of the inner axis to advance. Some fold locations, particularly those involving folds of long flexible elements (e.g., those connected to pad H), may need to be reinforced to prevent the folds from becoming too tight and damaging the overlay and / or copper traces. Reinforcement at fold locations can be achieved using various materials, such as adhesives, tapes, or thin-walled heat-shrink tubing (e.g., PET), to limit the bending radius of the flexible element to an acceptable level.

[0129] Figure 7 An integrated system 1200 is shown, comprising a steerable sheath 1202 and a medical tool 1204, wherein the system 1200 is connected to a console 4000 via a connector cable 2070. As previously described, such as for Figure 5Tool 1204 includes a proximal connector 2015 that forms a mating connection with cable 2070. As previously stated, it is desirable to relocate (e.g., reprocess and reuse) system 1200. It is further desirable to ensure that the system is relocated only by the original manufacturer and not by a non-affiliated third party, and to ensure that the device is reused only a specified number of times. To control the relocation process, a cryptographic authentication chip (cryptographic chip) is incorporated into tool 1204, preferably on PCB 2030, but other locations are also contemplated, such as within a steerable handle 1206 or within end 3000. The cryptographic chip can only be programmed by the original manufacturer who controls the authentication key. Console 4000 to which system 1200 is connected has a Trusted Platform Module (TPM), which also has the authentication key. During use of system 1200, console 4000 is able to authenticate system 1200 via the cryptographic chip and can read and write information to the chip as needed (e.g., via EEPROM features). In any of the scenarios discussed, RFID chips (preferably encrypted) can be used to read and transmit data between consoles, connectors, and devices.

[0130] As used herein, “cleaning” can refer to any type of cleaning, such as, but not limited to: cleaning the interior of an outer shaft using a rinsing system with detergents and / or disinfectants, and optionally mechanically scrubbing with a small brush; mechanically cleaning the exterior of an outer shaft and / or the exterior of a medical device shaft (e.g., an ultrasound probe) with detergents / disinfectants (e.g., wipes, brushes), and optionally immersing the shaft in an ultrasonic bath of detergents / disinfectants for a specified period of time; and optical cleaning methods, such as those involving the use of UV light. As used herein, “cleaning” does not refer to a specific cleaning process, but rather to the general concept of cleaning an object.

[0131] The disclosure herein also includes methods for assembling or reassembling any of the sub-components or components of this document (including any sub-component within any shank assembly of this document). For example, but not limited to, the disclosure herein includes methods for winding one or more draw cables above a support surface in a spindle support and then around the spindle.

[0132] The methods described herein also include manufacturing or constructing any individual component of the sub-components or any of the components described herein. For example, this disclosure includes a method of manufacturing a handle housing component having a specific configuration (e.g., guide, wall, etc.) that accommodates internal components that allow the components or sub-components described herein to function as intended.

[0133] Regardless of the reference numerals used, the handle assembly, medical instrument, steerable sheath, and electrical connector described herein can be used in any combination of each other within the system.

[0134] Any technology (including ultrasound and steering technology) from any of the following U.S. patent references may be incorporated into any of the medical tools, devices, systems, or methods of use described herein, the disclosures of which are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833, 7783339, 7791252 7791252, 7819802, 7824335, 7966058, 8057397, 8096951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 8659212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056 and 20080287783.

[0135] Any suitable disclosure above may be incorporated into any of the following embodiments. For example, unless specifically stated to the contrary, aspects of apparatus, systems, and methods of manufacture and use are incorporated herein and may be incorporated into any of the following embodiments.

[0136] Figure 8A and Figure 8BAn example handle assembly operatively communicatively with an outer shaft 131 and an inner shaft 132 is shown. In this example embodiment, the handle assembly 120 includes a handle body 123, a first actuator 121, and a second actuator 122, the handle body having an outer surface that can be gripped by a user. Actuator 121 is operatively communicatively with the outer shaft 131, and actuator 122 is operatively communicatively with the inner shaft 132. Actuator 121 is adapted to rotate and move axially relative to the handle body 123 (and relative to the second actuator 122). This allows actuator 121 to cause axial movement of the medical tool 103 and rotation of the medical tool 103 relative to a distal end of the inner shaft 132. The second actuator 122 is adapted to actuate (e.g., rotate in this embodiment) relative to the handle body 123 to cause deflection of the inner shaft 132. For example, the handle assembly may have an internal component that intersects with the proximal end of the pull wire, such that actuation of actuator 122 tensions one or more pull wires to cause deflection of the inner shaft. In this embodiment, actuator 121 is located distal to actuator 122, but in other designs, their relative positions may be reversed. Figure 8B It is shown that the actuator 121 has been relative to its position in Figure 8A The shank assembly 120 is advanced distally after its position in the center. This distal advancement causes the outer shaft 131 to advance distally, and thus causes the medical instrument to advance distally. The actuator 121 can similarly advance distally relative to its position in the center. Figure 8B The position in the middle retracts proximally. The tensioning member described further below refers to the actuator 121 that retracts proximally.

[0137] In other designs, actuator 121 may be operatively connected to an inner shaft, and actuator 122 may be operatively connected to an outer shaft.

[0138] As described herein, the outer shaft is axially movable relative to a deflectable inner shaft. The outer shaft may be constructed of material segments whose stiffness (e.g., hardness) varies along at least a portion of its length. For example, a first portion distal to a second portion may have a lower hardness than the second portion. Because the outer shaft is axially movable relative to the deflectable inner shaft, and because the stiffness of the outer shaft can vary along its length, the deflection of the entire device, including its degree (or amount), can be selectively controlled by controlling the axial position of the outer shaft (relative to the inner shaft). Therefore, axial movement of the outer shaft can selectively control the deflection of the device. For example, a user (e.g., a physician) can change or control the location of bending along the length of the device (measured from the distal end) by axially moving the outer shaft relative to the inner shaft. Additionally, for example, depending on the relative position of the outer shaft to the deflectable inner shaft, segments in the outer shaft with varying stiffness may allow for more or less deflection. For example, deflection of the inner shaft in a region of relatively high stiffness on the outer shaft may cause less deflection than when the inner shaft deflects in a region of relatively low stiffness on the outer shaft. Although the characteristics and control differences between inner and outer shafts are taken into account, this control of inner and outer shafts can be opposite, with the inner shaft being constructed for rotation and the outer shaft being constructed for deflection.

[0139] Figure 9C An example medical device 130 is shown, which includes an elongated inner shaft 132 (see example). Figure 9A ) and slender outer shaft 131 (see Figure 9B The medical device 130 may also be referred to herein as a “catheter” or other medical device comprising at least one elongated shaft.

[0140] Figure 9D It shows Figure 9C The cross-section AA shown in the component is a segment in the deflectable segment of the device. Figures 9A to 9C The components are similarly labeled. For example, in Figure 9D As can be seen, pull lines 111 and 112 are very close to each other and form an angle of approximately 180 degrees with the straightened pull line 116.

[0141] For example Figure 9DAs shown, the elongated inner shaft 132 includes two layers of braided material 119, and the pull wire is substantially sandwiched between the two layers of braided material at least at the location of this segment. An annular space 118 allows for freedom of movement and space for an optional lubricant. The inner shaft 132 may be made of, for example but not limited to, polymeric materials such as Pebax, and optionally has lubricating additives. The inner shaft 132 may include a liner 125, such as a PTFE liner. The flexible cable bundle 105 may be surrounded by one or more layers of insulation 126 (such as PTFE insulation). The outer shaft 131 may contain a polymeric material 127, such as Pebax. The outer shaft 131 may also include a radially inner liner 128, such as a PTFE liner. Any of the pull wires (e.g., 111, 112, 116) may be disposed within a lumen having a liner such as the PTFE liner 129.

[0142] Medical device 130 (or either elongated shaft 132 or elongated shaft 131, individually) may be used with any of the handle assemblies described herein (including...). Figure 8A and Figure 8B The handle assembly 120 shown is operatively connected.

[0143] Figures 10A to 10C and Figure 11 An additional example handle assembly is shown that can be operatively connected to any of the medical devices (including an ultrasound probe) described herein. For example, Figures 10A to 10C The example handle assembly shown can be coupled (directly or indirectly). Figures 9A to 9D The medical device 130 is shown and is operatively connected to the medical device. In a specific embodiment, both the elongated outer shaft 131 and the elongated inner shaft 132 are connected to... Figures 10A to 10C The handle assembly shown is operatively connected to the handle assembly.

