Management of long and thin medical devices

Abstract

To provide a robotic medical treatment system, particularly, a device and a method for robotically controlling movement and operation of an elongated medical device.SOLUTION: Provided is an EMD drive system including an on-device adapter 112 releasably fixed to a shaft of an EMD 102. The on-device adapter is received in the inside of a cassette. The cassette is releasably fixed to a drive module. The drive module is operably connected with the on-device adapter and moves the on-device adapter and the EMD together.SELECTED DRAWING: Figure 4A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 874,173, filed June 15, 2019, and entitled "Manipulation of an elongated medical device."

[0002] The present invention relates generally to the field of robotic medical treatment systems, and more particularly to apparatus and methods for robotically controlling the movement and motion of elongated medical devices. [Background technology]

[0003] Catheters and other elongated medical devices (EMDs) are often used for minimally invasive medical procedures to diagnose and treat various vascular conditions, including those known as neurovascular interventional procedures (NVI) or neurointerventional surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve navigating a guide wire through the vasculature and advancing a catheter over the guide wire. Such catheterization begins with gaining access to an appropriate vessel, such as an artery or vein, using an introducer sheath using standard percutaneous techniques. A sheath or guide catheter is then advanced through the introducer sheath to its primary location over the diagnostic guide wire. The location may be, for example, the internal carotid artery for NVI, the coronary ostium for PCI, or the surface of the femoral artery for PVI. A guide wire appropriate for the vasculature is then guided through the sheath or guide catheter to the target location within the vasculature. In certain circumstances, such as tortuous anatomy, a support catheter or microcatheter may be inserted over the guide wire to aid in guiding the guide wire. The physician or operator may use an imaging system (e.g., fluoroscopy) to obtain cine images with contrast injection, which may be used as a roadmap for selecting a fixed frame to guide the guide wire or catheter to the target (e.g., lesion) location. As the physician advances the guide wire or catheter, contrast-enhanced images may also be obtained, allowing the physician to confirm whether the device is moving along the correct path to the target location.Using fluoroscopy to view the anatomy, the physician manipulates the proximal end of the guidewire or catheter to orient its distal end within the appropriate vessel to the lesion or target anatomical location, while avoiding the distal end from bifurcation (advancing into a side branch).

[0004] Robotic catheter-based treatment systems have been developed to assist physicians in performing catheter procedures (e.g., NVI, PCI, and PVI). Examples of NVI procedures include coil embolization of aneurysms, fluid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke. In NVI procedures, physicians use robotic systems to control the manipulation of neurovascular guidewires or microcatheters to gain access to target lesions, deliver treatment sites, and restore normal blood flow. Target access is enabled by a sheath or guide catheter. However, in more distal areas, an intermediate catheter may be required to provide adequate support for the microcatheter or guidewire. The distal end of the guidewire may be guided into or through the lesion, depending on the lesion type and treatment. Alternatively, to treat multiple aneurysms, a microcatheter may be advanced to the lesion, the guidewire removed, and multiple thrombus coils deployed through the microcatheter to occlude blood flow into the aneurysm. Additionally, to treat arteriovenous malformations, liquid emboli may be injected into the malformation via a microcatheter. Mechanical thrombosis to treat vascular occlusions can be achieved through aspiration and / or the use of a stent retriever. Depending on the location of the thrombus, aspiration is performed through the aspiration catheter or, in the case of smaller arteries, through a microcatheter. Once the aspiration catheter reaches the lesion, negative pressure may be applied to remove the clot (thrombus) through the catheter. Alternatively, the clot may be removed by placing a stent retriever through the microcatheter. Once the thrombus is integrated with the stent retriever, it is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

[0005] During PCI, physicians may use a robotic system to manipulate a coronary guide wire to gain access to the lesion, deliver the treatment site, and restore normal blood flow. This access is achieved by placing a guide catheter within the coronary artery ostium. The distal end of the guide wire is guided through the lesion; in complex anatomy, a microcatheter may be used to properly support the guide wire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion site. The lesion may require preparation before stent placement, such as delivering a balloon for lesion predilatation, or atherectomy may be performed, using a laser or rotational atherectomy catheter and a balloon over a guide wire. Diagnostic imaging and physiological measurements may be performed to determine appropriate treatment using an imaging catheter or fractional flow reserve (FFR) measurements.

[0006] In PVI, physicians restore blood flow using techniques similar to NVI, using a robotic system to perform the procedure. The distal end of a guidewire is guided through the lesion, and a microcatheter may be used to provide adequate support for the guidewire against the complex anatomy. Blood flow can be restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging can also be used.

[0007] When support at the distal end of the catheter or guidewire is required, for example, to navigate tortuous or calcified vasculature to reach a distal anatomical location or cross a rigid lesion, over-the-wire (OTW) catheters or coaxial systems may be used. Because the guidewire extends the entire length of the catheter, OTW catheters have a lumen. This provides support for the guidewire along its entire length, resulting in a relatively stable system. However, this system has several drawbacks, including higher friction and a longer overall length compared to rapid or fast-exchange catheters (see below). Typically, to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For example, a 300 cm long guidewire is usually sufficient for this purpose. This is sometimes referred to as an exchange-length guidewire. However, due to the length of the guidewire, two operators are required to remove or exchange an OTW catheter. This becomes even more difficult with triple coaxial systems, known in the art as triaxial systems (although the use of quadruple coaxial catheters is also known). However, OTW systems are often used in NVI and PVI procedures due to their stability. Rapid-exchange (or monorail) catheters are often used in PCI procedures. The guidewire lumen of a rapid-exchange catheter runs only in the distal portion of the catheter, also known as the monorail or rapid exchange (RX) section. With an RX system, the operator manipulates the interventional devices parallel to each other (as opposed to the OTW system, where the devices are manipulated in a serial configuration), and the exposed length of the guidewire is only slightly longer than the RX section of the catheter. Rapid-exchange guidewires are typically 180–200 cm long. When a shorter guidewire and monorail are used, the RX catheter can be exchanged by a single operator.However, when more distal support is needed, RX catheters are often inadequate. Summary of the Invention [Means for solving the problem]

[0008] An EMD drive system is provided that includes an on-device adapter releasably secured to a shaft of the EMD. The on-device adapter is received within a cassette. The cassette is releasably secured to a drive module. The drive module is operatively coupled to the on-device adapter to move the on-device adapter and the EMD together.

[0009] In one embodiment, the EMD drive system includes a collet releasably secured to the EMD. The EMD secured to the collet is radially loaded into a robot drive. An EMD support is releasably applied non-axially to the EMD. The robot drive is operatively coupled to the collet to move (translate or advance) and / or rotate the collet and EMD.

[0010] In one embodiment, the robot system includes a robot drive including a base having a drive coupler. A cassette is releasably secured to the base. A collet within the cassette is releasably secured to the EMD. The collet has a driven member operably coupled to the drive coupler. The robot drive includes a motor operably coupled to the collet for moving the collet.

[0011] In one embodiment, a robotic system includes a collet having a first portion and a second portion, the first portion having a first collet coupler connected thereto and the second portion having a second collet coupler connected thereto. An EMD is releasably positioned within a path defined by the collet. A robotic drive including a base includes a first motor and a second motor operatively coupled to both the first collet coupler and the second collet coupler at all times, operatively clamping and unclamping the EMD within the path and rotating the EMD.

[0012] In one embodiment, the collet includes an inner member and an outer member, the inner member defining a passageway for receiving the EMD, and a plurality of engagement members for releasably engaging the EMD when the inner member is moved relative to the outer member.

[0013] In one embodiment, the EMD drive system includes a collet having a collet first member with a first engagement portion. The collet has a driven second member. The collet engagement member has a second engagement portion. The collet first member and the collet engagement member move between an engaged position and a disengaged position. When the collet first member and the collet engagement portion move to the engaged position, the first engagement portion engages with the second engagement portion. Rotation of the collet first member relative to the collet second member in a first direction in the engaged position pinches the EMD within the collet, and rotation of the collet first member relative to the collet second member in a second direction opposite the first direction unpinches (unpinches) the EMD within the collet.

[0014] In another embodiment, an EMD robotic drive system for rotating and moving an EMD using reset commands includes a drive module controlled by a control system, the drive module including a first actuator operatively rotating a first axis and / or a second axis, a second actuator operatively moving the first axis along its longitudinal axis from a first position to a second position relative to the second axis, a first tire assembly operatively attached to the first axis, a second tire assembly operatively attached to the second axis, and a third actuator operatively moving the first tire assembly toward and away from the second tire assembly to grip and disgrip an EMD having a longitudinal axis between the first and second tire assemblies. Movement (translation) of the first axis relative to the second axis causes the EMD to rotate about its longitudinal axis, and rotation of the first axis and / or the second axis causes the EMD to translate along its longitudinal axis. The control system provides a reset command to the third actuator to cause the EMD to ungrip; cause the second actuator to move the first tire assembly to a reset position relative to the second tire assembly; and cause the third actuator to grip the EMD.

[0015] In yet another embodiment, an EMD robot drive system is provided that includes a drive module, the drive module including: a first actuator operatively rotating a first axis and / or a second axis; a second actuator operatively moving (translating) the first axis along its longitudinal axis from a first position to a second position relative to the second axis; a first tire assembly releasably attached to the first axis; and a second tire assembly releasably attached to the second axis. An EMD having a longitudinal axis is disposed at a first position between the first tire assembly and the second tire assembly. Rotation of the first axis causes the EMD to translate along its longitudinal axis between the first tire assembly and the second tire assembly; and rotation of the second axis causes the EMD to rotate about its longitudinal axis. A third actuator moves the first tire assembly toward and away from the second tire assembly to grip and ungrip the EMD between the first and second tire assemblies, and a retaining clamp releasably clamps a portion of the EMD spaced from the first and second tires along a longitudinal axis of the EMD.

[0016] In one embodiment, an EMD robot drive system is provided that includes a first actuator that operably rotates a first axis and / or a second axis. A second actuator operably moves (translates) the first axis along its longitudinal axis relative to the second axis from a first position to a second position. A first tire assembly is operably attached to the first axis. A second tire assembly is operably attached to the second axis. A third actuator moves the first tire assembly relative to and away from the second tire assembly to grip and disengage an EMD having a longitudinal axis between the first and second tire assemblies. Movement (translation) of the first axis relative to the second axis rotates the EMD about its longitudinal axis, and rotation of the first axis and / or the second axis moves (translates) the EMD along its longitudinal axis. As the first shaft moves along its longitudinal axis away from the home position, the first actuator moves with the first shaft.

[0017] In one embodiment, a method for robotically (robotically driven) moving an EMD is provided, the method including: pinching an axis of the EMD within an on-device adapter; releasably securing the on-device adapter within a cassette; releasably securing the cassette relative to a drive module; and robotically moving the on-device adapter and EMD together along and / or rotating about a longitudinal axis of the EMD. In a further aspect, the method includes unclamping the EMD within the on-device adapter with an actuator once the on-device adapter is secured within the cassette. In a further aspect, the method robotically controls the unclamping of the EMD with an actuator. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a schematic diagram of an exemplary catheter treatment system according to one embodiment. [Figure 2]FIG. 2 is a schematic block diagram of an exemplary catheter treatment system according to one embodiment. [Figure 3] FIG. 3 is a perspective view of an exemplary bedside system for a catheterization system according to one embodiment. [Figure 4A] FIG. 4A is an exploded perspective view of a device module with a load sensing system and a cassette that receives an on-device adapter with an EMD, according to one embodiment. [Figure 4B] FIG. 4B is a perspective view of a cassette with an on-device adapter along with an EMD according to one embodiment. [Figure 4C] FIG. 4C is an exploded perspective view of the cassette showing the first and second parts of the separation element. [Figure 4D] FIG. 4D is an exploded perspective view of the lower part of the cassette and its connection to the drive module. [Figure 4E] FIG. 4E is a partial side view showing the on-device adapter with the EMD supported in a separate component as part of the cassette. [Figure 4F] FIG. 4F is a cross-sectional view of the embodiment of FIG. 4A with the EMD in position within the cassette. [Figure 4G] FIG. 4G is a perspective view of the cassette and device support. [Figure 4H] Figure 4H is a close-up perspective view of the device module shown in Figure 3. [Figure 5A] FIG. 5A is an exploded perspective view of a drive module including a drive module base assembly and a load sensing assembly. [Figure 5B] FIG. 5B is a close-up top view of FIG. 5A showing the load sensing components connected to the load sensor in the drive module base component. [Figure 5C] FIG. 5C is a top view of a drive module with a load sensing system, including an actuator for rotating and / or pinching / uncimping the EMD located outside the load sensing components, and a bearing support for the load sensing components in at least one off-axis (non-measuring) direction. [Figure 5D] FIG. 5D is a side view of a drive module with a load sensing system, illustrating an actuator for rotating and / or pinching / undipinching the EMD located outside the load sensing components, and a bearing support for the load sensing components in at least one off-axis (non-measuring) direction. [Figure 5E] FIG. 5E is a perspective view of a drive module including a load sensing component and a drive module base component. [Figure 6A] FIG. 6A is an exploded side view illustrating an EMD-on-device adapter according to one embodiment. [Figure 6B] Figure 6B is a side view of the assembled EMD-on-device adapter of Figure 6A. [Figure 6C] FIG. 6C is an exploded perspective view of an EMD-on-device adapter according to one embodiment. [Figure 6D] Figure 6D is a side view of the assembled EMD-on-device adapter of Figure 6C. [Figure 7A] FIG. 7A is a diagram of an on-device adapter according to one embodiment. [Figure 7B] Figure 7B is an exploded view of the on-device adapter of Figure 7A. [Figure 7C] FIG. 7C is a perspective view generally from the proximal direction of the on-device adapter of FIG. 7A. [Figure 7D] FIG. 7D is a perspective view generally from the bottom of the on-device adapter of FIG. 7A. [Figure 7E] FIG. 7E is a cross-sectional view of the on-device adapter of FIG. 7A with the lever in the open position. [Figure 7F] Figure 7F is a cross section of the on-device adapter of Figure 7A with the lever in the closed position. [Figure 8A] Figure 8A is a perspective view of the device adaptor with the catheter. [Figure 8B] FIG. 8B is a schematic perspective view of an embodiment of a catheter used with the on-device adapter of FIG. 8A. [Figure 9A]FIG. 9A is a perspective view of the collet. [Figure 9B] FIG. 9B is a perspective view of the inner member of the collet of FIG. 9A. [Figure 9C] FIG. 9C is a view of the collet of FIG. 9A taken generally along line 9C-9C. [Figure 9D] FIG. 9D is a top plan view of the inner member of the collet of FIG. 9A taken generally along line 9D-9D of FIG. 9B. [Figure 9E] FIG. 9E is an enlarged view of the free end of the inner member of FIG. 9D. [Figure 9F] FIG. 9F is a top plan view of the inner member of the collet of FIG. 9A taken generally along line 9F-9F of FIG. 9B. [Figure 9G] FIG. 9G is a perspective view of another collet. [Figure 9H] FIG. 9H is a view of the collet of FIG. 9G taken generally along line 9H-9H. [Figure 9I] FIG. 9I is a perspective view of the inner member of FIG. 9G. [Figure 10A] FIG. 10A is a perspective view of a cam-actuated collet. [Figure 10B] FIG. 10B is an exploded perspective view (assembly) of FIG. 10A. [Figure 10C.1] FIG. 10C.1 is a longitudinal cross-sectional view of FIG. 10A in the pinch-release configuration. [Figure 10C.2] FIG. 10C.2 is a cross-sectional view of FIG. 10A in the pinch-release configuration. [Figure 10D.1] FIG. 10D.1 is a longitudinal cross section of FIG. 10A in a pinched configuration. [Figure 10D.2] FIG. 10D.2 is a cross-sectional view of FIG. 10A in a pinched configuration. [Figure 11A] FIG. 11A is a longitudinal cross-sectional view of a flexure actuation collet. [Figure 11B] FIG. 11B is an assembled cross-sectional view of the flexure actuation collet of FIG. 11A. [Figure 11C] FIG. 11C is an exploded view (assembly) of the flexure actuation collet of FIG. 11A. [Figure 11D]FIG. 11D is a cross-sectional perspective view of the flexure actuation collet of FIG. 11A. [Figure 11E] FIG. 11E is a perspective view of the collar of the flexure actuation collet of FIG. 11A. [Figure 12A] FIG. 12A is a perspective view of a system including a dual gear collet drive assembly. [Figure 12B] FIG. 12B is a side view of the dual gear collet drive assembly of FIG. 12A. [Figure 12C] FIG. 12C is a perspective view of the dual gear collet drive assembly of FIG. 12A. [Figure 12D] FIG. 12D is an exploded perspective view (clamshell) showing two views of the dual gear collet drive assembly of FIG. 12A. [Figure 12E] FIG. 12E is a perspective view showing selected components of the dual gear collet drive assembly of FIG. 12A. [Figure 12F.1] FIG. 12F.1 is a cross-sectional top view showing the internal components of the dual gear collet drive assembly of FIG. 12A in the pinch release configuration. [Figure 12F.2] FIG. 12F.2 is a cross-sectional top view showing the internal components of the dual gear collet drive assembly of FIG. 12A in a pinch configuration. [Figure 13A] FIG. 13A is a perspective view of a dual gear slide collet drive system. [Figure 13B.1] FIG. 13B.1 is a side view of the dual gear sliding collet drive system of FIG. 13A in a proximal configuration.

Figure 13B.2

Figure 14C.2

Figure 14C.3

Figure 14C.4

[0019] FIG. 1 is a perspective view of an exemplary catheter-based treatment system 10, according to one embodiment. The catheter-based treatment system 10 may be used to perform catheter-based medical procedures, such as percutaneous coronary intervention (PCI) (e.g., treating STEMI), neurovascular interventional procedures (NVI) (e.g., treating emergency large vessel occlusion (ELVO)), and peripheral vascular intervention procedures (PVI) (e.g., treating critical limb ischemia (CLI)). Catheter-based medical procedures may include diagnostic catheterization procedures, during which one or more catheters or other elongated medical devices (EMDs) are used to aid in the diagnosis of a patient's condition. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through the catheter into one or more arteries to capture images of the patient's vasculature. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, peripheral vascular lesion treatment, clot removal, venous thrombosis, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat a lesion. Therapeutic procedures may be enhanced by the inclusion of additional devices 54 (see FIG. 2 ), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be understood that one skilled in the art can select a particular percutaneous interventional device or component (e.g., type of guidewire, type of catheter, etc.) based on the type of procedure being performed.The catheter-based treatment system 10 can be used to perform any number of catheter-based medical procedures, with minor adjustments to accommodate the particular percutaneous interventional device used in the procedure.

[0020] The catheter-based treatment system 10 includes, among other components, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic drive 24 and a positioning system 22 positioned near the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 may be, for example, a robotic arm, an articulated arm, a holder, or the like. One end of the positioning system 22 may be attached to, for example, a rail, a base, or a cart on the patient table 18. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 (along with the robotic drive 24) can be moved out of the way to allow the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robotic drive 24 relative to the patient 12 for treatment. According to one embodiment, the patient platform 18 is operably supported by a base 17 that is fixed to the floor and / or ground. The patient platform 18 can move with multiple degrees of freedom (e.g., roll, pitch, yaw) relative to the base 17. The bedside device 20 can also include a controller and display 46 (shown in FIG. 2). For example, the controller and display can be located on the housing of the robotic drive 24.

[0021] Generally, the robotic drive 24 includes appropriate percutaneous interventional devices and accessories 48 (see FIG. 2 ) (e.g., guidewires, balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid embolization devices, aspiration pumps, contrast delivery devices, medications, hemostasis valve adapters, syringes, stopcocks, inflation devices, etc.) for various controls (e.g., controls and inputs located at the control station 26) to enable the user or operator 11 to perform catheter-based medical procedures via the robotic system. The bedside device 20, and in particular the robotic drive 24, may include any number and / or combination of components to provide the functionality described herein for the bedside device 20. The user or operator 11 at the control station 26 may also be referred to as a control station user or control station operator, but will be referred to herein as a user or operator. The user or operator of the bedside device 20 may also be referred to as a bedside device user or bedside device operator. The robotic drive 24 includes multiple device modules 32a-d mounted on rails or linear members 60 (shown in FIG. 3 ). The rails or linear members 60 guide and support the device modules. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or guide wire. For example, the robotic drive 24 can be used to automatically feed a guide wire into a diagnostic catheter and into a guide catheter in an artery of the patient 12. One or more devices, such as an EMD, enter the body (e.g., a vessel) of the patient 12 at an insertion point 16, for example, via an introducer sheath.

[0022] The bedside device 20 is in communication with a control station 26, and signals generated by user inputs at the control station 26 can be transmitted wirelessly or via wired connections to the bedside device 20 to control various functions of the bedside device 20. As described below, the control station 26 may include a control computer system 34 (see FIG. 2) or may be coupled to the bedside device 20 via the control computer system 34. The bedside device 20 may also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computer system 34 (see FIG. 2), or both. Communication between the control computer system 34 and the various components of the catheter-based treatment system 10 can be provided via communication links, such as wireless connections, cabled (wired) connections, or any other means that allow communication between the components. The control station 26 or other similar control system may be located at either a local site (e.g., the local control station 38 shown in FIG. 2) or a remote site (e.g., the remote control station and computer system 42 shown in FIG. 2). The catheterization system 10 may be operated by a local control station, a remote control station, or both a local and a remote control station simultaneously. At a local site, the user or operator 11 and the control station 26 are located in the same room as the patient 12 and the bedside device 20 or in an adjacent room. In the examples used herein, the local site corresponds to the location of the bedside device 20 and the patient 12 or subject (e.g., an animal or cadaver), and the remote site corresponds to the location of the user or operator 11 and the control station 26 used to remotely control the bedside device 20. The control computer system at the local site and / or the control station 26 (and control computer system) and the bedside device 20 at the remote site may communicate using a communications system and services 36 (see FIG. 2), e.g., via the Internet.According to one embodiment, the remote site and the local (patient) site are separate from one another, such as multiple rooms in the same building, multiple buildings in the same city, multiple buildings in multiple cities, or other locations where the remote site does not have physical access to the bedside device 20 and / or patient 12 at the local site.

[0023] The control station 26 generally includes one or more input modules 28 configured to receive user inputs that operate various components or systems of the catheter-based treatment system 10. In the illustrated embodiment, the control station 26 enables the user or operator 11 to control the bedside device 20 to perform a catheter-based medical procedure. For example, the input module 28 may be configured to cause the bedside device 20 to perform various tasks using a percutaneous interventional device (e.g., an EMD) interfaced with the robotic drive 24 (e.g., advance, retract, or rotate a guidewire, advance, retract, or rotate a catheter, inflate or deflate a balloon located on a catheter, position and / or deploy a stent, position and / or deploy a stent retriever, position and / or deploy a coil, inject contrast into the catheter, inject a liquid embolic into the catheter, inject a medication or saline into the catheter, aspirate through the catheter, or perform any other function that may be performed as part of a catheter-based medical procedure). The robotic drive 24 includes various drive mechanisms for effecting movement (eg, axial and rotational movement) of components of the bedside device 20, including the percutaneous interventional device.

[0024] In one embodiment, the input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 may use additional user controls 44 (see FIG. 2), such as a footswitch or microphone, for voice commands, etc. The input module 28 may be configured to advance, retract, or rotate various components and percutaneous interventional devices (e.g., guidewires and one or more catheters or microcatheters, etc.). The buttons may include, for example, an emergency stop button, a multiplication button, a device selection button, and an auto-movement button. When the emergency stop button is pressed, power (e.g., electrical power) is shut off or removed from the bedside device 20. In a speed control mode, the multiplication button acts to increase or decrease the speed at which the associated component moves in response to manipulation of the input module 28. In a position control mode, the multiplication button changes the mapping between an input distance and an output commanded distance. The device selection button allows the user or operator 11 to select which percutaneous interventional device loaded on the robotic drive device 24 will be controlled by the input module 28. The auto-move button is used to enable the catheter-based treatment system 10 to perform algorithmic operations on the percutaneous interventional device without direct command from the user or operator 11. In one embodiment, the input module 28 may include one or more controls or icons (not shown) displayed on a touchscreen (which may or may not be part of the display 30) that, when activated, cause the operation of components of the catheter-based treatment system 10. The input module 28 may also include balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., that can be used to control the particular component or components to which dedicated controls are assigned.Additionally, the one or more touchscreens may display one or more icons (not shown) associated with various portions of the input module 28 or one or more icons (not shown) associated with various components of the catheter-based treatment system 10.

[0025] The control station 26 may include a display 30. In other embodiments, the control station 26 may include two or more displays 30. The display 30 may be configured to display information or patient-specific data to a user or operator 11 located at the control station 26. For example, the display 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.), lesion or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). Additionally, the display 30 may be configured to display procedure-specific information (e.g., procedure checklists, recommendations, procedure duration, catheter or guidewire position, delivered medication or contrast volume, etc.). Additionally, the display 30 may display information to provide functionality associated with the control computer system 34 (see FIG. 2). The display 30 may include touchscreen functionality to provide some of the system's user input functionality.

[0026] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 may be any medical imaging system that can be used in connection with a catheter-based medical procedure (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital x-ray imager in communication with a control station 26. In one embodiment, the imaging system 14 may include a C-arm (see FIG. 1 ) that allows the imaging system 14 to partially or fully rotate around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anterior-posterior view, etc.). In one embodiment, the imaging system 14 is a fluoroscope system that includes a C-arm having an x-ray source 13 and a detector 15, also known as an image intensifier.

[0027] The imaging system 14 may be configured to take x-ray images of appropriate regions of the patient 12 during a procedure. For example, the imaging system 14 may be configured to take one or more x-ray images of the head to diagnose a neurovascular condition. The imaging system 14 may also be configured to take one or more x-ray images (e.g., real-time images) during a catheter-based medical procedure to assist the user or operator 11 at the control station 26 in properly positioning a guide wire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, or the like during the procedure. One or more images may be displayed on the display 30. For example, images may be displayed on the display 30 to enable the user or operator 11 to accurately move a guide catheter or guide wire to the appropriate position.

[0028] To clarify the directions, a Cartesian coordinate system with X, Y, and Z axes is introduced. The positive X axis is oriented in the longitudinal (axial) distal direction, i.e., from the proximal end to the distal end, and the alternative is from the proximal to the distal direction. The Y and Z axes are in a plane perpendicular to the X axis, with the positive Z axis oriented upward, i.e., opposite to gravity, and the Y axis is automatically determined by the right-hand rule.

[0029] FIG. 2 is a block diagram of an exemplary embodiment of a catheter-based treatment system 10. The catheter treatment system 10 may include a control computer system 34. The control computer system 34 may be physically part of, for example, the control station 26 (see FIG. 1). The control computer system 34 may generally be an electronic control unit suitable for providing the catheter-based treatment system 10 with the various functions described herein. For example, the control computer system 34 may be an embedded system, dedicated circuitry, a general-purpose system programmed to provide the functions described herein, etc. The control computer system 34 is in communication with the bedside devices 20, communication systems and services 36 (e.g., the Internet, firewalls, cloud services, session managers, hospital networks, etc.), a local control station 38, additional communication systems 40 (e.g., telepresence systems), remote control stations and computer systems 42, and patient sensors 56 (e.g., electrocardiogram (ECG) devices, electroencephalogram (EEG) devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). The control computer system is also in communication with the imaging system 14, the patient table 18, additional medical systems 50, a contrast injection system 52, and additional devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside system 20 includes the robotic drive 24, the positioning system 22, and may include additional controls and displays 46. As described above, the additional controls and displays may be located on the housing of the robotic drive 24. Interventional devices and accessories 48 (e.g., guide wires, catheters, etc.) interface with the bedside system 20. According to one embodiment, the interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, contrast diagnostic catheters, etc.) that interface with each of the additional devices 54, i.e., the IVUS system, the OCT system, the FFR system, etc.

[0030] In various embodiments, the control computer system 34 is configured to generate control signals that enable a medical procedure to be performed using the catheter-based treatment system 10 based on user interaction with an input module 28 (e.g., a control station 26, such as a local control station 38 or a remote control station 42 (see FIG. 1 )) and / or information accessible to the control computer system 34. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and computer system 42 may include similar components as the local control station 38. The remote control station 42 and the local control station 38 may be configured differently depending on the functionality required. The additional user controls 44 may include, for example, one or more foot-input controls. The foot-input controls may be configured to allow a user to select functions of the imaging system 14, such as turning x-rays on and off to capture images, scrolling through various stored images, etc. In another embodiment, the foot input device may be configured to allow the user to select which device is mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) may be used to assist the operator in interacting with the patient, medical staff (e.g., angiography lab staff), and / or equipment near the bedside.

[0031] The catheter-based treatment system 10 may be connected to or configured to include any other systems and / or devices not expressly shown herein, such as an image processing engine, a data storage and archiving system, an automated balloon and / or stent expansion system, a medication infusion system, a medication tracking and / or logging system, a user log, an encryption system, a system for restricting access to or use of the catheter-based treatment system 10, etc.

