Systems, apparatus, and methods for robotic interventional procedures using multiple elongate medical devices
Through the multi-axis configuration and modular design of the robot drive system, the problem of catheter exchange complexity in the prior art is solved, and surgical efficiency and safety are improved, especially catheter support capabilities in complex vasculature systems.
Patent Information
- Application Number
- CN202510833870.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-15
- Filing Date
- 2020-07-14
- Publication Date
- 2025-08-01
AI Technical Summary
Existing robotic interventional surgical systems have challenges in distal support of catheters or guidewires, especially in tortuous or calcified vasculatures, resulting in a complex catheter exchange process and requiring multiple operators, affecting surgical efficiency and safety.
A robotic drive system is adopted, including linear members and multiple independent controllable device modules, which can switch between different configurations, provide multi-axis drive and support, support the operation of a variety of elongated medical devices, and simplify the catheter exchange process through coordinated movement between modules and the use of support arms.
Improves the operational efficiency and safety of the surgery, reduces dependence on the operator, simplifies the catheter exchange process, and enhances the support capacity in complex anatomical structures.
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Figure CN120392318A_ABST
Abstract
Description
[0001] This application is a divisional application of a Chinese patent application with application number 202080064648.9, filing date July 14, 2020, and titled "Systems, Devices, and Methods for Robotic Interventional Surgery Using Multiple Elongated Medical Devices".
[0002] Cross - reference to related applications
[0003] This application claims priority to and incorporates by reference in its entirety U.S. Serial No. 62 / 874,247, filed July 15, 2019, and titled "Systems, Devices, and Methods for Robotic Interventional Surgery Using Multiple Elongated Medical Devices". Technical field
[0004] The present invention generally relates to the field of robotic medical surgical systems, and particularly to systems, devices, and methods for controlling the movement and operation of elongated medical devices by a robot in robotic interventional surgery. Background art
[0005] Catheters and other elongated medical devices (EMDs) can be used in minimally invasive medical procedures for diagnosing and treating various vascular system diseases, including neurovascular interventions (NVIs) (also known as neurointerventional procedures), percutaneous coronary interventions (PCIs), and peripheral vascular interventions (PVIs). These procedures typically involve navigating a guidewire through the vasculature and advancing a catheter via the guidewire to deliver treatment. The catheter insertion procedure begins by obtaining access to the appropriate blood vessel (such as an artery or vein) through a introducer sheath using standard percutaneous techniques. Through the introducer sheath, a sheath or guiding catheter is then advanced over the diagnostic guidewire to a primary location, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. Then, a guidewire suitable for the vasculature is navigated through the sheath or guiding catheter to a target location within the vasculature. In some cases, such as in tortuous anatomies, a support catheter or micro - catheter is inserted over the guidewire to assist in navigating the guidewire. A doctor or operator can use an imaging system (e.g., fluoroscope) to obtain a movie with contrast agent injection and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to the target location, such as a lesion. While the doctor is delivering the guidewire or catheter, contrast - enhanced images can also be obtained so that the doctor can verify that the device is moving along the correct path towards the target location. While observing the anatomy using fluoroscopy, the doctor manipulates the proximal end of the guidewire or catheter to direct the distal tip towards the lesion or target anatomical location within the appropriate blood vessel and avoid advancing into a collateral.
[0006] Robot catheter-based surgical systems have been developed that can be used to assist doctors 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 for large vessel occlusion in the setting of acute ischemic stroke. In an NVI procedure, a doctor uses a robotic system to deliver treatment by controlling the manipulation of a neurovascular wire and a microcatheter to restore normal blood flow and thus gain access to the target lesion. The target access is achieved through a sheath or guiding catheter, but an intermediate catheter may also be required for more distal regions or to provide sufficient support for the microcatheter and wire. Depending on the type of lesion and treatment, the distal tip of the wire is navigated into or past the lesion. To treat an aneurysm, the microcatheter is advanced into the lesion, the wire is removed, and several embolization coils are deployed through the microcatheter into the aneurysm to block blood flow into the aneurysm. To treat an arteriovenous malformation, a liquid embolic agent is injected into the malformation via the microcatheter. Mechanical thrombectomy for treating vascular occlusion can be achieved by aspiration and / or using a stent retriever. Depending on the location of the clot, aspiration can be done either through an aspiration catheter or through a microcatheter for smaller arteries. Once the aspiration catheter is positioned at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, a stent retriever can be deployed through the microcatheter to remove the clot. Once the clot has been incorporated into the stent retriever, the clot is removed by retracting the stent retriever and the microcatheter (or intermediate catheter) into the guiding catheter.
[0007] In PCI, a doctor uses a robotic system to deliver treatment by manipulating a coronary wire and restore normal blood flow to gain access to the lesion. This access is achieved by placing a guiding catheter in the coronary ostium. The distal tip of the wire is navigated past the lesion, and for complex anatomies, a microcatheter can be used to provide sufficient support for the wire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may need to be prepared before stent placement, either by 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 on the wire. Diagnostic imaging and physiological measurements can be performed by using an imaging catheter or fractional flow reserve (FFR) measurement to determine the appropriate treatment.
[0008] In PVI, a doctor uses a robotic system to deliver treatment and restore blood flow using techniques similar to NVI. The distal tip of the wire is navigated past the lesion, and a microcatheter can be used to provide sufficient support for the wire for complex anatomies. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. As in PCI, lesion preparation and diagnostic imaging can also be used.
[0009] When support is needed at the distal end of a catheter or guidewire, for example, to navigate tortuous or calcified vasculature to reach a distal anatomical location or cross a hard lesion, an over-the-wire (OTW) catheter or coaxial system is used. The OTW catheter has a lumen for the guidewire that extends the full length of the catheter. This provides a relatively stable system as the guidewire is supported along its entire length. However, compared to rapid-exchange catheters, this system has some disadvantages, including higher friction and a longer overall length (see below). Typically, to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For this purpose, a 300-cm guidewire is usually sufficient and is often referred to as an exchange-length guidewire. Due to the length of the guidewire, two operators are required to remove or exchange the OTW catheter. If a tri-coaxial, i.e., a three-axis system known in the art, is used, this becomes even more challenging (quadruple coaxial catheters are also known to be used). However, due to its stability, the 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 only extends through the distal section of the catheter, called the monorail or rapid-exchange (RX) section. With the RX system, the operator manipulates the interventional device in parallel (as opposed to the OTW system, in which the devices are manipulated in a series configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. A rapid-exchange length guidewire is typically 180 - 200 cm long. Given the shorter length of the guidewire and the monorail, the RX catheter can be replaced by a single operator. However, when more distal support is needed, the RX catheter is often insufficient. Summary of the Invention
[0010] According to one embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member and at least four device modules coupled to the linear member. Each device module may be independently controllable. The plurality of device modules may be switched between a first configuration and a second configuration, in the first configuration, each device module is filled with an elongate medical device, and in the second configuration, a subset of the at least four device modules is filled with an elongate medical device.
[0011] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member and a plurality of device modules movably coupled to the linear member. Each drive module is configured to manipulate an elongate medical device, and each device module may be independently controllable; the plurality of device modules may be switched between a first configuration and a second configuration, the first configuration including at least one device module configured to drive a proximal region of a corresponding elongate medical device along a first longitudinal axis, and the second configuration including at least one device module configured to drive a proximal portion of a corresponding elongate medical device along a second longitudinal axis different from the first longitudinal axis.
[0012] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member and at least four device modules coupled to the linear member. Each device module is configured to manipulate an elongate medical device, and each device module may be independently controllable. The plurality of device modules may be switched between a three-axis configuration and a two-axis configuration. In the three-axis configuration, the elongate medical device manipulated by three of the at least four device modules is a catheter, and the elongate medical device manipulated by a fourth device module of the at least four device modules is a wire-based device. In the two-axis configuration, the elongate medical device manipulated by two of the at least four device modules is a catheter, the elongate medical device manipulated by a third device module of the at least four device modules is a wire-based device, and a fourth device module of the at least four device modules is unfilled.
[0013] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member, a first device module coupled to the linear member, and a second device module coupled to the linear member at a location distal to the first device module. The first device module is configured to manipulate a first elongate medical device and may be independently controllable. The second device module is configured to manipulate a second elongate medical device and may be independently controllable. The robotic drive system further includes a device support having a section movably positioned within the first device module and having a first end and a second end. The device support is configured to provide a passageway to accommodate and support a first elongate medical device within a distance between the first device module and the second device module. The first end and the second end of the device support are coupled to the second device module.
[0014] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member, a device module coupled to the linear member, and a distal support arm having a device support connection located distally of the device module. The device module is configured to manipulate the elongate medical device and may be independently controllable. The robotic drive system further includes a device support movably positioned within the device module and having a first end and a second end. The device support is configured to provide a passageway to accommodate and support the elongate medical device within the distance between the device module and the device support connection. The first end and the second end of the device support are coupled to the distal support arm.
[0015] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes: a linear member; a first drive module coupled to the linear member; a cartridge mounted to the first drive module and having a proximal end; and a second drive module coupled to the linear member at a location proximal to the first drive module. The second drive module is configured to be positioned in an area that overlaps the proximal end of the cartridge mounted to the first drive module.
[0016] According to one embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member, a first device module coupled to the linear member, a second device module coupled to the linear member, and a deployable elongate medical device having a first section and a second section. The first section is positioned on the first device module and the second section is positioned on the second device module. The first device module and the second device module may be independently controllable. Independent linear movement of the second device module along a track can be used to actuate the second section of the deployable elongate medical device.
[0017] According to another embodiment, a method for loading an elongate medical device into a device module of a robotic drive system, the robotic drive system having a plurality of device modules and being configured to drive a plurality of elongate medical devices, the method includes: using a robotic driver to move a proximal device module to a position a predetermined distance from a distal device module, the distal device module including a distal elongate medical device having a hub; receiving a first end of the proximal elongate medical device in the hub of the distal elongate medical device and receiving the proximal elongate medical device in the proximal device module. The predetermined distance is determined based on a desired gap between a first end of the distal elongate medical device and a first end of the proximal elongate medical device when the proximal elongate medical device is received in the proximal device module, the length of the distal elongate medical device, and the length of the proximal elongate medical device.
[0018] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member and a plurality of device modules coupled to the linear member. The plurality of device modules are configured to allow ready sub-assemblies of the plurality of elongate medical devices to be side-loaded into the plurality of device modules. Each of the plurality of device modules receives one of the plurality of elongate medical devices.
[0019] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member having a length, a first device module configured to manipulate a first elongate medical device, a first platform coupled to the linear member, and a first offset bracket connected between the first device module and the first platform to couple the first device module to the first platform. The first device module may be independently controllable and has a center point. The first platform has a center point. The first offset bracket defines a first offset distance between the center point of the first device module and the center point of the first platform. The system further includes a second device module configured to manipulate a second elongate medical device, a second platform coupled to the linear member, and a second offset bracket connected between the second device module and the second platform to couple the second device module to the second platform. The second device module may be independently controllable and has a center point. The second platform has a center point. The second offset bracket defines a second offset distance between the center point of the second device module and the center point of the second platform. The linear movement range of the first device module along the linear member and the linear movement range of the second device module along the linear member overlap. The linear movement range of the first device module extends distally beyond the length of the linear member.
[0020] According to another embodiment, a robotic drive system for driving one or more elongate medical devices includes a linear member having a length, a first device module configured to manipulate a first elongate medical device, a first platform coupled to the linear member, and a first offset bracket connected between the first device module and the first platform to couple the first device module to the first platform. The first device module may be independently controllable and has a center point. The first platform has a center point. The first offset bracket defines a first offset distance between the center point of the first device module and the center point of the first platform. The system further includes a second device module configured to manipulate a second elongate medical device, a second platform coupled to the linear member, and a second offset bracket connected between the second device module and the second platform to couple the second device module to the second platform. The second device module may be independently controllable and has a center point. The second platform has a center point. The second offset bracket defines a second offset distance between the center point of the second device module and the center point of the second platform. The first offset distance and the second offset distance are configured to minimize the length of the linear member. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The present invention will be more fully understood from the following detailed description in conjunction with the accompanying drawings, in which reference numerals represent like parts, wherein:
[0022] Figure 1 is a perspective view of an exemplary catheter-based surgical system according to an embodiment;
[0023] Figure 2 is a schematic block diagram of an exemplary catheter-based surgical system according to an embodiment;
[0024] Figure 3 is a perspective view of a robotic driver for a catheter-based surgical system according to an embodiment;
[0025] Figure 4 is a perspective view of a portion of a robotic driver for a catheter-based surgical system according to an embodiment;
[0026] Figure 5 is a perspective view of a drive module attached to a platform according to an embodiment;
[0027] Figure 6 is a side cross-sectional view of a drive module according to an embodiment;
[0028] Figure 7 is a perspective view of an exemplary cartridge according to an embodiment;
[0029] Figure 8 is a top view of an exemplary cartridge attached to a drive module according to an embodiment;
[0030] Figure 9 is a top view of an exemplary cartridge attached to a drive module that is connected to a platform according to an embodiment;
[0031] Figure 10 is a schematic diagram illustrating the manipulation axis of an elongate medical device and the entry point into a patient;
[0032] Figures 11a and 11b are schematic diagrams illustrating the effect of the thickness of a robotic driver on the loss of working length;
[0033] Figure 12 is a schematic diagram illustrating an exemplary orientation for minimizing the loss of working length;
[0034] Figure 13 is a perspective view of a device module having a horizontally mounted cartridge according to an embodiment;
[0035] Figure 14 is a rear perspective view of a device module having a horizontally mounted cartridge according to an embodiment;
[0036] Figure 15Front view of the distal end of a device module with a horizontally mounted cassette, according to an embodiment;
[0037] Figure 16 Front view of the distal end of a device module with a vertically mounted cassette, according to an embodiment;
[0038] Figure 17 Block diagram illustrating the occupied length on a linear member without offset between a device module and a platform, according to an embodiment;
[0039] Figure 18A Block diagram illustrating the occupied length on a linear member with offset between a device module and a platform, according to an embodiment;
[0040] Figure 18B Block diagram illustrating an example offset bracket configuration, according to an embodiment;
[0041] Figure 18C Block diagram illustrating an example offset bracket configuration, according to an embodiment;
[0042] Figure 19 Side view of a robotic actuator with an offset bracket, according to an embodiment;
[0043] Figure 20 Isometric view of a robotic actuator with an offset bracket, according to an embodiment;
[0044] Figure 21 Top view of a robotic actuator with an offset bracket, according to an embodiment;
[0045] Figure 22 Top view of a portion of a robotic actuator configured to drive four elongate medical devices, according to an embodiment;
[0046] Figure 23 Perspective view of a catheter with a device-on adapter, according to an embodiment;
[0047] Figure 24 Perspective view of a guidewire with a device-on adapter, according to an embodiment;
[0048] Figure 25 Perspective view of a cassette with an installed elongate medical device having a device-on adapter, according to an embodiment;
[0049] Figure 26 Exploded view of a cassette and an elongate medical device having a device-on adapter removed from the cassette, according to an embodiment;
[0050] Figure 27 Top view of a portion of a robotic actuator configured to drive three elongate medical devices, according to an embodiment;
[0051] Figure 28A is a schematic diagram of a first device module mechanically coupled to a second device module to share a linear movement of the first device module according to an embodiment;
[0052] Figure 28B is a schematic diagram of an exemplary mechanical mount of a device module according to an embodiment;
[0053] Figure 29 is a block diagram illustrating changing the position of a device module in a robotic actuator according to an embodiment, wherein the device module is mechanically coupled to another device module;
[0054] Figure 30 is a block diagram illustrating different positions of a device module in a robotic actuator according to an embodiment, wherein the device module is mechanically coupled to another device module;
[0055] Figure 31 is a block diagram illustrating changing the position of a device module in a robotic actuator according to an embodiment, wherein the device module is configured to be filled with more than one elongate medical device;
[0056] Figure 32 is a block diagram of a robotic actuator including three device modules and nested unfilled drive modules according to an embodiment;
[0057] Figure 33 is a block diagram of a robotic actuator including two device modules and two nested unfilled drive modules according to an embodiment;
[0058] Figure 34 is a side view of three unfilled drive modules and an offset bracket according to an embodiment;
[0059] Figure 35 is a rear side view of three unfilled drive modules and an offset bracket according to an embodiment;
[0060] Figure 36 is a side view of two nested unfilled drive modules and two device modules according to an embodiment;
[0061] Figure 37 is an isometric view of a robotic actuator having two nested unfilled drive modules and two device modules according to an embodiment;
[0062] Figure 38 is a block diagram illustrating a cartridge collision prevention device and method according to an embodiment;
[0063] Figure 39 is a block diagram illustrating an unfilled drive module collision prevention device and method according to an embodiment;
[0064] Figure 40 Front view of a robotic actuator with a linear member according to an embodiment, the linear member having two sliders;
[0065] Figure 41 According to an embodiment Figure 40 Perspective view of the robotic actuator;
[0066] Figure 42A - 42D Illustrates a translation device module according to an embodiment, which can be repositioned along the linear member in the robotic actuator;
[0067] Figure 43 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a three - axis configuration and including a drive module having more than one coupler;
[0068] Figure 44 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a two - axis configuration and including a drive module having more than one coupler;
[0069] Figure 45 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a single - axis configuration and including a drive module having more than one coupler;
[0070] Figure 46 Side view of a box with one degree of freedom according to an embodiment, the box being mounted to a drive module having more than one coupler;
[0071] Figure 47 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a three - axis configuration and including both a drive module having a single coupler and a drive module having more than one coupler;
[0072] Figure 48 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a two - axis configuration and including a box mounted to two drive modules;
[0073] Figure 49 Top view of a part of a robotic actuator according to an embodiment, the robotic actuator being in a single - axis configuration and including a box mounted to two drive modules;
[0074] Figure 50 Block diagram of a parallel configuration of an elongate medical device in a robotic actuator according to an embodiment;
[0075] Figure 51Top view of a cartridge having a bypass channel and an elongate medical device in a series configuration, according to an embodiment;
[0076] Figure 52 Top view of a cartridge having a bypass channel and an elongate medical device in a parallel configuration, according to an embodiment;
[0077] Figure 53 Block diagram of a parallel configuration of an elongate medical device in a robotic actuator, according to an embodiment;
[0078] Figure 54 Top view of a cartridge configured to receive two elongate medical devices in a parallel configuration, according to an embodiment;
[0079] Figure 55 Block diagram of a robotic actuator configuration having multiple device axes, according to an embodiment;
[0080] Figure 56 Block diagram of an elongate medical device positioned across two device modules in a first position, according to an embodiment;
[0081] Figure 57 Top view of an elongate medical device positioned across two device modules in a second position, according to an embodiment;
[0082] Figure 58 Top view of an elongate medical device positioned across two device modules in a third position, according to an embodiment;
[0083] Figure 59 Perspective view of an exemplary rotatable deployable elongate medical device having a device-on adapter, according to an embodiment;
[0084] Figure 60 is of a rotatable deployable Figure 59 EMD in a cross-sectional view in an undeployed state;
[0085] Figure 61 is of a rotatable deployable Figure 59 EMD in a cross-sectional view in a deployed state;
[0086] Figure 62 is of a Figure 59 rotatable deployable EMD in a cartridge on a drive module in a cross-sectional view;
