Sterile curtain for robotic drive

Abstract

A sterile barrier for a robotic drive includes a first drive module configured to move along a longitudinal axis of a drive body. The sterile barrier includes a first resilient member having a first free edge proximate the longitudinal axis. A first free edge adjacent the first drive module is resiliently biased away from and back to the longitudinal axis as the first drive module moves along the longitudinal axis.

Description

Technical Field

[0001] This invention relates generally to the field of robotic medical surgical systems, and more particularly to a curtain system for separating the non-sterile portion of a robot actuator from the sterile portion of the robot actuator. Background Technology

[0002] Catheters and other elongated medical devices (EMDs) are used in minimally invasive medical procedures to diagnose and treat a variety of vascular system diseases, including neurovascular intervention (NVI) (also known as neurointerventional surgery), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve guiding a guidewire through the vascular system and advancing a catheter via the guidewire to deliver treatment. The catheter insertion procedure begins with the appropriate vessel, such as an artery or vein, being entered through an introducer sheath using standard percutaneous techniques. The introducer sheath, sheath, or guide catheter is then advanced to the primary location via a diagnostic guidewire, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vascular system is then guided through the sheath or guide catheter to the target location within the vascular system. In some cases, such as in convoluted anatomy, a support catheter or microcatheter is inserted onto the guidewire to aid in its guidance. Physicians or operators can use imaging systems (e.g., fluorescein microscopes) to obtain images via contrast agent injection and select a fixed frame as a roadmap to guide the guidewire or catheter to a target location, such as a lesion. Contrast-enhanced images are also obtained as the physician delivers the guidewire or catheter, allowing the physician to verify that the device has moved along the correct path to the target location. When using fluoroscopy to view anatomical structures, the physician manipulates the proximal end of the guidewire or catheter to guide the distal tip into the appropriate vessel toward the lesion or target anatomical location, avoiding advancement into collateral vessels.

[0003] Robotic catheter-based surgical systems have been developed to assist physicians in performing catheter insertion procedures such as NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, fluid embolization of arteriovenous malformations, and mechanical thrombectomy for large vessel occlusion in cases of acute ischemic stroke. In NVI procedures, physicians use a robotic system to achieve access to the target lesion by manipulating a neurovascular guidewire and microcatheter to provide treatment and restore normal blood flow. The target access is achieved by a sheath or guide catheter, but intermediate catheters may also be needed for more distant areas or to provide adequate support for the microcatheter and guidewire. Depending on the type of lesion and treatment, the distal tip of the guidewire is guided into or across the lesion. To treat an aneurysm, a microcatheter is advanced into the lesion and the guidewire is removed, and several embolization coils are deployed through the microcatheter into the aneurysm to stop blood flow into the aneurysm. To treat an arteriovenous malformation, a fluid embolization is injected into the malformation site via the microcatheter. Mechanical thrombectomy can be performed to treat vascular occlusion by aspiration and / or the use of a stent retrieval device. Depending on the location of the clot, aspiration can be performed via an aspiration catheter or a microcatheter for smaller arteries. Once the aspiration catheter is positioned at the lesion site, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retrieval device using a microcatheter. Once the clot has integrated into the stent retrieval device, it is retrieved by retracting the stent retrieval device and the microcatheter (or intermediate catheter) into the guiding catheter.

[0004] In PCI, physicians use robotic systems to achieve access to the lesion by manipulating a coronary guidewire to provide treatment and restore normal blood flow. Access is achieved by placing a guiding catheter in the ostium of the coronary artery. The distal tip of the guidewire is guided through the lesion, and for complex anatomy, microcatheters can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation before stent implantation, either by delivering a balloon for pre-dilation of the lesion or by performing plaque resection using, for example, a laser or rotational plaque resection catheter and a balloon on the guidewire. Diagnostic imaging and physiological measurements can be performed using imaging catheters or fractional flow reserve (FFR) measurements to determine appropriate treatment.

[0005] In PVI, physicians use robotic systems to deliver treatment and restore blood flow using techniques similar to NVI. The distal tip of the guidewire is guided across the lesion, and for complex anatomy, microcatheters can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging can also be used.

[0006] When support is needed at the distal end of the catheter or guidewire, such as when guiding to a distal anatomical location in a tortuous or calcified vascular system or traversing a hard lesion, an on-line (OTW) catheter or coaxial system is used. An OTW catheter has a lumen for a guidewire that extends the entire length of the catheter. This provides a relatively stable system because the guidewire is supported along its entire length. However, this system has some drawbacks compared to quick-change catheters, including higher friction and a longer overall length (see below). To remove or change an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must typically be longer than the OTW catheter. A 300cm guidewire is usually sufficient for this purpose and is often referred to as a change-length guidewire. Due to the guidewire length, two operators are required to remove or change the OTW catheter. This becomes more challenging if a triple coaxial system, known in the art as a triaxial system (quadriaxial catheters are also known), is used. However, due to its stability, the OTW system is frequently used in NVI and PVI procedures. On the other hand, PCI procedures typically use quick-change (or single-rail) catheters. In quick-change catheters, the guidewire lumen only extends through the distal segment of the catheter, known as the single-rail or quick-change (RX) segment. Using the RX system, operators can manipulate interventional devices in parallel with each other (unlike the OTW system, where devices are manipulated in a serial configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX segment of the catheter. Quick-change guidewire lengths are typically 180-200 cm. Due to the shorter guidewire and single-rail lengths, RX catheters can be changed by a single operator. However, RX catheters are often insufficient when more distal support is required. Summary of the Invention

[0007] According to an embodiment, a sterile barrier for a robot actuator includes a first drive module configured to move along a longitudinal axis of a drive body. The sterile barrier includes a first elastic member having a first free edge adjacent to the longitudinal axis. As the first drive module moves along the longitudinal axis, the first free edge adjacent to the first drive module is elastically biased away from the longitudinal axis and returns to the longitudinal axis.

