Patent Description:
The present invention relates generally to the field of robotic medical procedure systems and, in particular, to a drape system for separating a non-sterile portion of a robotic drive from a sterile portion of the robotic drive.

Catheters and other elongated medical devices (EMDs) may be used for minimally-invasive medical procedures for the diagnosis and treatment of diseases of various vascular systems, including neurovascular intervention (NVI) also known as neurointerventional surgery, percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vasculature, and via the guidewire advancing a catheter to deliver therapy. The catheterization procedure starts by gaining access into the appropriate vessel, such as an artery or vein, with an introducer sheath using standard percutaneous techniques. Through the introducer sheath, a sheath or guide catheter is then advanced over a diagnostic guidewire to a primary location such as an internal carotid artery for NVI, a coronary ostium for PCI, or a superficial femoral artery for PVI. A guidewire suitable for the vasculature is then navigated through the sheath or guide catheter to a target location in the vasculature. In certain situations, such as in tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to assist in navigating the guidewire. The physician or operator may use an imaging system (e.g., fluoroscope) to obtain a cine with a contrast injection and select a fixed frame for use as a roadmap to navigate the guidewire or catheter to the target location, for example, a lesion. Contrast-enhanced images are also obtained while the physician delivers the guidewire or catheter so that the physician can verify that the device is moving along the correct path to the target location. While observing the anatomy using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to direct the distal tip into the appropriate vessels toward the lesion or target anatomical location and avoid advancing into side branches.

Robotic catheter-based procedure systems have been developed that may be used to aid a physician in performing catheterization procedures such as, for example, NVI, PCI and PVI. Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke. In an NVI procedure, the physician uses a robotic system to gain target lesion access by controlling the manipulation of a neurovascular guidewire and microcatheter to deliver the therapy to restore normal blood flow. Target access is enabled by the sheath or guide catheter but may also require an intermediate catheter for more distal territory or to provide adequate support for the microcatheter and guidewire. The distal tip of a guidewire is navigated into, or past, the lesion depending on the type of lesion and treatment. For treating aneurysms, the microcatheter is advanced into the lesion and the guidewire is removed and several embolization coils are deployed into the aneurysm through the microcatheter and used to block blood flow into the aneurysm. For treating arteriovenous malformations, a liquid embolic is injected into the malformation via a microcatheter. Mechanical thrombectomy to treat vessel occlusions can be achieved either through aspiration and/or use of a stent retriever. Depending on the location of the clot, aspiration is either done through an aspiration catheter, or through a microcatheter for smaller arteries. Once the aspiration catheter is at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retriever through the microcatheter. Once the clot has integrated into the stent retriever, the clot is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

In PCI, the physician uses a robotic system to gain lesion access by manipulating a coronary guidewire to deliver the therapy and restore normal blood flow. The access is enabled by seating a guide catheter in a coronary ostium. The distal tip of the guidewire is navigated past the lesion and, for complex anatomies, a microcatheter may be used to provide adequate support for the guidewire. The blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may need preparation prior to stenting, by either delivering a balloon for pre-dilation of the lesion, or by performing atherectomy using, for example, a laser or rotational atherectomy catheter and a balloon over the guidewire. Diagnostic imaging and physiological measurements may be performed to determine appropriate therapy by using imaging catheters or fractional flow reserve (FFR) measurements.

In PVI, the physician uses a robotic system to deliver the therapy and restore blood flow with techniques similar to NVI. The distal tip of the guidewire is navigated past the lesion and a microcatheter may be used to provide adequate support for the guidewire for complex anatomies. The blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging may be used as well.

When support at the distal end of a catheter or guidewire is needed, for example, to navigate tortuous or calcified vasculature, to reach distal anatomical locations, or to cross hard lesions, an over-the-wire (OTW) catheter or coaxial system is used. An OTW catheter has a lumen for the guidewire that extends the full length of the catheter. This provides a relatively stable system because the guidewire is supported along the whole length. This system, however, has some disadvantages, including higher friction, and longer overall length compared to rapid-exchange catheters (see below). Typically to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length (outside of the patient) of guidewire must be longer than the OTW catheter. A <NUM> long guidewire is typically sufficient for this purpose and is often referred to as an exchange length guidewire. Due to the length of the guidewire, two operators are needed to remove or exchange an OTW catheter. This becomes even more challenging if a triple coaxial, known in the art as a triaxial system, is used (quadruple coaxial catheters have also been known to be used). However, due to its stability, an OTW system is often used in NVI and PVI procedures. On the other hand, PCI procedures often use rapid exchange (or monorail) catheters. The guidewire lumen in a rapid exchange catheter runs only through a distal section of the catheter, called the monorail or rapid exchange (RX) section. With a RX system, the operator manipulates the interventional devices parallel to each other (as opposed to with an OTW system, in which the devices are manipulated in a serial configuration), and the exposed length of guidewire only needs to be slightly longer than the RX section of the catheter. A rapid exchange length guidewire is typically <NUM>-<NUM> long. Given the shorter length guidewire and monorail, RX catheters can be exchanged by a single operator. However, RX catheters are often inadequate when more distal support is needed.

<CIT> is directed to the positioning of medical devices such as catheters within a patient's body using a remotely controlled system wherein the delivery of the catheter is conducted through sterile means.

In accordance with an embodiment a sterile barrier for a robotic drive comprises a first drive module configured to move moving along a longitudinal axis of a drive body. The sterile barrier comprises a first resilient member having a first free edge proximate the longitudinal axis. The first free edge adjacent the first drive module is resiliently biased away from and returned to the longitudinal axis as the first drive module moves along the longitudinal axis.

The sterile barrier includes a second resilient member having a second free edge proximate the longitudinal axis, wherein the second free edge adjacent the first drive module resiliently is biased away from and returned to the longitudinal axis as the first drive module moves along the longitudinal axis between the first resilient member and the second resilient member.