[0032] As described above, the control computer system 34 is in communication with the bedside device 20, which includes the robotic drive 24, the positioning system 22, and may include additional controls and a display 46. The control computer system 34 may provide control signals to the bedside device 20 to control the operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Various drive mechanisms may be provided as part of the robotic drive 24. FIG. 3 is a perspective view of a robotic drive for a catheter-based treatment system 10, according to one embodiment. In FIG. 3, the robotic drive 24 includes multiple device modules 32a-d coupled to a linear member 60. Each device module 32a-d is coupled to the linear member 60 via a stage 62a-d that is movably mounted relative to the linear member 60. The device modules 32a-d may be connected to the stage 62a-d using connectors, such as offset brackets 78a-d. In another embodiment, the device modules 32a-d may be directly mounted to the stage 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device modules 32a-d coupled to each stage 62a-d) can move independently relative to each other and relative to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 3 , the drive mechanism includes an independent stage translation motor 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, which can be, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, or a chain via a sprocket. Alternatively, the stage translation motors 64a-d can be linear motors. In some embodiments, the stage drive mechanism 76 can be a combination of these mechanisms; for example, each stage 62a-d can use a different type of stage drive mechanism.In embodiments where the stage drive mechanism is a lead screw and a rotating nut, the lead screw may be rotated to disengage each stage 62a-d from the lead screw, for example, to move forward or backward. In the embodiment shown in Figure 3, the stages 62a-d and device modules 32a-d are in a serial drive configuration.

[0033] Each device module 32a-d includes a drive module 68a-d and a cassette 66a-d, which is mounted and coupled to the drive module 68a-d. In the embodiment shown in FIG. 3, each cassette 66a-d is mounted vertically to the drive module 68a-d. In other embodiments, each cassette 66a-d may be mounted to the drive module 68a-d in other mounting orientations. Each cassette 66a-d is configured to interface with and support a proximal portion of an EMD (not shown). Additionally, each cassette 66a-d may include components that provide one or more degrees of freedom in addition to the linear motion resulting from actuation of the corresponding stage 62a-d, which can move linearly along the linear member 60. For example, the cassettes 66a-d may include components that can be used to rotate the EMD when the cassette is coupled to the drive module 68a-d. Each drive module 68a-d includes at least one coupler, providing a drive interface for the mechanisms within each cassette 66a-d to provide additional degrees of freedom. Each cassette 66a-d also includes a channel within which a device support 79a-d is positioned, preventing twisting (buckling) of the EMD. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, and provide fixed points for supporting the proximal ends of device supports 79b, 79c, and 79d, respectively. The robot drive 24 may also include a device support connector 72 connected to device support 79a, a distal support arm 70, and a support arm 77o. Support arm 77o is used to provide a fixed point for supporting the proximal end of the most distal device support 79a housed within the most distal device module 32a. Additionally, an introducer interface support (redirector) 74 may be connected between the device support connection 72 and the EMD (eg, introducer sheath or sheath).By using an actuator on a single linear member, this configuration of the robot drive 24 has the advantage of reducing the volume and weight of the robot drive 24.

[0034] Medical staff use aseptic technique in the room housing the bedside device 20 and the patient 12 or subject (shown in FIG. 1 ) to prevent the patient from becoming contaminated with pathogens. The room housing the bedside device 20 and the patient 12 may be, for example, a cathode ray lab or angiography lab. Aseptic technique includes the use of sterile barriers, sterile equipment, proper patient preparation, environmental controls, and contact guidelines. Accordingly, all EMDs and interventional accessories are sterile and are only permitted to come into contact with either the sterile barrier or sterile instruments. In one embodiment, a sterile drape (not shown) is placed over the non-sterile robotic drive 24. Each cassette 66a-d is sterile and serves as a sterile interface between the draped robotic drive 24 and at least one EMD. Each cassette 66a-d may be configured for sterilization for a single use, or may be designed to be resterilized in whole or in part, allowing the cassette 66a-d or its components to be used in multiple procedures.

[0035] "Distal and proximal" The terms distal and proximal define the relative position of two different features. With respect to a robotic drive, the terms distal and proximal are defined by the location of the robotic drive in its intended use relative to a patient. When used to define relative position, a distal feature is a feature of the robotic drive that is closer to the patient than a proximal feature when the robotic drive is in its intended use position. Within a patient, any angiographic landmark further along a path from an access point is considered more distal than a landmark closer to the access point. Here, the access point refers to the point (location) where the EMD enters the patient. Similarly, a proximal feature is a feature that is farther from the patient than a distal feature when the robotic drive is in its intended use position. When used to define direction, a distal direction is the path something is moving, the path something is intended to move, or the path something is oriented or facing along when the robotic drive is in its intended use position, from a proximal feature toward a distal feature or a patient. The proximal direction is the opposite direction of the distal direction. By way of example, referring to FIG. 1, the robotic device is shown from the perspective of an operator facing the patient. In this orientation, the distal direction is along the positive X coordinate axis, and the proximal direction is along the negative X coordinate axis. Referring to FIG. 3, the EMD is moved distally on a path toward the patient through an introducer interface support 74, which defines the distal end of the robotic drive 24. The proximal end of the robotic drive 24 is the point furthest from the distal end along the negative X axis. Referring to FIG. 3, the most distal drive module is drive module 32a, which is closest to the distal end of the robotic drive 24. The most proximal drive module is drive module 32d, which is positioned furthest from the distal end of the robotic drive 24 along the negative X axis. The relative positions of the drive modules can be determined by their relative positions with respect to the distal end of the robotic drive. For example, drive module 32b is distal to drive module 32c. Referring to FIG. 3, the portions of cassette 66a and drive module 68a are defined by their position relative to the distal end of the robot drive.For example, when the cassette is in its in-use position on drive module 68a, the distal end of cassette 66a is the portion of the cassette closest to the distal end of the robotic drive, and the proximal end of cassette 66a is the portion of the cassette furthest from the distal end of the robotic drive along the negative X-axis. In other words, the distal end of cassette 66a is the portion of the cassette closest to the path to the patient when the EMD is in its in-use position.

[0036] "Vertical axis (longitudinal axis)" The term longitudinal axis or axis of a member (e.g., an EMD or other element in a catheter-based treatment system) refers to the line or axis along the length of the member that passes through the center of the cross section of the member in the direction from the proximal portion of the member to the distal portion of the member. For example, the longitudinal axis of a guidewire is the central axis in the direction from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is non-linear in the relevant section.

[0037] "Axial movement" The term axial movement of a member refers to movement (translation) of the member along its longitudinal axis. When the distal end of the EMD is moved axially distally along its longitudinal axis into or further into the patient, the EMD is advanced. When the distal end of the EMD is moved axially proximally along its longitudinal axis out of or further out of the patient, the EMD is withdrawn.

[0038] "Rotational motion" The term rotational motion of a member refers to a change in the angular orientation of the member about its local longitudinal axis. The rotational motion of an EMD corresponds to a clockwise or counterclockwise rotation about the EMD's longitudinal axis, depending on the applied torque.

[0039] "Axial and lateral insertion" The term axial insertion refers to inserting a first member into a second member along the longitudinal axis of the second member. An EMD axially loaded into a collet is then inserted axially into the collet. An example of axial insertion may be referred to as backloading a catheter onto the proximal end of a guidewire. The term lateral insertion refers to inserting a first member into a second member along a plane perpendicular to the longitudinal axis of the second member. This is also referred to as radial loading or side loading. In other words, lateral insertion refers to inserting a first member into a second member along a direction parallel to the radius of the second member and perpendicular to the longitudinal axis.

[0040] "Pinch / Unpinch" The term pinch refers to releasably securing an EMD to a member so that the EMD moves with the member when the member moves. The term unpinch refers to releasing an EMD from a member so that the EMD and member move independently when the member moves.

[0041] "Clamp / Unclamp" The term clamping refers to releasably securing an EMD to a member such that movement of the EMD is constrained relative to the member. The member can be secured with respect to a global coordinate system or with respect to a local coordinate system. The term unclamping refers to releasing the EMD from the member so that the EMD can move independently.

[0042] "Grip / Ungrip" The term "grip" refers to the application of a force or torque from a drive mechanism to an EMD to cause movement of the EMD without slipping in at least one degree of freedom. The term "ungrip" refers to the removal of the application of a force or torque from a drive mechanism to an EMD so that the position of the EMD is no longer constrained. In one example, an EMD is gripped between the rotation of two tires about their longitudinal axes as the tires move longitudinally relative to one another. The rotational motion of the EMD is distinct from the motion of the two tires. The position of the gripped EMD is constrained by the drive mechanism.

[0043] "twist" The term torsion (buckling) refers to the tendency of a flexible EMD to bend away from its longitudinal axis or intended path of travel when subjected to axial compression. In one embodiment, axial compression occurs in response to resistance as it is navigated through the vasculature. The distance an EMD travels unsupported along its longitudinal axis before kinking can be referred to herein as the device buckling distance. The device buckling distance is a function of the device's stiffness, shape (including, but not limited to, diameter), and the force applied to the EMD. Buckling can cause the EMD to form a bow that deviates from the intended path. If the EMD deforms inelastically and the result is permanent, the buckling is referred to as a kink.

[0044] "homing" The term "homing" refers to moving a member to a defined position. An example of a defined position is a reference position. Another example of a defined position is an initial position. The term "origin" refers to a defined position, which is typically used as a reference for subsequent linear or rotational positions.

[0045] "Upper / Lower, Anterior / Backwards, Medial / Lateral" The terms top, upper, and upper side refer to the general direction opposite to the direction of gravity. The terms bottom, lower, and lower side refer to the general direction of gravity. The term front refers to the side of the robotic drive that faces the bedside user, away from a positioning system such as an articulated arm. The term rear refers to the side of the robotic drive that is closest to a positioning system such as an articulated arm. The term inside refers to the inside portion of a feature. The term outside refers to the outside portion of a feature.

[0046] "stage" The term stage refers to a member, feature, or device used to couple a device module to a robot drive. For example, a stage can be used to couple a device module to a rail or linear member of a robot drive.

[0047] "Drive module" The term drive module generally refers to a portion (eg, the main portion) of a robotic drive system, typically including one or more motors and a drive coupler that interfaces with the cassette.

[0048] "Device Module" The term device module refers to the combination of a drive module and a cassette.

[0049] "cassette" The term cassette generally refers to a portion of a robotic drive system (a non-core portion, a consumable or sterilizable unit), typically providing a sterile interface (direct) between the drive module and at least one EMD, or a sterile interface (indirect) via a device adapter.

[0050] "Colette" The term collet refers to a device that can releasably secure a portion of an EMD. Secured here means that there is no intended relative movement between the collet and the EMD during operation. In one embodiment, the collet includes at least two members that move rotationally relative to one another to releasably secure the EMD to at least one of the two members. In one embodiment, the collet includes at least two members that move axially (along a longitudinal axis) relative to one another to releasably secure the EMD to at least one of the two members. In one embodiment, the collet includes at least two members that move both rotationally and axially relative to one another to releasably secure the EMD to at least one of the two members.

[0051] "Fixed" The term fixed means that there is no intentional relative movement of the first member with respect to the second member during operation.

[0052] "On-Device Adapter" The term on-device adapter refers to a sterilization apparatus that can releasably pinch an EMD and provide a drive interface. An on-device adapter may also be referred to as an end effector or EMD capture device. By way of a non-limiting example, an on-device adapter is a robotically controlled collet that operatively rotates the EMD about its longitudinal axis to pinch and / or unpinch the EMD relative to the collet and / or move the EMD along its longitudinal axis. In one embodiment, the on-device adapter is a hub drive mechanism, including, for example, a driven gear located on the hub of the EMD.

[0053] "Tandem Drive" The term tandem drive refers to a drive unit or subsystem within a robot drive that contains two or more EMD drive modules capable of operating one or more EMDs.

[0054] "EMD" The term elongated medical device (EMD) refers to medical devices including, but not limited to, catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), wire-based devices (e.g., guidewires, embolic coils, stent retrievers, etc.), and any combination thereof. In one example, wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and flow diverters. Typically, wire-based EMDs do not have a hub or handle at the end of their proximal terminal. In one embodiment, the EMD is a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub toward the distal end of the catheter, the shaft being more flexible than the hub. In one embodiment, the catheter includes an intermediate section transitioning between the hub and the shaft, the flexibility of which is intermediate between the two, and the stiffness of which is less than that of the hub but more than that of the shaft. In one embodiment, the intermediate portion is a strain relief.

[0055] "Hub (proximal) drive" The terms hub-driven or proximal-driven refer to holding and manipulating an EMD from a proximal location (e.g., a geared adapter on the catheter hub). In one embodiment, hub-driven refers to applying force or torque to the catheter hub to move and / or rotate the catheter. Hub-driven drives can cause the EMD to buckle, so anti-buckling features are often required. For devices without a hub or other interface (e.g., a guidewire), a device adapter may be added to the device to act as an interface for a device module. In one embodiment, the EMD does not include a mechanism for manipulating features within the catheter, such as a wire extending from the handle to the distal end of the catheter to deflect the distal end of the catheter.

[0056] "Shaft (distal) drive" The term shaft (distal) drive refers to holding and manipulating the EMD along the shaft. In one example, the on-device adapter is typically located near the Y-connector or hub where the device is inserted. When the on-device adapter is located near the insertion point (of the main body or other catheter or valve), the shaft drive typically does not require an anti-buckling feature (although an anti-buckling feature may be included to improve driveability).

[0057] "Sterilizable device" Sterilizable devices are devices that can be sterilized (free from pathogenic microorganisms). This includes, but is not limited to, cassettes, consumable devices, drapes, device adapters, and sterilizable drive modules / devices (which may contain electromechanical components). Sterilizable devices may come into contact with patients, other sterile equipment, or other items placed during aseptic technique in a medical procedure.

[0058] "Sterile Interface" The term sterile interface refers to the interface or boundary between a sterile device and a non-sterile device. For example, a cassette may be the sterile interface between a robotic drive and at least one EMD.

[0059] "Reset" The term reset means repositioning the drive mechanism from a first position to a second position, thereby allowing continued rotational and / or axial movement of the EMD. During reset, the EMD is not actively moved by the drive mechanism. In one embodiment, the EMD is released by the drive mechanism before repositioning the drive mechanism. In one embodiment, a clamp secures the position of the EMD while the drive mechanism is repositioned.

[0060] "Continuous movement" The term continuous motion refers to uninterrupted movement that does not require resetting.

[0061] "Discrete movement" The term discrete motion refers to a motion that is interrupted, requiring a reset.

[0062] "consumables" The term consumables generally refers to sterilizable devices (units) that are used only once in a medical procedure. The devices may also be reusable, by going through the sterilization process again, for use in another medical procedure.

[0063] "Device support" The term device support refers to a member, feature, or device that prevents buckling (twisting) of an EMD.

[0064] "Double Gear" The term double gear (also referred to as double gear) refers to two independently driven gears operatively connected to two different portions of a device. Each of the two gears may be the same or different designs. The term gear may refer to bevel gears, spiral bevel gears, spur gears, helical gears, internal gears such as bevel gears, miter gears, worm gears, helical gears, rack and pinion gears, screw gears, sun gears, involute spline shafts and bushings, or any other type of gear known in the art. In one example, a double gear includes a device in which a driving connection is maintained by two different portions of the device, including, but not limited to, a belt, friction engagement, or other coupling known in the art.

[0065] 3 and 4A, the EMD drive system includes an on-device adapter 112, which in one embodiment includes a collet releasably secured to the EMD 102. The collet 112 is a device that releasably secures the shaft portion of the EMD 102 thereto. As described in detail herein, the collet 112 pinches the shaft of the EMD 102, such that the rotation and / or movement of the entire collet 112 about its longitudinal axis is the same as the rotation and / or movement of the pinched shaft portion of the EMD 102. In one embodiment, the collet 112 may be a single molded part that defines an internal passage within its body through which a portion of the shaft of the EMD 102 can be secured. As described herein, the shaft of the EMD 102 is disposed within the internal passage of the collet and pinched therein. The shaft of the EMD 102 may be radially or axially loaded within the internal passage of the collet. Radial loading can also be referred to as side loading or lateral loading because the shaft of the EMD is loaded into the collet 112 through a longitudinal side of the collet body (i.e., the side of the collet body extending from the proximal end to the distal end of the collet body). Radial loading, side loading, or lateral loading is in contrast to axial loading, in which a shaft portion is loaded into the internal passage of the collet by first inserting the free end of the shaft into a proximal or distal opening in the internal passage.

[0066] In one embodiment, the collet 112 includes at least two members that move relative to one another, thereby releasably securing a shaft portion of the EMD relative to at least one of the two members. In one embodiment, two members moving together provide a mechanical advantage because they can increase the torque and / or force that can be transmitted from the collet body to the shaft of the EMD without the shaft of the EMD moving relative to the collet body. The pinching force on the EMD using the collet can be greater than the force required to actuate the pinch. When the shaft of the EMD is pinched, it is secured so that there is relative movement between the collet and the EMD within the acceptable operating parameters of the EMD procedure.

[0067] The EMD 102 is fixed relative to the collet 112 and radially loaded into the robot drive, also referred to herein as an EMD drive or device module 32. The EMD support 79 is releasably applied non-axially to the EMD 102. The robot drive 32 is operably coupled to the collet 112 to move and / or rotate the collet 112 and the EMD 102. In one embodiment, the EMD 102 is movably or releasably loaded into the robot drive 32.

[0068] In one embodiment, the collet 112 is within the robot drive 32 when the EMD 102 is radially loaded into the robot drive 32. In one embodiment, the collet 112 is releasably inserted into the robot drive 32 with the EMD 102 secured to the collet 112.

[0069] In one embodiment, EMD supports 79 limit buckling of EMD 102 along its length and prevent kinking when EMD 102 is translated and / or rotated.

[0070] In one embodiment, the robot system includes a robot drive 32 or device module, which includes a drive module 68 or base having a drive coupler 130 and a cassette 66 releasably secured to the drive module 68. A collet 112 in the cassette 66 is releasably secured to the EMD 102. The collet 112 has a driven member 136 operably coupled to the drive coupler 130. The robot drive 32 includes a motor or actuator operably coupled to the collet 112 to move the collet 112. In one embodiment, the cassette 66 is releasably secured to the base 68 by directly connecting the cassette 66 to the base 68. In one embodiment, the cassette 66 is indirectly releasably secured to the base 68, with an intermediate member disposed between the cassette 66 and the base 68.

[0071] The EMD 102 may be radially or axially loaded into the collet 112 before the collet 112 is positioned in the cassette 66, such that the EMD 102 and collet 112 are both loaded into the cassette 66. The EMD 102 may also be radially or axially loaded into the collet 112 when the collet 112 is already disposed in the cassette 66.

[0072] In one embodiment, the EMD 102 is radially releasably received within the collet 112, which is releasably received and positioned within the cassette 66. As described herein, the collet 112 may have a slot extending from the outer periphery of the collet body to its internal passageway. A portion of the EMD 102, such as a shaft portion, may be radially inserted into the passageway through the slot. The shaft portion of the EMD 102 is a portion of the EMD 102 intermediate the proximal end of the EMD 102 and the distal end of the EMD 102. The shaft portion of the EMD 102 is radially loaded into the collet while the proximal end of the EMD 102 and the distal end of the EMD 102 remain outside the collet and the passageway. Alternatively, the shaft portion of the EMD 102 may be loaded in a direction generally perpendicular to the longitudinal axis of the collet 112.

[0073] In one embodiment, the EMD 102 is releasably axially received within the collet 112, which is releasably received within the cassette 66. In this embodiment, one of the distal or proximal ends of the EMD 102 is inserted into the distal or proximal opening of the collet 112 and moved along the longitudinal axis of the collet 112 until the distal or proximal end of the EMD emerges from the other of the distal or proximal ends of the collet.

[0074] In one embodiment, EMD 102 is radially releasably received within collet 112, which is non-removably positioned within cassette 66. In one embodiment, EMD 102 is axially releasably received within collet 112, which is non-removably positioned within cassette 66. In one embodiment, collet 112 includes a positioning feature 408 that is located within cassette 66, and positioning feature 133 enables radial loading and rotation of the collet within cassette 66. In one embodiment, collet 112 also includes a distal end that is located within a positioning mechanism within cassette 66.

[0075] 4F , in one embodiment, the motor 124 is positioned within the base 68, which is operably coupled to the drive coupler 130. When the cassette 66 is secured to the base 68, the drive coupler 130 extends within the cassette 66. In one embodiment, the motor is located within the cassette 66. In one embodiment, the motor is located outside the base 68, but is operably connected to the drive coupler 130 within the base 68.

[0076] In one embodiment, the robotic system includes a clamp that releasably clamps a shaft portion of the EMD independent of the collet. In one embodiment, the clamp includes at least one tire.

[0077] As described in detail herein, in one embodiment, the moving collet 112 rotates the collet and the EMD 102. In one embodiment, the EMD 102 is selectively rotated in a clockwise and counterclockwise direction about the longitudinal axis of the EMD 102.

[0078] As detailed herein, in one embodiment, the moving collet 112 selectively pinches and unpinches the EMD within the collet. In one embodiment detailed herein, the moving collet 112 includes moving only one or more portions of the collet 112, rather than the entire collet, to pinch and unpinch the EMD.

[0079] As detailed herein, in one embodiment, the moving collet 112 selectively moves the collet and the EMD in a first direction and an opposite second direction along the longitudinal axis of the EMD.

[0080] As detailed herein, in one embodiment, the moving collet 112 rotates the collet and EMD, moves the collet and EMD, and selectively pinches and unpinches the EMD within the collet.

[0081] With reference to FIGS. 3, 4G, and 4H, the robotic system 24 includes multiple device modules 32a-32d. In one embodiment, there are two or more separate device modules. FIG. 3 illustrates a system with four device modules 32. In one embodiment, multiple modules are the same. In one embodiment, each device module is different. In one embodiment, some modules are the same and some modules are different. In FIG. 3 above, a system with four device modules 32 is illustrated. Each EMD device support 79a-79d includes a distal end and a proximal end that terminate in a distal connector 80. By way of example, with reference to FIG. 4H, device module 32c includes an EMD device support 79c having a proximal end 79c.1 and an opposing distal end connector 79c.2. The proximal end 79c.1 of the EMD device support 79c is secured to the proximal end 77b.1 of the arm 77b. Arm 77b has a distal end 77b.2 that is fixed to device module 32b, distal to device module 32c. Terminal end 77b.2 of EMD drive support device 77b is fixed to the proximal end of device module 32b, thereby preventing terminal end 77b.2 from moving distally to the distal end of device module 32b. In operation, distal end connector 80c releasably connects to proximal end connector 88b on device module 32b. In one embodiment, EMD supports 79a-79d include flexible tubes having longitudinal slits that allow EMDs to be inserted into and removed from their respective EMD device supports 79a-79d. In one embodiment, EMD supports 79a-79d operate as flexible tracks as described in U.S. Published Application No. 2016 / 0271368, which is co-owned with the present applicant and is entitled "Guide Catheter Control Flexible Track."Arm 77b moves linearly with drive module 32b; therefore, in one mode, proximal end 77c.1 and distal end 77c.2 move with drive module 32b relative to drive module 32c. EMD device support 79c is releasably applied to an EMD 102 manipulated non-axially by device module 32c. EMD 102 manipulated by device module 32c enters and exits support 79c through a longitudinal slit extending from the periphery of the EMD device support to the interior cavity of the EMD support. In one embodiment, the EMD device support is a telescoping member, as described later in this specification, where axial or non-axial loads are applied to the EMD within the EMD device support to provide anti-buckling support. Referring to FIG. 3, each drive module 32a-32d independently manipulates a different device. Each EMD device support 79a-79d allows each device to move a greater distance between two adjacent devices than would be possible without the EMD support. Without the EMD device support, the distance a device can move may be less than the device's buckling length. Thus, the system may require a drive reset each time an EMD moves its buckling length. The EMD support allows for no resetting during use of a given device relative to one another and / or in connection with a procedure. In other words, the EMD device support eliminates the need for collet resetting when using a given device. In one embodiment, the EMD support allows for fewer collet resets than would be required without the EMD support. Referring to FIG. 4G, device support 79 is guided through cassette 66c via channel 138 and proximal support member 82, the latter via channel 84 extending therethrough.

[0082] The EMD 102 is pinched by the on-device adapter and / or collet 112 by manually manipulating the collet 112, and then the collet and EMD are robotically rotated and moved. In one embodiment, the EMD 102 is robotically pinched and unclipsed by the collet 112, and is robotically rotated and moved by rotating and moving the collet 112.

[0083] Several robotic EMD drive systems are illustrated herein. Additionally, several collet configurations are illustrated. The specific collet configurations described herein, as well as collet configurations known in the art, can be used in the various EMD drive systems described herein. The collets described herein are also referred to as pin vises, chucks, bushings, or guidewire torquers.

[0084] 1, 4A, and 4D, the device module 32 includes a drive module 68 that includes a drive module base component 116 and a load sensing component 118. The EMD 102 is releasably coupled to the isolation component 106. The isolation component 106 is isolated from external loads other than the actual load acting on the EMD 102. The isolation component 106 is releasably coupled to the load sensing component 118. A load sensor 120 is fixed relative to the drive module base component 116, and the load sensing component 118 senses the actual load acting on the EMD 102.

[0085] In one embodiment, the load sensor 120 is the only support for the load sensing component 118 in at least one direction during load measurement. In one embodiment, the cassette housing 104 and the separation component 106 are internally connected so that they form one component. In one embodiment, the flexible membrane 108 connects the cassette housing 104 and the separation component 106, where the flexible membrane 108 exerts negligible force on the separation component 106 in the X direction (device direction). In one embodiment, the flexible membrane 108 represents the cassette interaction rather than a physical membrane.

[0086] Referring to Figures 4A and 4B, in one embodiment, the apparatus includes a cassette 66, which is comprised of a cassette cover 105 and a cassette housing 104 releasably attached to a drive module base component 116.

[0087] 5C-5E , according to one embodiment, a drive module base component 116 includes a load sensing component 118 and a load sensor 120. A drive module 68 includes the drive module base component 116 and the load sensing component 118 as separate components connected by a load sensor 120 disposed between the drive module base component 116 and the load sensing component 118. A bearing 128 of the load sensing component 118 supports the load sensing component in at least one off-axis (non-measuring) direction.

[0088] 8A and 8B, in one embodiment, an EMD on-device adapter 510 is connected to a catheter 512. The on-device adapter 510 includes an integrally connected bevel gear 522, which is releasably connected to a Y-connector shown with a hub 530, which can be releasably connected to a hemostasis valve on the proximal end. One embodiment of the EMD on-device adapter 510 includes a catheter 512 releasably connected to the bevel gear 522. The catheter 512 includes a catheter hub 514 and a catheter shaft 516 integrally connected thereto. In one embodiment, the catheter hub 514 is not a handle that includes a mechanism for manipulating a feature or portion of the catheter. In one embodiment, the EMD includes a handle with a mechanism for manipulating a feature within the catheter, such as a wire extending from the handle to the distal end of the catheter to manipulate or deflect the distal end of the catheter. In contrast, the hub is a rigid portion of the EMD at the proximal end that does not contain any mechanisms for manipulating features within the catheter.

[0089] 4B and 4C illustrate a separation component 106 disposed within the cassette housing 104, the separation component 106 being spaced apart from the cassette housing 104 and spaced apart along at least one direction when the separation component 106 is connected to the load sensing component 118. The separation component 106 includes a first component 106a and a second component 106b attached thereto. Referring to FIGS. 4A-4C, the first component 106a is disposed within the recess 143 of the cassette housing 104, with the first component 106a oriented in a first direction defined as a direction toward the drive module 68 in the use position in which the cassette 66 is secured to the drive module 68. The second component 106b is disposed within the recess 143, with the second component 106b oriented away from the load sensing component 118 and toward the first component 106a. Referring to FIG. 4C, in another method, the first part 106a is positioned in the recess 143 from above the cassette housing 104 in the -z-axis direction, and the second part 106b is positioned in the recess 143 from below the cassette housing 104 in the +z-axis direction.

[0090] 4C and 4F, the first and second parts 106a, 106b are fixed relative to one another. The cassette housing 104 includes two longitudinally oriented, spaced-apart, parallel rails 107 located within the recesses 143. The rails 107 are also referred to herein as linear guides. The rails 107 are substantially parallel to one another and spaced apart from one another. The first part 106a is located on the top surface of the rails 107 closest to the top surface of the cassette housing 104, and the second part 106b is located on the bottom surface of the rails 107 closest to the load sensing part 118. Note that although the assembly orientation of the first and second parts 106a, 106b of the separation part 106 is described relative to their in-use positions, the first and second parts of the separation part 106 are located away from the drive module 68. In other words, the first part 106 a of the separation part 106 is inserted into the recess 143 in a direction from the top surface of the cassette 66 toward the bottom surface of the cassette 66 , generally perpendicular to the longitudinal axis of the cassette housing 104 .

[0091] In one embodiment, a mechanical fastener or fasteners secure the first part 106a to the second part 106b of the separation part 106. In one embodiment, the first part 106a and the second part 106b are secured together using magnets. In one embodiment, the first part 106a and the second part 106b of the separation part 106 are secured with an adhesive. In one embodiment, the first part 106a and the second part 106b are releasably secured to one another without the use of tools. In one embodiment, the first part 106a and the second part 106b are permanently secured to one another.

[0092] Referring to FIG. 4F, in the use position where the second part 106b of the separation part 106 is releasably secured to the load sensing part 118, the first part 106a and the second part 106b are spaced apart from the rail 107 of the cassette housing 104, and therefore the first part 106a and the second part 106b are in a non-contacting relationship with the cassette housing 104.