[0008] In one embodiment, the sterile barrier includes a second elastic member having a second free edge adjacent to the longitudinal axis, wherein when the first drive module moves along the longitudinal axis between the first elastic member and the second elastic member, the second free edge adjacent to the first drive module is elastically biased away from the longitudinal axis and returns to the longitudinal axis.

[0009] In one embodiment, the sterile barrier includes a first rigid member removably coupled to the drive body, wherein a first elastic member is fixed to the first rigid member.

[0010] In one embodiment, the sterile barrier includes a flexible curtain connected to a first rigid member, the flexible curtain covering the drive body.

[0011] In one embodiment, the sterile barrier includes a first arm curtain member having a C-shaped clip removably attached to a portion of an arm supporting a drive body. The first arm curtain includes a lower arm curtain located below the arm, and wherein a flexible curtain includes an upper arm curtain section covering the upper portion of the arm, wherein the first arm curtain member and the upper arm curtain section cover the entire surface of the arm.

[0012] In one embodiment, the sterile barrier includes a second rigid member removably coupled to the drive body, wherein a second elastic member is fixed to the second rigid member.

[0013] In one embodiment, the first rigid member includes at least two sections that are folded in a packaging configuration and unfolded in an installation configuration.

[0014] In one embodiment, the first elastic member includes a first side and an opposite second side, with the first side facing the driving body.

[0015] In one embodiment, the first side of the first elastic member includes a first side and an opposite second side, and a portion of the first side contacts the outer surface of the first drive module when the first drive module moves along the longitudinal axis.

[0016] In one embodiment, the sterile barrier includes a second drive module that moves independently of the first drive module along the longitudinal axis of the drive body; wherein the first and second free edges of the sterile barrier adjacent to the second drive module elastically move away from the longitudinal axis and return to the longitudinal axis as the second drive module moves along the longitudinal axis.

[0017] In one embodiment, the sterile barrier includes a third drive module that moves independently of the first drive module and the second drive module along the longitudinal axis of the drive body; wherein the first free edge and the second free edge of the sterile barrier adjacent to the third drive module elastically move away from the longitudinal axis and return to the longitudinal axis as the third drive module moves along the longitudinal axis.

[0018] In one embodiment, the sterile barrier includes a first housing operably engaged with the transdermal device, the first housing being releasably secured to a first drive module, wherein the sterile barrier includes a drive module curtain secured to the first housing and removably covering a portion of the first drive module.

[0019] In one embodiment, the first box covers a first side of the first drive module and the drive module curtain covers at least one additional side of the first drive module.

[0020] In one implementation, the first box and drive module curtain substantially cover all sides of the first drive module.

[0021] In one implementation, the drive module curtain is a rigid member that is pivotally attached to the first box.

[0022] In one implementation, the drive module curtain is a flexible material fixed to the first box.

[0023] According to another embodiment, the catheter-based surgical system includes a robotic actuator comprising a drive body and a support arm. The drive body is supported by the support arm. A first drive module and a second drive module move along the longitudinal axis of the drive body. A sterile barrier includes a first flexible portion covering a portion of the support arm and the drive body, a second portion that is more rigid than the first flexible portion and removably connected to the drive body, and a third elastic portion extending from the second portion, the third elastic member having a first free edge close to the longitudinal axis and adjacent to the first drive module.

[0024] In one embodiment, the third elastic portion includes a second free edge that is separate from the first free edge and close to the longitudinal axis, and the first drive module is movable between the first free edge and the second free edge.

[0025] According to another embodiment, a method for applying a sterile barrier to a robot actuator having a drive body and a first drive module that moves along a longitudinal axis of the actuator includes: providing a sterile barrier having an elastic member having a first free edge; securing the sterile barrier to the drive body; and aligning the first free edge of the elastic member adjacent to the first drive module along the longitudinal axis of the drive body, wherein, as the first drive module moves along the longitudinal axis around the robot actuator, the first free edge adjacent to the first drive module is elastically biased away from the longitudinal axis and returns to the longitudinal axis.

[0026] In one embodiment, the method further includes securing a first box to an exposed portion of the first drive module, wherein the first box and the sterile barrier substantially cover all sides of the first drive module. The first box and the drive module curtain substantially cover all sides of the first drive module.

[0027] In one embodiment, the method further includes removably securing a rigid portion of the sterile barrier to the drive body. Attached Figure Description

[0028] The invention will be more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein reference numerals denote similar parts, and wherein: Figure 1 This is a perspective view of an exemplary catheter surgery system according to an embodiment; Figure 2 This is a schematic block diagram of an exemplary catheter surgery system according to an embodiment; Figure 3 This is a right perspective view of the curtain on a catheterization system; Figure 4 This is a left perspective view of the curtain on a catheterization system; Figure 5 This is an exploded view of the curtain assembly; Figure 6 This is an end view of the curtain on a catheterization system; Figure 7 It is roughly cut along line 7-7. Figure 6 A close-up image of the curtain on a catheterization surgical system; Figure 8 This is a close-up view of the elastic curtain section and the drive module; Figure 9 It is a perspective view of a box with a rigid curtain section; Figure 10 This is an end view of the box with the rigid curtain section on the catheterization system; Figure 11A This is an exploded view of the box attached to the drive module and the flexible curtain; Figure 11B This is an end view of the box with the flexible curtain section on the catheterization system; Figure 12 This is a side view of the first arm curtain that covers part of the robotic arm; Figure 13 yes Figure 12 A partial perspective view of the first arm curtain and the robotic arm; Figure 14 This is a partial perspective view of a sterile barrier system; Figure 15 It is a side view of a robot arm with a first and second arm curtain covering the robot arm; Figure 16 It is a partial perspective view of the first and second arm curtains fixed to the robot arm; Figure 17 It is a view of the robot driver, the box, the first arm curtain, the robot-driven curtain, and the second arm curtain; Figure 18 It is roughly along Figure 17 A close-up image taken from line 18-18; Figure 19 This is a perspective view of a sterile barrier system in a partially used location. Detailed Implementation