[0087] Figure 63 Block diagram of a parallel device configuration using a global dwell fixture, according to an embodiment;
[0088] Figure 64 Perspective view of a movable global dwell fixture, according to an embodiment;
[0089] Figure 65 is a top view of a device module according to an embodiment, the device module including a cassette having a module parking jig;
[0090] Figure 66 is a top view of a device module according to an embodiment, the device module including a cassette having a quick change tire driver;
[0091] Figure 67 is a perspective view of a drive mechanism and interface between a drive module and a quick change tire driver according to an embodiment;
[0092] Figure 68 is a perspective view of a drive mechanism and interface between a drive module and a quick change tire driver according to an embodiment;
[0093] Figure 69 is an exemplary robotic drive device module configuration including a quick change tire driver according to an embodiment;
[0094] Figure 70 is a block diagram of a robotic driver configuration including a dedicated guide wire and a quick change catheter device module according to an embodiment;
[0095] Figure 71 is a top view of a robotic driver having a plurality of parallel linear members according to an embodiment;
[0096] Figure 72 is a cross-sectional view of a device module having a position offset slider and the device module in a first position according to an embodiment;
[0097] Figure 73 is a cross-sectional view of a device module having a position offset slider and the device module in a second position according to an embodiment;
[0098] Figure 74 is a top view of device modules in an exemplary series configuration in a multi-linear member robotic driver according to an embodiment;
[0099] Figure 75 is a perspective view of device modules in an exemplary series configuration in a multi-linear member robotic driver according to an embodiment;
[0100] Figure 76 is a top view of device modules in an exemplary parallel configuration in a multi-linear member robotic driver according to an embodiment;
[0101] Figure 77 is a perspective view of device modules in an exemplary parallel configuration in a multi-linear member robotic driver according to an embodiment;
[0102] Figure 78A - C Illustrates reconfiguring the position of device modules using a positioning system according to an embodiment;
[0103] Figure 79 Is a perspective view of a device support having a fixed front (or distal) point and a rear (or proximal) point to provide tension according to an embodiment;
[0104] Figure 80 Is a top view showing a cartridge according to an embodiment, the cartridge having a device support in a retracted position to facilitate exchange of an elongate medical device;
[0105] Figure 81 Is a top view showing a cartridge according to an embodiment, wherein the device support is in an extended position with both ends constrained;
[0106] Figure 82 Is a top view of two device modules having a device support according to an embodiment;
[0107] Figure 83 Is a top view illustrating linear forward translation of a device module relative to a device support according to an embodiment;
[0108] Figure 84 Is a top view illustrating linear reverse translation of a device module relative to a device support according to an embodiment;
[0109] Figure 85 Is a top view illustrating linear reverse translation of a device support relative to a device module according to an embodiment;
[0110] Figure 86 Shows a simplified top view of four device modules and four device supports for a robotic actuator according to an embodiment;
[0111] Figure 87 Shows a simplified top view illustrating movement of a device module relative to a device support according to an embodiment;
[0112] Figure 88 Shows a simplified top view illustrating according to an embodiment Figure 86 Four device modules in a forward position relative to their respective device supports;
[0113] Figure 89 Shows a simplified top view illustrating according to an embodiment Figure 86 Four device modules in a retracted position relative to their respective device supports;
[0114] Figure 90 Is a side view of the proximal end of an extended device support and a rear restraint of a rear fixed point to which the device support is connected according to an embodiment;
[0115] Figure 91 Side view of the rear restraint of the proximal end of the partially retracted device support according to an embodiment and the connection of the device support to the rear fixing point;
[0116] Figure 92 Simplified top view of a device module having a device support stored on a reel according to an embodiment;
[0117] Figure 93 Exemplary winding tensioner according to an embodiment is shown;
[0118] Figure 94 Simplified top view of a device module having a drive device support according to an embodiment;
[0119] Figure 95 Exemplary gear tensioner according to an embodiment is shown;
[0120] Figure 96 Simplified top view of a device module having a device support formed by a telescopic joint or a spring according to an embodiment;
[0121] Figure 97 Compressed telescopic joint / spring according to an embodiment is illustrated;
[0122] Figure 98 Stretched telescopic joint / spring according to an embodiment is illustrated;
[0123] Figure 99A - C Perspective view of an exemplary slit shape for supporting a flexible tube of a device according to an embodiment;
[0124] Figure 100 Exploded view of a device module and an elongate medical device according to an embodiment;
[0125] Figure 101A Perspective view of a cartridge having a device support mounted thereon and in a retracted position according to an embodiment;
[0126] Figure 101B Perspective view of a cartridge having a device support mounted thereon according to an embodiment;
[0127] Figure 102 Top view of a device support and a connector extending from a cartridge in front of the EMD entry point according to an embodiment;
[0128] Figure 103 Top view of a device support and a connector retracted behind the EMD entry point according to an embodiment;
[0129] Figure 104 End view of a separator holding open a device support according to an embodiment;
[0130] Figure 105 Is a top view of a cartridge according to an embodiment, where the device support connector is retracted away from the device axis to facilitate loading of the EMD;
[0131] Figure 106 Is a perspective view of a forward restraint and connector according to an embodiment;
[0132] Figure 107 Is a perspective view of a forward restraint with a lid according to an embodiment;
[0133] Figure 108 Is a perspective view of a distal support arm and a distal support connector according to an embodiment;
[0134] Figure 109 Is a perspective view of a distal support connector coupled to a device support and a connector according to an embodiment;
[0135] Figure 110 Is a side view of a distal support arm, a distal support connector, and a guide interface support according to an embodiment;
[0136] Figure 111 Is a perspective view of a guide interface support connected to a guide sheath according to an embodiment;
[0137] Figure 112 Is a perspective view of a movable distal support arm in a first position according to an embodiment;
[0138] Figure 113 Is a perspective view of a movable distal support arm in a second position according to an embodiment;
[0139] Figure 114 Is a top view of a movable distal support arm and a movable support arm in a first position according to an embodiment;
[0140] Figure 115 Is a top view of a movable distal support arm and a movable support arm in a second position according to an embodiment;
[0141] Figure 116 Is a top view illustrating the movement of a distal support arm and a support arm from a second position to a first position according to an embodiment;
[0142] Figure 117 Is a block diagram illustrating a method for loading or unloading an EMD in a robotic actuator at a safe loading distance according to an embodiment;
[0143] Figure 118 Is a top view of a device module of a robotic actuator in a loading position according to an embodiment;
[0144] Figure 119 The top view of the device module in the loading position according to an embodiment and a set of prepared EMDs; and Figure 118
[0145] Figure 120 The top view of a set of prepared EMDs loaded into a suitable device module according to an embodiment; Figure 119
[0146] Figure 121 The schematic diagram of an elongate medical device, a clearance tool, and an on-device adapter according to an embodiment;
[0147] Figure 122 The schematic diagram of an elongate medical device, a clearance tool, and an on-device adapter according to an embodiment;
[0148] Figure 123 The schematic diagram of an exemplary clearance tool according to an embodiment; and
[0149] Figure 124 The schematic diagram of an exemplary clearance tool according to an embodiment. DETAILED DESCRIPTION
[0150] The following definitions will be used herein. The term elongate medical device (EMD) refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, balloon / stent catheters), wire-based devices (guidewires, embolization coils, stent retrievers, etc.), and devices having combinations thereof. Wire-based EMDs include, but are not limited to, guidewires, microfilaments, proximal pusher for embolization coils, stent retrievers, self-expanding stents, and shunts. Typically, wire-based EMDs do not have a hub or handle at their proximal end. In one embodiment, the EMD is a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub towards the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion that transitions between the hub and the shaft, the intermediate portion having an intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment, the intermediate portion is a strain relief.
[0151] The terms distal and proximal define the relative positions of two different features. With respect to a robotic drive, the terms distal and proximal are defined by the position of the robotic drive relative to the patient in its intended use. When used to define relative position, a distal feature is a feature of the robotic drive that is closer to the patient than a proximal feature when the robotic drive is in its intended use position. In the patient's body, any vasculature landmark along a path away from the access point is considered more distal than a landmark closer to the access point, where the access point is the point at which the EMD enters the patient's body. Similarly, when the robotic drive is in its intended use position, a proximal feature is a feature that is farther from the patient than a distal feature. When used to define a direction, the distal direction refers to the path along which something is moving or is intended to move when the robotic drive is in its intended use position, or the path along which something points or faces from a proximal feature toward a distal feature and / or the patient. The proximal direction is the direction opposite to the distal direction.
[0152] The term longitudinal axis of a member (e.g., the EMD or other element in a catheter-based surgical system) is the direction of orientation from the proximal portion of the member to the distal portion of the member. For example, the longitudinal axis of a guide wire is the direction of orientation from the proximal portion of the guide wire toward the distal portion of the guide wire, even if the guide wire may be non-linear in the relevant portion. The term "axial movement of a member" refers to the translation of the member along the longitudinal axis of the member. When the distal end of the EMD moves axially in the distal direction along its longitudinal axis into or further into the patient's body, the EMD is being advanced. When the distal end of the EMD moves axially in the proximal direction along its longitudinal axis out of or further out of the patient, the EMD is being withdrawn. The term rotational movement of a member refers to a change in the angular orientation of the member about the local longitudinal axis of the member. The rotational movement of the EMD corresponds to the clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque.
[0153] The term axial insertion refers to inserting a first member into a second member along the longitudinal axis of the second member. The term "lateral insertion" refers to inserting a first member into a second member in a direction along a plane perpendicular to the longitudinal axis of the second member. This may also be referred to as a radial load or side load. The term "clamping" refers to releasably fixing the EMD to a member such that when the member moves, the EMD and the member move together. The term "unclamping" refers to releasing the EMD from the member such that when the member moves, the EMD and the member move independently. The term "gripping" refers to releasably fixing the EMD to a member such that the movement of the EMD relative to the member is constrained. The member may be fixed relative to a global coordinate system or relative to a local coordinate system. The term "ungripping" refers to releasing the EMD from the member so that the EMD can move independently.
[0154] The term "grasp" refers to applying a force or torque to the EMD by a drive mechanism that causes the EMD to move without slipping in at least one degree of freedom. The term "release grasp" refers to releasing the force or torque applied to the EMD by the drive mechanism such that the position of the EMD is no longer constrained. In one example, when the tires move longitudinally relative to each other, the EMD grasped between the two tires will rotate about its longitudinal axis. The rotational movement of the EMD is different from the movement of the two tires. The position of the grasped EMD is constrained by the drive mechanism. The term "buckling" refers to the tendency of a flexible EMD to bend away from the longitudinal axis or the intended path along which it is advancing when axially compressed. In one embodiment, the axial compression occurs in response to resistance encountered while navigating through a vasculature system. The distance that the EMD can be driven without support along its longitudinal axis prior to buckling of the EMD is referred to herein as the device buckling distance. The device buckling distance is a function of device stiffness, geometry (including but not limited to diameter), and the force applied to the EMD. Buckling can cause the EMD to form an arcuate portion different from the intended path. Kinking is a case of buckling where the deformation of the EMD is inelastic, resulting in a permanent deformation.
[0155] The terms "top", "upward", and "upper" refer to a general direction away from the direction of gravity, and the terms "bottom", "downward", and "lower" refer to a general direction in the direction of gravity. The term "inward" refers to the inner portion of a feature. The term "outward" refers to the outer portion of a feature. The term sterile interface refers to the interface or boundary between a sterile and a non-sterile unit. For example, the cartridge can be a sterile interface between a robotic actuator and at least one EMD. The term "sterilizable unit" refers to a device (free of pathogenic microorganisms) that can be sterilized. This includes but is not limited to cartridges, consumable units, drapes, device adapters, and sterilizable drive modules / units (which may include electromechanical components). Sterilizable units may come into contact with patients, other sterile devices, or any other items placed within the sterile field of a medical procedure.
[0156] The term device on-adapter refers to a sterile device capable of releasably clamping an EMD to provide a drive interface. For example, the device on-adapter is also referred to as an end effector or an EMD capture device. In one non-limiting embodiment, the device on-adapter is a chuck that is operably controlled by a robot to rotate the EMD about its longitudinal axis to clamp the EMD to the chuck and / or release it, and / or to translate the EMD along its longitudinal axis. In one embodiment, the device on-adapter is a hub drive mechanism, such as a driven gear located on the hub of the EMD.
[0157] Figure 1is 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., for treating STEMI)), neurovascular interventional procedures (NVI) (e.g., for treating emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI), etc.). Catheter-based medical procedures can include diagnostic catheterization procedures, during which one or more catheters or other elongate medical devices (EMDs) are used to assist in diagnosing a patient's disease. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries via a catheter, and images of the patient's vasculature are taken. Catheter-based medical procedures can 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 a disease. The therapeutic procedure can be enhanced by including an assist device 54 (such as Figure 2 shown), such as, for example, 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., the type of guide wire, the 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 devices to be used in the procedure.
[0158] The catheter-based surgical system 10 particularly includes a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic actuator 24 and a positioning system 22 positioned adjacent to the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robotic actuator 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a holder, etc. One end of the positioning system 22 can be attached to, for example, a track, a base, or a cart on the patient table 18. The other end of the positioning system 22 is attached to the robotic actuator 24. The positioning system 22 can be moved away (along with the robotic actuator 24) to allow the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or reposition the robotic actuator 24 relative to the patient 12 for the procedure. In an embodiment, the patient table 18 is operably supported by a base 17 that is fixed to the floor and / or the ground. The patient table 18 is capable of moving relative to the base 17 in multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 can also include controls and a display 46 ( Figure 2as shown). For example, the control and display can be located on the housing of the robotic driver 24.
[0159] Generally, the robotic driver 24 can be equipped with suitable percutaneous intervention devices and accessories 48 (such as Figure 2 as shown) (e.g., guide wires, various types of catheters, including balloon catheters, stent delivery systems, stent retrieval devices, embolization coils, liquid embolic agents, aspiration pumps, devices for delivering contrast media, drugs, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow the user or operator 11 to perform catheter-based medical procedures via the robotic system by operating various controls (such as the controls and input devices located at the control station 26). The bedside unit 20, and particularly the robotic driver 24, can include any number and / or combination of components to provide the functions described herein to the bedside unit 20. The user or operator 11 at the control station 26 is referred to as the control station user or control station operator and is referred to herein as the user or operator. The user or operator at the bedside unit 20 is referred to as the bedside unit user or bedside unit operator. The robotic driver 24 includes a plurality of device modules 32a-d mounted on a track or linear member 60 (such as Figure 3 as shown). The track or linear member 60 guides and supports the device modules. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or a guide wire. For example, the robotic driver 24 can be used to automatically feed a guide wire into a diagnostic catheter and a guiding catheter in the artery of the patient 12. One or more devices (such as an EMD) enter the body (e.g., blood vessel) of the patient 12 at the insertion point 16 via, for example, a introducer sheath.
[0160] The bedside unit 20 communicates with the control station 26, thereby allowing signals generated by user input at the control station 26 to be transmitted wirelessly or via hardwiring to the bedside unit 20 to control various functions of the bedside unit 20. As discussed below, the control station 26 can include a control computing system 34 (such as Figure 2 as shown) or be coupled to the bedside unit 20 through the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34 ( Figure 2 as shown) or both. 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 device capable of allowing communication between the components. The control station 26 or other similar control systems can be located at a local site (e.g., Figure 2 the local control station 38 as shown) or a remote site (e.g., Figure 2at the remote control station and computer system 42) shown. The catheterization surgery system 10 can be operated by a control station at a local site, a control station at a remote site, or both the local control station and the remote control station simultaneously. At the local site, the user or operator 11 and the control station 26 are located in the same room or an adjacent room 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., animal or cadaver), and the remote site is the location of the user or operator 11 and the control station 26 for remotely controlling the bedside unit 20. The control station 26 (and control computing system) at the remote site and the bedside unit 20 and / or the control computing system at the local site can communicate using a communication system and service 36 (as Figure 2 shown) (e.g., via the Internet). In an embodiment, the remote site and the local (patient) site are remote from each other, e.g., in different rooms of the same building, different buildings in the same city, different cities, or other different locations where the remote site cannot physically access the bedside unit 20 and / or the patient 12 at the local site.
[0161] The control station 26 generally includes one or more input modules 28, which are configured to receive user input to operate various components or systems of the catheter-based surgery system 10. In the illustrated embodiment, the control station 26 allows the user or operator 11 to control the bedside unit 20 to perform catheter-based medical procedures. For example, the input module 28 can be configured to cause the bedside unit 20 to perform various tasks (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 retriever; positioning and / or deploying a coil; injecting contrast agent into the catheter; injecting liquid embolic agent into the catheter; injecting a drug or saline into the catheter; aspirating on the catheter; or performing any other function that can be performed as part of a catheter-based medical procedure) using a percutaneous intervention device (e.g., EMD) docked with the robotic driver 24. The robotic driver 24 includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of components of the bedside unit 20, including the percutaneous intervention device.
[0162] In one embodiment, the input module 28 can include one or more touchscreens, joysticks, rollers, and / or buttons. In addition to the input module 28, the control station 26 can use additional user controls 44 (as Figure 2as shown), such as a foot switch and a microphone for voice commands. The input module 28 can be configured to advance, retract, or rotate various components and percutaneous intervention devices, such as, for example, a guide wire and one or more catheters or microcatheters. The buttons can 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 pushed, the power (e.g., electricity) to the bedside unit 20 is cut off or removed. When in speed control mode, the multiplier button is used to increase or decrease the speed of movement of the associated component in response to manipulation of the input module 28. When in position control mode, the multiplier button changes the mapping between the input distance and the output command distance. The device selection button allows the user or operator 11 to select which percutaneous intervention devices loaded into the robotic driver 24 are controlled by the input module 28. The automatic movement button is used to implement the algorithmic movement that the catheter-based surgical system 10 can perform on the percutaneous intervention device without a direct command from the user or operator 11. In one embodiment, the input module 28 can include one or more controls or icons (not shown) displayed on a touch screen (which may or may not be part of the display 30), which when activated cause the operation of components of the catheter-based surgical system 10. The input module 28 can also include balloon or stent controls that are configured to inflate or deflate the balloon and / or deploy the stent. Each input module 28 can include one or more buttons, rollers, joysticks, touch screens, etc., which can be used to control one or more specific components dedicated to that control. Additionally, one or more touch screens can display one or more icons (not shown) related to the various parts of the input module 28 or the various components of the catheter-based surgical system 10.
[0163] The control station 26 can include a display 30. In other embodiments, the control station 26 can include two or more displays 30. The display 30 can be configured to display information or patient-specific data to the user or operator 11 located at the control station 26. For example, the display 30 can be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (such as blood pressure, heart rate, etc.), patient record information (such as medical history, age, weight, etc.), lesion or treatment assessment data (such as IVUS, OCT, FFR, etc.). Additionally, the display 30 can be configured to display procedure-specific information (e.g., a procedure checklist, recommendations, procedure duration, catheter or guide wire position, volume of drug or contrast agent delivered, etc.). Further, the display 30 can be configured to display information to provide the functionality associated with the control computing system 34 ( Figure 2 as shown). The display 30 can include touch screen capabilities to provide some user input capabilities of the system.
[0164] The catheter-based surgical system 10 further 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 the control station 26. In one embodiment, the imaging system 14 can include a C-arm ( Figure 1 shown), which allows the imaging system 14 to rotate partially or fully around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anteroposterior view, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an X-ray source 13 and a detector 15, also known as an image intensifier.
[0165] The imaging system 14 can be configured to take X-ray images of an appropriate region of the patient 12 during the procedure. For example, the imaging system 14 can be configured to take one or more X-ray images of the head to diagnose neurovascular conditions. The imaging system 14 can also be configured to take one or more X-ray images (e.g., real-time images) during a catheter-based medical procedure to assist the user or operator 11 of the control station 26 in correctly positioning a guide wire, guiding catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. One or more images can be displayed on the display 30. For example, the images can be displayed on the display 30 to allow the user or operator 11 to accurately move the guiding catheter or guide wire into the appropriate position.
