WO2025166320A1

WO2025166320A1 - Handheld oscillating wire torque device

Info

Publication number: WO2025166320A1
Application number: PCT/US2025/014237
Authority: WO
Inventors: Catalin Toma; Jared ROMEO
Original assignee: University of Pittsburgh; UPMC
Current assignee: University of Pittsburgh; UPMC
Priority date: 2024-02-01
Filing date: 2025-02-01
Publication date: 2025-08-07
Anticipated expiration: 2026-08-01

Abstract

A wire torque device for use in connection with an interventional wire includes a hand-held assembly comprising a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire.

Description

HANDHELD OSCILLATING WIRE TORQUE DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Patent Application Serial No. 63/627,969, filed February 1, 2024, the disclosure of which is incorporated herein by reference.

BACKGROUND ART

[0002] The following information is provided to assist the reader in understanding technologies disclosed below and the environment in which such technologies may typically be used. The terms used herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the technologies or the background thereof. The disclosure of all references cited herein are incorporated by reference.

[0003] Guidewires are flexible, precisely controllable wires that are used, for example, to access the coronary and peripheral vascular system. Guidewires are commonly used for placing and guiding devices such as catheters (for example, balloon dilation catheters during percutaneous transluminal coronary angioplasty or PTCA). In general, the guidewire is passed through the catheter during use. Wire torque devices are often used as supportive devices when guiding and/or manipulating such guidewires to a target site in medical procedures.

[0004] FIG. 1A illustrates a perspective view of a commercially available GLIDEWIRE® TORQUE™ device 10 (sometime referred to as a torquing device or torquer) available from Terumo Interventional Systems of Somerset, New Jersey US, showing an interventional wire or guidewire 50 in connection or operative connection therewith. An interventional wire such as a guidewire 50 passes through a passage 22 in a rotatable nut or nut member 20 and through a passage (not shown) through a body 30 of device 10, which is connected to rotatable nut 20. As described above, wire torque device 10 is a supportive device which is used in guiding and/or manipulating a guidewire. Such wire torque devices provide more contact surface for the user to facilitate manipulation of guidewire 50. Torque device 10 is, for example, indicated to be compatible with guidewires that range from 0.010" (0.26 mm) to 0.038" (0.97 mm) in diameter and to be usable with hydrophilic and standard/uncoated guidewires. Torque devices such as torque device 10 assist in torquability (rotatability), steering, and gripping of guidewire 50. In regard to torquability, rotation of device 10 by a user gripping body 30 (as represented by arrow A in FIG. 1A) causes rotation of connected guidewire 50 (as represented by arrow a in FIG. 1A).

[0005] FIG. IB illustrates another commercially available wire torque device 10a (available from Merit Medical OEM of South Jordan, Utah US), which, like device 10, includes a rotatable nut 20a connectable to a body 30a. In FIG. IB, torque device 10a is illustrated in a disconnected state wherein nut 20a is disconnected from body 30a and in a connected state wherein nut 20a is connected to body 30a. As illustrated in FIG. IB, nut 20a is rotatably connectible to body 30a via threating 32a on body 30a and cooperating threading (not shown) on an interior of nut 20a. When guidewire 50 is passed through device 10a, it passes through a clamping mechanism such as a pin vise 34a (as known in the mechanical arts) of body 30a. As known in the art, contact of one or more interior surfaces (not shown) of nut 20a (during tightening rotation of nut 20a relative to body 30a) causes pin vise 34a to form a clamping connection with guidewire 50. Conversely, loosening rotation of nut 20a relative to body 30a will cause release that locking or clamping connection.

[0006] Regardless of whether a torque device is used in connection with a guidewire or not, intravascular friction may create difficulty in navigating tortuous and narrow arteries during percutaneous vascular interventions. Currently, interventional wire passage may, for example, be facilitated by one of the following: 1) axial manual torquing; 2) vascular microcatheters; 3) vascular balloons; and/or 4) hydrophilic, polymer-jacketed guidewires. Each of those techniques has significant drawbacks including limited success, additional equipment, additional cost, and increased risk of thrombosis, vessel dissection, and vessel perforation, leading to increased clinical morbidity and mortality. Moreover, the use of such devices is restricted to high volume, complex, operators, limiting their general application to the population at large.