[0029] Figure 1This is a perspective view of an exemplary catheter-based surgical system 10 according to an embodiment. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as percutaneous coronary intervention (PCI) (e.g., treatment of STEMI), neurovascular intervention (NVI) (e.g., treatment of emergency large vessel occlusion (ELVO)), peripheral vascular intervention (PVI) (e.g., for severe limb ischemia (CLI), etc.). Catheter-based medical procedures may include diagnostic catheter insertion 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, during one embodiment of a catheter-based diagnostic procedure, contrast agent is injected through a catheter onto one or more arteries, and images of the patient's vascular system are taken. Catheter-based medical procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, treatment of arteriovenous malformations, treatment of aneurysms, etc.), during which a catheter (or other EMD) is used to treat the condition. The therapeutic procedure may include an accessory device 54 (such as... Figure 2 As shown), enhancements can be achieved using techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous interventional devices or components (e.g., type of guidewire, type of catheter, etc.) can be selected based on the type of procedure to be performed. The catheter-based surgical system 10 can perform any number of catheter-based medical procedures with only minor adjustments to accommodate the specific percutaneous interventional device used in the procedure.

[0030] The catheter-based surgical system 10 includes a bedside unit 20, a control station (not shown), and other components. The bedside unit 20 includes a robot actuator 24 positioned adjacent to the patient 12 and a positioning system 22. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robot actuator 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a retainer, etc. One end of the positioning system 22 can be attached to, for example, the patient table 18 (e.g., ...). Figure 1 The positioning system 22 is attached to the base or trolley. The other end of the positioning system 22 is attached to the robot actuator 24. The positioning system 22 (along with the robot actuator 24) can be removed to allow patient 12 to be placed on the patient table 18. Once patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robot actuator 24 relative to patient 12 for surgery. In one embodiment, the patient table 18 is operatively supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of moving relative to the base 17 in multiple degrees of freedom, such as rolling, pitching, and yaw. The bedside unit 20 may also include controls and a display 46 (e.g., ...). Figure 2(As shown). For example, controls and displays can be located on the housing of the robot driver 24.

[0031] Typically, the robot actuator 24 can be equipped with appropriate percutaneous intervention devices and accessories 48 (such as...). Figure 2 (As shown) (e.g., guidewires, various types of catheters, including balloon catheters, stent delivery systems, stent retrieval devices, embolization coils, fluid embolization, aspiration pumps, contrast agent delivery devices, medications, hemostatic valve adapters, syringes, stopcock valves, inflation devices, etc.), to allow a user or operator to perform catheter-based medical procedures via a robotic system by operating various controls (such as controls and inputs located at a control station). Bedside unit 20, particularly robotic actuator 24, may include any number and / or combination of components to provide the functionality described herein to bedside unit 20. Robotic actuator 24 includes multiple device modules 32a-d mounted to a track or linear member. Each device module 32a-d can be used to drive an EMD, such as a catheter or guidewire. For example, robotic actuator 24 can be used to automatically advance a guidewire into a diagnostic catheter and into a guiding catheter in an artery of patient 12. One or more devices, such as EMDs, enter the body (e.g., a blood vessel) of patient 12 at insertion point 16 via, for example, an introducer sheath.

[0032] Bedside unit 20 communicates with a control station (not shown), allowing signals generated by user input from the control station to be transmitted wirelessly or via hardwired to bedside unit 20 to control various functions of bedside unit 20. As discussed below, control station 26 may include control computing system 34 (such as...). Figure 2 (As shown) or connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also connect to the control station, control computing system 34 (as shown) Figure 2 (as shown) or both provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.). Communication between the control computing system 34 and the various components of the catheter-based surgical system 10 can be provided via a communication link, which can be a wireless connection, a cable connection, or any other means that allows communication between components. The control station or other similar control system can be located at a local site (e.g., Figure 2 The local control station 38 shown) or remote station (e.g., Figure 2The remote control station and computer system 42 are shown. The catheterization system 10 can be operated by a control station at a local site, by a control station at a remote site, or by both a local and a remote control station simultaneously. At the local site, the user or operator and the control station are located in the same room or adjacent to the patient 12 and the bedside unit 20. As used herein, the local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., an animal or a cadaver), and the remote site is the location of the user or operator and the control station used for remotely controlling the bedside unit 20. For example, the control station (and control computing system) at the remote site and the bedside unit 20 and / or control computing system at the local site can use a communication system and server 36 ( Figure 2 (As shown) Communicates via the Internet. In this embodiment, the remote site and the local (patient) site are geographically separated, for example, in different rooms within the same building, different buildings within the same city, different cities, or the remote site cannot physically access the bedside unit 20 and / or other different locations of the patient 12 from the local site.

[0033] The control station typically includes one or more input modules 28 configured to receive user input to operate various components or systems of the catheter-based surgical system 10. In the illustrated embodiment, the control station allows a user or operator to control the bedside unit 20 to perform catheter-based medical procedures. For example, the input modules 28 may be configured to cause the bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., an EMD) connected to a robot actuator 24 (e.g., advancing, retracting, or rotating a guidewire; advancing, retracting, or rotating a catheter; inflating or deflating a balloon located on the catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retrieval device; positioning and / or deploying a coil; injecting contrast agent into the catheter; injecting a fluid embolism into the catheter; injecting medication or saline into the catheter; aspirating from the catheter; or performing any other function that may be performed as part of a catheter-based medical procedure). The robot actuator 24 includes various actuation mechanisms to cause movement (e.g., axial and rotational movement) of the components of the bedside unit 20, including the percutaneous interventional device.