[0093] In one embodiment, when the on-device adapter 112 is coupled to the load sensing component 118, the on-device adapter 112 is spaced apart from and out of contact with the cassette housing 104. In one embodiment, the isolation component 106 is isolated in all directions from the cassette housing 104. In one embodiment, the isolation component 106 is separate from and in a contactless relationship with the cassette housing 104.

[0094] 4B and 4C, in one embodiment, cassette 66 includes a cassette cover 105 that is pivotally coupled by a hinge 103 to a separate piece 106 that is separate from and non-contacting with cassette housing 104. In one embodiment, cassette cover 105 is pivotally coupled to a first piece 106a of separate piece 106 by hinge 103. In one embodiment, cassette cover 105 is connected to first piece 106a of separate piece 106 using other means, such as a snap fit.

[0095] 1 and 4C, in one embodiment, the drive module 68 moves the EMD 102 in a first direction, and the separation component 106 is separated from the cassette housing 104 in the first direction. In one embodiment, the drive module 68 moves the EMD 102 in a second direction, and the separation component 106 is separated from the cassette housing 104 in both the first and second directions.

[0096] 4D , in one embodiment, the second part 106b of the separation part 106 is releasably secured to the load sensing part 118 using a fastener. In one embodiment, the fastener includes a quick release mechanism that can releasably secure the second part 106b of the separation part 106 to the load sensing part 118. In one embodiment, the fastener is a magnet.

[0097] 5A-5E , load sensing component 118 is disposed within drive module base component 116 and is secured to drive module base component 116 along with load sensor 120. In one embodiment, load sensor 120 includes a first portion secured to drive module base component 116 using first fastener 115 and a second portion secured to load sensing component 118 using second fastener 119. In one embodiment, the first portion of load sensor 120 is separate from and distinct from the second portion of load sensor 120. In one embodiment, first fastener 115 and second fastener 119 are bolts. In one embodiment, first fastener 115 and second fastener 119 are mechanical fasteners known in the art for establishing a mechanical connection. In one embodiment, first fastener 115 and second fastener 119 may be replaced with adhesive means to secure the mechanical connection. In one embodiment, first fastener 115 and second fastener 119 are magnets.

[0098] 5A , in one embodiment, drive module base component 116 includes a recess that receives load sensing component 118. In one embodiment, drive module base component 116 further defines a cavity extending from the recess to receive a portion of load sensor 120.

[0099] 4B and 4D, in one embodiment, cassette housing 104 is releasably connected to drive module base component 116 via quick release mechanism 121. In one embodiment, quick release mechanism 121 includes a spring-loaded member within cassette housing 104 that is actuated by latch release 123 that releasably engages quick release locking pin 117a fixed to drive module base component 116. In one embodiment, cassette housing 104 is aligned with drive module base component 116 by alignment pin 117b fixed to drive module base component 116.

[0100] 4C and 4F, separation component 106 is housed inside cassette housing 104 by mounting first part 106a of separation component 106 relative to second part 106b about rails 107 within cassette housing 104. In the use position, separation component 106 does not contact rails 107. As such, load interactions due to external forces and / or torques acting on EMD 102 occur at a single component within cassette 66.

[0101] The cassette housing 104 includes a cradle 132 configured to receive the EMD-on-device adapter 112 along with the EMD 102. A cassette bevel gear 134 within the cassette housing 104 is free to rotate relative to the cassette housing 104 about an axis aligned with a coupler axis 131 about which the coupler 130 of the drive module 68 rotates. In the assembled device module 32, the cassette 66 is positioned on the mounting surface of the drive module 68, and the cassette bevel gear 134 receives the coupler 130 along the coupler axis 131, freely engages and disengages along the coupler axis 131, and is integrally (non-freely) connected about the coupler axis 131 such that rotation of the coupler 130 corresponds equally to rotation of the cassette bevel gear 134. In other words, when coupler 130 rotates clockwise at a given speed, cassette bevel gear 134 rotates clockwise at the same given speed, and when coupler 130 rotates counterclockwise at a given speed, cassette bevel gear 134 rotates counterclockwise at the same given speed.

[0102] 1, 3, and 4, the EMD drive system includes an on-device adapter 112 releasably secured to the shaft of the EMD 102. The on-device adapter 112 is received within a cassette 66 that is releasably secured to a drive module 68. The drive module 68 is operatively coupled to the on-device adapter 112 to move the on-device adapter 112 and the EMD 102 together.

[0103] In one embodiment, the on-device adapter 112 is translated or moved. Referring to FIG. 3 , the drive module 68 is moved along the X-axis to move the cassette 68, on-device adapter 112, and EMD 102 together. In one embodiment, the movement along the X-axis is coaxial with the longitudinal axis of the on-device adapter 112, the longitudinal axis of the cassette, and the longitudinal axis of the EMD 102. Referring to FIG. 20A , the drive module includes a reset function that moves the on-device adapter and EMD. The translation or movement moves the components distally and proximally along the longitudinal axes of the cassette and on-device adapter.

[0104] In one embodiment, the on-device adapter moves by rotation about a longitudinal axis of the on-device adapter.

[0105] In one embodiment, the on-device adapter 112 includes a collet. The collet is not limited to the collets described herein and may include various collet configurations. See Figures 6A, 6B, 9A-9I, and 10A-11E.

[0106] 6A and 6B , according to one embodiment, a collet 400 includes a first member 402 that moves along and / or about a longitudinal axis 406 of a second member 404, thereby pinching the shaft of the EMD 102 within a third member 405. In one embodiment, the second member 404 has a generally cylindrical shape. However, the second member 404 can have other geometric shapes, such as a frustoconical shape, with a first portion closer to the engagement portion 136 and having a cross-section and a second portion closer to the first member 402 and having a larger cross-section. In one embodiment, the first member 402 is referred to as a nut, the second member 404 is referred to as a collet body or sleeve, and the third member 405 is referred to as a chuck. The nut 402 is secured to the body 404 to open and close the chuck 405 to pinch and unpinch the EMD 102. In one embodiment, the nut 402 is threadably engaged with the body 404 .

[0107] The on-device adapter 112 includes an engagement portion 136 that engages and is driven by a drive member 134 in the cassette 66, thereby rotating the on-device adapter 112. In one embodiment, the engagement portion 136 is a gear; however, other engagement portions driven by a drive member are also contemplated.

[0108] In one embodiment, the on-device adapter 112 includes a surface 408 that is supported by a bearing member within the cassette.

[0109] In one embodiment, on-device adapter 112 includes a thrust bearing surface 410 that prevents movement relative to a portion of cassette 66. In one embodiment, thrust bearing surface 410 includes a first portion 412 that prevents distal movement and a second portion 414 that prevents proximal movement. In one embodiment, first portion 412 and second portion 414 form a groove therebetween that defines a surface 408 that is supported by bearing member 133 in cassette 66.

[0110] In one embodiment, the on-device adapter 112 includes a luer connector 416. In one embodiment, the luer connector 416 is covered by the ISO 80369-7 standard, which is referenced herein. In one embodiment, the luer connector 416 is configured to allow the on-device adapter 112 to be flushed with a cleaning solution. The luer connector has a passageway through which it connects with a passageway within the on-device adapter 112. In one embodiment, the passageway is within the luer connector 416 and is coaxial with the passageway within the on-device adapter. In one embodiment, the passageway within the on-device adapter 112 is a passageway that receives the shaft of the EMD 102. In one embodiment, the luer connector 416 is a general connector, and in one embodiment, a connector covered by the ISO 80369-7 standard. In one embodiment, the luer connector is a luer lock.

[0111] 6C and 6D, the on-device adapter 112 includes a holder 418 having an engagement surface or gear 136 formed or attached thereto. The holder 418 has a plurality of slits 420 in its distal portion that extend to the distal end of the holder 418 forming a plurality of fingers 422. The holder 418 has a channel that receives a proximal portion of a collet 424. In one embodiment, the collet 424 may be a torque device, available from Merit™ as a PinVise™. The proximal body 426 of the collet 424 has an outer diameter that is larger than the inner diameter of the holder 418's channel at the distal end. The proximal end of body 426 is positioned within a channel in holder 418, causing fingers 422 to move outward and capture collet 424 within holder 418, such that movement and / or rotation of holder 418 results in movement and / or rotation of collet 424. By pinching the shaft of the EMD within split member 428, second member 430 rotates about threaded portion 432 of collet body portion 426. Split member portions 428 move toward each other and pinch the EMD 102 as the inner cone of second member 430 moves toward body portion 426, thereby causing split member portions 428 to engage and move toward each other.

[0112] 7A and 7B, the on-device adapter 112 is an assembly including a quick clamp 450 that engages the collet 424, as described above. However, it is contemplated that the quick clamp 450 may engage other collet configurations. In one embodiment, the quick clamp 450 quickly connects and / or releases the collet 424. With reference to FIGS. 7E and 7F, a lever 452 moves from a first, unclamping position to a second, clamping position to clamp the collet. In one embodiment, no additional tool is required to releasably engage the quick clamp onto the collet. With reference to FIGS. 7A and 7B, the quick clamp 450 includes a clamp body 454 defining a channel therein to receive the collet 424, such as the torquer described above. In one embodiment, the torquer 424 includes a proximal end 427 that is inserted into a distal opening 429 of the channel 431. The torquer's second portion 430, which rotates relative to the body 426, acts to pinch and unpinch the EMD within the channel defined by the body and second portion. Referring to Figures 7E and 7F, a lever 452 pivotally attached to the clamp body 454 moves from a first, open position to a second, closed position, the latter of which moves the clamp body from an unclamped position to a clamped position. The lever 452 includes a cam portion 457 that interacts with a portion 459 on the body 454. In the first, open position, a gap 461 exists between the outer surface of the body 454 and the surface of the clamp channel. The gap 461 allows the quick clamp 450 to secure a variety of commercially available collets, which may have a variety of outer body diameters. When the lever is pivoted from the open position to the closed position, gap 461 is eliminated by clamping the collet body against the quick clamp, such that movement and / or rotation of the quick clamp results in movement and / or rotation of the collet and EMD pinched by the collet. Gap 461 is eliminated because cam portion 457 interacts with surface 459, forcing body 454 to eliminate gap 461.Referring to Figure 7B, screw 455 connected to pin 453 allows for variation in gap 461 (see Figure 7E) before lever 452 is engaged. This allows for further adjustment of the quick clamp to engage collets with various outer diameters (the lever handle may be adjusted to fine tune the displacement for clamping force, while the screw handle may provide larger displacements based on size variations).

[0113] 7B, luer connector 456 is operably coupled to clamp body 454 along with connector 464, and in one embodiment, luer connector 456 is integral with part of clamp body 454. In one embodiment, engagement portion 458 includes gear 460 and surface 462, the latter of which is received within the cassette supported by bearings within the cassette.

[0114] In one embodiment, the EMD 102 is radially releasably received within the collet 112, and the collet 112 is releasably received and positioned within the cassette. In one embodiment, the EMD 102 is axially releasably received within the collet 112, and the collet is releasably received within the cassette. In one embodiment, the EMD is radially releasably received within the collet 112, and the collet 112 is non-removably positioned within the cassette. In one embodiment, the EMD 102 is axially releasably received within the collet 112, and the collet 112 is non-removably positioned within the cassette.

[0115] Referring to Figure 4F, the drive module includes an actuator operably coupled to a drive coupler, which is operably coupled to a drive member within the cassette. The drive module is operably coupled to a rail or linear support, and a second actuator moves the drive module along the rail or linear support.

[0116] In one embodiment, the EMD is a guidewire. In one embodiment, the EMD is a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub to the distal end of the catheter. The shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate section between the hub and the shaft that is less stiff than the hub and more stiff than the shaft.

[0117] 8A and 8B, an on-device adapter 510 holds an EMD 512, which in one embodiment is a catheter. The catheter 512 includes a hub 514 and a shaft 516. The on-device adapter 510 includes a body 518 having a cavity 520 extending inwardly from the proximal end of the body 518 to receive the hub 514. The catheter hub 514 at or adjacent the proximal end of the catheter 512 and shaft 516 extends from a region proximal to the hub 514 to a region proximal to the distal end of the catheter 512. In one embodiment, the hub 514 is received within the cavity 520 via a press fit or other engagement, preventing the catheter 516 from moving and / or rotating independently of the on-device adapter 510. The on-device adapter 510 includes an engagement feature 522 that engages with the drive member 134 in the cassette 66. In one embodiment, engagement feature 522 is a gear. Gear 522 may be similar to gear 136 described herein. The on-device adapter 510 and catheter 512 are moved with cassette 66 and / or drive module 68. An actuator operably rotates gear 134, thereby rotating gear 522, on-device adapter 510, and catheter 512, causing the on-device adapter 510 and catheter 512 to rotate about the longitudinal axis of the on-device adapter 510 and catheter 512.

[0118] The catheter hub 514 includes a hub body 524, which in one embodiment includes a pair of wings 526 extending radially outward from the hub body 524. Referring to FIGS. 8A and 8B, the wings 522 are received within a cavity 520 of the on-device adapter 510. In one embodiment, the catheter 512 includes a connector 528 at its proximal end. In one embodiment, the catheter 510 includes a strain relief 532 between the hub 514 and the shaft 516, which transitions between the hub 514 and the shaft 516. In one embodiment, the strain relief 532 has a proximal portion having a proximal diameter and a distal portion having a distal diameter, the latter being equal to or smaller than the proximal diameter of the shaft 516.

[0119] In one embodiment, the hub 514 includes a first port that provides access to the interior lumen 534 of the catheter shaft 516, either directly or through a hub shaft lumen 534. In one embodiment, the hub 514 includes an additional port in fluid communication with the catheter lumen, which may be used, for example, for balloon inflation.

[0120] The shaft 516 includes a lumen 534 that is in fluid communication with the hub lumen 536. The connector 528 includes a cavity that is in fluid communication with the hub lumen 536 and / or the shaft lumen 534. Another EMD, such as a guidewire, may enter an opening in the connector 528 and extend therethrough into the shaft cavity 534 and the hub cavity 536. In one embodiment, a strain relief surrounds the proximal portion of the shaft lumen 534. The connector 528 also allows fluid to flow therethrough, allowing fluid to be introduced into the hub lumen 536 and the shaft cavity 534 to flush the catheter and / or supply fluid to the distal end of the catheter shaft 516.

[0121] To describe how the catheter 512 interacts with another distal catheter, the catheter 512 and its features may be referred to as a first catheter and first features, and the distal catheter and its features may be referred to as a second catheter or second features. The first shaft 516 has a predetermined outer diameter that allows the first shaft 516 to enter a second lumen of a second catheter (not shown) and enter the patient's vasculature for diagnosis or treatment. The outer diameter of the first shaft 516 is smaller than the inner diameter of the second lumen of the second catheter, allowing it to be inserted therein. Note that a guide catheter typically enters an introducer sheath, not a separate catheter. Therefore, the guide catheter's hub has a geometry that prevents it from entering the introducer sheath or the patient's vasculature.

[0122] In contrast, the first hub 514 is not configured to fit into the second lumen of the second catheter, and therefore is not configured to fit into the lumen of the introducer sheath. In one embodiment, the first hub 514 has an outer periphery whose cross-section, at a location perpendicular to the longitudinal axis of the hub and / or catheter, is larger than the inner diameter of the second lumen of the second catheter and / or the second lumen of the second catheter hub. Therefore, the first hub 514 cannot fit into the second lumen of the second catheter. Furthermore, the geometry of the first hub 514 does not allow the proximal end of the catheter to enter the vasculature.

[0123] The shaft 516 has sufficient flexibility to allow the shaft 516 to bend within the second lumen of the second catheter and / or to allow the shaft to follow a non-linear path in the second catheter. In one embodiment, the shaft 516 has sufficient flexibility to allow the shaft to bend and follow a non-linear path in the vasculature.

[0124] In one embodiment, shaft 516 may comprise a stainless steel hypotube that is flexible enough to allow the shaft to follow the non-linear path of the second catheter and / or the non-linear angiographic contrast of the patient.

[0125] In one embodiment, connector 528 is a luer connector, and in one embodiment, the luer connector is a female luer connector, hi one embodiment, the luer connector has a lumen that communicates with the lumen of the hub, thereby allowing another EMD to pass therethrough or fluid to enter the hub and catheter through the luer connector.

[0126] In one embodiment, hub wings 526 are used by an operator to manually hold onto hub 524. Wings 526 can be used as a positioning device within cavity 520 of on-device adapter 510.

[0127] In one embodiment, hub 514 may be used without controls to manipulate features within catheter 512 (e.g., wires extending to the distal end of the catheter to deflect the tip). In one embodiment, catheter 512 does not include controls used to manipulate features within the catheter (e.g., wires extending to the distal end of the catheter to deflect the tip).

[0128] In one embodiment, the on-device adapter 510 is configured to pinch EMDs having a range of shaft outer diameters. In one embodiment, a Merit Medical torque device is used as part of the on-device adapter, which covers any of the following shaft diameter ranges: 0.009"-0.018", 0.018"-0.038", 0.010"-0.020", 0.013"-0.024", or 0.025"-0.040" (where the symbol "" represents inches). Note that torque devices available from Merit Medical may have overlapping ranges.

[0129] In one embodiment, one or more on-device adapters can be used in conjunction with the robotic drive system, depending on the outer diameter of the shaft of the EMD to be pinched.

[0130] In one embodiment, a robotic system controls one or more EMDs, where a first on-device adapter is used with a first EMD having a first outer diameter, and a second on-device adapter is used with a second EMD having a second outer diameter different from the first outer diameter of the first EMD. For example, the first on-device adapter is used to clamp an angiographic guide wire having an outer diameter of 0.035" or 0.038", and the second on-device adapter is used to clamp a microwire having an outer diameter of approximately 0.014". Angiographic guide wires are used to position guide catheters and can be referred to as diagnostic guide wires. Microwires can also be referred to as microguide wires or simply guide wires. For simplicity, the term "approximately" is used herein as an abbreviation for "approximately."

[0131] In one embodiment, the on-device adapter may not be designed to be separated (disassembled). In one embodiment, the on-device adapter may be designed to accept a single torquer. Note that the terms torquer and torque device are used interchangeably herein and may be a subset of collet as used herein. In one embodiment, the on-device adapter may provide sufficient clamping force on the torque device to withstand axial forces as the on-device adapter advances and retracts, and torsional forces as the on-device adapter is rotated to rotate the EMD for a given procedure. The pinch or clamping force applied by the on-device adapter to the torquer is sufficient to resist slip (axial or rotational) of the EMD as it advances and / or rotates with the on-device adapter. In one embodiment, the on-device adapter penetrates the exterior surface of the body of the torque device and / or deforms the surface of the torque device.

[0132] 12A-12F.2, the robotic system 910 includes a collet 964 having a first portion 965 with a first collet coupler 958 connected thereto and a second portion 966 with a second collet coupler 960 connected thereto. Referring to FIG. 12F.1, an EMD 912 is releasably disposed within a lumen or passageway 996 defined by the collet 964. The robotic drive includes a base 914 or drive module having a first motor 936 and a second motor 938 operably and serially coupled to both the first collet coupler 958 and the second collet coupler 960 to operably clamp and unclamp the EMD 914 within the cavity 996 to rotate the EMD 912. The first motor 936 and the second motor 938 described herein differentially rotate the first collet coupler 958 and the second collet coupler 960. In other words, the first motor 936 and the second motor 938 rotate independently of each other at different rates (speeds) and in different directions, including when the first motor rotates and the second motor does not. In one embodiment, both motors rotate at the same speed. In one embodiment, the first motor and the second motor are continuously engaged with the first collet coupler 958 and the second collet coupler 960, respectively. In one embodiment, the first portion 965 and the first collet coupler 958 are formed as a single component, although in other embodiments, they may be separate components. In one embodiment, the second portion 966 and the second collet coupler 960 are formed as a single component, although in other embodiments, they may be separate components.

[0133] The EMD robotic system 910 includes a collet that uses a dual-gear configuration to releasably engage the EMD 912 and rotate and translate the EMD 912. In one embodiment, the dual-gear configuration includes a double-bevel gear. The dual-gear collet drive system 910 has a proximal end 911 and a distal end 913. As the EMD 912 is moved from the proximal end 911 toward the distal end 913, the EMD 912 is advanced into the patient, and as the EMD 912 is moved from the distal end 913 toward the proximal end, the EMD 912 is retracted or withdrawn from the patient. To clarify directions, a Cartesian coordinate system with X, Y, and Z axes can be introduced. Here, the positive (+) Z axis is oriented in the longitudinal (axial) distal direction, i.e., from the proximal end to the distal end. The X-axis and Y-axis lie in a plane perpendicular to the Z-axis, with the positive Y-axis pointing upward, i.e., opposite to gravity, and the X-axis corresponding to a direction facing forward (usually toward the surgeon / physician at the bedside). The right-hand rule is used to determine the direction of rotation. Here, the thumb of the right hand is oriented along the positive X-, Y-, and Z-axes, with the curl of the fingers of the right hand associated with a clockwise direction. The opposite direction of the curl of the fingers of the right hand can be associated with a counterclockwise direction. As used herein, the terms clockwise and counterclockwise are relative terms that refer to a first rotational direction and a second rotational direction opposite the first rotational direction. Therefore, it should be noted that the use of either the clockwise or counterclockwise terms can refer to a first rotational direction and a second, opposite rotational direction. The terms clockwise and counterclockwise are used to aid in understanding the different rotational directions of the devices provided herein, although it is possible to configure devices with the clockwise and counterclockwise directions reversed.

[0134] The collet drive system 910 includes a drive module 914 that moves axially along the EMD 912 and is actuated by a drive module translation driver 916. The drive module 914 includes a drive module housing 918, a mounting bracket 920, a cassette 922, and a cassette cover 924. The cassette 922 includes a double-gear collet drive housing 926 and an EMD guide 928. The top of the double-gear collet drive housing 926 includes multiple openings 927 and multiple ribs 929. The EMD guide 928 includes multiple pairs of guides that act as V-shaped notches to provide open channels for guiding the EMD 912 through the drive system. Note that the open channels are open for loading but may be covered when the cassette cover is closed. The guides function as anti-buckling features. In one embodiment, the EMD guide 928 includes multiple pairs of V-shaped notches or U-shaped channels to act as guides. The tops of the V-shaped or U-shaped channels may be chamfered to aid in loading the EMD 912. In one embodiment, a pair of EMD guides 928 is used on the proximal side of the dual gear collet drive housing 926 and a pair of EMD guides 928 is used on the distal side of the dual gear collet drive housing 926. In one embodiment, multiple pairs of EMD guides 928 are used on the proximal side of the dual gear collet drive housing 926 and multiple pairs of EMD guides 928 are used on the distal side of the dual gear collet drive housing 926.

[0135] In one embodiment, the robotic system 910 includes a third motor 932 (not shown) operably coupled to the collet 964, thereby moving the collet 964 and the EMD 912 along the longitudinal axis of the collet 964. In one embodiment, the first motor 936 and the second motor 938 are fixed relative to the collet 964 during movement or translation of the collet and the EMD. The drive module movement actuator 916 includes a lead screw 930, which is driven by a screw drive motor 932 (not shown) inside a screw drive housing 934. The screw drive 930 is used to move the drive module 914 relative to the fixed housing 934. In one embodiment, the screw drive motor 932 is a stepper motor. In one embodiment, the screw drive motor 932 is a servo motor. In one embodiment, the screw drive motor 932 is a rotary actuator powered by electrical, pneumatic, hydraulic, or other means.

[0136] In one embodiment, drive module housing 918 and its contents are reusable. In one embodiment, cassette 922 is a consumable item, meaning that cassette 922 is discarded after use with a single patient. In one embodiment, cassette 922 may be made of sterilizable and reusable materials.

[0137] 12A and 12B, drive module housing 918 includes a first motor 936 operably connected to and driving a first coupler 940 and a second motor 938 operably connected to and driving a second coupler 942. In one embodiment, first motor 936 and second motor 938 are stepper motors. In one embodiment, first motor 936 and second motor 938 are servo motors. In one embodiment, first motor 936 and second motor 938 are rotary actuators powered by electrical, pneumatic, hydraulic, or other means.

[0138] The first coupler 940 extends through the drive module housing 918 and is integrally connected to a first coupler bevel gear 946. The second coupler 942 extends through the mount bracket 920 and is integrally connected to a second bevel gear 948. The first motor 936, the first coupler 940, and the first coupler bevel gear 946 are located distally within the drive module housing 918. The second motor 938, the second coupler 942, and the second coupler bevel gear 948 are located proximally within the drive module housing 918. In one embodiment, the first coupler 940 and the second coupler 942 pass through holes in the mount bracket 920. In one embodiment, the first coupler 940 and the second coupler 942 pass through a rotation bearing attached to the mount bracket 920.

[0139] Collet drive housing 926 includes a dual gear collet drive assembly 944 as described herein.

[0140] 12B and 12C, a first driven bevel gear 950 meshes with and is driven by the first coupler bevel gear 946. The first driven bevel gear 950 is integrally connected to a first shaft tip 951, which is integrally connected to a first wheel 954, which is integrally connected to a first shaft proximal end 953, all of which form a first composite (or cluster) assembly 958. A second driven bevel gear 952 meshes with and is driven by the second coupler bevel gear 948. The second driven bevel gear 952 is integrally connected to a second shaft proximal end 955, which is integrally connected to a second wheel 956, which is integrally connected to a second shaft distal end 957, all of which form a second composite (or cluster) assembly 960.

[0141] In one embodiment, the top surface 947 of the first coupler bevel gear 946 includes an open central bore to receive and drive the first coupler 940 along its central axis. In other words, the gear 946 has a bore along its longitudinal axis. In one embodiment, the top surface 947 of the first coupler bevel gear 946 is closed and is sealed to prevent fluid from transferring from the cassette to the base. In one embodiment, the top surface 949 of the second coupler bevel gear 948 includes an open central bore to receive and drive the second coupler 942 along its central axis. In one embodiment, the top surface 949 of the second coupler bevel gear 948 is closed and is sealed to prevent fluid from transferring from the cassette to the base.

[0142] In one embodiment, cassette 922 is releasably secured to base 914. A collet 964 is disposed within cassette 922. First collet coupler 958 and second collet coupler 960 are coupled to first motor 936 and second motor 938, respectively, via first drive coupler 940 and second drive coupler 942 disposed within base 914. In one embodiment, first drive coupler 940 includes a shaft operatively connected to motor 936 that extends from the base in a sealed manner and is operatively connected to gear 946, which is operatively engaged with first collet coupler 958. Similarly, the second drive coupler 942 includes a shaft operably connected to the motor 938, which extends from the base in a sealed manner and is operably connected to a gear 948, which is operably engaged with the second collet coupler 960.

[0143] The first composite section assembly 958 includes radial and longitudinal slits 962 extending from its outer surface and terminating at its radial center. The second composite section assembly 960 includes radial and longitudinal slits 963 extending from its outer surface and terminating at its radial center. The slits 962 and 963 allow for side or radial loading of the EMD 912. In one embodiment, the slits 962 and 963 use opposing, non-parallel walls to form a radial opening. In one embodiment, the slits 962 and 963 use opposing, parallel walls to form a generally radial opening. In one embodiment, the outer surfaces of the assemblies 958 and 960 include V-shaped notches oriented toward their central longitudinal axes and leading into the slits 962 and 963, respectively, to help guide the side or radial loading of the EMD 912. Note that slit 962 extends through first driven bevel gear 950 and slit 963 extends through second driven bevel gear 952. First coupler bevel gear 946 meshes with and drives first driven bevel gear 950 with slit 962 without loss of performance. Second coupler bevel gear 948 meshes with and drives second driven bevel gear 952 with slit 963 without loss of performance.

[0144] Referring to FIG. 12A , an outer portion of the first wheel 954 and an outer portion of the second wheel 956 extend through an opening 927 in the housing 926, allowing the wheels 954 and 956 to be manually manipulated by an operator. For example, in the event of a power loss, an operator can manually rotate the wheels 954 and 956 to remove the EMD 912. In one embodiment, an operator can remove the collet assembly, including the wheels 954 and 956, from the cassette by removing the double-bevel collet drive housing 926 from the cassette, allowing the operator to align slots in the collet assembly and remove the EMD from the cassette. In one embodiment, the first wheel 954 and the second wheel 956 are circular disks with notches on their outer peripheries. In one embodiment, the first wheel 954 and the second wheel 956 are circular disks with grooves on their outer peripheries. In one embodiment, the first wheel 954 and the second wheel 956 are circular disks with knurling on their peripheries. In one embodiment, the first wheel 954 and the second wheel 956 are circular disks with features on their peripheries to assist in manual manipulation. In one embodiment, the first wheel 954 and the second wheel 956 are circular disks without features on their peripheries, such as smooth walls.