[0144] Figures 10A to 10C and Figure 11 The handle assembly and Figure 8A and Figure 8B The handle assembly, individual parts, and sub-assemblies shown share some similarities. Unless otherwise stated, they can be combined with... Figures 10A to 10C The handle assembly in the middle comes from Figure 8A and Figure 8B The concepts, features, and usage methods are hereby incorporated by reference for all purposes. Figures 10A to 10C The figures shown and relative to Figures 10A to 10C The disclosure of the handle assembly described herein. Similarly, other handle assemblies that can be incorporated herein. Figures 10A to 10C The concepts, features, and methods of use shown and described herein are incorporated herein by reference for all purposes.

[0145] Figure 10A This is a side view of the handle assembly 140, with a portion of the handle body 141 removed to reveal some internal components of the handle assembly. The handle assembly 140 includes a first actuator 143 and a second actuator 142, and in this embodiment, the first actuator 143 is distal to the second actuator 142. The first actuator 143 is axially movable and rotateable simultaneously relative to the handle body and relative to the second actuator (actuator 142 in this embodiment). The first actuator 143 is associated with an external elongated body such as an outer shaft 131 (see...). Figure 9B The actuator 143 is operatively connected. Axial movement (towards the distal or proximal side) of the actuator 143 causes axial movement of the outer shaft 131; however, rotation of the actuator 143 causes rotation of the outer shaft. A second actuator 142 is connected to an inner shaft, such as the inner shaft 132 (see...). Figure 9A The second actuator 142 is operatively connected to the inner shaft. Actuation of the second actuator 142 (rotation in this embodiment) causes deflection of the inner shaft. In this embodiment, the rotatable and axially movable actuator (i.e., the first actuator 143) is operatively connected to the outer shaft. While reference is made to actuation of the second actuator 142 causing deflection of the inner shaft, alternatively, actuation of the second actuator 142 can cause rotation of the inner shaft. Similarly, actuation of the actuator 143 can alternatively cause deflection of the outer shaft.

[0146] The first actuator 143 is connected to Figure 10B The elongated outer shaft motion assembly 150, as shown in the exploded view, causes motion of the assembly 150 due to movement of the first actuator 143. The elongated outer shaft motion assembly 150 is similarly coupled to the elongated outer shaft such that movement of the first actuator also causes movement of the elongated outer shaft. In this embodiment, the outer elongated shaft is attached to a removable member 153 after it is inserted into the channel 156. The removable member 153 and the channel 156 are configured such that the removable member 153 is constrained by at least one inner surface of the channel when inserted into it. The elongated outer shaft motion assembly 150 also includes a distal head portion 151 fixed to the first actuator. The elongated outer shaft motion assembly 150 also includes a rotation limiting mechanism similar to the rotation limiting mechanism described herein, which limits rotation of the first actuator 143, thereby limiting rotation of the outer elongated shaft. Any disclosure above relating to the rotation limiting subassemblies, functions, and uses is incorporated into this embodiment for all purposes and may be incorporated into this design and similar designs. During rotation, component 157 (see...) Figure 10B ) interacts with component 161, and component 162 interacts with component 158. The physical interaction of these two sets of components limits rotation to a desired rotation limit, for example, limiting rotation to a maximum of 630 degrees of rotation of the outer body (in other embodiments, the allowed rotation may be greater than 630 degrees, such as up to 720 degrees and including 720 degrees).

[0147] If it is desired, for example, to clean the outer shaft after use, the removable part 153 can be separated from the outer shaft to allow the outer shaft to be removed from the shank assembly and cleaned before being reinserted and reattached to the removable part 153 or a new removable part (if part 153 is damaged or broken).

[0148] The shank assembly 140 also includes an inner shaft deflection assembly 146, which is operatively communicated with the second actuator 142. The inner shaft deflection assembly 146 includes a center gear 147 adapted and configured to rotate when the second actuator 142 rotates. The center gear 147 engages via a gear interface with a first spindle 148 and a second spindle 149, such that rotation of the center gear 147 causes rotation of the spindles in opposite directions. The inner shaft deflection assembly 146 (including the spindle) extends further proximally than the elongated outer body motion assembly 150. The inner shaft extends through the outer shaft and extends further proximally within the shank assembly 150 than the outer shaft. This allows one or more draw cables, as part of the inner shaft, to extend radially outward and intersect with the spool 160.

[0149] Although the center gear 147 and gear drive interface are shown as having spur gears, helical gears may be used in other embodiments. Helical gears provide smoother control and reduced tilting of the first actuator 143 and the second actuator 142. Helical gear designs provide smoother operating performance than spur gears. Helical gears may have a greater number of “virtual teeth” than actual teeth. Compared to a spur gear with both actual teeth and “virtual teeth,” a helical gear may have the same number of “virtual teeth” while having fewer actual teeth, allowing the device to have the same or better functionality using a smaller area. Helical gears may have stronger teeth, as measured by bending and surface fatigue, compared to a spur gear with the same number of actual teeth. Helical gears can reduce undercut, thus requiring fewer actual teeth compared to the minimum number of actual teeth required for a spur gear. Example helical gear configurations may include twenty-six (26) gear teeth, seventeen (17) pinion teeth, a 26:17 (26:17) gear ratio, a 20-degree (20°) pressure angle, and a 20-degree (20°) helix angle. Example helical gear configurations may include meshing gears at a zero-degree (1.0°) point for alignment, thus allowing for easy manufacturing. Helical gears can be molded. Helical gears may include configurations similar to spur gears. Helical gear configurations may include spindles, such as a first spindle 148 and a second spindle 149, which include through holes, as have been present in the spindles of a spur gear configuration.

[0150] The absence of interaction between the elongated outer shaft motion assembly 150 and the elongated inner shaft motion assembly 146 allows the inner and outer elongated shafts to be independently controlled by the first actuator 143 and the second actuator 142.

[0151] Handle assembly 140 also includes a printed circuit board (“PCB”) 170 disposed within handle body 141, the PCB being electrically connected to a cable harness, such as Figure 53 The flexible cable bundle 105, or any of the cable bundles in this document that are connected to a medical instrument (such as an ultrasound transducer).

[0152] The handle assembly 140 also includes a rotation indicator 180, which can be used to indicate to a user the degree of rotation of at least one of the first and second actuators relative to its original or neutral position. The first actuator 143 may include a rotation indicator 181, which is aligned with the rotation indicator 180 along an axis when the first actuator 143 is in the neutral position. Figure 11 As shown. When the first actuator 143 rotates, the rotation indicator 181 rotates relative to the rotation indicator 180 along its extending axis, allowing the user to visually understand that the first actuator 143 and therefore the outer shaft rotate to some extent relative to the neutral position. Similarly, the second actuator 142 may also have a rotation indicator 182, which, when the second actuator 142 is in the neutral position, is aligned along the axis with the rotation indicator 180, as shown. Figure 11 As shown, when the second actuator 143 rotates, the rotation indicator 182 rotates relative to the rotation indicator 180 along its extending axis, which allows the user to visually understand that the second actuator 143 and therefore the inner axis are deflected to some extent relative to its neutral position.

[0153] In some alternative embodiments, the shank assembly may include one or more sensors to track how much rotation has occurred on the outer shaft or how much deflection has occurred on the inner shaft. In some embodiments, the shank assembly may include an encoder for each actuator.

[0154] In any of the embodiments described herein that include an outer shaft and an inner shaft, the device may include one or more lubricants between the inner and outer shafts to facilitate movement of the inner and outer shafts relative to each other by reducing friction between them. If the medical device requires cleaning for reuse, additional lubricant may be added between the inner and outer shafts after the cleaning process.

[0155] In some embodiments herein, the medical device may include flexible components, such as flexible conductor bundles (which may be referred to herein as conductor bundles, flexible bundles, or other similar derivatives thereof), which are coupled to a distal region of the medical device (e.g., a probe tip) and extend from that distal region toward a proximal region of the medical device (see example). Figures 4 to 6G The conductor bundle shown is 2020; or from Figure 9B (The bundle 105). The probe tip may include an ultrasonic transducer electrically connected to the flexible conductor bundle. In some embodiments herein (e.g., Figures 9A to 11 The probe tip and conductor bundle can be connected via a stalk actuator (e.g., such as...). Figure 10A Actuation of the actuator 143 (shown) causes axial (proximal and / or distal) displacement. In some cases, the conductor bundle is disposed within an elongated member (e.g., a steerable inner elongated body 132; or an elongated member 131) and moves axially relative to the elongated member as the probe tip advances distally or retracts proximally. When the distal region (e.g., an ultrasound probe) and the conductor bundle retract proximally (after distal advancement), the conductor bundle may tend to fold, converge, or otherwise bend near or adjacent to its distal end due to friction between the bundle and, for example, the elongated member in which the conductor bundle is disposed (e.g., a steerable inner axis 132). Convergence can occur when the medical device is in a straight configuration as well as when the medical device has a degree of curvature (e.g., after deflection from a straight or linear configuration).