[0034] 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 also use additional user controls 44 (such as…). Figure 2As shown), such as a foot switch and a microphone for voice commands. Input module 28 can be configured to advance, retract, or rotate various components and percutaneous interventional devices, such as guidewires, and one or more catheters or microcatheters. Buttons may include, for example, an emergency stop button, a multiplier button, a device selection button, and an automatic movement button. When the emergency stop button is pressed, the power (e.g., electrical power) to bedside unit 20 is cut off or removed. In speed control mode, the multiplier button is used to increase or decrease the speed at which the relevant component moves in response to manipulation of input module 28. In position control mode, the multiplier button changes the mapping between input distance and output command distance. The device selection button allows the user or operator to select which percutaneous interventional devices loaded into robot actuator 24 are controlled by input module 28. The automatic movement button is used to enable algorithmic movement that the catheter-based surgical system 10 can perform on percutaneous interventional devices without direct commands from the user or operator 11. In one embodiment, 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 a display) that, when activated, cause operation of components of the catheter-based surgical system 10. Input module 28 may also include balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., which can be used to control one or more specific components dedicated to that control. Furthermore, one or more touchscreens may display one or more icons (not shown) associated with various parts of input module 28 or with various components of the catheter-based surgical system 10.

[0035] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with catheter-based medical procedures (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 imaging device that communicates with a control station. In one embodiment, the imaging system 14 may include a C-arm (such as...) Figure 1 As shown, the C-arm allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images (e.g., sagittal view, tail view, anterior and posterior view, etc.) at different angular positions relative to the patient 12. In one embodiment, the imaging system 14 is a fluorescence fluoroscopy system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0036] Imaging system 14 can be configured to take X-ray images of appropriate areas of patient 12 during surgery. For example, imaging system 14 can be configured to take one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to take one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to help the user or operator 11 of control station 26 correctly position guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, balloons, etc., during surgery. One or more images can be displayed on display 30. For example, images can be displayed on the display to allow the user or operator to move the guiding catheter or guidewire accurately to the appropriate position.

[0037] To define directions, a Cartesian coordinate system with X, Y, and Z axes is introduced. The positive X-axis is oriented in the longitudinal (axial) direction, that is, in the direction from the proximal end to the distal end; in other words, from the proximal direction to the distal direction. The Y and Z axes lie in the transverse plane of the X-axis, with the positive Z-axis oriented upwards, that is, in the direction opposite to gravity, and the Y-axis is automatically determined by the right-hand rule.

[0038] Figure 2This is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter-based surgical system 10 may include a control computing system 34. The control computing system 34 may be physically, for example, part of a control station. The control computing system 34 may typically be an electronic control unit adapted to provide the various functions described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The control computing system 34 communicates with a bedside unit 20, a communication system and server 36 (e.g., the Internet, firewall, cloud server, session manager, hospital network, etc.), a local control station 38, an additional communication system 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). The control computing system also communicates with the imaging system 14, patient table 18, auxiliary medical system 50, contrast agent injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. As described above, the additional controls and display may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) are connected to the bedside system 20. In embodiments, interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for contrast imaging, etc.) connected to their respective auxiliary devices 54, i.e., the IVUS system, OCT system, and FFR system, etc.

[0039] In various embodiments, the control computing system 34 is configured to generate control signals based on user interaction with input modules 28 (e.g., a control station such as local control station 38 or remote control station 42) and / or based on information accessible to the control computing system 34, thereby enabling the performance of medical procedures using the catheter-based surgical system 10. 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 computing system 42 may include components similar to those of the local control station 38. The remote control station 42 and the local control station 38 may be different and may be customized based on their required functionality. The additional user controls 44 may include, for example, one or more foot input controls. The foot input controls may be configured to allow the user to select functions of the imaging system 14, such as turning X-rays on and off and scrolling through different stored images. In another embodiment, the foot input device may be configured to allow the user to select which devices are mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) can be used to help operators interact with patients, medical staff (e.g., vascular kit personnel) and / or bedside devices.

[0040] The catheter-based surgical system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for restricting access to or use of the catheter-based surgical system 10, etc.

[0041] As mentioned, the control computing system 34 communicates with the bedside unit 20, which includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. The bedside unit 20 can provide control signals to the bedside unit 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 robot actuator 24.

[0042] refer to Figure 3The robot actuator 24 includes a drive body 100 having a top wall 102, a proximal wall 104, a distal wall 106, a first longitudinal wall 108, and a second longitudinal wall 110. When the robot actuator 24 is in the use position on the patient table 18, the top wall 102 is the wall furthest from the patient table 18, and the proximal wall 104 is the wall closest to or closest to the feet of the patient table 18. The distal wall 106 is the wall furthest from or closest to the head of the patient table 18. The first longitudinal wall 108 and the second longitudinal wall 110 are the walls closest to and furthest from the bed track 112, which is closest to the base of the positioning system 22. When the robot actuator 24 is in the use position, the drive body 100 includes a bottom wall 114 closest to the patient table 18. The bottom wall 114 has a groove 116 extending longitudinally between the proximal wall 104 and the distal wall 106.

[0043] The first device module 32a includes a drive module 118 driven along the longitudinal axis 128 of the drive body 100, and a connecting platform member 120 extending through a slot 116 and operably engaging with a drive mechanism that moves the drive module 118 along the longitudinal axis of the drive body 100. The drive body 100 and drive module 118 of the robot actuator 24 are basic equipment and are not part of the sterile portion of the bedside unit 20.