The sterile barrier includes a first rigid member removably coupled to the drive body wherein the first resilient member is secured to the first rigid member.

In one implementation the sterile barrier includes a flexible drape connected to the first rigid member, the flexible drape covering the drive body.

In one implementation the sterile barrier includes a first arm drape member having a C shaped clip removably secured to a portion of an arm supporting the drive body, the first arm drape including a lower arm drape being positioned under the arm, and wherein the flexible drape includes an upper arm drape section covering an upper portion of the arm, wherein the first arm drape member and the upper arm drape section cover an entire surface of the arm.

In one implementation the sterile barrier includes a second rigid member removably coupled to the drive body wherein the second resilient member is secured to the second rigid member.

In one implementation the first rigid member includes at least two sections that are in a folded orientation in a packaged configuration and an unfolded orientation in an install configuration.

In one implementation the first resilient member includes a first side and an opposing second side, the first side facing the drive body.

In one implementation the first side of first resilient member includes a first side and an opposing second side, a portion of the first side contacting an outer surface of the first drive module as the first drive module moves along the longitudinal axis.

In one implementation the sterile barrier includes a second drive module moving along the longitudinal axis of the drive body independently of the first drive module; wherein the first free edge and the second free edge of the sterile barrier, adjacent the second drive module resiliently move away from the longitudinal axis and back to the longitudinal axis as the second drive module moves along the longitudinal axis.

In one implementation the sterile barrier includes a third drive module moving along the longitudinal axis of the drive body independently of the first drive module and the second drive module; wherein the first free edge and the second free edge of the sterile barrier, adjacent the third drive module resiliently move away from the longitudinal axis and back to the longitudinal axis as the third drive module moves along the longitudinal axis.

In accordance with another embodiment, a method of applying a sterile barrier on a robotic drive having a drive body and a first drive module moving along a longitudinal axis of the drive, the method comprises providing a sterile barrier having a resilient member having a first free edge; securing the sterile barrier to the drive body; and aligning the first free edge of the resilient member along the longitudinal axis of the drive body adjacent a first drive module, the first free edge adjacent the first drive module being resiliently biased away from and returned to the longitudinal axis as the first drive module moves along the longitudinal axis about the robotic drive. The sterile barrier includes a second resilient member having a second free edge proximate the longitudinal axis, wherein the second free edge adjacent the first drive module resiliently is biased away from and returned to the longitudinal axis as the first drive module moves along the longitudinal axis between the first resilient member and the second resilient member. The sterile barrier includes a first rigid member removably coupled to the drive body wherein the first resilient member is secured to the first rigid member.

The invention will become more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein the reference numerals refer to like parts in which:.

<FIG> is a perspective view of an example catheter-based procedure system <NUM> in accordance with an embodiment. Catheter-based procedure system <NUM> may be used to perform catheter-based medical procedures, e.g., percutaneous intervention procedures such as a percutaneous coronary intervention (PCI) (e.g., to treat STEMI), a neurovascular interventional procedure (NVI) (e.g., to treat an emergent large vessel occlusion (ELVO)), peripheral vascular intervention procedures (PVI) (e.g., for critical limb ischemia (CLI), etc.). 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 disease. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast media is injected onto one or more arteries through a catheter and an image of the patient's vasculature is taken. Catheter-based medical procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, arterial venous malformation therapy, treatment of aneurysm, etc.) during which a catheter (or other EMD) is used to treat a disease. Therapeutic procedures may be enhanced by the inclusion of adjunct devices <NUM> (shown in <FIG>) such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. It should be noted, however, that one skilled in the art would recognize that certain specific percutaneous intervention devices or components (e.g., type of guidewire, type of catheter, etc.) may be selected based on the type of procedure that is to be performed. Catheter-based procedure system <NUM> can perform any number of catheter-based medical procedures with minor adjustments to accommodate the specific percutaneous intervention devices to be used in the procedure.

Catheter-based procedure system <NUM> includes, among other elements, a bedside unit <NUM> and a control station (not shown). Bedside unit <NUM> includes a robotic drive <NUM> and a positioning system <NUM> that are located adjacent to a patient <NUM>. Patient <NUM> is supported on a patient table <NUM>. The positioning system <NUM> is used to position and support the robotic drive <NUM>. The positioning system <NUM> may be, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system <NUM> may be attached at one end to, for example, the patient table <NUM> (as shown in <FIG>), a base, or a cart. The other end of the positioning system <NUM> is attached to the robotic drive <NUM>. The positioning system <NUM> may be moved out of the way (along with the robotic drive <NUM>) to allow for the patient <NUM> to be placed on the patient table <NUM>. Once the patient <NUM> is positioned on the patient table <NUM>, the positioning system <NUM> may be used to situate or position the robotic drive <NUM> relative to the patient <NUM> for the procedure. In an embodiment, patient table <NUM> is operably supported by a pedestal <NUM>, which is secured to the floor and/or earth. Patient table <NUM> is able to move with multiple degrees of freedom, for example, roll, pitch, and yaw, relative to the pedestal <NUM>. Bedside unit <NUM> may also include controls and displays <NUM> (shown in <FIG>). For example, controls and displays may be located on a housing of the robotic drive <NUM>.

Generally, the robotic drive <NUM> may be equipped with the appropriate percutaneous interventional devices and accessories <NUM> (shown in <FIG>) (e.g., guidewires, various types of catheters including balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid embolics, aspiration pumps, device to deliver contrast media, medicine, hemostasis valve adapters, syringes, stopcocks, inflation device, etc.) to allow a user or operator to perform a catheter-based medical procedure via a robotic system by operating various controls such as the controls and inputs located at the control station. Bedside unit <NUM>, and in particular robotic drive <NUM>, may include any number and/or combination of components to provide bedside unit <NUM> with the functionality described herein. The robotic drive <NUM> includes a plurality of device modules 32a-d mounted to a rail or linear member. Each of the device modules 32a-d may be used to drive an EMD such as a catheter or guidewire. For example, the robotic drive <NUM> may be used to automatically feed a guidewire into a diagnostic catheter and into a guide catheter in an artery of the patient <NUM>. One or more devices, such as an EMD, enter the body (e.g., a vessel) of the patient <NUM> at an insertion point <NUM> via, for example, an introducer sheath.