[0007] Further, chronic total coronary occlusion (CTO) lesions often prevent passage of guidewire therethrough and various techniques have developed for crossing CTO. A number of studies have been conducted to determine if high-frequency (20 kHz) vibration can be used to safely recanalize guidewire refractory CTOs. See Klaus, T., et al., High-Frequency Vibration for the Recanalization of Guidewire Refractory Chronic Total Coronary Occlusions, Catheterization and Cardiovasc Interv, 72:771-780 (2008). In such studies, a CROSSER™ catheter was connected to a generator of the high-frequency vibrations that were propagated to a blunt, stainless steel tip of the catheter through a Nitinol transmission wire to fragment occlusive fibrous tissue using a drill-like mechanism of operation. Saline irrigation was used to cool the system. Such studies of intravascular oscillatory systems demonstrated promise and safety. However, those techniques were not adopted because of the need for bulky intravascular housing systems, limited deliverability to target vasculature, reduced tactile feedback, and limited applicability to modern PVI techniques.

[0008] In a number of other studies, approximal end of a microcatheter is clamped to a device which generates reciprocal or vibratory motion. A guidewire is passed through the catheter. See, Rees, M.R. and Michalis, L.K., Activated-guidewire technique for treating chronic coronary artery occlusion, The Lancet, 346: 943-944 (1995). The generated vibratory motion is transmitted to the guidewire and produces complex motion at the distal end of the guidewire.

SUMMARY OF THE INVENTION

[0009] In one aspect, a wire torque device for use in connection with an interventional wire includes a hand-held assembly comprising a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire. The oscillator may, for example, include a motor. In a number of embodiments, the motor is an eccentric rotating mass motor or a linear oscillatory motor.

[0010] In a number of embodiments, the body of the hand-held assembly further includes a housing in which the oscillator is positioned. One or more controls (for example, one or more switches, knobs or other controls) may, for example, be in connection with (for example, positioned on) the housing and be in electrical connection with the oscillator to control the oscillator (for example, to control various states such as the on/off state, the frequency, the power, etc. of the oscillator).

[0011] In a number of embodiments, the oscillator is configured to oscillate at a frequency of 1000 Hz or less. The oscillator may, for example, be configured to oscillate at a frequency in the range of 50 Hz to 200 Hz or in the range of 50 Hz to 150 Hz.

[0012] The interventional wire may pass through the body of the wire torque device. The interventional wire may, in a number of embodiments, pass through an axis of the oscillator. The interventional wire may alternatively pass around at least a portion of the oscillator (for example, around a housing of the oscillator). [0013] In another aspect, a method of placement of an interventional wire in a target region of a vasculature, includes oscillating the interventional wire via a wire torque device including a hand-held assembly including a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire. As described above, in a number of embodiments the oscillator comprises a motor. The motor may, or example, be an eccentric rotating mass motor or a linear oscillatory motor.

[0014] As also described above, the body of the hand-held assembly may further include a housing in which the oscillator is positioned. One or more controls may, for example, be in connection with the housing and be in electrical connection with the oscillator to control the on/off state of the oscillator.

[0015] In a number of embodiments, the oscillator is configured to oscillate at a frequency of 1000 Hz or less. The oscillator may, for example, be configured to oscillate at a frequency in the range of 50 Hz to 200 Hz or in the range of 50 Hz to 150 Hz.

[0016] The interventional wire may pass through the body of the wire torque device. The interventional wire may, in a number of embodiments, pass through an axis of the oscillator. The interventional wire may alternatively pass around a housing of the oscillator.

[0017] In a further aspect, a method of placement of an interventional wire in a target region of a vasculature, comprising oscillating the interventional wire at a frequency of 1000 kHz or less during placement thereof.

[0018] The present devices, systems, and methods, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

[0019] FIG. 1A illustrates a perspective view of a commercially available wire torque device showing a guidewire in connection or operative connection therewith.

[0020] FIG. IB illustrates a top plan view of another commercially available wire torque device in a disconnected state wherein the nut of the wire torque device is disconnected from the body of the wire torque device and in a connected state wherein the nut is connected to the body. [0021] FIG. 2A illustrates schematically, a side, hidden-line view of a representative embodiment of a handheld oscillating wire torque device of the present invention for use in, for example, the placement of interventional wires.

[0022] FIG. 2B illustrates schematically the wire torque device of FIG. 2A with the motor removed therefrom and a section of the housing of the torque device shown in a cutaway view.

[0023] FIG. 2C illustrates schematically the wire torque device of FIG. 2A in operative connection with a patient.

[0024] FIG. 3 illustrates an isometric view of the eccentric rotating mass motor (ERM) of FIG. 2B wherein the wire is illustrated passing through the motor shaft.