[0156] To reduce or even completely prevent the tendency to converge or bend, any of the medical devices described herein may include a structural tensioning member adapted and configured to apply or maintain tension on a flexible member (such as a flexible conductor bundle) at a location proximal to where the conductor bundle is coupled to a distal medical instrument. By tensioning the flexible member, folding or convergence of the flexible member can be minimized or even prevented. When used in this context, a “tensioning” member is adapted and configured to reduce convergence of one or more distal regions of the flexible conductor bundle (compared to a device without a tensioning member) by moving at least a distal portion of the flexible conductor bundle proximally as the distal probe retracts proximally. In some embodiments, the structural tensioning member (e.g., a tensioning bar) may be physically fixed to the flexible conductor bundle (e.g., directly or indirectly attached). Generally, the tensioning member described herein is operatively connected to the flexible member (e.g., the flexible conductor bundle) such that movement or actuation of the tensioning member applies a force to the flexible member and can cause movement of the flexible member (e.g., proximally). In some example implementations, the structural tensioning member may be located in or carried by the handle assembly of the medical device. In this case, the structural tensioning member may be a single component or an assembly of separate components.

[0157] Figures 12A to 12F A handle assembly portion of an example medical device is shown that can be incorporated into any suitable medical device described herein. For example, Figures 12A to 12F The handle assembly may be part of a medical device that includes a medical tool (e.g., an ultrasound imaging probe) at or near its distal end, examples of which are described herein. Any other embodiments or features herein are incorporated by reference. Figures 12A to 12F The example handle component shown.

[0158] Example handle assembly 310 includes a first actuator 314 and a second actuator 322, wherein the first actuator 314 is distal to the proximal actuator 322. The first actuator 314 is adapted and configured to move axially (distally and proximal) relative to the second actuator 322 (and optionally also rotate relative to the second actuator), and is operatively communicateable with an elongated body (e.g., 131 or 132) that may include a medical tool (e.g., 103) located in a distal region. Handle assembly 310 (including actuators) may incorporate any relevant disclosure from any other handle assembly herein. Medical devices in which handle assembly 310 is part also include flexible members (e.g., Figure 9B The flexible conductor bundle 105 in the middle, the flexible member being securely connected at a first distal position to (directly or indirectly) a medical instrument (e.g., such as...). Figure 9B and Figure 9C As shown, the medical tool 103 is fixed to the flexible member 105 and extends proximally from the medical tool toward the handle assembly 310. The flexible member may be a flexible conductor bundle and may extend into the handle assembly 310, as shown. A portion of the flexible member is disposed within the outer surface of the elongated body (e.g., within 131 and / or 132). The medical device also includes a tensioning member fixed to the flexible member at a second position 316, proximity to the first position (in this context, the "first position" may be referred to as the first distal position or a derivative thereof). Figure 12A An example tensioning member 312 is shown, while Figure 12A Reference numeral 312 also refers to an optional elongated rigid member of the tensioning member (in this embodiment, the elongated rigid member is linear and extends axially). The tensioning member 312 is adapted and configured to tension the flexible member when the medical instrument retracts proximally. This may be referred to herein as applying tension to the flexible member, or tensioning the flexible member, or maintaining tension in the flexible member. In this example embodiment, the tensioning member 312 is adapted and configured to tension the flexible member when the medical instrument retracts proximally, which in this embodiment is achieved by the first actuator 314 from its... Figure 12A , Figure 12D and Figure 12FThis occurs when the device retracts proximally at the position shown. Tension can be applied to the tensioning member in this paper when the medical device is in a straight configuration and when it is in a non-straight (linear) configuration, such as when the device can deflect or bend.

[0159] In this embodiment, the tensioning member 312 (which may include Figure 12A The tensioning bar shown is fixed (e.g., directly attached) to the flexible conductor bundle at position 316, which in this embodiment is inside the shank assembly. The tensioning member may alternatively be fixed to the flexible member at a location not within the shank (such as outside the shank, or inside one or both of the outer and inner shafts). In this embodiment, the tensioning member is also axially fixed relative to the first actuator 314, such that axial movement of the first actuator 314 causes axial movement of the tensioning member 312 (which may be in a 1:1 ratio). Because the tensioning member 312 is also fixed to the flexible member (e.g., at position 316), axial movement of the tensioning member 312 also causes axial movement of the flexible member at position 316. By securing the tensioning member 312 to the flexible member, when the first actuator 314 retracts proximally, the flexible member is tensioned distal to the location where the tensioning member is secured to the flexible member. This prevents the flexible member from folding or bunching up in the vicinity of or in the distal region of the medical instrument (or at least reduces the degree of folding / bunching up compared to a device without a tensioning member).

[0160] Flexible components may include flexible conductor bundles, such as any of the flexible conductor bundles described herein. Figures 12A to 12F In this context, the tensioning member includes a rigid, slender member with a fixed length (in...). Figure 12A (Commonly referred to as 312). The rigid tensioning member shown in the figure has a generally longitudinal axis, which in this embodiment is parallel to the longitudinal axis of the medical device and / or the longitudinal axis of the handle assembly. The rigid tensioning member can be made of a variety of materials, such as rigid plastic members.

[0161] The tensioning member described herein ensures that the distance traveled by the medical instrument is the same as the distance traveled by any point between the first and second positions on the flexible member. The tensioning member described herein ensures that the distance traveled by the medical instrument is related to the position where the tensioning member is fixed to the flexible member (e.g., Figure 12A The distance traveled is the same as that at position 316.

[0162] When the medical instrument retracts proximally (when the medical device is in a straight configuration), the anchoring relationship between the tensioning member and the flexible member maintains a substantially flat or straight configuration for the flexible member between a first position and a second position. In this context, a flattened configuration may include embodiments in which the flexible member can also be twisted (i.e., the flexible member can be flat and still twisted, but not folded / folded). As used herein, a flattened configuration indicates that the flexible member is not folded or folded.

[0163] The medical device incorporating a tensioning member can also be steerable or deflectable. The tensioning member described herein can be adapted and configured to apply tension to the flexible member even when the medical device (including the flexible member) is in a non-straight (e.g., deflected, steered, bent) configuration. When this disclosure refers to maintaining a substantially flattened configuration in the flexible member, it refers to a situation where the medical device can be in a straight configuration, but this is not necessarily the case, such as when the medical device has been steered, bent, or deflected.

[0164] When the medical instrument retracts proximally, the fixed relationship between the tensioning member and the flexible member (described herein) prevents the flexible member from folding (i.e., bending or converging) between a first position and a second position. In this context, folding, bending, and converging include a first region of the flexible member that axially overlaps with a second region of the flexible member, and also include general bending and converging of the flexible member, such as unevenness of the flexible member and, for example, areas forming bends, flexed regions, and / or zigzags.

[0165] The flexible member may have a flat top surface and a flat bottom surface (e.g., a conductor bundle having one or more flat surfaces), and optionally, the tensioning member may be fixed to at least one of the top and bottom surfaces. For example, Figures 6A to 6G Flexible members are shown having a flat or substantially flat first surface and a second surface (e.g., a top surface and a bottom surface), and tensioning members can be fixed to one or both of the flat or substantially flat surfaces (e.g., such as at position 316). They can be fixed using a variety of techniques, such as using adhesives, welding or other bonding techniques.

[0166] The tensioning member may be operatively connected (directly or indirectly) to the handle actuator, such that axial movement of the actuator causes axial movement of the tensioning member. The handle actuator may also be adapted and configured to rotate (e.g., actuator 314) to cause rotation of the medical instrument, and optionally, wherein rotation of the actuator does not cause rotation of the tensioning member. Thus, the tensioning member may be adapted to move axially when the actuator moves axially, but not rotate when the actuator rotates. This can be achieved by operatively connecting the tensioning member to the actuator (directly or indirectly).