[0044] refer to Figure 7 and Figure 8 The sterile barrier 122 includes a first elastic member 124 having a first free edge 126 adjacent to a longitudinal axis 128. The longitudinal axis 128 is the axis along which the drive module moves. The sterile barrier 122 provides a sterile barrier between the bottom wall 114 and the groove 116 of the drive body 100. As the first drive module 32a moves along the longitudinal axis, a portion of the first free edge 126 adjacent to the first drive module 32a is elastically biased away from the longitudinal axis and returns to the longitudinal axis. The first elastic member 124 extends from the proximal end of the groove 116 to the distal end of the groove 116, such that substantially the entire groove 116 is covered. Only a portion of the first free edge 126 of the first elastic member 124 immediately adjacent to the first drive module 32a is biased away from the longitudinal axis. In other words, the portion of the first free edge 126 of the first elastic member 124 located distal to the first drive module 32a is not biased away from the longitudinal axis. For example and with reference to… Figure 8The region of the first free edge 126 adjacent to point A, which is immediately adjacent to the first drive module 32a, is biased away from the longitudinal axis 128. Once the first drive module 32a moves along the longitudinal axis 128 such that the region of the first free edge 126 adjacent to point A is no longer immediately adjacent to the first drive module 32a, the region of the first free edge 126 adjacent to point A will elastically return to the longitudinal axis. In one embodiment, the free edges of the first elastic member 124 and the second elastic member 130 move from the longitudinal axis or a stress-free position and return to the longitudinal axis or a stress-free position within a distance of 0.75 cm from the contact drive module curtain 158. In one embodiment, the free edges of the first elastic member 124 and the second elastic member 130 move from their stress-free positions and return to their stress-free positions within a distance of less than 1.0 cm. In one embodiment, the free edges of the first elastic member 124 and the second elastic member 130 move from their stress-free positions and return to their stress-free positions within a distance of less than 0.5 cm.

[0045] In one embodiment, the robot actuator 24 includes a second device module 32b, which includes a separate drive module and a separate stage extending through the slot 116. The second device module 32b translates independently of the first drive module 32a along the longitudinal axis of the drive body. In the presence of two separate drive modules, a second portion of the first elastic member 124 adjacent to the second device module 32b is biased away from the longitudinal axis. In the embodiment of two independently moving drive modules, the first and second portions adjacent to the first drive module 32a and the second device module 32b, respectively, are biased away from the longitudinal axis, while the remaining portions of the first elastic member 124 not adjacent to the first drive module 32a and the second device module 32b are not biased away from the longitudinal axis of the drive body. Similarly, in the presence of more than two drive modules, only the portion of the first elastic member 124 adjacent to each drive module will be biased away from the longitudinal axis of the drive body. Each portion of the first elastic member 124 biased away from the longitudinal axis of the drive body returns to a stress-free state, such that the first free edge 126 of that portion returns to a position close to the longitudinal axis of the drive body. In this way, the slot 116 between the drive modules is substantially covered by the first elastic member 124. In other words, in one embodiment, the third drive module moves independently of the first and second drive modules along the longitudinal axis of the drive body. As the third drive module moves along the longitudinal axis, a portion of the first free edge 126 and a portion of the second free edge 132 adjacent to the third drive module elastically move away from the longitudinal axis and back to the longitudinal axis.

[0046] refer to Figure 6 and Figure 7In one embodiment, the sterile barrier 122 includes a second elastic member 130 having a second free edge 132 adjacent to the first elastic member 124. In one embodiment, the first elastic member 124 and the second free edge 132 overlap. In one embodiment, the first elastic member 124 and the second free edge 132 are in close abutment. In one embodiment, the first elastic member 124 and the second free edge 132 are spaced apart from each other by a predetermined distance. The first elastic member 124 extends from a first edge of the groove 116, and the second elastic member 130 extends from a second edge of the groove 116. The second elastic member 130 is formed of an elastic material such that the second free edge 132 adjacent to the drive module is biased away from the longitudinal axis. In one embodiment, the first elastic member 124 and the second elastic member 130 are made of the same material. In one embodiment, the first elastic member 124 and the second elastic member 130 are made of different materials.

[0047] refer to Figure 7 The first elastic member 124 includes a first side 134 and an opposing second side 136. The first side 134 faces the bottom wall 114 and the groove 116, and the second side 136 faces away from the bottom wall 114 and the groove 116. The region of the first side 134 of the first elastic member 124 adjacent to the device module is biased away from the bottom wall 114 and the groove 116, and returns towards the bottom wall 114 and the groove 116 once the device module is no longer adjacent. As the first drive module moves along the longitudinal axis, a portion of the first side 134 contacts the outer surface of the first drive module. In this way, the second side 134 maintains a partially sterile environment while the first side 134 contacts the non-sterile environment of the robot actuator 24.

[0048] Similarly, the second resilient member 130 includes a first side 138 and a second side 140. The first side 138 faces the bottom wall 114 and the slot 116, and the second side 140 faces away from the bottom wall 114 and the slot 116. The area of ​​the second resilient member 130 adjacent to the device module is biased away from the bottom wall 114 and the slot 116, and returns towards the bottom wall 114 and the slot 116 once the device module is no longer adjacent. In this way, the second side 140 maintains a partially sterile environment, while the first side 138 contacts the non-sterile environment of the robot actuator 24.

[0049] The platform portion of each drive module extends between the first free edge 126 of the first elastic member 124 and the second free edge 132 of the second elastic member 130. In one embodiment, a region adjacent to the first side 134 of the first elastic member 124 and a region adjacent to the first side 138 of the second elastic member of each drive module contacts a portion of the drive module.

[0050] refer to Figure 7The longitudinal portion 142 of the first elastic member 124, away from the first free edge 126, is fixed to the drive body 100, and the longitudinal portion 144 of the second elastic member 130, away from the free edge 132, is fixed to the drive body 100. In one embodiment, the first rigid member 146 is releasably fixed to the drive body 100, and the first elastic member 124 is fixed to the first rigid member 146. The first elastic member 124 is fixed to the drive body 100 via the first rigid member 146. In one embodiment, the first rigid member 146 is positioned along the first wall portion 148 of the first rigid member 146 in a fixed position. Figure 5 The first rigid member 146 includes a second wall portion 150 that extends away from the first wall portion 148 and is positioned adjacent to the bottom wall 114. Figure 5 In one embodiment, the first wall portion 148 is fixed to the drive body 100 on the first longitudinal wall 108. In one embodiment, the second wall portion 150 is fixed to the bottom wall 114.