[0025] FIG. 4 illustrates a cutaway view of two sections of an embodiment of a housing for use in the oscillating torque devices hereof, wherein the housing is bisected through an axial plane in forming the two sections.

[0026] FIG. 5A illustrates a perspective view of another representative embodiment of a torque device hereof in a disassembled state and an ERM which is removed from the housing, wherein the housing is shown with a portion thereof cut away and the rear cap is removed.

[0027] FIG. 5B illustrates a rear perspective, cutaway view of the housing of FIG. 5A with the rear cap of the housing removed.

[0028] FIG. 5C illustrates a front perspective cutaway view of the housing of FIG. 5A.

[0029] FIG. 5D illustrates a front view of an embodiment of a rear cap of the housing of FIG. 5A.

[0030] FIG. 5E illustrates a rear view of the rear cap of the housing of FIG. 5A.

[0031] FIG. 5F illustrates another perspective cutaway view of housing of FIG. 5A and a perspective view of the cutaway section thereof, wherein (when assembled) surface F' of the cutaway section abuts surface F of the housing.

[0032] FIG. 5G illustrates another perspective cutaway view of the housing sections of FIG. 5F.

[0033] FIG. 5H illustrates front perspective view of an embodiment of a nut hereof for use with the housings of FIG. 5A.

[0034] FIG. 51 illustrates a rear perspective view of the nut of FIG. 5H.

[0035] FIG. 5J illustrates a front view of the nut of FIG. 5H.

[0036] FIG. 5K illustrates another perspective cutaway view of the housing of FIG. 5A showing an opening for seating a control and a recessed portion of the housing surrounding the opening.

[0037] FIG. 6A illustrates a front view of another representative embodiment of a torque device hereof. [0038] FIG. 6B illustrates a bottom view of the torque device of FIG. 6A.

[0039] FIG. 6C illustrates a rear view of the torque device of FIG. 6A.

[0040] FIG. 6D illustrates a side, cross-sectional view of the torque device of FIG. 6A along section B-B illustrated in FIG. 6B.

[0041] FIG. 6E illustrates a side view (rotated 180 degrees from the view of FIG. 6D) of the torque device of FIG. 6A.

[0042] FIG. 6F illustrates an isometric, exploded or disassembled view of the torque device of FIG. 6A.

DESCRIPTION

[0043] It will be readily understood that the components of the embodiments, as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations in addition to the described representative embodiments. Thus, the following more detailed description of the representative embodiments, as illustrated in the figures, is not intended to limit the scope of the embodiments, as claimed, but is merely illustrative of representative embodiments.

[0044] Reference throughout this specification to "one embodiment" or "an embodiment" (or the like) means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearance of the phrases "in one embodiment" or "in an embodiment" or the like in various places throughout this specification are not necessarily all referring to the same embodiment.

[0045] Furthermore, described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a thorough understanding of embodiments. One skilled in the relevant art will recognize, however, that the various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, et cetera. In other instances, well known structures, materials, or operations are not shown or described in detail to avoid obfuscation.

[0046] As used herein and in the appended claims, the singular forms "a,” "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a switch or control" includes a plurality of such switches or controls and equivalents thereof known to those skilled in the art, and so forth, and reference to "the switch or control" is a reference to one or more such switches or controls and equivalents thereof known to those skilled in the art, and so forth. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each separate value, as well as intermediate ranges, are incorporated into the specification as if individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contraindicated by the text. As used herein, the terms approximately, about, and the like when used in connection with a value refer to ±5% (and more desirably ±1%) of the stated value.

[0047] The terms "electronic circuitry", "circuitry" or "circuit," as used herein include, but are not limited to, hardware, firmware, software, or combinations of each to perform a function(s) or an action(s). For example, based on a desired feature or need, a circuit may include a software controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device. Field programmable gate arrays (FPGAs) include integrated circuits that are "field programmable." In that regard, FPGAs may be reconfigured to meet specific use case requirements after the manufacturing process. A circuit may also be fully embodied as software. As used herein, "circuit" is considered synonymous with "logic." The term "logic", as used herein includes, but is not limited to, hardware, firmware, software, or combinations of each to perform a function(s) or an action(s), or to cause a function or action from another component. For example, based on a desired application or need, logic may include a software controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device. Logic may also be fully embodied as software.

