Motion control locking mechanism for interventional imaging probes

Abstract

This invention relates to an invasive / interventional device or probe, comprising a control handle and an insertion tube operably connected to an imaging system. The control handle includes: a body; a motion control mechanism at least partially disposed within the body and having one or more control elements disposed on the body; one or more gears rotatably disposed within the body and operably connected to the control elements; and one or more cables engaging the gears, the cables extending outward from the body and adapted to engage with the tip of an interventional medical device. The control handle also includes a motion locking mechanism at least partially disposed within the body, the motion locking mechanism having one or more brake levers biased to engage with the gears, and a release switch engaging the brake levers to selectively position the brake levers to engage or disengage with the gears.

Description

[0001] Technical Field and Background Technology

[0002] The embodiments disclosed herein relate generally to interventional imaging, and more specifically to the structure of a control handle for manipulating an interventional imaging probe and the method of operation thereof in these interventional procedures.

[0003] Various medical conditions affect internal organs and structures. Effective diagnosis and treatment of these conditions often require physicians to directly observe the patient's internal organs and structures. For example, the diagnosis of various heart diseases typically requires cardiologists to directly examine the affected areas of the patient's heart. Instead of more invasive surgical techniques, ultrasound imaging is often used to directly visualize the patient's internal organs and structures.

[0004] For example, interventional procedures such as transesophageal echocardiography (TEE) and / or intracardiac echocardiography (ICE) can be used to provide high-resolution images of intracardiac anatomy. These high-resolution images then allow for real-time guidance of interventional devices during structural heart disease (SHD) interventions, such as transcatheter aortic valve implantation (TAVI), perivalvular regurgitation repair, and / or mitral valve intervention.

[0005] TEE (Transcatheter Echocardiography) procedures are typically performed in examinations, interventions, and operating room settings (open-heart surgery) where imaging of the patient's internal structures is required. The equipment used to perform TEE typically includes an invasive or interventional device or probe, a processing unit, and a monitor. The probe is connected to the processing unit, which in turn is connected to the monitor. During the procedure, the processing unit sends a trigger signal to the probe. The probe then transmits the ultrasound signal to the patient's heart via an imaging element within the probe. The probe then detects the echo of the previously transmitted ultrasound signal. The probe then sends the detected signal to the processing unit, which converts the signal into an image. This image is then displayed on the monitor. The probe typically includes a semi-flexible insertion cannula containing a transducer located near the tip of the probe.

[0006] Typically, during TEE, an insertion tube is introduced into the patient's mouth and positioned in the esophagus. The insertion tube is then positioned such that the transducer is in a position favorable for cardiac imaging. That is, the insertion tube is positioned so that the heart or other internal structure to be imaged is in the field of view of the imaging element or transducer located within the insertion tube. Typically, the transducer transmits ultrasound signals through the esophageal wall in contact with the heart or other internal structure. The transducer then receives the ultrasound signals as they bounce back from various points within the patient's internal structure. The transducer then typically transmits the received signals back through the insertion tube via wiring. After the signal travels through the insertion tube and the probe, it typically enters the processing unit via a wire that connects the probe to the processing unit.

[0007] Typically, in addition to the heart, it may be desirable to image other internal structures within the patient using other interventional imaging procedures and devices, such as bronchoscopy or colonoscopy. Imaging other internal structures may require repositioning or using different probes to view the desired internal organs or other internal structures of the patient. Additionally, viewing the heart and / or other internal structures from various angles and perspectives may require probe repositioning during these procedures.

[0008] While TEE allows for well-defined workflows and good image quality, it may not be suitable for all cardiac interventions. Therefore, ICE can be used in other interventional procedures to provide high-resolution images of cardiac structures, typically under conscious sedation. Furthermore, ICE devices utilizing probes that are structurally highly similar to those used for TEE can be coupled with other interventional imaging systems, allowing for supplemental imaging that can provide additional information for device guidance, diagnosis, and / or treatment. For example, CT, MRI, PET, ultrasound, fluoroscopy, electrophysiology, and / or X-ray imaging systems can be used to provide supplemental views of the anatomy of interest in real time, facilitating ICE-assisted interventional procedures.

[0009] In any of these procedures or any similar invasive or interventional procedures, as previously stated, such as Figures 1 to 3 As shown, the probe or interventional device 1000 inserted into the patient 1002 includes a control handle 1004 having an elongated flexible insertion tube 1006 extending outwardly from the handle 1004. The tube 1006 surrounds a suitable movement mechanism 1007 operatively connected to a control device 1008 on the control handle 1004, allowing an operator to control the movement of the mechanism 1007 and the movement of the flexible tube 1006 within the patient 1002. Opposite to the control handle 1004, the flexible insertion tube 1006 includes an imaging element, such as a transducer 1010, operable to obtain ultrasound images of the patient 1002's anatomy 1018.

