Magnetic release from medical equipment

Abstract

A detachment device according to some embodiments may include an actuator, a medical device, and a detachment connection portion that couples the actuator and the medical device, the detachment connection portion having an actuator portion on the actuator side and a medical device portion on the medical device side. The actuator portion may include an actuator support portion, an actuator side ferromagnetic block, and a slider element. The medical device portion may include a medical device support portion, a medical device side ferromagnetic block, and a slider element. At least one of the actuator side ferromagnetic block and the medical device side ferromagnetic block includes a magnet, and the actuator is coupled to the medical device by a magnetic coupling force. The actuator separates from the medical device when a separation force is greater than a predetermined amount.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority from U.S. Provisional Application No. 63 / 308,713, filed February 10, 2022, and U.S. Provisional Application No. 63 / 314,940, filed February 28, 2022, each of which is incorporated by reference in its entirety herein.

[0002] FIELD OF THE DISCLOSURE This disclosure relates generally to medical connectors, and more particularly to magnetic breakaway for medical devices. [Background technology]

[0003] Minimally invasive imaging, diagnostic, and therapeutic devices are used in image-guided therapies to view inside the body. These types of medical procedures can be performed with flexible medical devices and tools, such as catheters, endoscopes, colonoscopes, bronchoscopes, and ablation devices. The medical devices are then inserted into the patient's body and instruments are passed through the tools to examine or treat areas within the body. A bronchoscope is an endoscopic instrument used to look inside a patient's airways. Catheters and other medical tools can be inserted through the tool channels of the bronchoscope to provide a pathway to a target area within the patient for diagnosis, treatment, or other purposes.

[0004] Continuum robots, robotically controlled and / or snake-like catheter assemblies are exemplary medical structures or configurations in which flexible medical devices can be implemented to perform medical procedures. Such medical configurations typically include a rotary drive assembly that provides rotational motion to a steerable catheter or guidewire of an endoscope or other medical device. The drive assembly may be releasably connected to the catheter, and a detachment mechanism may be used to disengage the drive assembly from the catheter in response to a detachment force.

[0005] A basic snake catheter assembly, for example, generally includes a steerable catheter actuated by push-pull wires, a powered actuator that drives movement of the catheter tip via the push-pull wires, and a controller that translates user / software commands into actuator movement.

[0006] Steerable catheters with push-pull wires have the advantage over conventional steerable catheters of generating large bending moments without retracting the catheter along the axial direction. However, the tension and retraction forces exerted on the wire by actuating the wire in both the pushing and pulling directions can lead to failure modes such as fracture of the wire anchor (the wire anchor is the attachment mechanism between the wire and the catheter tip), wire dislodgement and extrusion, and excessive lateral bending forces on internal tissues such as lung tissue.

[0007] The release mechanism generally has two stages including a compression release mechanism and a tension release mechanism, as shown in Figure 17. In the compression release mechanism, a pushing force acts on the center of the magnet. This type of release mechanism presents challenges related to stiffness, force density and bandwidth.

[0008] Regarding stiffness, for a compression device to function properly, the mechanism requires a plunger to contain the magnet. The purpose of this component is to form the connection between the magnet and the guidewire. Certain types of release mechanisms require tightly controlled fit between two or more components. Thus, the components must be manufactured to strict process and material standards. These components are non-magnetic and very thin, so they do not weaken the release force. High failure rates can be caused by issues such as material defects, tooling errors, and poor process control. However, common manufacturing techniques generally require a minimum wall thickness of 0.5 mm, making the components difficult to manufacture. Release mechanisms typically require a thickness of nearly 0.1 mm, with a magnet that is 1 / 4 inch outside diameter. This means that the overall diameter and volume of the release mechanism must be large to achieve sufficient release force. Also, the plunger walls must be thin, so the part is not very stiff and may break away under cyclic loading.

[0009] With regard to force density, there are problems with not only being able to generate sufficient force due to wall thickness manufacturing constraints, but also with the loss of ferrous metal volume due to the plunger passing through the center of the mechanism.

[0010] Regarding bandwidth, having two stages and two connections increases the system complexity and spring-damper effect, which may impact the system bandwidth.

[0011] It would be beneficial to alleviate these concerns, improve safety, and address issues related to stiffness, force density, and bandwidth. Summary of the Invention

[0012] Advantageously, the present disclosure provides a magnetic breakaway configuration that enhances safety and addresses concerns regarding stiffness, force density and bandwidth.

[0013] A breakaway device according to some embodiments includes an actuator, a medical device, and a breakaway connection that couples the actuator and the medical device, the breakaway connection including an actuator portion on the actuator side and a medical device portion on the medical device side. The actuator portion may include an actuator support portion, an actuator side ferromagnetic block, and a slider element. The medical device portion may include a medical device support portion, a medical device side ferromagnetic block, and a slider element. At least one of the actuator side ferromagnetic block and the medical device side ferromagnetic block includes a magnet, and the actuator is coupled to the medical device by a magnetic coupling force. The actuator separates from the medical device when a separation force is greater than a predetermined amount.

[0014] The actuator portion may include a spacer attached to the actuator ferromagnetic block and facing the medical device ferromagnetic block, the spacer defining a gap between the actuator ferromagnetic block and the medical device ferromagnetic block. Both the actuator ferromagnetic block and the medical device ferromagnetic block may include magnets.

[0015] The slider element of the actuator portion and the slider element of the medical device portion may be a single slider element that is connected to both the actuator support portion and the medical device support portion.

[0016] The actuator may include a motor, drive, or motorized drive assembly. The actuator may include a rotary drive assembly that provides rotary motion to a plurality of drive wires. The plurality of drive wires may include a monolithic wire of material configured to accommodate both pushing and pulling motions.

[0017] The medical device may be a catheter, an endoscope, a colonoscope, a bronchoscope, or an ablation device. The medical device may be a steerable catheter with a distal end and a proximal end and a plurality of drive wires. The steerable catheter may have a plurality of bendable sections located at the distal end of the steerable catheter, one of the plurality of drive wires passing through each of the bendable sections. The drive wire is a push-pull wire that may have a distal end attached to the distal end of one of the plurality of bendable sections and a proximal end attached to the medical device portion.

[0018] Upon application of a tensile threshold force equal to or greater than a predetermined value to at least one of the plurality of drive wires, a tensile force release mechanism may be actuated to terminate transmission of the tensile force to the steerable catheter via the actuator portion. The tensile force release mechanism may be disposed within the steerable catheter. The plurality of drive wires may include a superelastic material in the form of a nickel-titanium alloy. The plurality of drive wires are configured to reach a superelastic plateau of the superelastic material in a stress-strain relationship at the tensile threshold force, and elongation of the plurality of drive wires in the superelastic plateau state terminates transmission of the tensile force. The plurality of drive wires in the superelastic plateau state may have a maximum elongation equal to or greater than a predetermined operating stroke distance of the plurality of drive wires, the predetermined operating stroke distance corresponding to a maximum operating stroke distance and a maximum elongation.

[0019] Upon application of a compression threshold force to at least one of the plurality of drive wires, a compression force break-away mechanism can be activated to terminate transmission of compression force from the actuator to the steerable catheter via the at least one drive wire. The compression force break-away mechanism can be disposed within the actuator. The compression force break-away mechanism can include a permanent magnet.

[0020] The slider element of the actuator portion and the slider element of the medical device portion can collectively constrain the multiple drive wires in at least one dimension. The slider element of the actuator portion and the slider element of the medical device portion can collectively constrain the multiple drive wires in five dimensions.

[0021] The detachment device may include at least one force sensor coupled to the steerable catheter or medical device portion to measure push / pull forces on the multiple drive wires, at least one motor for pushing and pulling the multiple drive wires based on an operation command, and a controller to issue an operation command to the at least one motor. The controller can issue a command based on metrics calculated using force measurements from the force sensor to stop increasing the push / pull force on the push / pull wires. The actuator can exert a linear force provided by the motor. The linear force can act on the medical device via the detachment device.

[0022] The actuator portion and the medical device portion may be offset from one another in a direction of a magnetic coupling force. An actuator pusher may be coupled to the actuator. The medical device may include a medical device wire pusher. The actuator ferromagnetic block and the medical device ferromagnetic block are configured to be permeable to magnetic flux and form a coupling between one another.

[0023] A system according to some embodiments may include an actuator, a steerable device having a number of drive wires, and a number of release connections coupling the actuator and the steerable device, each release connection having an actuator portion on the actuator side and a steerable device portion on the medical device side.

[0024] Each of the actuator portions may include an actuator support, an actuator-side ferromagnetic block, and a slider element. Each of the steerable device portions may have a device support, a steerable device-side ferromagnetic block, and a slider element. At least one of the actuator-side ferromagnetic block and the device-side ferromagnetic block may include a magnet. When a tensile threshold force is applied to at least one of the plurality of drive wires that is equal to or greater than a predetermined value, a tensile force breakaway mechanism may be activated to stop the transmission of the tensile force to the steerable device via the actuator portion. When a compressive threshold force is applied to at least one of the plurality of drive wires, a compressive force breakaway mechanism may be activated to stop the transmission of the compressive force to the steerable device via the actuator. The system may include at least six breakaway connections, and the steerable device may have at least three drive wires. The actuator is coupled to the medical device by a magnetic coupling force, and the actuator separates from the steerable device when a separation force is greater than a predetermined amount.

[0025] Both the actuator ferromagnetic block and the steerable device ferromagnetic block may include magnets. The slider element of the actuator portion and the slider element of the steerable device portion may be a single slider element connected to both the actuator support and the steerable device support. The actuator may include a motor, drive, or motorized drive assembly.

[0026] The system may also include any combination of the additional features described above for the detachment device.

[0027] Further features of the present disclosure will become apparent from the following description of illustrative embodiments which refer to the accompanying drawings, in which like structure is indicated with like reference numerals, and in which: [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 illustrates a breakaway connection comprising a magnet, according to an example embodiment. [Diagram 2] FIG. 2 illustrates a slider mechanism which supports some features of the breakaway connection of FIG. 1 in an engaged configuration. [Diagram 3] FIG. 3 illustrates the slider mechanism of FIG. 2 in a disengaged configuration. [Figure 4] FIG. 4 illustrates a breakaway connection comprising a magnet and a spacer, according to an example embodiment. [Diagram 5] FIG. 5 illustrates a slider mechanism which supports some features of the breakaway connection of FIG. 4 in an engaged configuration. [Figure 6] FIG. 6 illustrates the slider mechanism of FIG. 5 in a disengaged configuration. [Figure 7] FIG. 7 illustrates a breakaway connection comprising two magnets and a spacer, according to an example embodiment. [Figure 8] FIG. 8 illustrates the components of the breakaway connection of FIG. 7 positioned on a slider mechanism in an engaged orientation. [Figure 9] FIG. 9 illustrates the breakaway connection of FIG. 8 in a disengaged configuration. [Figure 10] FIG. 10 illustrates a diagram showing tensile test data for a single magnet versus a double magnet. [Figure 11] FIG. 11 illustrates a tensile test diagram according to some embodiments. [Figure 12] FIG. 12 illustrates a force management diagram according to some embodiments. [Figure 13] FIG. 13 illustrates another force management diagram according to some embodiments. [Figure 14] Figure 14 illustrates the stress-strain curve of superelastic Nitinol. [Figure 15] FIG. 15 illustrates the force-displacement curves of the tested Nitinol wires. [Figure 16] FIG. 16 illustrates a breakaway connection according to an example embodiment. [Figure 17] FIG. 17 illustrates a breakaway connection according to an example embodiment. [Figure 18] FIG. 18 illustrates a breakaway connection according to an example embodiment. [Figure 19] FIG. 19 illustrates a sliding mechanism for implementing a breakaway connection, according to some embodiments. [Figure 20] FIG. 20 illustrates a medical device according to some embodiments. [Figure 21] FIG. 21 illustrates a block diagram of the medical device of FIG. [Figure 22] FIG. 22 illustrates a block diagram of a controller according to some embodiments. [Figure 23] 23A and 23B illustrate a catheter according to some embodiments. [Figure 24] FIG. 24 illustrates a release device according to the prior art. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Various example embodiments, features and aspects of the present disclosure relating to magnetic breakaway configurations for medical devices that address issues of stiffness, force density and bandwidth while increasing safety are described below with reference to the drawings, which may include different characteristics, advantages, disadvantages, performance parameters, etc. The present disclosure is not limited to any particular configuration.