[0048] The term "processor," as used herein includes, but is not limited to, one or more of virtually any number of processor systems or stand-alone processors, such as microprocessors, microcontrollers, central processing units (CPUs), and digital signal processors (DSPs), in any combination. The processor may be associated with various other circuits that support operation of the processor, such as random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), clocks, decoders, memory controllers, or interrupt controllers, etc. These support circuits may be internal or external to the processor or its associated electronic packaging. The support circuits are in operative communication with the processor. The support circuits are not necessarily shown separate from the processor in block diagrams or other drawings.

[0049] The term “memory system" refers to a collection of electronic components that store data and instructions. In computerized systems, a processor system can quickly access information stored in a memory system. Memory allows storage and retrieval of information and may, for example, include primary memory and secondary memory. Primary memory includes, for example, RAM, cache memory, etc. Secondary memory includes, for example, hard drives, hard disk drives etc.

[0050] The term "controller," as used herein includes, but is not limited to, any circuit or device that coordinates and controls the operation of one or more input and/or output devices. A controller may, for example, include a device having one or more processors, microprocessors, or central processing units capable of being programmed to perform functions.

[0051] The term “software," as used herein includes, but is not limited to, one or more computer readable or executable instructions that cause a computer or other electronic device to perform functions, actions, or behave in a desired manner. The instructions may be embodied in various forms such as routines, algorithms, modules, or programs including separate applications or code from dynamically linked libraries. Software may also be implemented in various forms such as a stand-alone program, a function call, a servlet, an applet, instructions stored in a memory, part of an operating system or other types of executable instructions. It will be appreciated by one of ordinary skill in the art that the form of software is dependent on, for example, requirements of a desired application, the environment it runs on, or the desires of a designer/programmer or the like.

[0052] In a number of embodiments, devices, systems, and methods hereof include a handheld, interventional wire torque device that imparts oscillations or vibrations (that is, lateral or generally lateral to and fro or reciprocal motion) to an interventional wire. The oscillations or vibrations reduce intravascular friction and ease the wiring of tortuous and/or narrow arteries to facilitate percutaneous vascular interventions (PVI).

[0053] FIGS. 2A through 2C illustrate an embodiment of a torque device 110 hereof which is similar in a number of respects in operation and fabrication to torque devices 10 and 10a. Wire torque device 110 includes a hand-held assembly comprising a body 112 and an oscillator or vibrator connected or operatively connected to body 112 as described further below. Wire torque device 110 further includes one or more connectors configured to connect to an interventional wire 50 (see FIG. 2 B) to transmit oscillation or vibration from the oscillator to interventional wire 50. In the illustrated embodiment, body 112 includes or functions as a housing 130 for an oscillator such as a motor 200 as described further below.

[0054] Interventional wire 50 may, for example, be passed through device 110 in a similar manner to that described for devices 10 and 10a and locked in connection via a nut 120 and pin vise 140 (or other clamp, lock, or attachment mechanism to grip and form an attachment with wire 50). The oscillator or vibrator may, for example, include a built-in or integrated, eccentric rotating mass motor (ERM) 200, positioned within housing 130 along with a battery-based (for example, a 3V battery-based) power system 250, which may also be incorporated within housing 130. An example of a suitable ERM for use herein is the PICO VIBE™ coreless vibration motor available from Precision Microdrives of London, England United Kingdom. An enlarged view of that motor 200 is provided in, for example, FIG. 3. In the illustrated embodiment, a motor shaft 210 extends to connect to an eccentric mass counter weight 214 as known in the ERM arts. Counter weight 214 may be housed in a secondary housing 130' as illustrated in broken lines in FIG. 2A or motor 200 and counter weight 214 may both be housed within housing 130.

[0055] One or more controls or switches as represented by switch or button 136 (see FIG. 2A) may be in connection with housing 130 via one or more passages as represented by passage 132 (see FIGS. 2A and 3) formed in housing 130 to activate motor 200. In a number of embodiments of devices hereof, additional controls to for example, control power, frequence etc. may be provided. The one or more controls may, for example, be positioned remote from device 110 (or other devices hereof) and controlled via, voice command, a footswitch, etc. Such controls may be placed in connection with a device hereof in a wired or wireless manner (for example, using BLUETOOTH, a wireless communication protocol administered by Bluetooth SIG, Inc. of Kirland, Washington, wireless ethernet, etc.) as known in the electrical and computer arts.