[0010] In some existing technology intervention probe control handle configurations, such as Figure 1 and Figure 2As shown, the probe 1000 has a control handle 1004 that allows a user to manipulate the transducer 1010 within the esophagus 1020 of the patient 1002 in two planes (i.e., the anterior-posterior (AP) plane 1014 and the left-right (RL) plane 1016), enabling the acquisition of desired images of structures of interest within the anatomical structure 1018 (e.g., the heart) via the transducer 1010. To allow the transducer 1010 to move within either plane 1014, 1016, a control device 1008 disposed on the control handle 1004 can selectively control the movement of the transducer 1010 within either plane 1014, 1016. For example, the control device 1008 may take the form of a pair of control wheels 1022, 1024 rotatably mounted to the control handle 1004. By rotating the small control wheel 1022, the transducer 1010 can be manipulated in the RL plane 1016, that is, to the left or right relative to the anatomical structure 1018 of the patient 1002. By rotating the large control wheel 1024, the transducer 1010 can be manipulated in the AP plane 1014, that is, forward or backward relative to the anatomical structure 1018 of the patient 1002.

[0011] When the probe 1000 is in use, in order to maintain or hold the transducer 1010 in the desired position to obtain a specific image view, the user can actively hold it on the wheels 1022, 1024 for a short period of time to prevent any unintentional movement of the wheels 1022, 1024 and therefore the transducer 1010. However, if the image view of the transducer 1010 needs to be maintained for a longer period of time, the user can activate the deflection brake or deflection lock 1026 on the control handle 1004. The deflection lock 1026 fixes the wheels 1022, 1024 in the selected position and prevents any movement of the wheels 1022, 1024 until the lock 1026 disengages.

[0012] In the prior art, the deflection lock 1026 can take various forms, such as those disclosed in each of U.S. Patent Nos. 9,999,434; 9,924,855; 9,526,406; 9,259,141; 8,808,168; 10,064,639 and 6,699,182, but each form includes one or more deficiencies regarding the lock's structure and / or operating mode. Therefore, it is desirable to develop an improved deflection lock for interventional probes that avoids these drawbacks of the prior art. Summary of the Invention

[0013] In one exemplary embodiment of the invention, a control handle for an interventional medical device includes: a body; a motion control mechanism at least partially disposed within the body, the motion control mechanism having: one or more control elements disposed on the body; one or more gears rotatably disposed within the body and operably connected to the one or more control elements, the one or more gears including a plurality of engagement structures thereon; and one or more cables engaging with the one or more gears, the one or more cables extending outward from the body and adapted to engage with a tip of the interventional medical device; and a motion locking mechanism at least partially disposed within the body, the motion locking mechanism having: one or more brake levers biased to engage with engagement structures on the one or more gears; and a release switch engaging with the one or more brake levers to selectively position the one or more brake levers to engage or disengage with engagement structures on the one or more gears.

[0014] In another exemplary embodiment of the invention, the interventional medical device includes: an insertion tube assembly having an imaging tip at one end; and a control handle operably connected to the insertion tube relative to a transducer and adapted for connection to an imaging system, wherein the control handle includes: a body; a motion control mechanism at least partially disposed within the body, the motion control mechanism having: one or more control elements disposed on the body; one or more gears rotatably disposed within the body and operably connected to the one or more control elements, the one or more gears including a plurality of engagement structures thereon; and one or more cables engaging the one or more gears, the one or more cables extending outward from the body and engaging the imaging tip; and a motion locking mechanism at least partially disposed within the body, the motion locking mechanism having: one or more brake levers biased to engage with engagement structures on the one or more gears; and a release switch engaging the one or more brake levers to selectively position the one or more brake levers to engage or disengage with engagement structures on the one or more gears.

[0015] In another exemplary embodiment of the invention, a method for controlling the movement of an interventional medical device in an interventional medical procedure includes the following steps: providing an interventional medical device having: an insertion tube assembly having an imaging tip at one end; and a control handle opposite a transducer, operably connected to the insertion tube and adapted for connection to an imaging system, wherein the control handle includes: a body; a movement control mechanism at least partially disposed within the body, the movement control mechanism having: one or more control elements disposed on the body; one or more gears rotatably disposed within the body and operably connected to the one or more control elements, the one or more gears including a plurality of engagement structures thereon; and one or more cables engaging with the one or more gears, the one or more cables extending outward from the body and engaging with the imaging tip; and a motion locking mechanism at least partially disposed within the body, the motion locking mechanism having: one or more brake levers biased to engage with engagement structures on the one or more gears; and a release switch engaging with the one or more brake levers to selectively position the one or more brake levers to engage or disengage with engagement structures on the one or more gears; operating the movement control mechanism to move the tip; and operating the motion locking mechanism to restrict movement of the movement control mechanism in one or more directions.