[0030] In the following embodiments, a magnetic detachment arrangement is described that functionally interacts with a medical device. The medical device is preferably a flexible device and may be a catheter, endoscope, colonoscope, bronchoscope, ablation device, etc. The medical device may be used in conjunction with various medical structures or configurations for performing medical procedures, such as a continuum robot, a robotically controlled or snake-like catheter assembly, etc., where the medical device is inserted into a patient's body and the tool is instrumented to examine or treat a site within the body. Such medical structures have an actuator with a motor or drive configured as a rotary drive assembly that imparts rotational motion to a drive wire or guide wire of a steerable catheter, endoscope, or other medical device. The drive wire may include one or more push-pull wires, drive wires, support wires, or other types of wires, and the drive assembly may drive a bendable section of the catheter by pushing or pulling the drive wire in a push / pull or insertion / withdrawal direction. The detachment arrangement according to some embodiments may be used to releasably connect and disconnect the drive assembly to and from the medical device in response to a coupling or detachment force greater than a predetermined amount.

[0031] The steerable catheter device, configuration, or structure is an exemplary configuration of a medical device according to some embodiments and may include a steerable catheter with a catheter tip actuated by push-pull wires, a motorized actuator for driving movement of the catheter tip via the push-pull wires, and a controller for translating user / software commands into actuator movement, as well as other elements and components. The catheter may have a proximal end near the actuator and a distal end near the catheter tip. Variations and other configurations of this medical device are within the scope of this disclosure and are not limited to these structures.

[0032] FIG. 1 shows a detachment device 100 with a magnet according to an exemplary embodiment. The detachment device 100 includes a magnetic detachment connection with a medical device side and an actuator side. The detachment device 100 interconnects a medical or therapeutic device 130 on the medical device side with an actuator 140 (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (see FIG. 2). With reference to the drawings and throughout this application, references are made to the "medical device side" and the "actuator side", with the medical device components on the left side of the page and the actuator components (motors) on the right side of the page. As used herein, sometimes "medical device" or "treatment" are referred to interchangeably (e.g., "treatment side" or "treatment device" rather than "medical device side" or "medical device") and correspond to the same general characteristics. The medical device component and the actuator component of the detachment component face each other, such that the actuator side magnet block is to the left of the medical device side block.

[0033] The drive assembly is releasably connected to and disconnected from the medical device in response to a desired or predetermined amount of engagement or disengagement force. The drive assembly is configured as a rotary drive assembly that imparts rotational motion to at least one drive wire of the medical device. The drive wire may be a monolithic material wire configured for both pushing and pulling motions and may include one or more drive wires, push-pull wires, support wires, tendons, strands, or other types of wires. The drive assembly can drive the bendable section of the medical device by pushing and pulling the drive wire in a push / pull or insertion / extraction direction. The wire is preferably made of a single material and is preferably not braided or coiled. The medical device is preferably a flexible device and may be a catheter, endoscope, colonoscope, bronchoscope, ablation device, or other type of medical device.

[0034] The actuator side includes one or more of an actuator support 110, an actuator pusher 112, a magnet 114, and a ferromagnetic block 116, and may include other elements and components. The actuator support 110 and the actuator pusher 112 may be configured together as the same entity according to some embodiments. The medical device side includes one or more of a medical device support 120, a medical device wire pusher 122, and a ferromagnetic block 124, and may include other elements and components. The magnet 114 may be housed within the ferromagnetic block 116 and has a coupling force capability that varies depending on the properties of the material, shape, configuration, weight, temperature, composition, workload mass, and may include various other factors. The actuator side is coupled to the medical device side by a magnetic coupling force greater than or equal to a predetermined amount.

[0035] The actuator pusher 112 exerts a linear force provided by a motor or motorized drive assembly. This force acts through the release connection 100 and is exerted on the medical device wire pusher 122. The actuator support 110 and the medical device support 120 on either side of the release connection 100 direct the force from the respective pushers 112, 122 to the release components. The actuator support 110 and the medical device support 120 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release connection 100 is offset, which is why there are supports 110, 120 on the actuator pusher side and the medical device side. The ferromagnetic blocks 116, 124 are made from a strong metallic material such as steel, alloy steel, tungsten, titanium, chromium, etc. (e.g., 1018 steel) having predetermined strength criteria (e.g., tensile strength, compressive strength, yield strength, impact strength, etc.) and function to transmit magnetic flux from a magnetic force characterized by a predetermined or desired bonding force to form a bond between the two sides of the actuator support portion 110 and the medical device support portion 120.

[0036] The release connection 100 may have a compression release mechanism located on the actuator side or proximal end of the medical device that decouples the actuator from the drive wire when a threshold force is exceeded or occurs. The release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism 100, with the magnet 114 housed within the ferromagnetic block 116, can separate the actuator from the drive wire when the force is greater than or equal to the threshold force.

[0037] According to some embodiments, the release arrangement may include a linear motion device including a plurality of guide rails arranged parallel and linearly at a predetermined distance apart. The linear motion device may include a plurality of sliders arranged on both sides of the plurality of guide rails and operable on the guide rails. The movable part may be provided across all of the plurality of guide rails, may be supported by the plurality of sliders, and may be operable along the plurality of guide rails.

[0038] Figure 2 illustrates a slider 126, which is a slider mechanism that supports some features of the breakaway connection 100 of Figure 1 in an engaged configuration. Figure 3 illustrates the breakaway connection 100 of Figure 2 in a disengaged configuration.

[0039] The slider 126 in Figs. 2 and 3 is an example linear motion device configured as a slide mechanism for implementing a release connection according to example embodiments. The release device 100 interconnects a medical device 130 on the medical device side with an actuator 140 (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side. The slider 126 is a linear guide rail and may have an aluminum pusher on the medical device side and an aluminum pusher on the actuator side. The magnet 114 may be, for example, an N52 NdFeB magnet or other type of magnet. Linear guide rails, guideways and slides are mechanical systems consisting of rails and bearings that support and move a physical load along a linear path with a low coefficient of friction. They are generally considered to be of the rolling element or plain bushing type. Common types of guideways and bearings include profiled (square) rails with recirculating ball bearing blocks, roller bearing guideways, round rails with recirculating ball bushings or plain bushings. The slides may be saddle, cantilever, or other types of slides. The slider 126 may have a plurality of guide rails that are parallel and linearly arranged at a predetermined distance. A plurality of sliders operable on the guide rail may be arranged on each of the plurality of guide rails, and a movable part is provided across all of the plurality of guide rails, is supported by the plurality of sliders, and is operable along the plurality of guide rails. For further details of the slide mechanism according to some embodiments, please refer to FIG. 19.

[0040] The release device according to some embodiments may include an actuator, a medical device, and a release connection 100 that connects the actuator 140 and the medical device 130, the release connection 100 having an actuator portion on the actuator 140 side and a medical device portion on the medical device 130 side. The actuator portion may include an actuator support portion 110, an actuator side ferromagnetic block 116, and a slider element 126. The medical device portion may include a medical device support portion 120, a medical device side ferromagnetic block 124, and a slider element 126. At least one of the actuator side ferromagnetic block 116 and the medical device side ferromagnetic block 124 includes a magnet 114, and the actuator is coupled to the medical device by a magnetic coupling force. The actuator separates from the medical device when a separation force is greater than a predetermined amount.

[0041] FIG. 4 shows a detachment device 200 with magnets and spacers according to an exemplary embodiment. The detachment device 200 interconnects a medical or therapeutic device 230 on the medical device side with an actuator 240 (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (see FIG. 5). The drive assembly releasably connects to and disconnects from the medical device in response to a desired or predetermined amount of coupling force. The drive assembly is configured as a rotary drive assembly that provides rotational motion to at least one drive wire of the medical device. The drive wire may be a monolithic material wire configured to accommodate both pushing and pulling motions and may include one or more drive wires, push-pull wires, support wires, tendons, strands, or other types of wires. The drive assembly can drive the bendable section of the medical device by pushing and pulling the drive wire in a push / pull or insertion / withdrawal direction. The wire is preferably made of a single material and is preferably not braided or coiled. The medical device is preferably a flexible device and may be a catheter, endoscope, colonoscope, bronchoscope, ablation device, or other type of medical device. The release connection 200 is similar to that of FIG.

[0042] The actuator side includes one or more of an actuator support 210, an actuator pusher 212, a magnet 214, a ferromagnetic block 216, and a spacer 218, and may include other elements and components. The actuator support 210 and the actuator pusher 212 may be configured together as the same entity according to some embodiments. The medical device side includes one or more of a medical device support 220, a medical device wire pusher 222, and a ferromagnetic block 224, and may include other elements and components. The magnet 214 may be housed within the ferromagnetic block 216 and has a binding force capability that varies depending on properties such as material, shape, configuration, weight, temperature, composition, workload mass, and may include various other factors.

[0043] Since the bonding strength depends on the gap between the two ferromagnetic blocks 216, 224, to achieve a given or desired bonding strength, spacers 218 are used to maintain the desired gap. The spacers 218 or shims may be made from plastic or non-ferrous metals such as aluminum. A thicker spacer will result in a lower bonding strength and a thinner spacer will result in a higher bonding strength.

[0044] The actuator pusher 212 exerts a linear force provided by a motor or motorized drive assembly. This force acts through the release connection 200 and is exerted on the treatment wire pusher 222. The actuator support 210 and treatment support 220 on either side direct the force from the respective pusher 212, 222 to the release component. The actuator support 210 and treatment support 220 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release is offset, which is why there are supports 210, 220 on the actuator pusher side and the treatment side. The ferromagnetic blocks 216, 224 are made from a strong metallic material such as steel, alloy steel, tungsten, titanium, chromium, etc. (e.g., 1018 steel) having predetermined strength criteria (e.g., tensile strength, compressive strength, yield strength, impact strength, etc.) and function to transmit magnetic flux from a magnetic force characterized by a predetermined or desired bonding strength to form a bond between the two sides of the actuator support portion 210 and the therapy support portion 220.

[0045] The release connection 200 may include a compression release mechanism located on the actuator side or proximal end of the medical device that decouples the actuator from the drive wire when a threshold force is exceeded or occurs. The release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism 200, in which the magnet 214 is housed within the ferromagnetic block 216, can separate the actuator from the drive wire when a threshold force is exceeded.

[0046] The release device according to some embodiments may include an actuator, a medical device, and a release connection 200 that connects the actuator and the medical device, the release connection 200 having an actuator portion on the actuator side and a medical device portion on the medical device side. The actuator portion may include an actuator support portion 210, an actuator side ferromagnetic block 216, and a slider element 226. The medical device portion may include a medical device support portion 220, a medical device side ferromagnetic block 224, and a slider element 226. At least one of the actuator side ferromagnetic block 216 and the medical device side ferromagnetic block 224 includes a magnet 214, and the actuator is connected to the medical device by a magnetic coupling force. The actuator is separated from the medical device when the separation force is greater than a predetermined amount.

[0047] Figure 5 illustrates slider 126, a slider mechanism that supports some features of the breakaway connection 200 of Figure 4 in an engaged configuration. Figure 6 illustrates the breakaway connection 200 of Figure 5 in a disengaged configuration.

[0048] The slider 226 in Figs. 5 and 6 is an example linear motion device configured as a slide mechanism for implementing a release connection according to example embodiments. The release device 200 interconnects a medical device 230 on the medical device side with an actuator 240 (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side. The slider 226 is a linear guide rail and may have an aluminum pusher on the medical device side and an aluminum pusher on the actuator side. The magnet 214 may be, for example, an N52 NdFeB magnet or other type of magnet. Linear guide rails, guideways and slides are mechanical systems consisting of rails and bearings that support and move a physical load along a linear path with a low coefficient of friction. They are generally considered to be of the rolling element or plain bushing type. Common types of guideways and bearings include profiled (square) rails with recirculating ball bearing blocks, roller bearing guideways, round rails with recirculating ball bushings or plain bushings. The slides may be saddle, cantilever, or other types of slides. The slider 226 may have a plurality of guide rails that are parallel and linearly arranged at a predetermined distance. A plurality of sliders operable on the guide rail may be arranged on each of the plurality of guide rails, and a movable part is provided across all of the plurality of guide rails, is supported by the plurality of sliders, and is operable along the plurality of guide rails. For further details of the slide mechanism according to some embodiments, please refer to FIG. 19.

[0049] FIG. 7 shows a detachment device 300 with two magnets and a spacer according to an exemplary embodiment. The detachment device 300 interconnects a medical or therapeutic device 330 on the medical device side with an actuator 340 (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (see FIG. 8). The drive assembly releasably connects to and disconnects from the medical device in response to a desired or predetermined amount of coupling force. The drive assembly is configured as a rotary drive assembly that provides rotational motion to at least one drive wire of the medical device. The drive wire may be a monolithic material wire configured to accommodate both pushing and pulling motions and may include one or more drive wires, push-pull wires, support wires, tendons, strands, or other types of wires. The drive assembly can drive the bendable section of the medical device by pushing and pulling the drive wire in a push / pull or insertion / withdrawal direction. The wire is preferably made of a single material and is preferably not braided or coiled. The medical device is preferably a flexible device and may be a catheter, endoscope, colonoscope, bronchoscope, ablation device, or other type of medical device. The release connection 300 is similar to that of Figure 4, but also includes an additional magnet 314 on the treatment side.