[0166] To define directions, a rectangular coordinate system with X, Y, and Z axes is introduced. The positive X-axis is oriented in the longitudinal (axial) distal direction, i.e., in the direction from proximal to distal, in other words, from the proximal to the distal direction. The Y-axis and Z-axis are in the transverse plane of the X-axis, where the positive Z-axis is oriented upward, i.e., in the direction opposite to gravity, and the Y-axis is automatically determined by the right-hand rule.
[0167] Figure 2 is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter surgical system 10 can include a control computing system 34. The control computing system 34 can be physically, for example, the control station 26 as Figure 1a portion of (as shown). The control computing system 34 can generally be an electronic control unit suitable for providing the various functions described herein for the catheter-based surgical system 10. For example, the control computing system 34 can 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 the bedside unit 20, the communication systems and services 36 (such as the Internet, firewall, cloud services, session manager, hospital network, etc.), the local control station 38, the additional communication system 40 (such as a telepresence system), the remote control station and computing system 42, and the patient sensors 56 (such as 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, the patient table 18, the additional medical system 50, the contrast injection system 52, and the accessory devices 54 (such as IVUS, OCT, FFR, etc.). The bedside unit 20 includes the robot driver 24, the positioning system 22, and can include additional controls and a display 46. As described above, the additional controls and the display can be located on the housing of the robot driver 24. The intervention device and accessories 48 (such as wires, catheters, etc.) are docked to the bedside system 20. In an embodiment, the intervention device and accessories 48 can include dedicated devices (such as an IVUS catheter, an OCT catheter, an FFR wire, a diagnostic catheter for angiography, etc.), which are docked to their corresponding accessory devices 54, namely the IVUS system, the OCT system, the FFR system, etc.
[0168] In various embodiments, the control computing system 34 is configured to generate control signals based on the user's interaction with the input module 28 (such as a control station 26 such as the local control station 38 or the remote control station 42 (shown in Figure 1 )) and / or based on information accessible to the control computing system 34, such that a medical procedure can be performed 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 can include components similar to those of the local control station 38. The remote control station 42 and the local control station 38 can be different and customized based on their required functions. The additional user controls 44 can include, for example, one or more foot pedal input controls. The foot pedal input controls can be configured to allow the user to select functions of the imaging system 14, such as turning on and off the X-ray and scrolling through different stored images. In another embodiment, the foot pedal input device can be configured to allow the user to select which devices are mapped to the rollers included in the input module 28. The additional communication system 40 (such as audio conferencing, video conferencing, telepresence, etc.) can be used to assist the operator in interacting with the patient, medical staff (such as vascular room staff), and / or devices near the bedside.
[0169] The catheter-based surgical system 10 can be connected or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 can include an image processing engine, a data storage and archiving system, an automatic 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.
[0170] As described above, the control computing system 34 communicates with the bedside unit 20 that includes the robotic driver 24 and the positioning system 22, and can include additional controls and a display 46, and can provide control signals to the bedside unit 20 to control the operation of motors and drive mechanisms for driving percutaneous intervention devices (e.g., guidewires, catheters, etc.). Various drive mechanisms can be provided as part of the robotic driver 24. Figure 3 is a perspective view of a robotic driver for a catheter-based surgical system 10 according to an embodiment. In Figure 3 the robotic driver 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each device module 32a-d is coupled to the linear member 60 via a platform 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the platforms 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are directly mounted to the platforms 62a-d. Each platform 62a-d can be independently actuated to linearly move along the linear member 60. Thus, each platform 62a-d (and the corresponding device module 32a-d coupled to the platform 62a-d) can move independently of each other and the linear member 60. Drive mechanisms are used to actuate each platform 62a-d. In Figure the illustrated embodiment, the drive mechanisms include independent platform translation motors 64a-d and platform drive mechanisms 76 coupled to each platform 62a-d, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, a chain via a sprocket, or the platform translation motors 64a-d themselves can be linear motors. In some embodiments, the platform drive mechanisms 76 can be a combination of these mechanisms, for example, each platform 62a-d can employ a different type of platform drive mechanism. In an embodiment where the platform drive mechanism is a lead screw and a rotating nut, the lead screw can rotate, and each platform 62a-d can engage and disengage with the lead screw to move, for example, advance or retract. In the illustrated embodiment, the platforms 62a-d and the device modules 32a-d are in a series drive configuration.
[0171] Each device module 32a-d includes a drive module 68a-d and a cartridge 66a-d mounted and coupled to the drive module 68a-d. In In the illustrated embodiment, each of cartridges 66a-d is mounted to a drive module 68a-d in a vertical orientation. In other embodiments, each of cartridges 66a-d may be mounted to a drive module 68a-d in other mounting orientations. Each of cartridges 66a-d is configured to dock with and support a proximal portion (not shown) of the EMD. Additionally, each of cartridges 66a-d may include elements that provide one or more degrees of freedom in addition to the linear motion provided by actuation of the corresponding platforms 62a-d to linearly move along the linear member 60. For example, cartridges 66a-d may include elements that can be used to rotate the EMD when the cartridge is coupled to the drive module 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to the mechanisms in each of cartridges 66a-d, thereby providing additional degrees of freedom. Each of cartridges 66a-d also includes a channel in which device supports 79a-d are positioned, and each of device supports 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are respectively attached to each of device modules 32a, 32b, and 32c to provide fixed points for supporting the proximal ends of device supports 79b, 79c, and 79d, respectively. The robotic driver 24 may also include a device support connector 72, a distal support arm 70, and a support arm 770 connected to the device support 79. The support arm 770 is used to provide a fixed point for supporting the proximal end of the most distal device support 79a housed in the most distal device module 32a. Additionally, a guide interface support (steerer) 74 may be connected to the device support connector 72 and the EMD (such as a guide sheath). The configuration of the robotic driver 24 has the advantage of reducing the volume and weight of the robotic driver 24 by using actuators on a single linear member.
[0172] To prevent pathogen contamination of the patient, healthcare providers use aseptic technique in the room housing the bedside unit 20 and the patient 12 or subject (as shown). The room housing the bedside unit 20 and the patient 12 may be, for example, a catheter laboratory or an angiography suite. Aseptic technique includes the use of aseptic barriers, aseptic equipment, appropriate patient preparation, environmental control, and contact guidelines. Accordingly, all EMDs and interventional accessories are sterilized and can only come into contact with aseptic barriers or aseptic equipment. In an embodiment, a sterile drape (not shown) is placed over the non-sterile robotic driver 24. Each of cartridges 66a-d is sterilized and serves as a sterilization interface between the draped robotic driver 24 and at least one EMD. Each of cartridges 66a-d may be designed to be single-use sterile or may be fully or partially re-sterilized such that the cartridge 66a-d or its components can be used in multiple procedures.
[0173] As described above, the linear movement of each of the device modules 32a-d along the track or linear member 60 can be independently controlled. In an embodiment, the linear movement ranges of each of the different device modules along the track 60 can overlap. In other words, the ranges of positions at which the different device modules can be positioned along the track 60 can overlap such that the different device modules can occupy the same space at different times, although not at the same time. In one embodiment, two successive device modules (e.g., 32a and 32b, 32b and 32c, 32c and 32d) can have overlapping linear movement ranges. In another embodiment, non-successive modules (e.g., 32a and 32c or 32b and 32d) can have overlapping linear movement ranges.
[0174] As described above, each of the cassettes 66a-d of each of the device modules 32a-d is configured to dock with and support the proximal portion of the EMD. In various embodiments, depending on, for example, the type of surgery being performed using the robotic actuator 24, different numbers and types of EMDs can be utilized in the robotic actuator 24. For example, the EMD can be located in the first device module 32a while the second device module 32b, the third device module 32c, and the fourth device module 32d are unfilled. In various other embodiments, the robotic actuator 24 can be used to implement any combination of the filled device modules, such as, for example, filling the first device module 32a and the second device module 32b with the EMD, filling the first device module 32a and the fourth device module 32d with the EMD, filling the first device module 32a, the second device module 32b, and the third device module 32c with the EMD, filling the first device module 32a, the third device module 32c, and the fourth device module 32d with the EMD, filling the first device module 32a, the second device module 32b, and the fourth device module 32d with the EMD, filling the first device module 32a, the second device module 32b, and the fourth device module 32d with the EMD, and so on. Additionally, each of the device modules 32a-d can receive different types of EMDs, including but not limited to sheaths (also referred to as long sheaths), guiding catheters, balloon guiding catheters, guiding sheaths, diagnostic wires (also referred to as angiographic wires), intermediate catheters, support catheters, digital access catheters, aspiration catheters, microcatheters, delivery catheters, wire-based EMDs (e.g., wires, micro-wires, stent retrievers, embolization coils), etc. In some embodiments, the specific configuration of the filled device modules and the specific type of EMD can be changed during the surgery, i.e., the surgery can utilize more than one configuration.
[0175] Hub drive or proximal drive refers to holding and manipulating the EMD from a proximal position (e.g., a gear adapter on a catheter hub). In one embodiment, hub drive refers to imparting force or torque to the hub of a catheter to translate and / or rotate the catheter. In hub drive, frequently applying typical clinical loads will cause the EMD to buckle. Therefore, hub drive often requires incorporating additional anti-buckling features in the EMD or the drive mechanism. For an EMD that does not have a hub or other interface (such as a guide wire), a device adapter can be added to the device to act as a temporary hub. Shaft drive refers to holding the EMD and manipulating the EMD along its axis. For example, a device-on adapter can be placed proximal to the hub or Y-connector into which the device is inserted. If the position of the device-on adapter is close to the insertion point (the body or another catheter or valve), shaft drive generally does not require anti-buckling features (but can include anti-buckling features to enhance the driving ability). This type of shaft drive can be referred to as distal drive. In , each drive module 32a-d is configured to hub drive the EMD. However, in various embodiments described further below, the robotic driver 24 or one and / or more of the device modules 32a-d can be configured to provide one or more shaft-driven EMDs. As described above, in , the drive modules 32a-d are in a series drive configuration (e.g., over-the-wire (OTW)). A series driver configuration or layout uses an actuator (or driver) to drive the EMD into a more distal EMD hub. The EMD can also be driven in a parallel configuration or layout. A parallel configuration or layout uses series actuators (or drivers) to drive two or more EMDs into a common EMD hub. The series and parallel configurations can be attached together in different combinations. In various embodiments described further below, the robotic driver 24 and / or one or more of the drive modules 32a-d can be configured to provide one or more of the drive modules 32a-d or EMDs in a parallel drive configuration (e.g., rapid exchange).
[0176] In an alternative embodiment, separate tracks or linear members can be used to support and translate each of the platforms 62a-d and the device modules 32a-d. is a perspective view of a portion of a robotic driver for a catheter surgery system according to an embodiment. The robotic driver 25 includes a device module 32a coupled to a first track or linear member 80 using a platform 62a, a device module 32b coupled to a second track or linear member 82 using a platform 62b, and a device module 32c coupled to a third track or linear member 84 using a platform 62c. The first track 60, the second track 82, and the third track 84 are parallel to each other. A first platform translation motor 86 is used to translate the platform 62a along the first track 80, a second platform translation motor 88 is used to translate the platform 62b along the second track 82, and a third platform translation motor 90 is used to translate the platform 62b along the third track 84. An advantage of the configuration shown is that the platform translation motor for linear translation is fixed. Accordingly, the mass of the moving device modules 32a-c and platforms 62a-c is reduced and repositioned to a more advantageous point (i.e., toward the rear of the track to assist with reaction moment loading). In the various other embodiments described below with reference to a robotic actuator having multiple parallel tracks can be configured to allow the device modules to pass by each other.
[0177] As described above, each device module 32a-d includes a drive module 68a-d and a cartridge 66a-d mounted on and coupled to the corresponding drive module 68a-d. Each cartridge 66a-d is releasably coupled to the drive module 68a-d. is a perspective view of a drive module attached to a platform according to an embodiment, and is a side cross-sectional view of a drive module according to an embodiment. Referring to and 6 , the drive module includes a mounting surface 92 and a coupler 98. A motor 94 is connected to the coupler 98 via a belt 96. The motor 94 and the belt 96 are used to change the rotational position of the coupler 98. In an embodiment, the coupler 98 rotates about a coupler axis 99. The drive module 68 may include an encoder (not shown) for device position feedback. and 6 The drive module 68 shown in has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as further described below. Rotation of the coupler 98 can be used to provide another degree of freedom for an elongate medical device positioned in a cartridge mounted on the mounting surface 92 to dock with the coupler 98. For example, the coupler 98 can be used to rotate an elongate medical device in the cartridge. Alternatively, the coupler 98 can be used to translate an elongate medical device. If the drive module 68 has two or more couplers 98, each coupler can be used to provide a different degree of freedom for one elongate medical device or multiple elongate medical devices coupled to the same drive module. As described above, the cartridge 66 (as shown in ) can be positioned on the mounting surface 92 of the drive module 68 and is used to dock with an elongate medical device positioned in the cartridge. As further described below with reference to , in an embodiment, the drive module 68 may also include one or more additional elements (not shown) on the mounting surface 92, such as, for example, positioning pins, alignment pins, locking pins, etc., to interact with elements on the cartridge 66 mounted on the drive module 68 to enable the cartridge 66 to be releasably attached to the drive module 68.
[0178] is a perspective view of an exemplary cartridge according to an embodiment. In , the cartridge 91 includes an outer housing 93. The outer housing includes a carriage 95 configured to receive an elongate medical device. A bevel gear 97 is used to dock with a coupler 98 of a drive module (as shown) and to dock with the elongate medical device to rotate the elongate medical device. In other embodiments, the cartridge may be configured to provide linear degrees of freedom, or the cartridge may be configured to provide two or more degrees of freedom. is a top view of an exemplary cartridge attached to a drive module according to an embodiment. In , the cartridge 101 includes a pair of tires 103, 105 that may be connected to a coupler 98 (not shown) of a drive module. The pair of tires 103, 105 may be used to provide linear movement to an elongate medical device positioned within a channel 107. Embodiments of a device module including the cartridge 101 are further described below with reference to . is a top view of an exemplary cartridge attached to a drive module that is connected to a platform. In , the cartridge 111 is configured to provide two degrees of freedom in addition to translation of components. For example, the cartridge 111 may be configured to provide rotation and to clamp and release an elongate medical device 113 positioned within a channel 115. Such a cartridge may be mounted to, for example, a drive module having two or more couplers. Embodiments of a device module including the cartridge 111 and a drive module having two or more couplers are further described below with reference to . In another embodiment further described below with reference to and 49 , two separate drive modules that are coupled together either mechanically or electrically may provide two degrees of freedom to the cartridge 111.
[0179] As shown, one or more EMDs may enter a patient's body (e.g., a blood vessel) at an insertion point 16 using, for example, a guide and a guide sheath. The guide sheath is typically angled with respect to the axis of the blood vessel within the patient 120, typically less than 45 degrees (as shown). Any height difference between the position at which the EMD enters the body (the proximal opening 126 of the guide sheath as shown) and the longitudinal drive axis of the robotic driver 124 will directly affect the working length of the elongate medical device. The greater the need for the elongate medical device to compensate for differences in displacement and angle when the robotic driver is at its maximum distal (forward) position, the less able the elongate medical device will be to enter the body. It is beneficial to have a robotic driver that is at the same height and angle as the guide sheath. is a schematic diagram illustrating the longitudinal axis of an elongate medical device manipulation and the point of entry into a patient's body. Shows the height difference (d) 123 between the proximal end 126 of the introducer sheath 122 and the longitudinal device axis, and the angular difference (θ) 128 between the introducer sheath 122 and the longitudinal device axis 125 of the robotic driver 124. The elongate medical device 121 is constrained along each axis and produces a curve with tangentially aligned end points. The length of this curve represents the length of the elongate medical device 121 that cannot be further driven forward by the robotic driver 124 and cannot enter the introducer sheath 122 due to misalignment. A higher angle (θ) 128 also results in higher device friction. Generally, lower angular misalignment (θ) and linear misalignment d123 result in reduced friction and reduced loss of working length. Although The figure illustrates a simplified example demonstrating a linear offset and a rotational offset, but it should be understood that this problem occurs in three dimensions, namely three linear offsets and three rotational offsets. The thickness of the robotic driver 124 also plays a role in determining the position of the longitudinal device axis 125 relative to the introducer sheath 122.
[0180] Figures 11a and 11b are schematic diagrams illustrating the effect of the thickness of the drive module or the overall robotic drive on the loss of working length. Figure 11a shows the position of the longitudinal device axis 125 of the robotic driver 124 relative to the introducer sheath 122 when the robotic driver 124 is as thick as the distance (X) 129 between the upper and lower surfaces of the robotic driver 124, indicated by d 123. Figure 11b shows the position of the longitudinal device axis 125 of the robotic driver 124 relative to the introducer sheath 122 when the robotic driver 124 is shallower as shown by the distance (X) 129 between the upper and lower surfaces of the robotic driver 124, indicated by the shorter d 123'. Reducing the thickness of the robotic driver 124 to be closer to the patient and the introducer sheath reduces the distance 123 between the introducer sheath axis and the device axis and reduces the loss of the working length of the elongate medical device. Is a schematic diagram illustrating an exemplary orientation for minimizing the loss of working length. In this, the robotic driver is positioned to align the longitudinal device axis 125 of the robotic driver 124 with the longitudinal device axis of the introducer sheath 122. This eliminates the loss of working length due to angular and linear misalignment of the elongate medical device. However, due to the length and size of the robotic driver 124, this position of the robotic driver 124 may not be practical. Orienting the robotic driver at an acute angle also affects usability as it makes loading and unloading the elongate medical device and adjusting and operating the robotic driver difficult.
[0181] To reduce the distance between the robotic driver and the patient and the distance between the longitudinal device axis of the robotic driver and the introducer sheath, the cassette of device module 3 ( as shown) can be horizontally oriented and mounted to the drive module. is a perspective view of a device module with a horizontally mounted cassette according to an embodiment, and is a rear perspective view of a device module with a horizontally mounted cassette according to an embodiment. In and 14 , device module 132 includes a cassette 138 horizontally mounted to drive module 140. Device module 132 is connected to a platform 136 that is movably mounted to a track or linear member 134. Drive module 140 includes a coupler 142 that provides a power interface to cassette 138 to, for example, rotationally position an elongate medical device (not shown) within the cassette. Coupler 142 rotates about axis 143. By horizontally mounting cassette 138, the drive module 140 to which cassette 138 is attached is moved away from the side and is no longer positioned between cassette 138 and the patient. is a front view of the distal end of a device module with a horizontally mounted cassette according to an embodiment. In , the distance 146 between the device axis of the elongate medical device 144 and the bottom surface of device module 132 is shown. The horizontal mounting of cassette 138 eliminates the need to place drive module 140 below the device axis and between the elongate medical device 144 and the patient. Instead, only a portion of cassette 138 is positioned between the elongate medical device 138 and the patient. Horizontally mounting cassette 138 also reduces the distance 146 between the elongate medical device and the bottom surface of device module 132, which allows the robotic driver to be closer to the patient and reduces the loss of working length in the elongate medical device. In contrast, is a front view of the distal end of a device module with a vertically mounted cassette according to an embodiment. In , device module 132 is shown, where cassette 138 is vertically mounted to drive module 140. Drive module 140 is located below cassette 138 and increases the distance 148 between the device axis of the elongate medical device 144 and the bottom surface of device module 132. This can prevent the device axis from getting as close as possible to the introducer (not shown). Drive module 140 positioned below cassette 138 may also interfere with the patient. In various other embodiments, the cassette can be mounted to the drive module at any angle. In yet another embodiment, the cassette can be vertically mounted on the underside of the drive module to eliminate the need for the drive module between the device axis and the patient.