[0145] 12A, 12B, and 12C, the first composite section assembly 958 and the second composite section assembly 960 each rotate about a longitudinal axis aligned with the EMD 912, with each assembly maintained in its longitudinal position by a circular cutout in the rib 929 that acts as a bearing. In one embodiment, the open circular cutouts in the rib 929 snap onto the first wheel 954 and the second wheel 956 on either side of the wheels. In other words, the first composite section assembly 958 and the second composite section assembly 960 may snap into open cutouts in the rib 929 that are partially surrounded by the first shaft distal end 951 and the first shaft proximal end 953 of the first composite section assembly 958 and the second shaft proximal end 955 and the second shaft distal end 957 of the second composite section assembly 960. The open cutouts in rib 929 act like thrust bearings, preventing axial (longitudinal) movement and allowing rotational movement. The open cutouts in rib 929 do not completely enclose shafts 951, 953, 955, and 957. In one embodiment, the open cutouts in rib 929 provide 210 degrees of encirclement for each of shafts 951, 953, 955, and 957. In one embodiment, the open cutouts provide greater than 180 degrees but less than 360 degrees of encirclement for each of shafts 951, 953, 955, and 957. In one embodiment, the ribs with open cutouts are made of a material, such as, for example, plastic, according to a custom standard.

[0146] 12A and 12D, dual gear collet drive assembly 944 includes first composite section assembly 958, collet 964 including inner collet portion 965 and outer collet portion 966 having threaded splines, and second composite section assembly 960. Due to a snap-fit ​​feature due to open notches in ribs 929, dual gear collet drive assembly 944 (not including first coupler bevel gear 946 or second coupler bevel gear 948) can be manually removed from and re-installed in housing 926.

[0147] 12D and 12E, the inner collet portion 965 includes a collet first portion 968 integrally connected to a tapered collet second portion 970, which is divided into tapered cantilever jaws 972, each having a substantially semicircular cross-section. In one embodiment, the collet first portion 968 has a prismatic shape with a substantially constant radius. In one embodiment, the collet first portion 968 has a prismatic shape with a square cross-section. In one embodiment, the collet 968 has a non-prismatic shape with a non-constant cross-section. The collet second portion 970 extends from the collet first portion 968 in a frustoconical shape, such that the diameter of the second portion continuously decreases from the region adjacent the first portion to a proximal free end 974 of the second portion 970. Note that the proximal end 974 is furthest from the region of the second portion adjacent the first portion 968. In one embodiment, inner collet portion 965 and first composite section assembly 958 are separate pieces. For example, tapered collet second portion 970 may be a metal insert pressed into collet first portion 968. In one embodiment, inner collet portion 965 and first composite section assembly 958 are combined as one piece. Collet 964 may be any collet device known in the art and is not limited to the collet embodiments described herein.

[0148] The screw spline 966 includes a screw spline first portion 976 that is integrally connected to a screw spline second portion 978. The screw spline first portion 976 includes external axial spline threads 980 that mate with internal axial spline threads 982 of the second composite section assembly 960 to allow relative movement along a longitudinal axis 988. The screw spline second portion 978 includes external helical circumferential screw threads 984 that mate with internal screw threads 986 of the first composite section assembly 958 to allow relative rotational movement in either a clockwise or counterclockwise direction 990. The screw spline 966 has both axial spline threads 980 and helical circumferential screw threads 984 that allow the screw spline 966 to rotate and translate relative to the inner collet portion 965 while maintaining a fixed longitudinal distance between the first driven coupler bevel gear 950 and the second driven coupler bevel gear 952 and meshing with the first coupler bevel gear 946 and the second coupler bevel gear 948, respectively.

[0149] In one embodiment, the EMD 912 does not rotate when it is being pinched and released. The collet first portion 968 is the portion that releasably secures the EMD 912 thereto. By keeping the collet first portion 968 stationary while the second portion 966 rotates, the EMD 912 does not rotate. In other words, releasing the EMD from the collet 964 without rotation relative to the EMD 912 about the collet's longitudinal axis can be achieved by holding the collet's inner collet portion 965, which directly secures and abuts the EMD 912, stationary relative to the patient and rotating the outer collet portion 966 relative to the inner collet portion 965 to release the EMD 912 from its fixed relationship relative to the inner collet portion 965. In one embodiment, it may be desirable to continue rotating the EMD 912 at the beginning of the release process. In this embodiment, the first collet portion 968 rotates at a different speed than the outer collet portion 966 .

[0150] 12D and 12E , the inner collet portion 965 includes a radial longitudinal slit 992 in the collet first portion 968, thereby allowing for side or radial loading of the EMD 912 into the lumen 996. The longitudinal slit 992 extends radially from the outer surface of the first portion 968 and terminates at the radial center of the inner collet portion 965. The longitudinal slit 992 extends longitudinally through the seam of the jaws 972 to the second tapered portion 970. The screw spline 966 includes a radial longitudinal slit 994, thereby allowing for side or radial loading of the EMD 912. The longitudinal slit 994 extends radially from the outer surface of the screw spline 966 and terminates at the center thereof.

[0151] Referring to FIG. 12F.1 , the dual gear collet drive assembly 944 is illustrated in an unpinched configuration, in which the jaws 972 of the tapered collet second portion 970 are open and do not lock down (engage) (pinch) the EMD 912. In the fully unpinched configuration, the screw spline 966 is in its proximal-most position. In one embodiment, the screw spline 966 is limited to its proximal-most position by a hard stop at the proximal end of its longitudinal spline. In one embodiment, the screw spline 966 is limited to its proximal-most position by a feature such as a flange or lip that prevents further movement within the longitudinal spline. Referring to FIG. 12F.2 , the dual gear collet drive assembly 944 is illustrated in a pinched configuration, in which the jaws 972 of the tapered collet second portion 970 are closed together to lock down (engage) (pinch) the EMD 912. In the fully pinched configuration, the screw spline 966 is at its most distal position. In one embodiment, the screw spline 966 is limited to its most distal position by a hard stop caused by thread stripping. That is, the threads are geometrically constrained so that further threading is not possible. In one embodiment, the screw spline 966 is limited to its most distal position by a feature, such as a flange or lip, that stops further movement.

[0152] 12F.1 and 12F.2, movement of the inner collet portion 965 in the direction of the screw spline 966 is illustrated, causing the jaws 972 of the tapered collet second portion 972 to move toward each other, pinching the EMD 912. Moving the inner collet portion 965 away from the direction of the screw spline 966 causes the jaws 972 of the tapered collet second portion 972 to move away from each other, allowing the EMD 912 to be unpinched.

[0153] In operation, dual gear collet drive assembly 944 uses two rotational degrees of freedom provided by motors 936 and 938 to enable four motions: pinching EMD 912, unclipping EMD 912, rotating dual gear collet drive assembly 944 clockwise, and rotating dual gear collet drive assembly 944 counterclockwise. These four motions are caused by movement of inner collet portion 965 relative to screw spline 966 based on the direction of rotation of first coupler 940 and the direction of rotation of second coupler 942.

[0154] In a first mode of operation, this results in clockwise rotation of the dual gear collet drive assembly 944, which in turn rotates the first coupler 940 in a counterclockwise direction and the second coupler 942 in a clockwise direction. In the second mode of operation, this results in counterclockwise rotation of the dual gear collet drive assembly 944, with the first coupler 940 rotating clockwise and the second coupler 942 rotating counterclockwise. In a third mode of operation, this results in the EMD 912 being unpinched, with the first coupler 940 not rotating and the second coupler 942 rotating counterclockwise. In the fourth mode of operation, the EMD 912 is thereby pinched, with the first coupler 940 not rotating and the second coupler 942 rotating clockwise. In the third and fourth modes of operation, the collet is released and pinched, respectively. In one embodiment of the third and fourth modes of operation, movement continues until a hard stop is reached. In one embodiment of the release mode, the hard stop is reached when the end of the spline threads on the screw spline first portion 976 is reached. In one embodiment of the pinch mode, the hard stop is reached when the end of the threads on the screw spline second portion 978 is reached, where it meets the screw spline first portion 976. During the fourth mode of operation, while pinching, the first coupler 940 is rotated clockwise to initiate rotation of the EMD sooner.

[0155] The first motor 936 and the second motor 938 can be controlled by limiting the amount of torque applied to each motor. In one embodiment, the first motor 936 and the second motor 938 are servo motors, and each motor can be controlled by current limiting to constrain the torque applied to each motor. The current limit can be set to different values ​​for the third and fourth operating modes. For example, the current is limited to a lower value when pinching compared to when unpinching because of the need to overcome static friction during unpinching.

[0156] In one embodiment, the dual gear collet drive system 910 includes a system for preventing buckling (twisting) of the EMD 912 at the proximal end 911 of the collet drive system. In one embodiment, the dual gear collet drive system 910 incorporates a system for preventing buckling of the EMD 912 at the distal end 913 of the collet drive system. In one embodiment, the buckling prevention system is a tube having an inner diameter slightly larger than the outer diameter of the EMD 912. In one embodiment, the buckling prevention system is a set of telescoping tubes, the smallest of which has an inner diameter slightly larger than the outer diameter of the EMD 912. In one embodiment, the buckling prevention system is a side-loadable track.

[0157] 13A , a dual gear sliding collet drive system 1000 releasably engages an elongated medical device (EMD) 1002 to rotate and move the EMD 1002. The dual gear sliding collet drive system 1000 includes a proximal end 1004 and a distal end 1006. As the EMD 1002 is moved from the proximal end 1004 toward the distal end 1006, the EMD 1002 is advanced into the patient, and as the EMD 1002 is moved from the distal end 1006 toward the proximal end 1004, the EMD 1002 is retracted or withdrawn from the patient.

[0158] The sliding collet drive system 1000 includes a carrier 1008 that moves along the axial direction of the EMD 1002, actuated by a carrier movement drive 1010 mounted on a fixed base 1012. The carrier 1008 includes a carrier housing 1014, a carrier arm 1016, and a rack 1018, all three of which are integrally connected. The carrier movement drive 1010 includes a pinion gear 1020 integrally connected to a motor shaft (not shown) of a movement drive motor 1022. The movement drive motor 1022 rotates the pinion gear 1020, which meshes with the rack 1018 to move the carrier 1008. A linear guide or linear bearing (not shown) integrally connected to the base 1012 constrains the carrier 1008 to move only in the proximal and distal directions along the axial direction of the EMD 1002.

[0159] The carrier housing 1014 includes a flat base plate with perpendicular side extensions at its proximal and distal ends. In one embodiment, the carrier housing 1014 is a single, integrated part with the base plate, proximal extension, and distal extension made of the same material. In one embodiment, the carrier housing 1014 includes the base plate, proximal extension, and distal extension as three separate pieces made of the same material and integrally connected. In one embodiment, the carrier housing 1014 includes the base plate, proximal extension, and distal extension as three separate pieces made of different materials and integrally connected. The proximal and distal extensions of the carrier housing 1014 include holes that support the collet and rotary drive system 1024 (described below). In one embodiment, rotary bearings are mounted within the holes in the proximal and distal extensions of the carrier housing 1014.

[0160] The first motor 1026 and the second motor 1028 are mounted to a fixed base 1012. In one embodiment, the first motor 1026 and the second motor 1028 are fixed relative to the base 1012 during movement of the collet 1056 and the EMD 1002. As described herein, the carrier 1008 moves with the collet 1056 independently of the base 1012, the first motor 1026, and the second motor 1028. In other words, when the collet 1056 moves along its longitudinal axis, the first motor 1026 and the second motor 1028 do not move with the collet 1056 during at least one mode of operation. The first motor 1026 drives the first coupler 1030. The second motor 1028 drives the second coupler 1032. The first motor 1026 and the first coupler 1030 are located below or within the base 1012. The second motor 1028 and the second coupler 1032 are located proximally below the fixed base 1012. In one embodiment, the first coupler 1030 and the second coupler 1032 pass through holes in the fixed base 1012. In one embodiment, the first coupler 1030 and the second coupler 1032 pass through a rotational bearing and seal attached to the fixed base 1012.

[0161] In one embodiment, the travel drive motor 1022, the first motor 1026, and the second motor 1028 are stepper motors; however, other motor types known in the art are contemplated. In one embodiment, the travel drive motor 1022, the first motor 1026, and the second motor 1028 are servo motors. In one embodiment, the travel drive motor 1022, the first motor 1026, and the second motor 1028 are rotary actuators powered by electricity, pneumatics, hydraulics, or other means.

[0162] 13B.1 and 13B.2, the collet and rotational drive system 1024 (described below) moves relative to the fixed base 1012. With reference to FIG. 13B.1, the translation drive motor 1022 rotates the pinion 1020 in one direction (clockwise) to move the rack 1018 and therefore the collet and rotational drive system 1024 in a proximal direction. With reference to FIG. 13B, the translation drive motor 1022 rotates the pinion 1020 in the opposite direction (counterclockwise) to move the rack 1018 and therefore the collet and rotational drive system 1024 in a distal direction. In one embodiment, the collet and rotational drive system 1024 moves relative to the fixed base 1012 via a rack and pinion mechanism as described herein. In one embodiment, the collet and rotary drive system 1024 moves relative to the fixed base 1012 by a different mechanism, and may utilize, for example, a reciprocating mechanism such as a slider-crank or scotch-yoke mechanism. The advantage of a reciprocating mechanism is that the translation drive motor 1022 does not need to change direction.

[0163] Movement of the collet and rotary drive system 1024 is achieved without the need to move the first motor 1026 (and first coupler 1030 and first drive (driver) bevel gear 1034) and second motor 1028 (and second coupler 1032 and second drive bevel gear 1042), both of which are mounted to the fixed base 1012, thus avoiding inertia problems associated with accelerating and decelerating the movement of the first motor 1026 and second motor 1028.

[0164] 13C , the first coupler 1030 is integrally connected to a first drive bevel gear 1034, which meshes with a first driven bevel gear 1036. The first driven bevel gear 1036 is integrally connected to a first shaft 1037, which is integrally connected to a first spur gear 1038, all of which form a first compound (or cluster) gear assembly 1040. The second coupler 1032 is integrally connected to a second drive bevel gear 1042, which meshes with a second driven bevel gear 1044. The second driven bevel gear 1044 is integrally connected to a second shaft 1045, which is integrally connected to a second spur gear 1046, all of which form a second compound (or cluster) gear assembly 1048. The first spur gear 1038 meshes with a first collet spur gear 1050, which is movable relative to the first spur gear 1038. The second spur gear 1046 meshes with a second collet spur gear 1052, which is movable relative to the second spur gear 1046. A short first shaft 1051 is provided at the distal end of the first collet spur gear 1050, which is coaxially aligned with and integrally connected to the first collet spur gear 1050. A short second shaft 1053 is provided at the proximal end of the second collet spur gear 1052, which is coaxially aligned with and integrally connected to the second collet spur gear 1052. In one embodiment, the first shaft 1051 is supported by a bore in the distal extension of the carrier housing 1014. In one embodiment, the first shaft 1051 is supported by a rotation bearing mounted in a bore in the distal extension of the carrier housing 1014. In one embodiment, the second shaft 1053 is supported by a bore in the proximal extension of the carrier housing 1014. In one embodiment, the second shaft 1053 is supported by a rotation bearing mounted in a bore in the proximal extension of the carrier housing 1014.

[0165] The first collet spur gear 1050 and the second collet spur gear 1052 are wide gears, i.e., longer gears that are wider than the width of the first spur gear 1038 and the second spur gear 1046. In one embodiment, the width of the first collet spur gear 1050 and the second collet spur gear 1052 is ten times the width of the first spur gear 1038 and the second spur gear 1046, respectively. In one embodiment, the width of the first collet spur gear 1050 and the second collet spur gear 1052 is less than ten times the width of the first spur gear 1038 and the second spur gear 1046, respectively. In one embodiment, the width of the first collet spur gear 1050 and the second collet spur gear 1052 is more than ten times the width of the first spur gear 1038 and the second spur gear 1046, respectively.

[0166] The first compound section gear assembly 1040 and the second compound section gear assembly 1048 are supported relative to the base 1012 so that they are coaxially aligned and can rotate about a longitudinal axis. In one embodiment, a first shaft 1037 connecting the first driven bevel gear 1036 and the first spur gear 1038 passes through and is supported by a hole in an extension from the base 1012. In one embodiment, the first shaft 1037 connecting the first driven bevel gear 1036 and the first spur gear 1038 passes through and is supported by a rolling bearing in an extension from the base 1012. In one embodiment, a second shaft 1045 connecting the second driven bevel gear 1044 and the second spur gear 1046 passes through and is supported by a hole in the extension from the base 1012. In one embodiment, a second shaft 1045 connecting the second driven bevel gear 1044 and the second spur gear 1046 passes through and is supported by a rolling bearing in an extension from the base 1012 .

[0167] 13A and 13C, the collet and rotary drive 1024 includes a first collet spur gear 1050 having a first shaft 1051, a collet mechanism 1054 (described below), and a second collet spur gear 1052 having a second shaft 1053, all coaxially aligned along a longitudinal axis. In one embodiment, the collet and rotary drive 1024 can be manually removed from the carrier housing 1014 and re-installed within the carrier housing 1014 by snap-fit ​​features on the proximal and distal sides of the carrier housing 1014.

[0168] In one embodiment, the first collet spur gear 1050 is integrally connected to a first wheel (not shown) having a larger diameter than the spur gear 1050, and the second collet spur gear 1052 is integrally connected to a second wheel (not shown) having a larger diameter than the spur gear 1052. The first and second wheels are accessible for manual manipulation by an operator. For example, in the event of a power loss, an operator may manually rotate the first and second wheels to remove the EMD 1002. In one embodiment, the first and second wheels are circular disks with notches on their peripheries. In one embodiment, the first and second wheels are circular disks with grooves on their peripheries. In one embodiment, the first and second wheels are circular disks with teeth on their peripheries. In one embodiment, the first and second wheels are circular disks with features on their peripheries to facilitate manual manipulation. In one embodiment, the first wheel and the second wheel are circular disks without features on their periphery, e.g., smooth walls. In one embodiment, the first collet spur gear 1050 and the first wheel are a single, integrated part made of the same material, and the second collet spur gear 1052 and the second wheel are a single, integrated part made of the same material. In one embodiment, the first collet spur gear 1050 and the first wheel are separate parts that are integrated together, and the second collet spur gear 1052 and the second wheel are separate parts that are integrated together.

[0169] In one embodiment, the carrier arm 1016 can be manually detached from the proximal side of the carrier housing 1014 and reconnected to the proximal side of the carrier housing 1014 by snap-fit ​​features incorporated into the proximal side of the carrier housing 1014. In one embodiment, the carrier arm 1016 can be manually detached from the rack 1018 and reconnected to the rack 1018 by snap-fit ​​features incorporated into the distal side of the rack 1018.

[0170] In one embodiment, the collet and rotary drive 1024 is a consumable item. In one embodiment, the collet and rotary drive 1024 and the carrier 1008 are consumable items. In one embodiment, the collet and rotary drive 1024 and the carrier housing 1014 are consumable items. In one embodiment, the collet and rotary drive 1024, the carrier housing 1014, and the carrier arm 1016 are consumable items.

[0171] 13D.1 and 13D.2, a first collet spur gear 1050 and a second collet spur gear 1052 are connected by components internal to a collet mechanism 1054. The collet mechanism 1054 includes a collet inner member 1056 and a collet outer member 1058. The collet inner member 1056 and the collet outer member 1058 may be any collet device known in the art and are not limited to the collet embodiments described herein.

[0172] The collet inner member 1056 is comprised of a first portion 1060 and a second portion 1062. The first portion 1060 of the collet inner member 1056 has a cylindrical collar or sleeve shape, the center of its longitudinal axis of which is collinear with the axis of the EMD 1002, and its outer periphery is integrally connected to the inner wall 1064 of the first collet spur gear 1050. The second portion 1062 of the collet inner member 1056 has a tapered shape with respect to the central longitudinal axis and has an internal cavity (lumen). In one embodiment, the second portion 1062 of the collet inner member 1056 includes two separate, tapered jaws. In one embodiment, the second portion 1062 of the collet inner member 1056 includes more than two separate, tapered jaws. In one embodiment, the first and second portions 1060, 1062 of the collet inner member 1056 and the first collet spur gear 1050 are an integrated part. In one embodiment, the first and second portions 1060, 1062 of the collet inner member 1056 and the first collet spur gear 1050 are separate pieces that are integrally connected.

[0173] The collet outer member 1058 is comprised of a first portion 1066 and a second portion 1068. The first portion 1066 of the collet outer member 1058 has a cylindrical collar or sleeve shape with its longitudinal axis centered collinear with the axis of the EMD 1002 and its outer periphery integrally connected to an inner wall 1070 of the second collet spur gear 1052. The second portion 1068 of the collet outer member 1058 has a cylindrical collar or sleeve shape with an external screw thread 1074 on its outer periphery and with its longitudinal axis centered collinear with the axis of the EMD 1002. In one embodiment, the first portion 1066 and second portion 1068 of the collet outer member 1058 and the second collet spur gear 1052 are a unitary component. In one embodiment, the first and second portions 1066, 1068 of the collet outer member 1058 and the second collet spur gear 1052 are separate pieces that are integrally connected.

[0174] The outer screw threads 1074 of the second portion 1068 of the collet outer member 1058 mate with the inner screw threads 1072 of the second portion 1062 of the collet inner member 1056. Because the inner screw threads 1072 mate with the outer screw threads 1074, rotation of the collet inner member 1056 relative to the collet outer member 1058 about the longitudinal axis corresponds to movement of the collet inner member 1056 relative to the collet outer member 1058 along the longitudinal axis. Because the first collet spur gear 1050 is integrally connected to the collet inner member 1056 and the second collet spur gear 1052 is integrally connected to the collet outer member 1058, rotation of the first collet spur gear 1050 relative to the second collet spur gear 1052 about the longitudinal axis corresponds to movement of the first collet spur gear 1050 relative to the second collet spur gear 1052 along the longitudinal axis. Rotation of the first collet spur gear 1050 is achieved by its meshing with the first spur gear 1038. Rotation of the second collet spur gear 1052 is achieved by its meshing with the second spur gear 1046.

[0175] To ensure continuous meshing between the first collet spur gear 1050 and the first spur gear 1038, the first collet spur gear 1050 is made wider than the first spur gear 1038. This is necessary to accommodate (cover) the movement of the first collet spur gear 1050 when rotated by the first spur gear 1038 and to accommodate the movement of the first collet spur gear 1050 when moved by the carrier 1008. To ensure continuous meshing between the second collet spur gear 1052 and the second spur gear 1046, the second collet spur gear 1052 is made wider than the second spur gear 1046. This is necessary to accommodate the movement of the second collet spur gear 1052 when rotated by the second spur gear 1046 and to accommodate the movement of the second collet spur gear 1052 when moved by the carrier 1008. In one embodiment, the first collet spur gear 1050 and the second collet spur gear 1052 remain engaged with the first motor 1026 and the second motor 1028 during movement of the collet 1054. In other words, the first collet spur gear 1050 includes teeth with a sufficient face width to allow the teeth of the gear 1050 to engage with the gear 1038 when the gear 1050 is moved with the collet 1054 relative to the motor 1026. Similarly, the second collet spur gear 1052 includes teeth with a sufficient face width to allow the teeth of the gear 1052 to engage with the gear 1046 when the gear 1052 is moved with the collet 1054 relative to the motor 1028.

[0176] Referring to FIG. 13D.1 , in the pinched-out configuration of the collet and rotary drive system 1024, the jaws of the second portion 1062 of the collet inner member 1056 are open and do not lock down (pinch) the EMD 1002. In the fully pinched-out configuration, the collet outer member 1058 is in its proximal-most position relative to the collet inner member 1056. In one embodiment, the collet outer member 1058 is limited to its proximal-most position by a hard stop at the proximal end of its travel. In one embodiment, the collet outer member 1058 is limited to its proximal-most position by a feature such as a flange or lip that prevents further longitudinal movement. Referring to FIG. 13D.2 , in the pinched configuration of the collet and rotary drive system 1024, the jaws of the second portion 1062 of the collet inner member 1056 are closed together and lock down (pinch) the EMD 1002. In the fully pinched configuration, the collet outer member 1058 is in its most distal position relative to the collet inner member 1056. In one embodiment, the collet outer member 1058 is limited to its most distal position by a hard stop due to thread stripping, i.e., it cannot be threaded any further because it is constrained by its geometry. In one embodiment, the collet outer member 1058 is limited to its most distal position by a feature such as a flange or lip to stop further longitudinal movement.

[0177] 12C and 12D . As the first collet spur gear 1050 and the second collet spur gear 1052 are rotated, they thread toward each other and the inner surface of the second portion 1068 of the collet outer member 1058 presses against the second portion 1062 of the collet inner member 1056, pinching the EMD 1002. As the first collet spur gear 1050 and the second collet spur gear 1052 are rotated and they thread against each other, the inner surface of the second portion 1068 of the collet outer member 1058 is released and stops pressing against the second portion 1062 of the collet inner member 1056, releasing the pinch on the EMD 1002.

[0178] In operation, the dual gear collet and rotary drive system 1024 uses two rotational degrees of freedom from motor 1026 and motor 1028 to achieve four motions: pinching the EMD 1002, unclipping the EMD 1002, rotating the dual gear collet and rotary drive system 1024 clockwise, and rotating the dual gear collet and rotary drive system 1024 counterclockwise. These four motions are caused by movement of the collet inner member 1056 relative to the collet outer member 1058 based on the direction of rotation of the first coupler 1030 and the direction of rotation of the second coupler 1032.

[0179] In a first mode of operation, this results in clockwise rotation of the dual gear collet and rotary drive system 1024, with the first coupler 1030 rotating in a clockwise direction and the second coupler 1032 rotating in a counterclockwise direction. In the second mode of operation, this results in counterclockwise rotation of the dual gear collet and rotary drive system 1024, with the first coupler 1030 rotating counterclockwise and the second coupler 1032 rotating clockwise. In the third mode of operation, the EMD 1002 is thereby unpinched, with the first coupler 1030 rotating clockwise and the second coupler 1032 rotating clockwise. In the fourth mode of operation, the EMD 1002 is pinched, which results in the first coupler 1030 rotating counterclockwise and the second coupler 1032 rotating counterclockwise. In the third and fourth modes of operation, the collet inner member 1056 is pinched and unpinched, respectively, until a hard stop is reached.

[0180] In one embodiment, the pinching and unpinching of the collet mechanism 1054 is synchronized with the rotational position of the shaft of the translation drive motor 1022 .

[0181] In one embodiment, a longitudinal slit (not shown) is included as part of the dual gear sliding collet drive system 1000 to allow radial or side loading of the EMD 1002 into the collet cavity (lumen) 1076.

[0182] In one embodiment, the robotic system 1000 includes a pinch / unpinch mode, a rotation mode, and a translation mode. The pinch / unpinch mode, the rotation mode, and the translation mode may occur individually or simultaneously. In one embodiment, the rotation mode and the translation mode occur simultaneously.

[0183] Referring to FIG. 14A , one embodiment of a dual-gear sliding collet drive system with a reset mechanism is shown. A disposable cassette 1080 is releasably attached to a fixed base 1012 and includes a distally disposed collet and rotational drive system 1024 (described above) and a proximally disposed reset mechanism 1082. The reset mechanism 1082 (described below) is configured to advance, retract, and retain the EMD 1002. The cassette 1080 includes a top cassette cover 1084 and a bottom cassette housing 1086. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 by a rear hinge, allowing the cover to rotate open and close from the front. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 by a front hinge, allowing the cover to rotate open and close from the back. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 from the side by a hinge, allowing the cover to be opened and closed. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 by a fastener that allows the cover to be opened and closed by rotation, translation, or a combination of rotation and translation relative to the housing 1086. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 by a press-fit feature that allows the cover to be opened and closed by rotation, translation, or a combination of rotation and translation relative to the housing 1086. In one embodiment, the cassette cover 1084 is connected to the cassette housing 1086 by a press-fit feature that allows the cover to be removed from and reattached to the housing 1086.

[0184] The proximal and distal sides of the cassette cover 1084 include cover notches 1088 to allow free passage of the EMD 1002. The proximal and distal sides of the cassette housing 1086 include housing notches 1090 to align with the cover notches 1088. In one embodiment, the cover notches 1088 and the housing notches 1090 are triangular cutouts to allow free passage of the EMD 1002. In one embodiment, the cover notches 1088 and the housing notches 1090 are cutouts of any shape to allow free passage of the EMD 1002. The underside of the cassette cover 1084 includes cover ribs 1092. When the cassette cover 1084 is closed, the cover ribs 1092 seat the EMD 1002 in the alignment notches 1090 of the cassette housing 1086, maintaining the vertical position of the EMD 1002 within the alignment grooves or channels, and maintaining the lateral position of the EMD 1002.

[0185] As described above, the collet and rotary drive system 1024 is actuated by a first motor 1026, which drives a first coupler 1030, and a second motor 1028, which drives a second coupler 1032. The reset mechanism 1082 is actuated by a reset mechanism motor 1094, which drives a reset mechanism coupler 1096. In one embodiment, the reset mechanism motor 1094 is a stepper motor. In one embodiment, the reset mechanism motor 1094 is a servo motor. In one embodiment, the reset mechanism motor 1094 is a rotary actuator powered by electrical, pneumatic, hydraulic, or other means.