[0050] The actuator side includes one or more of an actuator support 310, an actuator pusher 312, a magnet 314, and a ferromagnetic block 316, and may include other elements and components. The actuator support 310 and the actuator pusher 312 may be configured together as the same entity according to some embodiments. The therapy side includes one or more of a therapy support 320, a therapy wire pusher 322, a ferromagnetic block 324, and an additional magnet 314, and may include other elements and components. The magnet 314 may be housed within each of the ferromagnetic blocks 316, 324 and has a binding force capability that varies depending on the properties of the material, shape, configuration, weight, temperature, composition, workload mass, and may include various other factors.

[0051] The breakaway connection 300 includes two magnets 314 instead of the single magnet in Figures 1 and 4. It is important that the polarity of both magnets 314 point in the same direction to create an attractive force. The advantage of two magnets 314 compared to a single magnet is not only a higher coupling force, but also a smaller force deflection with changes in gap. The advantage of two magnets 314 compared to a single magnet is shown in pull test data for a single magnet vs. a dual magnet. Single vs. double magnetic force results in This is shown clearly in diagram 400 of FIG.

[0052] The actuator pusher 312 exerts a linear force provided by a motor or motorized drive assembly. This force acts through the release connection 300 and is exerted on the treatment wire pusher 322. The actuator support 310 and treatment support 320 on either side direct the force from the respective pusher 312, 322 to the release component. The actuator support 110 and treatment support 320 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release is offset, which is why there are supports 310, 320 on the actuator pusher side and the treatment side. The ferromagnetic blocks 316, 324 are made from a strong metallic material such as steel, alloy steel, tungsten, titanium, chromium, etc. (e.g., 1018 steel) having predetermined strength criteria (e.g., tensile strength, compressive strength, yield strength, impact strength, etc.) and function to transmit magnetic flux from a magnetic force characterized by less than a predetermined or desired bonding strength, forming a bond between the two sides of the actuator support portion 310 and the therapy support portion 320.

[0053] The release connection 300 may include a compression release mechanism located on the actuator side or proximal end of the medical device that decouples the actuator from the drive wire when a threshold force is exceeded or occurs. The release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism 300, in which a magnet 314 is housed within a ferromagnetic block 316, can separate the actuator from the drive wire when a threshold force is exceeded.

[0054] The release device according to some embodiments may include an actuator, a medical device, and a release connection 300 that connects the actuator and the medical device, the release connection 300 having an actuator portion on the actuator side and a medical device portion on the medical device side. The actuator portion may include an actuator support portion 310, an actuator side ferromagnetic block 316, and a slider element 326. The medical device portion may include a medical device support portion 120, a medical device side ferromagnetic block 324, and a slider element 126. At least one of the actuator side ferromagnetic block 316 and the medical device side ferromagnetic block 324 includes a magnet 314, and the actuator is coupled to the medical device by a magnetic coupling force. The actuator is separated from the medical device when the separation force is greater than a predetermined amount.

[0055] Figure 8 illustrates a slider 326, which is a slider mechanism that supports some features of the breakaway connection 300 of Figure 7 in an engaged configuration. Figure 9 illustrates the breakaway connection 300 of Figure 8 in a disengaged configuration.

[0056] The slider 326 of Figs. 8 and 9 is an example linear motion device configured as a slide mechanism for implementing a breakaway connection according to example embodiments. The slider 326 is a linear guide rail and may have an aluminum pusher on the medical device side and an aluminum pusher on the actuator side. The magnet 314 may be, for example, an N52 NdFeB magnet or other type of magnet. Linear guide rails, guideways and slides are mechanical systems consisting of rails and bearings that support and move a physical load along a linear path with a low coefficient of friction. They are generally considered to be of the rolling element or plain bushing type. Common types of guideways and bearings include profiled (square) rails with recirculating ball bearing blocks, roller bearing guideways, round rails with recirculating ball bushings or plain bushings. The slides may be saddle, cantilever, or other types of slides. The slider 226 may have multiple guide rails that are parallel and linearly laid at a predetermined distance apart. Each of the multiple guide rails may have multiple sliders arranged thereon that are operable on the guide rail, and a movable part is provided across all of the multiple guide rails, is supported by the multiple sliders, and is operable along the multiple guide rails. For further details of the slide mechanism according to some embodiments, please refer to FIG. 19.

[0057] The drive wire preferably has elastic or superelastic properties or attributes to function as a safety mechanism and may be made from suitable materials such as nickel titanium alloy (nitinol), Flexinoff, nickel chrome, copper, aluminum, stainless steel, silver, gold, polycarbonate, polypropylene, polyurethane, silicone, and may include other metallic, non-metallic or polymeric materials, or combinations thereof. Superelastic materials such as nitinol are 10-20 times more flexible than stainless steel and can handle large bending without buckling, twisting or permanent deformation. Nitinol is a non-ferromagnetic superelastic shape memory alloy with a lower magnetic susceptibility than stainless steel, providing clearer images with fewer artifacts than stainless steel. Superelastic materials are beneficial in medical applications by improving performance such as torsional resistance, fatigue resistance, elastic deployment, thermal deployment, and biocompatibility.

[0058] A tension breakaway mechanism may be disposed within the medical device. The tension breakaway mechanism may be constructed using a superelastic drive wire, such as Nitinol. Above a predetermined threshold force, the superelastic drive wire of the detachment mechanism allows for a large stroke without increasing tension. The tension breakaway mechanism may also be constructed such that the mechanism safely breaks at its weakest point when a force above the predetermined threshold force occurs.

[0059] A key feature of the release mechanism according to some embodiments is the placement of dedicated tension and compression release mechanisms at different locations: specifically, a compression release mechanism may be located on the actuator and a tension release mechanism may be located on the steerable medical device.

[0060] Failure due to compressive forces on the wires can occur anywhere through the push-pull wires, the connections between the wires, and the actuators. Such failures can include buckling of the wires or failure of the anchors. Therefore, the preferred configuration to prevent these types of failures would be located at the closest point between the force transmission lines of the push-pull wires.

[0061] On the other hand, failure due to tension may occur mainly in the anchor portion or the thin-diameter portion of the push-pull wire, i.e., the medical device body. To cover failure due to tension, the release structure for tension can be arranged more distally than the actuator. By arranging the tension release mechanism in the medical device, the actuator and the connection portion can be simplified, and more space can be allocated to the compression release mechanism, minimizing the size of the release connection portion 300.

[0062] When a pull-away mechanism is placed within a medical device and constructed using a superelastic drive wire, such as Nitinol, the superelastic properties of the Nitinol wire can act as a safety mechanism. (NiTi wire tensile test, 0.25mm / s, n=3) As shown in Figure 1, above a force threshold (e.g., 20 N (Newtons)), the force / displacement ratio transitions from the linear region to the superelastic plateau region (circled section), where the force no longer increases with increasing stroke. Since the wire compresses and deviates before entering the superelastic region, this deviance mechanism can only function in the tensile (pulling) direction. In this case, the superelastic properties of the Nitinol wire can act as a safety mechanism, where forces above a certain force allow large strokes without increasing the tensile force. Superelastic materials reversibly deform up to high strains in response to high stresses.

[0063] If the tensile detachment mechanism is configured to safely break at its weakest point when a force equal to or exceeds a predetermined threshold force is applied, the tensile detachment mechanism may include an ultimate failure mechanism that acts as a backup to the previous detachment mechanism configured with a superelastic Nitinol drive wire. This can be achieved by locating a concentrated failure point at the proximal section of the medical device. Previously, ultimate failure would occur at the tip of the medical device, potentially causing harm to the patient. In this embodiment, failure always occurs at the hub of the medical device.

[0064] This can be accomplished by providing the medical device with an unsupported area that is configured to deflect at or below a minimum deflection force.

[0065] According to some embodiments, a force sensor can be placed between the actuator and the drive wires to provide electrical sensing and software intervention. The force sensor can detect forces in any direction or along each axis of a three-dimensional coordinate system of XYZ. When a force is induced between the actuator and the drive wires, the force sensor can output a voltage to the controller. If programmed software or firmware limitations detect or sense that the voltage is high or exceeds a desired or predefined threshold voltage, the controller can stop motion and send a warning signal to the user. This is sometimes referred to as a "motor stop circuit."

[0066] This type of threshold voltage may occur at a lower force than a mechanical release mechanism because it is easier to restore to a normal operating state since no damage or mechanical engagement has occurred. This electrical sensing may prevent the actuator from inducing further force into the release mechanism, but external factors may still induce additional forces in the medical device. This is when the mechanical threshold comes into play.

[0067] The force sensor can also trigger an "auto-relax mode" that may occur before the "motor stop circuit", but at the upper limit of the allowable wire motion force. This may be a software algorithm that pauses motion to relieve tension / compression on the wire to improve performance and prevent larger wire forces from being induced.

[0068] According to some embodiments, force management for various force thresholds can be implemented by user or software intervention. As shown in the force management diagram 600 of FIG. 12 and the force management diagram of FIG. 13, the force thresholds for force management can include an automatic release threshold, a motor stop threshold, a mechanical detachment threshold, a hyperelastic plateau threshold, a treatment device damage threshold, a harmful force threshold, and may include other types of force thresholds. In the force management diagram 610 shown in FIG. 13, in section (A), a wire force tension / compression range with an automatic release mode can occur. In section (B), a wire force at detachment can occur, and in section (C), a wire tension that affects an object such as a human body or a medical device can occur. Wire tension can be in use up to the automatic release mode in section (A). The margin between section (B) and section (C) is an unknown wire force tension / compression range that will be determined during operation.

[0069] The processor, controller, user, or combination thereof may execute force management software that periodically detects the force sensor readings. An auto-relax mode or threshold may occur at the upper limit of wire force during normal use. A motor stop threshold may stop motion of all actuator motors or motorized drive assemblies and prevent additional forces from being induced by the actuators on the medical device. A mechanical breakaway threshold is a passive mechanical breakaway threshold (i.e., magnetic breakaway) that operates regardless of electrical signals. A superelastic plateau threshold is a superelastic threshold of the Nitinol drive wire that occurs only in tension and prevents additional forces from being induced on the tip of the medical device. A medical device failure threshold occurs at the proximal section of the medical device. There are multiple safety thresholds so that it is highly unlikely that harmful forces will be induced on the tip of the medical device.

[0070] Figure 14 shows the superelastic Nitinol (0.013") FIG. 15 illustrates a stress-strain curve 700 of the Nitinol wire under test. FIG. 15 illustrates a force-displacement curve 800 of the Nitinol wire under test.

[0071] Some materials, such as Nitinol wire, do not follow the standard stress-strain curve, but instead exhibit the behavior of a superelastic material. Nitinol has advantageous properties regarding strain resistance and shape memory. Nitinol can memorize its shape and return to its original shape when heated. In a standard material, there is an elastic linear region where the stress / strain is constant, and when the load is removed the material will return to its original shape. After a certain strain input, the material enters the plastic region, where the stress / strain becomes nonlinear, and the material will no longer return to its original shape. For superelastic Nitinol and the stress-strain curve 700 shown in FIG. 14, the material behaves like a standard material at strains below 1%, where the stress / strain is linear. However, above 1% strain, it enters the superelastic region where the stress does not increase with increasing strain (see the loading plateau). When the load is removed from Nitinol, it experiences hysteresis as shown in the unloading plateau, but eventually returns to its original shape without plastic deformation.

[0072] Considering these properties of superelastic Nitinol, by incorporating a superelastic material such as Nitinol into the breakaway configuration of the present disclosure, the material acts as a breakaway for the tensile force. Crimping pusher rod for driving wire As shown in the force-displacement curve 800, assuming the Nitinol diameter is optimized for snake catheter performance, a pull force of approximately 25 N can be achieved before entering the superelastic region, where the drive wire is unable to induce larger forces unless a strain of approximately 8% is achieved, although the actuator limits this from occurring due to end of travel limits and hard stops.

[0073] The actuator includes an end-of-travel limit sensor and a hard stop to prevent the catheter wire from reaching 8% strain (leaving the superelastic region and inducing forces greater than 30 N). The electronic limit sensor may be located approximately 14 mm from the center of travel, and the hard stop may be From the center of movement It is placed at approximately 15 mm.