[0167] The medical device may include an internal elongated body (e.g., 132) comprising a lumen in which at least a portion of a flexible member is disposed. The internal elongated body may be independently steerable, such as by utilizing a separate, independently actuable stalk actuator (e.g., actuator 322). Aspects of other embodiments of the present invention, wherein the medical device includes internal and external components, and the internal components are independently controllable (e.g., axially and rotationally), are fully incorporated in any of the embodiments herein.

[0168] Flexible components can be coupled to a printed circuit board in the handle assembly (e.g., as shown in the image). Figure 12A (As shown in 321 "board"). The tensioning member may be coupled to a flexible member proximal to the printed circuit board. In an alternative embodiment, the tensioning member may be coupled to a flexible member distal to the printed circuit board.

[0169] Figures 12A to 12F An example of a medical device includes an elongated outer body (e.g., 131) comprising a probe tip in a distal region of the elongated body; and a flexible conductor bundle (e.g., 105) securely coupled to the probe tip at a first location (in... Figure 9B and Figure 9C (As shown herein) and extending proximally from the medical instrument and into the handle assembly, a flexible member is disposed within the outer surface of the elongated body; an inner elongated body (e.g., 131), at least a portion of which is disposed within the elongated outer body, optionally steerable, wherein at least a portion of the flexible conductor bundle is disposed within the inner elongated body and configured to be axially movable relative to the inner elongated body; a tensioning member is fixed to the flexible member at a second position in the handle assembly, the tensioning member being adapted and configured to apply tension to the flexible member when the probe tip retracts proximally. As used herein, the probe tip may include one or more ultrasonic transducers.

[0170] Figure 12C and Figure 12E Half of the outer housing 320 of the handle is shown, with two portions forming part of the outer surface of the handle assembly 310. The handle housing 320 includes radially inwardly extending features 315 adapted to engage with a controller that controls the movement of the tensioning member 312. Features 315 may include guides configured to engage with the tensioning member at one or more locations and help stabilize the tensioning member.

[0171] Any other handle assembly component in any other embodiment of this document that may be suitably integrated into handle assembly 310 is incorporated herein by reference.

[0172] In any embodiment and claim herein, the phrase "tensioning member" may be replaced by "straightening member," "flattening member," or derivatives thereof. As described herein, a straightening member or flattening member refers to a substantially straight or flattened configuration in a flexible member when the medical device is in a straightened configuration, and it is not required that the device always have a straightened configuration. Thus, even if the flexible member is not necessarily placed under tension, it can still be kept straight (i.e., non-folding configuration) along at least a portion of its length due to the straightening member. For example, Figure 12A Component 312 is an example of a straightening component, although it can also be used as a tensioning component. This applies to all tensioning components described, shown, and claimed herein. In some embodiments herein, a “component” may be a straightening component (or a flattening component) and may also be used as a tensioning component. Additionally, the phrase “tensioning component” herein may be replaced by “anti-folding component,” “anti-bending component,” “anti-gathering component,” or derivatives thereof.

[0173] The above disclosure describes that, in some embodiments, a flexible member such as the conductor bundle 2010 may be twisted along a portion of its length. For example, the conductor bundle may be twisted to provide a more balanced cross-section along a portion of the length of the medical device. The conductor bundle may be twisted only in a portion of the medical device that will undergo deflection.

[0174] Figures 13A to 13E A portion of an example medical device is shown, which includes torsionally flexible components such as flexible conductor bundles. Figures 13A to 13E The implementation scheme described herein can be combined with any other suitable features and / or medical devices described herein.

[0175] Figures 13A to 13E The portion 330 of the illustrated medical device includes a medical tool 332 located in a distal region, a flexible member 331 coupled to and extending proximally from the medical tool, and a proximal end region 333 including a plurality of electrical connectors. The flexible member 331 may be a flexible conductor bundle, such as any of the bundles described herein. The medical tool 332 may include an ultrasound imaging transducer 339. The flexible conductor bundle 331 has a region 338 in which the conductor bundle is twisted, the twisted region 338 having a distal end and a proximal end. The flexible conductor bundle 331 also includes an untwisted region 336 distal to the twisted region 334 and an untwisted region 340 proximal to the twisted region 336. The medical tool 332 may be coupled to an outer shaft, such as... Figure 9B The outer shaft 131 is shown.

[0176] The length of the torsion region 338 from its distal end to its proximal end can vary, and in some embodiments is 5 cm to 15 cm, such as 8 cm to 15 cm, such as 11 cm. The length of the complete loop formed above it can vary considerably, such as 1 cm to 5 cm, such as 3 cm.

[0177] The number of twists along the length of the twisted region can also vary, such as, but not limited to, 7 to 9 complete twists.

[0178] An example way to form the torsion region of a flexible member (e.g., a flexible conductor bundle) is to attach the flexible member to a medical instrument at its distal end (e.g., the tip of a probe). A thin, heat-shrinkable segment of PET can then be advanced over the flexible conductor bundle. One portion of the device can be held in place while another portion is twisted to the desired number of turns to form the torsion region. While maintaining the torsion configuration, the PET can be heat-shrink over the torsion bundle region. Additional PET layers can then be added. An elongated member (e.g., shaft 131) can then be placed over the bundle (including the torsion region), and the elongated member can be bonded to the medical instrument.

[0179] Reference Figures 14 to 18 The system 2800 includes a handle assembly 2802 and a steering and medical device portion 2810 (e.g., shown as resembling a sheath 1208). Figure 4 The system includes an outer sheath that may also enclose the inner shaft and tool. The system is adapted to allow the handle assembly 2802 to be actuated to cause steering and steerable portion of the medical device section 2810, and optionally to be further actuated to cause movement of the medical device coupled thereto. As an illustrative example, the handle assembly 2802 includes a first actuator 2806 and a second actuator 2808. One or more of the first actuator 2806 or the second actuator 2808 are adapted (e.g., configured to) be actuated (rotated in this example) relative to the handle body of the handle assembly 2802 to cause steering of the steerable portion 2810, such as steering the outer sheath. Steering may include rotation or deflection. As an example, one of the actuators 2806, 2808 controls rotation, while the other controls deflection. As another example, one of the actuators 2806 and 2808 controls the rotation of one or more of the inner or outer shafts, while the other of the actuators 2806 and 2808 controls the deflection of one or more of the inner or outer shafts.

[0180] like Figure 17As shown more clearly in the diagram, a neutral position mark 3102 may be provided on the body of the handle assembly 2802 to indicate (e.g., visually, tactilely, etc.) a fixed reference point. One or more of the actuators 2806, 2808 may also include marks 3104, 3106 to indicate the alignment or position of the actuators 2806, 2808 relative to the neutral position mark 3102. As an example, mark 3104 may indicate deflection of a shaft relative to the neutral position mark 3102, and mark 3106 may indicate rotation of a component (e.g., a transducer surface disposed in the housing 2810) relative to the neutral position mark 3102, or vice versa. Marks 3104, 3106 may indicate other positions. Additionally or alternatively, mechanical registration mechanisms (such as stoppers) may be used to provide tactile feedback to the user to indicate certain positions of actuators 2806, 2808, such as when actuators 2806, 2808 are in the neutral position.

[0181] The handle assembly 2802 may include any other handle components or functionalities described in any other handle herein. For example, a socket 2804 may be provided at the proximal end of the handle assembly 2802 and adapted to receive a plug, such as a dislodged plug. Figure 16 As shown more clearly in the diagram, jack 2804 may include visual and / or tactile orientation marks for registration and alignment of the disconnect plug and jack 2804.

[0182] The navigation connector 2812 can be coupled to the handle assembly 2802 via a navigation conduit 2814 (e.g., a navigation cable sheath). The navigation connector 2812 can be configured to interface with a navigation system, allowing system 2800 to communicate with the navigation system. As an example, the navigation system can provide tracking and navigation of a part of a system (e.g., a medical device) during use. As shown, for example, the navigation conduit 2814 can be coupled to the body of the handle assembly 2802 to provide passage for one or more cables from the navigation connector 2812 to components within the housing of the handle assembly 2802. Figure 18 As shown more clearly, navigation connector 2812 can be configured to interface with navigation system connector 3204 (e.g., a jack), which may be proprietary to the navigation system manufacturer. Other configurations may be used.