Bedside unit <NUM> is in communication with the control station (not shown), allowing signals generated by the user inputs of the control station to be transmitted wirelessly or via hardwire to the bedside unit <NUM> to control various functions of bedside unit <NUM>. As discussed below, control station <NUM> may include a control computing system <NUM> (shown in <FIG>) or be coupled to the bedside unit <NUM> through the control computing system <NUM>. Bedside unit <NUM> may also provide feedback signals (e.g., loads, speeds, operating conditions, warning signals, error codes, etc.) to the control station, control computing system <NUM> (shown in <FIG>), or both. Communication between the control computing system <NUM> and various components of the catheter-based procedure system <NUM> may be provided via a communication link that may be a wireless connection, cable connections, or any other means capable of allowing communication to occur between components. The control station or other similar control system may be located either at a local site (e.g., local control station <NUM> shown in <FIG>) or at a remote site (e.g., remote control station and computer system <NUM> shown in <FIG>). Catheter procedure system <NUM> may be operated by a control station at the local site, a control station at a remote site, or both the local control station and the remote control station at the same time. At a local site, a user or operator and the control station are located in the same room or an adjacent room to the patient <NUM> and bedside unit <NUM>. As used herein, a local site is the location of the bedside unit <NUM> and a patient <NUM> or subject (e.g., animal or cadaver) and the remote site is the location of a user or operator and a control station used to control the bedside unit <NUM> remotely. A control station (and a control computing system) at a remote site and the bedside unit <NUM> and/or a control computing system at a local site may be in communication using communication systems and services <NUM> (shown in <FIG>), for example, through the Internet. In an embodiment, the remote site and the local (patient) site are away from one another, for example, in different rooms in the same building, different buildings in the same city, different cities, or other different locations where the remote site does not have physical access to the bedside unit <NUM> and/or patient <NUM> at the local site.

The control station generally includes one or more input modules <NUM> configured to receive user inputs to operate various components or systems of catheter-based procedure system <NUM>. In the embodiment shown, control station allows the user or operator to control bedside unit <NUM> to perform a catheter-based medical procedure. For example, input modules <NUM> may be configured to cause bedside unit <NUM> to perform various tasks using percutaneous intervention devices (e.g., EMDs) interfaced with the robotic drive <NUM> (e.g., to 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 media into a catheter, inject liquid embolics into a catheter, inject medicine or saline into a catheter, aspirate on a catheter, or to perform any other function that may be performed as part of a catheter-based medical procedure). Robotic drive <NUM> includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of the components of the bedside unit <NUM> including the percutaneous intervention devices.

In one embodiment, input modules <NUM> may include one or more touch screens, joysticks, scroll wheels, and/or buttons. In addition to input modules <NUM>, the control station <NUM> may use additional user controls <NUM> (shown in <FIG>) such as foot switches and microphones for voice commands, etc. Input modules <NUM> may be configured to advance, retract, or rotate various components and percutaneous intervention devices such as, for example, a guidewire, and one or more catheters or microcatheters. Buttons may include, for example, an emergency stop button, a multiplier button, device selection buttons and automated move buttons. When an emergency stop button is pushed, the power (e.g., electrical power) is shut off or removed to bedside unit <NUM>. When in a speed control mode, a multiplier button acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of input modules <NUM>. When in a position control mode, a multiplier button changes the mapping between input distance and the output commanded distance. Device selection buttons allow the user or operator to select which of the percutaneous intervention devices loaded into the robotic drive <NUM> are controlled by input modules <NUM>. Automated move buttons are used to enable algorithmic movements that the catheter-based procedure system <NUM> may perform on a percutaneous intervention device without direct command from the user or operator <NUM>. In one embodiment, input modules <NUM> may include one or more controls or icons (not shown) displayed on a touch screen (that may or may not be part of a display), that, when activated, causes operation of a component of the catheter-based procedure system <NUM>. Input modules <NUM> may also include a balloon or stent control that is configured to inflate or deflate a balloon and/or deploy a stent. Each of the input modules <NUM> may include one or more buttons, scroll wheels, joysticks, touch screen, etc. that may be used to control the particular component or components to which the control is dedicated. In addition, one or more touch screens may display one or more icons (not shown) related to various portions of input modules <NUM> or to various components of catheter-based procedure system <NUM>.

Catheter-based procedure system <NUM> also includes an imaging system <NUM>. Imaging system <NUM> may be any medical imaging system that may be used in conjunction with a catheter based medical procedure (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, imaging system <NUM> is a digital X-ray imaging device that is in communication with the control station. In one embodiment, imaging system <NUM> may include a C-arm (shown in <FIG>) that allows imaging system <NUM> to partially or completely rotate around patient <NUM> in order to obtain images at different angular positions relative to patient <NUM> (e.g., sagittal views, caudal views, anterior-posterior views, etc.). In one embodiment imaging system <NUM> is a fluoroscopy system including a C-arm having an X-ray source <NUM> and a detector <NUM>, also known as an image intensifier.

Imaging system <NUM> may be configured to take X-ray images of the appropriate area of patient <NUM> during a procedure. For example, imaging system <NUM> may be configured to take one or more X-ray images of the head to diagnose a neurovascular condition. Imaging system <NUM> 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 <NUM> of control station <NUM> to properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The image or images may be displayed on display <NUM>. For example, images may be displayed on a display to allow the user or operator to accurately move a guide catheter or guidewire into the proper position.