[0074] FIG. 16 illustrates a release connection 900 including an actuator side and a medical device or therapy side according to an exemplary embodiment. The release connection 900 interconnects a medical or therapy device on the medical device side with an actuator (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (not shown, see FIG. 2). The actuator side includes one or more of a support 910, an actuator pusher 912, a magnet (not shown), and a ferromagnetic block 914, and may include other elements and components. The therapy side includes one or more of a support 920, a therapy wire pusher 922, and a ferromagnetic block 924, and may include other elements and components. The magnet is housed within the ferromagnetic block 914 on the actuator side and has a binding force capability that varies depending on the properties of the material, shape, configuration, weight, temperature, composition, workload mass, and may include various other factors.

[0075] The actuator pusher 912 exerts a linear force, provided by a motor, motorized drive assembly, or the like. This force acts through the release connection 900 and is exerted on the treatment wire pusher 922. The actuator support 910 and treatment support 920 on either side direct the force from the respective pusher 912, 922 to the release component. The supports 910, 920 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release is offset, which is why there are supports 910, 920 on the actuator pusher side and the treatment side. The ferromagnetic blocks 914, 924 are made from a strong metallic material such as steel (e.g., 1018 steel) and function to transmit magnetic flux from a magnetic force characterized by a magnetic force equal to a predetermined or desired coupling strength to form a coupling between the two sides of the actuator support portion 910 and the therapy support portion 920.

[0076] The release connection 900 may include a compression release mechanism located on the actuator side or proximal end of the medical device that releases the drive wire or guide The release mechanism 900 decouples the actuator from the wires. The release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism 900, in which a magnet is housed within a ferromagnetic block 914, is capable of decoupling the actuator from the drive wires when a threshold force is exceeded.

[0077] The drive wire preferably has elastic or superelastic properties or attributes to function as a safety mechanism and may be made from suitable materials such as Nitinol, Flexinoff, nickel chrome, copper, aluminum, stainless steel, silver, gold, polycarbonate, polypropylene, polyurethane, silicone, and may include other metallic, non-metallic, or polymeric materials, or combinations thereof. Superelastic materials such as Nitinol are 10-20 times more flexible than stainless steel and can handle large bending without buckling, twisting, or permanent deformation. Nitinol is a non-ferromagnetic, superelastic, shape memory alloy with a lower magnetic susceptibility than stainless steel, providing clearer images with fewer artifacts than stainless steel. Superelastic materials are beneficial in medical applications by improving performance such as torsional resistance, fatigue resistance, elastic deployment, thermal deployment, and biocompatibility.

[0078] A tension breakaway mechanism may be disposed within the medical device. The tension breakaway mechanism may be constructed using a superelastic drive wire, such as Nitinol. Above a predetermined threshold force, the superelastic drive wire of the detachment mechanism allows for a large stroke without increasing tension. The tension breakaway mechanism may also be constructed such that the mechanism safely breaks at its weakest point when a force above the predetermined threshold force occurs.

[0079] A key feature of the release mechanism according to some embodiments is the placement of dedicated tension and compression release mechanisms at different locations: specifically, a compression release mechanism may be located on the actuator and a tension release mechanism may be located on the steerable medical device.

[0080] Failure due to compressive forces on the wires can occur anywhere through the push-pull wires, the connections between the wires, and the actuators. Such failures can include buckling of the wires or failure of the anchors. Therefore, the preferred configuration to prevent these types of failures would be located at the closest point between the force transmission lines of the push-pull wires.

[0081] On the other hand, failure due to tension may occur mainly in the anchor portion or the thin-diameter portion of the push-pull wire, i.e., the medical device body. To cover failure due to tension, the release structure for tension can be disposed distal to the actuator. By disposing the tension release mechanism in the medical device, the actuator and the connection portion can be simplified, and more space can be allocated to the compression release mechanism, minimizing the size of the release connection portion 900.

[0082] When a tension breakaway mechanism is placed in a medical device and constructed with a superelastic drive wire, such as Nitinol, the superelastic properties of the Nitinol wire can act as a safety mechanism. As shown in the tension test diagram 500 of FIG. 11, once a force threshold (e.g., 20 N (Newtons)) is exceeded, the force / displacement ratio transitions from a linear region to a superelastic plateau region (circled section) where the force no longer increases with increasing stroke. The wire compresses and breaks away before entering the superelastic region, so the breakaway mechanism can only function in the tension (pulling) direction. In this case, the superelastic properties of the Nitinol wire can act as a safety mechanism, where forces above a certain force allow for large strokes without increasing the tension force.

[0083] If the tensile detachment mechanism is configured to safely break at its weakest point when a force equal to or exceeds a predetermined threshold force is applied, the tensile detachment mechanism may include an ultimate failure mechanism that acts as a backup to the previous detachment mechanism configured with a superelastic Nitinol drive wire. This can be achieved by locating a concentrated failure point at the proximal section of the medical device. Previously, ultimate failure would occur at the tip of the medical device, potentially causing harm to the patient. In this embodiment, failure always occurs at the hub of the medical device.

[0084] This can be accomplished by providing the medical device with an unsupported area that is configured to deflect at or below a minimum deflection force.

[0085] According to some embodiments, a force sensor may be placed between the actuator and the drive wires. When a force is induced between the actuator and the drive wires, the sensor can output a voltage to the controller. Due to programmed software or firmware limitations, if a threshold voltage is exceeded, the controller can stop motion and send a warning signal to the user. This is sometimes referred to as a "motor stop circuit."

[0086] This type of threshold voltage may occur at a lower force than a mechanical release mechanism because it is easier to restore to a normal operating state since no damage or mechanical engagement has occurred. This electrical sensing may prevent the actuator from inducing further force into the release mechanism, but external factors may still induce additional forces in the medical device. This is when the mechanical threshold comes into play.

[0087] The force sensor can also trigger an "auto-relax mode" that may occur before the "motor stop circuit", but at the upper limit of the allowable wire actuation force. This may be a software algorithm that pauses the actuation and relieves tension / compression on the wire to improve performance and prevent larger wire forces from being induced.

[0088] According to some embodiments, force management can be performed for various force thresholds. As shown in force management diagram 600 of Figure 12, the force thresholds for purposes of force management can include an automatic relaxation threshold, a motor stall threshold, a mechanical breakaway threshold, a hyperelastic plateau threshold, a medical device damage threshold, a harmful force threshold, and may include other types of force thresholds.

[0089] An auto-relax mode or threshold may occur at the upper limit of wire force during normal use. A motor stop threshold may stop all actuator motion and prevent additional forces being induced by the actuators on the medical device. A mechanical breakaway threshold is a passive mechanical breakaway threshold (i.e., magnetic breakaway) and operates regardless of electrical signals. A superelastic plateau threshold is the superelastic threshold of the Nitinol drive wire that occurs only in tension and prevents additional forces being induced on the tip of the medical device. A medical device failure threshold occurs in the proximal section of the medical device. There are multiple safety thresholds so that it is highly unlikely that harmful forces will be induced on the tip of the medical device.

[0090] FIG. 17 illustrates a release connection 1000 including an actuator side and a medical device or treatment side according to an example embodiment. The release connection 1000 interconnects a medical or treatment device on the medical device side with an actuator (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (not shown, see FIG. 2). The actuator side includes one or more of a support 1010, an actuator pusher 1012, a magnet (not shown), and a ferromagnetic block 1014, and may include other elements and components. The actuator support 1010 and the actuator pusher 1012 may be configured together as the same entity according to some embodiments. The treatment side includes one or more of a support 1020, a treatment wire pusher 1022, and a ferromagnetic block 1024, and may include other elements and components. The magnets are housed within a ferromagnetic block 1014 on the actuator side and have binding force capabilities that vary depending on properties such as material, shape, configuration, weight, temperature, composition, workload mass, and may include a variety of other factors.

[0091] The actuator pusher 1012 exerts a linear force provided by a motor or motorized drive assembly. This force acts through the release connection 1000 and is exerted on the treatment wire pusher 1022. The actuator support 1010 and treatment support 1020 on either side direct the force from the respective pusher 1012, 1022 to the release component. The supports 1010, 1020 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release is offset, which is why there are supports 1010, 1020 on the actuator pusher side and the treatment side. The ferromagnetic blocks 1014, 1024 are made from a strong metallic material such as steel (e.g., 1018 steel) and function to transmit magnetic flux from a magnetic force characterized by a magnetic force equal to a predetermined or desired coupling strength, forming a coupling between the two sides of the actuator support portion 1010 and the therapy support portion 1020.

[0092] The release connection 1000 may have a compression release mechanism located on the actuator side or proximal end of the medical device that decouples the actuator from the drive wire or guide wire when a threshold force is exceeded or occurs. This release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism, in which a magnet is housed within a ferromagnetic block 1016, can separate the actuator from the drive wire when a threshold force is exceeded.

[0093] The drive wire preferably has elastic or superelastic properties or attributes to function as a safety mechanism and may be made from suitable materials such as Nitinol, Flexinoff, nickel chrome, copper, aluminum, stainless steel, silver, gold, polycarbonate, polypropylene, polyurethane, silicone, and may include other metallic, non-metallic, or polymeric materials, or combinations thereof. Superelastic materials such as Nitinol are 10-20 times more flexible than stainless steel and can handle large bending without buckling, twisting, or permanent deformation. Nitinol is a non-ferromagnetic, superelastic, shape memory alloy with a lower magnetic susceptibility than stainless steel, providing clearer images with fewer artifacts than stainless steel. Superelastic materials are beneficial in medical applications by improving performance such as torsional resistance, fatigue resistance, elastic deployment, thermal deployment, and biocompatibility.

[0094] A tension breakaway mechanism may be disposed within the medical device. The tension breakaway mechanism may be constructed using a superelastic drive wire, such as Nitinol. Above a predetermined threshold force, the superelastic drive wire of the detachment mechanism allows for a large stroke without increasing tension. The tension breakaway mechanism may also be constructed such that the mechanism safely breaks at its weakest point when a force above the predetermined threshold force occurs.

[0095] A key feature of the release mechanism according to some embodiments is the placement of dedicated tension and compression release mechanisms at different locations: specifically, a compression release mechanism may be located on the actuator and a tension release mechanism may be located on the steerable medical device.

[0096] Failure due to compressive forces on the wires can occur anywhere through the push-pull wires, the connections between the wires, and the actuators. Such failures can include buckling of the wires or failure of the anchors. Therefore, the preferred configuration to prevent these types of failures would be located at the closest point between the force transmission lines of the push-pull wires.

[0097] On the other hand, failure due to tension may occur mainly in the anchor portion or the thin-diameter portion of the push-pull wire, i.e., the medical device body. To cover failure due to tension, the release structure for tension can be arranged more distally than the actuator. By arranging the tension release mechanism in the medical device, the actuator and the connection can be simplified, and more space can be allocated to the compression release mechanism, minimizing the size of the release connection portion 100.

[0098] When a tension breakaway mechanism is placed in a medical device and constructed with a superelastic drive wire, such as Nitinol, the superelastic properties of the Nitinol wire can act as a safety mechanism. As shown in the tension test diagram 500 of FIG. 11, once a force threshold (e.g., 20 N (Newtons)) is exceeded, the force / displacement ratio transitions from a linear region to a superelastic plateau region (circled section) where the force no longer increases with increasing stroke. The wire compresses and breaks away before entering the superelastic region, so the breakaway mechanism can only function in the tension (pulling) direction. In this case, the superelastic properties of the Nitinol wire can act as a safety mechanism, where forces above a certain force allow for large strokes without increasing the tension force.

[0099] If the tensile detachment mechanism is configured to safely break at its weakest point when a force equal to or exceeds a predetermined threshold force is applied, the tensile detachment mechanism may include an ultimate failure mechanism that acts as a backup to the previous detachment mechanism configured with a superelastic Nitinol drive wire. This can be achieved by locating a concentrated failure point at the proximal section of the medical device. Previously, ultimate failure would occur at the tip of the medical device, potentially causing harm to the patient. In this embodiment, failure always occurs at the hub of the medical device.

[0100] This can be accomplished by providing the medical device with an unsupported area that is configured to deflect at or below a minimum deflection force.

[0101] According to some embodiments, a force sensor may be placed between the actuator and the drive wires. When a force is induced between the actuator and the drive wires, the sensor can output a voltage to the controller. Due to programmed software or firmware limitations, if a threshold voltage is exceeded, the controller can stop motion and send a warning signal to the user. This is sometimes referred to as a "motor stop circuit."

[0102] This type of threshold voltage may occur at a lower force than a mechanical release mechanism because it is easier to restore to a normal operating state since no damage or mechanical engagement has occurred. This electrical sensing may prevent the actuator from inducing further force into the release mechanism, but external factors may still induce additional forces in the medical device. This is when the mechanical threshold comes into play.