[0056] As illustrated in FIG. 2A, in a number of embodiments electronic circuitry 500 may be integrated with device 110 (for example, positioned within housing 130) or placed in communicative connection with device 110 (in either a wired or wireless manner). Electronic circuitry 500 (which is illustrated schematically in FIG. 2A) may, for example, be distributed between device 110 and one or more other devices as known in the computer arts (for example, computers, servers, etc.). In a number of embodiments, electronic circuitry 500 may include a processor system 510, a memory system 520 in communication with processor system 510. One or more software executable by processor system 510 may be stored in memory system 520. Electronic circuity may further include a user interface 530, a communication system 540, a sensor system 550, an input/output system 560 and/or other electronics components as known in the art. Electronic circuitry 500 may be used as a controller to control device 110 and to analyze data as, for example, measure by sensor system 550 (for example, to control ON/OFF state, frequency, power, etc.). Sensor system 550 may, for example, be used to effect feedback control of device 110.

[0057] The size of device 110 may readily be adjusted (for example, miniaturized) to be of a size similar to existing, commercially available wire torque devices such as torque devices 10 and 10a or to be of an optimized size for a particular use or user. Interventional wire torque devices hereof such as torque device 110 can be actuated or triggered to oscillate or vibrate interventional wire or guidewire 50 that is connected or operatively connected thereto in a manner such that oscillatory or vibrational energy /force is transmitted to interventional wire 50. In a number of embodiments, interventional wire 50 passes through the central axis of device 110 (including, for example, through the central axis/motor shaft 210 of motor 200 via a passage 212 therethrough) as illustrated, for example, in FIG. 4. In other embodiments, interventional wire 50 may pass around the shell or housing 220 of motor 200. For example, interventional wire 50 may pass through linearly or through a baffle path or system (as discussed further below) within housing 130 to bypass the housing of motor 200. As described above, vibrating eccentric mass counter weight 214 may transmit oscillation/vibration to interventional wire 50 through a connector such as cooperating nut 120 and pin vise 140 or other connector mechanism attachable to interventional wire 50.

[0058] In a number of embodiments, it may be desirable that interventional wire 50 pass through an axis corresponding to the center of mass of device 110, including through the center of mass of motor 200 as illustrated in FIG. 4. In that regard, such positioning of intervention wire 50 may foster efficient transmission of oscillation/vibration. The mass of motor 200 may assist in transmitting oscillation/vibration. Further, passing interventional wire 50 through the center of axis of motor 200 assists in achieving miniaturization. Moreover, passing interventional wire 50 through the center of axis of motor 200 facilitates the ability of interventional wire 50 to be torqued or rotated in a one-to-one fashion, and in a single plane with, torquing/ rotation of device 110. If interventional wire 50 is baffled eccentrically, torque/rotation of device 110 may not be provide a one-to-one response in the torque/rotation transmitted to interventional wire 50. Even small variations in transmission of torque can have relatively large consequences because of the length of interventional wire 50 and the size of the vascular vessels through which interventional wire 50 passes.

[0059] Passing wire 50 through the axis of shaft 210 as illustrated in FIG. 4 will typically require development of a dedicated ERM or modification of commercially available vibrators such as ERM 200. FIGS. 5A through 5K illustrate another embodiment of a device 110a hereof in which a commercially available vibrator such as an ERM motor maybe used without modification. Device 110a includes a body 112a which may be formed from or include a housing 130a. Housing 130a may, for example, be formed from a polymeric material such as hard plastic material. Housing 130a includes an interior volume which, in the illustrated embodiment is compartmentalized to house a miniaturized ERM such as ERM 200, or another motor. Housing 130a may, for example, include a seating, volume or compartment 131a including a rearward or distal section 132a and a forward or proximal section 132a' for seating of motor housing 220 and eccentric mass counter weight 214, respectively. A forward abutment (not shown) may be provided to contact a forward end of motor housing 220 to assist in proper position thereof within compartment 131a. A seating, volume or compartment 133a is provide for seating a battery such as a 3V battery (not shown). Another seating, volume or compartment 133a' is provide for a control assembly for a control (not shown). Housing 130a is illustrated in a cutaway sectional view in FIGS. 5A and 5B. Cutaway or remaining section 130a' of housing 130a is illustrated in FIGS. 5F and 5G.