[0186] 14B, the underside of the fixed base 1012 is shown. The reset mechanism 1082 is housed in a reset mechanism frame 1098 that is integrally connected to the fixed base 1012. A reset mechanism coupler 1096 is integrally connected to a reset mechanism crank 1100, which is rotatable relative to the frame 1098 and the base 1012. In one embodiment, the reset mechanism coupler 1096 passes through a hole in the reset mechanism frame 1098. In one embodiment, the reset mechanism coupler 1096 passes through a rotation bearing mounted within the reset mechanism frame 1098. The reset mechanism crank 1100 is connected to a connecting link 1104 by a first joint 1102. The connecting link 1104 is connected to a cross slider 1108 by a second joint 1106. The cross slider 1108 is constrained from longitudinal movement (i.e., movement only along the axis of the EMD 1002) by a cross slider first linear bearing 1110 and a cross slider second linear bearing 1112, both of which are integrally connected to the cross slider 1108. The first linear bearing 1110 is a prismatic joint that is movable relative to a first guide 1114, and the second linear bearing 1112 is a prismatic joint that is movable relative to a second guide 1116. The tips of the first guide 1114 and the second guide 1116 are integrally connected to a fixed base 1012, to which the guides 1114 and 1116, etc., are fixed.

[0187] The proximal first linear bearing 1118 and the distal first linear bearing 1120 are integrally attached to the front corners of the reset mechanism frame 1098. The proximal second linear bearing 1122 and the distal second linear bearing 1124 are integrally attached to the rear corners of the reset mechanism frame 1098. The first guide 1114 is movable relative to the proximal first linear bearing 1118 and the distal first linear bearing 1120. The second guide 1116 is movable relative to the proximal second linear bearing 1122 and the distal second linear bearing 1124. Because the four bearings 1118, 1120, 1122, and 1124 are integrally attached to the reset mechanism frame 1098, the reset mechanism 1082 is capable of longitudinal movement relative to the fixed base 1012.

[0188] In one embodiment, the first coupler 1030 has a first coupler slotted end 1126 that seats within a slotted receiver of a shaft integrally connected to the first drive (driver) bevel gear 1034. The second coupler 1032 has a second coupler slotted end 1128 that seats within a slotted receiver of a shaft integrally connected to the second driver bevel gear 1042 (see FIG. 13C).

[0189] 14C.1, 14C.2, 14C.3, and 14C.4, the operation of the linear positioning mechanism 1082 is shown in a series of steps. The mechanism 1082 includes a rotatable reset clamp cam 1130 and a fixed clamp support 1132. The reset cam 1130 rotates about a vertical axis via a reset cam coupler 1134. In one embodiment, the reset cam 1130 rotates through the reset cam coupler 1134, which is driven by a motor (not shown). In one embodiment, the reset cam 1130 rotates through the reset cam coupler 1134, which is driven by a mechanism actuated by the reset mechanism motor 1094. In one embodiment, the reset cam coupler 1134 has a slotted end that seats within a receiver within the cam 1130. The reset cam 1130 has a curved outer surface 1136. In one embodiment, the curved outer surface 1136 of the reset cam 1130 has a convex shape. In one embodiment, the curved outer surface 1136 of the reset cam 1130 has an arc shape. The retaining cam 1132 has a curved outer surface 1138. In one embodiment, the curved outer surface 1138 of the retaining cam 1132 has a convex shape. In one embodiment, the curved outer surface 1138 of the retaining cam 1132 has an arc shape.

[0190] In operation, the reset cam 1130 can be in a closed position or an open position. In the closed position, the reset cam 1130 is positioned opposite the retaining cam 1132. In one embodiment, in the closed position, there is no gap between the reset cam outer surface 1136 and the retaining cam outer surface 1138, and the two surfaces 1136 and 1138 are in contact. In one embodiment, in the closed position, there is a gap between the reset cam outer surface 1136 and the retaining cam outer surface 1138, with the gap distance being less than the diameter of the EMD 1002. In the closed position, the EMD 1002 is sandwiched between the reset cam outer surface 1136 and the retaining cam outer surface 1138, thereby preventing longitudinal movement of the EMD 1002. In one embodiment, the reset cam outer surface 1136 and the retaining cam outer surface 1138 comprise an elastomeric material or other deformable or flexible material and deforms relative to the EMD in the closed position. The open position reset cam 1130 rotates away from the retaining cam 1132 such that there is a gap between the reset cam outer surface 1136 and the retaining cam outer surface 1138. The open position reset cam 1130 does not contact the EMD 1002, allowing the EMD 1002 to move longitudinally at the position of the retaining cam 1132. In one embodiment, the reset cam 1130 rotates 60 degrees away from the retaining cam 1132 to the open position. In one embodiment, the reset cam 1130 rotates less than 60 degrees away from the retaining cam 1132 to the open position. In one embodiment, the reset cam 1130 rotates more than 60 degrees away from the retaining cam 1132 to the open position.

[0191] 14C.1 , the collet and rotary drive system 1024 is pinched onto the EMD 1002, the reset cam 1130 is in the open position, and the cross slider 1108 is in a proximal position relative to the reset mechanism frame 1098. As a result of this step, the EMD 1002 is gripped by the collet and rotary drive system 1024.

[0192] 14C.2, the collet and rotary drive system 1024 pinches the EMD 1002, the reset cam 1130 is in an open position, and the cross slider 1108 has moved distally from a proximal position relative to the reset mechanism frame 1098. In one embodiment, the cross slider 1108 has moved distally due to clockwise rotation of the reset mechanism crank 1100 by the reset mechanism motor 1094. As a result of this step, the collet and rotary drive system 1024 advances distally, which means the EMD 1002 advances distally.

[0193] 14C.3, the collet and rotary drive system 1024 has unpinched the EMD 1002, the reset cam 1130 is in the closed position, and the cross slider 1108 is in its distal-most position relative to the reset mechanism frame 1098. As a result of this step, the EMD 1002 is no longer gripped by the collet and rotary drive system 1024.

[0194] Referring to FIG. 14C.4, the collet and rotary drive system 1024 has unpinched the EMD 1002, the reset cam 1130 is in a closed position, and the cross slider 1108 has moved proximally relative to the reset mechanism frame 1098. In one embodiment, the cross slider 1108 is translated proximally by counterclockwise rotation of the reset mechanism crank 1100 by the reset mechanism motor 1094. This step results in the collet and rotary drive system 1024 advancing proximally and the system is reset, after which it can be restarted (returning to FIG. 14C.1).

[0195] 17A , a single plunger-collet system 1280 releasably engageable with an EMD includes a spring 1282 and a plunger 1284 movably disposed along a plunger axis 1286 within a receiving cavity 1288 of a housing 1290. In the embodiment of FIG. 17A , the housing 1290 has a rectangular prism shape with a first side surface 1292, a second side surface 1294, and a convex top surface 1296. The first side surface 1292 is parallel to a plane defined by the plunger axis 1286 and the EMD axis 1298. The second side surface 1294 is parallel to a plane defined by the plunger axis 1286 and a vertical axis 1302, which is perpendicular to the plunger axis 1286 and the EMD axis 1298. In one embodiment, the housing 1290 has a rectangular prism shape, with the top surface 1296 and the opposing bottom surface being rectangular flats. In one embodiment, for example, in the embodiment of FIG. 18A , the housing 1290 is a cylindrical disk shape with the plunger axis 1286 aligned with the diameter axis of the disk, and the embodiment of FIG. 17A is a section removed from such a cylindrical disk. With reference to FIGS. 18B and 18D , an outer housing 1291 is positioned around the periphery of the housing 1290. The outer housing 1291 includes a plurality of cam surfaces on its inner wall that operably engage with the respective plungers 1284 as the outer housing 1291 rotates about its longitudinal axis relative to the housing 1290. In one embodiment, the longitudinal axis of the housing 1290 is collinear with the longitudinal axis of the outer housing 1291. In one embodiment, at least a portion of the outer housing 1291 and / or a portion of the housing 1290 is arcuate and / or circular.

[0196] The first side surface 1292 of the housing 1290 has a slit 1300 oriented to extend from the surface 1292 and terminate at the EMD axis 1298 in a plane defined by the EMD axis 1298 and a vertical axis 1302, where the EMD axis 1298 passes through the housing 1290 from the second side surface 1294 to the opposite side surface. In one embodiment, the walls of the slit 1300 are non-parallel, such as V-shaped walls with an apex pointing toward the EMD axis 1298. In one embodiment, the slit 1300 has a lead-in chamfer on the first side surface 1292. In one embodiment, the slit 1300 does not have a lead-in chamfer on the first side surface 1292.

[0197] A second side 1294 of the housing 1290 includes a plunger pin bore 1304 for a plunger pin 1306 (not shown in FIG. 17A ) and a guide bore 1308 for an alignment pin (not shown). The plunger pin bore 1304 is aligned with a plunger pin axis 1307 that is parallel to the EMD axis 1298 in a plane defined by the plunger axis 1286 and the EMD axis 1298, which extends from the second side surface 1294 through the housing 1290 and terminates at the opposite outer surface. The guide hole 1308 is aligned with an axis parallel to the EMD axis 1298 on the plane defined by the plunger axis 1286 and the EMD axis 1298, which extends from the second lateral surface 1294 through the wall of the housing and terminates on the inner surface of the wall opposite the cavity 1288 in the housing 1290. In one embodiment, the guide hole 1308 is a well or cap hole in the second lateral surface 1294 and does not terminate on the inner surface of the wall opposite the cavity 1288 in the housing 1290. In the embodiment of the single-plunger collet system 1280 of FIG. 17A , the guide hole 1308 is not required. The guide hole 1308 is used to align the multiple-plunger assembly.

[0198] 17B, ​​the plunger-collet system 1280 is shown in a pinch-release configuration, in which the EMD 1314 is not operably secured relative to the collet 1280. An applied force 1310 acts on the top surface 1312 of the plunger 1284, depressing the plunger 1284 within the cavity 1288 of the housing 1290 and compressing the spring 1282 located below the plunger 1284 with its major axis oriented along the plunger axis 1286. In one embodiment, when the plunger 1284 is fully depressed within the cavity 1288, the bottom outer surface 1326 of the plunger 1284 abuts a lip 1328 within the cavity 1288 of the housing 1290, thereby restricting further movement of the plunger 1284. Contact between surface 1326 and lip 1328 causes plunger 1284 to reach its most depressed configuration, with spring 1282 at maximum compression. In this state, plunger notch 1316 in plunger 1284 is furthest from housing notch 1318 in housing 1290, and EMD 1314 can be moved into open slit 1300 in the direction of plunger axis 1286. In one embodiment, plunger notch 1316 is a V-shaped channel or groove with its apex facing downward. In one embodiment, plunger notch 1316 is a well with its recess facing downward. In one embodiment, plunger notch 1316 is a generally downward-facing depression and can have any geometric shape. In one embodiment, housing notch 1318 is a V-shaped channel or groove with its apex facing upward. In one embodiment, housing notch 1318 is a well with its recess facing upward. In one embodiment, the housing notch 1318 is generally an upward depression and can have any geometric shape.

[0199] Once the EMD 1314 is fully inserted into the well of the slit 1300 at the plunger stem 1286, the applied force 1310 is removed. Referring to FIG. 17C , the plunger-collet system 1280 is shown in a pinched configuration, where the EMD 1314 is trapped between the plunger notch 1316 and the housing notch 1318 at the plunger stem 1286 in the well of the slit 1300 such that it cannot move freely relative to the collet due to the restoring force 1320 of the spring 1282 pushing up on the plunger 1284. In the pinched configuration, a gap exists between the bottom outer surface 1326 of the plunger 1284 and a lip 1328 within the cavity 1288 of the housing 1290. Furthermore, in the pinched configuration, a portion 1322 of the plunger 1284 is exposed and protrudes outside the top surface 1296 of the housing 1290.

[0200] 17B and 17C, the plunger-collet system 1280 is in a normally closed collet configuration, meaning that no force 1310 is applied and the collet is in a pinched configuration.

[0201] The bottom of the compression spring 1282 contacts the bottom inner surface 1330 of the cavity 1288 of the housing 1290. The top of the compression spring 1282 contacts the bottom inner surface 1332 of the plunger 1284. In one embodiment, the bottom inner surface 1332 of the plunger 1284 has a pocket or cup that receives the top of the spring 1282 and is restrained by a lip 1328. The outer diameter of the spring 1282 is smaller than the inner diameter of the bottom cavity 1288 of the housing 1290, thereby allowing free compression. In one embodiment, the outer diameter of the spring 1282 is smaller than the inner diameter of the bottom cavity 1288 of the housing 1290 and larger than the diameter that would cause the spring to buckle or bend, preventing the spring from buckling or bending. In one embodiment, a compression spring 1282 is utilized. In one embodiment, multiple springs can be utilized, such as two nested springs.

[0202] The plunger 1284 includes a plunger slot 1324 oriented along a plunger axis 1286, allowing the plunger 1284 to move along the plunger axis 1286 relative to the housing 1290 and is constrained by the walls of a cavity 1288 in the housing 1290 and the plunger pin 1306. To unpinch the collet 1280, a force 1310 is applied to the plunger's top surface 1312, causing the plunger 1284 to be pushed downward. In operation, the plunger 1284 is a cam follower, and its top surface 1312 is a driven surface that contacts a cam (not shown), which presses down on the cam follower with the applied force 1310. An outer member (not shown) having an internal cam contacts the top surface 1312 of the plunger 1284. Rotation of the outer member relative to the housing 1290 causes the inner cam of the outer member to press down on the upper surface 1312 , thereby depressing the plunger 1284 and unpinching the EMD 1314 within the collet 1280 .

[0203] 18A, the single plunger collet system 1280 operates on the same principle as a housing 1290, which is a circular disk with a central hole 1334 for an EMD 1314 (not shown). The embodiment of FIG. 18A includes six guide holes 1308, which are the same radial distance away from the EMD axis 1298 and are symmetrically positioned about the EMD axis 1298.

[0204] 18B, the multiple plunger collet system 1336 is shown assembled with six single plunger assemblies 1280, each of which, in the embodiment of FIG. 18A, are serially cascaded to rotate incrementally relative to each other about the EMD axis 1298. In one embodiment, each of the six serially connected single plunger assemblies 1280 are serially rotated incrementally (i.e., rotated sequentially in the same direction) by 60 degrees relative to each other so that the guide holes 1308 are aligned. In this embodiment, each serially connected single plunger assembly is rotated 60 degrees from the assembly prior to serialization. That is, if the first assembly is considered the reference at 0 degrees, then the second assembly is rotated 60 degrees clockwise relative to the first assembly, the third assembly is rotated 120 degrees clockwise relative to the first assembly, the fourth assembly is rotated 180 degrees clockwise relative to the first assembly, the fifth assembly is rotated 240 degrees clockwise relative to the first assembly, and the sixth assembly is rotated 300 degrees clockwise relative to the first assembly. Thus, the plungers of the first and fourth assemblies are oppositely oriented (180 degrees apart), the plungers of the second and fifth assemblies are oppositely oriented (180 degrees apart), and the plungers of the third and sixth assemblies are oppositely oriented (180 degrees apart).

[0205] Referring to Figure 18C, a multiple plunger collet system 1336 is shown in the assembled configuration shown in Figure 8B, with the first single plunger assembly 1280 separated. Similarly, the system 1336 includes six single plunger assemblies (1280), each of the embodiment shown in Figure 18A, cascaded in series, each incrementally rotated 60 degrees about the EMD axis 1298 relative to the assembly before it.

[0206] Referring to FIG. 18D , an end view of the assembled multiple plunger system 1336 shown in FIG. 18B is shown, with the first single plunger assembly 1280 shown in solid lines and the second through sixth single plunger assemblies 1280 shown in dashed (phantom) lines, with each single plunger assembly rotated incrementally by 60 degrees about the EMD axis 1298 prior to assembly so that the guide holes 1308 are aligned. Three visible single plunger assemblies correspond to the first and fourth assemblies, the second and fifth assemblies, and the third and sixth assemblies, with each pair positioned in opposite directions (180 degrees apart). The central holes 1334 of these six single plunger assemblies 1280 are aligned for axial loading of the EMDs 1314. In one embodiment, six single plunger assemblies 1280 are used, each rotated incrementally by 60 degrees about the EMD axis 1298 relative to the assembly before. In one embodiment, four single plunger assemblies 1280 may be used, each rotated incrementally by 90 degrees about the EMD axis 1298 relative to the assembly before. In one embodiment, three single plunger assemblies 1280 may be used, each rotated incrementally by 120 degrees about the EMD axis 1298 relative to the assembly before. In one embodiment, two single plunger assemblies 1280 may be used, with the second assembly rotated 180 degrees about the EMD axis 1298 relative to the first assembly. In one embodiment, two single plunger assemblies 1280 are used together, with the second assembly rotated less than 180 degrees about the EMD axis 1298 relative to the first assembly. In one embodiment, two single plunger assemblies 1280 are used together, with the second assembly rotated 180 degrees or more about the EMD axis 1298 relative to the first assembly. In one embodiment, more than two single plunger assemblies 1280 are used, each incrementally rotated any number of degrees about the EMD axis 1298 relative to the assembly before use.In this example embodiment, if the first assembly is at 0 degrees, and four single plunger assemblies 1280 are used, the second assembly is rotated 45 degrees clockwise relative to the first assembly, the third assembly is rotated 135 degrees clockwise relative to the first assembly, and the fourth assembly is rotated 180 degrees clockwise relative to the first assembly. This embodiment allows for radial loading of the EMD within the collet. In one embodiment, the single plunger assemblies 1280 of a multiple plunger collet system are identical. In one embodiment, the single plunger assemblies 1280 of a multiple plunger collet system do not have to be identical.

[0207] 18E, the pinch-release configuration of the multiple plunger collet system 1336 is shown, where six single plunger assemblies 1280 require the application of an external force 1310, which is exerted from an outer member cam (not shown) on each plunger 1284. In the pinch-release configuration, there is no EMD 1314 contact between the plunger and the housing for any single plunger assembly 1280 in the multiple plunger system 1336.

[0208] Referring to FIG. 18F , a pinch configuration of a multiple plunger collet system 1336 having six single plunger assemblies 1280 is illustrated. In this pinch configuration, there is abutment of the EMD 1314 between the plunger and the housing in each single plunger assembly 1280 in the multiple plunger system 1336 due to the reaction force 1320 from each compression spring 1282. As each single plunger assembly 1280 is rotated incrementally relative to the assembly before it, contact occurs on different surfaces on the EMD 1314, providing more torque capacity to the collet system 1336. In the embodiment of FIG. 18F , contact occurs on a portion of the bottom surface 1338 of the EMD 1314 in the first single plunger assembly 1280 (shown on the left) and on a portion of the top surface 1340 of the EMD 1314 in the fourth single plunger assembly 1280 (from the left). Contact at different surface portions of the EMD 1314 with each single plunger assembly 1280 means that contact occurs at different portions longitudinally along the EMD.

[0209] With reference to FIGS. 18G, 18H, and 18I, a multiple plunger collet system 1336 is illustrated in a pinched configuration, with six single plunger assemblies 1280 shown in side and front views along with an EMD 1314. With reference to FIG. 18G, the multiple plunger collet system 1336 is shown with all six single plunger assemblies 1280 oriented in the same direction. The side view of the EMD 1314 is shown as a straight line, and the front view of the EMD 1314 is shown as a dot. With reference to FIG. 18H, the multiple plunger collet system 1336 has six single plunger assemblies 1280, each oriented 180 degrees away from the assembly in front of it. The side view of the EMD 1314 is shown as a roughly sinusoidal line in a plane, and the front view of the EMD 1314 is shown as a single dot moving up and down along a vertical line. 18I, the multiple plunger collet system 1336 has six single plunger assemblies 1280, each shown oriented 60 degrees away from the assembly in front of it. Each is shown gradually turning 60 degrees away from the assembly in front of it. The side of the EMD 1314 is shown as a roughly sinusoidal line in a plane, and the front of the EMD 1314 is shown as a single dot moving around the circumference of a circle.

[0210] Compared to the torque (transmission) capacity of the multiple plunger collet system 1336 illustrated in FIG. 18G in the pinched configuration, the torque (transmission) capacity of the multiple plunger collet system 1336 illustrated in FIG. 18H is increased. The 180-degree offset of the single plunger assemblies 1280 in the multiple plunger collet system illustrated in FIG. 18H causes the EMD 1314 to bend in a bent configuration, traveling up and down in the side view and with the most torque resistance above and below the vertical line in the front view (the neutral device axis is at the center of the line). Compared to the torque (transmission) capacity of the multiple plunger collet system 1336 illustrated in FIG. 18H in the pinched configuration, the torque (transmission) capacity of the multiple plunger collet system 1336 illustrated in FIG. 18I when pinched is further improved. The 60 degree offset of the multiple single plunger assemblies 1280 in the multiple plunger collet system illustrated in FIG. 18H forces the EMD 1314 into a spiral path configuration, i.e., a helix, where the EMD is always away from the central axis 1298 of the EMD, providing the most resistant torque.

[0211] In the pinch configuration of the multiple plunger collet system 1336, the deformation of the EMD 1314 is a function of the diameter of the through hole in the center of the plunger housing, the clearance between the plunger and the plunger housing, and the force applied by the spring mechanism.

[0212] In one embodiment, a series of pinching elements are present in a robot-driven collet where the pinching elements are independently actuated. Instead of all of the elements acting together, the actuation mechanism, such as a cam, allows the elements to actuate sequentially, for example. This feature acts to reduce actuation forces.

[0213] In one embodiment, the multiple plunger collet system 1336 is comprised of multiple pinch pieces that are rotationally clocked relative to one another to increase the overall torque capacity of the collet, where rotationally clocked (clockwise) refers to positioning the pinch pieces at various angles in a plane perpendicular to the longitudinal axis of the collet 1336.

[0214] 18B , the collet 1336 has an inner member defining a passageway for receiving the EMD 1314 and an outer member, with a plurality of engaging members 1284 releasably engaging the EMD 1314 when the inner member is moved relative to the outer member. In one embodiment, a spring 1282 biases the engaging members 1284. In one embodiment, the spring 1282 biases the engaging members 1284 away from the passageway, and in one embodiment, the spring 1282 biases the engaging members 1284 toward the passageway. In one embodiment, the engaging members 1284 are normally closed or located inside the passageway and must be moved to an open position to insert the EMD. In one embodiment, the engaging members 1284 are normally open or located outside the passageway and must be moved to a closed position to engage the EMD. In one embodiment, the engaging members 1284 sequentially engage the EMD. In one embodiment, referring to FIG. 181, the engagement members 1284 are circumferentially offset around the EMD. In one embodiment, referring to FIG. 18G, the engagement members 1284 are axially offset. In one embodiment, referring to FIG. 18H, a first engagement member is positioned 180 degrees from a second engagement member. In one embodiment, the engagement members 1284 are independent and not directly connected to one another. In one embodiment, movement of the inner member relative to the outer member is by rotation. In one embodiment, movement of the inner member relative to the outer member is by translation. In one embodiment, movement of the inner and outer members relative to one another is robotically driven. In one embodiment, movement of the inner and outer members relative to one another is manually driven. In one embodiment, referring to FIGS. 18H and 181, the engagement members 1284 are radially offset around the EMD forming a curved path. In one embodiment, referring to FIG. 18H, the curved path lies in a single plane. In one embodiment, referring to FIG. 18I, the curved path does not lie on a single plane.

[0215] 19A, 19B, 19C, and 19E, an opposing pad collet system 1360 is illustrated that releasably engages an EMD 1388 and includes an inner housing 1362, an outer housing 1363, a plurality of springs 1364a, b, c, ..., a plurality of levers 1366a, b, c, ..., and a pivot pin 1368. In one embodiment, the inner housing 1362 of the collet system 1360 has a right cylindrical shape with its longitudinal axis oriented along the EMD axis 1370. The inner housing 1362 includes an internal cavity 1372, radial and longitudinal slits 1374, and a plurality of circumferential slits 1376a, b, c, .... In one embodiment, the outer housing 1363 has a right cylindrical shape with its longitudinal axis oriented along the EMD axis 1370. The outer housing 1363 includes radial and longitudinal slits 1367, an internal cavity 1369, and a plurality of cam surfaces 1365a, b, c, ... on the inner surface (wall) of the outer housing 1363. In one embodiment, the outer housing 1363 is a cylindrical tube having a wall thickness that is more than 10 percent greater than the inner diameter and having a plurality of cam surfaces 1365a, b, c, ... on the inner surface. In one embodiment, the outer housing 1363 is a cylindrical tube having a wall thickness that is less than 10 percent greater than the inner diameter and having a plurality of cam surfaces 1365a, b, c, ... on the inner surface. (With reference to Figures 19A-19G, it should be noted that the wall thickness of the outer housing 1363 in Figure 19A is shown as a representative example, and the geometric shape of the outer housing 1363 differs from the representative cross-sections illustrated in Figures 19B-19G.) The outer diameter of the inner housing 1362 is smaller than the diameter of the internal cavity 1369 of the outer housing 1363, so that in the assembled configuration, the inner housing 1362 is disposed inside the outer housing 1363.

[0216] In one embodiment, the longitudinal axis of the inner housing 1362 is collinear with the longitudinal axis of the outer housing 1363. In one embodiment, at least a portion of the outer housing 1363 and / or a portion of the inner housing 1362 are arcuate and / or circular. In one embodiment, all of the levers 1366a,b,c... rotate about a single pivot pin 1368. In one embodiment, multiple pivot pins 1368a,b,c... are used, where lever 1366a rotates about pin 1368a, lever 1366b rotates about pin 1368b, etc. In one embodiment, multiple cam surfaces 1365a,b,c... are spaced apart incrementally along the longitudinal axis around the inner circumference of the outer housing 1363. In one embodiment, the plurality of cam surfaces 1365a, b, c, . . . are grooves or recesses spaced apart along the longitudinal axis around the inner periphery of the outer housing 1363.

[0217] The circumferential slits 1376 a, b, c, ... of the inner housing 1362 are oriented parallel to a plane perpendicular to the EMD axis 1370. In the embodiment of FIG. 19A , nine circumferential slits 1376 a, b, c, ..., i are shown, correspondingly exposing nine arms 1384 a, b, c, ..., i of the levers 1366 a, b, c, ..., i. In other implementations, a different number of circumferential slits and a corresponding number of exposed arms are used. For example, in one embodiment, one circumferential slit 1376 a is used to expose arm 1384 a of lever 1366 a. In one embodiment, two circumferential slits 1376 a, b are used to correspondingly expose arms 1384 a, b of levers 1366 a, b. In one embodiment, more than one circumferential slit 1376 is used. In one embodiment, the circumferential slits 1376a,b,c... extend radially inward from the outer surface of the inner housing 1362 to the internal cavity 1372 of the inner housing 1362. In one embodiment, the circumferential slits 1376a,b,c... extend radially inward from the outer surface of the inner housing 1362 to an interior portion of the inner housing 1362 that is not part of the cavity 1372. In one embodiment, the circumferential slits 1376a,b,c... extend radially inward from the outer surface of the inner housing 1362 to the internal cavity 1372 of the inner housing 1362 and to an interior portion of the inner housing 1362 that is not part of the cavity 1372. In one embodiment, the walls of the slits 1376a,b,c... are parallel. In one implementation, the walls of the circumferential slits 1376a,b,c... are non-parallel. In one embodiment, the circumferential slits 1376 a, b, c, ... have a lead-in chamfer on the outer surface of the inner housing 1362. In one implementation, the circumferential slits 1376 a, b, c, ... do not have a lead-in chamfer on the outer surface of the inner housing 1362.

[0218] Radial and longitudinal slits 1367 of the outer housing 1363 extend from the outer surface of the outer housing 1363 and terminate on the inner surface of the internal cavity 1369 of the outer housing 1363. The gap between the two walls of the radial and longitudinal slits 1367 is larger than the diameter of the EMD 1388, thereby allowing the EMD 1388 to enter therein. In one embodiment, the walls of the radial and longitudinal slits 1367 are parallel. In one embodiment, the walls of the radial and longitudinal slits 1367 are non-parallel, e.g., V-shaped walls, with an apex toward the EMD axis 1370. In one embodiment, the radial and longitudinal slits 1367 have a lead-in chamfer on the outer surface of the outer housing 1363. In one embodiment, the radial and longitudinal slits 1367 do not have a lead-in chamfer on the outer surface of the outer housing 1363.

[0219] The radial and longitudinal slits 1374 of the inner housing 1362 extend from the outer surface of the inner housing 1362, terminate at its radial center (corresponding to the EMD axis 1370), and extend longitudinally through the inner housing 1362. The gap distance between the two walls of the radial and longitudinal slits 1374 is greater than the diameter of the EMD 1388, allowing the EMD 1388 to enter therethrough. In one embodiment, the walls of the radial and longitudinal slits 1374 are parallel. In one embodiment, the walls of the radial and longitudinal slits 1374 are non-parallel, e.g., V-shaped walls, with an apex toward the EMD axis 1370. In one embodiment, the radial and longitudinal slits 1374 have a lead-in chamfer on the outer surface of the inner housing 1362. In one embodiment, the radial and longitudinal slits 1374 do not have a lead-in chamfer on the outer surface of the inner housing 1362.