[0103] The force sensor can also trigger an "auto-relax mode" that may occur before the "motor stop circuit", but at the upper limit of the allowable wire motion force. This may be a software algorithm that pauses motion to relieve tension / compression on the wire to improve performance and prevent larger wire forces from being induced.

[0104] According to some embodiments, force management can be performed for various force thresholds. As shown in force management diagram 600 of Figure 12, the force thresholds for purposes of force management can include an automatic relaxation threshold, a motor stall threshold, a mechanical breakaway threshold, a hyperelastic plateau threshold, a medical device damage threshold, a harmful force threshold, and may include other types of force thresholds.

[0105] An auto-relax mode or threshold may occur at the upper limit of wire force during normal use. A motor stop threshold may stop all actuator motion and prevent additional forces being induced by the actuators on the medical device. A mechanical breakaway threshold is a passive mechanical breakaway threshold (i.e., magnetic breakaway) and operates regardless of electrical signals. A superelastic plateau threshold is the superelastic threshold of the Nitinol drive wire that occurs only in tension and prevents additional forces being induced on the tip of the medical device. A medical device failure threshold occurs in the proximal section of the medical device. There are multiple safety thresholds so that it is highly unlikely that harmful forces will be induced on the tip of the medical device.

[0106] FIG. 18 illustrates a release connection 1100 including an actuator side and a medical device side or treatment side according to an example embodiment. The release connection 1100 interconnects a medical or treatment device on the medical device side with an actuator (configured as a motor, drive, motorized drive assembly, etc.) on the actuator side (not shown, see FIG. 2). The release connection 1100 includes multiple release connections, similar to the release connection 900 illustrated in FIG. 16. The actuator side includes one or more of a support 1110, an actuator pusher 1112, a magnet (not shown), and a ferromagnetic block 1114, and may include other elements and components. The actuator support 1110 and the actuator pusher 1112 may be configured together as the same entity according to some embodiments. The treatment side includes one or more of a support 1120, a treatment wire pusher 1122, and a ferromagnetic block 1124, and may include other elements and components. The magnets are housed within a ferromagnetic block 1114 on the actuator side and have binding force capabilities that vary depending on properties such as material, shape, configuration, weight, temperature, composition, workload mass, and may include a variety of other factors.

[0107] The actuator pusher 1112 exerts a linear force provided by a motor or motorized drive assembly. This force acts through the release connection 1100 and is exerted on the treatment wire pusher 1122. The actuator support 1110 and treatment support 1120 on either side guide the force from the respective pusher 1112, 1122 to the release component. The supports 1110, 1120 are preferably rigid to handle the force and may be made from a non-ferrous metal such as aluminum. In medical devices, the pitch circle of the drive wires is generally small, so the magnetic force must not exceed a certain level that is large enough to fit axially between the wires without interfering with each other. The release is offset, which is why there are supports 1110, 1120 on the actuator pusher side and the medical device side. The ferromagnetic blocks 1114, 1124 are made from a strong metallic material such as steel (e.g., 1018 steel) and function to transmit magnetic flux from a magnetic force characterized by a magnetic force equal to a predetermined or desired coupling strength, forming a coupling between the two sides of the actuator support portion 1110 and the treatment support portion 1120.

[0108] The release connection 1100 may have a compression release mechanism located on the actuator side or proximal end that decouples the actuator from the drive wire when a threshold force is exceeded or occurs. This release mechanism is a passive mechanical assembly that does not require power to operate. Specifically, the release mechanism, in which a magnet is housed within a ferromagnetic block 1116, can separate the actuator from the drive wire when a threshold force is exceeded.

[0109] The drive wire preferably has elastic or superelastic properties or attributes to function as a safety mechanism and may be made from suitable materials such as Nitinol, Flexinoff, nickel chrome, copper, aluminum, stainless steel, silver, gold, polycarbonate, polypropylene, polyurethane, silicone, and may include other metallic, non-metallic, or polymeric materials, or combinations thereof. Superelastic materials such as Nitinol are 10-20 times more flexible than stainless steel and can handle large bending without buckling, twisting, or permanent deformation. Nitinol is a non-ferromagnetic, superelastic, shape memory alloy with a lower magnetic susceptibility than stainless steel, providing clearer images with fewer artifacts than stainless steel. Superelastic materials are beneficial in medical applications by improving performance such as torsional resistance, fatigue resistance, elastic deployment, thermal deployment, and biocompatibility.

[0110] A tension breakaway mechanism may be disposed within the medical device. The tension breakaway mechanism may be constructed using a superelastic drive wire, such as Nitinol. Above a predetermined threshold force, the superelastic drive wire of the detachment mechanism allows for a large stroke without increasing tension. The tension breakaway mechanism may also be constructed such that the mechanism safely breaks at its weakest point when a force above the predetermined threshold force occurs.

[0111] A key feature of the release mechanism in some embodiments is the placement of dedicated tension and compression release mechanisms in different locations: specifically, a compression release mechanism may be located on the actuator and a tension release mechanism may be located on the steerable medical device.

[0112] Failure due to compressive forces on the wires can occur anywhere through the push-pull wires, the connections between the wires, and the actuators. Such failures can include buckling of the wires or failure of the anchors. Therefore, the preferred configuration to prevent these types of failures would be located at the closest point between the force transmission lines of the push-pull wires.

[0113] On the other hand, failures due to tension force generally occur mainly in the anchor portion or the thin-diameter portion of the push-pull wire, i.e., the medical device body. To cover failures due to tension force, the release structure for tension force can be located distal to the actuator. By locating the tension release mechanism in the medical device, the actuator and the connection portion can be simplified, and more space can be allocated to the compression release mechanism, minimizing the size of the release connection portion 1100.

[0114] When a tension breakaway mechanism is placed in a medical device and constructed with a superelastic drive wire, such as Nitinol, the superelastic properties of the Nitinol wire can act as a safety mechanism. As shown in the tension test diagram 500 of FIG. 11, once a force threshold (e.g., 20 N (Newtons)) is exceeded, the force / displacement ratio transitions from a linear region to a superelastic plateau region (circled section) where the force no longer increases with increasing stroke. The wire compresses and breaks away before entering the superelastic region, so the breakaway mechanism can only function in the tension (pulling) direction. In this case, the superelastic properties of the Nitinol wire can act as a safety mechanism, where forces above a certain force allow for large strokes without increasing the tension force.

[0115] If the tensile detachment mechanism is configured to safely break at its weakest point when a force equal to or exceeds a predetermined threshold force is applied, the tensile detachment mechanism may include an ultimate failure mechanism that acts as a backup to the previous detachment mechanism configured with a superelastic Nitinol drive wire. This can be achieved by locating a concentrated failure point at the proximal section of the medical device. Previously, ultimate failure would occur at the tip of the medical device, potentially causing harm to the patient. In this embodiment, failure always occurs at the hub of the medical device.

[0116] This can be accomplished by providing the medical device with an unsupported area that is configured to deflect at or below a minimum deflection force.

[0117] According to some embodiments, a force sensor may be placed between the actuator and the drive wires. When a force is induced between the actuator and the drive wires, the sensor can output a voltage to the controller. Due to programmed software or firmware limitations, if a threshold voltage is exceeded, the controller can stop motion and send a warning signal to the user. This is sometimes referred to as a "motor stop circuit."

[0118] This type of threshold voltage may occur at a lower force than a mechanical release mechanism because it is easier to restore to a normal operating state since no damage or mechanical engagement has occurred. This electrical sensing may prevent the actuator from inducing further force into the release mechanism, but external factors may still induce additional forces in the medical device. This is when the mechanical threshold comes into play.

[0119] The force sensor can also trigger an "auto-relax mode" that may occur before the "motor stop circuit", but at the upper limit of the allowable wire motion force. This may be a software algorithm that pauses motion to relieve tension / compression on the wire to improve performance and prevent larger wire forces from being induced.

[0120] According to some embodiments, force management can be performed for various force thresholds. As shown in force management diagram 600 of Figure 12, the force thresholds for purposes of force management can include an automatic relaxation threshold, a motor stall threshold, a mechanical breakaway threshold, a hyperelastic plateau threshold, a medical device damage threshold, a harmful force threshold, and may include other types of force thresholds.

[0121] An auto-relax mode or threshold may occur at the upper limit of wire force during normal use. A motor stop threshold may stop all actuator motion and prevent additional forces being induced by the actuators on the medical device. A mechanical breakaway threshold is a passive mechanical breakaway threshold (i.e., magnetic breakaway) and operates regardless of electrical signals. A superelastic plateau threshold is the superelastic threshold of the Nitinol drive wire that occurs only in tension and prevents additional forces being induced on the tip of the medical device. A medical device failure threshold occurs in the proximal section of the medical device. There are multiple safety thresholds so that it is highly unlikely that harmful forces will be induced on the tip of the medical device.

[0122] According to some embodiments, the release arrangement may include a linear motion device including a plurality of guide rails arranged parallel and linearly at a predetermined distance apart. The linear motion device may include a plurality of sliders arranged on both sides of the plurality of guide rails and operable on the guide rails. The movable part may be provided across all of the plurality of guide rails, may be supported by the plurality of sliders, and may be operable along the plurality of guide rails.

[0123] 19 shows an example linear motion device configured as a slide mechanism 1200 for implementing a release connection according to an example embodiment. The example sliders 126, 226, 326 have already been described, and further features are disclosed below. The slide mechanism 1200 is a linear guide rail, and includes an aluminum pusher 1210 on the treatment side, an aluminum pusher 1211 on the actuator side, two magnets 1212 housed in two steel containers 1213, two plastic or non-ferrous spacers or shims 1214, and a linear bearing 1215. . magneticThe stone 1212 may be, for example, a N52 NdFeB magnet or other type of magnet. Linear guide rails, guideways and slides are mechanical systems consisting of rails and bearings that support and move a physical load along a linear path with a low coefficient of friction. They are generally considered to be of the rolling element or flat bushing type. Common types of guideways and bearings include profiled (square) rails with recirculating ball bearing blocks, roller bearing guideways, round rails with recirculating ball bushings or flat bushings. Slides may be saddle, cantilever, or other types of slides. The slide mechanism 1200 may have multiple guide rails laid parallel and linearly at a predetermined distance. Each of the multiple guide rails may have multiple sliders arranged thereon that are operable on the guide rails, and a movable part is provided across all of the multiple guide rails, supported by the multiple sliders, and operable along the multiple guide rails.

[0124] According to some embodiments, both the actuator side and the therapy side may include slider mechanisms. The actuator side slider mechanism and the therapy side slider mechanism together can constrain at least one drive wire in at least one or more dimensions (e.g., 5 or 6 dimensions). Each bendable section preferably includes at least 3 drive wires.

[0125] With the integration of magnetic breakaway, the magnetic breakaway configuration described above can be integrated into a sliding mechanism 1200 with a single linear rail bearing and two carriages mounted on the rail. This allows the two pushers of the actuator and medical device to move freely when separated during breakaway, or move together when coupled during normal operation. When breakaway occurs, the linear rail aligns the two pushers and facilitates reconnection so normal operation can resume.

[0126] To allow the components of the breakaway connection to slide on the guide rails, the medical device may be coupled to the linear guide rails of the slide mechanism 1200. The linear guide rails may include guide rails with two or more shafts attached to the bottom of the breakaway connection.

[0127] The magnetic detachment arrangement in some embodiments functionally interacts with a medical instrument with a rotational drive assembly or a continuum robot, robotically controlled or snake-type catheter assembly to impart rotational motion to a steerable catheter, endoscope or other surgical instrument guidewire.

[0128] A steerable catheter device according to some embodiments may include a steerable catheter having a distal end and a proximal end, a number of curved sections, an actuator for pushing and pulling a push-pull wire, and may include other features.

[0129] The push-pull wire may be attached at one end to the distal end of the curved section and at the other end to an actuator proximal to the curved section to bend the curved section.

[0130] The tension force release mechanism can be actuated at a tension threshold force above a predetermined value to stop the transmission of tension forces from the actuator to the steerable catheter via the push-pull wires, and the compression force release mechanism can be actuated at a compression threshold force above a predetermined value to stop the transmission of compression forces from the actuator to the steerable catheter via the push-pull wires.

[0131] The tension release mechanism may be provided within the steerable catheter.

[0132] The compression force take-off mechanism may be provided within the actuator.

[0133] The push-pull wires of the tensile force release mechanism may be made from a superelastic material in the form of a nickel titanium alloy or Nitinol. The push-pull wires can reach a superelastic plateau of the superelastic material in the stress-strain relationship at the tensile threshold force, and elongation of the push-pull wires at the superelastic plateau can stop the transmission of the tensile force.