[0060] Further, housing 130a includes a guide system to direct an interventional wire such as wire 50 through housing 130a in a manner to bring the interventional wire in close contact with motor 200 (for example, with motor housing 220) to assist in providing maximal transmission of vibratory force from motor 200 to the interventional wire as described further below. In the illustrated embodiment, the wire (not shown) is passed through the proximal, centrally oriented device lumen 134a, which is centrally aligned with pin vise support or seating 135a. A pin vise (not shown in FIGS. 5A through 5K) such as illustrated in FIG. IB may be seated within pin vise support 135a. Pin vise support 135a includes threading 136a which cooperates with cooperating threading 124a of a nut 120 (see FIGS. 51 and 5J). A passage or lumen 122a (see FIGS. 5H and 5J) in nut 120a aligns with lumen 134a when nut 120a is placed in connection with pin vise support 135a of housing 130a. Nut 120a may include a ridged surface (as illustrated in FIGS. 5A through 5J) or other surface features to facilitate gripping thereof. [0061] Referring to FIG. 5B, in the illustrated embodiment, guidewire 50 (represented schematically as a broken line in FIG. 5B) enters an interior volume of housing 130a via a lumen 134a (each of which desirably coincide with or are colinear with the axis of the housing) and passes along generally along axis A (see FIG. 5A) of housing 130a into channel 137a that passes adjacent to housing 220 of ERM 200 (when positioned within compartment 131a. On passing rearward of the housing of the ERM, guidewire 50 passes through an opening or passage 142a in distal end cap 140a (see FIGS. 5D and 5E). Wire 50 thus enters device 110a colinear with or approximately colinear with central axis A thereof and leaves device 110a colinear with or approximately colinear with central axis A thereof to maintain a central rotational axis for wire torque transmission. As illustrated in FIG. 5D, a forward surface of end cap 140a includes a forward projecting abutment 144a in the illustrated embodiment which abuts or contacts a rearward surface of ERM housing 220 to assist in positioning ERM 200 within compartment 131a.

[0062] As used herein in connection with device 110a (and other devices hereof), terms such as "rearward” or "distal" refer to a direction away from support 135a, and terms such as "forward" or "proximal" refer to a direction toward support 135a.

[0063] Housing 220 of ERM 200 is desirably positioned or seated within compartment 131a with tight packing to further transmit the vibrational force throughout device housing 130a and reduce air damping. On/off toggling (as well as other control) of device 110a may, for example, be incorporated in a number of embodiments via an integrated miniature control or switch (not shown) that controls ERM 200 as described in connection with device 110. The control or switch may be housed or attached on device 110a within a passage 138a positioned in a recessed section 139a of housing 130a (see FIG. K). Recessed section 139a assists in preventing tactile obstruction during manual housing manipulation.

[0064] In a number of other embodiments (for example, in the case of and ERM with a housing having a diameter larger than that of housing 220), after passing guidewire through passage or lumen of the nut and through the forward lumen of the housing (each of which desirably coincide with or are colinear with the axis of the housing), guidewire 50 may then be diverted laterally to pass through a precut channel (similar to channel 137a, but not colinear with axis A) that passes adjacent to the housing of the ERM. On passing rearward of the housing of the ERM, guidewire 50 may, be redirected (for example, via another channel) to be reoriented centrally to be colinear or approximately colinear with the axis of the housing, to allow central exit of the wire through an end opening in the distal end cap (as described above for end cap 140a). Similar to the case of device 110a, the wire thus enters the housing colinear with or approximately colinear with the central axis thereof and leaves the housing colinear with or approximately colinear with the central axis thereof to maintain a central rotational axis for wire torque transmission.

[0065] As described above, It is desirable that the guidewire interact with the oscillator to efficiently transfer oscillatory or vibratory energy from the oscillator to the motor. Such energy transfer is desirably optimized. For example, in passing the guidewire through the body (or through a housing thereof), the guidewire may be brought into direct contact with the housing of the oscillator. The length of contact may be optimized. If the guidewire is place in connection with the oscillator via one or more intervening elements or components, it is desirable that such elements or components efficiently transfer oscillatory or vibratory motion therethrough to the guidewire.

[0066] FIGS. 6A through 6E illustrates another embodiment of a torque device 110b hereof. Similar to device 110a, a commercially available vibrator such as an ERM motor 200b maybe used without modification in device 110b. Device 110b includes a body 112b which may be formed from or include a housing 130b. As described above, housing 130b may, for example, be formed from a polymeric material. In the illustrated embodiment, housing 130b includes a first housing section or base 130b' and a second housing section or cover 130b" which are assembled to form housing 130b via cooperating snap fittings 130bs' and 130bs" (see FIG. 6F) or other connectors as known in the mechanical arts. First section 130b' includes a seating, volume or compartment 131b which is conformed or dimensioned for relatively snugly or tightly seating of motor housing 220b of motor 200b. Second housing section 130b" includes a seating, volume or compartment 133b for seating a battery such as a 3V battery and a seating, volume, or compartment 133b' for seating a control assembly 170b including one or more controls such as button 172b in the illustrated embodiment. Second housing section 130b" further includes one or more passages 138b for passage of such controls, wherein a single passage 138d is provided for single button 172b in the illustrated embodiment.