[0220] The springs 1364a,b,c... are compression springs, such as coil springs, disposed within an internal cavity 1372 of the inner housing 1362. One end of the springs 1364a,b,c... is restrained by an internal wall 1378 of the cavity 1372 of the inner housing 1362. The other end of the springs 1364a,b,c... is seated above and extends to the protrusions 1380a,b,c... of the levers 1366a,b,c.... In one embodiment, the protrusions 1380a,b,c... of the levers 1366a,b,c... extend within one end of the coil of the springs 1364a,b,c... In one embodiment, the protrusions 1380a,b,c,... of the levers 1366a,b,c,... extend into the ends of more than one coil of the springs 1364a,b,c,... In one embodiment, the protrusions 1380a,b,c,... of the levers 1366a,b,c,... are operably connected to one end of a coil of the springs 1364a,b,c,... In one embodiment, the protrusions 1380a,b,c,... of the levers 1366a,b,c,... are operably connected to the ends of more than one coil of the springs 1364a,b,c,... In one embodiment, one compression spring 1364 is used. In one embodiment, multiple compression springs are used. In one embodiment, the number of springs equals the number of levers. In one embodiment, a collar or sleeve is used to surround each spring 1364a,b,c,... to prevent the springs from buckling or bending.

[0221] In the assembled configuration, the springs 1364a, b, c... are in a compressed state. In operation, when the outer housing 1363 is rotated about its longitudinal axis relative to the inner housing 1362, the cam surfaces 1365a, b, c... on the inner surface (wall) of the outer housing 1363 operably engage with the respective arms 1384a, b, c... of the levers 1366a, b, c... exposed in the slits 1376a, b, c.... Referring to FIG. 19B , the opposing pad collet system 1360 is shown in an unpinched (uncinched) configuration, in which the EMD 1388 is not operably secured relative to the collet 1360. In this configuration, the radial and longitudinal slits 1367 of the outer housing 1363 are aligned with the radial and longitudinal slits 1374 of the inner housing. Force 1382a is applied to act on arm 1384a of lever 1366a, causing lever 1366a to rotate counterclockwise about pivot pin 1368 and placing spring 1364a under compression within cavity 1372 of inner housing 1362. Due to the position of lever 1366a, pad 1386a of lever 1366a is directed away from EMD axis 1370 and away from radial and longitudinal slits 1374 near EMD axis 1370. In this pinch-release configuration, EMD 1388 can move in the direction of EMD axis 1370, within radial longitudinal slit 1374, and within radial longitudinal slit 1367. In one embodiment, outer housing 1363 is rotated relative to inner housing 1362 by an actuator (not shown). The actuator that rotates the outer housing 1363 relative to the inner housing 1362 is in one embodiment in the drive module, and in one embodiment it is in the cassette.

[0222] To pinch and unpin the opposing pad collet system 1360, the lever 1366a pivots about a pivot pin 1368 within a limited range of motion. In one embodiment, the angular range of motion of the lever 1366a is less than 10 degrees. In one embodiment, the angular range of motion is greater than 10 degrees. The lever 1366a acts as a primary lever and pivots between a force and a load. A force or input 1382a is applied to an arm 1384a of the lever 1366a. A load or output acts on the pad 1386a of the lever 1366a.

[0223] Upon full insertion of the EMD 1388 into the radial and longitudinal slits 1374, the applied force 1382a is released. Referring to FIG. 19C , the opposing pad collet system 1360 is shown in a pinched configuration, where the EMD 1388 is trapped between the pad 1386a and the walls of the radial and longitudinal slits 1374 by the restoring force 1390a of the spring 1364a pushing up on the arm 1384a of the lever 1366a, preventing the EMD 1388 from moving freely relative to the collet. In one embodiment in the pinched configuration, the outer end of the arm 1384a protrudes and is exposed within the circumferential slit 1376a of the inner housing 1362.

[0224] 19B and 19C, the opposing pad collet system 1360 is a normally closed collet, meaning that without the application of force 1382a, the collet is in a pinched (gripped) configuration.

[0225] The operating arm 1384a of the lever 1366a is a cam follower, with the outer surface of the arm 1384a being the follower surface that abuts the cam (the inner surface of the outer housing 1363), which pushes against the cam follower with an applied force 1382a. The outer member 1363 with its internal cam abuts the outer surface of the arm 1384a. Rotation of the outer housing 1363 relative to the inner housing 1362 causes the inner cam of the outer member to push against the outer surface of the arm 1384a, which is exposed at the circumferential slit 1376a, thereby rotating the lever 1366a and moving the pad 1386a of the lever 1366a away from the EMD shaft 1370 to unpinch the EMD 1388 in the collet 1360. In one embodiment with a single circumferential slit 1376a, the cam includes a finger or tab that presses against the outer surface of the arm 1384a. In one embodiment with multiple circumferential slits 1376a,b,c,..., the cam includes multiple fingers or tabs that press against the outer surfaces of the multiple arms 1384a,b,c,.... In one embodiment, multiple levers 1366a,b,c,... are used with their pads 1386a,b,c,... to pinch the EMD 1388 at multiple locations along its length. In one embodiment, contact of the EMD 1388 occurs between the pads 1386a of a single lever 1366a along the length of the collet system.

[0226] 19D-19G, an increasing pinch sequence is illustrated by the opposing pad collet system 1360. (Right-side springs 1364a,b,c are present but not shown in the figures. Also, left-side springs 1364a,b,c,... are not numbered but are indicated by lightly dashed circles in the figures.) Referring to FIG. 19D, the opposing pad collet system 1360 is shown in a pinch-release configuration for radial loading of the EMD 1388. In the fully compressed configuration of the compression springs 1364a,b,c,... during actuation, the inner wall of the outer housing 1363 maintains the arms 1384a,b,c,... of the levers 1366a,b,c,... such that there is no contact between the pads 1386a,b,c,... and the EMD 1388. Referring to FIG. 19E , a first rotational increment (corresponding to one clockwise arrow) of outer housing 1363 relative to inner housing 1362 corresponds to engagement of pad 1386a of lever 1366a with EMD 1388, which is a result of rotation of lever 1366a due to the recess of cam 1365a on the inner surface of outer housing 1363. Spring 1364a is slightly relaxed from its maximum compression state and is the source of force between pad 1386a and EMD 1388. At this first rotational increment, all other pads 1386b, c, … of levers 1366b, c, … remain in the unpinched configuration. This first rotational increment does not allow removal of EMD 1388 from opposing pad collet system 1360. 19F , the second increment of rotation of outer housing 1363 relative to inner housing 1362 (corresponding to the two clockwise arrows) corresponds to engagement of pads 1386a and 1386b with EMD 1388, which is the result of rotation of levers 1366a and 1366b by recesses in cams 1365a and 1365b on the inner surface of outer housing 1363. Springs 1364a and 1364b, slightly relaxed from their maximum compression state, are the source of force between pads 1386a and 1386b and EMD 1388.In this second increment of rotation, all other pads 1386c, d, ... on levers 1366c, d, ... remain in the pinch-release configuration. Referring to FIG. 19G , a third rotational increment of outer housing 1363 relative to inner housing 1362 (corresponding to the three clockwise arrows) corresponds to engagement of pads 1386a, b, c with EMD 1388, which is the result of rotation of levers 1366a, b, c by recesses in cams 1365a, b, c on the inner surface of outer housing 1363. Springs 1364a, b, c have been slightly relaxed from their maximum compression state and are the source of force between pads 1386a, b, c and EMD 1388. In this third increment of rotation, all other pads 1386d, e, ... on levers 1366d, e, ... remain in the pinch-release configuration. (Note that in Figures 19E-19G, EMD 1388 shows an exaggerated deflection at the engagement location.)

[0227] In one embodiment, a 20 degree rotation of the outer housing 1363 relative to the inner housing 1362 corresponds to an increment of rotation for engagement of the pads 1386a,b,c,... of the corresponding levers 1366a,b,c,... with the EMD 1388. In one embodiment, a rotation of the outer housing 1363 less than 20 degrees relative to the inner housing 1362 corresponds to an increment of rotation for engagement of the pads 1386a,b,c,... of the corresponding levers 1366a,b,c,... with the EMD 1388. In one embodiment, a rotation of the outer housing 1363 more than 20 degrees relative to the inner housing 1362 corresponds to an increment of rotation for engagement of the pads 1386a,b,c,... of the corresponding levers 1366a,b,c,... with the EMD 1388.

[0228] 20A, a collet drive system 1500 capable of rotating, moving, and pinching an EMD 1502 includes a collet 1504, a collet engagement member 1506, a first drive module 1508, and a second drive module 1510. Collet drive system 1500 may also be referred to as a quick-release collet with two linear drives and axial spline engagement.

[0229] The collet 1504 has a collet first member 1512 having a first engagement portion 1514. The collet 1504 has a collet second member 1516 that is driven.

[0230] The collet engagement member 1506 has a second engagement portion 1518 .

[0231] Collet first member 1512 and collet engagement member 1506 move between an engaged position and a disengaged position. Referring to Figure 20C, collet first member 1512 and collet engagement member 1506 are shown in the disengaged position.

[0232] First engagement portion 1514 engages second engagement portion 1518 when collet first member 1512 and collet engagement member 1506 are moved to the engaged position. Referring to Figures 20C-20G, collet first member 1512 and collet engagement member 1506 are shown in the engaged position.

[0233] Rotation of the collet first member 1512 relative to the collet second member 1516 in a first direction 1520 in the engaged position pinches the EMD 1502 within the collet 1504, and rotation of the collet first member 1512 relative to the collet second member 1516 in a second direction 1522 opposite the first direction 1520 does not pinch the EMD 1502 within the collet 1504.

[0234] In collet drive system 1500, first engagement portion 1514 includes a plurality of splines that extend circumferentially around at least a portion of collet first member 1512. Second engagement portion 1518 includes a plurality of members that operably engage with the plurality of splines of first engagement portion 1514.

[0235] In one embodiment, collet second member 1516 is connected to a bevel gear 1524 that meshes with and is driven by a capstan bevel gear 1526. In one embodiment, collet second member 1516 is driven by a coupler.

[0236] In one embodiment, the plurality of splines of the first engagement portion 1514 includes longitudinally extending external spline teeth. In one embodiment, the plurality of members of the second engagement portion 1518 includes internal spline teeth that extend longitudinally to mate with the longitudinally extending external spline teeth of the plurality of splines of the first engagement portion 1514.

[0237] The collet engagement member 1506 is integrally connected to the first drive module 1508 and is oriented so that its centerline is longitudinally aligned with the axis of the EMD 1502 .

[0238] The first drive module 1508 and the second drive module 1510 move longitudinally relative to a fixed lead screw 1528 (illustrated in FIG. 3 by reference numeral 76) and are independently driven by first actuator 1530 and second actuator 1532 (illustrated in FIG. 3 as translation motor 64), respectively. In one embodiment, the lead screw 1528 is a ball screw. In one embodiment, the first drive module 1508 and the second drive module 1510 are independently driven by belt drives. In one embodiment, the first actuator 1530 is a motor powered by electricity, pneumatics, hydraulics, or other means. In one embodiment, the second actuator 1532 is a motor powered by electricity, pneumatics, hydraulics, or other means.

[0239] 20A, collet drive system 1500 is connected to the overall robotic system 24. In particular, the connections of lead screw 1528, first actuator 1530, second actuator 1532, first drive module 1508, and second drive module 1510 to the overall robotic system are illustrated.

[0240] In one embodiment, movement of the first drive module 1508 is achieved as follows: the drive shaft of the first actuator 1530 is integrally connected to a first actuation pulley 1534 that drives a first belt 1536, which drives a first nut pulley 1538, which is integrally connected to a first nut and bearing assembly 1540, which meshes with the lead screw 1528 and is integrally connected to the first drive module 1508. Similarly, in one embodiment, movement of the second drive module 1510 is achieved as follows. The drive shaft of the second actuator 1532 is integrally connected to a second actuation pulley 1544 that drives a second belt 1546, which in turn drives a second nut pulley 1548, which is integrally connected to a second nut and bearing assembly 1550, which meshes with the lead screw 1528 and is integrally connected to the second drive module 1510.

[0241] The first drive module 1508 includes a clamping and rotational drive mechanism that acts to clamp / unclamp and move the EMD along its longitudinal axis. In one embodiment, the clamping and rotational drive mechanism includes a drive tire 1558 and an idler tire 1568. In one embodiment, the drive tire 1558 is driven as follows: the drive tire 1552 meshes with a drive tire gear 1554, which is integrally connected to a drive tire capstan 1556 that is integrally connected to the drive tire 1558. It is contemplated that other clamping and movement devices known in the art may be used as well.

[0242] 20A and 20B, in one embodiment, the drive (driver) gear 1552 is driven by a third actuator 1560 that is integrated within the first drive module 1508. In one embodiment, the third actuator 1560 is a motor that is powered by electricity, pneumatics, hydraulics, or other means.

[0243] In one embodiment, rotation of the drive gear 1552 is achieved as follows: The drive shaft of the third actuator 1560 is integrally connected to a third actuation pulley 1562 (supported by a bearing), which drives a second belt 1564 that drives a drive gear pulley 1566 (supported by a bearing), which is integrally connected to the drive gear 1552.

[0244] The first drive module 1508 includes a straddle rocker 1570 and a spring 1572. The straddle rocker 1570 rotates about a pivot 1574 parallel to the axes of the drive tire 1558 and the idle tire 1568. The spring 1572 is a tension spring having one end connected to a rocker distal post 1575 integrally connected to the straddle rocker 1570 and one end connected to a driver gear extension post 1576 extending from the driver gear 1552. The straddle rocker 1570 is a spring-loaded bell crank, i.e., a spring-loaded lever having two arms and the pivot 1574. One arm of the straddle rocker 1570 is integrally connected at its free end to the rocker distal post 1575. One arm of the straddle rocker 1570 supports the idle tire 1568 at its free end.

[0245] The second drive module 1510 includes a driven capstan bevel gear 1526 and a capstan 1527. The capstan bevel gear 1526 is integrally connected to the capstan 1527, which is driven by an actuator (not shown). The second drive module 1510 is integrally connected to an extension link 1578, which extends from the distal end of the second drive module 1510 (i.e., the end furthest from the lead screw 1528) toward the first drive module 1508 and in a direction parallel to the lead screw 1528 and the EMD 1502. In one embodiment, the extension link 1578 is a rectangular bar, with its length greater than its width and its width greater than its height (thickness). The extension link 1578 includes a first lip 1580 and a second lip 1581. In one embodiment, the first lip 1580 and the second lip 1581 are rectangular bar protrusions, such as flanges, oriented upward and perpendicular to the extension link 1578. In one embodiment, the first lip 1580 is located at the proximal end of the extension link 1578 and the second lip 1581 is located near the proximal end of the extension link 1578 such that there is a gap between the inner surface of the first lip 1580 and the second lip 1581.

[0246] In one embodiment, the collet drive system 1500 includes a cassette (not shown) that includes a collet 1504 , a collet engagement member 1506 , a drive tire 1558 , and an idle tire 1568 .

[0247] The operation of the collet drive system 1500, as described herein, consists of multiple states (phases).

[0248] 20C , the collet drive system 1500 is illustrated in a driven state (first state). In the driven state, the collet 1504 pinches the EMD 1502, causing the collet 1504 to rotate the EMD 1502, the first drive module 1508 and the second drive module 1510 move together, maintaining the same separation distance, the spline teeth of the first engagement portion 1514 and the second engagement portion 1518 do not intermesh (i.e., engage), and the drive tire 1558 and the idle tire 1568 are separated and do not grip the EMD 1502. In the driven state, the rocker distal post 1575 contacts the inner surface of the first lip 1580, and the straddle rocker 1570 is positioned to keep the idle tire 1568 separated from the drive tire 1558.

[0249] 20D , the collet drive system 1500 is illustrated in a collet locked state (second state). In the collet locked state, the collet 1504 pinches the EMD 1502, the first drive module 1508 and the second drive module 1510 move toward each other while decreasing their separation distance (e.g., the second drive module 1510 moves toward the fixed first drive module 1508), the spline teeth of the first engagement portion 1514 mesh with the spline teeth of the second engagement portion 1518 (i.e., they are engaged but not fully engaged), and the drive tire 1558 and the idle tire 1568 are slightly spaced apart and do not grip the EMD 1502. In the collet locked state, the rocker distal post 1575 contacts the inner surface of the first lip 1580, and the straddle rocker 1570 rotates the idler tire 1568, which moves toward the drive tire 1558, but the tire does not grip the EMD 1502.

[0250] 20E, the collet drive system 1500 is illustrated in a device change state (second alternate state), in which the collet 1504 is not pinching the EMD 1502, the first drive module 1508 and the second drive module 1510 move toward each other while decreasing their separation distance (similar to the collet lock state), the splined teeth of the first engagement portion 1514 mesh with the splined teeth of the second engagement portion 1518 (i.e., they mesh but are not fully interlocked), and the drive tire 1558 and the idler tire 1568 are separated from each other and do not grip the EMD 1502. In the exchange state, similar to the collet lock state, the rocker distal post 1575 contacts the inner surface of the first lip 1580, and the straddle rocker 1570 rotates the moving idle tire 1568 toward the drive tire 1558, but the tire does not grip the EMD 1502.

[0251] In the replacement state, the rotation of the capstan bevel gear 1526 causes the collet 1504 to unpin the EMD 1502, and the capstan bevel gear 1526 meshes with and rotates the driven bevel gear 1524, which rotates the collet second member 1516 relative to the collet first member 1512. Note that the collet first member 1512 is locked (immovable) by the engagement between the spline teeth of the stationary second engagement portion 1518 and the spline teeth of the first engagement portion 1514. When the collet 1504 is released from the pinch, the EMD 1502 can be removed. In one embodiment, removal of EMD 1502 can be accomplished by lateral or radial unloading (unloading) by aligning collet slits 1582 in collet 1504 with collet engagement member slits 1584 in collet engagement member 1506. In one embodiment, EMD 1502 can be removed by axial unloading.

[0252] 20A , collet slits 1582 extend longitudinally from the outer periphery and radially through collet 1504 to its centerline, and collet engagement member slits 1584 extend longitudinally from the outer periphery and radially through collet engagement member 1506 to its centerline. In one embodiment, slits 1582 and 1584 have parallel walls. In one embodiment, slits 1582 and 1584 have non-parallel walls, such as V-shaped walls with an apex toward the radial center. In one embodiment, slits 1582 and 1584 have a lead-in chamfer on their outer surfaces. In one embodiment, slits 1582 and 1584 do not have a chamfer on their outer surfaces.

[0253] 20F, the collet drive system 1500 is illustrated in a collet pinched, tire-gripping state (third state). In the collet pinched, tire-gripping state, the collet 1504 pinches the EMD 1502, the first drive module 1508 and the second drive module 1510 move relative to each other to minimize their separation distance (e.g., move the second drive module 1510 toward the fixed first drive module 1508), the spline teeth of the first engagement portion 1514 fully mesh with (i.e., fully engage) the spline teeth of the second engagement portion 1518, and the drive tire 1558 and the idle tire 1568 do not separate and grip the EMD 1502. In the collet pinched, tire grip condition, the rocker distal post 1575 contacts the inner surface of the second lip 1581, and the straddle rocker 1570 rotates the moving idle tire 1568 into the drive tire 1558 so that the tire grips the EMD 1502.

[0254] 20G, the collet drive system 1500 is illustrated in a tire drive state (fourth state), in which the collet 1504 does not pinch (unpinch) the EMD 1502, the first drive module 1508 and the second drive module 1510 move relative to each other to minimize their separation distance (e.g., moving the second drive module 1510 toward the fixed first drive module 1508), the spline teeth of the first engagement portion 1514 fully mesh with (i.e., fully engage) the spline teeth of the second engagement portion 1518, and the drive tire 1558 and the idle tire 1568 do not separate and grip the EMD 1502. Similar to the tire grip condition with the collet pinched, in the tire drive condition, the rocker distal post 1575 contacts the inner surface of the second lip 1581, and the straddle rocker 1570 rotates the moving idle tire 1568 into the drive tire 1558 so that the tire grips the EMD 1502.

[0255] In the tire-driven state, the rotation of the capstan bevel gear 1526 causes the collet 1504 to unpinch the EMD 1502, and the bevel gear 1526 meshes with and rotates the driven bevel gear 1524, which rotates the collet second member 1516 relative to the collet first member 1512. Note that the collet first member 1512 is locked (does not move) due to the engagement between the spline teeth of the stationary second engagement portion 1518 and the spline teeth of the first engagement portion 1514. Because the collet 1504 is in the unpinched state, the EMD 1502 can be moved by the rotation of the drive tire 1558, which grips the EMD 1502 relative to the idle tire 1568.

[0256] Collet drive system 1500 operates in a reset mode or a replacement mode. In the reset mode, the sequence of operations includes a drive state (first state), a collet lock state (second state), a collet pinch, tire grip state (third state), a tire drive state (fourth state), a collet pinch, tire grip state (third state), a collet lock state (second state), and a return to the drive state (first state). In the replacement mode, the sequence of operations includes a drive state (first state), a collet lock state (second state), a device replacement state (second alternate state), a collet lock state (second state), and a return to the drive state (first state).

[0257] The collet drive system 1500 includes a collet 1504. To minimize the amount of actuation required, the collet drive system 1500 can be configured to lock one half of the collet 1504 to prevent rotational movement, while still allowing the other half a rotational degree of freedom to unpinch and pinch the EMD 1502. There are multiple ways to lock the halves of the collet 1504. Note that the term lock refers to keeping a part (component) stationary and fixed relative to the patient. For purposes herein, if a part is stationary relative to a patient bedrail, it is stationary and fixed relative to the patient. In one embodiment, an engagement spline is included. In one embodiment, a locking pin is inserted into a hole. In one embodiment, a key is inserted into a keyway. In one embodiment, a mechanical interference is included to prevent rotation.

[0258] In one embodiment, the EMD 1502 is unpinched (unpinched), and after the EMD is unpinched, various components are moved to a homing position to allow the EMD to be removed from the device through the aligned slots.

[0259] 21A, a "collet drive system" 1600 capable of rotating, moving, and pinching an EMD 1602 includes a device drive 1604, an EMD support 1606, and a y-connector assembly 1608. The device drive 1604 includes a cassette 1610 and a drive module 1612.

[0260] The drive module 1612 moves longitudinally relative to a fixed lead screw 1614 (shown in FIG. 3 as reference numeral 76) and is driven by an actuator 1616 (shown in FIG. 3 as translation motor 64). In one embodiment, the lead screw 1614 is a ball screw. In one embodiment, the actuator 1616 is a motor powered by electricity, pneumatics, hydraulics, or other means.

[0261] 21A, the collet drive system 1600 is connected to the overall robotic system 24. In particular, the connections of the lead screw 1614, actuator 1616, and drive module 1612 to the overall robotic system are illustrated.

[0262] In one embodiment, movement (translation) of the drive module 1612 is accomplished similarly to the drive module illustrated in Figure 20A. (Note that Figures 21A, 21B, 21C, and 21D do not show some components that connect the drive module 1612 to an actuation system for movement.)

[0263] 21A, 21B, 21C, and 21D, the collet drive system 1600 can pinch and unpinch the EMD 1602, rotate the EMD 1602 clockwise and counterclockwise, and advance and retract (i.e., move back and forth) the EMD 1602. In one embodiment, the cassette 1610 is the same as the cassette 922 illustrated in FIG. 12A and includes a double-bevel collet and rotary drive to enable pinching and unpinchment of the EMD 1602 and rotation of the EMD 1602 within the pinched collet. In other words, the collet drive system 1600 includes a collet, such as the collet 964 illustrated in FIG. 12D, to enable pinching and unpinchment of the EMD 1602.

[0264] The EMD support 1606 is a restriction that prevents the EMD 1602 from buckling (kinking) as the EMD 1602 is advanced distally. In one embodiment, the EMD support 1606 is a telescoping system with an inner diameter that is larger than the diameter of the EMD 1602. In one embodiment, the EMD support 1606 is a track that allows for radial loading of the device. In one embodiment, the EMD support 1606 is a tube. In one embodiment, the EMD support 1606 is any system that prevents the EMD 1602 from buckling or bending as it is advanced.

[0265] 21B, the collet drive system 1600 illustrated in FIG. 21A is illustrated with a retaining clamp 1618 as part of the y-connector assembly 1608. The EMD support 1606 is used between the y-connector assembly 1608 and the cassette 1610. The retaining clamp 1618 is a safety mechanism so that when reset, the EMD 1602 does not move. In one embodiment, the retaining clamp 1618 includes two opposing blocks that can be clamped, which constrains the position of the EMD 1602 relative to the y-connector assembly 1608, or unclamped, which does not constrain the position of the EMD 1602, meaning that the two opposing blocks can move freely. In one embodiment, the retaining clamp 1618 includes two opposing pads that can be clamped or unclamped. An actuation system for engaging (clamping) and disengaging (disengaging) the clamp 1618 is not shown.

[0266] 21C, the collet drive system 1600 illustrated in FIG. 21A is illustrated with a first tire 1620 and a second tire 1622 that oppose each other and press against each other to grip the EMD 1602. The first tire 1620 and the second tire 1622 are located proximal to the cassette 1610. An EMD support 1606 is used between the y-connector assembly 1608 and the cassette 1610. An actuation system for moving the first tire 1620 and the second tire 1622 toward and away from each other is not shown. Rotating the first tire 1620 and the second tire 1622 at the same speed and in opposite directions allows the EMD 1602 to move at a faster rate than would be possible using a lead screw drive. The use of the first tire 1620 and the second tire 1622 provides for high-speed traversal of the EMD 1602 while providing unlimited travel. In one embodiment, the travel speed of the device drive 1604 can be synchronized with the rotational speed of the first tire 1620 and the second tire 1622, thereby preventing the EMD 1602 from moving. A reset method for use of the collet drive system illustrated in FIG. 21C includes gripping the EMD 1602 between the tires 1620 and 1622. The collet 964 then releases the pinch, freeing the EMD 1602 secured relative to it. The drive module 1612 is then moved in a first direction, rotating the tires 1620 and 1622 while maintaining the EMD in a fixed position relative to the ground and / or patient. Once the drive module 1612 has moved to a new desired position, the collet is actuated, pinching the EMD 1602 there so that the tires 1620 and 1622 no longer grip the EMD 1602. Thus, the collet drive module is reset for continued movement. In one embodiment, reset occurs when the EMD 1602 is moved distally until the drive module can no longer move distally. To reset the drive module to continue driving the EMD 1602 distally, the drive module 1612 is moved proximally to a reset position.During the movement reset for continued distal drive, the first direction is the proximal direction. As the drive module 1612 moves proximally to keep the EMD 1602 stationary relative to the patient, the tires 1620 and 1622 rotate to keep the EMD 1602 stationary relative to the patient, compensating for the proximal movement of the drive module 1612.

[0267] 21D , the collet drive system 1600 illustrated in FIG. 21A is shown with a third tire 1624 and a fourth tire 1626, which face each other and press together to grip the EMD 1602. The third tire 1624 and the fourth tire 1626 are located proximal to the y-connector assembly 1608 and distal to the EMD support 1606. The EMD support 1606 is used between the y-connector assembly 1608 and the cassette 1610. The third tire 1624 and the fourth tire 1626 replace the retaining clamp 1618 illustrated in FIG. 21B . An actuation system for moving the third tire 1624 and the fourth tire 1626 toward and away from each other is not shown.

[0268] "Colette" Several collet designs are provided herein that can be used in the robotic system. Referring to FIG. 9A , collet 800 releasably engages an EMD (not shown). Collet 800 includes an inner member 802 that is movably positioned distally or proximally within a receiving sleeve having a tapered cavity 816 in outer member 804. Outer member 804 has a longitudinal slit 805 that extends from the outer surface of the outer member and terminates at its radial center. In one embodiment, the walls of slit 805 are parallel. In one embodiment, the walls of slit 805 are non-parallel, e.g., V-shaped walls with an apex toward the radial center. In one embodiment, a lead-in chamfer is present on the outer surface of slit 805. In one embodiment, the outer surface of slit 805 is free of a chamfer.

[0269] 9B , inner member 802 includes a first section 806 having a substantially constant radius and a second section 808 extending from first section 806 in a frustoconical, tapered shape. Therefore, the diameter of second section 808 continuously decreases from the region adjacent to first section 806 to a distal free end 810 of second section 808. Note that distal free end 810 of second section 808 is distal from the region adjacent to first section 806. In one embodiment, the lengths of first section 806 and second section 808 are the same. In one embodiment, the length of first section 806 is greater than the length of second section 808. In one embodiment, the length of first section 806 is less than the length of second section 808.

[0270] First portion 806 has a longitudinal slit 812 that extends from the outer surface of the first portion and terminates at the radial center of inner member 802. Tapered second portion 808 has a longitudinal slit 814 that extends entirely through second portion 808, from a portion of the second portion's outer surface aligned with slit 812 in first portion 806 to a portion of the second portion's outer surface 180 degrees away (opposite) from the first outer surface region. Second slit 814 may include a first plane and a second plane angled relative to the first plane. In one embodiment, the walls of slit 812 are parallel, and in one embodiment, the walls of slit 814 are non-parallel. In one embodiment, the walls of slit 812 and slit 814 are parallel. In one embodiment, the walls of slit 812 and slit 814 are non-parallel.

[0271] Referring to Figure 9B, an example is provided for the two cross sections shown in Figures 9D and 9F. In one embodiment, slits 812 are present at the top of inner member 802 and slits 812 are absent at the bottom of inner member 802.

[0272] Referring to FIG. 9C, first portion 806 and second portion 808 are connected along a lower connecting portion of inner member 802 at seam line 807 .