[0016] It should be understood that the above brief description is provided to introduce selected concepts further described in the detailed embodiments in a simplified form. This is not intended to identify key or essential features of the claimed subject matter, the scope of which is uniquely defined by the claims following the detailed embodiments. Furthermore, the claimed subject matter is not limited to embodiments that address any shortcomings mentioned above or in any part of this disclosure. Attached Figure Description

[0017] Figure 1 This is a top plan view of a prior art interventional probe, including the insertion tube and control handle.

[0018] Figure 2 yes Figure 1 A side view of the interventional probe.

[0019] Figure 3 This is a schematic diagram of an interventional probe inserted into a patient's body.

[0020] Figure 4 This is a schematic diagram of an exemplary imaging system according to various aspects of this disclosure.

[0021] Figure 5 This is an isometric view of an interventional device including a control handle constructed according to an exemplary embodiment of the present disclosure and operable with an ultrasound imaging system.

[0022] Figure 6 The exemplary embodiments of this disclosure include control mechanisms. Figure 5 A top view of the partially disconnected control handle.

[0023] Figure 7 yes Figure 6 A top view of the partially disconnected control mechanism of the control handle.

[0024] Figure 8 yes Figure 6 A side front view of the control mechanism of the control handle that is partially disconnected.

[0025] Figure 9 yes Figure 6 A bottom view of the control mechanism of the control handle, showing a partial disconnection.

[0026] Figure 10 It is along Figure 7 The cross-sectional view along line 10-10 illustrates a deflection locking mechanism according to an exemplary embodiment of the present disclosure.

[0027] Figure 11 It is along Figure 10 Cross-sectional view of line 11-11.

[0028] Figure 12 It is along Figure 10 The cross-sectional view of line 12-12.

[0029] Figure 13 It is along Figure 10 The cross-sectional view of line 13-13.

[0030] Figures 14A to 14D yes Figure 9 Partially disconnected cross-sectional views and bottom plan views of the various operating structures of the deflection locking mechanism.

[0031] Figures 15A to 15E These are top and bottom views of the control switch for operating the deflection locking mechanism according to an exemplary embodiment of the present disclosure, at different positions on the control handle.

[0032] Figure 16 This is a cross-sectional view of a partially disconnected electronic deflection locking mechanism according to an exemplary embodiment of the present disclosure.

[0033] Figure 17 yes Figure 16 A bottom-view plan view of the electronic deflection locking mechanism.

[0034] Figure 18 This is a top view of the control switch used to operate the electronic deflection locking mechanism. Detailed Implementation

[0035] Figure 4 An exemplary imaging system 100 for optimal visualization of a target structure 102 used during interventional procedures is shown. For discussion purposes, system 100 is described with reference to a TEE system. However, in some embodiments, system 100 may be implemented in other interventional imaging systems, such as TTE systems, ICE systems, OCT systems, magnetic resonance imaging (MRI) systems, CT systems, positron emission tomography (PET) systems, and / or X-ray systems. Additionally, it may be noted that although this embodiment is described with reference to imaging a region corresponding to the patient's heart, some embodiments of system 100 may be used with other biological tissues, such as lymphatic vessels, cerebral blood vessels, and / or in non-biological materials.

[0036] In one implementation, system 100 uses ultrasound signals to acquire image data corresponding to a target structure 102 on the subject. Furthermore, system 100 can combine the acquired image data corresponding to the target structure 102 (e.g., the cardiac region) with supplemental image data. For example, supplemental image data may include previously acquired images and / or real-time intraoperative image data generated by a supplemental imaging system 104, such as CT, MRI, PET, ultrasound, fluoroscopy, electrophysiology, and / or X-ray systems. Specifically, the combination of acquired image data and / or supplemental image data can allow the generation of composite images that provide a greater amount of medical information for accurate guidance of interventional procedures and / or for providing more accurate anatomical measurements.