[0067] A pin vise 150b such as illustrated in FIGS. 6D and 6F is seated within a pin vise support 135b of first housing section 130b'. Pin vise support 135b includes threading 136b which cooperates with cooperating threading 124b of a nut 120b. A passage or lumen 122b (see FIG. 6D) in nut 120b aligns with a lumen 134b in first housing section 130b' when nut 120b is placed in connection with pin vise support 135b of housing 130b. As described above for nut 120a, nut 120b may include a ridged surface or other surface features to facilitate gripping thereof.

[0068] Referring to FIG. 6D, guidewire 50 (represented schematically as a broken line in FIG. 6D) enters an interior volume of first housing section 130b' via a lumen 134b (which desirably coincides with or is colinear with the axis A of the housing 130b; see FIG. 6E) and passes along or generally along axis A of housing 130b adjacent to housing 220b of ERM 200b. In the illustrated embodiment, the eccentric rotating member (not shown) of motor 200b is positioned within housing 220b thereof. Guidewire 50 distally exits housing 130b through an opening or passage 142b in distal end cap 140b. Wire 50 thus enters device 110b colinear with or approximately colinear with central axis A thereof and leaves device 110b colinear with or approximately colinear with central axis A thereof to maintain a central rotational axis for wire torque transmission. As illustrated in FIG. 6D, a forward surface of end cap 140b includes a forward projecting member, contact member, or abutment member 144b in the illustrated embodiment which interacts a rearward surface of ERM housing 220b to assist in positioning ERM 200b within compartment 131b. In the illustrated embodiment, projecting member 144b interact with motor 200b via an intermediate extending member 144b' (for example, a rod or other extending element; see FIG. 6D), which contacts the forward surface of projecting member 144b at one end thereof and contacts the rearward surface of motor housing 220b at the other end thereof. In other embodiment, projecting member 144b may contact motor 200b directly. The forward surface of end cap 140b further includes a forward projecting member, contact member, or abutment 146a which interacts a rearward surface of battery 160b to assist in positioning batter 160b within compartment 133b of second housing section 130b”.

[0069] The devices, systems, and methods hereof provide the ability to oscillate or vibrate an interventional wire such as wire 50 at relatively high frequency via an extracorporeal, hand-held, wire torque device such as device 110, device 110a or device 110b. Wire torque devices hereof may be manufactured to be similar in size and tactile feedback to standard, commercially available coronary guidewire torque/torquing devices. The ability to oscillate interventional wire 50 at relatively high frequency provides a significant advance compared to current techniques. In that regard, relatively high frequency oscillation reduces kinetic wire friction and facilitates the ability to manipulate and deliver interventional wires in otherwise complex, tortuous, or calcified anatomy. Such functionality is likely to reduce the failure rate of complex PVI and reduce the complication rate of wire vessel trauma experienced with conventional wiring techniques. In a number of embodiments hereof, the frequency of oscillation is 1 kHz or less, or 200 Hz or less. In a number of embodiments, the frequency of oscillation is in the range of 50 Hz to 200 Hz or in the range of 50 Hz to 150 Hz.

[0070] The wire torque devices hereof are readily manufactured, cost-effective, and may be disposable after a single use. The wire torque devices hereof require no additional equipment that must be delivered within the vasculature and can be used with any style of intravascular interventional wire/guidewire. As described above, the wire torque devices hereof may be miniaturized to be approximately the same size as commercially available wire torque devices. The wire torque devices hereof are operated in a similar manner to currently available wire torque devices, requiring no additional training, but add the functionality and advantages of oscillating the interventional wire. Other than the oscillator or vibrator hereof (for example, a motor such as an ERM or linearly oscillatory motor), components of wire torque devices hereof may be manufactured in a similar manner and from similar materials as currently available wire torque device. Housings 130, 130', 130a and 130b as well as rotating nuts 120, 120a may, for example, be manufactured from polymeric materials as known in the art. Miniature ERMs suitable for use herein are readily available and are very inexpensive. Any oscillator suitable to impart the oscillation/vibration described herein may be used in the wire torque devices hereof. As described above, in addition to ERMs, linear oscillatory or vibratory motors may also be used herein. In a number of embodiments, the wire torque devices hereof may, for example, be 5 to 10 mm in diameter and 10 to 30 mm in length. The wire torque devices hereof are, for example, compatible with guidewires that range over the full range of available diameters (for example, from 0.010" (0.26 mm) to 0.038" (0.97 mm)) and with coated and standard/uncoated guidewires. The wire torque devices hereof also require no specialized training to apply in clinical practice. Tactile ridges may me provided on wired torque devices hereof to aid in torquability, steering, and gripping of a connected guidewire.