[0273] 9A, movement of inner member 802 from first end 823 of outer member cavity toward tapered end 825 of the outer member cavity causes two portions 818 and 820 to move toward each other and pinch the EMD (not shown). Similarly, movement of inner member 802 from second tapered end 825 of outer member 804 toward first open end 823 of the outer member causes two portions 818 and 820 to pivot about a line through seam 807 and move away from each other.

[0274] 9D, in one embodiment, contact between inner member 802 and outer member 804 occurs between the inner circumferential surface of tapered cavity 816 and the outer circumferential surface of distal end 810 of second portion 808. In one embodiment, this contact is limited to a longitudinal distance of 1-5 mm. In one embodiment, this contact is greater than a 5 mm longitudinal distance.

[0275] 9D, 9E, and 9F, the two portions 818 and 820 of the second portion 808 of the inner member 802 gradually separate toward the distal end 810 in the "normally open" unloaded configuration.

[0276] In operation, movement of inner member 802 into tapered cavity 816 of outer member 804 forces the two portions 818 and 820 of second portion 808 to move toward each other, thereby moving the two opposing surfaces 819 and 821 of portions 818 and 820 toward each other and pinching the EMD. As inner member 802 is moved distally within outer member 804, contact between inner member 802 and outer member 804 creates compressive forces (created between the inner circumferential surface of tapered cavity 816 and the outer circumferential surface of the distal end of inner second portion 808) acting on the two portions of inner member second portion 808. These forces overcome the inherent compliance of the two portions of inner member second portion 808, causing the two opposing surfaces 819 and 821 of portions 818 and 820, respectively, to move toward each other into a loaded configuration.

[0277] In one embodiment of the loading configuration, the inner surfaces 819 and 821 of the second portion 808 of the inner member 802 first contact the EMD at the distal free end 810 and then continue to contact the EMD progressively proximally at the slit 814 of the tapered second portion 808 of the inner member.

[0278] Moving the inner member 802 within the outer member 804 requires the application of an external driving force in a distal direction to the inner member 802 from an operator or a robotic system (not shown). In one embodiment, the external driving force in the distal direction is applied at the proximal end of the inner member 802. In one embodiment, the inner member is moved relative to the outer member 804 by rotating one of the inner member 802 and outer member 804 with a rotational input that engages a screw member, thereby linearly moving the inner member 802 relative to the outer member along the longitudinal axis of the collet.

[0279] To move the inner member 802 further distally within the outer member 804, an increasing external driving force is required to overcome increasing compliance forces (to move the two opposing surfaces 819 and 821 of portions 818 and 820, respectively, toward each other) and to overcome increasing frictional forces (as a result of increasing contact between the inner circumferential surface of the tapered cavity 816 and the outer circumferential surface of the distal end of the second portion 808).

[0280] The loaded configuration becomes the locked configuration when the two opposing surfaces 819 and 821 of portions 818 and 820, respectively, lock the EMD, preventing it from moving. In the locked configuration, no external driving force is required. Frictional forces (due to contact between the inner circumferential surface of tapered cavity 816 and the outer circumferential surface of the distal end of second portion 808) maintain collet 800 in the locked configuration. In other words, in the locked configuration, inner member 802 is frictionally locked with outer member 804.

[0281] In operation, when the inner member 802 is withdrawn from the outer member 804, the two portions 818 and 820 of the second portion 808 separate from one another as the inner member 802 is moved away from the tapered cavity 816 of the outer member 804, causing the two opposing surfaces 819 and 821 of portions 818 and 820, respectively, to move away from one another to unpinch the EMD. As the inner member 802 is withdrawn from the outer member 804, the inherent compliance of the two portions of the inner member's second portion 808 restores the two opposing surfaces 819 and 821 of portions 818 and 820, respectively, to their normal, open, unloaded configuration.

[0282] Moving the inner member 802 away from the outer member 804 requires an external driving force to be applied in the proximal direction from an operator or robotic system (not shown) to the inner member 802. The external driving force in the proximal direction must overcome the frictional forces that maintain the collet mechanism 800 in the locked configuration. In one embodiment, the external driving force is applied to the proximal end of the inner member 802.

[0283] In one embodiment, the two portions of the inner member second portion 808 are connected by a living hinge that has spring characteristics that urge the two portions apart when the inner member is moved toward the open end of the outer member. In one embodiment, a separate spring may be used to urge the two portions apart.

[0284] In one embodiment, the outer surface of the tapered second portion 808 of the inner member has smooth walls. In one embodiment, the outer surface of the tapered second portion 808 of the inner member has non-smooth walls, for example, with one or more recessed pockets or wells on the outer surface. A non-smooth-walled design generally results in less uniform and lower inherent compliance between the two portions of the tapered second portion 808 of the inner member compared to a smooth-walled design.

[0285] In one embodiment, inner member 802 is formed using a moldable plastic. In one embodiment, inner surfaces 819 and 821 of second portion 808 of inner member 802 include an elastomeric or other deformable or compliant material, which allows deformation relative to the EMD during pinching and locking configurations.

[0286] In one embodiment, when slits 805, 812, and 814 are aligned, an EMD is radially loaded through slit 805 of the outer member and slits 812 and 814 of the inner member. This radial loading allows a user to center the EMD in the collet without having to thread the free end of the EMD through first end 823. Rather, a portion of the EMD is positioned directly in the radial center of the collet between the first and second ends of the EMD through aligned slits 805, 812, and 814. During radial loading, a first terminal end of the EMD remains distal to the distal end of the collet, and an opposite second terminal end of the EMD remains proximal to the proximal end of the collet, with a portion of the EMD intermediate the first and second ends of the EMD being inserted through slits 805, 812, and 814 to the radial center of the collet. The loading of EMDs described in this paragraph may be referred to herein as side loading or radial loading.

[0287] 9A and 9D, the taper angle (α1) 822 of the inner cavity 816 of the outer member 804 is greater than the taper angle (α2) 824 of the outer surface of the second portion 814 of the inner member, thereby forcing the two portions 818 and 820 toward each other when the inner member is moved into the cavity 816 in a direction toward the second end of the outer member 804.

[0288] 9C , in one embodiment of inner member 802, longitudinal slits 812 extending from the outer surface of first portion 806 terminate at the central longitudinal axis of inner member 802. In one embodiment of inner member 802, longitudinal slits 812 extending from the outer surface of first portion 806 terminate away from the central longitudinal axis of inner member 802.

[0289] In one embodiment, first portion 806 and second portion 808 define two cantilever sections extending from the inner member first portion. Cantilever portions 818 and 820 vary the spring force along their respective longitudinal lengths such that surfaces 819 and 821 that contact the EMD disposed therebetween conform well with the EMD, keeping the pressure applied to the EMD low and spread along surfaces 819 and 821. Varying the cross-sectional thickness of cantilever portions 818 and 820 along the longitudinal axis of collet 800 can vary the spring force applied to the EMD.

[0290] Collet 800 provides increased stiffness features for greater release force due to the complete slit 814 in the second portion 808 of inner member 802 and the partial slit 812 in the first portion 806 of inner member 802.

[0291] Referring to Figure 9G, collet 826 has an inner member 828 and an outer member 804. Outer member 804 has the same geometry as outer member 804 illustrated in Figure 9A and described above. The principle of operation of collet 826 is similar to the operation of collet 800 illustrated in Figure 9A.

[0292] 9H and 9I, inner member 828 has a longitudinal slit 830 that extends through inner member 828 from region 832 on outer surface 834 of inner member 828 and terminates at region 836 near, but not through, the outer surface approximately 180 degrees away (opposite) from opening 838 of slit 830.

[0293] Referring to FIG. 9H , longitudinal slit 830 defines two generally semicircular cross sections of inner member 828, first portion 840 and second portion 842, allowing for pivoting at region 836 where slit 830 terminates. In one embodiment, slit 830 defines opposing parallel walls from portions 840 and 842 in the unloaded or unpinched configuration. In one embodiment, slit 830 defines opposing non-parallel walls from portions 840 and 842 in the unloaded or unpinched configuration, creating, for example, V-shaped walls. In one embodiment, stress relief 848 may be used in the region of inner member adjacent the bottom of slit 830 to minimize the effects of stress concentration and, thereby, the potential for fracture. In one embodiment, other means for stress relief are used in the region of inner member adjacent the bottom of slit 830.

[0294] 9G, movement of inner member 828 from first end 844 of the outer member cavity toward tapered end 846 of the outer member cavity causes first portion 840 and second portion 842 of inner member 828 to move toward each other, pinching the EMD (not shown). Similarly, movement of inner member 828 from second tapered end 846 of outer member 804 toward first open end 844 of the outer member causes first portion 840 and second portion 842 of inner member 828 to pivot away from each other about a line through longitudinal slit 838, unpinning the EMD (not shown).

[0295] In one embodiment, the area of ​​inner member 836 adjacent the bottom of slit 830 is provided with an integral hinge having spring properties that bias the two sections apart as the inner member is moved toward the open end of the outer member. In one embodiment, a separate spring may be provided to act to bias the two sections 838 and 840 apart.

[0296] Frictional forces (due to contact between the inner circumferential surface of the tapered cavity of outer member 804 and the outer circumferential surface of the distal end of second portion 834) maintain collet 826 in the locked configuration. In other words, in the locked configuration, inner member 828 is frictionally locked relative to outer member 804.

[0297] Based on the dimensions and angle of the longitudinal slit 830 that forms the two portions of the inner member 828, the first portion 840 and the second portion 842, the collet can accommodate a larger range of diameters of EMDs compared to the collet illustrated in FIG. F2A.

[0298] 10A and 10B, collet 852 has an inner member 854, two internal components including a driven pad 856 and driven fingers 858, and an outer member 860. Outer member 860 has a prismatic internal cavity 862 that receives internal components 856 and 858 oriented by an internal cavity 864 of inner member 854. Outer member 860 has a circumferential retention channel 863 on its inner surface toward its proximal end. Inner member 854 has a key 859 on its outer surface sized to fit within channel 863. In one embodiment, driven pad 856 and driven fingers 858 are separate components. In one embodiment, driven pad 856 and driven fingers 858 are integrally connected to a unified component. In one embodiment, driven pad 856 and driven fingers 858 are made of the same material. In one embodiment, the follower pad 856 and the follower fingers 858 are made of different materials. For example, in one embodiment, the follower pad 856 is made of an elastomeric material and the follower fingers 858 are made of a moldable plastic. In one embodiment, the follower pad 856 is composed of one material. In one embodiment, the follower pad 856 is made of more than one material, for example, using a moldable plastic with an elastomeric coating. In one embodiment, the follower pad 856 has two parallel flat surfaces. In one embodiment, the follower pad 856 has two non-parallel flat surfaces. In one embodiment, the follower pad 856 has one flat surface and one curved surface, such as a convex surface.

[0299] Inner member 854 has a longitudinal slit 855 extending from the outer surface of the inner member and extending along its entire length, terminating at its radial center. Outer member 860 has a longitudinal slit 861 extending from the outer surface of the outer member and extending along its entire length, terminating at its radial center. In one embodiment, slits 855 and 861 have parallel walls. In one embodiment, slits 855 and 861 have non-parallel walls, such as V-shaped walls with their apexes pointing toward the radial center. In one embodiment, slits 855 and 861 have a recessed chamfer on their outer surface. In one embodiment, slits 855 and 861 do not have a chamfer on their outer surface.

[0300] 10C.1 and 10D.1, diametric cross sections of assembled collet 852 are illustrated in pinch-release (release) and pinch (closed) configurations, respectively, based on the relative angular orientation of inner member 854 about the longitudinal axis with respect to outer member 860. Referring to FIG. 10C.2, a gap 866 exists between the outer surface of follower pad 856 and the inner surface of inner member 854, unpinching EMD 867. (EMD 867 is not shown in FIG. 10C.1.) In the default pinch-release configuration, gap 866 exists due to the dimensional geometry of inner cam 865 of inner member 854, such that there is no contact between inner cam surface 865 and follower finger 858. Referring to FIG. 10D.2, there is no gap 866 between the outer surface of driven pad 856 and the inner surface of inner member 854 because the relatively large dimensions of internal cam 865 abut against driven finger 858, thereby pinching EMD 867. (EMD 867 is not shown in FIG. 10D.1.) In the pinched configuration, collet 852 remains locked. In one embodiment, when capturing EMD 867 in the pinched configuration, inner surface 857 of inner member 854 that receives driven pad 856 is flat. In one embodiment, when capturing EMD 867 in the pinched configuration, inner surface 857 of inner member 854 that receives driven pad 856 is concave, e.g., having a contour similar to the contour of the outer surface of driven pad 856. In one embodiment, inner member 854 is constructed of a single material. For example, in one embodiment, inner member 854 is constructed of a moldable plastic. In one embodiment, the inner member 854 is constructed of more than one material. For example, in one embodiment, the inner surface 857 of the inner member 854 that receives the follower pads 856 comprises a moldable plastic inner member 854 with an elastomeric lining or coating thereon.

[0301] Transitioning from the pinch release (unpinched) configuration to the pinch configuration or from the pinch configuration to the pinch release configuration requires a user or drive system to impart relative angular motion between the inner member 854 and the outer member 860 about a longitudinal axis. In one embodiment, a 90-degree rotation of the inner member 854 relative to the outer member 860 about the longitudinal axis corresponds to transitioning from the pinch release configuration to the pinch configuration. In one embodiment, a 180-degree rotation of the inner member 854 relative to the outer member 860 about the longitudinal axis corresponds to transitioning from the pinch release configuration to the pinch configuration. In one embodiment, any rotation of the inner member 854 relative to the outer member 860 about the longitudinal axis less than 360 degrees corresponds to transitioning from the pinch release configuration to the pinch configuration.

[0302] In one embodiment, the internal cam 865 is configured to achieve the pinch configuration upon clockwise rotation of the outer member 860 relative to the inner member 854 about the longitudinal axis. In one embodiment, the cam is configured to achieve the pinch configuration upon counterclockwise rotation of the outer member 860 relative to the inner member 854 about the longitudinal axis.

[0303] In one embodiment, the internal cam 865 is configured to achieve the pinched configuration in one position during rotation of the inner member 854 relative to the outer member 860 about the longitudinal axis. In one embodiment, the cam is configured to achieve the pinched configuration in two or more positions during rotation of the inner member 854 relative to the outer member 860 about the longitudinal axis.

[0304] In one embodiment, the internal cam 865 is configured to persist so that relative rotation between the inner member 854 and the outer member 860 does not result in a change of state so that the collet system 852 in the pinched configuration remains in the pinched configuration, or so that the collet system 852 in the pinched configuration remains in the pinched configuration. This may be achieved by having no change in the radial dimension of the profile of the internal cam 865 throughout the range of relative rotation between the inner member 854 and the outer member 860. In one embodiment, the persistence accommodates possible errors in the displacement command to the motors that rotate the inner member 854 and the outer member 860, providing some margin of error in the case of the pinched configuration so that the EMD 867 remains pinched.

[0305] In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by 90 degrees maintains the EMD in the pinched configuration. In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by less than 90 degrees maintains the EMD in the pinched configuration. In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by more than 90 degrees maintains the EMD in the pinched configuration.

[0306] In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by 90 degrees maintains the EMD in the unpinch configuration. In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by less than 90 degrees maintains the EMD in the unpinch configuration. In one embodiment, cam 865 is configured such that rotation of inner member 854 relative to outer member 860 about the longitudinal axis by more than 90 degrees maintains the EMD in the unpinch configuration.

[0307] In the assembled collet 852, the key 859 of the inner member 854 is retained in the channel 863 of the outer member 860, allowing rotational freedom of the inner member 854 relative to the outer member 860, but not rotational freedom of the inner member 854 relative to the outer member 860. The key 859 captured in the channel 863 ensures that the inner and outer members 854, 860 are aligned during assembly, with the outer surface of the pad 856 of the follower finger 858 positioned on the longitudinally opposite surface 857 within the inner member 854. The key 859 captured in the channel 863 prevents the members from being pulled apart in both the pinched and unpinched configurations.

[0308] In the initial configuration, slits 855 in inner member 854 of collet 852 align with slits 861 in outer member 860 to allow for lateral or radial loading of an EMD, as described herein.

[0309] Referring to FIG. 11A, collet 868 has an inner member 870 , two internal parts consisting of a curved portion 872 and a collar 874 , and an outer member 876 .

[0310] Inner member 870 has longitudinal slit 871 extending from the outer surface of the inner member and extending along its entire length, terminating at its radial center. Outer member 876 has longitudinal slit 877 extending from the outer surface of the outer member and extending along its entire length, terminating at its radial center. In one embodiment, slits 871 and 877 have parallel walls. In one embodiment, slits 871 and 877 have non-parallel walls, such as V-shaped walls with their apexes pointing toward the radial center. In one embodiment, slits 871 and 877 have a recessed chamfer on their outer surface. In one embodiment, slits 871 and 877 do not have a chamfer on their outer surface.

[0311] Referring to FIG. 11B, collet 868 is illustrated in a fully assembled configuration, with slit 871 in inner member 870 aligned with slit 877 in outer member 876 for lateral or radial loading of EMD 878.

[0312] 11C, inner member 870 is a four-section, single, integral member having a longitudinal slit 871 extending from its outer surface to its radial center. Starting from the proximal-most portion, first portion 882 is a cylindrical portion having an internal cavity at its radial center. Distal to first portion 882 is second portion 884, which is a cylindrical portion having an internal cylindrical cavity. Distal to second portion 884 is third portion 886, which is a cylindrical portion having external threads 890 and an internal cylindrical cavity. Distal to third portion 886 is fourth portion 888, which is an extension of third portion 886. In one embodiment, the outer diameter of second portion 884 is larger than the outer diameter of first portion 882. In one embodiment, the outer diameter of second portion 884 is the same as the outer diameter of first portion 882. In one embodiment, the outer diameter of second portion 884 is smaller than the outer diameter of first portion 882. In one embodiment, fourth portion 888 is a rhythmic extension having a rectangular (rectangular or square) cross-section perpendicular to the longitudinal axis. In one embodiment, fourth portion 888 is a prismatic extension having a non-rectangular cross-section perpendicular to the longitudinal axis. In one embodiment, fourth portion 888 is a non-prismatic extension having a non-rectangular cross-section perpendicular to the longitudinal axis.

[0313] Outer member 876 is a two-part, single, integral member having a longitudinal slit 877 extending from its outer surface to its radial center. Starting at the proximal most end, first portion 896 is a cylindrical cup portion having internal threads 892 at its proximal portion and an internal cylindrical cavity at its distal portion. Internal threads 892 mate with external threads 890 of inner member 870. The cylindrical cavity at the distal portion of first portion 896 receives collar 874. Second portion 898 of outer member 876 is a cylindrical portion having an internal cavity at its radial center.

[0314] 11C, 11D, and 11E, collar 874 is a cylindrical portion having a distal portion with a closed end, a proximal portion with an internal cavity, and a keyway pocket 875 removed from its outer periphery along its entire length. In one embodiment, collar 874 has a closed end with a flush outer circular surface perpendicular to the longitudinal axis and an internal cavity. In one embodiment, collar 874 has a closed end with an arcuate edge relative to the outer circular surface perpendicular to the longitudinal axis and an internal cavity. In one embodiment, the closed end of collar 874 has a lip or flange extending from the outer circular surface perpendicular to the longitudinal axis and an internal cavity. In one embodiment, the internal cavity of collar 874 is centered relative to the central longitudinal axis of its outer diameter plane. In one embodiment, the internal cavity of collar 874 is not centered relative to the central longitudinal axis of its outer diameter plane. In one embodiment, the internal cavity of collar 874 has a rectangular shape. In one embodiment, the internal cavity of collar 874 has a cylindrical shape. In one embodiment, the internal cavity of collar 874 does not have a rectangular or cylindrical shape. In one embodiment, the internal cavity of collar 874 has corner pockets or wells to receive the distal end of bend 872.

[0315] Collar 874 has a longitudinal slit 894, which includes a radial slit through the collar circumferential wall to its center. In one embodiment, slit 894 has parallel walls. In one embodiment, slit 894 has non-parallel walls, such as a V-shaped wall with its apex pointing toward the radial center. In one embodiment, slit 894 has a recessed chamfer on its outer surface. In one embodiment, slit 894 does not have a chamfer on its outer surface.

[0316] In one embodiment, an extension 888 on inner member 870 seats collar 874 in the distal portion of the internal cavity of outer member 876. Extension 888 functions as a mechanical key, ensuring that collar 874 rotates with inner member 870 and that the ends of bends 872 are pressed together longitudinally and not subjected to relative rotation or torque. In other words, the ends of bends 872 can translate relative to one another but do not rotate relative to one another. Extension 888 is rotationally constrained by pocket 875 in collar 874, which acts as a keyway, allowing it to move freely longitudinally when inner member 870 is rotated relative to outer member 868.

[0317] 11A and 11C , in one embodiment, the proximal portion of the internal cavity of inner member 870 has a corner pocket or hole (well) to receive the proximal end of bend 872. Bend 872 is a rectangular prism having a length along the axial direction that is greater than either its width or height in a plane perpendicular to the axial direction. In one embodiment, bend 872 is a rectangular prism having the same width and height in a plane perpendicular to the axial direction, meaning that bend 872 has a square cross section. In one embodiment, bend 872 is a rectangular prism having a width greater than its height in a plane perpendicular to the axial direction, meaning that bend 872 has a rectangular cross section and a width greater than its height. In one embodiment, bend 872 is a rectangular prism having a width less than its height in a plane perpendicular to the axial direction, meaning that bend 872 has a rectangular cross section and a height greater than its width. In one embodiment, bend 872 is a rectangular prism having a sharp end. In one embodiment, flexure 872 is a rectangular prism with rounded ends. In one embodiment, flexure 872 is a generally rectangular prism. In one embodiment, flexure 872 is made of a compliant material such as a moldable plastic or acrylic. Flexure 872 has elastic bending properties that are a function of its geometry (length, width, and height) and its material properties (primarily its elastic modulus).

[0318] In operation, pinching the EMD 878 is achieved by rotating the inner member 870 relative to the outer member 876 about its longitudinal axis so that the outer threads 890 and inner threads 892 thread together. As such, the curved portion 872 can be made to bend or flex (have a small radius of curvature), allowing the outer surface 873 of the curved portion 872 (at and near the longitudinal center of the curve) to be used to pinch the EMD 878 against the inner surface 880 of the inner member 870. The longitudinal distance between the two ends of the curved portion 872 is determined by the rotation of the inner member 870 relative to the outer member 876 and can be used to vary the amount of bending. As the longitudinal distance between the two ends of curve 872 decreases, the deflection or bending of the curve increases, giving the curve a smaller radius of curvature and a larger lateral distance, which is defined by the distance perpendicular to the longitudinal axis at the longitudinal center of the curve between the outer surface 873 of the uncurved curve and the outer surface 873 of the curved curve 872. The lateral distance is constrained by the internal cavity, so that EMD 878 is trapped between the outer surface 873 of curve 872 and the inner surface 880 of inner member 870.

[0319] In operation, unpinching (de-pinching) the EMD 878 is achieved by rotating the inner member 870 relative to the outer member 876 about the longitudinal axis such that the outer threads 890 and inner threads 892 are unthreaded together. Thus, the curved portion 872 can be made rigid or non-bending (having a large radius of curvature), and the outer surface 873 of the curved portion 872 allows the EMD 878 to unpinch from the inner surface 880 of the inner member 870. The longitudinal distance between the two ends of the curved portion 872 is determined by the rotation of the inner member 870 relative to the outer member 876 and can be used to vary the amount of bending (deflection). As the longitudinal distance between the two ends of curved portion 872 increases, the deflection or bending of the curved portion decreases, giving the curved portion a larger radius of curvature and a smaller lateral distance, which is defined by the distance perpendicular to the longitudinal axis at the longitudinal center of the curve between the outer surface 873 of the uncurved curved portion and the outer surface 873 of the curved curved portion 872. In the unpinched configuration, the lateral distance between the outer surface 873 of curved portion 872 and the inner surface 880 of inner member 870 is greater than the diameter of EMD 878, so EMD 878 is free.

[0320] In one embodiment, the inner surface 880 of the inner member 870 that receives the curved portion 872 when capturing the EMD 878 in the pinched configuration is concave, e.g., has a smaller profile relative to the profile of the outer surface 873 of the curved bend 872. This can increase the surface area that contacts the EMD 878 and move it away from the central axis of rotation, thereby increasing the resistive torque on the EMD 878. In one embodiment, the inner surface 880 of the inner member 870 that receives the curved portion 872 when capturing the EMD 878 in the pinched configuration is flat.

[0321] In one embodiment, inner member 870 is made from one material, such as moldable plastic. In one embodiment, inner member 870 is composed of more than one material. For example, in one embodiment, inner surface 880 of inner member 870, which receives curved portion 872 when capturing EMD 878 in a pinched configuration, has an elastomeric lining or coating on moldable plastic inner member 870.

[0322] In one embodiment, flexure 872 is made from one material, such as moldable plastic. In one embodiment, flexure 872 is composed of more than one material. For example, in one embodiment, flexure 872 has an elastomeric lining or coating over a moldable plastic inner portion.

[0323] One embodiment of the collet 868 uses a single flexure 872. One embodiment of the collet 868 uses more than one flexure 872. For example, two flexures oriented 180 degrees apart about a central longitudinal axis may be used to pinch and unpinch the EMD 878, which may be based on relative rotation of the inner member 870 and outer member 876 using the concepts described herein.

[0324] In the initial configuration, slits 871 in inner member 870 of collet 868 align with slits 877 in outer member 876 to allow for lateral or radial loading of EMDs as described herein.

[0325] 15A , flexible bellows collet drive system 1150, which allows for rotation, translation, and pinching of EMD 1154, includes device retainer 1152, drive block set 1156, and retaining block set 1158. Device retainer 1152 is a device support and includes a longitudinal portion of flexible bellows 1160 that is disposed between drive block set 1156 and retaining block set 1158. Flexible bellows 1160 is a device support that allows for movement between drive block set 1156 and retaining block set 1158. In one embodiment, drive block set 1156 is located distally of flexible bellows 1160, and retaining block set 1158 is located proximally of flexible bellows 1160. In one embodiment, drive block set 1156 is located proximally of flexible bellows 1160 and retainer block set 1158 is located distally of flexible bellows 1160. In one embodiment, device retainer 1152 includes distal tapered section 1162, distal uniform section 1164, proximal uniform section 1166, and proximal tapered section 1168. In one embodiment, device retainer 1152 includes distal uniform section 1164 and proximal uniform section 1166, and does not have distal tapered section 1162 or proximal tapered section 1168.

[0326] Referring to FIG. 15A, flexible bellows collet drive system 1150 includes a drive system (not shown) that longitudinally moves (advances and retracts) a drive block set 1156 relative to a holding block set 1158 .

[0327] 15B, the drive block set 1156 is shown in an open configuration, where there is no contact between the drive block set 1156 and the device retainer 1152. In one embodiment, the drive block set 1156 includes a first drive block assembly 1170 and a second drive block assembly 1172. In one embodiment, the drive block set 1156 includes the first drive block assembly 1170 but does not include the second drive block assembly 1172. In one embodiment, the configuration of the first block assembly 1170 and the second drive block assembly 1172 are the same. In one embodiment, the configuration of the first block assembly 1170 and the second drive block assembly 1172 are not the same.

[0328] The first drive block assembly 1170 includes a first spur gear 1174, a first spur gear pin 1176, and a first drive block retainer 1178. In one embodiment, the first spur gear 1174 rotates about the first spur gear pin 1176, which is retained within a side wall of the first drive block retainer 1178. In one embodiment, the first spur gear 1174 is integrally coupled to the first spur gear pin 1176 midway along its length, and the ends of the first spur gear pin 1176 on either side of the first spur gear 1174 are supported in holes to act as rotational bearings within the outer wall of the first drive block retainer 1178. In one embodiment, first spur gear 1174 is integrally coupled to a first spur gear pin 1176 midway along its length, and the ends of first spur gear pin 1176 on either side of first spur gear 1174 are supported by rolling bearings mounted on the outer wall of first drive block retainer 1178. In one embodiment, first drive block retainer 1178 includes a first drive block notch 1180, which exposes a portion of first spur gear teeth 1182 of first spur gear 1174. In one embodiment, first drive block notch 1180 has a semicircular convex cross-section in a plane transverse to the longitudinal axis.

[0329] The second drive block assembly 1172 includes a second spur gear 1184, a second spur gear pin 1186, and a second drive block retainer 1188. In one embodiment, the second spur gear 1184 rotates about the second spur gear pin 1186, which is retained within a side wall of the second drive block retainer 1188. In one embodiment, the second spur gear 1184 is integrally connected to the second spur gear pin 1186 midway along its length, and the ends of the second spur gear pin 1186 on either side of the second spur gear 1184 are supported in holes and act as rotational bearings within the outer wall of the second drive block retainer 1188. In one embodiment, the second spur gear 1184 is integrally connected midway along its length to a second spur gear pin 1186, and the ends of the second spur gear pin 1186 on either side of the second spur gear 1184 are supported by rolling bearings mounted on the outer wall of a second drive block retainer 1188. In one embodiment, the second drive block retainer 1188 includes a second drive block notch 1190, exposing a portion of a second spur gear tooth 1192 of the second spur gear 1184. In one embodiment, the second drive block notch 1190 has a semicircular convex cross-section on a plane transverse to the longitudinal axis.