In order to clarify directions, a rectangular coordinate system is introduced with X, Y, and Z axes. The positive X axis is oriented in a longitudinal (axial) distal direction, that is, in the direction from the proximal end to the distal end, stated another way from the proximal to distal direction. The Y and Z axes are in a transverse plane to the X axis, with the positive Z axis oriented up, that is, in the direction opposite of gravity, and the Y axis is automatically determined by right-hand rule.

<FIG> is a block diagram of catheter-based procedure system <NUM> in accordance with an example embodiment. Catheter-procedure system <NUM> may include a control computing system <NUM>. Control computing system <NUM> may physically be, for example, part of a control station. Control computing system <NUM> may generally be an electronic control unit suitable to provide catheter-based procedure system <NUM> with the various functionalities described herein. For example, control computing system <NUM> may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionality described herein, etc. Control computing system <NUM> is in communication with bedside unit <NUM>, communications systems and services <NUM> (e.g., Internet, firewalls, cloud services, session managers, a hospital network, etc.), a local control station <NUM>, additional communications systems <NUM> (e.g., a telepresence system), a remote control station and computing system <NUM>, and patient sensors <NUM> (e.g., electrocardiogram (ECG) devices, electroencephalogram (EEG) devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). The control computing system is also in communication with imaging system <NUM>, patient table <NUM>, additional medical systems <NUM>, contrast injection systems <NUM> and adjunct devices <NUM> (e.g., IVUS, OCT, FFR, etc.). The bedside unit <NUM> includes a robotic drive <NUM>, a positioning system <NUM> and may include additional controls and displays <NUM>. As mentioned above, the additional controls and displays may be located on a housing of the robotic drive <NUM>. Interventional devices and accessories <NUM> (e.g., guidewires, catheters, etc.) interface to the bedside system <NUM>. In an embodiment, interventional devices and accessories <NUM> may include specialized devices (e.g., IVUS catheter, OCT catheter, FFR wire, diagnostic catheter for contrast, etc.) which interface to their respective adjunct devices <NUM>, namely, an IVUS system, an OCT system, and FFR system, etc..

In various embodiments, control computing system <NUM> is configured to generate control signals based on the user's interaction with input modules <NUM> (e.g., of a control station such as a local control station <NUM> or a remote control station <NUM>) and/or based on information accessible to control computing system <NUM> such that a medical procedure may be performed using catheter-based procedure system <NUM>. The local control station <NUM> includes one or more displays <NUM>, one or more input modules <NUM>, and additional user controls <NUM>. The remote control station and computing system <NUM> may include similar components to the local control station <NUM>. The remote <NUM> and local <NUM> control stations can be different and tailored based on their required functionalities. The additional user controls <NUM> may include, for example, one or more foot input controls. The foot input control may be configured to allow the user to select functions of the imaging system <NUM> such as turning on and off the X-ray and scrolling through different stored images. In another embodiment, a foot input device may be configured to allow the user to select which devices are mapped to scroll wheels included in input modules <NUM>. Additional communication systems <NUM> (e.g., audio conference, video conference, telepresence, etc.) may be employed to help the operator interact with the patient, medical staff (e.g., angio-suite staff), and/or equipment in the vicinity of the bedside.

Catheter-based procedure system <NUM> may be connected or configured to include any other systems and/or devices not explicitly shown. For example, catheter-based procedure system <NUM> may include image processing engines, data storage and archive systems, automatic balloon and/or stent inflation systems, medicine injection systems, medicine tracking and/or logging systems, user logs, encryption systems, systems to restrict access or use of catheter-based procedure system <NUM>, etc..

As mentioned, control computing system <NUM> is in communication with bedside unit <NUM> which includes a robotic drive <NUM>, a positioning system <NUM> and may include additional controls and displays <NUM> and may provide control signals to the bedside unit <NUM> to control the operation of the motors and drive mechanisms used to drive the percutaneous intervention devices (e.g., guidewire, catheter, etc.). The various drive mechanisms may be provided as part of a robotic drive <NUM>.

Referring to <FIG> robotic drive robotic drive <NUM> includes a drive body <NUM> having a top wall <NUM>, a proximal wall <NUM>, a distal wall <NUM>, a first longitudinal wall <NUM>, and a second longitudinal wall <NUM>. When robotic drive <NUM> is in an in-use position on patient table <NUM> top wall <NUM> is the furthest wall from patient table <NUM>, proximal wall <NUM> is the wall most proximal or closest to a foot of patient table <NUM>. Distal wall <NUM> is the wall most distal or closest to the head of patient table <NUM>. The first longitudinal wall <NUM> and the second longitudinal wall <NUM> are the walls closet to and furthest from the bed rail <NUM> closest the base of positioning system <NUM>. Drive body <NUM> includes a bottom wall <NUM> that is closest to patient table <NUM> when robotic drive <NUM> is in the in-use position. Bottom wall <NUM> has a slot <NUM> extending longitudinally between proximal wall <NUM> and distal wall <NUM>.

A first device module 32a includes a drive module <NUM> that is driven along a longitudinal axis <NUM> of drive body <NUM> and includes a connecting stage member <NUM> extending through slot <NUM> and is operatively engaged with a drive mechanism that moves drive module <NUM> along the longitudinal axis of drive body <NUM>. Drive body <NUM> of robotic drive <NUM> and drive module <NUM> are capital equipment and is not part of a sterile portion of bedside unit <NUM>.