[0134] The push-pull wire in the elastic plateau state may have a maximum elongation that is equal to or greater than a predetermined operating stroke distance of the push-pull wire, and the predetermined operating stroke distance may correspond to the maximum operating stroke distance and the maximum elongation.

[0135] The pull-off mechanism may have an irreversible break point that can irreversibly physically disconnect the push-pull wire from the actuator, terminating the transmission of the pull force.

[0136] The compression force breakaway mechanism may include a permanent magnet.

[0137] The actuator may include a force sensor that measures the push / pull force applied to the push / pull wire, a motor that pushes and pulls the push / pull wire based on an operational command, a controller that issues the operational command to the motor, and may include other elements and components.

[0138] The controller can issue a command based on metrics calculated using the force measurements from the force sensor to stop increasing the push / pull force on the push-pull wire.

[0139] By separating the tensile and compressive force breakaway mechanisms of the push-pull wires, the magnetic breakaway configuration according to embodiments described herein provides mechanisms optimized for tensile and compressive forces with different principles.

[0140] Since a failure of the push-pull drive wire due to a compression force occurs basically on the force transmission line of the push-pull drive wire, by disposing the compression force release mechanism in the actuator, the release mechanism covers all of the force transmission line of the push-pull wire between the push-pull wire and the actuator. On the other hand, since a failure of the push-pull drive wire due to a tension force occurs basically around the anchor point or in the thin-diameter part of the push-pull drive wire of the steerable catheter body, the tension force release mechanism may be provided in the steerable catheter.

[0141] By constructing the push-pull drive wire from superelastic Nitinol, the tension detachment mechanism can be formed without adding additional structure to the push-pull drive wire itself, thus allowing for a smaller catheter size with a detachment mechanism.

[0142] By making the extension of the push-pull drive wires greater than the maximum required operating stroke, the system ensures that the push-pull drive wires are protected from failure. Specifically, the actuator may be equipped with a stroke limiter for the maximum operating stroke distance, and a simple distance limiter may be used to prevent the actuator from reaching the pull-away mechanism. Prevents push-pull drive wires from being positioned It is possible.

[0143] Irreversible detachment allows the detachment action to be achieved using a simple mechanical structure without the use of electricity, which also allows the catheter to be compact even when equipped with a pull detachment mechanism.

[0144] By combining force management using force sensors and motor control using tension and compression breakaway mechanisms, the system can reduce the situations in which the breakaway mechanism needs to operate.

[0145] 20 illustrates an exemplary medical device 1300 in the form of a robotic catheter assembly or snake configuration that can functionally interact with a magnetic detachment arrangement, according to some embodiments. FIG. 21 illustrates a hardware configuration of the medical device 1300.

[0146] The medical device 1300 includes one or more of a handheld controller 1302, a medical tool 1304, an actuator (motor) 1306, a medical instrument 1308, an imaging device 1310, a sensor 1312, a detector 1314, a console 1316, a display 1318, and a miniature display 1320, and may also include other elements or components. The medical tool 1304 is referred to as a "biopsy tool" and the medical instrument 1308 is referred to as a "catheter" by way of example. Any one or more of various other types of tools, instruments, configurations, or structures, such as catheters, snake-type robotic catheters, endoscopes, colonoscopes, bronchoscopes, ablation instruments, sheaths, guidewires, needles, probes, forceps, and the like, are also within the scope of the present disclosure.

[0147] The medical device 1300 according to some embodiments can perform functions using one or more processes, techniques, algorithms, etc. that can prevent unintended motion while providing better work efficiency for physicians during medical procedures.

[0148] The controller 1302 has a housing with an elongated handle or handle section that can be grasped by hand, and one or more input devices, such as levers, buttons, or other input devices that allow a user (doctor, nurse, technician, etc.) to send commands to the medical device 1300 to move the catheter 1308. The controller 1302 executes software, computer instructions, algorithms, etc., such that a user can complete all operations with the handheld controller 1302 by holding the handheld controller 1302 in one hand.

[0149] The medical tool 1304 can be a biopsy tool or other type of tool. The actuator 1306 can include one or more motors to drive each section of the catheter 1308. The controller 1302, the medical device 1308, the console 1314, and other elements are interconnected to the actuator 1306. The controller 1302 includes at least one processor and is configured to control the medical device 1308 via the actuator 1306 and to control the actuator 1306 according to manipulation by a user.

[0150] The medical device 1308 may be configured as a catheter, an endoscope, or another type of medical device. The imaging device 1310 is a mechanical, digital, or electronic device configured to record, store, or transmit visual images, such as a camera, camcorder, or movie camera. The sensor 1312 may be an electromagnetic tracking sensor (EM tracking sensor) and is attached to the tip of the catheter 1308. The detector 1314 detects the position of the EM tracking sensor 1312 and outputs the detected position information to the controller 1302 and / or the console 1318. The controller 1302 receives catheter tip position information directly from the tracking sensor 1310 or the detector 1314.

[0151] The console 1316 executes software, computer instructions, algorithms, etc., to control the display of navigational screens on the display 1318 and other types of images and information on the small display 1320. The console 1316 can generate a three-dimensional (3D) model of the patient's internal branch structures (e.g., lungs and other internal structures) based on medical images such as CT or MRI. Alternatively, the 3D model may be received by the console 1316 from another device.

[0152] The console 1316 obtains the catheter position information from the detector 1314. Alternatively, the console 1316 can obtain the catheter position information directly from the tracking sensor 1312.

[0153] The console 1316 executes software based on the 3D model and the catheter position information to generate a navigation screen and output it to the display 1318. The navigation screen can show the current position of the catheter 1308 on the 3D model. The navigation screen allows the user to recognize the current position of the catheter 1308 in the branched structure.

[0154] The console 1316 can perform corrections of the acquired 3D model based on the catheter position information to minimize discrepancies between the catheter position and the trajectory mapped onto the 3D model.

[0155] Display 1318 and / or miniature display 1320 may be display devices configured as, for example, a monitor, an LCD (liquid crystal display), an LED (light emitting diode) display, an OLED (organic LED) display, a plasma display, an organic electroluminescent panel, etc. Based on control of the device, a navigation screen may be displayed on display 1316 showing one or more images being captured, captured images, captured video recorded to storage, etc. Miniature display 1318 is smaller than display 1216, and they may each display similar or other types of images and / or information.

[0156] The controller 1302 and / or console 1316 may include one or more or a combination of levers, keys, buttons, switches, a mouse, a keyboard, etc. for controlling elements of the device 1300, and each has components 1400 (shown in FIG. 22 ) including one or more or a combination of a processor 1401, a memory 1402, a sensor 1403, an input / output (I / O) interface 1404, a communications interface 1405, a display 1406, a power source 1407, and may include other elements or components. The device 1400 may be interconnected with medical instruments and various other equipment, and may be controlled independently, externally, or remotely by the controller 1402 and / or console 1414.

[0157] The processor 1401 (including one or more processors, circuitry, or a combination thereof) provides overall control of the medical device 1300 and may execute programs, instructions, code, or software stored in the memory 1402 to perform various data processing, calculation, algorithmic tasks, and other functions of the medical device 1300. The memory 1402 may store programs, software, computer instructions, information, other data, or a combination thereof. The memory 1402 is used as a working memory. The processor 1401 executes software stored in the memory 1402.

[0158] The sensors 1403 can monitor, measure or detect various types of data of the medical device 1300 and transmit or send the sensor readings or data to a host over a network. The I / O interface 1404 can interconnect various components with the medical device 1300 to exchange data or information with the medical device 1300. The I / O interface 1404 can input catheter position information to the console 1316 and output information to the display 1316 for displaying navigation screens. The communication interface 1405 can interconnect various components with the medical device 1300 to facilitate communication with the medical device 1300.

[0159] The display 1406 corresponds to the display 1320 and / or the display 1322 and can present a display for a user to view images, data, and other information, and can be configured as an LCD or other type of display. The controller 1302 and / or the console 1314 can control the display of the display 1406 and the input of various settings or default information set by the input / output interface 1404 and the communication interface 1405, and can provide input to the medical device 1300.

[0160] The power source 1407 provides power to the medical device 1300 and maintains a regulated power supply to the medical device 1300 and may operate in a power on mode, a power off mode, and other modes. The power source 1407 may include a battery housed within the medical device 1300, or may include an external power source, such as line power from a power outlet or an AC power source, which may be interconnected with the medical device 1300 via an AC / DC adapter and DC / DC converter, or an AC / DC converter, to adapt the power voltage from the power source to one or more voltages used by the components of the medical device 1300.

[0161] The components are connected to each other by a bus 1408 so that the components can communicate with each other. The bus 1408 connects the medical device 1300 to input devices, output devices, communication devices, and other devices. The input devices are configured to allow a user to transmit information and select commands to the medical device 1300 and may include one or more or a combination of a mouse with keys or buttons with alphanumeric characters, icons, pictograms, or other types of symbols, a keyboard, a touch screen, and the like. The output devices are configured to display data or images generated by the medical device 1300 and may include a printer, display, or other output configuration.

[0162] The bus 1408 transmits and receives data between these connected hardware devices, or transmits commands from the processor 1401 to other hardware devices. The components may be implemented by one or more physical devices that can be coupled to the processor 1401 through a communication channel. For example, the controller 1302 and / or the console 1314 may be implemented using circuitry in the form of an ASIC (Application Specific Integrated Circuit) or the like. Alternatively, the controller 1302 and / or the console 1314 may be implemented as a combination of hardware and software, in which case the software is loaded into the processor from a memory or via a network connection. The functionality of the controller 1302 and / or the console 1314 may be stored in a storage medium, which may include a RAM (Random Access Memory), a ROM (Read Only Memory), a magnetic or optical disk, a diskette, a cloud storage, or the like.

[0163] The sensor 1403 may include one or more or a combination of a processor, detection circuitry, memory, hardware, software, firmware, and may include other circuitry, elements, or components. The sensor 1403 may be a plurality of sensors and obtains sensor information output from one or more sensors that detect forces, motion, current position, and operation of components interconnected with the medical device 1300. The sensor 1403 may include a multi-axis acceleration sensor or an accelerometer sensor and a multi-axis gyroscope sensor, a combination of an acceleration sensor and a gyroscope sensor, and may include other sensors and may be configured using a piezoelectric transducer, a mechanical switch, a single axis accelerometer, a multi-axis accelerometer, or other types of configurations. The sensor 1403 can monitor, detect, measure, record or store physical, operational, quantified or other characteristic parameters of the medical device 1300, including one or more or combinations of force, impact, shock, drop, descent, motion, acceleration, deceleration, velocity, rotation, temperature, pressure position, orientation, movement or other types of data of the medical device 100 along multiple axes, multiple dimensions, x-axis, y-axis, z-axis or any combination thereof, and can generate sensor readings, information, data, digital signals, electrical signals or other types of information corresponding to the detected conditions. The medical device 1300 can transmit or send the sensor reading data to a remote host or server in a wireless or wired manner. The sensor 1403 can be interrogated and can generate sensor reading signals or information that can be processed in real time, stored, post-processed or any combination thereof. The information or data generated by the sensor 803 can be processed, demodulated, filtered or conditioned to remove noise or other types of signals.The sensors 1403 may include one or more or combinations of a force sensor, an acceleration sensor, a deceleration sensor or accelerometer sensor, a gyroscope sensor, a power sensor, a battery sensor, a proximity sensor, a motion sensor, a position sensor, a rotation sensor, a magnetic sensor, an air pressure sensor, a light sensor, a pressure sensor, an angular position sensor, a temperature sensor, an altimeter sensor, an infrared sensor, a sonic sensor, an air monitoring sensor, a piezoelectric sensor, a strain gauge sensor, a sonic sensor, a vibration sensor, a depth sensor, and may include other types of sensors.

[0164] According to some embodiments, a force sensor may be placed between the actuator and the drive wires. When a force is induced between the actuator and the drive wires, the sensor can output a voltage to the controller. Due to programmed software or firmware limitations, if a threshold voltage is exceeded, the controller can stop motion and send a warning signal to the user. This is sometimes referred to as a "motor stop circuit."

[0165] This type of threshold voltage may occur at a lower force than a mechanical release mechanism because it is easier to restore to a normal operating state since no damage or mechanical engagement has occurred. This electrical sensing may prevent the actuator from inducing further force into the release mechanism, although additional forces may still be induced in the catheter due to external factors. This is when the mechanical threshold comes into play.