[0330] The first spur gear 1174 is driven by a first spur gear drive system (not shown) to rotate the first spur gear 1174 in a clockwise or counterclockwise direction or to prevent rotation of the first spur gear 1174. The second spur gear 1184 is driven by a second spur gear drive system (not shown) to rotate the second spur gear 1184 in a clockwise or counterclockwise direction or to prevent rotation of the second spur gear 1184. In one embodiment, the first spur gear drive system, second spur gear drive system, and translation drive system may be included in a combined translation-rotation drive system (not shown) to simultaneously rotate the first spur gear 1174, rotate the second spur gear 1184, and translate the drive block set 1156. In one embodiment, the first spur gear drive system, the second spur gear drive system, and the drive system may be included in a combined translation-rotation drive system (not shown) to sequentially rotate the first spur gear 1174, rotate the second spur gear 1184, and translate the drive block set 1156.

[0331] 15B, device retainer 1152 includes gear mechanism 1194, a longitudinal section with external spur gear teeth oriented along the longitudinal axis of device retainer 1152 and sized to mesh with the teeth of first spur gear 1174 and second spur gear 1184. Gear mechanism 1194 is located proximal to distal uniform portion 1164 and distal to flexible bellows 1160. The length of gear mechanism 1194 is greater than the width of first spur gear 1174 or the width of second spur gear 1184. In one embodiment, the length of gear mechanism 1194 is ten times the width of first spur gear 1174 or the width of second spur gear 1184. In one embodiment, the length of gear mechanism 1194 is less than 10 times the width of first spur gear 1174 or second spur gear 1184. In one embodiment, the length of gear mechanism 1194 is greater than 10 times the width of first spur gear 1174 or second spur gear 1184. In one embodiment, the spur gear teeth of gear mechanism 1194 are molded into a portion of device retainer 1152.

[0332] In one embodiment, device retainer 1152 includes a distal drive collar 1196 and a proximal drive collar 1198. Distal drive collar 1196 is located distally of gear mechanism 1194 and proximal to distal uniform portion 1164. Proximal drive collar 1198 is located proximal to gear mechanism 1194 and distal to flexible bellows 1160. Distal drive collar 1196 and proximal drive collar 1198 are longitudinal sections having flanges or lips extending outwardly from device retainer 1152. In one embodiment, device retainer 1152 includes a first intermediate uniform portion 1200, which is located distally of flexible bellows 1160 and proximal to proximal drive collar 1198.

[0333] 15B and 15D, in the open configuration of the device retainer 1152, an opening 1202 into a central channel 1204 is provided for the EMD 1154. In one embodiment, the cross section of the opening 1202 is a sector (a portion of a circle) where a circular cross section of the device retainer 1152 is removed to expose the first face 1206 and the second face 1208. In one embodiment, the cross section of the central channel 1204 is a circular pocket that is opened to seat or hold the EMD 1154. In one embodiment, the center of the central channel 1204 is aligned with the center of the device retainer 1152.

[0334] 15C , drive block set 1156 is shown in a closed configuration in which first drive block assembly 1170 and second drive block assembly 1172 move toward each other in the direction of the central axis of the device retainer such that exposed teeth 1182 of first spur gear 1174 mesh with teeth of gear mechanism 1194, and exposed teeth 1192 of second spur gear 1184 mesh with teeth of gear mechanism 1194. In the closed configuration, a portion of the outer distal wall of first drive block retainer 1178 and a portion of the outer distal wall of second drive block retainer 1188 contact or are in close proximity to distal drive collar 1196, preventing distal movement of first drive block assembly 1170 and second drive block assembly 1172 relative to device retainer 1152. In the closed configuration, parts of the outer proximal wall of the first drive block retainer 1178 and parts of the outer proximal wall of the second drive block retainer 1188 contact or are in close proximity with the proximal drive collar 1198, preventing proximal movement of the first drive block assembly 1170 and the second drive block assembly 1172 relative to the device retainer 1152. Thus, in the closed configuration, the drive block set 1156, constrained by the distal drive collar 1196 and the proximal drive collar 1198, acts like a thrust bearing, allowing rotational movement of the device retainer 1152 and preventing movement of the device retainer 1152 relative to the drive block set 1156. In other words, if there is no movement of the drive block set 1156, there is no movement of the device retainer 1152. When there is movement of the drive block set 1156 (such as longitudinally forward and backward), there is a corresponding movement of the device retainer 1152 as well.

[0335] 15C and 15E , in the closed configuration of the device retainer 1152, the first surface 1206 and the second surface 1208 face each other and meet at a closed seam 1210, and the central channel 1204 surrounds and pinches the EMD 1154. Thus, in the closed configuration, the EMD 1154 is pressed by the walls of the central cavity 1204 of the device retainer 1152 and cannot move relative to the device retainer 1152. In other words, without movement of the device retainer 1152, there is no movement of the EMD 1154. When there is movement of the device retainer 1152 (such as longitudinally forward and backward), there is a similar corresponding movement of the EMD 1154. Thus, without movement of the drive block set 1156, there is no movement of the EMD 1154. When there is movement of the drive block set 1156 (such as forward and backward along its length), there is a similar corresponding movement of the EMD 1154.

[0336] The drive block set 1156 includes a drive block open / close actuation system (not shown) that can move the first drive block assembly 1170 and the second drive block assembly 1172 transversely to the longitudinal axis toward and away from the device retainer 1152. Referring to FIG. 15B , the drive block open / close actuation system moves the first drive block assembly 1170 and the second drive block assembly 1172 to an open configuration. Referring to FIG. 15C , the drive block open / close actuation system moves the first drive block assembly 1170 and the second drive block assembly 1172 to a closed configuration. In one embodiment, the drive block open / close actuation system smoothly transitions the first drive block assembly 1170 and the second drive block assembly 1172 from an open configuration to a closed configuration, or from a closed configuration to an open configuration. In one embodiment, the drive block opening and closing actuation system discretely positions the first drive block assembly 1170 and the second drive block assembly 1172 to an open or closed configuration.

[0337] 15F , the retaining block set 1158 is shown in an open configuration, with no contact between the first retaining block 1212 and the device retainer 1152 and no contact between the second retaining block 1214 and the device retainer 1152. In one embodiment, the retaining block set 1158 includes a first retaining block 1212 and a second retaining block 1214. In one embodiment, the retaining block set 1158 includes the first retaining block 1212 but does not include the second retaining block 1214. In one embodiment, the configuration of the first retaining block 1212 and the configuration of the second retaining block 1214 are the same. In one embodiment, the configuration of the first retaining block 1212 and the configuration of the second retaining block 1214 are not the same.

[0338] In one embodiment, the first retaining block 1212 includes a first retaining block cutout 1216 and the second retaining block 1214 includes a second retaining block cutout 1218. In one embodiment, the first retaining block cutout 1216 and the second retaining block cutout 1218 each have a semicircular convex cross-section in a plane transverse to the longitudinal axis.

[0339] In one embodiment, device retainer 1152 includes a distal retention collar 1220 and a proximal retention collar 1222. Distal retention collar 1220 is located proximal to flexible bellows 1160 and distal to uniform retention portion 1224, which is a longitudinal portion of device retainer 1152 having a uniform cross-section perpendicular to the longitudinal direction. Proximal retention collar 1222 is located distal to proximal uniform portion 1166 and distal to uniform retention portion 1224. Distal retention collar 1220 and proximal retention collar 1222 are longitudinal portions having flanges or lips extending outward from device retainer 1152. In one embodiment, device retainer 1152 includes a second intermediate uniform portion 1226, which is located proximal to flexible bellows 1160 and distal to distal retention collar 1220. The device retainer 1152 acts as an anti-buckling support, ensuring that the collet is longer than the distance the device will buckle (twist).

[0340] 15G , the retaining block set 1158 is shown in an intermediate configuration, in which the first retaining block 1212 and the second retaining block 1214 have moved toward each other in the direction of the central axis of the device retainer 1152. In the intermediate configuration, a portion of the outer distal wall of the first retaining block 1212 and a portion of the outer distal wall of the second retaining block 1214 contact or are in close proximity to the distal retention collar 1220, preventing distal movement of the retaining block set 1158 relative to the device retainer 1152. In the intermediate configuration, a portion of the outer proximal wall of the first retaining block 1212 and a portion of the outer proximal wall of the second retaining block 1214 contact or are in close proximity to the proximal retention collar 1222, preventing proximal movement of the retaining block set 1158 relative to the device retainer 1152. Thus, in the intermediate configuration, the retaining block set 1158 is constrained by the distal retaining collar 1220 and the proximal retaining collar 1222, acting like a thrust bearing to allow rotation of the device retainer 1152 while preventing movement of the device retainer 1152 relative to the retaining block set 1158. In the intermediate configuration, the retaining block set 1158 is constrained from movement and the EMD 1154 is not fully pinched.

[0341] 15H , the retention block set 1158 is shown in a closed configuration, with the first retention block 1212 and the second retention block 1214 moving toward each other in the direction of the central axis of the device retainer 1152. In the closed configuration, a portion of the outer distal wall of the first retention block 1212 and a portion of the outer distal wall of the second retention block 1214 contact or are adjacent to the distal retention collar 1220, preventing distal movement of the retention block set 1158 relative to the device retainer 1152. In the closed configuration, a portion of the outer proximal wall of the first retention block 1212 and a portion of the outer proximal wall of the second retention block 1214 contact or are adjacent to the proximal retention collar 1222, preventing proximal movement of the retention block set 1158 relative to the device retainer 1152. Thus, in the closed configuration, the retaining block set 1158, constrained by the distal retaining collar 1220 and the proximal retaining collar 1222, acts like a thrust bearing, allowing rotation of the device retainer 1152 and preventing movement of the device retainer 1152 relative to the retaining block set 1158. In the closed configuration, the retaining block set 1158 is constrained from movement and the EMD 1154 is fully pinched.

[0342] The retaining block set 1158 includes a retaining block actuation system (not shown) that allows the first retaining block 1212 and the second retaining block 1214 to move transversely to the longitudinal axis toward and away from the device retainer 1152. Referring to FIG. 15F, the retaining block actuation system moves the first retaining block 1212 and the second retaining block 1214 to the open configuration. Referring to FIG. 15G, the retaining block actuation system moves the first retaining block 1212 and the second retaining block 1214 to the intermediate configuration. Referring to FIG. 15H, the retaining block actuation system moves the first retaining block 1212 and the second retaining block 1214 to the closed configuration. In one embodiment, the holding block actuation system smoothly transitions the first holding block 1212 and the second holding block 1214 from the open configuration to the intermediate configuration, and from the intermediate configuration to the closed configuration, and from the closed configuration to the intermediate configuration, and from the intermediate configuration to the open configuration. In one embodiment, the holding block actuation system discretely positions the first holding block 1212 and the second holding block 1214 in the open, intermediate, or closed configuration.

[0343] 16A and 16B, the compression collet system 1240 includes a plunger 1242, a donut 1244, and a receiver 1246. In one embodiment, the plunger 1242 is a rigid right cylinder having a central cavity 1248 and a cylindrical longitudinal axis, the cavity axial direction aligned with the EMD longitudinal axis 1250. In one embodiment, the cavity 1248 has a circular cross section on a plane transverse to the EMD longitudinal axis 1250, with the cavity diameter being larger than the outer diameter of the EMD 1252. The donut 1244 is a ring torus formed from a flexible material. In one embodiment, the donut 1244 is an O-shaped ring. In one embodiment, the donut 1244 is constructed from a resilient material. In its rest state, i.e., its unloaded state, the internal bore 1254 of the donut 1244 has a bore diameter larger than the outer diameter of the EMD 1252. The receiver 1246 is a rigid receptacle that includes a well 1256 aligned with the EMD longitudinal axis 1250 and an internal cavity 1258, where the diameter of the cavity is larger than the outer diameter of the EMD 1252. In one embodiment, the receiver 1246 is a rectangular prism with a well 1256 on one face, the opening of which has the shape of a right circular cylinder. In one embodiment, the well 1256 has straight walls. In one embodiment, the well 1256 has conical walls that taper into the well.

[0344] 16C and 16D, a plunger actuation system (not shown) moves plunger 1242 relative to receiver 1246 along EMD longitudinal axis 1250, applying plunger force 1260.

[0345] Referring to FIG. 16C, compression collet system 1240 is shown in an unloaded configuration, in which plunger 1242 is not pressing against donut 1244 in well 1256, i.e., no plunger force 1260 is being applied thereto. Donut 1244 is in its rest state, undeformed, and EMD 1252 is free to move relative to receiver 1246. (As shown in FIG. 16C, the donut has a circular cross-section in the poloidal plane.)

[0346] Referring to FIG. 16D , compression collet system 1240 is shown in a loaded configuration, in which plunger 1242 presses donut 1244 within well 1256 with plunger force 1260. As a result, donut 1244 is compressed and deformed (e.g., donut 1244 is deformed in the poloidal plane from a circular cross-section to an elliptical cross-section, as shown in FIG. 16D ). In its deformed state, a portion of wall 1262 of the deformed surface of donut cavity 1254 pinches around EMD 1252. As a result, EMD 1252 cannot move freely relative to receiver 1246.

[0347] In one embodiment, a rotational drive system (not shown) rotates (clockwise and counterclockwise) the compression collet system 1240 about the longitudinal axis 1250 of the EMD 1252. In one embodiment, a translational drive system (not shown) translates (advances and retracts) the compression collet system 1240 along the longitudinal axis 1250 of the EMD 1252.

[0348] In one embodiment, the compression collet system 1240 includes a slit (not shown) to allow for lateral or radial loading of the EMD 1252.

[0349] In one embodiment, the collet can include a collet first member and a collet second member that move relative to one another to pinch and unpinch the EMD. In one embodiment, the collet first member and the collet second member can be formed as a single piece, with a compliant connection between the collet first member and the collet second member. As one non-limiting example, the collet first member and the collet second member can be connected by a living hinge, allowing them to move relative to one another via an accordion portion of the flexible portion.

[0350] 22A-22X, drive mechanism 210 is a tire actuation device that robotically controls the movement of an EMD. In one embodiment, the drive mechanism includes a pair of tires and pinches the EMD between them. In one embodiment, multiple pairs of tires are actuated together, such as, but not limited to, four pairs, to increase the grip of the EMD. When the tires rotate about their longitudinal axes, they move the EMD linearly along its longitudinal axis, and when the tires move axially in opposite directions, they drive the rotating EMD along its longitudinal axis. As described herein, drive mechanism 210 includes three integrated mechanisms for rotating the tires, moving the tires axially, and pinching and unclamping the tires. Additionally, in one embodiment, a clamping mechanism operates to clamp and unclamp a portion of the EMD away from the pair of tires.

[0351] 22A , the robotic drive system includes a drive module 210 that uses at least one pair of tire assemblies 222 and 224 to rotate an EMD 208 about its longitudinal axis, move the EMD 208 along its longitudinal axis, and reset the tire assemblies during operation of the EMD 208. The drive module 210 is controlled by a control system. The drive module 210 includes a first actuator 240 that operably rotates a first shaft 272 and / or a second shaft 282. A second actuator 244 operably moves the first shaft 272 along its longitudinal axis relative to the second shaft 282 between a first position and a second position. The first tire assembly 222 is operably attached to the first shaft 272, and the second tire assembly 224 is operably attached to the second shaft 282. A third actuator 248 operably moves the first tire assembly 222 toward or away from the second tire assembly 224 to grip and disengage the EMD 208 along its longitudinal axis from between the first tire assembly 222 and the second tire assembly 224. As detailed herein, movement of the first shaft 272 relative to the second shaft 282 rotates the EMD 208 about the EMD's longitudinal axis, and rotation of the first shaft 272 and / or the second shaft 282 moves the EMD 208 along the EMD's longitudinal axis. The control system provides a reset command to the third actuator 248, causing the EMD 208 to release its grip, the second actuator 244 to move the first tire assembly 222 relative to the second tire assembly 224 to the reset position, and the third actuator 248 to grip the EMD 208. In one embodiment, the reset command is provided continuously.

[0352] The reset position is determined automatically as a function of one or more input device commands, the offset distance between the two tire assemblies, and the position of the EMD.

[0353] In one embodiment, the control system provides a reset command when the second position reaches a predetermined distance from the first position. Referring to FIG. 22V , the EMD 208 is positioned on the first tire assembly 222 and the second tire assembly 224 at first positions 370 and 373, respectively. In one embodiment, the first positions 370 and 373 are centered between the first longitudinal ends 382, ​​392 and the second opposing longitudinal ends 386, 388 of the first tire assembly 222 and the second tire assembly 224, respectively. In one embodiment, the control system provides a reset command when the second position reaches a predetermined distance from the first position.

[0354] When an operator provides a command via user input to rotate the EMD 208 about its longitudinal axis in a first direction, the first tire assembly 222 and the second tire assembly 224 move along their longitudinal axes in opposite directions until the EMD 208 reaches a second position 372 on the first tire assembly 222 and a third position 375 on the second tire assembly 224. The controller automatically resets the first tire assembly 222 and the second tire assembly 224 along their respective longitudinal axes 242, 246 to a reset position. If the user continues to provide commands to rotate the EMD 208 in the same first direction after the first and second tire assemblies reach or have reached their respective second and third positions, the controller automatically sets the reset position to third position 374 on first tire assembly 222 and second position 371 on second tire assembly 224. In this manner, tire assemblies 222 and 224 are positioned to continue rotating the EMD 208 in the first direction at a greater number of revolutions than if the reset position were center positions 370 and 373. In other words, first tire assembly 222 and second tire assembly 242 move relative to one another along their corresponding longitudinal axes 242 and 246 between a first extended position illustrated in FIG. 10B and a second extended position opposite the first extended position illustrated in FIG. 10C. In the first extended position, the top of the first tire assembly 222 is near the bottom of the second tire assembly 224. In the second extended position, the bottom of the first tire assembly 222 is near the top of the second tire assembly 224.

[0355] In one embodiment, the reset position is a function of the input device commands, including the duration of input device inactivity. The controller detects the duration of time during which no commands to rotate the EMD are given. When the duration reaches a predetermined time interval, the system automatically resets the first tire assembly 222 and the second tire assembly 224 to their respective inactive reset positions. In one embodiment, the inactive reset positions are center positions such that a central portion of the first tire assembly 222 is proximate a central portion of the second tire assembly 224 and the first location 370 of the first tire assembly 222 is adjacent to the first location 373 of the second tire assembly 224. However, other inactive reset positions may be used.

[0356] 22A and 22B, drive mechanism 210 will be described in more detail. Drive mechanism 210 includes a base 212, an actuation assembly 214, and an EMD engagement mechanism 216. Base 212 includes the reusable components of drive mechanism 210. Actuation assembly 214 is operably secured within a cavity defined in base 212. Linkage mechanism 218 operably connects actuation assembly 214 with EMD engagement mechanism 216. In one embodiment, base 212 includes an upper plate AA and a lower plate BB.

[0357] Coupling mechanism 218 includes first support 268 and second support 280, which extend outside base 212 via shaft 272 and shaft 282, respectively. EMD engagement mechanism 216 includes first tire assembly 222 and second tire assembly 224. Tire assemblies 222 and 224 are disposed within housing 220, which is operatively connected to base 212. EMD engagement mechanism 216 includes first tire assembly 222 and second tire assembly 224. In one embodiment, first tire assembly 222 and second tire assembly 224 are identical. First tire assembly 222 includes hub 226 and supports tire 228 disposed about an outer surface of hub 226. Similarly, second tire assembly 224 includes hub 227 and supports tire 229 disposed about an outer surface of hub 227. Each tire 228 and 229 includes a roller about which the tire rotates along its longitudinal axis. Tire 228 has an outer surface that contacts the EMD. In one embodiment, the outer surface of each tire has a constant radius from the first end of the tire to the opposing second end of the tire. In one embodiment, the radius of the outer surface varies along the tire's longitudinal axis. In one embodiment, the radius of the outer surface midway between the two ends of the tire is greater than the radius of the outer center at each of the two ends of the tire. In one embodiment, the outer surface has a prolate shape. In one embodiment, the tire's outer surface has a frustoconical shape or profile, where the tire's diameter near its free end is greater than the diameter at the other end of the tire. When the first and second tires grip the EMD between them, the surfaces that press against the EMD are substantially parallel to each other, and the surfaces that do not press against the EMD are not parallel. Referring to Figure 22P, an example is shown in which the tire has a conical shape to compensate for possible deflections and gaps in the shafts 272, 282 and bearings (not shown, but which may be located in the openings of the first housing coupler 268 and second housing coupler 280). In the unpinched state, the conical tire has parallel axes, meaning that its surfaces are not parallel. In the pinched state, the abutting tire surfaces may be parallel.The cone angle is equal to the amount the shaft deviates from parallel due to shaft flex and bearing clearance. In one embodiment, the cone tire has an angle in the range of 0.1 degrees to 10 degrees. In one embodiment, the cone layer has an angle in the range of 0.5 degrees to 3.0 degrees.

[0358] Moving tires 228, 229 toward or away from each other grips and disengages an EMD disposed therebetween. As described herein, moving tires 228 and 229 about their longitudinal axes moves an EMD gripped therebetween, and moving tires 228 and 229 relative to each other about their longitudinal axes rotates the gripped EMD about its longitudinal axis.

[0359] In one embodiment, the hub 226 includes a first portion 230 having an outer cylindrical shape and a second portion 232 having an outer frusto-conical shape that extends from the first portion 230 and terminates at an upper end 234. A pair of engagement arms 236 extend from the bottom of the first portion 230 and terminate in hook-barb shaped members 238 that operably engage a portion of the second support 268.

[0360] 22C and 22D, actuation assembly 214 provides three actuation motions, including rotational drive, axial drive, and grip / unclamp. In one embodiment, the clamp / unclamp drive may be part of the grip / unclamp mode or may be a separate, fourth mode. The rotational drive mode rotates the EMD about its longitudinal axis. The axial drive mode drives the EMD along its longitudinal axis. The grip / unclamp and clamp / unclamp modes act to both grip / unclamp a portion of the EMD between two tires and clamp / unclamp a portion of the EMD away from two tires. In one embodiment, there is no clamp.

[0361] A first motor 240 is operably coupled to the first tire assembly 222 to provide rotational movement to the first tire assembly 222, and therefore to the tire 228 about the longitudinal axis 242 of the first tire assembly 222. Control of the first motor 240 from a workstation provides control of the linear movement of the EMD. In one embodiment, the first motor 240 has an output shaft 290 operably coupled to a first pulley 292. The first pulley rotates with the output shaft 290 and rotates a second pulley 270 via a belt 294. In one embodiment, pulleys 292 and 270 are gears, either directly connected via gear teeth or connected via a gear chain having at least one additional gear connected to gears 292 and 270. In one embodiment, the output shaft 290 is connected directly to shaft 272 or to the tire assembly 222 using a coupler.

[0362] Referring to FIG. 22F, a second motor 244 is operably coupled to the first and second supports 268, 280 to provide linear movement of the tire assemblies relative to one another. The first tire assembly 222 moves along a longitudinal axis 242 in a first direction and an opposite second direction to the second tire assembly 224. The second tire assembly includes a longitudinal axis 246, but is spaced apart from and parallel to the longitudinal axis 242 of the first tire assembly and moves an equal distance in the opposite direction along a second longitudinal axis 246, spaced apart from and parallel to the first longitudinal axis 242. Control of the second motor 244 from the workstation provides control of the rotational movement of the EMD.

[0363] 22F and 22G, a third motor 248 is operably coupled to a clamp assembly 250, which is operably coupled to a grip / ungrip mechanism 296 that affects the tire assembly 216. As described herein, control of the third motor 248 from the workstation provides tire assembly resetting and loading and unloading of the EMD to incrementally rotate the EMD about its longitudinal axis in discrete increments.

[0364] 22A , in response to control from a workstation, a linear drive of actuation assembly first motor 240 rotates a pulley or gear 292. A belt or gear train 294 operatively rotates a second pulley or gear, which is operatively connected to a first engagement member 218 fixed to first tire assembly 216. Rotating the output shaft of first motor 240 in a clockwise direction rotates first tire assembly 222 in a clockwise direction about its longitudinal axis 242. Rotating the output shaft of first motor 240 in a counterclockwise direction rotates first tire assembly 222 in a counterclockwise direction. In one embodiment, first tire assembly 222 and second tire assembly 224 are biased toward one another such that clockwise and counterclockwise rotation of first tire assembly 222 results in counterclockwise and clockwise rotation of second tire assembly 224, respectively. This movement can occur in one embodiment where the tires contact each other and in another embodiment where an idle tire is driven by the EMD. The insertion direction is defined as the direction in which the EMD moves along its longitudinal axis from the proximal end of the housing 220 toward the distal end of the housing 220 when the first tire assembly 222 is rotated counterclockwise. The insertion direction moves the EMD further into the patient's vasculature. The withdrawal direction is defined as the direction in which the EMD moves along its longitudinal axis from the distal end of the housing 220 toward the proximal end of the housing 220 when the first tire assembly 222 is rotated clockwise. In one embodiment, the longitudinal axis of the output shaft of the first motor is offset from the longitudinal axis 242 of the first tire assembly 222. In one embodiment, the longitudinal axis of the first motor output shaft is offset from both the longitudinal axis 242 of the first tire assembly 222 and the longitudinal axis 246 of the second tire assembly.

[0365] 22C and 22D , the rotational drive includes a coupler 252 that operably connects the second motor 244 to the first linkage 218 and the second linkage 254. In one embodiment, the second motor 244 has an output shaft that is connected to the coupler 252. In one embodiment, the coupler 252 is a link and is connected to the output shaft of the second motor 244 at a central connection 254. Rotation of the output shaft of the second motor 244 causes rotation of the coupler 252 relative to the axial direction of the output shaft of the second motor 244. A first end 256 of the coupler 252 is operably fixed to the first tire assembly 222 and a second end 258 of the coupler 252 is operably fixed to the second tire assembly 224.

[0366] Referring to FIG. 22D, a first end 262 of a rod 260 is pivotally attached to a first end 256 of the coupler 252. A second end 264 of the rod 260 is fixed to a first housing coupling member 266. Referring to FIGS. 22M and 22N, the coupling mechanism 218 includes a first support or first coupler 268 having a shaft 272 connected to the first housing coupling member 266, such that movement of the first housing coupler 266 along the longitudinal axis 242 causes longitudinal movement of the first support 268 in the same direction and by an equal distance as the first housing coupler. A second end 360 of a second rod 356, whose first end 358 is pivotally attached to the second end 258 of the coupler 252, is fixed to a second housing coupler 288. First end 358 and second end 360 are fixed to coupler 252 and coupler 288, with the rod ends providing the necessary swivel for the additional degree of freedom needed when the tire assembly is moved between the gripped and disengaged positions. Rotating the output shaft of second motor 244 in a first direction rotates rocker 252 in a first direction, resulting in movement of rod 260, first housing coupler 266, coupler 268, and first tire assembly in a first direction along longitudinal axis 242, and movement of second rod 356, coupler 280, and second tire assembly 224 in a second directi...

Claims

1. A system for driving at least one elongated medical device (EMD) using an EMD-on-device adapter, comprising: a drive module including load sensing components and a load sensor; A separation part; a cassette configured to be coupled to the drive module; The drive module includes: a drive module base component to which a cassette housing of the cassette is releasably connected, the load sensing component being connected to the drive module base component via the load sensor; The cassette comprises: a cradle in the cassette housing configured to receive the EMD-on-device adapter and a recess configured to receive the separation component; The separation part is a load sensing component coupled to the load sensing component and configured to interface with the EMD-on-device adapter within the recess; The separation component coupled to the load sensing component and disposed within the recess is out of contact with the cassette housing in at least one direction.

2. 2. The system of claim 1, wherein the EMD-on-device adapter is supported on the separation component so as to be in contact with the cassette housing.

3. The system of claim 1 , wherein the separation piece is spaced from the cassette housing in all directions.

4. The system of claim 1 , wherein the cassette housing and the separation component are connected via a flexible membrane.

5. The system of claim 1 , wherein the isolation component is removably secured to the load sensing component.

6. the separation component includes a first component and a second component; The system of claim 1 , wherein the first component is disposed in the recess with a first orientation defined as a direction toward the drive module when the cassette is in a use position.

7. The system of claim 6 , wherein the second component is disposed within the recess in a direction toward the first component and away from the load sensing component.

8. 7. The system of claim 6, wherein the first component is inserted into the recess in a direction generally perpendicular to a longitudinal axis of the cassette housing, in a direction from a top surface of the cassette toward a bottom surface of the cassette.

9. The system of claim 1 , wherein the EMD-on-device adapter includes a thrust bearing surface that prevents translational motion relative to a portion of the cassette.

10. The system of claim 9 , wherein the thrust bearing surface includes a first portion that prevents translational motion in a distal direction and a second portion that prevents translational motion in a proximal direction.

11. 11. The system of claim 10, wherein the first and second portions of the thrust bearing surface form a groove therebetween that defines a surface supported by a bearing member of the cassette.

12. The system of claim 1 , wherein the EMD-on-device adapter comprises a luer connector.

13. 13. The system of claim 12, wherein the passageway in the luer connector is coaxial with and communicates with the passageway of the EMD-on-device adapter.

14. The system of claim 1 , wherein the EMD-on-device adapter includes a holder that defines a plurality of fingers.

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