Referring to <FIG> and <FIG> a sterile barrier <NUM> includes a first resilient member <NUM> having a first free edge <NUM> proximate longitudinal axis <NUM>. Longitudinal axis <NUM> is the axis along which the drive modules move. Sterile barrier <NUM> provides a sterile barrier between the bottom wall <NUM> and slot <NUM> of drive body <NUM>. A portion of first free edge <NUM> adjacent the first drive module 32a is resiliently biased away from and returned to the longitudinal axis as the first drive module 32a moves along the longitudinal axis. First resilient member <NUM> extends from a proximal end of slot <NUM> to a distal end of slot <NUM> such that the substantially the entire slot <NUM> is covered. Only a portion of first free edge <NUM> of first resilient member <NUM> that is closely adjacent first drive module 32a is biased away from the longitudinal axis. Stated another way the portion of first free edge <NUM> of first resilient member <NUM> that is distal first drive module 32a is not biased away from the longitudinal axis. By way of example and referring to <FIG> a region of first free edge <NUM> proximate point A that is closely adjacent first drive module 32a is biased away from the longitudinal axis <NUM>. Once first drive module 32a moves along the longitudinal axis <NUM> such that region of first free edge <NUM> proximate point A is no longer closely adjacent first drive module 32a the region of first free edge <NUM> proximate point A will resiliently return to the longitudinal axis. In one implementation the free edges of first resilient member <NUM> and second resilient member <NUM> are moved from and return to the longitudinal axis or non-stressed position between within <NUM> of contacting drive module drape <NUM>. In one implementation the free edges of first resilient member <NUM> and second resilient member <NUM> move from and return to their non-stressed position in less than <NUM>. In one implementation the free edges of first resilient member <NUM> and second resilient member <NUM> move from and return to their non-stressed position in less than <NUM>.

In one implementation robotic drive <NUM> includes a second device module 32b including a separate drive module and a separate stage extending through slot <NUM>. Second device module 32b is translated along the longitudinal axis of the drive body independently of first drive module 32a. Where there are two separate drive modules a second portion of first resilient member <NUM> closely proximate second device module 32b is biased away from the longitudinal axis. In the implementation of two independently moving drive modules a first portion and a second portion proximate first drive module 32a and second device module 32b respectively are biased away from the longitudinal axis, while the remaining portion of first resilient member <NUM> not closely adjacent to first drive module 32a and second device module 32b are not biased away from the drive body longitudinal axis. Similarly, where there are more than two drive modules only the portions of first resilient member <NUM> closely adjacent each drive module will be biased away from the drive body longitudinal axis. Each portion of first resilient member <NUM> that is biased away from the drive body longitudinal axis returns to a non-stressed condition such that first free edge <NUM> of such portion returns to a position proximate the drive body longitudinal axis. In this manner slot <NUM> between drive modules is substantially covered by first resilient member <NUM>. Stated another way in one implementation a third drive module moves along the longitudinal axis of the drive body independently of the first drive module and the second drive module. A portion of first free edge <NUM> and a portion of second free edge <NUM> adjacent the third drive module resiliently move away from the longitudinal axis and back to the longitudinal axis as the third drive module moves along the longitudinal axis.

Referring to <FIG> in one implementation sterile barrier <NUM> includes a second resilient member <NUM> having a second free edge <NUM> that is proximate first resilient member <NUM>. In one implementation first resilient member <NUM> and second free edge <NUM> overlap. In one implementation first resilient member <NUM> and second free edge <NUM> closely abut. In one implementation first resilient member <NUM> and second free edge <NUM> are spaced from one another a predetermined distance. First resilient member <NUM> extends from a first edge of slot <NUM> and second resilient member <NUM> extends from a second edge of slot <NUM>. Second resilient member <NUM> is formed of a resilient material such that second free edge <NUM> closely adjacent a drive module is biased away from the longitudinal axis. In one implementation first resilient member <NUM> and second resilient member <NUM> are the same material. In one implementation first resilient member <NUM> and second resilient member <NUM> are a different material.

Referring to <FIG> first resilient member <NUM> includes a first side <NUM> and an opposing second side <NUM>. First side <NUM> faces bottom wall <NUM> and slot <NUM> and second side <NUM> faces away from the bottom wall <NUM> and slot <NUM>. The region of first side <NUM> of first resilient member <NUM> that is closely adjacent a device module is biased away from bottom wall <NUM> and slot <NUM> and returns toward bottom wall <NUM> and slot <NUM> once a device module is no longer closely adjacent. A portion of first side <NUM> contacts an outer surface of the first drive module as the first drive module moves along the longitudinal axis. In this manner second side <NUM> remains part of the sterile environment while first side <NUM> contacts the non-sterile environment of robotic drive <NUM>.

Similarly, second resilient member <NUM> includes a first side <NUM> and a second side <NUM>. First side <NUM> faces bottom wall <NUM> and slot <NUM> and second side <NUM> faces away from the bottom wall <NUM> and slot <NUM>. The region of second resilient member <NUM> that is closely adjacent a device module is biased away from bottom wall <NUM> and slot <NUM> and returns toward bottom wall <NUM> and slot <NUM> once a device module is no longer closely adjacent. In this manner second side <NUM> remains part of the sterile environment while first side <NUM> contacts the non-sterile environment of robotic drive <NUM>.

The stage portion of each drive module extends between first free edge <NUM> of first resilient member <NUM> and second free edge <NUM> of second resilient member <NUM>. In one implementation the region of first side <NUM> of first resilient member <NUM> and the region of first side <NUM> of second resilient member immediately adjacent each drive module contacts a portion of that drive module.

Referring to <FIG>, a longitudinal portion <NUM> of first resilient member <NUM> distal first free edge <NUM> is secured to drive body <NUM> and a longitudinal portion <NUM> of second resilient member <NUM> distal free edge <NUM> is secured to drive body <NUM>. In one implementation a first rigid member <NUM> is releasably secured to drive body <NUM> and first resilient member <NUM> is secured to first rigid member <NUM>. First resilient member <NUM> is secured to drive body <NUM> via first rigid member <NUM>. In one embodiment first rigid member <NUM> is adjacent to first longitudinal wall <NUM> along a first wall portion <NUM> (<FIG>) of first rigid member <NUM> in a secured position. First rigid member <NUM> includes a second wall portion <NUM> (<FIG>) extending away from first wall portion <NUM> and positioned adjacent bottom wall <NUM>. In one implementation first wall portion <NUM> is secured to drive body <NUM> on first longitudinal wall <NUM>. In one implementation second wall portion <NUM> is secured to bottom wall <NUM>.