[0166] The force sensor can also trigger an "auto-relax mode" that may occur before the "motor stop circuit", but at the upper limit of the allowable wire motion force. This may be a software algorithm that pauses motion to relieve tension / compression on the wire to improve performance and prevent larger wire forces from being induced.

[0167] According to some embodiments, force management can be performed with respect to various force thresholds. As shown in force management diagram 600 of Figure 12, force thresholds for purposes of force management can include an automatic relaxation threshold, a motor stop threshold, a mechanical disengagement threshold, a hyperelastic plateau threshold, a catheter breakage threshold, a detrimental force threshold, and may include other types of force thresholds.

[0168] An automatic relaxation mode or threshold may occur at the upper limit of wire force during normal use. A motor stop threshold may stop all actuator motion and prevent additional forces from being induced on the catheter by the actuators. A mechanical breakaway threshold is a passive mechanical breakaway threshold (i.e., magnetic breakaway) and operates regardless of the electrical signal. A superelastic plateau threshold is the superelastic threshold of the Nitinol drive wire that occurs only in tension and prevents additional forces from being induced on the tip of the catheter. A catheter breakage threshold occurs in the proximal section of the catheter. There are multiple safety thresholds so that it is highly unlikely that harmful forces will be induced on the tip of the catheter.

[0169] For example, an acceleration sensor can detect or measure the movement of mass of a component of the medical device 1300 by position or can detect the speed of movement of a component of the medical device 1300. A gyroscope sensor can detect or measure the angular velocity or angle of movement and can measure the motion of the medical device 1300 with up to six degrees of freedom in three-dimensional space, such as three translational degrees of freedom along Cartesian x, y, and z coordinates, and rotation along one or more of the yaw, pitch, roll, and horizontal axes to change orientation between the axes. Yaw is when a component of the medical device 1300 rotates left or right on a vertical axis. Rotation on the front-to-back axis is called roll. Rotation from side to side is called pitch.

[0170] Examples of the acceleration sensor include a gravity sensor and a fall detection sensor. The gyroscope sensor may include an angular velocity sensor, an image stabilization sensor, a geomagnetic sensor, and the like. The position sensor may be a GPS sensor that receives data output from a global positioning system (GPS). The longitude and latitude of the current position can be obtained from information output from an access point of a radio frequency identification device (RFID) and a WiFi device and a wireless base station, so that, for example, their detection can be used as a position sensor. Such a sensor may be disposed inside or outside the medical device 1300.

[0171] The medical device 1308, according to some embodiments, may be configured as a catheter 1500, as shown in Figures 23A and 23B.

[0172] In Figure 23A, a catheter 1500 is shown as a flexible medical device including a proximal section 1510A, a middle section 1510B, and a distal section 1510C. A hollow chamber 1540 runs from proximal to distal through the catheter 1500 and can be used as a working channel for a medical procedure. The catheter 1500 includes a number of drive wires 1542 and support wires 1544, each disposed in a lumen 1546 that surrounds the central hollow chamber 1540, as shown in cross-sectional view in Figure 23B.

[0173] Each of the proximal section 1510A, the middle section 1510B, and the distal section 1510C of the catheter 1500 can be bent by a number of drive wires 1542 (drive linear members) as a drive backbone. The position of the catheter 1500 can be maintained by a support wire 1544 (support linear member) as a passive sliding backbone. One or more lumens can be left free to facilitate the use of additional optical fibers or wires added to the catheter 1500. The atraumatic tip 1548 of the catheter 1500 is attached with a tracking sensor 1310. At the proximal end of the catheter 1500, the drive wires 1542 are connected to an actuator 1506. The actuator 1306 may include one or more motors and drives each section of the catheter 1500 by pushing and pulling the drive wires 1542 in a push / pull or insert / withdraw direction.

[0174] The controller 1302 can control the catheter 1308 based on an algorithm known as a follow-the-leader (FTL) algorithm. By applying the FTL algorithm, the intermediate and proximal sections (the follower sections) of the catheter 1308 move at a first location in the same manner as the distal section moves at a second location at or near the first location.

[0175] The release connections of some embodiments provide compression release, rigid support mechanisms, reset capabilities, precise and repeatable bonding forces, high force per volume, and numerous advantages over known technology.

[0176] For example, the alternative methods require slippage, which creates wear on the surfaces where the slippage occurs. In the above breakaway configuration, where there may be an axial magnetic force but no lateral frictional forces, minimal wear occurs.

[0177] In the repeatable force example, the binding force varies with the volume of the magnet and the gap between the magnet and the steel. This makes it easier to precisely control the force between the parts, creating a precisely repeatable force between the units. This makes manufacturing more expensive. Also, if friction causes separation, the force will gradually decrease over time as it wears.

[0178] The detachment arrangements of the above embodiments allow for support after a detachment event. If a detachment occurs, the detachment arrangements of some embodiments can still function after the detachment event because there is a sliding member that supports the catheter and the actuator moving parts separately. This also allows for easy re-engagement of the two after detachment.

[0179] As discussed above, a magnetic breakaway configuration has been described that advantageously increases safety and addresses issues related to stiffness, force density and bandwidth.

[0180] A detachment device according to some embodiments includes an actuator, a medical device, and a detachment connection that couples the actuator and the medical device, the detachment connection having an actuator portion on the actuator side and a medical device portion on the medical device side. The actuator portion may include an actuator support portion, an actuator side ferromagnetic block, and a slider element. The medical device portion may include a medical device support portion, a medical device side ferromagnetic block, and a slider element. At least one of the actuator side ferromagnetic block and the medical device side ferromagnetic block includes a magnet, and the actuator is coupled to the medical device by a magnetic coupling force. The actuator separates from the medical device when a separation force is greater than a predetermined amount.

[0181] The actuator portion may include a spacer attached to the actuator ferromagnetic block and facing the medical device ferromagnetic block, the spacer defining a gap between the actuator ferromagnetic block and the medical device ferromagnetic block. Both the actuator ferromagnetic block and the medical device ferromagnetic block may include magnets.

[0182] The slider element of the actuator portion and the slider element of the medical device portion may be a single slider element that is connected to both the actuator support portion and the medical device support portion.

[0183] The actuator may include a motor, drive, or motorized drive assembly. The actuator may include a rotary drive assembly that provides rotary motion to a plurality of drive wires. The plurality of drive wires may include a monolithic wire of material configured to accommodate both pushing and pulling motions.

[0184] The medical device may be a catheter, an endoscope, a colonoscope, a bronchoscope, or an ablation device. The medical device may be a steerable catheter with a distal end and a proximal end and a plurality of drive wires. The steerable catheter may have a plurality of bendable sections located at the distal end of the steerable catheter, one of the plurality of drive wires passing through each of the bendable sections. The drive wire is a push-pull wire that may have a distal end attached to the distal end of one of the plurality of bendable sections and a proximal end attached to the medical device portion.

[0185] Upon application of a tensile threshold force equal to or greater than a predetermined value to at least one of the plurality of drive wires, a tensile force release mechanism may be actuated to terminate transmission of the tensile force to the steerable catheter via the actuator portion. The tensile force release mechanism may be disposed within the steerable catheter. The plurality of drive wires may include a superelastic material in the form of a nickel-titanium alloy. The plurality of drive wires are configured to reach a superelastic plateau of the superelastic material in a stress-strain relationship at the tensile threshold force, and elongation of the plurality of drive wires in the superelastic plateau state terminates transmission of the tensile force. The plurality of drive wires in the superelastic plateau state may have a maximum elongation equal to or greater than a predetermined operating stroke distance of the plurality of drive wires, the predetermined operating stroke distance corresponding to a maximum operating stroke distance and a maximum elongation.

[0186] Upon application of a compression threshold force to at least one of the plurality of drive wires, a compression force break-away mechanism can be activated to terminate transmission of compression force from the actuator to the steerable catheter via the at least one drive wire. The compression force break-away mechanism can be disposed within the actuator. The compression force break-away mechanism can include a permanent magnet.

[0187] The slider element of the actuator portion and the slider element of the medical device portion can collectively constrain the multiple drive wires in at least one dimension. The slider element of the actuator portion and the slider element of the medical device portion can collectively constrain the multiple drive wires in five dimensions.

[0188] The detachment device may include at least one force sensor coupled to the steerable catheter or medical device portion to measure push / pull forces on the multiple drive wires, at least one motor for pushing and pulling the multiple drive wires based on an operation command, and a controller to issue an operation command to the at least one motor. The controller can issue a command based on metrics calculated using force measurements from the force sensor to stop increasing the push / pull force on the push / pull wires. The actuator can exert a linear force provided by the motor. The linear force can act on the medical device via the detachment device.

[0189] The actuator portion and the medical device portion may be offset from one another in a direction of a magnetic coupling force. An actuator pusher may be coupled to the actuator. The medical device may include a medical device wire pusher. The actuator ferromagnetic block and the medical device ferromagnetic block are configured to be permeable to magnetic flux and form a coupling between one another.

[0190] A system according to some embodiments may include an actuator, a steerable device having a number of drive wires, and a number of release connections coupling the actuator and the steerable device, each release connection having an actuator portion on the actuator side and a steerable device portion on the medical device side.

[0191] Each of the actuator portions may include an actuator support, an actuator-side ferromagnetic block, and a slider element. Each of the steerable device portions may have a device support, a steerable device-side ferromagnetic block, and a slider element. At least one of the actuator-side ferromagnetic block and the device-side ferromagnetic block may include a magnet. When a tensile threshold force is applied to at least one of the plurality of drive wires that is equal to or greater than a predetermined value, a tensile force breakaway mechanism may be activated to stop the transmission of the tensile force to the steerable device via the actuator portion. When a compressive threshold force is applied to at least one of the plurality of drive wires, a compressive force breakaway mechanism may be activated to stop the transmission of the compressive force to the steerable device via the actuator. The system may include at least six breakaway connections, and the steerable device may have at least three drive wires. The actuator is coupled to the medical device by a magnetic coupling force, and the actuator separates from the steerable device when a separation force is greater than a predetermined amount.

[0192] Both the actuator ferromagnetic block and the steerable device ferromagnetic block may include magnets. The slider element of the actuator portion and the slider element of the steerable device portion may be a single slider element connected to both the actuator support and the steerable device support. The actuator may include a motor, drive, or motorized drive assembly.

[0193] The system may also include any combination of the additional features described above for the detachment device.

[0194] The release mechanisms of the present disclosure provide various advantages over the related art with respect to minimal wear, repeatable forces, allowing for support after a release occurs, and other advantages.

[0195] With regard to minimal wear, related art methods require slippage and wear occurs on the surfaces where slippage occurs, whereas the release mechanism of the present disclosure can only generate axial magnetic forces, without lateral frictional forces.

[0196] In terms of repeatable force, the bond strength varies with the volume of the magnet and the gap between the magnet and the steel. This allows for precise control of the force between parts and breakaways of the same part. When working with slip designs, tight tolerances must be made to produce precise repeatable forces between units. This makes manufacturing more expensive. Also, when breakaway occurs due to friction, the force gradually decreases over time as it wears away.

[0197] To allow for support after a detachment event, the detachment mechanism of the present disclosure can function even after a detachment event, and there is a sliding member that supports the catheter and actuator moving parts separately, allowing the two to be easily re-engaged after detachment.

[0198] Features of the release mechanism in some embodiments include compression release, rigid support mechanism, reset capability, precise and repeatable binding force, and high force per volume, although other features may also be present.

[0199] A steerable catheter device according to some embodiments may include a steerable catheter having a distal end and a proximal end, a number of curved sections, an actuator for pushing and pulling a push-pull wire, and may include other features.

[0200] The push-pull wire may be attached at one end to the distal end of the curved section and at the other end to an actuator proximal to the curved section to bend the curved section.

[0201] The tension force release mechanism can be actuated at a tension threshold force above a predetermined value to stop the transmission of tension forces from the actuator to the steerable catheter via the push-pull wires, and the compression force release mechanism can be actuated at a compression threshold force above a predetermined value to stop the transmission of compression forces from the actuator to the steerable catheter via the push-pull wires.

[0202] The tension release mechanism may be provided within the steerable catheter.

[0203] The compression force take-off mechanism may be provided within the actuator.

[0204] By separating the tension and compression force breakaway mechanisms of the push-pull wires, the benefits of these features can be applied to mechanisms that are optimized for tension and compression forces with different principles.

[0205] In addition, since a failure of the push-pull drive wire due to a compressive force basically occurs on the force transmission line of the push-pull drive wire, by disposing the compressive force release mechanism in the actuator, the release mechanism covers the entire force transmission line of the push-pull wire up to the connection between the push-pull wire and the actuator. On the other hand, since a failure of the push-pull drive wire due to a tensile force basically occurs around the anchor point or in the thin-diameter part of the push-pull drive wire of the steerable catheter body, the tensile force release mechanism may be provided in the steerable catheter.