[0037] Therefore, in one embodiment, system 100 includes an interventional device or probe 106, such as an ultrasound probe, laparoscope, bronchoscope, colonoscope, needle, catheter, and / or endoscope. The interventional device 106 is adapted for use in confined medical or surgical settings, such as a body cavity, orifice, or chamber corresponding to a subject (e.g., a patient). The interventional device 106 may further include at least one imaging subsystem 108 disposed at a distal end of the interventional device 106. The imaging subsystem 108 may be configured to generate cross-sectional images of the target structure 102 for evaluating one or more corresponding features. Specifically, in one embodiment, the imaging subsystem 108 is configured to acquire a series of three-dimensional (3D) and / or four-dimensional (4D) ultrasound images corresponding to the subject, although the subsystem 108 may also acquire one-dimensional (1D) and two-dimensional (2D) ultrasound images. In some embodiments, system 100 may be configured to generate a 3D model relative to time, thereby generating a 4D model or image corresponding to a target structure (such as a patient's heart). For example, system 100 can use 3D and / or 4D image data to visualize a 4D model of target structure 102 in order to provide medical practitioners with real-time guidance for navigating probes / interventional devices 106 inside a patient.

[0038] Therefore, in some embodiments, the imaging subsystem 108 may be an ultrasound imaging system including a transmitting circuit 110 that can be configured to generate pulsed waveforms to operate or drive imaging elements 111 (such as one or more transducer elements 112). The transducer elements 112 are configured to transmit and / or receive ultrasonic energy and may contain any material suitable for converting signals into acoustic energy and / or converting acoustic energy into signals. For example, according to an exemplary embodiment, the transducer element 112 may be a piezoelectric material, such as lead zirconate titanate (PZT) or a capacitive micromachining ultrasonic transducer (CMUT). The interventional device 106 may include more than one transducer element 112, such as two or more transducer elements 112 arranged in an array or separated from each other on the interventional device 106. The transducer elements 112 generate echoes that return to the transducer elements 112 and are received by the receiving circuit 114 for further processing. The receiving circuit 114 is operatively coupled to the beamformer 116, which can be configured to process the received echo and output a corresponding radio frequency (RF) signal.

[0039] Furthermore, system 100 includes a processing unit 120 communicatively coupled to acquisition / imaging subsystem 108, operatively connected via wired or wireless communication network 118 to beamformer 116, interventional device 106, and / or receiving circuitry 114. Processing unit 120 can be configured to receive and process acquired image data, such as RF signals, according to multiple selectable ultrasound imaging modes in near real-time and / or offline modes.

[0040] Furthermore, in one embodiment, processing unit 120 may be configured to store acquired volumetric images, imaging parameters, and / or viewing parameters in memory device 122. For example, memory device 122 may include storage devices such as random access memory, read-only memory, disk drives, solid-state memory devices, and / or flash memory. Additionally, processing unit 120 may display volumetric images and / or information derived from the images to a user (such as a cardiologist) for further evaluation on an operatively connected display 126, for manipulation using one or more connected input-output devices 124 to transmit information and / or receive commands and input from the user, or for processing by a video processor 128, which may be connected and configured to perform one or more functions of processing unit 120. For example, video processor 128 may be configured to digitize received echoes and output the resulting digital video stream on display device 126.

[0041] See now Figure 5In the illustrated exemplary embodiment, the interventional device 106 is disclosed as an ultrasound probe / TEE probe 200. The ultrasound probe 200 includes a control handle 202 operatively connected to the processing unit 120 via a cable 203; and an insertion tube 204 extending outward from the control handle 202 opposite to the cable 203, wherein the imaging subsystem 108 is housed within the tube 204, which includes a tip 207 opposite to the handle 202. The control handle 202 includes one or more control elements 206 thereon, which enable an operator of the ultrasound probe 200 to control internal movement and various operations of the imaging mechanism, as well as associated wiring and / or other connections (not shown) disposed within the hollow interior of the insertion tube 204.

[0042] View now Figures 6 to 13 In an exemplary embodiment, the control handle 202 includes an elongated body 210 formed of a lightweight and durable material, such as plastic or metal, and having any suitable construction to form the body 210, such as a one-piece, two-piece, or other multi-piece construction.