A second rigid member <NUM> (<FIG>) is secured to bottom wall <NUM> adjacent the second side of slot <NUM>. Second rigid member <NUM> is removably secured to bottom wall <NUM> of drive body <NUM>. Second resilient member <NUM> is secured to a longitudinal portion of second rigid member <NUM>.

First rigid member <NUM> and second rigid member <NUM> are coupled to drive body <NUM> with a coupler such as a fastener, magnet, hook and loop, or other know couplers. Since first resilient member is secured to the first rigid member and the second resilient member is secured to the second rigid member, the first resilient members are removably coupled to drive body <NUM>.

In one implementation a first cassette <NUM> (<FIG>) operatively engaging a percutaneous device, is releasably secured to first drive module 32a. Cassette <NUM> is secured to first drive module 32a such that first wall portion <NUM> of first rigid member <NUM> (<FIG>) is between drive body <NUM> and first cassette <NUM>. Cassette <NUM> is part of the sterile environment and separated from drive body <NUM> by sterile barrier <NUM>.

Referring to <FIG> and <FIG> sterile barrier <NUM> includes a flexible drape portion <NUM> covering portions of robotic drive <NUM> and positioning system <NUM>. Flexible drape covers top wall <NUM>, proximal wall <NUM>, distal wall <NUM>, second longitudinal wall <NUM> and at least a portion of first longitudinal wall <NUM>. In one implementation first rigid member <NUM> also covers a portion of bottom wall <NUM>. In one implementation first rigid member <NUM> is secured to flexible drape portion <NUM> such that the entire first longitudinal wall <NUM> is covered by sterile barrier <NUM>. In one implementation second rigid member <NUM> is secured to flexible drape portion <NUM> covering at least part of bottom wall <NUM>. In one implementation flexible drape portion <NUM> is formed from a polyethylene material having a thickness of <NUM> inches (<NUM>) or other materials known in the art can be used. First rigid member <NUM> is formed from a polycarbonate material having a thickness of <NUM> inches (<NUM>) or other materials known in the art can be used. First resilient member <NUM> and second resilient member <NUM> are formed of EPDM (Ethylene Propylene Diene Monomer) rubber having a thickness of <NUM>/<NUM> inch (<NUM>). First rigid member <NUM> has a rigidity greater than flexible drape portion <NUM>. First resilient member <NUM> and second resilient member <NUM> are more resilient than flexible drape portion <NUM>. In one implementation first wall portion <NUM> is secured to flexible drape portion <NUM> forming a continuous sterile barrier. First wall portion <NUM> is secured to flexible drape portion <NUM> with an adhesive bond, sonic welding, mechanical fastener, tape or other connections known in the art. Second rigid member <NUM> is similarly fastened to a portion of flexible drape portion <NUM> in a similar manner. First resilient member <NUM> and second side <NUM> are secured to first rigid member first rigid member <NUM> and second rigid member <NUM> respectively in a similar manner. Second rigid member <NUM> may also be connected to a portion of flexible drape portion <NUM> in a similar manner. Flexible drape portion <NUM> may have a slit or free edges to allow for easy installation onto robotic drive <NUM> and positioning system <NUM> and the slit may be covered by an adhesive tape or other mechanical fastener known in the art.

Referring to <FIG> a drive module drape <NUM> is secured to cassette <NUM>. In one implementation drive module drape <NUM> is pivotally secured to cassette <NUM> to releasably cover a portion of drive module <NUM>. Drive module drape <NUM> moves from an uncovered position to a covered position. Drive module drape <NUM> includes a bottom wall, a first side wall, a second side wall, and a third rear wall. In a covered position drive module drape <NUM> covers at least a portion of at least one of a bottom wall, a first side wall, a second side wall, and third rear wall of drive module <NUM>. In one implementation cassette <NUM> is releasably secured to at least one side of the drive module <NUM>. In one implementation substantially all of the drive module <NUM> is covered by drive module drape <NUM> and cassette <NUM>. In one implementation drive module drape is rigid and includes a fastener to fasten drive module drape <NUM> to cassette <NUM>.

Referring to <FIG> drive module drape <NUM> is a flexible member having a bag shape with an opening, side wall and bottom that is removably placed over drive module <NUM> to substantially cover exposed portions of drive module <NUM>. In one implementation flexible drive module drape <NUM> is also attached to a portion of cassette <NUM>.

In one implementation sterile barrier <NUM> covers a robotic drive including a support arm of positioning system <NUM>, a drive body <NUM> supported by the support arm. A first drive module 32a and a second drive module 32b move along a longitudinal axis of the drive body <NUM>. Sterile barrier <NUM> includes a first flexible portion <NUM> covering the robotic arm and a portion of the drive body <NUM>, a second rigid member146 being more rigid than the first flexible portion <NUM>. The second rigid portion <NUM> being removably connected to drive body <NUM>. Sterile barrier <NUM> also includes a resilient member <NUM> extending from the second rigid member <NUM>, the resilient member <NUM> having a first free edge <NUM> proximate a longitudinal axis of the drive body and being adjacent the first drive 32a. In one implementation the resilient member <NUM> includes a free edge <NUM> separate from the first free edge <NUM> and proximate the longitudinal axis, the drive module 32a being movable between the first free edge and the second free edge.