[0051] Second rigid member 152 ( Figure 5 The second rigid member 152 is removably fixed to the bottom wall 114 of the drive body 100. The second elastic member 130 is fixed to the longitudinal portion of the second rigid member 152.

[0052] The first rigid member 146 and the second rigid member 152 are connected to the drive body 100 via a connector such as a fastener, magnet, hook, or other known connector. Since the first elastic member is fixed to the first rigid member and the second elastic member is fixed to the second rigid member, the first elastic member is removably connected to the drive body 100.

[0053] In one embodiment, the first box 154 of the transdermal device is operably engaged. Figure 9 The housing 154 is releasably fixed to the first drive module 32a. The housing 154 is fixed to the first drive module 32a such that the first wall portion 148 of the first rigid member 146 ( Figure 5 It is located between the drive body 100 and the first box 154. Box 154 is part of the sterile environment and is separated from the drive body 100 by a sterile barrier 122.

[0054] refer to Figure 3 , Figure 4 and Figure 5The sterile barrier 122 includes a flexible curtain portion 156 covering a portion of the robot actuator 24 and the positioning system 22. The flexible curtain covers at least a portion of the top wall 102, proximal sidewall 104, distal sidewall 106, second longitudinal wall 110, and first longitudinal wall 108. In one embodiment, a first rigid member 146 also covers a portion of the bottom wall 114. In one embodiment, the first rigid member 146 is secured to the flexible curtain portion 156 such that the entire first longitudinal wall 108 is covered by the sterile barrier 122. In one embodiment, a second rigid member 152 is secured to the flexible curtain portion 156 covering at least a portion of the bottom wall 114. In one embodiment, the flexible curtain portion 156 is formed of a polyethylene material with a thickness of 0.002 inches (0.00508 cm), or other materials known in the art may be used. The first rigid member 146 is formed of a polycarbonate material with a thickness of 0.03 inches (0.0762 cm), or other materials known in the art may be used. The first elastic member 124 and the second elastic member 130 are formed of EPDM (ethylene propylene diene monomer) rubber with a thickness of 1 / 32 inch (0.0794 cm). The first rigid member 146 has a greater stiffness than the flexible curtain portion 156. The first elastic member 124 and the second elastic member 130 are more elastic than the flexible curtain portion 156. In one embodiment, the first wall portion 148 is secured to the flexible curtain portion 156 to form a continuous sterile barrier. The first wall portion 148 is secured to the flexible curtain portion 156 by adhesive bonding, acoustic welding, mechanical fasteners, tape, or other connection methods known in the art. The second rigid member 152 is similarly fastened to a portion of the flexible curtain portion 156 in a similar manner. The first elastic member 124 and the second side 140 are similarly secured to the first rigid member 146 and the second rigid member 152, respectively. The second rigid member 152 may also be attached to a portion of the flexible curtain portion 156 in a similar manner. The flexible curtain portion 156 may have slits or free edges to allow easy mounting to the robot actuator 24 and positioning system 22, and the slits may be covered by tape or other mechanical fasteners known in the art.

[0055] refer to Figure 9 and Figure 10The drive module curtain 158 is fixed to the housing 154. In one embodiment, the drive module curtain 158 is pivotally fixed to the housing 154 to releasably cover a portion of the drive module 118. The drive module curtain 158 moves from an uncovered position to a covered position. The drive module curtain 158 includes a bottom wall, a first side wall, a second side wall, and a third rear wall. In the covered position, the drive module curtain 158 covers at least a portion of at least one of the bottom wall, the first side wall, the second side wall, and the third rear wall of the drive module 118. In one embodiment, the housing 154 is releasably fixed to at least one side of the drive module 118. In one embodiment, substantially all of the drive module 118 is covered by the drive module curtain 158 and the housing 154. In one embodiment, the drive module curtain is rigid and includes fasteners for securing the drive module curtain 158 to the housing 154.

[0056] refer to Figure 11A and Figure 11B The drive module curtain 158 is a flexible, bag-shaped member with an opening, sidewalls, and a bottom, which is removably positioned above the drive module 118 to substantially cover the exposed portion of the drive module 118. In one embodiment, the flexible drive module curtain 158 is also attached to a portion of the housing 154.

[0057] In one embodiment, a sterile barrier 122 covers a robot actuator including a support arm of a positioning system 22 and a drive body 100 supported by the support arm. A first drive module 32a and a second drive module 32b are movable along the longitudinal axis of the drive body 100. The sterile barrier 122 includes a first flexible portion 156 covering a portion of the robot arm and the drive body 100, and a second rigid member 146 that is more rigid than the first flexible portion 156. The second rigid portion 146 is removably connected to the drive body 100. The sterile barrier 122 also includes an elastic member 130 extending from the second rigid member 152, the elastic member 130 having a first free edge 132 adjacent to the longitudinal axis of the drive body and adjacent to the first actuator 32a. In one embodiment, the elastic member 130 includes a free edge 132 separated from the first free edge 126 and adjacent to the longitudinal axis, and the drive module 32a is movable between the first free edge and the second free edge.

[0058] refer to Figure 9 , Figure 10 , Figure 11A and Figure 11BIn one embodiment, the bedside unit 20 has a robot actuator 24 with a first drive module that moves along the longitudinal axis of the drive body. A first box is removably connected to the first drive module. A drive module curtain is attached to the first box and removably covers a portion of the first drive module. In one embodiment, the drive module curtain is formed of a rigid material operably fixed to the box. In one embodiment, the drive module curtain is formed of a flexible material operably fixed to the box.

[0059] refer to Figure 12 In one embodiment, the sterile barrier system 200 includes a bottom arm sterile barrier 202 that covers the bottom portion of the positioning system 22. The bottom arm sterile barrier 202 may also be used in conjunction with the sterile barrier 122 discussed herein.