[0183] Figures 19 to 24 An example distal region of a steerable system including a medical tool is shown. As an illustrative example, Figure 19The medical instrument shown may include a steerable end effector 3300 disposed at the distal end of a sheath. The steerable end effector 3300 may include a transducer 3304 (e.g., an ultrasonic transducer) at least partially surrounded by a material 3302 (e.g., a polymer). The end effector 3300 may include an electronic module 3306, which may include sensors, control boards, thermistors, etc. As an example, a triaxial sensor (TAS) 3308 may be configured to communicate with module 3306. As another example, a sensor cable harness 3310 may be configured to provide electrical communication to one or more components coupled to module 3306.

[0184] As an illustrative example, Figure 20 The medical instrument shown may include a steerable end effector 3400 disposed at the distal end of a sheath. The steerable end effector 3400 may include a transducer 3404 (e.g., an ultrasonic transducer, a folded transducer) at least partially surrounded by a material 3402 (e.g., a polymer). The end effector 3400 may include sensors, control panels, thermistors, etc. As an example, in conjunction with... Figure 19 When comparing the configuration of the end 3300, the triaxial sensor (TAS) 3408 can be positioned closer to the distal end of the end 3400. By shifting the sensor 3406, the deflectability of the end 3400 is increased.

[0185] although Figure 19 and Figure 20 A TAS sensor 3308 is shown, but in other embodiments, a single-axis sensor (SAS) or a dual-axis sensor (DAS) may be used. Replacing the TAS sensor 3308 with a SAS or DAS reduces the length and column length associated with the end 3300, thereby allowing deflection to the more distal side. As an illustrative example, Figures 41-43 The projection of end rotation and shaft curvature can be calculated using a DAS 4402 located at or near the end portion 4400 (e.g., 17 mm distal to the end) and a SAS 4404 located at a distance from the distal end of the inner shaft terminating in the end portion 4400 (e.g., 105 mm from the DAS 4402). As shown in the figure, Figure 42 It is along Figure 41 The cross-section taken by line A in the diagram. Figure 43 It is along Figure 41The cross-section is taken from line B in the diagram. For example, the angle between X1 and X2 around Z can be used to project an independent end rotation. As another example, the angle between Z1 and Z2 can be used to project the axis curve. DAS 4402 is preferably coupled to a proximal extension of the transducer end (e.g., at the end of end portion 4400), which is also coupled to the outer shaft, such that DAS 4402 moves together with the outer shaft and the end. SAS 4404 is preferably coupled to the inner shaft. Therefore, DAS can move independently of SAS 4404. The position of SAS 4404 on the inner shaft is preferably near the deflection position. This position is also preferably located on the higher stiffness portion of the inner shaft, near both the deflection region and the lower stiffness portion of the shaft that is exactly near the deflection region. The position of SAS 4404 can be within a range of 5-15 cm from the distal end of the inner shaft.

[0186] As an illustrative example, Figure 21 The medical instrument shown may include a steerable end effector 3500 disposed at the distal end of a sheath. The steerable end effector 3500 may include a transducer 3502 (e.g., an ultrasonic transducer, a folded transducer). As an example, an ASIC 3504 may be disposed adjacent to the transducer 3502. As another example, a passive piezoelectric element may be disposed adjacent to the transducer 3502. The end effector 3500 may include various sensors, control boards, thermistors, etc. As shown, the end effector 3500 includes a thermistor 3506 disposed proximal to the transducer 3502. Figure 23 As shown more clearly, at least a portion of the end 3500 may be at least partially surrounded by a first material 3700 (e.g., a polymer), and at least a portion of the end 3500 may be at least partially surrounded by a second material 3704. The first material 3700 and the second material 3704 may be configured to have the same or different properties, such as different stiffnesses (e.g., hardness). As an illustrative example... Figure 23 As further shown, the navigation sensor 3702 may be positioned at or adjacent to the proximal end of the end-effector 3500. The navigation sensor 3702 may communicate with the navigation system to provide tracking of the end-effector 3500 and its position, and to provide feedback to the user.

[0187] As an illustrative example, Figure 22The medical instrument shown may include a steerable end effector 3600 disposed at the distal end of a sheath. The steerable end effector 3600 may include a transducer 3602 (e.g., an ultrasonic transducer, a folded transducer). When compared to end effector 3500, end effector 3600 may include a shortened folded end effector 3601. Passive piezoelectric material of adjacent transducers 3602 may be minimized. As an example, an ASIC 3604 may be positioned adjacent to transducer 3602. End effector 3600 may include various sensors, control boards, thermistors, etc. As shown, end effector 3600 includes a thermistor 3606 disposed proximal to transducer 3602. Circuitry (such as flexible circuitry) may be electrically connected to one or more components in end effector 3600. As an example, flexible circuitry may be layered and selectively communicate with components. Figure 24 As shown more clearly, at least a portion of the end 3600 may be at least partially surrounded by a first material 3800 (e.g., a polymer), and at least a portion of the end 3600 may be at least partially surrounded by a second material 3804. The first material 3800 and the second material 3804 may be configured to have the same or different properties, such as different stiffnesses (e.g., hardness). Figure 24 As further shown, navigation sensor 3802 can be positioned adjacent to transducer 3602. Navigation sensor 3802 can communicate with the navigation system to provide tracking of end effector 3600 and its position, and provide feedback to the user.

[0188] Figure 25 A medical tool is illustrated that may include a steerable endpiece 3902 disposed at the distal end of a sheath 3906. As shown, a biaxial sensor (DAS) 3908 may be disposed at or adjacent to the proximal end of the endpiece 3902. An inner sheath 3904 may include segments configured for deflection 3912 and may be disposed adjacent to the endpiece 3902 and within the sheath 3906. One or more DAS sensors 3910, 3910' may be disposed along the length of the sheath 3904. One or more of the DAS sensors 3910, 3910' may alternatively be configured as SAS sensors.

[0189] Figure 26An example configuration of a triaxial navigation sensor 4000 is shown, comprising an x-axis coil 4000A, a y-axis coil 4000B, and a z-axis coil 4000C. The TAS sensor position can be generated via an additional cavity in a molded end cap 4010, within which the TAS sensor 4000 can be incorporated. The TAS position directly beneath the transducer 4112 provides a closer alignment with the transducer, which improves the accuracy of the ultrasound volume relative to the catheter end when displayed in the CARTO system. For example, the distance from the end of the device to the center of the y-coil can be measured at a first length 4002. The distance from the center of the active transducer 4002 to the y-coil can be a second length 4004. The distance from the sensor axis to the end axis can be a third length 4006. The distance from the sensor axis to the face of the ultrasound transducer can be a fourth length 4008. These lengths can be programmed as calibration parameters into an EEPROM within the catheter, which is read by the CARTO system to ensure accurate catheter positioning within the system. The TAS sensor 4000 can be optionally replaced by a DAS sensor with alternative calibration parameters.

[0190] Figures 27A to 27C Various arrangements of the draw cables are shown, with a first aspect 4130 and a second aspect 4140 vertically paired for comparison. For example, the shank assembly may have an internal component that intersects with the proximal ends of these draw cables, such that actuation of one or more actuators tensions one or more draw cables to cause deflection of the inner shaft. As shown, for example, wire 4102 may have a relative configuration within the inner shaft 4100. Wire 4106 may have a relative configuration within the inner shaft 4104. Wire 4110 may have a relative configuration within the inner shaft 4108. Wire 4114 may have a relative configuration within the inner shaft 4112. Wire 4118 may have a relative configuration within the inner shaft 4116. Wire 4122 may have a relative configuration within the inner shaft 4120.

[0191] Go to Figures 28 to 29 For example, from left to right, the configuration of the inner axis 4150 and line 4160 (showing the vertically paired first aspect 4130 and second aspect 4140 for comparison) can represent the distal portion 4170, the middle portion 4180 and the proximal portion 4190 along the length of the inner axis. Figures 28 to 29The diagram illustrates that the drawwire 4160 can vary its spacing and configuration along the length of one or more shafts or sheaths. As shown, for example, the distal portion 4170, intermediate portion 4180, and proximal portion 4190 along the length of the inner shaft 4150 can have varying stiffness, as illustrated only for illustrative purposes. Stiffness can be achieved based on material selection, such as by using materials of different hardness (35D Pebax, 40D Pebax, 55D Pebax, 63D Pebax, 72D Pebax, Nylon 12, etc.). As a further illustration, the selection of stiffness (or other properties) for one or more portions of the shaft can be based on the desired bending, straightness, and / or shape of the shaft to provide a variety of control modes.