Referring to <FIG>, <FIG> in one implementation bedside unit <NUM> has a robotic drive <NUM> with a first drive module moving along a longitudinal axis of a drive body. A first cassette is removably connected to the first drive module. A drive module drape is attached to the first cassette and removably covers a portion of the first drive module. In one implementation drive module drape is formed of a rigid material operatively secured to the cassette. In one implementation drive module drape is formed of a flexible material that is operatively secured to the cassette.

Referring to <FIG> in one implementation a sterile barrier system <NUM> includes a bottom arm sterile barrier <NUM> that covers the bottom portion of positional system <NUM>. Bottom arm sterile barrier <NUM> may also be used in conjunction with sterile barrier <NUM> discussed herein.

Bottom arm sterile barrier <NUM> includes a flexible drape portion <NUM> coupled to a clip <NUM> that is removably coupled to positioning system <NUM> about an upper rotational joint 22a. Bottom arm sterile barrier <NUM> extends from clip <NUM> below the positioning system <NUM> from upper rotational joint 22a to the bottom rotational joint 22c. Referring to <FIG> a pair of straps 208a and 208b extending from a terminal end of flexible drape portion <NUM> is secured to a base portion positioning system <NUM>. In this manner flexible drape portion <NUM> covers the bottom portion of positioning system <NUM>. In one implementation bottom arm sterile barrier <NUM> includes a pocket (not shown) secured to flexible drape portion <NUM> adjacent clip <NUM> to allow a user to position clip <NUM> onto positioning system <NUM> without a user touching a sterile portion of flexible drape portion <NUM>.

Referring to <FIG> sterile barrier system <NUM> includes a distal drape portion <NUM> defining an interior cavity that is pulled over the distal end of robotic drive <NUM>. Distal drape portion <NUM> includes a first pocket 212a on the external portion of distal drape portion <NUM> that allows a user to place the user's hand within the first pocket 212a to pull the distal drape portion <NUM> over the distal end of robotic drive <NUM>. In one implementation a second pocket 212b on distal drape portion <NUM> allow a user to place the user's second hand into second pocket 212b to assist in distal drape portion <NUM> over the distal end robotic drive <NUM>. In one implementation distal drape portion <NUM> extends a predetermined distance from the distal end of robotic drive <NUM> toward the proximal end of robotic drive <NUM> where the predetermined distance does not extend the entire length of robotic drive <NUM> along the robotic drive longitudinal axis.

In one implementation a first portion of a snap (not shown) is snapped onto a second portion of a snap on the top wall <NUM> of robotic drive <NUM>. Other attachment features are contemplated such as a magnet on top wall <NUM> of robotic drive <NUM> that releasably secures a magnetophilic material (such as an iron disc or washer) secured to distal drape portion <NUM>.

In one implementation sterile barrier system <NUM> includes a second flexible drape portion <NUM> that covers a portion of first longitudinal wall <NUM>, top wall <NUM> and second longitudinal wall <NUM>. A distal portion of second flexible drape portion <NUM> is secured to distal drape portion <NUM>. Sterile barrier system <NUM> includes a first rigid member system <NUM> that is similar to first rigid member <NUM> of sterile barrier <NUM>. In one implementation first rigid member system <NUM> has a number of adjacent sections 216a, 216b, 216c, and 216d that allow each of the sections to be folded on one another for convenient packaging shipping and deployment. While rigid member system <NUM> is shown in one implementation having four sections it is contemplated that rigid member system <NUM> may include one or more sections. In one implementation the number of folds is two. In one implementation the number of folds is three. In one implementation the number of folds is between and including <NUM> through <NUM>. In one implementation the number of folds is greater than <NUM>. Each section of rigid member system <NUM> is connected to an adjacent section by a living hinge, where the term living hinge is a is a thin flexible hinge made from the same material as the two rigid pieces it connects. In one implementation each section is not directly connected at their proximal and/or distal ends and in one implementation each adjacent section is connected by a flexible material allowing the sections to fold against one another as an accordion. Each section of the rigid member system <NUM> has an upper longitudinal edge and a lower longitudinal edge.

Rigid member system <NUM> is unfolded and secured to a proximal end of robotic drive <NUM>. In one implementation proximal end of the rigid member system <NUM> includes a proximal portion that includes a proximal cavity that is positioned over and cover a proximal end of robotic drive <NUM>. In one implementation rigid member system <NUM> in one implementation is secured to a front portion of robotic drive <NUM> with a snap feature (or other attachment mechanisms discussed above and known in the art) where one portion of the snap is secured to the rigid member system <NUM> and the second snap feature is secured to the front of robotic drive <NUM>. In one implementation (<FIG>) each folded section of rigid member system <NUM> is secured to first longitudinal wall <NUM> of robotic drive <NUM>. Each folded section of rigid member system <NUM> may be secured with a snap connection as discussed herein with a first portion of each snap connection being secured to the robotic drive and a second portion of each snap connection being secured to each folded section. In one implementation each folded portion of rigid member system <NUM> is secured to first longitudinal wall <NUM> of robotic drive <NUM> with a magnetic connection where one of the robotic drive <NUM> and rigid member system <NUM> includes a magnet and the other of the robotic drive <NUM> and rigid member system <NUM> includes a metal disc or member that is magnetically connected to a corresponding magnet.

A portion of second flexible drape portion <NUM> is secured to rigid member system <NUM> and is in a folded orientation when packaged. Referring to <FIG>, the sections of rigid member system <NUM> are unfolded and secured to robotic drive <NUM> second flexible drape portion <NUM> is then positioned by a user upwardly covering first longitudinal wall <NUM>, across top wall <NUM> and downwardly along second longitudinal wall <NUM>. However, it is also contemplated that second flexible drape portion <NUM> will cover first longitudinal wall <NUM>, top wall <NUM> and second longitudinal wall <NUM> prior to securing rigid member system <NUM> to robotic drive <NUM>.