[0071] The oscillation achieved in the present devices, systems, and methods is quite different from the high frequency (20KHz) oscillations previously used to generate a penetrative force to "drill" through calcified lesions. As described above, the goal achieved with the technology hereof is quite different from such technologies. Such oscillating, drilling systems were free standing, bulky systems that required a separate backup system to which the oscillating catheter thereof is connected. Unlike the handheld wire torque devices hereof, that backup system of such oscillating, drilling systems constituted durable medical equipment. Further, by directly connecting or associating the guidewire with the source of oscillation, the transmission of oscillation to the guidewire is more efficient that clamping an associated catheter to the source of oscillation as done in a number of studies. As described above, the guidewires used in connection with the torque devices hereof may, for example, be associated with an oscillator (for example, including a motor) housed within the body of the torque device in a manner to maximize or optimize transmission of oscillation or vibration to the guidewire. Moreover, as described above, associating the source of oscillation or vibration with a torque device hereof (for example, via housing the source of oscillation of vibration within the body of the torque device), significantly facilitates the use of devices hereof.

[0072] The foregoing description and accompanying drawings set forth a number of representative embodiments at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope hereof, which is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A wire torque device for use in connection with an interventional wire, comprising: a hand-held assembly comprising a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire.

2. The wire torque device of claim 1 wherein the oscillator comprises a motor.

3. The wire torque device of claim 2 wherein the motor is an eccentric rotating mass motor or a linear oscillatory motor.

4. The wire torque device of claim 2 wherein the body of the hand-held assembly comprises a housing in which the oscillator is positioned.

5. The wire torque device of claim 4 wherein one or more controls are in connection with the housing to control the oscillator.

6. The wire torque device of any one of claims 1 through 5 wherein the oscillator is configured to oscillate at a frequency of 1000 Hz or less.

7. The wire torque device of claim 6 wherein the oscillator is configured to oscillate at a frequency in the range of 50 Hz to 200 Hz, or optionally in the range of 50 Hz to 150 Hz.

8. The wire torque device of any one of claims 1 through 5 wherein the interventional wire passes through an axis of the oscillator.

9. The wire torque device of any one of claims 1 through 5 wherein the interventional wire passes around a housing of the oscillator.

10. A method of placement of an interventional wire in a target region of a vasculature, comprising: oscillating the interventional wire via a wire torque device comprising a hand-held assembly comprising a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire.

11. The method of claim 10 wherein the oscillator comprises a motor.

12. The method of claim 11 wherein the motor is an eccentric rotating mass motor or a linear oscillatory motor.

13. The method of claim 11 wherein the body of the hand-held assembly comprises a housing in which the oscillator is positioned.

14. The method of claim 13 wherein one or more controls are in connection with the housing to control the oscillator.

15. The method of any one of claims 10 through 14 wherein the oscillator is oscillated at a frequency of 1000 Hz or less.

16. The method of claim 15 wherein the oscillator is oscillated at a frequency in the range of 50 Hz to 200 Hz, or optionally in the range of 50 Hz to 150 Hz.

17. The method of any one of claims 10 through 14 wherein the interventional wire passes through an axis of the oscillator.

18. The method of any one of claims 10 through 14 wherein the interventional wire passes around a housing of the oscillator.

19. A method of placement of an interventional wire in a target region of a vasculature, comprising oscillating the interventional wire at a frequency of 1000 kHz or less during placement thereof.

20. The method of claim 19 wherein the interventional wire is oscillated via a hand-held assembly comprising a body, an oscillator connected to the body, and a connector via which the interventional wire may be placed in connection with the hand-held assembly to transmit oscillation from the oscillator to the interventional wire.

21. The method of claim 20 wherein the oscillator comprises a motor.

22. The method of claim 21 wherein the motor is an eccentric rotating mass motor or a linear oscillatory motor.