[0182] To reduce the length of the track or linear member 60 ( as shown) of the robotic drive system 24 ( as shown), an offset bracket 78 ( as shown) can be used to create an offset between the platform and the device module to reduce the gap between the platforms on the linear member when the cartridges are placed together. is a block diagram illustrating the occupied length on the linear member according to an embodiment, with no offset between the device module and the platform. As described above, in one embodiment, the device module can be directly mounted to the platform, with no offset between the device module and the platform. In , four device modules 150 are shown, and each device module 150 includes a cartridge 152 mounted to a drive module 154. Each device module 150 is directly connected to a platform 156, and the platform 156 is coupled to a rail or linear member 158. When the device modules 150 are brought closer together along the rail 158, the platforms 156 for each device module 150 also come closer together. However, as shown, the length of each cartridge 152 of each device module 150 can limit how close each platform 156 can be brought to another platform 156 on the rail. The four platforms 156 (plus safety buffers on each side) define the occupied rail length 160, which affects the total length required for the rail 158. As shown, the occupied rail length and the total length of the rail 158 can be shortened by using an offset and an offset bracket.
[0183] is a block diagram illustrating the occupied length on the linear member according to an embodiment, where there is an offset between the device module and the platform. In Four device modules 150 are shown, and each device module 150 includes a cartridge 152 mounted to a drive module 154. Each device module 150 is connected to offset brackets 168, 170, 172, 174 that are used to connect the device module 150 to a platform 156. Each platform is coupled to a track or linear member 158. When the four platforms 156 are brought close together, they define an occupied track length 162, which, as described above, affects the total length required for the track 158. Each offset bracket 168, 170, 172, 174 defines an offset distance from the center of the respective platform 156 to which it is attached to the center of the cartridge 152 of the device module 150 attached to the platform 156. For example, the first offset bracket 168 defines a first offset 164 between the center of the associated platform 156 and the center of the associated cartridge 152. The fourth offset bracket 174 may be configured to define an offset that is the same distance as the first offset 164 or a different offset distance. The third offset bracket 172 defines a second offset 166 between the center of the associated platform 156 and the center of the associated cartridge 152. The second offset bracket 170 may be configured to define an offset that is the same distance as the second offset 166 or a different offset. The offset allows the platforms 156 to be brought towards the center of the track 158, which reduces the total length of the robotic drive. An embodiment of the configuration of the offset brackets is shown; however, in other embodiments, different offset bracket configurations may be used, for example, as and 18C shown. In each of the offset brackets 171, 173, 175, 177 positioned along the linear member or track 159 extends distally (i.e., facing forward) away from the distal end of the linear member 159 in the direction towards the patient. This configuration may allow the linear member 159 (and other elements of the robotic drive) to be positioned away from the access site within the patient and the imaging system of the catheterization system. In each of the offset brackets 181, 183, 185, 187 positioned along the linear member 159 extends proximally (i.e., backward) towards the proximal end of the linear member or track 159 away from the patient. is a side view of a robotic drive having offset brackets according to an embodiment. is an isometric view of a robotic drive having offset brackets according to an embodiment. is a top view of a robotic drive having offset brackets according to an embodiment. In In this case, the offset brackets 168, 170, 172, and 174 are used to compensate for the length of the cassette 152 in order to eliminate the dead zone between the platforms 156. The offset created by the offset brackets 168, 170, 172, and 174 is used to minimize the length of the track or linear member 158 by eliminating the dead zone between the platforms 156. Additionally, if the length of the platforms 156 is greater than the length of the device module 150, the offset can be used to compensate for the length difference between the platforms 156 and the device module 150.
[0184] is a top view of a portion of a robotic driver configured to drive four elongate medical devices according to an embodiment. In this case, this portion of the robotic driver 200 includes four device modules, specifically a first device module 902 having a first cassette 210, a second device module 204 having a second cassette 212, a third device module 906 having a third cassette 214, and a fourth device module 208 having a fourth cassette 216. The robotic driver 200 is configured to drive four elongate medical devices, and thus, each cassette 210, 212, 214, and 216 is filled with an elongate medical device. For example, a first elongate medical device 218 may be positioned in the first cassette 210 and may be, for example, a guide catheter configured to receive three proximal elongate medical devices within the lumen of the guide catheter. A second elongate medical device 220 may be positioned in the second cassette 212 and may be, for example, a distal access catheter or a diagnostic catheter configured to receive two proximal elongate medical devices within the lumen of the distal access catheter. A third elongate medical device 222 may be positioned in the third cassette 214 and may be, for example, an over-the-wire balloon catheter or a microcatheter configured to receive the most proximal elongate medical device within the lumen of the elongate medical device 222. A fourth elongate medical device 224 may be positioned in the fourth cassette 216 and may be, for example, a guide wire. To support different numbers and configurations of elongate medical devices for different procedures, in one embodiment, each cassette may be similar, and on-device adapters may be used to dock the elongate medical devices to the cassettes. For example, different steps of an intravascular procedure may require different numbers of elongate medical devices. The procedure may start with two coaxial catheters (a double coaxial catheter or a biaxial configuration) and a guide wire, then switch to a configuration having three coaxial catheters (a triple coaxial catheter or a triaxial configuration) and a guide wire, and subsequently return to the biaxial catheter system and the guide wire. As used herein, the terms triaxial, biaxial, and uniaxial refer to the number of concentric catheters in series, but do not include any wire-based EMDs. When fewer elongate medical devices are used during a procedure, the device module in which the elongate medical device is positioned can be changed without the need to remove the cassette to change the position and without the need to remove the unfilled cassette from the robotic driver. Instead, the elongate medical device and the on-device adapter between the elongate medical device and the cassette can be moved between the unfilled cassettes.
[0185] is a perspective view of a catheter with an on-device adapter according to an embodiment, and is a perspective view of a guidewire with an on-device adapter according to an embodiment. As used herein, an on-device adapter is a sterile device that is capable of releasably clamping to an EMD to provide a drive interface. In , the catheter 230 includes a hemostatic valve or hub (e.g., a rotary hemostatic valve) 234 on the proximal end 236 of the catheter 230. The on-device adapter 232 is positioned on the catheter 230 distal to the hemostatic valve 234 on the proximal end 236 of the catheter. In embodiments, the outer surface of the on-device adapter is formed as a gear. The gear feature of the on-device adapter 232 is configured to interact with the gear 97 of the cartridge (as shown), e.g., the cartridge 91 shown. When power is transferred from a device module (not shown) to the gear in the cartridge (e.g., via a coupler), the gear in the cartridge interacts with the gear 232 on the catheter 230 to rotate the catheter. In another embodiment, the rotation of the on-device adapter 232 can be configured to clamp / loosen the catheter 230. In one embodiment, the inner surface of the on-device adapter 232 is firmly attached to a standard Luer section of an elongate medical device (e.g., the catheter 230). In another embodiment, the inner surface of the on-device adapter is clamped to the lateral surface of the proximal end of the elongate medical device. In another embodiment, the on-device adapter is attached to a cylindrical section (shaft) of the EMD. In yet another embodiment, the on-device adapter is not directly attached to the EMD, but is attached to the EMD via an interface. Power can be transferred from the cartridge to the on-device adapter in different ways, such as, for example, gears (as described above), or friction surfaces (e.g., tires and rollers), belts, pneumatic, or magnetic / electromagnetic coupling.
[0186] In , the guidewire 240 is shown as having an on-device adapter 242. In embodiments, the on-device adapter 242 is a chuck having a gear 244 on the proximal end 246 of the chuck. The chuck 242 is configured to grip the guidewire 240. As used herein, the term chuck is a device that releasably secures a portion of an EMD thereto. In one embodiment, the chuck includes at least two members that move relative to each other to releasably secure the EMD to at least one of the two members. Securing means that there is no intentional relative movement between the chuck and the EMD during the operating parameters. The gear 244 is configured to interact with the gear 97 of the cartridge (as shown), e.g., The cassette 91 shown. When power is transferred from a device module (not shown) to a gear in the cassette (e.g., via a coupler), the gear in the cassette interacts with the gear 244 on the guidewire 240 to rotate the guidewire 240. In another embodiment, the adapter 242 on the device can be configured to clamp / loosen the guidewire 240 via the rotation of the gear 244. As shown, the elongate medical device and the adapter on the device can be positioned within the cassette. In it, the guidewire 240 and the chuck 242 are positioned within the carriage 252 of the cassette 250.
[0187] As described above, the elongate medical device and the adapter on the device can be removed from one cassette and moved to another unfilled cassette. Shown is the guidewire 240 and the chuck 244 with gears removed from the cassette 250. As described above, when the cassettes are similar and the adapter on the device is used to dock the elongate medical device to the cassette, the device and the adapter on the device can be moved between unfilled cassettes, enabling the number of devices and the configuration of the robotic drive to be changed. For example, the number of devices in the exemplary robotic drive 200 in it can be changed to three devices, as shown. In it, the first cassette 210, the second cassette 212, and the third cassette 214 are respectively filled with a first elongate medical device 218 (e.g., a guiding catheter), a second elongate medical device 220 (e.g., a distal access catheter), and a third elongate medical device 222 (e.g., a guidewire). The fourth cassette 216 is unfilled and can remain attached to its drive module in the robotic drive. Thus, when fewer elongate medical devices need to be actuated for the procedure, the more proximal cassettes in the robotic drive can remain unfilled. In the example, the user can install all the cassettes in the robotic drive at the start of the procedure and does not need to unload the cassettes to move the devices. The devices (and the corresponding adapters on the devices) can be moved into and out of different cassettes. This can greatly improve usability and exchange speed. Additionally, this can make it easier to change the device size. For example, in the manual case, 0.035 and 0.014 wires typically have different chuck sizes. For reference to the system described, different adapters on the devices will allow different sized devices to be driven in the same cassette. For example, different sized chucks can be used, which correspond to 0.035 or 0.014 wires, thereby allowing devices of each size to be changed and used in either of the cassettes.
[0188] As described above, the linear movement of the device module in the robotic driver can be provided by coupling the device module to a platform that is connected to a track or linear member and a platform translation motor. Then, by using the platform translation motor to actuate the platform to move along the track, the device module can be linearly translated. In another embodiment, the linear movement of the first device module can be provided by directly mounting the first device module to a second device module in the robotic driver rather than coupling the first device module to a track. is a schematic diagram of a first device module that is mechanically coupled to a second device module to share the linear movement of the first device module. In , a first device module 260 having a first drive module 262 is shown. For simplicity, the cassette for the first device module 260 is not shown. However, the first device module 260 will also include a cassette mounted on the drive module 262. In one embodiment, the first drive module 262 includes a plurality of couplers 271 to provide a plurality of degrees of freedom to an elongate medical device positioned within a cassette (not shown) mounted on the first drive module 262. The second device module 264 includes a second drive module 268 and a cassette 266 mounted to the second drive module 268. In an embodiment, the first device module 260 can be mechanically mounted to the second device module 264. In another embodiment, the first device module 260 can also be electrically coupled to the second device module 264. A mounting member 270 can be used to mechanically couple the first device module 260 to the second device module 264. The mounting member 270 can be a kinematic mount, such as the kinematic mount 272 shown. The mount can be configured to allow removal of the first device module 260 so that it can be moved and removably mounted to a different device module in the robotic driver to facilitate different configurations of the elongate medical device. For example, the first device module 260 can be manually repositioned by a user to change the number of catheters driven in front of it in the robotic driver. is a block diagram illustrating changing the position of a device module in a robotic driver between positions where the device module is mechanically coupled to another device module. In , the robotic driver 274 includes a first device module 278 mounted to a second device module 280. The second device module 280 is mounted on a track or linear member 276. The first device module 278 and the second device module can move linearly together along the track 276. The robotic driver 274 also includes a third device module 282 and a fourth device module 284, each of which is mounted to the track 276. By mounting the first device module 278 to the third device module 282, the first device module 278 can be disconnected from the second device module 280 and moved to a different position. Then, when the third device module 282 moves linearly along the track 276, the first device module 278 will move linearly.
[0189] is a block diagram showing different positions of device modules in a robotic actuator according to an embodiment, where the device modules are mechanically coupled to another device module. In a first configuration 286, a first device module 278 is mounted to a second device module 980, and each of four device modules 278, 280, 282, and 284 is filled with an elongate medical device. In a second configuration 288, the first device module 278 is mounted to a third device module 282, and each of four device modules 278, 280, 282, and 284 is filled with an elongate medical device. In a third configuration 290, the first device module 278 is mounted to the third device module 282, and the first device module 278, the third device module 282, and the fourth device module 284 are filled with elongate medical devices. In the third configuration, the second device module 280 is not filled with an elongate medical device. In a fourth configuration 292, the first device module 278 is mounted to the fourth device module 284, and the first device module 278, the third device module 282, and the fourth device module 284 are filled with elongate medical devices. In the fourth configuration, the second device module 980 is not filled with an elongate medical device. In a fifth configuration 294, the first device module 278 is mounted to the fourth device module 284, and the first device module 278 and the fourth device module 284 are filled with elongate medical devices. In the fifth configuration, the second device module 980 and the third device module 282 are not filled with an elongate medical device.
[0190] In another embodiment, a device module configured to be filled with more than one elongate medical device may move between platforms on a track or a linear member in a robotic actuator.
[0191] is a block diagram showing changing the position of device modules in a robotic actuator according to an embodiment, where the device modules are configured to be filled with more than one elongate medical device. In a first configuration 281, a first device module 285 is coupled to a first platform 291 movably mounted to a track or a linear member 297. A second device module 287 is coupled to a second platform 293 movably mounted to the track 297. A third device module 289 is coupled to a third platform 295 movably mounted to the track 297. The first device module 285 and the second device module 287 are each filled with a single elongate medical device, such as a catheter. The third device module 289 is configured to be filled with two elongate medical devices. In 295. In the embodiment of FIG. 296, the third equipment module 289 is populated with the guidewire 277 and the guide catheter 279. As described above, the third equipment module 289 can be removed from the third platform 295 and moved to a different platform mounted to the rails 297. In the second configuration 283, the second equipment module 287 has been removed from the second platform 293. Additionally, the third equipment module 289 has been removed from the third platform 295 and coupled to the second platform 293 and is positioned behind the first equipment module 285. In the second configuration 283, the equipment module is not coupled to the third platform 295.
[0192] In robot drives (e.g. In various embodiments of the robotic drive 24 shown in FIG, a device stack for a particular procedure may require that a device module (e.g., a device module for a guidewire) be located in a specific position, such as the proximal-most platform connected to a track or linear member. However, the device stack may not require the use of all positions in front of the proximal-most platform. To facilitate configuration with fewer devices, the robotic drive can be configured to allow nesting of unfilled drive modules in unused volume below the cassette, either distally or proximally of the unfilled drive module. is a block diagram of a robot driver including three device modules and a nested unpopulated drive module according to an embodiment. , the robotic drive 300 includes a track or linear member 302 and a first device module 304 connected to a first platform 324, a second device module 306 connected to a second platform 326, an unfilled drive module 310 connected to a third platform 328, and a third device module 308 connected to a fourth platform 330. The first device module 304 includes a cartridge 312 mounted to a drive module 318, the second device module 306 includes a cartridge 314 mounted to a drive module 320, and the third device module 308 includes a cartridge 316 mounted to a drive module 322. The unfilled drive module 310 is positioned (or nested) in an area overlapping the proximal end of the cartridge 314 of the second device module 306, for example, in an unused volume below the cartridge 314. This allows the unfilled drive module 310 to be skipped in the device stack, and the elongated medical device filled in the cartridge 316 of the third device module 308 to be fed directly to the second device module 306. Additionally, the third device module 308 can be moved closer to the second device module 306. In another embodiment, the second drive module can be unpopulated and nested in an area overlapping the proximal end of the cartridge, for example, in an unused volume below the cartridge. is a block diagram of a robot driver including two device modules and two nested unpopulated drive modules according to an embodiment. , from the second device module 306 ( The cassette (as shown) is removed, leaving the second unfilled drive module 348. In this embodiment, the second unfilled drive module 348 can be positioned in an area that overlaps with the proximal end of the cassette 312, for example, in the unused volume below the cassette 312 of the first device module 304. The first unfilled drive module 310 is positioned in an area that overlaps with the proximal end of the cassette 316, for example, in the unused volume below the cassette 316 of the second device module 346. This allows the unfilled drive modules 310 and 348 to be skipped in the device stack, and the elongate medical device filled in the cassette 316 of the second device module 308 can be fed directly into the first device module 344. Additionally, the second device module 346 can be moved closer to the first device module 344.
[0193] To nest unfilled drive modules, the length of the drive modules can be minimized, and the drive modules should be able to be very close to each other. To facilitate nesting of unfilled drive modules between device modules, offset brackets can be used to connect the device modules or unfilled drive modules to the platform. The offset created by the offset brackets allows the drive modules to be close enough to nest properly, without the need to change the length of the platform to which the drive modules are attached. Referring and 33 , the first device module 304 is connected to a first offset bracket 336, which defines a first offset 332 between the center of the first platform 324 and the center of the drive module 318 of the first device module 304. The third device module 308 or the second device module 346 can also be connected to a similar fourth offset bracket 342 to define the first offset 332. The first unfilled drive module 310 is connected to a third offset bracket 340, which defines a second offset 334 between the center of the third platform 328 and the center of the unfilled drive module 310. The second device module 306 or the second unfilled drive module 348 can be connected to a similar second offset bracket 338 to define the second offset 334. is a side view of three unfilled drive modules and offset brackets according to an embodiment, and is a side rear view of three unfilled drive modules and offset brackets according to an embodiment. In and 35 , the first drive module 356 is connected to the first offset bracket 350, the second drive module 358 is connected to the second offset bracket 352, and the third drive module 360 is connected to the third offset bracket 354.
[0194] is a side view of two device modules and two nested unfilled drive modules according to an embodiment, and Is an isometric view of a robotic actuator having two device modules and two nested unfilled drive modules according to an embodiment. In and 37 , the first device module 362 includes a cartridge 378 mounted to a drive module 371, and the second device module 364 includes a cartridge 379 mounted to a drive module 373. The first device module 362 is connected to a first platform 370, and the second device module 364 is connected to a fourth platform 376. The first unfilled drive module 366 and the second unfilled drive module 368 are respectively connected to a second platform 372 and a third platform 374, and are located between the first drive module 362 and the second drive module 364 along a track or linear member. In and 37 embodiments, the first unfilled drive module 366 and the second unfilled drive module 368 are positioned (or nested) in the unused volume below the cartridge 378 of the first device module 362. To facilitate nesting the unfilled drive modules, each drive module 366, 368, and 371 has at least one dimension that is less than or fewer than at least one dimension of the cartridge (e.g., cartridge 378) that can be mounted on the drive module. For example, when the device modules 366, 368, 371 are coupled to a linear member or track, the length of the drive modules 366, 368, 371 as measured from proximal to distal can be less than or fewer than the length of the cartridge (e.g., cartridge 378) along the longitudinal axis of the cartridge. In some embodiments, the size and dimensions of the drive modules 366, 368, and 371 are minimized such that, for example, the drive modules occupy a minimum amount of space along the linear member or track (e.g., the linear member or track 60 shown) of the robotic actuator when not filled with cartridges. In an embodiment, the unused volume below the cartridge 378 is defined by the length difference between the cartridge 378 and the drive module 371 to which the cartridge 378 is mounted. As and 37 shown, the nested unfilled drive modules 366 and 368 allow the second device module 364 to be close to the first device module 362, and in an embodiment, the need for a device support between the second device module 364 and the first device module 362 can be eliminated.