[0043] The control element 206 located on the body 210 may include one or more switches 212, buttons, or other elements 206, together with a motion control mechanism 213 formed by a pair of control wheels 214, 216. The wheels 214, 216 are rotatably mounted to the exterior of the body 210 in a configuration that allows them to be easily engaged and rotated by an individual using the probe 200, such as... Figures 6 to 10 The stacked configuration is illustrated in an exemplary embodiment. Wheels 214 and 216 are each rotatably disposed about a fixed central axis 218 extending through and fixed to the body 210. The first wheel 214 is disposed adjacent to and attached to a first gear 220 disposed within the body 210 about the central axis 218. The second wheel 216 is positioned adjacent to the first wheel 214, opposite the body 210, and includes a rotatable shaft 222 extending through the first gear 220 and attached to a second gear 224 disposed within the body 210 adjacent to the first gear 220. A pair of bearings 226 are disposed between the second gear 224 and the central axis 218 to allow the second gear 224 and the second wheel 216 to rotate relative to the central axis 218 and the body 210. Another separate bearing 228 is disposed between the rotatable shaft 222 and the first gear 220 to allow the first gear 220 to rotate independently of the second gear 224 relative to the central axis 218 and the body 210.

[0044] The first gear 220 and the second gear 224 are similarly formed to each other and each includes a pair of spaced-apart circumferential grooves 230, 232 disposed on the gear and defining a central ring 231 therebetween, wherein the central ring 231 includes a plurality of spaced teeth 233 spaced apart by grooves 235. Figure 7 Alternatively, other suitable engagement structures may be provided on the central ring. Each groove 230, 232 includes a stop 234, wherein the stop 234 of each groove 230, 232 is located on the opposite side of the gears 220, 224. A pair of control cables / wire ropes / stranded wires 236, 238 are positioned within the respective grooves 230, 232, wherein one end of each cable 236, 236 engages with the stop 234 in the groove 230, 232. Opposite to the stop 234, each control cable 236, 238 engages with a separate connector 240, which also engages with connector cables 242, 244 opposite to the control cables 236, 238. Connector cables 242, 244 extend through aligned bushings 246, which are located in structural supports 247 provided within the body 210 and spaced apart from the gears 220, 224. Bushing 246 maintains the vertical and horizontal orientation of control cables 236, 238 and connector cables 242, 244 aligned with grooves 230, 232, thereby preventing interference between cables 236, 238, 242, 244 as they move via the rotation of gears 220, 224. Alternatively, control cables 236, 238 and connector cables 242, 244 can be formed as a single cable, eliminating the need for connector 240.

[0045] Connector cables 242, 244 extend from bushing 246 through cable guides 248, 250, which are connected to bushing 246 and positioned along insertion tube 204. Connector cables 242, 244 and guides 248, 250 are terminated and connected to opposite sides (top and bottom or left and right) of tip 207, such that cable loops are formed between each gear in gears 220, 224 and tip 207, thereby allowing rotation of gears 220, 224 to be converted into linear movement of tip 207, i.e., forward / backward or right / left, when using motion control mechanism 213.

[0046] View now Figures 6 to 1 4. The probe 200 further includes a motion locking mechanism 260 that engages with gears 220 and 240. This locking mechanism 260 includes a housing 262 disposed within a body 210 between control cables 236 and 238. The housing 262 includes a first portion 264 located near the bracket 247 and a second portion 266 located near the gears 220 and 224. Figure 10As best shown, the first portion 264 includes a pair of blind holes 268, 270 formed therein, which are aligned with the first gear 220 and the second gear 224, respectively. Each of the holes 268, 270 receives a biasing member 272 therein. In an exemplary embodiment, the biasing member is a compression spring 274, such as a wave spring or a coil spring, or other suitable type of biasing member. The compression spring 274 receives a rod portion 276 of the brake lever 278, 280 therein. The rod portion 276 extends through a central space 282 defined within the compression spring 274 into an alignment channel 284 provided at the end of each of the holes 268, 270 to maintain the alignment of the rod portion 276 relative to the holes 268, 270.

[0047] Opposite to the lever portion 276, each of the brake levers 278 and 280 includes a head 286 and 288, on which a wedge-shaped member 308 is disposed opposite to the lever portion 276. Each head 286 and 288 has at least one dimension larger than the space 282 defined within the center of the compression spring 274, such that each head 286 and 288 is positioned on and engages with the end of the compression spring 274 opposite to the channel 284. Furthermore, the heads 286 and 288 of each brake lever 278 and 280 are shaped to be slightly smaller in size than the holes 268 and 270, such that the heads 286 and 288 remain aligned with the holes 268 and 270 as they move along the holes.

[0048] like Figures 10 to 13 As best shown, each of the heads 286, 288 includes an arm 292, 294 extending outward from the corresponding head 286, 288, which, in the illustrated exemplary embodiment, is shown in a direction generally perpendicular to the long axis 296 of each brake lever 287, 280. Additionally, the head 288 on the brake lever 280 has a recess 298 formed below the head 286 on the brake lever 278, and the arm 292 extends through this recess. The recess 298 is sized such that the arm 292 can extend through the recess 298 without contacting the periphery of the recess 298. Furthermore, each arm 292, 294 extends through alignment holes 300, 302 in the second portion 266 to terminate opposite to the corresponding head 286, 288 in an aligned position outside the second portion 266.