[0206] The push-pull wires of the tensile force release mechanism may be made from a superelastic material in the form of a nickel titanium alloy or Nitinol. The push-pull wires can reach a superelastic plateau of the superelastic material in the stress-strain relationship at the tensile threshold force, and elongation of the push-pull wires at the superelastic plateau can stop the transmission of the tensile force.

[0207] By constructing the push-pull drive wire from superelastic Nitinol, the tension detachment mechanism can be formed without adding additional structure to the push-pull drive wire itself, thus allowing for a smaller catheter size with a detachment mechanism.

[0208] The push-pull wire in the elastic plateau state may have a maximum elongation that is equal to or greater than a predetermined operating stroke distance of the push-pull wire, and the predetermined operating stroke distance may correspond to the maximum operating stroke distance and the maximum elongation.

[0209] By making the extension of the push-pull drive wires greater than the maximum operating stroke distance, the device can ensure that the push-pull drive wires are protected from failure. Specifically, the actuator may be equipped with a stroke limiter for the maximum required operating stroke, and a simple distance limiter may be used to limit the force outside the range of the pull-away mechanism. Prevents push-pull drive wires from being positioned It is possible.

[0210] The pull-off mechanism may have an irreversible break point that can irreversibly physically disconnect the push-pull wire from the actuator, terminating the transmission of the pull force.

[0211] Irreversible detachment allows the detachment action to be achieved using a simple mechanical structure without the use of electricity, which also allows the catheter to be compact even when equipped with a pull detachment mechanism.

[0212] The compression force breakaway mechanism may include a permanent magnet.

[0213] A compression release mechanism using permanent magnets can provide reliable release with sufficient release threshold force and low wear.

[0214] Furthermore, since the compression release mechanism is provided in the actuator, the device can hide the permanent magnet from the outside, improving compatibility and safety with magnet-sensitive equipment.

[0215] The actuator may include a force sensor that measures the push / pull force applied to the push / pull wire, a motor that pushes and pulls the push / pull wire based on an operational command, a controller that issues the operational command to the motor, and may include other elements and components.

[0216] The controller can issue a command based on metrics calculated using the force measurements from the force sensor to stop increasing the push / pull force on the push-pull wire.

[0217] By combining force management using force sensors and motor control using tension and compression breakaway mechanisms, the device is able to reduce the situations in which the breakaway mechanism needs to operate.

[0218] The detachment mechanism according to some embodiments is incorporated into a medical device in the form of a robotic or snake-like catheter assembly or other type of medical assembly having a rotary drive assembly that imparts rotational motion to a guidewire of a medical device (such as a catheter, optical catheter, or other flexible elongated tubular device) made of a medical material that can be inserted through an opening in a body cavity (e.g., a blood vessel) to perform various medical functions. A fiber optic catheter is an example of an optical catheter and includes a flexible sheath, a coil, and an optical probe and / or imaging core housed within the coil. The catheter may include a "guide catheter" that functions similarly to the sheath. The drive assembly is releasably connected to the catheter, and the detachment mechanism can be used to separate the drive assembly from the catheter in response to a coupling force.

[0219] Although the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the present disclosure is not limited to the disclosed exemplary embodiments, and the scope of the following claims should be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

1. An actuator; Medical equipment and a detachment connection part that connects the actuator and the medical device, the detachment connection part having an actuator part on the actuator side and a medical device part on the medical device side; A release device comprising: the actuator portion includes an actuator support, an actuator-side ferromagnetic block, and a slider element; the medical device portion includes a medical device support portion, a medical device side ferromagnetic block, and a slider element; At least one of the actuator-side ferromagnetic block and the medical device-side ferromagnetic block has a magnet; the actuator is coupled to the medical device by a magnetic coupling force, and the actuator separates from the medical device when a separation force is greater than a predetermined amount. Release device.

2. The actuator portion comprises: a spacer attached to the actuator ferromagnetic block and facing the medical device ferromagnetic block, the spacer defining a gap between the actuator ferromagnetic block and the medical device ferromagnetic block; Further comprising The release device of claim 1 .

3. Both the actuator-side ferromagnetic block and the medical device-side ferromagnetic block have magnets. The release device of claim 1 .

4. the slider element of the actuator portion and the slider element of the medical device portion are a single slider element connected to both the actuator support and the medical device support. The release device of claim 1 .

5. The actuator comprises a motor, a drive or a motorized drive assembly. The release device of claim 1 .

6. the actuator includes a rotary drive assembly that imparts rotary motion to at least one drive wire of the medical device. The release device of claim 1 .

7. The medical device comprises a catheter, an endoscope, a colonoscope, a bronchoscope, or an ablation device; The release device of claim 1 .

8. the medical device is a steerable catheter having a distal end and a proximal end and a plurality of drive wires; The release device of claim 7.

9. the plurality of drive wires includes a monolithic material wire configured to accommodate both pushing and pulling motions; The release device of claim 8.

10. the steerable catheter further comprising a plurality of bendable sections located at a distal end of the steerable catheter, at least one of the plurality of drive wires passing through each of the bendable sections. The release device of claim 8.

11. the drive wire is a push-pull wire having a distal end attached to a distal end of one of the plurality of bendable sections and a proximal end attached to the medical device portion. The release device of claim 10.

12. a tension release mechanism is activated upon application of a tension threshold force to at least one of the plurality of drive wires that is equal to or exceeds a predetermined value to terminate transmission of tension to the steerable catheter via the actuator portion. The release device of claim 10.

13. the tension release mechanism is disposed within the steerable catheter; The release device of claim 12.

14. the plurality of drive wires comprising a superelastic material in the form of a nickel-titanium alloy; The release device of claim 12.

15. the plurality of drive wires are configured to reach a superelastic plateau of the superelastic material in a stress-strain relationship at the tensile threshold force, and elongation of the plurality of drive wires at the superelastic plateau state ceases transmission of the tensile force.

15. The release device of claim 14.

16. the plurality of drive wires in the superelastic plateau state have a maximum elongation that is equal to or greater than a predetermined operating stroke distance of the plurality of drive wires, the predetermined operating stroke distance corresponding to a maximum operating stroke distance and the maximum elongation.

16. The release device of claim 15.

17. a compressive force release mechanism is actuated upon application of a compressive threshold force to at least one of the plurality of drive wires to terminate transmission of compressive force from the actuator to the steerable catheter via the at least one drive wire. The release device of claim 10.

18. The compression force release mechanism is provided within the actuator.

20. The release device of claim 17.

19. the compression force breakaway mechanism includes a permanent magnet; 20. The release device of claim 18.

20. the slider element of the actuator portion and the slider element of the medical device portion collectively constrain the plurality of drive wires in at least one dimension. The release device of claim 10.

21. the slider element of the actuator portion and the slider element of the medical device portion collectively constrain the plurality of drive wires in five dimensions. The release device of claim 10.

22. at least one force sensor coupled to the steerable catheter or medical device portion for measuring push / pull forces on the plurality of drive wires; at least one motor for pushing and pulling the plurality of drive wires based on an operation command; a control device that issues the operation command to the at least one motor; 10. The release device of claim 1, further comprising:

23. the controller is configured to issue the command based on metrics calculated using force measurements from the force sensor to stop increasing the push / pull force on the push-pull wire.

23. The release device of claim 22.

24. The actuator is configured to exert a linear force provided by a motor. The release device of claim 1 .

25. the linear force acts on the medical device via the release device; 25. The release device of claim 24.

26. the actuator portion and the medical device portion are offset from one another in the direction of the magnetic coupling force. The release device of claim 1 .

27. an actuator pusher coupled to the actuator; 10. The release device of claim 1, further comprising:

28. the medical device comprises a medical device wire pusher; The release device of claim 1 .

29. the actuator ferromagnetic block and the medical device ferromagnetic block are configured to transmit magnetic flux and form a coupling between each other. The release device of claim 1 .

30. An actuator; a steerable device having a plurality of drive wires; a plurality of release connections connecting the actuator and the steerable device, each release connection having an actuator portion on the actuator side and a steerable device portion on the medical device side; A system comprising: Each of the actuator portions includes an actuator support, an actuator-side ferromagnetic block, and a slider element; Each of the steerable device portions includes a device support, a steerable device side ferromagnetic block, and a slider element; At least one of the actuator-side ferromagnetic block and the device-side ferromagnetic block has a magnet, a tension release mechanism is actuated to stop transmission of tension to the steerable device via the actuator portion when a tension threshold force equal to or greater than a predetermined value is applied to at least one of the plurality of drive wires; a compressive force release mechanism is actuated upon application of a compressive threshold force to at least one of the plurality of drive wires to cease transmission of compressive force to the steerable device via the actuator; system.

31. the system includes at least six release connections and the steerable device has at least three drive wires; 31. The system of claim 30.

32. the actuator is coupled to the medical device by a magnetic coupling force, and the actuator separates from the steerable device when a separation force is greater than a predetermined amount.

31. The system of claim 30.

33. The actuator portion comprises: a spacer attached to the actuator side ferromagnetic block and facing the steerable device side ferromagnetic block, the spacer defining a gap between the actuator side ferromagnetic block and the steerable device side ferromagnetic block; Further comprising 31. The system of claim 30.

34. Both the actuator side ferromagnetic block and the steerable device side ferromagnetic block both have magnets.

31. The system of claim 30.

35. the slider element of the actuator portion and the slider element of the steerable device portion are a single slider element connected to both the actuator support and the steerable device support.

31. The system of claim 30.

36. The actuator comprises a motor, a drive or a motorized drive assembly.

31. The system of claim 30.

37. the actuator includes a rotary drive assembly that imparts rotary motion to the plurality of drive wires.

31. The system of claim 30.

38. the plurality of drive wires includes a monolithic material wire configured to accommodate both pushing and pulling motions; 38. The system of claim 37.

39. The steerable device comprises a catheter, an endoscope, a colonoscope, a bronchoscope, or an ablation device.

31. The system of claim 30.

40. the steerable device is a catheter having a distal end and a proximal end; 40. The system of claim 39.

41. The catheter further comprises a plurality of bendable sections located at a distal end of the catheter, with at least one of the plurality of drive wires passing through each of the bendable sections.

41. The system of claim 40.

42. the at least one of the plurality of drive wires is a push-pull wire having a distal end attached to a distal end of one of the plurality of bendable sections and a proximal end attached to the steerable instrument portion.

42. The system of claim 41.

43. the tension release mechanism is disposed within the steerable catheter; 31. The system of claim 30.

44. the plurality of drive wires comprising a superelastic material in the form of a nickel-titanium alloy; 42. The system of claim 41.

45. the plurality of drive wires are configured to reach a superelastic plateau of the superelastic material in a stress-strain relationship at the tensile threshold force, and elongation of the plurality of drive wires at the superelastic plateau state ceases transmission of the tensile force.

45. The system of claim 44.

46. the plurality of drive wires in the superelastic plateau state have a maximum elongation that is equal to or greater than a predetermined operating stroke distance of the plurality of drive wires, the predetermined operating stroke distance corresponding to a maximum operating stroke distance and the maximum elongation.

46. ​​The system of claim 45.

47. The compression force release mechanism is provided within the actuator.

31. The system of claim 30.

48. the compression force breakaway mechanism includes a permanent magnet; 48. The system of claim 47.

49. the slider element of the actuator portion and the slider element of the steerable device portion collectively constrain the plurality of drive wires in at least one dimension.

31. The system of claim 30.

50. the slider element of the actuator portion and the slider element of the steerable device portion collectively constrain the plurality of drive wires in five dimensions.

31. The system of claim 30.

51. at least one force sensor coupled to the steerable device portion to measure push and pull forces on the plurality of drive wires; at least one motor for pushing and pulling the plurality of drive wires based on an operation command; a control device that issues the operation command to the at least one motor; 31. The system of claim 30, further comprising:

52. the controller is configured to issue the command based on metrics calculated using force measurements from the force sensor to stop increasing the push / pull force on the push-pull wire.

52. The system of claim 51.

53. The actuator is configured to exert a linear force provided by a motor.

31. The system of claim 30.

54. the linear force acts on the steerable device via the release device; 54. The release device of claim 53.

55. the actuator portion and the steerable device portion are offset from one another in the direction of the magnetic coupling force.

31. The system of claim 30.

56. an actuator pusher coupled to the actuator; 31. The system of claim 30, further comprising:

57. the medical device comprises a medical device wire pusher; 31. The system of claim 30.

58. the actuator ferromagnetic block and the steerable device ferromagnetic block are configured to transmit magnetic flux and form a coupling between each other.

31. The system of claim 30.

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