[0195] The robotic actuator may include a collision prevention control system to control the degree to which the cartridges and drive modules can approach each other without contact. In an embodiment of the robotic actuator, which includes the ability to nest unfilled drive modules as described above with reference to , the collision prevention control system can be configured to have a first set of parameters for drive modules with attached cartridges and a second set of parameters for drive modules without attached cartridges (i.e., the drive modules are unfilled). is a block diagram illustrating a cartridge collision prevention apparatus and method according to an embodiment. In the first device module 381 includes a first cartridge 383 mounted to a first drive module 385. The first device module 381 is coupled to a first platform 387 mounted to a track or linear member 380. The first device module 381 also includes a cartridge proximity sensor 389 and a drive module proximity sensor 390. The sensors 389, 390 are shown positioned on the drive module 385. In other embodiments, the sensors 389, 390 may be positioned on the platform, the cartridge, etc. The second device module 382 includes a second cartridge 384 mounted to a second drive module 386. The second device module 382 is coupled to a second platform 388 mounted to the track 380. A cartridge collision stop marker 393 and a module collision stop marker 395 are located in the platform 388. Alternatively, the collision stop markers 393, 395 may be located on the drive module 386. In an embodiment, the collision stop markers 393, 395 are formed of metal and trigger the corresponding proximity sensors 389, 390, respectively, when moved in front of the proximity sensors. The second device module 382 also includes a cartridge presence sensor 391, which may be located, for example, on the second drive module 386. The cartridge presence sensor 391 may be, for example, a reed switch sensor having a magnet. If the second cartridge 384 is present on the second drive module 386, the cartridge presence sensor 391 may provide a signal indicating that the second cartridge 384 is mounted on the second drive module 386. In this case, the cartridge proximity sensor 389 is used to determine whether the second cartridge 384 is too close to the first cartridge 383. In one embodiment, when the second cartridge 384 is within a threshold distance of the first cartridge 383, e.g., when the cartridge collision stop marker 393 is moved in front of the proximity sensor 389, the cartridge proximity sensor 389 provides a control signal and may provide an alert to the user or may stop the movement of the second cartridge.
[0196] If the second cartridge 384 is not mounted to the second device module 386, the drive module proximity sensor 390 is used to determine the position of the second drive module 386 relative to the first drive module 385. is a block diagram illustrating an unfilled drive module collision prevention apparatus and method according to an embodiment. In In [the figure], the first device module 381 includes a first cassette 383 mounted to a first drive module 385. The first device module 381 is coupled to a first platform 387 mounted to a rail or linear member 380. The first drive module 381 also includes a cassette proximity sensor 389 and a drive module proximity sensor 390. The sensors 389, 390 are shown positioned on the drive module 385. In other embodiments, the sensors 389, 390 may be positioned on the platform, cassette, etc. The second drive module 386 is not filled with a cassette and is coupled to a second platform 388 mounted to the rail 380. A cassette collision stop marker 393 and a module collision stop marker 395 are located in the platform 388. Alternatively, the collision stop markers 393, 3905 may be located on the drive module 386. In an embodiment, the collision stop markers 393, 395 are formed of metal and trigger the corresponding proximity sensors 389, 390, respectively, when moving in front of the proximity sensors. The second drive module 386 also includes a cassette presence sensor 391. The cassette presence sensor 391 may be, for example, a reed switch sensor having a magnet. If no cassette is present on the second drive module 386, the cassette presence sensor 391 may provide a signal indicating that the cassette is not mounted on the second drive module 386. In this case, the drive module proximity sensor 390 is used to determine whether the second drive module 386 is too close to the first drive module 385. In one embodiment, when the second drive module 386 is within a threshold distance of the first drive module 385, e.g., when the module collision stop marker 395 moves in front of the proximity sensor 390, the drive module proximity sensor 390 provides a control signal and may provide an alert to the user or may stop the movement of the second drive module. In another embodiment, if the robotic drive is configured to allow nesting of drive modules, the control computing system may be configured to couple the linear movement of the nested drive module to the linear movement of the device module having a cassette with the nested drive module positioned thereunder.
[0197] In another embodiment, a rail or linear member having two sliders may be provided to allow certain device modules to move along the linear member toward or away from the patient to different positions reached by an unfilled drive module. is a front view of a robotic drive having a linear member according to an embodiment, the linear member having two sliders, and is according to an embodiment of the robotic drive. Referring to and 41 , the rail or linear member 400 has a first slider 402 and a second slider 404, which are configured to connect to platforms and corresponding device modules or unfilled drive modules. Although and 41The embodiments in show a track where a first slider 402 is on the upper surface of the track and a second slider is on the lower surface of the track, but it should be understood that the sliders can be other opposing surfaces of the track. In another embodiment, two separate tracks can be used instead of a track with two sliders. The first device module 406 is connected to the first slider 402 of the track 400 using a platform 416. The second device module 424 is connected to the second slider 404 of the track 400 using a second platform 418. The first unfilled drive module 408 is connected to the first slider 402 of the track 400 using a third platform 426. The second unfilled drive module 422 is connected to the first slider 402 of the track 400 using a fourth platform 428. The unfilled drive modules 408, 422 can be configured to move from a vertical position to a horizontal position (e.g., "flip up"). As and 41 shown, the first unfilled drive module 408 includes a pivot 410 located on the first end 412 of the first unfilled drive module 408. When rotated about the pivot, the second end 414 of the first unfilled drive module with a coupler 420 moves from a vertical position to a horizontal position. In this position, the second drive module 424 can move linearly by moving the second platform 418 along the second slider 404 past the "flipped up" drive module 408. For example, the device module 424 on the second slider 404 can be a dedicated guide wire module, and the second slider (or track) allows reconfiguration of the robotic actuator by changing the number of catheter device modules in front of the guide wire module, for example.
[0198] In another embodiment, the device module can be connected to a second slider on a track or a second track and is configured to translate in a way that allows the device module to move past another device module or an unfilled drive module to reach different positions. Illustrated is a translating device module according to an embodiment that can be repositioned along a track in a robotic actuator. Shown is a robotic actuator 430 that includes a first device module 432 connected to a first slider (e.g., the first slider 402 shown) of a track or linear member 438 using a first platform 440, a second device module 434 connected to the first slider of the track 438 using a second platform 442, and a third device module 436 connected to a second slider (e.g., the second slider 404 shown) of the track 438 using a third platform 443. The third device module 436 includes as The extension member 444 shown can be pulled out from the track 438 such that the device module 436 can pass over other device modules 432 and 434 (or alternatively, unfilled drive modules) on the first slider of the track 438. The third drive module 436 can then be linearly moved by moving the third platform along the second slider of the track 438 to a position passing over the second device module 434, as shown. In , when the third device module 436 is in the desired position, the extension member 444 can be moved back towards the track 438.
[0199] As described above, in one embodiment, a cartridge (e.g., the cartridge 91 shown) used in a device module can be configured to provide one degree of freedom (e.g., rotation). Thus, a drive module having a single coupler (e.g., the drive module 68 shown) can be used to drive the single degree of freedom of the cartridge. In another embodiment, a cartridge (e.g., the cartridge 111 shown) used in a device module can be configured to provide two or more degrees of freedom (e.g., rotation and clamping / loosening for a guide wire). Thus, the drive module can be configured to include two or more couplers to support a cartridge providing one or more degrees of freedom. In an embodiment, a drive module having two or more couplers includes a separate motor for each coupler. is a top view of a portion of a robotic actuator in accordance with an embodiment in a triaxial configuration and including a drive module having more than one coupler. As described above, as used herein, the terms triaxial, biaxial, and uniaxial refer to the number of concentric tubes in series, but do not include any wire-based EMDs. In , a first drive module 450, a second drive module 452, a third drive module 454, and a fourth drive module 456 are shown. Cartridges 458, 460, 462, and 464 are respectively mounted to each drive module 450, 452, 454, and 456. Cartridges 458, 460, 462 are configured to provide one degree of freedom, and the fourth cartridge 464 is configured to provide two degrees of freedom. Each of the four drive modules includes two couplers, as and 45 shown. is a top view of a portion of a robotic actuator in accordance with an embodiment in a biaxial configuration and including a drive module having more than one coupler, and is a top view of a portion of a robotic actuator in a uniaxial configuration and including a drive module having more than one coupler in accordance with an embodiment. In , the fourth drive module 456 is unfilled, and in In [description], the third drive module 454 and the fourth drive module 456 are not filled. In In [description], the unfilled drive module 456 includes a first coupler 466 and a second coupler 468. A separate motor (not shown) can be provided in the drive module 456 to drive each coupler 466, 468. The first coupler 466 and the second coupler 468 are aligned along the device axis (not shown), which enables them to be placed into a grid / matrix. Each drive module 450, 452, 454, and 456 can be used to couple to a cartridge having one or two degrees of freedom. For example, in In [description], the second drive module 452 is coupled to a cartridge 460 having a single degree of freedom, and in In [description], the second drive module 452 is coupled to a cartridge having two degrees of freedom. Each drive module 450, 452, 454, and 456 uses a separate platform translation motor to drive the corresponding drive module along a track or a linear member for linear movement.
[0200] is a side view of a cartridge having a single degree of freedom according to an embodiment, the cartridge being mounted to a drive module having more than one coupler. In In [description], the cartridge 476 having a single degree of freedom is mounted to the drive module 470 using a first coupler (not shown), and the second coupler 474 remains unfilled and does not engage with the cartridge 476. In an embodiment, the control computing system of the robotic actuator can be configured to automatically lock the unused coupler 474. In one example, a sensor can be provided in the drive module 470, which can detect which type of cartridge is mounted to the drive module. In another example, the user can input the type of the cartridge using, for example, a control station. In another embodiment, the robotic actuator can include a combination of a drive module having a single coupler and a drive module having two or more couplers. is a top view of a part of a robotic actuator according to an embodiment in a three-axis configuration and including a drive module having a single coupler and a drive module having more than one coupler. Shows three drive modules 478, 480, and 482 having a single coupler and one drive module 484 having two couplers. Cartridges 486, 488, and 490 having a single degree of freedom are respectively mounted to the drive modules 478, 480, and 482. The cartridge 492 having two degrees of freedom is mounted to the drive module 484 through two couplers. A robotic drive system having drive modules including two or more couplers provides the ability to reconfigure the robotic actuator simply by moving the cartridges between the drive modules.
[0201] In another embodiment, a cartridge configured to provide two or more degrees of freedom (e.g., rotation and clamping / loosening for a guide wire) can be mounted on two independently driven drive modules. In other words, the cartridge can straddle between two drive modules that engage a coupler on each drive module. Thus, two drive modules can be used to manipulate an elongate medical device that requires more complex degrees of freedom. is a top view of a portion of a robotic drive in a biaxial configuration according to an embodiment and including a cartridge mounted to two drive modules, and is a top view of a portion of a robotic drive in a uniaxial configuration according to an embodiment and including a cartridge mounted to two drive modules. In it, a first drive module 500, a second drive module 502, and a third drive module 504 are provided, each having a single coupler and being connected to a first platform 510, a second platform 512, and a third platform 514, respectively. A fourth drive module 506 includes two couplers, as described above with reference to and is connected to a fourth platform 516. Although the fourth drive module 506 is shown as having two couplers, the fourth drive module can also be a single-coupler drive module similar to drive modules 500 - 504. A cartridge 508 configured to provide two degrees of freedom is mounted so as to engage both the coupler of the third drive module 504 and one of the couplers of the fourth drive module 506. For example, the cartridge 508 can be configured to provide rotation and clamping / loosening of an elongate medical device. Linear movement of the elongate medical device is provided by linear movement of the third drive module 504 and the fourth drive module 506 along a track or linear member via the third platform 514 and the fourth platform 516. Each coupler can provide power to drive one of the degrees of freedom of the cartridge 508. The third drive module 504 and the fourth drive module are positioned a predetermined distance apart from each other, which allows the cartridge to be mounted on each of the drive modules 504, 506. A control computing system (not shown) of the robotic drive can be configured to linearly translate the third drive module 504 and the fourth drive module 506 as a unit such that the relative distance between the couplers on each of the drive modules 504, 506 remains the same. For example, the third drive module 504 and the fourth drive module 506 are electrically coupled to effectively form a single drive module. In another embodiment, the cartridge can be mounted to two single-coupler drive modules. In In this case, the cassette 508 is mounted so as to engage the coupler of the second drive module 502 and the coupler of the third drive module 504. In another embodiment, two independent drive modules can be mechanically coupled together and connected to a single platform such that a single platform translation motor can be used to drive the pair of mechanically coupled drive modules. For example, this can be used to reduce the number of conduits in front of the device module having a cassette providing two or more degrees of freedom. A straddle drive can also be used for a single device requiring relative linear translation. For example, some self-expanding stents or coils may require pulling a wire or shaft to deploy. Two modules can be utilized, where one module remains on the body or sheath of the deployment device and the other module handles the deployment of the wire or shaft.
[0202] As described above, the robotic drive can be reconfigured to provide various series device configurations. In other embodiments, various devices and methods can be used to provide both series and parallel device configurations for the robotic drive. is a block diagram of a parallel configuration of an elongate medical device in a robotic drive according to an embodiment. The robotic drive configuration 520 includes a first device module 522, a second device module 524, and a third device module 526 connected to a rail or linear drive module 528 using a first platform 530, a second platform 532, and a third platform 534, respectively. The first device module 522 includes a first elongate medical device (EMD) 536, the second device module 524 includes a second EMD 538, and the third device module 526 includes a third EMD 540. The first EMD 536 is supported by a first support rail 542 and is configured to receive the second EMD 538 and the third EMD 540 in a parallel configuration. The second EMD 538 and the third EMD 540 are supported between the second device module 524 and the first device module 522 using a second support rail 544. The third EMD 540 is supported between the third device module 526 and the second device module 524 using a third support rail 546. In an embodiment, the first support rail 542, the second support rail 544, and the third support rail 546 can be device supports, as further described below with reference to Further described. The third EMD 540 is positioned in a bypass channel on the cassette of the second device module (such as and 52as shown), so as to bypass the hub and enter the second support guide rail 544 parallel to the second EMD 538, rather than entering the hub of the second device module 524 and passing through the second EMD 538 in a series configuration. The second EMD 538 and the third EMD 540 then enter the hub 548 of the first EMD 536 on the first device module 522. The second EMD 538 and the third EMD 540 can then enter and pass through the first EMD 536 in a parallel configuration. As described above, the cartridge in the second device module 524 includes a bypass channel to support the third EMD 540 when the third EMD 540 bypasses the second EMD 538. is a top view of a cartridge having a bypass channel and an elongate medical device in a series configuration according to an embodiment, and is a top view of a cartridge having a bypass channel and an elongate medical device in a parallel configuration according to an embodiment. Referring to and 52 , the cartridge 550 includes a bypass channel 554 and a bypass channel connection point 564. The cartridge 550 includes a first EMD 558 and a first support guide rail 552. In , a second EMD 560 supported by a second support guide rail 556 is shown, and the second support guide rail 556 is connected to the hub 562 such that the second EMD can enter the hub 562 and pass through the first EMD 558 in a series configuration. In an embodiment, the first support guide rail 552 and the second support guide rail 556 can be device supports, as further described below with reference to . In , to provide a parallel device configuration, the second support guide rail 556 is connected to the connection point 564 such that the second EMD 560 can be positioned in the bypass channel 554 and move along the bypass channel 554. The first support guide rail 552 is configured to receive the second EMD 560 at the distal end of the bypass channel 554 such that the second EMD 560 travels parallel to the first EMD 558 through the second support guide rail 552. In the embodiment shown in , the first EMD 558 is a catheter positioned along the central axis of the cartridge 550, and the second EMD 560 is a wire-based device (e.g., a guide wire). In another embodiment, the first EMD 558 can be a wire-based device positioned along the central axis of the cartridge 550, and the second EMD 560 can be a catheter (e.g., a rapid exchange catheter).
[0203] In another embodiment, when the elongate medical device bypasses the hub to provide a parallel device configuration, support guide rails can be used to support the elongate medical device. FIG. 0 is a block diagram of a parallel configuration of an elongate medical device in a robotic driver according to an embodiment. The robotic driver configuration 521 includes a first device module 523, a second device module 525, and a third device module 527 that are each connected to a track or linear member 529 using a first platform 531, a second platform 533, and a third platform 535, respectively. The first device module 523 includes a first elongate medical device (EMD) 537, the second device module 525 includes a second EMD 539, and the third device module 527 includes a third EMD 541. The first EMD 537 is supported by a first support rail 543 and is configured to receive the second EMD 539 and the third EMD 541 in a parallel configuration. The second EMD 539 is supported by a second support rail 545 between the second device module 525 and the first device module 523. In an embodiment, the first support rail 542 and the second support rail 545 may be device supports, as further described below with reference to The second support rail is connected to a hub adapter 549 in the first device module 523. The third EMD 541 is supported between the third device module 527 and the first device module 523 using a third support rail 547. The third EMD 541 and the third support rail 547 are positioned to bypass the hub rather than enter the hub of the second device module 525 and pass through the second EMD 539 in a series configuration. The third support rail 547 is connected to the hub adapter 549. The second EMD 539 and the third EMD 541 enter the hub adapter 549 and then enter the hub 551 of the first EMD 537 in a parallel configuration. The second EMD 539 and the third EMD 541 may then enter and pass through the first EMD 537 in a manner parallel to each other. The hub adapter 549 is configured to connect to and receive two or more support rails. FIG. 4 is a top view of a cartridge according to an embodiment that is configured to receive two elongate medical devices in a parallel configuration. The cartridge 553 includes a first EMD 561 and a first support rail 555. A second EMD 563 is shown that is supported by a second support rail 557 connected to a hub adapter 567. A third EMD 565 is shown that is supported by a third support rail 559 connected to the hub adapter 567. Thus, the hub adapter 567 is configured to connect to the second support rail 557 and the third support rail 559 such that the second EMD 563 and the third EMD 565 can enter the hub 569 and pass through the first EMD 555 in a parallel configuration.
[0204] In another embodiment, a parallel device configuration may be facilitated by providing multiple couplers on each drive module to provide multiple device axes in the robotic driver. is a block diagram of a robotic drive configuration having multiple device axes. A first drive module 570, a second drive module 572, a third drive module 574, a fourth drive module 576, and a fifth drive module 578 are each connected to a track or linear member 580 using a first platform 582, a second platform 584, a third platform 586, a fourth platform 588, and a fifth platform 589, respectively. Each drive module includes two couplers 593. The two couplers 593 on each drive module 570, 572, 574, 576, 578 are positioned parallel to each other such that each coupler defines a device axis. A first device axis 591 is defined by the first coupler on each drive module 570, 572, 574, 576, 578, and a second device axis 592 is defined by the second coupler on each drive module 570, 572, 574, 576, 578. In , the couplers on the fourth drive module 576 and the fifth drive module 578 are not filled. A first box 590 is mounted to the first drive module 570 and includes a first EMD (not shown) supported in a first support rail 596. A second box 594 is mounted to the coupler 593 on the first device axis 591 and includes a second EMD 597 supported by a second support rail 571 between the second drive module 572 and the first drive module 570. The second coupler on the second drive module 572 located on the second device axis 592 is not filled. A third box 595 is mounted to the coupler 593 on the second device axis 592 and includes a third EMD 599 supported by a third support rail 573 between the second drive module 572 and the first drive module 570. In an embodiment, the first support rail 596, the second support rail 571, and the third support rail 573 may be device supports, as further described below with reference to . The second coupler on the third drive module 574 located on the first device axis 591 is not filled. The second support rail 571 and the third support rail 573 each connect to a hub adapter 598 (e.g., the hub adapter as described above with reference to ). The second EMD 597 and the third EMD 599 enter the hub adapter 598 in a parallel configuration and then enter the hub 575 of the first EMD. In other embodiments, additional boxes and EMDs in the fourth drive module 576 and the fifth drive module 578 may be provided in a series or parallel configuration.