[0192] For a given pair of draw wires 4160, the draw wires may be closely adjacent in the shank assembly, further separated over most of the shaft length, and then brought together again on the distal side, where the shaft is expected to deflect. As an illustrative example, and as... Figures 28 to 29 As shown, at least one pair of pull wires 4160 are arranged in a parallel configuration adjacent to each other along the longitudinal length of the deflectable axis from the handle assembly (not shown, adjacent to the proximal portion 4190) to a selected bifurcation region (e.g., 4180) located distal to the handle assembly. At least one pair of pull wires is spaced further apart at the bifurcation region than in the handle assembly, and at least one pair of pull wires is spaced closer together in a second region (e.g., 4170) of the deflectable axis located distal to the bifurcation region than in the bifurcation region. As another example, at least a portion of the second region exhibits less stiffness than the bifurcation region.

[0193] Extending this non-limiting example, at least a first pair of pull wires 4160 may be arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a first region (e.g., 4190) of the deflectable shaft until a selected first bifurcation position is located distal to the handle assembly, and at least a second pair of pull wires 4160 may be arranged adjacent to each other in a parallel configuration along the longitudinal length of the deflectable shaft in a second region of the deflectable shaft until a selected second bifurcation position is located distal to the handle assembly. Thus, at least the first pair of pull wires 4160 may be further spaced apart from each other in a third region distal to the first bifurcation point, and the second pair of pull wires 4160 may be further spaced apart from each other in a fourth region distal to the second bifurcation point.

[0194] Additionally or alternatively, the guy wires discussed herein may be configured such that the bifurcation point of the guy wire is located within a region of high stiffness (e.g., the 72D region), which provides desired control over deflection (e.g., deflection of the shaft on a portion distal to the bifurcation point). Other configurations may be used. Additionally or alternatively, the convergence and bifurcation positions of the guy wires may be configured to be the same or different on either side of the inner shaft. As an example, when the guy wires on opposite sides of the inner shaft converge or bifurcate at the same longitudinal position on each side, the deflection of the shaft may be symmetrical in either direction. However, when the guy wires on opposite sides of the inner shaft converge or bifurcate at different longitudinal positions, the deflection of the shaft in one direction may have a larger or smaller radius of curvature, and asymmetric deflection control may be provided.

[0195] As another example, Figures 32 and 33 illustrate how contrasting changes in stiffness and length in the first and second aspects affect the lengths of the flexible and straight sections of the shaft. As shown in Figures 32 and 33, for example, the second embodiment shows a straight section end length of 33 mm, while the first embodiment shows a straight section end length of 40 mm. Additionally, bifurcation of the line (e.g., a drawwire) can provide additional control over the inner shaft, such as… Figure 34 As shown.

[0196] Figure 34 Examples are shown Figures 28 to 29 and Figure 32 to Figure 34 The second aspect configuration, as shown, allows the catheter to bend at point 4200. Additionally, the transition from a more flexible region 4202 to a more rigid region 4204 in the region proximal to the deflection area improves catheter maneuverability. This configuration can be used in a variety of applications, such as navigating to more distal regions of the heart. As an example, the catheter may need to pass through the tricuspid valve and then bend upwards and across the PA valve. As the catheter passes through the heart, it may need to bend into an "S" curve to mitigate excessive force transmission. The stiffness transition proximal to the deflection area also assists the catheter as it advances forward in the heart. As shown, the second aspect configuration allows the catheter to bend from the right ventricular outflow tract into the right atrium. Furthermore, the second aspect configuration allows the catheter to be maneuver in the right atrium when its tip is in the pulmonary artery or deeper in the left atrium.

[0197] in addition, Figures 35 to 36 The contrasting changes in stiffness and length of the first and second aspects of the inner shaft relative to the bifurcation point of the line are shown. Other variations in the stiffness combination of the inner and outer shafts can be used to optimize the stiffness transition along the approximately 15 cm distal portion of the conduit.

[0198] As an illustrative example, the symmetrical design causes the wire to fork and change its relative position to each other in the various segments of the shaft. By controlling the stiffness of the shaft and the positioning of the wire (e.g., moving the fork point to the more distant side), off-axis curling can be reduced, while providing more precise control over the deflection of the more distant end of the shaft.

[0199] This document discloses a medical device including a distal end. The distal end may include a single tail comprising a transducer and an application-specific integrated circuit (ASIC). The single tail may include multilayer flexible electrodes. The transducer and / or ASIC may utilize methods including multilayer flexible electrodes. The single tail may include multilayer foil traces to facilitate high-density wiring. The single tail may include anisotropic conductive film (ACF) bonding technology to accommodate electroacoustic module (EAM) (SAP) traces and ASIC lines. The multilayer flexible design may incorporate via connections to connect or isolate the layers. These connections may include blind via connections, through-hole connections, and / or buried via connections. The systems and methods described herein support numerous implementations, including unilateral multilayer flexible elements or bilateral connection pads. The elimination of folds enhances robustness and reduces the overall length of the rigid segment at the catheter tip, which directly improves maneuverability and accessibility within the patient's anatomy.

[0200] In another implementation, a multi-layer flexible design can be used to integrate long flexible elements. The EAM can be manufactured with long flexible elements and zero insertion force (ZIF) connectors at the proximal and / or distal ends for printed circuit board (PCB) connections, which reduces touch time, manufacturing complexity, and overall product cost.

[0201] The advantage of the systems and methods described herein is that the multilayer flexible components, as described herein, allow for the creation of separate flexible components for transducers and ASICs. This allows for the cutting of acoustic stacks on dedicated panels, thereby mitigating the risk of damage to PCB components during the cutting process.

[0202] EAM can be a key component in medical devices such as catheter assemblies. EAM can reside in... Figure 44The illustrated medical device configuration may include an ultrasound transducer attached to an integrated ASIC and flexible circuitry. The flexible circuitry may have two ends, a distal end 4430 and a proximal end 4440. A transducer stack 4450 may be mounted on top of the transducer flexible element 4410 and the ASIC 4460, and a backing may be mounted on the back of the ASIC flexible element 4420. A problem with this configuration is the need to fold the distal flexible element 180 degrees for assembly into the EAM end. This bilateral configuration presents several challenges. First, the folding of the distal flexible element increases the risk of trace breakage due to the sharp bend radius required for this assembly. Additionally, this configuration increases the overall length of the EAM components, thereby lengthening the rigid segment of the catheter. This lengthening of the rigid segment of the catheter limits maneuverability by further shifting the deflection curve proximally relative to the transducer.

[0203] Go to Figure 45 The diagram illustrates a medical device construction. This construction may include a dual-wing flexible circuit design that requires folding of the distal tail. The construction may include a 180-degree fold 4502. The construction may also include a folded distal flexible tail 4504. This construction may be prone to trace breakage. Trace breakage may be due to a small bending radius. The construction may include a flexible stack. This flexible stack may consist of two separate flexible circuits, one for a transducer and the other for an ASIC.

[0204] Go to Figure 46 The diagram illustrates a medical device construction. This medical device construction may include a foldable flexible wing 4602. The medical device construction may include a long flexible member 4604. The long flexible member 4604 may include an M-shaped fold. The long flexible member 4604 may extend the ridge length of the EAM end.

[0205] Go to Figure 47 This illustration shows a medical device construction according to the present disclosure. The medical device construction may include a preloaded thermistor 4702. The medical device construction may include a flexible element 4704. The flexible element 4704 may include a single-wing design. The flexible element 4704 may not include folds. The flexible circuit 4704 may include anisotropic conductive film (ACF) pad spacing and length updates. The flexible element 4704 may include a double-sided short flexible element. Figure 46 Compared to the long flexible component 4604 in the medical device structure, according to Figure 47 The flexible component 4704 in the medical device construction may include lower manufacturing costs.

[0206] Go to Figure 48This illustration shows a medical device construction according to the present disclosure. The medical device construction may include an EAM 4802. The EAM 4802 may be mounted to a multilayer flexible circuit 4804. The multilayer flexible circuit 4804 may include double-sided ACF bonding pads 4806a-4806b. The medical device construction may include a single tail EAM design. The medical device construction may use multilayer foil to route traces and ACF bonding pads 4806a-4806b. Higher density multilayer flexibility allows all traces to be routed on the distal side of the EAM 4802.