[0060] The bottom arm sterile barrier 202 includes a flexible curtain portion 204 coupled to a clip 206, which is removably coupled to a positioning system 22 surrounding an upper rotary joint 22a. The bottom arm sterile barrier 202 extends from the clip 206 below the positioning system 22 from the upper rotary joint 22a to the bottom rotary joint 22c. (Reference) Figure 13 A pair of strips 208a and 208b extending from the end of the flexible curtain portion 204 are secured to the base portion positioning system 22. In this way, the flexible curtain portion 204 covers the bottom portion of the positioning system 22. In one embodiment, the bottom arm sterile barrier 202 includes a recess (not shown) secured to the flexible curtain portion 204 adjacent to the clip 206 to allow a user to position the clip 206 onto the positioning system 22 without the user contacting the sterile portion of the flexible curtain portion 204.

[0061] refer to Figure 14 The sterile barrier system 200 includes a distal curtain portion 210 defining an internal cavity that is pulled across the distal end of the robot actuator 24. The distal curtain portion 210 includes a first recess 212a on its outer portion, allowing a user to place their hand within the first recess 212a to pull the distal curtain portion 210 across the distal end of the robot actuator 24. In one embodiment, a second recess 212b on the distal curtain portion 210 allows a user to place a second hand within the second recess 212b to assist with pulling the distal curtain portion 210 across the distal end of the robot actuator 24. In one embodiment, the distal curtain portion 210 extends a predetermined distance from the distal end of the robot actuator 24 toward the proximal end of the robot actuator 24, wherein this predetermined distance does not extend along the entire length of the robot actuator 24 along its longitudinal axis.

[0062] In one embodiment, a first portion of the latch (not shown) latches onto a second portion of the latch on the top wall 102 of the robot actuator 24. Other attachment features are also conceivable, such as magnets on the top wall 102 of the robot actuator 24, which are releasably fixed to a magnetically affinity material (such as a metal disc or washer) on the distal curtain portion 210.

[0063] In one embodiment, the sterile barrier system 200 includes a second flexible curtain portion 214 that covers a portion of the first longitudinal wall 108, the top wall 102, and the second longitudinal wall 110. A distal portion of the second flexible curtain portion 214 is secured to the distal curtain portion 210. The sterile barrier system 200 includes a first rigid member system 216 similar to a first rigid member 146 of the sterile barrier 122. In one embodiment, the first rigid member system 216 has a plurality of adjacent segments 216a, 216b, 216c, and 216d, which allow each segment to fold over the other for easy packaging, transport, and unfolding. Although the rigid member system 216 is shown in one embodiment as having four segments, it is conceivable that the rigid member system 216 may include one or more segments. In one embodiment, the number of folds is 2. In one embodiment, the number of folds is 3. In one embodiment, the number of folds is between 2 and 4, including 2 to 4. In one embodiment, the number of folds is greater than 4. Each segment of the rigid member system 216 is connected to adjacent segments via a movable hinge, wherein the term movable hinge refers to a thin, flexible hinge made of the same material as the two rigid members to which it is connected. In one embodiment, each segment is not directly connected at its proximal and / or distal ends, and in another embodiment, each adjacent segment is connected by a flexible material, thereby allowing these segments to fold one over the other like an accordion. Each segment of the rigid member system 216 has an upper longitudinal edge and a lower longitudinal edge.

[0064] The rigid member system 216 deploys and is secured to the proximal end of the robot actuator 24. In one embodiment, the proximal end of the rigid member system 216 includes a proximal portion comprising a proximal cavity located above and covering the proximal end of the robot actuator 24. In one embodiment, the rigid member system 216 is secured to a front portion of the robot actuator 24 by a snap-fit ​​feature (or other attachment mechanisms discussed above and known in the art), wherein a portion of the snap-fit ​​is secured to the rigid member system 216 and a second snap-fit ​​feature is secured to the front portion of the robot actuator 24. In one embodiment (… Figure 19Each folded segment of the rigid component system 216 is secured to the first longitudinal wall 108 of the robot actuator 24. Each folded segment of the rigid component system 216 can be secured using snap-fit ​​connections as discussed herein, wherein a first portion of each snap-fit ​​connection is secured to the robot actuator and a second portion of each snap-fit ​​connection is secured to each folded segment. In one embodiment, each folded portion of the rigid component system 216 is secured to the first longitudinal wall 108 of the robot actuator 24 by a magnetic connection, wherein one of the robot actuator 24 and the rigid component system 216 includes a magnet, and the other of the robot actuator 24 and the rigid component system includes a metal disk or component magnetically connected to the corresponding magnet.

[0065] A portion of the second flexible curtain section 214 is fixed to the rigid member system 216 and is in a folded orientation during packaging. (See reference) Figure 19 The rigid component system 216 is deployed and secured to the robot actuator 24, and then the user positions the second flexible curtain portion 214 to cover the first longitudinal wall 108 upwards, across the top wall 102, and downwards along the second longitudinal wall 110. However, it is also conceivable that the second flexible curtain portion 214 would cover the first longitudinal wall 108, the top wall 102, and the second longitudinal wall 110 before the rigid component system 216 is secured to the robot actuator 24.

[0066] The upper arm curtain portion 218 extends from the second flexible curtain portion 214. (Reference) Figure 15 and Figure 16 Part 218 is placed on the top positioning system 22. The free end of part 218 is secured to the base portion of the positioning system by a pair of strips 220a and 220b. Part 218 includes a first edge and a second edge extending above the longitudinal edge of the bottom arm sterile barrier 202. Strip members 222 secure the bottom arm sterile barrier 202 and part 218 to the positioning system 22, with sufficient space between them to allow movement of rotary joints 22a, 22b, and 22c, and arms 22e and 22d extending between the rotary joints.