[0205] In another embodiment, an EMD including a deployable portion may be positioned across two device modules, and independent linear motion of the device modules is used to deploy the EMD. For example, a self-expanding stent or coil may require pulling a wire or shaft or knob to deploy. It is a top view of an elongate medical device positioned across two device modules in a first position. The first device module 600 is connected to a rail or linear member 604 using a first platform 606, and the second device module 602 is connected to the rail 604 using a second platform 608. A first linear translation motor 624 is coupled to the first platform 606 and is configured to linearly move the first platform 606 and the first device module 600 along the rail 604. A second linear translation motor 626 is coupled to the second platform 608 and is configured to linearly move the second platform 608 and the second device module 602 along the rail 604. The linearly deployable EMD includes a first section 610 positioned in the first device module 600 and a second section 612 positioned in the second device module 604. The first section 610 can be, for example, the body or sheath of the linearly deployable EMD, and the second section 612 can be, for example, the deployment wire and / or the deployment shaft or knob. The linear movement of the first device module 600 and the second device module 602 (e.g., as indicated by arrow 616) can be coupled together such that the two modules move together from the first position 614 ( as shown) to the second position 618 ( as shown) to linearly translate the deployable EMD. It is a top view of an elongate medical device positioned across two device modules in a second position. In , by coupling the linear movement of the first platform 606 and the second platform 608 along the rail or linear member 604, the first drive module 600 and the second drive module 602 have moved together in the distal direction. To deploy the linearly deployable EMD, the second platform 608 and the second device module 602 can be moved independently using the second platform translation motor 626. It is a top view of an elongate medical device positioned across two device modules in a third position. In Figure 58 , the second platform 608 and the second device module 602 have moved away from the first platform 606 and the first device module 600 in the proximal direction as indicated by arrow 620. The second device module 602 having the second section 612 of the EMD is shown in the third position 622. The linear movement of the second device module 602 provides the linear motion (e.g., pulling) required to deploy the device on the second section 612 of the EMD.
[0206] In another embodiment, a coupler in the drive module of the device module can be used to deploy a rotatably deployable EMD. For example, a stent system can include a shaft or knob to retract a sheath over a self-expanding stent. Rotational movement can be used to complete the unsheathing. Figure 59Perspective view of an exemplary rotatable deployable elongate medical device with an on-device adapter according to an embodiment. The rotatable deployable EMD 630 includes a shaft or knob 632 that can be rotated to deploy, for example, a stent. The on-device adapter 634 (e.g., a gear) is disposed about the shaft to dock with a cartridge in a device module of a robotic driver. Figure 60 Cross-sectional view of a rotatable deployable EMD according to an embodiment in an undeployed state Figure 59 Figure 61 Cross-sectional view of a rotatable deployable EMD according to an embodiment in a deployed state, and Figure 59 Figure 62 Cross-sectional view of a rotatable deployable EMD in a cartridge on a drive module according to an embodiment. The shaft 632 includes a deployable element 636 that is shown in Figure 59 a first position 638 in which the device 630 is not deployed. The deployment element 636 can be, for example, a screw mechanism. As Figure 60 shown, the on-device adapter 634 can be used to dock with a bevel gear 648 in a cartridge 646. The bevel gear is coupled to a coupler 642 in a drive module 644, and the cartridge 646 is mounted to the drive module 644. Rotation of the coupler 642 causes the bevel gear 648 to rotate, which in turn causes the on-device adapter 634 to rotate. Rotation of the on-device adapter 634 causes the shaft 632 to rotate, which linearly translates the deployment element 636 to a second position 640, as Figure 62 shown, which results in deployment (e.g., unsheathing) of the device 630. Figure 61
[0207] In another embodiment, a parallel device layout can be provided by using a detent fixture mounted to a frame of the robotic driver or a track or linear member movably mounted to the robotic driver. Figure 63is a block diagram of a parallel device configuration using a global stop fixture according to an embodiment. The global stop fixture 662 is mounted to the frame 652 of the robotic actuator, which includes a first device module 654 and a second device module 656. The first device module 654 is connected to a rail or linear member 650 using a first platform 658, and the second device module is connected to the rail 650 using a second platform 660. The first device module includes a first EMD 664 that is configured to receive a second EMD 666 included in the second device module 656 and a third EMD 668 held by the global stop fixture 662. The global stop fixture 662 can be configured to fix, for example, the third EMD 668 relative to a patient (not shown). The fixture 662 allows the other modules 654, 656 to move linearly while keeping the clamped third EMD 668 fixed relative to the patient. The second EMD 666 and the third EMD 668 enter the first EMD 664 parallel to each other. In another embodiment, the global stop fixture can be movable. Figure 64 is a perspective view of a movable global stop fixture according to an embodiment. In Figure 64 , the device module 672 is connected to a first rail or linear member 670 using a first platform 678. The global stop fixture 674 is coupled to a second rail 682 using a mounting bracket 676 that is connected to a second platform 680 mounted to the second rail 682. Thus, the global stop fixture 674 can be moved manually or automatically by linearly translating the second platform 680 along the second rail 682 using a platform translation motor (not shown). As described above, the global stop fixture 674 can be used to hold an EMD (not shown) provided in a parallel configuration.
[0208] The stop fixture can also be directly provided on the cartridge to facilitate a parallel device configuration. Figure 65 is a top view of a device module including a cartridge having a module stop fixture according to an embodiment. In Figure 65 , the device module 690 includes a cartridge 692 mounted to a drive module 694. The module stop fixture 698 is mounted to the proximal end 696 of the cartridge 692. Thus, the stop fixture 698 is fixed relative to an EMD (not shown) inserted into and held by the fixture 698. The EMD held by the fixture 7698 can be positioned so as to enter a hub 691 in a case where the EMD positioned in the cartridge is parallel to another EMD configured in series with the hub 691. When the fixture 698 is activated to adjust the position of the clamped EMD, the linear movement of the device module 690 can be used to move the EMD in the fixture 698. The fixture 698 can be actuated manually or automatically. In one embodiment, the fixture 698 can be used to hold a deployment wire for a self-expanding stent. In another embodiment, the fixture can be used to stop a balloon for balloon-assisted coiling.
[0209] In another embodiment, a parallel device configuration can be provided by using a cartridge that is configured to provide linear degrees of freedom for a rapid exchange elongate medical device (such as, for example, a rapid exchange balloon). Figure 66 is a top view of a device module according to an embodiment, the device module including a cartridge having a rapid exchange tire drive. The device module 700 includes a cartridge 702 mounted to a drive module 704. In an embodiment, the drive module 704 can include an auxiliary encoder (not shown) that can be used to measure movement of the EMD. The cartridge 702 includes a first tire 706 and a second tire 708 located on opposite sides of a channel 710. An EMD (not shown) can be positioned within the channel 710. The pair of tires 706, 708 can be used to provide linear movement to the EMD positioned within the channel 710. The channel 710 is used to guide the EMD driven by the tires 706, 708 to start entering a hub that is more distal to the distal EMD (not shown) into which it is being driven. The tires 706 and 708 can be connected to a coupler (as Figure 67 and 68 shown) of the drive module 704 to receive power for driving the EMD. Thus, the cartridge 702 is configured to re - use a coupler that is typically used for rotational degrees of freedom and use it for the linear degrees of freedom of a tire drive formed by a pair of tires 706 and 708.
[0210] Figure 67 is a perspective view of an interface between a drive mechanism and a drive module and a rapid exchange tire drive according to an embodiment, and Figure 68 is a perspective view of an interface between a drive mechanism and a drive module and a rapid exchange tire drive according to an embodiment. Referring to Figure 67 and 68 , the cartridge 702 is configured to dock with a coupler 712 (i.e., a rotational power interface) of the drive module 704 and, via a tire drive (e.g., Figure 66 and 68The tires 706 and 708 shown convert rotational motion into translational motion. The cartridge 702 includes a gear assembly 714 that docks with a coupler 712. When the cartridge 702 is mounted to the drive module 704, the coupler 712 couples to a first gear 716 of the gear assembly 714 in the bottom surface of the cartridge 702. The first gear contacts a second gear 718 for rotating the second tire 708, and the second gear contacts a third gear 720 for rotating the first tire 706. The first tire 706 and the second tire 708 are positioned on the cartridge 702 offset from the axis of rotation of the coupler 712, allowing the tires 706, 708 to be longitudinally away from the central device axis. The gear assembly 714 also includes a manual release arm 722 that can be used to disengage the clamping of the tires 706 and 708 to facilitate loading and unloading of the EMD. The manual release arm 722 is used to separate the tires 706, 708 for all EMDs to be unloaded from the drive. When the release lever 722 is not actuated, it can also clamp the EMD with a certain force between the tires 706, 708 via a spring (not shown). In an embodiment, the force can be adjusted to increase or decrease the driving force of the clamping. For example, the adjustment mechanism can be a screw that changes the spring compression length. Rotation of the coupler 712 causes rotation of the first gear 716, which in turn rotates the second gear 718, which in turn causes rotation of the third gear 720. Thus, the first tire 706 and the second tire 708 can rotate to cause linear motion of the EMD in the channel 710 (as Figure 66 shown). In an embodiment, the EMD positioned in the channel 710 and driven by the tires 706 and 708 is a rapid exchange EMD, such as, for example, a rapid exchange catheter or a rapid exchange balloon. In an embodiment, the drive module 704 can include a sensor to detect when the rapid exchange cartridge 702 is mounted to the drive module.
[0211] Figure 69 is an exemplary robotic drive device module configuration including a rapid exchange tire driver according to an embodiment. Figure 69 The configuration shown includes a first drive module 724, a second device module 726, a third device module 728, and a fourth device module 730. The third device module 728 includes a rapid exchange cartridge 732 (e.g., as referenced above Figure 66The described cartridge 702) provides EMDs in parallel in addition to those that can be provided in series in the first device module 724, the second device module 726, and the fourth device module 730. The third device module 728 with the quick-change cartridge 732 (including a tire driver) can be positioned directly behind the second device module 726 and thus directly behind the y-shaped connector on the second drive module 726. Thus, the tire driver will not interfere with the more proximal EMDs. Additionally, this configuration can allow for a reduction in the loss of working length of the more proximal EMDs by allowing the more proximal EMDs to be closer to the more distal hub. The ability to position the third device module 728 directly behind the second device module 726 can eliminate the need for a support rail (or device support) between the second device module 726 and the third device module 728. The second device module 726 and the third device module 728 can be mechanically or electronically coupled such that they move linearly together. In other embodiments, the quick-exchange cartridge 732 can be set in different positions in the order of the device modules in the robotic driver. For example, the quick-exchange cartridge can be used on the second device module 726 and a non-quick-exchange cartridge can be used in the third device module 728. In this example, the fourth device module 730 can remain unfilled. The quick-exchange cartridge 732 can also be removed from the robotic driver if not needed in a particular case. The ability to perform linear translation of an EMD that only requires linear degrees of freedom using a tire driver (i.e., shaft drive) instead of a hub drive for a single-degree-of-freedom EMD can have several advantages, such as full manipulation throughout the EMD range once inside the y-shaped connector, faster traversal speed without reset (continuous motion), and elimination of the need for a device support rail.
[0212] Figure 70 is a block diagram of a robotic driver configuration including a dedicated guidewire and a quick-exchange catheter device module according to an embodiment. Figure 70 The configuration in includes a first device module 740 and a second device module 742 coupled to a track or linear member 746 using a first platform 748 and a second platform 750, respectively. Additionally, the most proximal device module 744 is a dedicated guidewire and quick-exchange catheter device module. The guidewire and quick-exchange catheter device module 744 is coupled to the track 746 using a third platform 752. The guidewire and quick-exchange catheter device module 744 includes a cartridge 745 configured to provide linear translation to a quick-exchange catheter 758 using, for example, a tire 754 and to provide rotation and linear translation to a guidewire 756. The guidewire 756 and the quick-exchange catheter 758 move in parallel through an EMD located distal to the guidewire and quick-exchange catheter device module 744. In Figure 70In this case, the first device module 740 and the second device module 742 may include a catheter configured to receive a guide wire 756 and a rapid exchange catheter 758. Thus, in this configuration, a plurality of catheters may be disposed in front of (i.e., distal to) the guide wire and the rapid exchange catheter driver.
[0213] In another embodiment, the robotic driver may include a plurality of parallel tracks or linear members that enable the device modules to move past one another and are designed to facilitate reconfiguration of the device modules between series and parallel configurations. Figure 71 is a top view of a robotic driver having a plurality of parallel tracks according to an embodiment. The robotic driver 760 includes a first track or linear member 762, a second track or linear member 764, and a third track or linear member 766 that are positioned parallel to one another. The first device module 768 is coupled to the first track 762 using a first platform 780. A first platform translation motor 774 is used to linearly drive the first platform 780 along the first track 762. The second device module 770 is coupled to the second track 764 using a second platform 784. A second platform translation motor 776 is used to linearly drive the second platform 784 along the second track 764. The third device module 772 is coupled to the third track 766 using a third platform 785 (as Figure 75 and 77 shown). A third platform translation motor 778 is used to linearly drive the third platform 785 along the third track 766. A first position offset slider 782 is mounted to the first platform 780 and can be used to adjust the position of the first device module 768 relative to the first track 762, the second track 764, and the third track 766. A second position offset slider 786 is mounted to the second platform 784 and can be used to adjust the position of the second device module 770 relative to the first track 762, the second track 764, and the third track. A third position offset slider (not shown) may also be mounted to the third platform 785 (as Figure 75 and 77 shown) for adjusting the position of the third device module 772. When each of the device modules 768, 770, and 772 is in its aligned position on the respective tracks 762, 764, 766 to which it is attached, each of the device modules 768, 770, 772 can move linearly and can pass by one another along their respective tracks. Additionally, the positions of the first device module 768, the second device module 770, and the third device module 772 can be adjusted such that the various device modules are aligned in a series or parallel configuration for driving an EMD (EMD not shown). In Figure 71In it, the first device module 768 has been moved along the first position offset slider 782 to a position on the first gap 788 between the first track 762 and the third track 766. The second device module 770 has been moved along the second position offset slider 786 to a position on the second gap 790 between the second track 764 and the third track 766. The device modules can be moved along the position offset sliders manually or automatically.
[0214] Figure 72 is a cross-sectional view of a device module with a position offset slider and the device module in the first position, and Figure 73 is a cross-sectional view of a device module with a position offset slider and the device module in the second position. The first device module 768 includes a cartridge 769 mounted to a drive module 771. The drive module 771 is mounted to the first position offset slider 782, which is mounted to a first platform 780 connected to the first track 762. The first device module 768 is shown in the first position 761, where the first device module 768 is positioned on the first track 762. The first device module 768 can be moved along the first position offset slider 782 from the first position to the second position 763 as Figure 73 shown. The first device module 768 moves in the direction towards the third track 766 (indicated by arrow 765). In the second position 763, the first device module 768 is in a position on the third track 766. In an embodiment, the drive module can include a spring-loaded plunger 773, and the spring-loaded plunger 773 can be used to lock the position of the device module 768 along the first position offset slider 782. For example, the spring-loaded plunger 773 can be positioned in one of the holes 781 in the first position offset slider 782 to fix it in place to prevent the device module 768 from moving, for example, from the second position 763. In other embodiments, the first device module 768 can be moved along the first position offset slider 782 until it is in a position on the second track 764. The positions of other device modules can also be adjusted to provide different configurations, as described below.
[0215] Figure 74 is a top view of device modules in an exemplary series configuration in a multi-track robot drive according to an embodiment. The first device module 768, the second device module 770, and the third device module 772 are in a series configuration, with each device module positioned on the third track 766. The first device module 768 is positioned along the first track 762 and along the first position offset slider 782 such that it is behind the third device module 772. The second device module 770 is positioned along the second track 764 and along the second position offset slider 786 such that it is behind the first device module 768. In Figure 74In the series configuration, the device axes of each of the device modules 768, 770, and 772 are aligned. Figure 75 is a perspective view of a device module in an exemplary series configuration in a multi-track robot drive according to an embodiment. In Figure 75 , a first device module 768, a second device module 770, and a third device module 770 are in a series configuration, with each device module positioned on a gap 788 between a first track 762 and a third track 766. The first device module 768 is positioned along the first track 762 and along a first-position offset slider 782 such that it is behind the third device module 772. The second device module 772 is positioned along the second track 764 and along a second-position offset slider 786 such that it is behind the first device module 768. In Figure 75 In the series configuration, the device axes of each of the device modules 768, 770, and 772 are aligned.
[0216] Figure 76 is a top view of a device module in an exemplary parallel configuration in a multi-track robot drive according to an embodiment. A first device module 768 and a second device module 770 are in a parallel configuration. The first device module 768 is positioned on a gap 788 between a first track 762 and a third track 766, and the second device module 770 is positioned on a gap 790 between a second track 764 and a third track 766. The third device module 772 is positioned on the third track 766 and is located at a position in front of the first device module 768 and the second device module 770 along the third track 766. The first device module 768 is positioned along the first track 762 and a first-position offset slider 782 such that it is behind the third device module 772 and on the gap 788. The second device module 770 is positioned along the second track 764 and a second-position offset slider 786 such that it is behind the first device module 768 and on the gap 790. In Figure 76 In the configuration, the EMDs (not shown) in the first device module 768 and the EMDs (not shown) in the second device module 770 will be paralleled into the hub of the third device module 772. Figure 77Perspective view of device modules in an exemplary parallel configuration in a multi-track robotic actuator according to an embodiment. The first device module 768 and the second device module 770 are in a parallel configuration. The first device module 768 is positioned on the first track 762, and the second device module 770 is positioned on the third track 766. The third device module 772 is positioned on the gap 788 between the first track 762 and the third track 766, and is located at a position in front of the first device module 768 and the second device module 770 along the third track 766. The first device module 768 is positioned along the first track 762 and the first position offset slider 782 such that it is located behind the third device module 772 and on the first track 762. The second device module 770 is positioned along the second track 764 and the second position offset slider 786 such that it is located behind the first device module 768 and on the third track 766. In Figure 77 this configuration, the EMDs (not shown) in the first device module 768 and the second device module 770 will be paralleled into the hub of the third device module 772.
[0217] In another embodiment, the positioning of the device modules can be performed using a positioning system, such as, for example, a robotic arm. Figure 78A-C Illustrated is the repositioning of device modules using a positioning system according to an embodiment. In Figure 78A this, the first device module 794 is in a fixed position. The positioning system 792 (e.g., a robotic arm) is connected to the second device module 796 and is operated to move and hold the second device module 796 in a parallel configuration. The robotic arm 792 can be used to move the second device module 796 to a series configuration as shown in Figure 78B . In Figure 78C this, the robotic arm 792 can further be used to linearly translate the second device module 796. In other embodiments, two or more robotic arms can be provided, each robotic arm connected to a device module and used to move and reconfigure the position of the corresponding drive module relative to other drive modules. In this embodiment, the device modules are not attached to tracks or linear members, but act as end effectors of the arms. For a series configuration, the arms align the device modules to follow a line or other trajectory, which can include a curved path to avoid patient interference. For a parallel configuration, the arms align the selected modules in a parallel configuration, allowing the proximal hubs to pass by each other.