[0207] Go to Figure 49 This illustration shows a medical device construction according to the present disclosure. The medical device construction may include conductive layers 4902a-d. Conductive layers 4902a-d may include conductive foil. The conductive foil may include copper. The medical device construction may include insulating layers 4904a, 4904b located between conductive layers 4902. Insulating layers 4904a, 4904b may include polyimide. Conductive layers 4902a-d may have a top surface 4902a and a bottom surface 4902d. The medical device construction may include one or more through-holes (e.g., connections, etc.), such as through-hole 4906. The through-hole may extend through each of the conductive layers 4902a-d and is visible on both the top surface 4902a and the bottom surface 4902d. The medical device construction may include one or more blind vias (e.g., connections, etc.), such as blind via 4908. The blind via may be exposed on one of the top surface 4902a or the bottom surface 4902d, but terminates before extending to the other surface. The medical device may include one or more buried vias (e.g., connections, etc.), such as buried via 4910. The buried via may be housed within a conductive layer such that it is not visible on either the top surface 4902a or the bottom surface 4902d. Various embodiments may be used to create bilaterally flexible elements using through-holes (such as 4906), blind vias (such as 4908), and buried vias (such as 4910).

[0208] The multi-layered flexible components described in this article prevent folding. (See reference...) Figures 50 to 53 As shown, eliminating the need for folded flexible elements allows for a shorter overall length of the catheter's rigid segment. This reduction in the length of the rigid segment increases catheter maneuverability. By shortening the rigid segment, the deflection curve can be shifted distally, improving catheter maneuverability and accessibility to patient anatomy.

[0209] Figure 50A medical device configuration with a folded flexible element is shown. The medical device configuration may have a distal folded length 5002. The medical device configuration may have a distal end length 5004. The distal end length 5004 may be 17 mm. The medical device configuration may have a rigid segment length 5006. The rigid segment length 5006 may be 21.9 mm. The medical device configuration may include a flexible length 5008. The flexible length 5008 may be 56.8 mm.

[0210] Figure 51 A medical device configuration according to the present disclosure is shown. The medical device configuration may have a distal end length 5104. The distal end length 5104 may be 14.7 mm. The medical device configuration may have a rigid segment length 5106. The rigid segment length 5106 may be 18.2 mm. The medical device configuration may include a flexible length 5108. The flexible length 5108 may be 31.2 mm.

[0211] Figure 52 A medical device configuration with folded flexible components is shown. This medical device configuration may include an ACF pad length 5202. The ACF pad length 5202 may be 3 mm. The medical device configuration may include the length of the space between AFC pads 5204. The length of the space between ACF pads 5204 may be 3 mm.

[0212] Figure 53 A medical device configuration according to this disclosure is shown. The medical device configuration may include a preloaded thermistor 5302. The medical device configuration may include an ACF pad length 5304. The ACF pad length 5304 may be 1.2 mm. The medical device configuration may include the length of the space between AFC pads 5306. The space length between ACF pads 5306 may be 1.8 mm.

[0213] Figure 54 A medical device configuration is shown. The medical device configuration includes an EAM connected to a long flexible ACF 5402 and a proximal ACF junction 5404.

[0214] Figure 55 A medical device configuration according to this disclosure is shown. The medical device configuration may include a distal end 5502. Figure 54 Compared to the medical device construction, the terminal 5502 may include a redesigned EAM with a shorter terminal. Figure 55The medical device configuration may include a long flexible member 5504. The long flexible member 5504 may be pre-connected to a redesigned EAM with automated sub-components. The medical device configuration may include a handle 5506. The handle 5506 may be connected to the long flexible member 5504 using a zero-intercept (ZIF) connector. The connection of the handle 5506 to the long flexible member 5504 via proximal ZIF eliminates the need to attach the handle 5506 to the long flexible member 5504 using an ACF engagement.

[0215] Figure 55 The structure of the medical device shown is Figure 54 Improvements in the construction of medical devices, due to the integration of long, flexible components. Figure 55 In the medical device construction, the EAM (Equipment Angle) is integrated. Integrating the long flexible component into the EAM eliminates the need to bond the ACF (Anchor Component Fiber) to the EAM.

[0216] Figure 56 A medical device configuration according to this disclosure is illustrated. This medical device configuration may include a transducer stack 5602 and an ASIC 5604. The transducer stack 5602 may be mounted (e.g., attached, connected, etc.) to a modular transducer stack flexible member 5606. The modular transducer stack flexible member 5606 may be a separate flexible component for the transducer stack 5602. The ASIC 5604 may be mounted to a multi-flexible printed circuit board assembly (PCBA) 5608. This medical device configuration enables the cutting process of acoustic stacks on a dedicated panel. This medical device configuration avoids the problems of cutting PCBA components and enhances the modularity of the manufacturing process.

[0217] Figures 47 to 49 , Figure 51 , Figure 53 and Figures 55 to 56 The medical device configuration can be combined in various implementation schemes.

[0218] Regardless of the reference numerals used, the handle assembly, medical instrument, steerable sheath, and electrical connector described herein can be used in any combination of each other within the system.

[0219] Implementation Terms

[0220] Example Clause 1: A medical device configured and sized for placement within a subject, the medical device comprising: a flexible circuit including at least two conductive layers, wherein a first conductive layer is disposed on a first surface of the flexible circuit, and a second conductive layer is disposed on a second surface opposite the first surface, such that electrical energy can be conducted through the flexible circuit to the first conductive layer and the second conductive layer; and an electroacoustic module (EAM) disposed at or near a distal region of the flexible circuit, the EAM being coupled to the flexible circuit to define a distal end of the medical device, wherein the at least two conductive layers create a trace route via the flexible circuit to the EAM.

[0221] Example Clause 2: The medical device according to Example Clause 1, wherein one or more of the at least two conductive layers comprise conductive foil.

[0222] Example Clause 3: The medical device according to Example Clause 1 or Example Clause 2, wherein the conductive foil comprises copper.

[0223] Example 4: A medical device according to any one of Examples 1 to 3, wherein at least the first conductive layer and the second conductive layer are electrically connected via at least one of a through-hole connection, a blind via connection, and a buried via connection.

[0224] Example Clause 5: A medical device according to any one of Example Clauses 1 to 4, wherein the distal end of the medical device includes a single tail of the flexible circuit.

[0225] Example 6: The medical device according to any one of Examples 1 to 5, wherein the flexible circuit further includes bidirectional anisotropic conductive film (ACF) bonding pads disposed on one or more of the first conductive layer and the second conductive layer.

[0226] Example Clause 7: A medical device according to any one of Examples Clauses 1 to 6, wherein polyimide is disposed between at least two of the at least two conductive layers.

[0227] Example Clause 8: A medical device configured and sized for placement within a subject's body, the medical device comprising: an electroacoustic module (EAM) disposed at or near a distal region of the medical device, the EAM being at least partially enclosed in material to define a distal end of the medical device; a handle disposed at or near a proximal region of the medical device and spaced apart from the EAM; and a flexible circuit connecting the EAM and the handle, the flexible circuit comprising at least two conductive layers, wherein a first conductive layer is disposed on a first surface of the flexible circuit, and a second conductive layer is disposed on a second surface opposite the first surface, such that electrical energy can be conducted through the flexible circuit to the first conductive layer and the second conductive layer, and wherein the at least two conductive layers create a trace route via the flexible circuit to the EAM.

[0228] Example Clause 9: The medical device according to Example Clause 8, wherein the at least two conductive layers comprise at least two conductive foil layers.

[0229] Example Clause 10: The medical device according to Example Clause 8 or Example Clause 9, wherein the conductive foil comprises copper.

[0230] Example 11: A medical device according to any one of Examples 8 to 10, wherein at least the first conductive layer and the second conductive layer are electrically connected via at least one of a through-hole connection, a blind via connection, and a buried via connection.

[0231] Example Clause 12: A medical device according to any one of Example Clauses 8 to 11, wherein the distal end of the medical device includes a single tail of the flexible circuit.

[0232] Example 13: A medical device according to any one of Examples 8 to 12, wherein the flexible circuit further includes bidirectional anisotropic conductive film (ACF) bonding pads disposed on one or more of the first conductive layer and the second conductive layer.

[0233] Example Clause 14: A medical device according to any one of Examples Clauses 8 to 13, wherein a polyimide is disposed between at least two of the at least two conductive layers.