[0049] At the end of each arm 292, 294 located outside the second portion 266, each arm 292, 294 includes a pin 304 that engages with and extends outward therefrom. In the illustrated exemplary embodiment, the pin 304 is generally cylindrical in shape and includes a tab 305 positioned relative to the arm 292, 294. Each pin 304 includes a bearing sleeve 306 disposed around the pin 304 between the arm 292, 294 and the tab 305, the bearing sleeve being rotatable relative to the pin 304 and held on the pin 304 by the tab 305.

[0050] View now Figure 10 and Figure 11 Opposite to lever 276, each head 286, 288 includes a wedge 308 formed thereon. Each wedge 308 projects outward from the corresponding head 286, 288 in a direction along the long axis 296 of the brake lever 278, 280, and aligns with openings 310, 312 in a second portion 264 generally opposite to the first portion 264. Due to engagement with spring 274, the heads 286, 288 are continuously biased to push the wedge 308 into and through the associated alignment openings 310, 312, as... Figure 10 The position of the brake lever 278 is illustrated. In this position, the wedge 308 is inserted into the groove 235 on the central ring 231 of the gear 220, between adjacent teeth 233 engaged by the wedge 308, thereby preventing the gear 220 and the associated wheel 214 from rotating.

[0051] Now for reference Figures 9 to 12 To disengage or remove the wedge 308 from the groove 235 and engage with the teeth 233, the motion locking mechanism 260 includes a release switch 314. In an exemplary embodiment, the release switch 314 is formed with an actuator / knob 316 disposed on a central shaft 218 on a body 210 opposite to wheels 214, 216. The knob 316 is connected to a cam 318, which is located at least partially around the central shaft 218 within the body 210, adjacent to a second gear 224 opposite to the first gear 220. A bearing 320 is disposed between the cam 318 and the central shaft 218 to allow the cam 318 to rotate independently of the first gear 220 and the second gear 224 relative to the central shaft 218.

[0052] Cam 318 includes an engagement flange 322 extending outward from cam 318 into a recess 324 formed in body 310 adjacent to cam 318. The shapes of flange 322 and recess 324 are complementary to each other to allow flange 322 to rotate freely within recess 324 due to movement of third gear 318 about central axis 218. In the illustrated exemplary embodiment, flange 322 is formed in a fan shape, having a curved narrow end 326 attached to cam 318 and a curved wide end 328 opposite to narrow end 326. A plurality of notches 330 separated by ridge 332 are formed in wide end 328, including a wide shallow central notch 334 and a plurality of smaller deep side notches 336 disposed on each side of central notch 334. The position and length of flange 322 between narrow end 326 and wide end 328 are such that pin 304 on each arm 292, 294 can engage in one of the notches 330 on flange 322. The engagement of flange 322 with pin 304 resists the bias of spring 274, allowing flange 322 to selectively press pin 304 and brake levers 278, 280 into the second portion 266 of housing 262 to displace wedge 308 out of groove 235 between teeth 233 on one or both of gears 220, 224, thereby disengaging wedge 308 from teeth 233.

[0053] View now Figure 10 , Figure 12 and Figures 14A to 14D The shallow central recess 334 is less deep than the deep side recess 336, which allows the central recess 334 to resist the bias of the spring 274 and press the pin 304 and brake levers 278, 280 into the housing 262. The greater depth of the side recess 336 allows the spring 274 to press the pin 304 into the recess 336 until the wedge 308 on the brake levers 278, 280 associated with the pin 304 in the recess 336 can engage with the teeth 233 on the aligned gears 220, 224.

[0054] exist Figures 14A to 14D The different operating positions of the release switch 314 are illustrated in the diagram. Figure 14A In this configuration, both pins 304 are located within the central recess 334. In this position, the flange 332 engages and presses the pins 304, and by extension, the two locking levers 278, 280 resist the bias of the spring 274 into the housing 262. Thus, the wedge-shaped element 308 on each locking lever 278, 280 is spaced apart from the teeth 233 on the gears 220, 224, allowing each gear 220, 224 to rotate freely to operate the movement control mechanism 213 to position the tip 207 at a desired location in each of the AP and RL planes.