[0218] As referred to above Figure 3As described, the robotic driver 24 may include device supports 79a-d between each of the device modules 32a-d and between the outermost device module 32a and the device support connection 72. Each device support 79a-d is configured to prevent buckling of the elongate medical device as it is advanced outside the patient and before being advanced further distally into the EMD. In an embodiment, each device support 79a-d may be a flexible tube having a longitudinal slit and is used in conjunction with a separator on the cartridge. Each device support 79a-d is fixed or constrained at both ends such that the device support can remain taut, such that the flexible tube is limited in the amount of displacement in which it can buckle under a compressive load. Buckling of the EMD limits the magnitude of the force that can be applied and can permanently damage the elongate medical device. The compressive load can be caused by several factors, which may include friction between the EMD and the device support, friction between the device support and the cartridge (such as the separator in the cartridge (discussed below with reference to Figures 102-104 ). Holding the device support taut can eliminate the need for additional break strength and allow for smaller, more flexible device supports. In one embodiment where the device support is a flexible tube, tension can be provided by fixing the front (or distal) and rear (or proximal) points or locations of the flexible tube. Figure 3 The device supports 79a-d shown in
[0219] Figure 79 are an embodiment of a device support having fixed front (or proximal) and rear (or distal) points (or locations) to provide appropriate tension. Figure 79 Illustrated is Figure 3 the device support embodiment shown in Figure 79 In Figure 79In this case, the first device support member 828 extends from the distal end of the first cartridge 806, and the first end of the first device support member 828 is connected to the proximal end of the second device module 804 at the first front (or distal) fixed point 810. The second device module 804 is located distally of the first device module 802. The second device module 804 includes a second cartridge 808 and a support arm 816 that extends proximally from the second device module 804 toward the first cartridge 806. The second end of the first device support member 828 extends from the proximal end of the first cartridge 806 and is connected to the proximal end of the support arm 816 of the second device module 804 at the first rear (or proximal) fixed point 812. The first device support member 828 is held in place by the fixed (or constrained) first front point 810 and the first rear point 812. The first front fixed point 810 and the first rear fixed point 812 maintain a constant distance from each other. The first front fixed point 810 and the first rear fixed point 812 can be rigid or can have some flexibility to account for manufacturing and assembly tolerances. The first device module 802 also includes a support arm 814 that can be used to provide a rear (or proximal) fixed point for the device support member of a cartridge (not shown) located proximally of the first cartridge 806.
[0220] The second device module 804 is the most distal module and is closest to the patient (not shown). The second cartridge 808 of the second device module 804 includes a second device support member 830, such as a flexible tube, positioned within a channel 826 of the second cartridge 808. The second cartridge 808 and the second device support member 830 are movable relative to each other. Since there is no device module or cartridge in front of the second device module 804, a distal support connector 832 mounted to a distal support arm 834 is used to provide a second front (or distal) fixed point 820 for the distal end of the second device support member 830. The distal support connector 832 and the distal support arm 834 will be described further below with reference to Figures 108-116 The second end of the second device support member 830 extends from the proximal end of the second cartridge 808 and is connected to the proximal end of a support arm 818 at a second rear (or proximal) fixed point 822, the support arm 818 being connected to the distal support arm 834. The second device support member 830 is held in tension by the fixed second front point 820 and the rear point 822. The second front fixed point 820 and the second rear fixed point 822 maintain a constant distance from each other. The second front fixed point 820 and the second rear fixed point 822 can be rigid or can have some flexibility to account for manufacturing and assembly tolerances.
[0221] In one embodiment, the distal end of the first device support member 828 connected to the first front fixed point 810 and the distal end of the second device support member 830 connected to the second front fixed point 820 can be separated or disconnected, as discussed further below, to facilitate loading and unloading of the EMD before, during, and after surgery. Figure 80is a top view of a cassette according to an embodiment, the cassette having a device support in a retracted position to facilitate the exchange of an elongate medical device. In Figure 80 , the device support 842 of the cassette 840 has been separated from the front (or distal) fixed point 850 and is in a retracted position that exposes the EMD 848 to facilitate the loading and unloading of the EMD. As discussed above, the front fixed point 850 is located on the device module distal to the cassette 840. For clarity, in Figure 80 , the device support 842 is shown on the lid of the cassette 840. The first (or distal) end 844 of the device support 842 is located at the distal end of the cassette 840. The second (or proximal) end 846 of the device support 842 has moved past the rear (or proximal) fixed point 852. As described above, the rear fixed point 852 is distal to the cassette 840 and is located on a support arm of, for example, the cassette, the drive module, or the platform. Additionally, the fixed rear point 852 can be attached to the frame of the robotic actuator. Figure 81 is a top view of a cassette according to an embodiment, where the device support is in an extended position constrained at both ends. When the device support 842 is pulled onto the EMD 848, the first end 844 is attached to the front fixed point 850 and the second end 846 is constrained by the rear fixed point 852. As described above, the front fixed point 850 and the rear fixed point 852 are fixed relative to the device module into which the distal end of the EMD 848 is entering. For clarity, in Figure 81 , the device support 842 is shown on the lid of the cassette 840.
[0222] Constraining (fixing) each device support at both ends allows for relative movement between all device modules in the robotic actuator. Figure 82 is a top view of two device modules having device supports according to an embodiment. The first device module 860 has a first device support 868 that is constrained at a first front (or distal) fixed point 872 at the proximal end of the second device module 862 and at a first rear (or proximal) fixed point 874 on the proximal end of the support arm 871 of the second device module 862. The second device module 862 has a second device support 870 that is constrained at a second front (or distal) fixed point (not shown) in the proximal end of the support arm 873 of a device module (not shown) distal to the second device module 862 and at a second rear (or proximal) fixed point 875. The first device module 860 can be translated forward from a first position 864. The second device module 862 is located at a first position 876. Figure 83FIG. is a top view showing a linear forward translation of a device module relative to a device support according to an embodiment. When the first device module 860 moves forward (as shown by arrow 177) from the first position 864 toward the patient to the second position 866, the first rear (or proximal) fixation point 874 bears the load (e.g., friction between the cartridge and the first device support 868) generated as the cartridge of the first device module 860 (and the device module) moves along the first device support 868. Accordingly, the first device support 868 will not flex between the distal end of the cartridge on the first device module 860 and the proximal or rear end of the cartridge on the second device module 862. When the first device module 860 is advanced distally toward the second device module 862 (in this example, the second device module 862 is stationary at its first position 876), it moves relative to the first device support 868, as shown by reference points A and B positioned along the length of the first device support 868. When the first device module 860 is in the first position 864, the reference point A and the reference point B are near the distal end of the first device module 860. As the first device module 860 is advanced along the first device support 868, the first device support 868 remains stationary because the second device module 862 to which it is coupled via the first front fixation point 872 and the first rear fixation point 874 is also stationary. When the first device module 860 is in the second position 866, the reference point A and the reference point B are offset from the axis and proximal to the first device module 860. The first device module 860 can also be translated backward from the second position 866 to the first position 864.
[0223] Figure 84It is a top view showing the linear reverse translation of a device module according to an embodiment relative to a device support. When the first device module 860 moves backward (retracts) from the second position 866 away from the patient (as shown by arrow 879) to the first position 864, the first front (distal) fixed point 872 bears the load (e.g., friction between the cartridge and the first device support 868) generated as the cartridge of the first device module 860 (and the device module) moves along the first device support 868. Thus, the first device support 868 will not buckle between the cartridge on the first device module 860 and the first rear fixed point 874. When the first device module 860 moves proximally away from the second device module 862 (in this example, the second device module 862 is stationary at its first position 876), it moves relative to the first device support 868, as shown by reference points A and B positioned along the length of the first device support 868. When the first device module 860 is at the second position 866, the reference point A and the reference point B are offset from the axis and proximal to the first device module 860. When the first device module 860 moves proximally (retracts) along the first device support 868, the first device support 868 remains stationary because the second device module 862 to which it is coupled via the first distal fixed point 872 and the first proximal fixed point 874 is also stationary. When the first device module 860 is at the first position 864, the reference point A and the reference point B are near the distal end of the first device module 860.
[0224] Figure 85This is a top view showing the linear reverse translation of the device support relative to the device module according to an embodiment. When the second device module 862 moves backward from the first position 876 away from the patient (as shown by arrow 869) to the second position 878, the second front (or distal) fixed point (not shown) on the distal side of the second device module 862 bears the load (e.g., friction between the cartridge and the second device support 870) generated as the cartridge of the second device module 862 (and the device module) moves along the second device support 870. Therefore, the second device support 870 will not buckle between the cartridge on the second device module 862 and the second rear fixed point 875. Since the device supports 868 and 870 are each supported between two known points, the length of each device support does not need to change. When the second device module 862 moves proximally towards the first device module 860 (in this example, the first device module 860 is stationary at its first position 864), the second device module 862 moves relative to the second device support 870. Additionally, the first device support 868 (coupled to the second device module 862 via the first distal fixed point 872 and the first proximal fixed point 874) moves relative to the first device module 860, as shown by reference points A and B positioned along the length of the first device support 868. When the second device module 862 is at the first position 876, the reference point A and the reference point B are near the distal end of the first device module 860, as Figure 82 shown. When the second device module 862 moves proximally (retracts) along the second device support 870, the second device support 870 remains stationary because it is coupled to a more distal device module (not shown) that is stationary in this example. However, the first device support 868 moves proximally with the second device module 862 to which it is coupled via the first distal fixed point 872 and the first proximal fixed point 874. At the second position 878 of the second device module 862, the reference point A and the reference point B are off-axis and proximal to the first device module 860.
[0225] Figure 86A simplified top view showing four device modules and four device supports for a robotic actuator according to an embodiment is presented. The first device module 902 includes a first device support 904, one end of which is connected to the support arm 218 and one end is connected to the distal support point. The second device module 906 includes a second device support 908, one end of which is connected to the support arm 920 and one end is connected to the first device module 902. The third device module 910 includes a third device support 912, one end of which is connected to a first front (or distal) fixed point 926 on the second device module 906 and the other end is connected to a first rear (or proximal) fixed point 928 on the support arm 922. The fourth device module 914 includes a fourth device support 916, one end of which is connected to a second front (or distal) fixed point 930 on the third device module 910 and the other end is connected to a second rear (or proximal) fixed point 932 on the support arm 924. In various embodiments, the support arms 918, 920, 922, and 924 may be connected to the housing of the device module or the drive module. In another embodiment, the support arms 918, 920, 922, and 924 may be foldable, telescopic, or use other methods to shorten the length of the support arms when not in operation. Figure 87A simplified top view is shown which illustrates the movement of a device module according to an embodiment relative to a device support. The third device module 910 starts at a first position 934 (shown in dashed lines) and moves to a second position 936 (as indicated by arrow 946). As the third device module 910 moves forward (towards the patient), it moves along the third device support 912 which is fixed to the second device module 906 at a first front (distal) fixed point 926 and to a support arm 922 extending from the second device module 906 at a first rear (proximal) fixed point 928. As the third device module translates, the portion of the device support 912 passing through the third device module 910 changes while the first front fixed point 926 and the first rear fixed point 928 do not move. The length of a first section 942 of the device support 912 spanning between the second device module 906 and the third device module 910 decreases while the length of a second section 944 of the device support 912 spanning between the third device module 910 and the rear fixed point 928 increases. This allows the third device module 910 (and associated EMD) to remain fully supported between the span between the third device module 910 and the second device module 906 during linear movement. Another relative movement occurring during the movement of the third device module 910 between the first position 934 and the second position 936 involves a fourth device support 916 of the fourth device module 914 and a second front (or distal) point 930 and a second rear (or proximal) point 932 of the fourth device support 916. The fourth device support 914 is fixed to the third device module 910 at the second front fixed point 930 and to a support arm 924 extending from the third device module 910 at the second rear fixed point 932. Since the third device module 910 is moving, the second front fixed point 930 and the second rear fixed point 932 are also moving. A first section 938 of the fourth device support 916 slides through the fourth device module 914 such that the length increases across the span between the fourth device module 914 and the third device module 910 while the length of a second section 940 of the fourth device support 916 decreases across the span between the fourth device module 914 and the rear fixed point 932.
[0226] Figure 88 A simplified top view is shown which illustrates the four device modules of FIG. 11 according to an embodiment in a forward position relative to their respective device supports. In Figure 88 this, the first device module 902, the second device module 906, the third device module 910 and the fourth device module 914 are each shown in a maximum forward position along their respective device supports 904, 208, 912 and 916. Figure 89 A simplified top view is shown which illustrates according to an embodiment in a retracted position relative to their respective device supports Figure 86Four device modules. In Figure 89 , the first device module 902, the second device module 906, the third device module 910, and the fourth device module 914 are shown in their maximum extended (rear) positions along their respective device supports 904, 908, 912, and 916. In an embodiment, the device support length is determined by the straight-line length of the device support and an S-shaped spline that offsets the device support from the longitudinal device axis of the device module and guides it toward the support arm longitudinal axis. In one embodiment, each of the device supports 904, 908, 912, and 914 may include compliance to protect the device support and thus assist in relaxation when transitioning between forward and reverse directions.
[0227] As discussed above, each device support is constrained at a rear (or proximal) fixed point that is connected to a support arm extending from a device module in front of (e.g., distal to) the device module associated with the device support. In an embodiment, the rear (or proximal) fixed point includes a rear restraint that may be configured to act only against tension. Figure 90 is a side view of the proximal end of an extended device support according to an embodiment and the rear restraint of the rear (or proximal) fixed point to which the device support is connected, and Figure 91 is a side view of the proximal end of a partially retracted device support according to an embodiment and the rear restraint of the rear (or proximal) fixed point to which the device support is connected. The proximal end 952 of the support arm includes a retaining clip 954 that holds the proximal end of the device support 950. A hard stop 956 is positioned at the end of the device support and is configured to hold the device support in tension when the device support moves forward and to allow the device support to retract for device loading (as described above with respect to Figure 80 and 81 ). The forward movement and retraction of the device support 950 are indicated by arrow 958. The operator can pull back the device support 950 without removing it from the retaining clip 954. The rear restraint formed by the retaining clip 954 and the hard stop 956 acts only against pulling force. The device support will not buckle because the retaining clip 954 cannot act against compressive force.
[0228] In another embodiment, tension on the device support provided by the front (or distal) fixed point and the rear (or proximal) fixed point that connect the device support to a more distal device module is created by storing the proximal end of the device support on a spool or reel at each cassette. In this embodiment, it will not be necessary for the support arm to provide a fixed point on the proximal end of the device support. Figure 92 shows a simplified top view of a device module with a device support stored on a spool according to an embodiment, and Figure 93 shows an exemplary winding tensioner according to an embodiment. In Figure 92In this case, each device module 960 includes a spool or reel 962 around which the device support can be wound. Figure 93 An exemplary winding tensioner is shown in which includes a reel 962 around which a flexible tube of the device support 964 is wound. The proximal end of the device support is fixed to the reel 962. The distal or "free" end of the device support can be pulled out by an operator or actuated automatically by a robotic drive and attached to a front fixed point on the distal cassette. Torque can be applied to the reel to apply tension to the device support 964. The torque can be applied by a separate mechanical device such as a constant torque spring or a rack and pinion. In another embodiment, the torque can be applied by a motor (not shown) controlled, for example, by the control computing system 34 as Figure 2 shown. Figure 94 A simplified top view of a device module having a driven device support according to an embodiment is shown, and Figure 95 an exemplary gear tensioner according to an embodiment is shown. In Figure 94 this case, each device module 970 includes a drive mechanism 974 that interacts or engages with the device support 972 to provide tension on the device support and allow the device support 972 to move forward and backward. The drive mechanism can be, for example, a wheel or a gear. In one embodiment, the drive mechanism 974 can support the device through frictional engagement on the wall of the flexible tube of the device support 972. In another embodiment, the device support can have radial holes along one side that are then engaged by a pin drive gear, also known as a traction feeder. In another embodiment, the device support is a ribbed or helical tube and the drive mechanism is a gear that engages and tensions the ribbed or helical tube. Figure 95 An exemplary gear tensioner 976 is shown that engages a helical flexible tube 978.
[0229] In another embodiment, the device support can be a telescoping joint or a spring. Figure 96 A simplified top view of a device module having a device support formed by a telescoping joint or a spring according to an embodiment is shown. In Figure 96 this case, the device support between the device modules 980 is formed by a telescoping joint element 986 and two linear guides 984 that are positioned parallel to each other on opposite sides of the telescoping joint element 986. The EMD 982 passes through an opening 992 (as Figure 98 shown) in each segment 994 (as Figure 98Positioned as shown). The device support of the telescoping joint is always under tension. In one embodiment, the telescoping joint device support has built-in compliance such that relative translational movement between two device modules 980 can be handled. Even though the telescoping joint member acts as a tension spring and is generally kept under tension, it may still deviate from the device axis when an axial load is applied. Figure 96 The linear guide (or guide track) 984 shown in restricts the telescoping joint, thereby limiting its deflection away from the device axis. In one embodiment, the linear guide 984 of the first device module is mounted to the proximal end of the more distal second device module, and the other end of the linear guide 984 freely slides through the telescoping joint and the first device module. An embodiment with four telescoping joints to support four device modules may have offset telescoping joint linear guides such that the linear guides do not interfere with each other when the device modules are closed. Figure 97 Illustrates the compressed state 988 of the telescoping joint element 986. For clarity, Figure 97 the linear guide is not shown in. Figure 98 Illustrates the stretched state 980 of the telescoping joint element 986. For clarity, the linear guide is not shown. The telescoping joint element 986 includes a plurality of segments 994, each segment 994 including an opening 992 through which the EMD can be positioned. The number of segments 994 and the length of the segments 994 can be optimized such that the unsupported distance between the discrete segments 994 is such that the EMD will not buckle under the maximum loads experienced during the procedure. The telescoping joint device support has a plurality of flexures that automatically balance to give equal spacing, independent of the total tension, such that a single gap across the length of the segment 994 does not become large enough to buckle. In other words, the gap across the length of each segment 994 is desired to be the same across all segments 994. This helps to minimize the unsupported distance the EMD needs to travel, which allows the telescoping joint element 986 to reach higher loads before buckling.
[0230] The profile of the device support formed by the flexible tube should support being opened and closed, for example, to allow the EMD to be loaded into the device support. When the slits at the distal end of the device support flexible tube are forced apart (e.g., using a separator discussed further below), the device support can be advanced to encapsulate the EMD, and when closed, the EMD is adequately supported and held such that it will not pop out and buckle. Figure 99A-C is a perspective view of an exemplary slit shape of a device support flexible tube according to an embodiment. In Figure 99A it, a device support flexible tube 1000 is shown having a straight slit 1002 along the longitudinal direction of the tube. In another example, as Figure 99B shown, the device support flexible tube 1000 can have a serrated slit 1004 along the longitudinal direction of the tube. In yet another example, as Figure 99CAs shown, the device support flexible tube 1000 can have a waveform slit 1006 along the longitudinal direction of the tube, which is similar to a sine wave. The slit of the device support 1000 can be opened by a wedge or a separator (shown in Figures 102-104 and further discussed below), which is positioned near the entry point of the EMD to the device support. The wedge or separator expands the opening wide enough to clear the EMD. The elasticity of the flexible tube causes the slit to recover and close on the other side of the EMD, thereby encapsulating and holding the EMD. A serrated shape and a sine-like shape can be used so that the materials in the slit area overlap to improve the holding of the EMD in the device support.
[0231] The EMDs utilized in the robotic actuators for interventional procedures can vary in size. For example, the various EMDs that can be used can range from 9FR to 2FR, or even a.010” guide wire. For example, in a multi-axis robotic actuator configured for an endovascular treatment procedure for treating acute ischemic stroke, it can be expected that the first EMD in the device stack is between 6 and 9FR. The second and third EMDs in the device stack can be between 2.5 and 6FR. The fourth EMD can be a wire-based EMD with a diameter between.010” and.038”. To properly support and hold EMD devices of different sizes, different device supports can be provided for each EMD, where the device support for each EMD is designed to work with the EMD of the corresponding size. For example, by minimizing the diameter gap between the EMD and the device support tube, any device that buckles inside the tube will store less energy and have less linear motion lag. In an embodiment, the device supports for each cartridge can be designed to be modular, such that the correct-sized device support can be added to the cartridge based on the EMD supported by the cartridge. Additionally, the separator and the device support connector (both will be further discussed below with reference to Figures 102-107 ) that are designed to work with a specific-sized EMD can also be modular and switched based on the specific size of the EMD supported by the cartridge. In another embodiment, different versions of the cartridge can be provided for each subset of device sizes, where the cartridge has a pre-installed appropriate-sized device support. The appropriate cartridge design for a specific size or size range of EMD can be installed on the actuator of the robotic actuator and removed when different sizes or different size ranges of EMDs require different designs. For example, the cartridge can be designed to support a size range of wire-based EMDs, which can vary between.010” and 0.38”.