[0234] Example Clause 15: A medical device configured and sized for placement within a subject, the medical device comprising: a flexible circuit including at least two conductive layers, wherein the at least two conductive layers include a printed circuit board assembly (PCBA); an electroacoustic module (EAM) disposed at or near a distal region of the flexible circuit, the EAM being coupled to a first side of the flexible circuit by means of material to define a distal end of the medical device; and an application-specific integrated circuit (ASIC) disposed at or near the distal region of the flexible circuit, the ASIC being coupled to a second side of the flexible circuit opposite to the first side.

[0235] Example Clause 16: The medical device according to Example Clause 15, wherein one or more of the at least two conductive layers comprise conductive foil.

[0236] Example Clause 17: The medical device according to Example Clause 15 or Example Clause 16, wherein the conductive foil comprises copper.

[0237] Example Clause 18: A medical device according to any one of Examples Clauses 15 to 17, wherein at least the first conductive layer and the second conductive layer of the at least two conductive layers are electrically connected via at least one of a through-hole connection, a blind via connection, and a buried via connection.

[0238] Example Clause 19: A medical device according to any one of Examples Clauses 15 to 18, wherein the distal end of the medical device includes a single tail of the flexible circuit.

[0239] Example 20: A medical device according to any one of Examples 15 to 19, wherein the flexible circuit further includes a bi-sided anisotropic conductive film (ACF) bonding pad disposed on one or more of the first and second conductive layers of the at least two conductive layers.

[0240] Example Clause 21: A medical device according to any one of Examples Clauses 15 to 20, wherein polyimide is disposed between at least two of the at least two conductive layers.

[0241] Any technology (including ultrasound and steering technology) from any of the following U.S. patent references may be incorporated into any of the medical tools, devices, systems, or methods of use described herein, the disclosures of which are incorporated herein by reference: 6100626, 6537217, 6559389, 7257051, 7297118, 7331927, 7338450, 7451650, 7451650, 7527591, 7527592, 7569015, 7621028, 7731516, 7740584, 7766833, 7783339, 7791252 7791252, 7819802, 7824335, 7966058, 8057397, 8096951, 8207652, 8207652, 8213693, 8364242, 8428690, 8451155, 8527032, 8659212, 8721553, 8727993, 8742646, 8742646, 8776335, 8790262, 8933613, 8978216, 8989842, 9055883, 9439625, 9575165, 9639056 and 20080287783.

[0242] The foregoing disclosure provides examples and descriptions, but is not intended to be exhaustive or to limit specific implementations to the exact forms disclosed. Modifications may be made based on the foregoing disclosure, or modifications may be derived from the practice of specific implementations. As used herein, the term "component" is intended to be interpreted broadly as hardware, firmware, or a combination of hardware and software. It will be apparent that the systems and / or methods described herein can be implemented in various forms of hardware, firmware, and / or combinations of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods does not limit specific implementations. Therefore, the operation and behavior of these systems and / or methods are described herein without reference to specific software code; it should be understood that software and hardware can be used to implement these systems and / or methods based on the description herein. As used herein, satisfying a threshold may refer to a value greater than a threshold, greater than or equal to a threshold, less than a threshold, less than or equal to a threshold, equal to a threshold, etc., depending on the context. Although specific combinations of features are recited in the claims and / or disclosed in the specification, these combinations are not intended to limit the disclosure of various specific implementations. In fact, many of these features can be combined in ways not specifically described in the claims and / or not disclosed in the specification.

[0243] Although each dependent claim listed below may directly depend on only one claim, the disclosure of various specific embodiments includes a combination of each dependent claim with each other claim in the claim set. Unless expressly stated otherwise, no element, action, or instruction used herein should be construed as critical or necessary. Furthermore, as used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more.” Furthermore, as used herein, the article “the” is intended to include one or more items referenced in combination with the article “the” and may be used interchangeably with “one or more.” Furthermore, as used herein, the term “set” is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, etc.) and may be used interchangeably with “one or more.” Where only one item is intended to be described, the phrase “only one” or similar language is used. Furthermore, as used herein, the terms “having,” “comprising,” “containing,” etc., are intended as open-ended terms. Furthermore, unless expressly stated otherwise, the phrase “based on” is intended to mean “at least partially based on.” Furthermore, as used herein, the term “or” is intended to be inclusive when used in enumeration and may be used interchangeably with “and / or” unless otherwise expressly stated (e.g., if used in conjunction with “any” or “only one of them”).

Claims

1. A medical device configured and sized for placement within a subject's body, the medical device comprising: A flexible circuit includes at least two conductive layers, wherein a first conductive layer is disposed on a first surface of the flexible circuit, and a second conductive layer is disposed on a second surface opposite to the first surface, such that electrical energy can be conducted through the flexible circuit to the first conductive layer and the second conductive layer. and An electroacoustic module (EAM) is disposed in or near the distal region of the flexible circuit, and the EAM is coupled to the flexible circuit to define the distal end of the medical device. The at least two conductive layers thereunder create a trace route from the flexible circuit to the EAM.

2. The medical device according to claim 1, wherein, One or more of the at least two conductive layers include conductive foil.

3. The medical device according to claim 2, wherein, The conductive foil includes copper.

4. The medical device according to claim 1, wherein, At least the first conductive layer and the second conductive layer are electrically connected via at least one of through-hole connection, blind-hole connection and buried-hole connection.

5. The medical device according to claim 1, wherein, The distal end of the medical device includes a single tail portion of the flexible circuit.

6. The medical device according to claim 1, wherein, The flexible circuit also includes bi-directional anisotropic conductive film (ACF) bonding pads disposed on one or more of the first and second conductive layers.

7. The medical device according to claim 1, wherein, Polyimide is disposed between at least two of the at least two conductive layers.

8. A medical device configured and sized for placement within a subject's body, the medical device comprising: An electroacoustic module (EAM) is disposed in or near the distal region of the medical device, and the EAM is at least partially enclosed in material to define the distal end of the medical device; A handle, wherein the handle is disposed in or near the proximal region of the medical device and spaced apart from the EAM; as well as A flexible circuit connecting the EAM and the handle, the flexible circuit including at least two conductive layers, wherein a first conductive layer is disposed on a first surface of the flexible circuit and a second conductive layer is disposed on a second surface opposite to the first surface, such that electrical energy can be conducted through the flexible circuit to the first conductive layer and the second conductive layer, and wherein the at least two conductive layers create a trace route to the EAM via the flexible circuit.

9. The medical device according to claim 8, wherein, The at least two conductive layers include at least two conductive foil layers.

10. The medical device according to claim 9, wherein, The conductive foil includes copper.

11. The medical device according to claim 8, wherein, At least the first conductive layer and the second conductive layer are electrically connected via at least one of through-hole connection, blind-hole connection and buried-hole connection.

12. The medical device according to claim 8, wherein, The distal end of the medical device includes a single tail portion of the flexible circuit.

13. The medical device according to claim 8, wherein, The flexible circuit also includes bi-directional anisotropic conductive film (ACF) bonding pads disposed on one or more of the first and second conductive layers.

14. The medical device according to claim 8, wherein, Polyimide is disposed between at least two of the at least two conductive layers.

15. A medical device configured and sized for placement within a subject's body, the medical device comprising: A flexible circuit, the flexible circuit comprising at least two conductive layers, wherein the at least two conductive layers comprise a printed circuit board assembly (PCBA); An electroacoustic module (EAM) is disposed in or near the distal region of the flexible circuit, the EAM being coupled to a first side of the flexible circuit by means of material to define the distal end of the medical device; as well as An application-specific integrated circuit (ASIC) is disposed at or near the distal region of the flexible circuit and is coupled to a second side of the flexible circuit opposite to the first side.

16. The medical device according to claim 15, wherein, One or more of the at least two conductive layers include conductive foil.

17. The medical device according to claim 16, wherein, The conductive foil includes copper.

18. The medical device according to claim 15, wherein, At least the first and second conductive layers of the at least two conductive layers are electrically connected via at least one of through-hole connection, blind-hole connection, and buried-hole connection.

19. The medical device according to claim 15, wherein, The distal end of the medical device includes a single tail portion of the flexible circuit.

20. The medical device according to claim 15, wherein, The flexible circuit further includes bi-directional anisotropic conductive film (ACF) bonding pads disposed on one or more of the first and second conductive layers of the at least two conductive layers.

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