[0055] View now Figure 14BWhen the release switch 314 / cam 318 reference Figure 14B When rotated counterclockwise in the exemplary orientation shown, the pin 304 associated with the locking lever 278 is further pressed into the housing 262 by the ridge 332 until the pin 304 aligns with the notch 336. Due to the depth of the notch 336, when the pin 304 for the braking lever 278 is located in the notch 336, the braking lever 278 moves out of the housing 262 and enters the position where the wedge 308 on the lever 278 contacts and engages the tooth 233 on the first gear 220. Due to this engagement of the wedge 308 on the lever 278 with the tooth 233 on the gear 220, the free rotation of the gear 220 is stopped, thus locking the gear 220 in that position. Therefore, the tip 207 is locked or held in the AP or RL position or orientation specified by the specific position of the first gear 220. However, the pin 304 associated with the brake lever 280 is held within the central recess 334, such that the brake lever 280 remains disengaged from the second gear 224, thereby allowing the second gear 224 and thus the tip 207 to move freely in the associated AP or RL plane.

[0056] about Figure 14C Release switch 314 / cam 318 from Figure 14B The position is further rotated clockwise so that each pin 304 is positioned within the notch 336. Due to the depth of the notch 336, the two rods 278, 280 are allowed to move their wedge-shaped members 308 to engage with the aligned first gear 220 and second gear 224, thereby stopping the rotation of each gear 220, 224 and preventing any movement of the tip 207 using the wheels 214, 216.

[0057] Similar to Figure 14B The structure, now let's examine it. Figure 14D When the release switch 314 / cam 318 is relative to Figure 14D When the exemplary orientation is rotated clockwise, the pin 304 associated with the brake lever 278 moves out of the central recess 334 and into the adjacent recess 336, while the pin 304 for the lever 278 remains within the central recess 334. In this position, the wedge 308 on the lever 280 engages with the teeth 233 on the second gear 220, while the wedge 308 on the lever 278 remains disengaged from the first gear 224. Thus, movement of the second gear 224 prevents the tip 207 from moving in the associated AP or RL plane, while rotation of the first gear 220 allows the tip 207 to move in another plane within the AP or RL plane. Furthermore, although in Figures 14A to 14D Not shown in the diagram, release switch 314 / cam 318 is in Figure 14D Further clockwise rotation places each pin 304 in the notch 336 into the center notch 334. Figure 14C The structure is on the opposite side, but with Figure 14C The same construction is shown, which allows rods 278 and 280 to engage gears 220 and 224 to prevent the tip 207 from moving in both the AP plane and the RL plane.

[0058] View now Figures 15A to 15E Instead of knob 316, release switch 314 / cam 318 includes actuator 338 connected to cam 318 and positioned on and / or above the body 310. Actuator 338 allows a user to rotate cam 318 and flange 322 within body 210 to select a desired operating configuration for motion locking mechanism 260. Marker 340 may be placed on or near actuator 338 to illustrate the position of actuator 338 associated with various operating configurations of motion locking mechanism 260. Furthermore, as... Figures 15A to 15E As shown in each figure, the actuator 338 can take various forms and be located in different positions on the exterior of the body 210, for example, aligned with wheels 214, 216. Figure 15A , Figure 15C and Figure 15D ) or adjacent wheels 214, 216 ( Figure 15B and Figure 15E ).

[0059] As previously described, each lever 278, 280 engages with a spring 274 in the housing 262, which has a biasing force acting on the lever 278, 280. This biasing force can be overcome by rotation of the release switch 314, allowing the motion locking mechanism 260 to selectively allow movement of the tip 207 using the movement control mechanism 213. When the wedge 308 engages with the gears 220, 224, such as when the user retracts the motion locking mechanism 260 in an emergency and / or when the force applied to the tip 207 within the patient 202 is too high and could damage the tip 207 and / or injure the patient 202, the biasing force provided by the spring 274 can also be overcome when sufficient rotational force / torque is applied to one or both wheels 214, 216 to rotate the gears 220, 224. In one exemplary embodiment, spring 274 is selected to provide a biasing force on levers 278, 280, which is high enough to prevent any unintentional rotation of wheels 214, 216 from revoking motion locking mechanism 260, but the biasing force is below a force threshold that would cause damage to the tissue of patient 202. However, the configuration of teeth 233 and wedges 308 (e.g., each including an inclined engagement surface) allows teeth 233 and wedges 308 to slide relative to each other when a force exceeding the biasing force of spring 274 is applied to tips 207 and / or wheels 214, 216, while allowing teeth 233 and wedges 308 to easily re-engage with each other in a ratchet-like manner, thus maintaining engagement of motion locking mechanism 260 after accommodating the applied excessive force.