[0067] refer to Figure 5 , Figure 17 and Figure 18 Each segment of the rigid member system 216 has an L-shape, which includes a front panel 224 adjacent to the first longitudinal wall 108 of the robot actuator 24 and a second shorter portion 226 adjacent to the bottom wall 114 or the robot actuator 24. Note that the L-shape of the rigid member system 216 is similar to that of the rigid member 146 (see [link to rigid member system 216]). Figure 5The first elastic member 124 is secured to the second shorter portion 226 of the rigid member system 216 and operates in the same manner as the first elastic member 124 described above with respect to the sterile barrier 122. The second rigid member 230 is secured to the bottom wall 114. The second elastic member 130 is secured to the second rigid member 230 and operates in the same manner as the second elastic member 130 described above with respect to the sterile barrier 122. In one embodiment, the second rigid member 230 is not connected to the flexible curtain portion of the sterile barrier system 200. As discussed herein, sections of the rigid member system 216 may have movable hinges or flexible materials connecting adjacent sections; however, in one embodiment, the first member 130 is continuous and does not have movable hinges but is flexible enough to allow the second elastic member 130 to bend to allow the second elastic member 130 to be packaged with folded sections of the rigid member system 216. In one embodiment, the second elastic member 130 does have movable hinges or flexible materials corresponding to the movable hinges or flexible materials of the rigid member system 216.

[0068] In operation, the sterile barrier system 200 is folded and oriented, packaged, and placed in a bag before use. In one embodiment, the sterile barrier system 200 includes a bottom arm sterile barrier 202 covering the bottom of the positioning system 22 and a second curtain covering the top portion of the robot actuator 24 and the positioning system 22. In one embodiment, the bottom arm sterile barrier 202 and the second curtain are combined and packaged together.

[0069] The user picks up the bottom arm sterile barrier 202 and places their hand in a recess formed in a portion of the bottom arm sterile barrier 202. The user then attaches a flexible portion of the bottom arm sterile barrier 202 to a portion of the positioning system using clips while keeping their hand in the recess. A strip extending from the flexible portion of the bottom arm sterile barrier 202 is placed on the patient table, and the user then wraps the strip around the base portion of the positioning system and secures the strips to each other using fasteners such as hook-and-loop fasteners (e.g., Velcro), thereby securing the bottom arm sterile barrier 202 to the positioning system.

[0070] The user then grasps the folded rigid plate sections 216a-216d and inserts their hand into the first recess 212a. The user then unfolds their hand to place the distal curtain portion 210 onto the distal portion of the robot actuator 24. A snap fastener positioned adjacent to the first recess 212a is then attached to a corresponding snap fastener on the robot actuator housing to secure the distal curtain portion 210 to the robot actuator.

[0071] The user then unfolds one folded rigid panel segment at a time, ensuring they are flush with the first longitudinal wall 108 (the user-facing wall) of the robot actuator housing. The user then uses their right index and middle fingers to press the snap-fit ​​features on the recesses adjacent to the nearest rigid panel segment and the corresponding engaging snap-fit ​​features on the robot actuator to secure the curtain to the robot actuator. The user places each hand into its respective nearest recess, guiding the curtain over the top of the robot actuator with one hand and guiding it behind the actuator with the other. Using the engaging snap-fit ​​features, the user snaps the curtain to the back of the actuator, thus securing the curtain to the back of the robot actuator. The user then uses tabs on the curtain to lift a portion of it upwards and over the robot actuator housing.

[0072] The user then separates the bottom elastic panel from the now unfolded folding panel and uses the mating snap feature to secure a portion of the first elastic member 124 to the bottom of the robot driver housing, and secures a portion of the second elastic member 130 to the rear portion of the bottom of the robot driver housing.

[0073] The user then places the upper positioning system portion of the curtain on top of the positioning system. Using strips, the upper positioning portion of the curtain is secured to the sterile barrier 202 of the bottom arm to completely cover the positioning system. In one embodiment, the positioning system is a hinged arm. While snaps are indicated as some attachment features, other connection methods known in the art are also conceivable. As a non-limiting example, magnets, tapes, hooks, and other mechanical, electromechanical, and chemical connections may be used in combination with or in place of the mechanical snaps and hook-and-loop connectors described herein.

[0074] Although this disclosure has been described with reference to exemplary embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of the subject matter. For example, while different exemplary embodiments may have been described as including one or more features that provide one or more benefits, it is conceivable that the described features may be interchanged or alternatively combined with each other in the described exemplary embodiments or in other alternative embodiments. Due to the relative complexity of the technology of this disclosure, not all technical variations are foreseeable. The description of this disclosure is obviously intended to be as broad as possible. For example, unless otherwise specifically stated, the enumeration of a single particular element also includes multiple such particular elements.

Claims

1. A method of applying a sterile barrier over a robotic drive having a drive body and a first drive module that moves along a longitudinal axis of the drive body, the method comprising: providing a sterile barrier having a resilient member with a first free edge; securing the sterile barrier to the drive body with the first free edge of the resilient member aligned adjacent the first drive module along the longitudinal axis of the drive body, the first free edge adjacent the first drive module being resiliently biased away from and back toward the longitudinal axis as the first drive module moves about the robotic drive along the longitudinal axis.

2. The method of claim 1, further comprising securing a first cassette to an exposed portion of the first drive module, wherein, the first cassette and the sterile barrier substantially covering all sides of the first drive module.

3. The method of claim 2, further comprising removably securing the rigid portion of the sterile barrier to the drive body.

4. A method of applying a sterile barrier over a robotic drive having a drive body and a first drive module that moves along a longitudinal axis of the drive body, the method comprising: providing a robotic drive body; providing a support arm that supports the robotic drive body; providing a first drive module configured to move along a longitudinal axis of the robotic drive body; providing a second drive module configured to move along a longitudinal axis of the robotic drive body, the second drive module being separate from the first drive module; and providing a sterile barrier comprising a first resilient member having a first free edge proximate the longitudinal axis; securing the sterile barrier to the drive body with the first free edge of the resilient member aligned adjacent the first drive module along the longitudinal axis of the drive body, the first free edge adjacent the first drive module being resiliently biased away from and back toward the longitudinal axis as the first drive module moves about the robotic drive along the longitudinal axis. ​

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