An upper arm drape portion <NUM> extends from second flexible drape portion <NUM>. Referring to <FIG> and <FIG>, portion <NUM> is placed over the top positioning system <NUM> A free end of portion <NUM> is secured to the base portion of positioning system with a pair of straps 220a and 220b. Portion <NUM> includes a first edge and a second edge that extend over the longitudinal edges of bottom arm sterile barrier <NUM>. A strap member <NUM> secures bottom arm sterile barrier <NUM> and portion <NUM> over positioning system <NUM> with sufficient space between to allow movement of the rotational joints 22a, 22b and 22c as well as arms 22e and 22d extending between the rotational joints.

Referring to, <FIG>, <FIG> each section of rigid member system <NUM> has an L shape having a front panel <NUM> adjacent to first longitudinal wall <NUM> of robotic drive <NUM> and a second shorter portion <NUM> adjacent to bottom wall <NUM> or robotic drive <NUM>. Note the L shape of the rigid member system <NUM> is similar to rigid member <NUM> (See <FIG>). A first resilient member <NUM> second shorter portion <NUM> of rigid member system <NUM> and operates in the same manner as first resilient member <NUM> described above with respect to sterile barrier <NUM>. A second rigid member <NUM> is secured to bottom wall <NUM>. A second resilient member <NUM> is secured to second rigid member <NUM> and operates in the same manner as second resilient member <NUM> described above with respect to sterile barrier <NUM>. In one implementation second rigid member <NUM> is not connected to a flexible drape portion of sterile barrier system <NUM>. As discussed herein the sections of rigid member system <NUM> might have a living hinge or a flexible material connecting adjacent sections, however, in one implementation first member <NUM> is continuous and does not have a living hinge but is sufficiently pliable to allow second resilient member <NUM> to bend to allow second resilient member <NUM> to be packaged with the folded sections of rigid member system <NUM>. In one implementation second resilient member <NUM> does have a living hinge or flexible material corresponding with the living hinge or flexible material of rigid member system <NUM>.

In operation sterile barrier system <NUM> is packaged prior to use in a folded orientation and positioned in a pouch. In one implementation sterile barrier system <NUM> includes a bottom arm sterile barrier <NUM> covering a bottom of the positioning system <NUM> and a second drape that covers the robotic drive <NUM> and the top portion of the positioning system <NUM>. In one implementation bottom arm sterile barrier <NUM> and the second drape are combined and packaged together.

A user takes bottom arm sterile barrier <NUM> and places a hand within a pocket formed in a portion of bottom arm sterile barrier <NUM>. The user then attaches a flexible portion of bottom arm sterile barrier <NUM> to a portion of the positioning system with a clip while maintain the user's hand within the pocket. Straps extending from the flexible portion of bottom arm sterile barrier <NUM> are placed on a patient table the user then wraps the straps about a base portion of the positioning system and secures the straps to one another using a fastener such as a hook and loop style fastener (e.g., Velcro) thereby securing the bottom arm sterile barrier <NUM> to positioning system.

The user than grasping the folded rigid plate sections 216a - 216d and inserts the user's hand into a first pocket 212a. The user then spreads the user's hands apart to place a distal drape portion <NUM> over the distal portion of the robotic drive <NUM>. A snap located adjacent first pocket 212a is then attached to a corresponding snap portion on the robotic drive housing to secure the distal drape portion <NUM> to the robotic drive.

The user then unfolds the folded rigid plate sections one at a time making sure they are flush against the first longitudinal wall <NUM> of the robotic drive housing (the wall facing the user). The user then using a right index finger and middle finger presses a snap feature on a pocket adjacent the most proximal rigid plate section with a corresponding mating snap feature on the robotic drive to secure the drape plates to the robotic drive. A user places each of the user's hand into a respective proximal pocket using one hand to guide the drape over the top of the robotic drive and one hand to guide the drape behind the drive. Using mating snap features the user snaps the drape to the back of the drive securing the drape to the back of the robotic drive. Using tabs provided on the drape a user then lifts a portion of the drape up and over the robotic drive housing.

The user then separates the bottom resilient drape plates from the now unfolded folded drape plants and using mating snap features secures a portion of the first resilient member <NUM> to the bottom of the robotic drive housing and secures a portion of second resilient member <NUM> to the rear portion of the bottom of the robotic drive housing.

The user then places an upper positioning system portion of the drape over the top of the positioning system. Using straps, the upper positioning portion of the drape is secured to the bottom arm sterile barrier <NUM> to fully cover the positioning system. In one implementation the positioning system is an articulated arm. While snaps are indicated as some of the attaching features, other coupling methods known in the art are also contemplated. As a nonlimiting example, magnets, adhesive tape, hooks and other mechanical, electromechanical and chemical coupling may be used in conjunction with or instead of the mechanical snap and hook and loop connectors described herein.

Claim 1:
A sterile barrier (<NUM>) (<NUM>) for a robotic drive (<NUM>) comprising a first drive module (<NUM>) configured to move along a longitudinal axis (<NUM>) of a drive body (<NUM>), the sterile barrier (<NUM>) comprising:
a first resilient member (<NUM>) having a first free edge (<NUM>) proximate the longitudinal axis (<NUM>), the first free edge (<NUM>) adjacent the first drive module (<NUM>) is resiliently biased away from and returned to the longitudinal axis (<NUM>) as the first drive module (<NUM>) moves along the longitudinal axis (<NUM>),
a second resilient member (<NUM>) having a second free edge (<NUM>) proximate the longitudinal axis (<NUM>), wherein the second free edge (<NUM>) adjacent the first drive module (<NUM>) being resiliently biased away from and returned to the longitudinal axis (<NUM>) as the first drive module (<NUM>) moves along the longitudinal axis (<NUM>) between the first resilient member (<NUM>) and the second resilient member (<NUM>), and
a first rigid member (<NUM>) removably coupled to the drive body (<NUM>), wherein the first resilient member (<NUM>) is secured to the first rigid member (<NUM>).