[0060] See Figures 16 to 18 An exemplary embodiment is illustrated, showing a motion locking mechanism 400 for probe 200, which includes a motor 402 located within a body 210. Motor 402 is an electric motor, such as a high-torque direct current (DC) motor, which can be powered via cable 203 or using a rechargeable power source (not shown) (such as a rechargeable battery or inductive charging power supply), and has a drive shaft 404 that engages a first spur gear 406 to rotate the spur gear 406. The first spur gear 406 can directly mesh with a driven gear 408 operably connected to a cam 318, or directly mesh with a second spur gear 410 disposed between the first spur gear 318 and the driven gear 408. When rotated by motor 402, driven gear 408 rotates cam 318 and flange 322 to position flange 322 and recesses 334, 336 thereon in the desired configuration of motion locking mechanism 400, as per [reference to previous description]. Figures 14A to 14D Furthermore, the actuator 412 for mechanism 400 is formed of a suitable electrical switch 414 (such as a membrane switch) including a mark 416 indicating the location of the portion of switch 414 associated with a specific construction of mechanism 400.

[0061] This written description uses examples to disclose the invention, including the best mode, and also enables those skilled in the art to practice the invention, including making and using any device or system and performing any included methods. The scope of the invention is defined by the claims and may include other examples that would occur to those skilled in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements that are not indistinguishable from the literal language of the claims, or if they include equivalent structural elements that have minor differences from the literal language of the claims.

Claims

1. A control handle for an interventional medical device, the control handle comprising: -main body; - A movement control mechanism, which is at least partially disposed within the main body, the movement control mechanism comprising: -A pair of control elements disposed on the main body; - Two gears, rotatably disposed within the body and operably connected to the pair of control elements, the two gears including a plurality of engagement structures thereon; and - One or more cables engaging with the two gears, the one or more cables extending outward from the body and adapted to engage with the tip of an interventional medical device; and - A motion locking mechanism, which is at least partially disposed within the body, the motion locking mechanism comprising: - One or more brake levers, said one or more brake levers being biased to engage with said engagement structure on said two gears; and - A release switch, which engages with the one or more brake levers to selectively position the one or more brake levers to engage or disengage with the engagement structure on the two gears.

2. The control handle of claim 1, wherein, The motion locking mechanism includes one or more springs that bias the one or more brake levers.

3. The control handle according to claim 2, wherein the one or more springs are compression springs.

4. The control handle according to claim 3, wherein the one or more brake levers comprise: - A rod portion, wherein the rod portion is disposed within one or more compression springs; and - A head, which is configured to abut against the end of the compression spring.

5. The control handle of claim 1, wherein, The one or more brake levers include a pin extending outward from the one or more brake levers and engaging with the release switch.

6. The control handle of claim 5, wherein, The release switch includes an engagement flange having a plurality of recesses in which one or more pins are received.

7. The control handle according to claim 6, wherein, The release switch includes an actuator disposed on the exterior of the main body.

8. The control handle according to claim 7, wherein, The release switch also includes a motor operably connected between the actuator and the engagement flange.

9. The control handle according to claim 6, wherein, The plurality of notches includes one or more shallow notches and one or more deep notches.

10. The control handle according to claim 1, wherein, The one or more brake levers include a wedge-shaped element that selectively engages with the engagement structure on the two gears.

11. The control handle according to claim 10, wherein, The engagement structure is formed as teeth on the two gears.

12. The control handle according to claim 1, wherein, The pair of control elements includes two control wheels that engage with the two gears.

13. An interventional medical device comprising a control handle according to any one of claims 1 to 12.

14. The interventional medical device of claim 13, further comprising an insertion cannula assembly having an imaging tip at one end, wherein, The control handle is operatively connected to the insertion tube relative to the transducer and is adapted for connection to an imaging system.

15. A method for controlling the movement of an interventional medical device according to any one of claims 13 to 14, the method comprising the steps of: - Operate the movement control mechanism to move the tip; as well as - Operate the motion locking mechanism to restrict the movement of the motion control mechanism in one or more directions.

16. The method according to claim 15, wherein, The steps of operating the motion locking mechanism include moving a release switch to selectively overcome bias on one or more brake levers, thereby selectively engaging the motion locking mechanism with the motion control mechanism.

17. The method according to claim 15, wherein, The one or more brake levers include pins extending outwardly from the one or more brake levers, and wherein the release switch includes an engagement flange having a plurality of recesses therein for receiving one or more pins, and wherein the step of moving the release switch includes rotating the engagement flange to position the one or more pins within the respective recesses on the engagement flange.

Images