[0232] As discussed above with reference to Figure 3 , the device module 32 of the robotic actuator 24 includes a drive module 68 and a cartridge 66, and the cartridge 66 is mounted on the drive module 68 and releasably coupled to the drive module 68.Figure 100 It is an exploded view of a device module and an elongate medical device according to an embodiment. The drive module 1010 includes a mounting surface 1012 and a coupler 1014. A motor and a drive belt (not shown) can be housed in the drive module 1010 and connected to the coupler 1014. The motor and the belt are used to control the rotational position of the coupler 1014. The drive module 1010 can include an encoder (not shown) for device position feedback. Figure 100 The illustrated drive module 1010 has one coupler 1014. However, it should be understood that the drive module 1010 can have more than one coupler 1014 and more than one motor (e.g., one motor per coupler or one motor driving multiple couplers). The rotation of the coupler 1014 can be used to provide another degree of freedom for the EMD positioned in the cartridge 1016, and the cartridge 1016 can be mounted on the mounting surface 1012 to dock with the coupler 1014. For example, when the EMD 1024 is positioned in the cartridge 1016, the coupler 1014 can be used to rotate the EMD 1024. If the drive module 1010 has two or more couplers 1014, each coupler can be used to provide a degree of freedom for the EMD.
[0233] As described above, the cartridge 1016 can be positioned on the mounting surface 1012 of the drive module 1010 and is used to dock with the EMD 1024 positioned in the cartridge 1016. As described above, the drive module 1010 can be configured to have at least one dimension that is less than or fewer than Figure 100 at least one dimension of the illustrated cartridge 1016. For example, the length of the drive module 1010 measured from proximal to distal when the drive module 1010 is coupled to a linear member or track can be less than or fewer than the length of the cartridge 1016 along the longitudinal axis of the cartridge. In some embodiments, the size and dimensions of the drive module 1010 can be minimized such that, for example, the drive module 1010 along the linear member or track of the robotic driver (e.g., Figure 2The linear member or track 60) shown occupies a minimal amount of space. The cartridge 1016 includes a housing 1018. In an embodiment, the cartridge housing 1018 may be releasably attached to the drive module 1010. The drive module 1010 may also include one or more additional elements 1013 on the mounting surface 1012, such as, for example, alignment pins, positioning pins, etc., to interact with elements (such as connection points, slots, channels, etc.) on the cartridge 1016 to enable the cartridge 1016 to be releasably attached to the drive module 1010. In one embodiment, the cartridge housing 1018 is releasably connected to the drive module 1010 using a quick release mechanism 1021. In one embodiment, the quick release mechanism 1021 includes a spring-biased member in the cartridge housing 1018 that is actuated by a latch release 1023 that releasably engages a quick release locking pin 1015 fixed to the drive module 1010.
[0234] The cartridge housing 1018 includes a carriage 1020 that is configured to receive the EMD 1024. A bevel gear 1022 is used to dock with the coupler 1014 of the drive module 1010 and to dock with the EMD 1024 to rotate the EMD 1024. In one embodiment, the EMD 1024 is provided with a device-on adapter 326 (discussed further below with reference to Figures 23-25 and further discussed) to dock the EMD 1024 to the cartridge 1016, such as to the docking of the bevel gear 1022. In Figure 100In the example shown, the EMD is a guide wire, and the adapter 1026 on the device is a chuck with a gear 1027. When power is transferred from the device module 1010 to the gear 1022 in the cartridge 1016 (e.g., via the coupler 1014), the gear 1022 in the cartridge interacts with the gear 1027 on the chuck to rotate the guide wire 1024. The device support 1028 is positioned in the cartridge, within the channel 1042, which may be covered by the housing 1018. As discussed above, the device support 1028 and the cartridge 1016 are configured to move relative to each other. The device support 1028 includes a connector 1030 that is configured to connect to a device module (e.g., a cartridge, other elements of the device module, or elements positioned within the device module) distal (or in front of) the cartridge 1016 in a robotic drive. The connector 1030 includes a recess 1032. In the retracted or withdrawn position, the connector 1030 is positioned in the recess 1036 in the housing 1018 at the distal end 1034 of the cartridge 1016. As discussed above, the connector 1030 and the device support 1028 can be pulled outwards from the cartridge 1016 so that the connector can be attached to a more distal cartridge in the robotic drive. A forward restraint 1040 is provided on the proximal end 1038 of the cartridge 1016 and is configured to connect to a connector of a device support on another cartridge proximal (or behind) the cartridge 1016 in the robotic drive. Figure 101A is a perspective view of a cartridge with a device support installed and in a retracted position, according to an embodiment. In the retracted position, the connector 1030 is positioned in the recess 1036 of the housing 1018 at the distal end 1034 of the cartridge 1016. Figure 101B is a perspective view of a cartridge with a device support installed and in a retracted position, according to an embodiment. The device support 1028 is positioned in the channel 1042 of the cartridge. The cartridge 1016 includes a proximal support member 1031 positioned on the proximal end 1038 of the cartridge 1016. The proximal support member 1031 includes an opening and is configured to provide support to the device support 1028. The device support 1028 is positioned in and passes through the opening 1033. The opening 1033 is sized such that the device support can move through the opening 1033 as the device support 1028 is advanced and retracted.
[0235] Figure 102Is a top view of a device support and a connector extending from a cartridge in front of the EMD entry point according to an embodiment. The device support 1028 and the connector 1030 extend from a recess in the distal end 1034 of the cartridge housing. When the device support 1028 is moved into and out of the recess 1036 and the channel 1042, the guide 1044 and the separator 1048 are positioned in the recess 1036 on opposite sides of the path of the device support 1028. In the extended position, the device support encapsulates the EMD 1024. The EMD enters the device support 1028 at the EMD entry point 1046, which is between the proximal and distal sections of the separator 1048. The proximal and distal sections of the separator are shown in dashed lines. As described above, the device support 1028 includes a longitudinal slit, so that the device support can be forced apart (e.g., by using a separator as described below) and closed to allow the device support to encapsulate the EMD when the device support is advanced. As Figure 104 shown, the connector 1030 keeps the end of the device support tube open, thus allowing it to pass through the separator 1048. Referring Figure 102 and 104 , as the connector 1030 and the device support 1028 pass through the separator 1048 and the EMD entry point 1046, the separator 1048 keeps the slit in the device support 1028 open when the EMD 1024 is encapsulated by the device support 1028. The end of the device support tube 1028 is positioned in the recess 1032 of the connector. Using the separator 1048 to keep the device support 1028 open on both sides of the EMD entry point 1046 reduces or eliminates the frictional force on the EMD 1024. For example, this prevents the wall of the device support 1028 tube from rubbing against the EMD 1024, which would damage the EMD 1024 at the entry point 1046 and would introduce noise into a load sensing system (not shown), which can be used to read the force or torque applied to the EMD. The EMD 1024 passes through the cavity 1052 in the center of the separator 1048. The connector 1030 and the separator 1048 are designed to remain open when the device support 1028 passes through the gap between the proximal and distal sections of the separator 1048. The separator 1048 is also designed so that the unsupported length of the EMD 1024 at any point does not catastrophically buckle. The guide 1044 is configured to guide the device support 1028 across the gap and hold the device support 1028 on the separator 1048. As described above, the separator 1048 can be designed for a specific range of EMD and device support sizes. Figure 103 Is a top view of the device support and the connector retracted behind the EMD entry point according to an embodiment, and Figure 105is a top view of a cartridge according to an embodiment, where the device support connector is retracted and moved away from the device axis to facilitate loading of the EMD. To facilitate loading of the EMD 1024 into the cartridge 1016 (as Figure 100 shown), prior to loading the EMD 1024, the device support 1028 and the connector 1030 are retracted into the recess 1036. As Figure 103 and 105 shown, the connector 1030 can be retracted onto the separator 1048 and the guide 1044 and behind (or proximal to) the EMD entry point 1046. Additionally, the retracted (or withdrawn) position of the connector 1030 is offset from the longitudinal EMD axis 1050. This allows the EMD to be placed into the cartridge 1016, e.g., loading a side-loaded EMD. Retracting the connector 1030 behind the EMD entry point also reduces the unsupported EMD length and reduces the working length loss.
[0236] As discussed above, the connector 1030 and the device support 1028 can be pulled outwards from the cartridge 1016 such that the connector can be attached to a device module (e.g., a cartridge of a device module) further distally in the robotic actuator. In an embodiment, a forward restraint 1040 ( Figure 100 shown) can be provided on the proximal end 1038 of the first cartridge and is used to connect to a connector of a device support on a second cartridge proximal (or behind) the first cartridge in the robotic actuator. Figure 106 is a perspective view of a forward restraint and a connector according to an embodiment. The forward restraint 1040 includes a latching mechanism 1054, such as a spring latch. The connector 1030 of the device support 1028 from a proximal cartridge (not shown) is attached to the spring latch 1054. In one embodiment, the connector 1030 is connected to the latching mechanism 1054 by pushing the connector 1030 into the forward restraint 1040. In an embodiment, in addition to axial translation to engage the latching mechanism 1054, the latching mechanism 1054 may not require auxiliary movement, but one or more additional movements may be required to disengage the latching mechanism 1054 and remove the connector from the forward restraint 1040. For example, a release button, lever, or knob may be required before the connector 1030 disengages. The connector 1030 can be manually disengaged or disengaged using the control computing system 34 (as Figure 2 shown). The connector 1030 is attached to the forward restraint 1040 approximately along the longitudinal EMD axis 350 of an EMD (not shown) contained in the device support 1028. This prevents shearing of the EMD by moving perpendicular to the latching mechanism 1054. In another embodiment, an auxiliary latch or fastening mechanism can be provided to further secure the connector 1030 and reduce play. Figure 107 is a perspective view of a forward restraint with a lid according to an embodiment. In Figure 107In [description], the lid 1056 is connected to the forward restraint 1040, for example, using a pivot. The lid 1056 can be closed and locked onto the connector 1030 to further restrain the connector 1030 in the forward restraint 1040.
[0237] As discussed above in reference Figure 3 The distal support connector mounted to the distal support arm can be used to provide a front (or distal) fixed point to support the distal end of the device support in the cassette of the most distal device module (i.e., the device module closest to the patient) in the robotic actuator. Figure 108 is a perspective view of a distal support arm and a distal support connector according to an embodiment. The cassette 1062 is mounted to the drive module 1064, and the drive module 1064 is connected to the platform 1066 using an offset bracket 1068. The platform 1066 is movably mounted to a track or linear member 1060 and can move linearly along the track 1060. The distal support arm 1070 can be attached to the frame of the robotic actuator, such as the frame of the track 1060. In one embodiment, the distal support arm 1070 can be rigidly attached to the frame. In another embodiment, the distal support arm 1070 can be attached to the patient table or the patient. The distal support arm 1070 extends away from the robotic actuator and is connected to the device support connector 1072 to provide a distal fixed point for the device support. In one embodiment, the distal support arm 1070 can also be used to provide distal definition for the cassette 1062 and the drive module 1064. Distal definition is used to define the most distal aspect of the most distal device of the robotic actuator (e.g., the cassette 1062 and the drive module 1064). In another embodiment, a separate distal definition arm (not shown) can be used to provide distal definition, which can be coupled to, for example, the frame of the robotic actuator. The distal support connector 1072 can also be coupled to the guide sheath hub. The guide interface support 1076 can be connected to the device support connector 1072. The connector 1074, such as the connector on the distal end of the device support described above in reference Figures 102-105 can be attached to the device support connector 1072 to provide a front (or distal) fixed point and support for the distal end of the device support. Figure 108 The device support is not shown in [figure], but as Figure 109 shown, the device support will be positioned in the cassette 1062. Figure 109 is a perspective view of a distal support connector coupled to a device support and a connector. The device support 1078 is shown as a dashed line encapsulating the EMD 1079 and extending between the cassette 1062 and the device support connector 1072. The connector 1074 is attached to the device support connector 1072. The device support connector 1072 can be, for example, as previously referenced Figure 106 and 107The described forward restraint. The device support connector 1072 is mounted to the distal support arm 1070 and can be connected to the guide interface support 1076. Figure 110 is a side view of a distal support arm, a distal support connector, and a guide interface support according to an embodiment. The guide interface support 1076 is configured to support the EMD 1079 (as Figure 109 shown) between the device support 1078 (as Figure 109 shown) and the guide sheath 1075, and the guide sheath 1075 is connected to the distal end of the guide interface support 1076, as discussed further below. The guide interface support 1076 ensures that the EMD 1079 does not buckle or prolapse between the distal end of the device support 378 and the hub of the guide sheath 1075. In an embodiment, the guide interface support 1076 can also be used to redirect the EMD from a position axially aligned with the robotic drive device axis 1065 to a position axially aligned with the guide sheath 1075 or other support member.
[0238] The guide sheath 1075 is inserted into the patient's vasculature at an access point (e.g., the femoral artery), which will direct the EMD to a target site (e.g., a lesion) within the patient. The guide sheath 1075 should be held in place such that it does not come out of the patient's body. In one embodiment, the distal support arm 1070 and the device support connector 1072 can be used to fix the position of the guide sheath 1075 and can react to forces on the guide sheath 1075 generated by friction between the guide sheath 1075 and the EMD moving within the guide sheath 1075. In another embodiment, the guide sheath 1075 can be supported by a structure separate from the distal support arm 1070 and the device support connector 1072. For example, the guide sheath 1075 can be attached to the patient or the patient table using known methods.
[0239] Figure 111Is a perspective view of a guide interface support connected to a guide sheath according to an embodiment. The guide interface support 1076 is connected to the device support connection member 1072 at its proximal end 1080, and the device support connection member 1072 is connected to the distal support arm 1070. The guide sheath 1075 is connected to the distal end 1082 of the guide interface support 1076. The guide interface support 1076 can be configured to receive a guide sheath 1075 having a side port (not shown). The side port and its tubing (not shown) can allow the administration of drugs, contrast agents, or saline injections or the extraction of blood samples. The EMD (not shown) enters the patient's body through the guide sheath 1075 inserted into a blood vessel (usually an artery). In one embodiment, the guide interface support 1076 is opened to allow the EMD to be placed in the guide interface support 1076. In another embodiment, the EMD can be axially inserted into the guide interface support 1076. In another embodiment, the EMD and the guide interface support 1076 can be frictionally engaged such that the guide interface support 1076 does not need to be opened or the EMD axially inserted. As described above, the guide interface support 1076 provides support for the EMD over the distance between the connector 1072 and the guide sheath 1075. The guide interface support 1076 can be rigid (as Figure 111 shown) or flexible. For example, the guide interface support 1076 can be made of a flexible material, or the guide interface support 1076 can have a joint near the device support connection member 1072 that allows a limited range of motion at the distal end 1082 (where the guide sheath 1075 is held) to address perturbations from robotic actuators or patient movement.
[0240] In another embodiment, the distal support arm 1070 can be movably connected to a robotic actuator. The movable distal support arm 1070 can have one or more degrees of freedom to account for excess exposed EMD length that may not need to be actuated. For example, for shorter patients and / or less tortuous patients, more of the first guide catheter may be exposed because it will never need to enter the patient's body. If the distal support arm (and thus the device support connection member 1072) can move forward, it can address the excess length of the guide catheter that does not need to be actuated. This can also help reduce the total length of the track or linear member 1061 (and Figure 108 and 110 the track 1060 shown). Figure 112 Is a perspective view of a movable distal support arm in a first position according to an embodiment. The distal support arm 1070 can be movably connected to the track or linear member 1061 using the platform 1090. In Figure 112In [the figure], the distal support arm 1070 is in the first position 1094, where the distal support connection member 1072 is located near the distal end of the device module 1092. The platform 1090 can be moved manually or automatically along the track 1061 to change the position of the distal support arm 1070. Figure 113 is a perspective view of a movable distal support arm in a second position according to an embodiment. In Figure 113 [the figure], the platform 1090 and the distal support arm 1070 have been linearly moved from the device module 1092 to a second, more distal position 1096. Accordingly, the device support connection member 1072 and the device module 1092 are separated by a distance 395. In Figure 112 and 113 In the illustrated embodiment, the distal support arm 1070 has one degree of freedom. In another embodiment, the distal support arm 1070 can be an articulated arm or a driven arm having multiple degrees of freedom.
[0241] As discussed above, each end of the device support can be connected to a fixed point (front (or distal) and back (or proximal)) to provide appropriate tension to the device support between device modules or between the farthest device module and the device support connection member, thereby preventing EMD buckling. The above-described device support connection member 1072 provides a front (or distal) fixed point for the device support of the farthest box in the robotic actuator. Using a support arm (e.g., Figure 3 the support arm 77 shown in [the figure]), the device support of the farthest box can be provided with a back (or proximal) fixed point. For a movable distal support arm, the support arm will also be movable. Figure 114 is a top view of a movable distal support arm and a movable support arm in a first position according to an embodiment. In Figure 114 [the figure], the distal support arm 1110 is in the first position 1114. The device module 1106 is connected to the track or linear member 1100 using the first platform 1102. The device support 1108 is positioned within the device module 1106 (e.g., in a box of the device module), and the distal end of the device support 1108 is connected to a device connection point 1111 (front (or distal) fixed point) that is connected to the distal support arm 1110. The proximal end of the device support 1108 is connected to the proximal end of the support arm 1112 at a back (or proximal) fixed point 1109. The second platform 1103 is connected to the track 1100 (or a different track (not shown) in the system) and can be moved manually or automatically along the track 1100 to change the positions of the distal support arm 1110 and the support arm 1112. Figure 115 is a top view of a movable distal support arm and a movable support arm in a second position according to an embodiment. In Figure 115In [the figure], the second platform 1103, the distal support arm 1110, and the support arm 1112 have been linearly moved to a second position 1116 that is more distal from the device module 1106. The support arm 1112 moves along with the device support connector 1111, so there is always a device support member 1108 of the same length between the device support connector 1111 and the rear fixed point 1109. Figure 116 is a top view showing the movement of the distal support arm and the support arm from the second position to the first position according to an embodiment. In Figure 116 [the figure], the device support connector 1111, the support arm 1112, the distal support arm 1110, and the second platform 1103 start at the second position 1116 (indicated by the dashed line). The second platform 1103 can be actuated to linearly move along the track 1100 to the first position 1114, as indicated by the arrow 1118. The first positions of the device support connector, the support arm, the distal support arm, the rear fixed point, and the second platform are respectively indicated by the reference numerals 1111', 1112', 1110', 1109', and 1103'.
[0242] Performing a surgery using a catheter-based surgical system with a robotic actuator may include loading a device into the system, unloading a device from the system, and exchanging devices. For loading / unloading a device, the device being loaded / unloaded is within the next distal EMD that has a more proximal device (e.g., a microfilament) that has a retained portion. Device exchange includes having a more proximal device (e.g., a microfilament) with a retained portion, and the device being unloaded needs to be removed from the proximal device without disturbing the retained position. The speed, safety, and efficiency of the exchange may be affected by various factors, including the experience level of the user or operator, the time-critical nature of the type of surgery (e.g., endovascular treatment of acute ischemic stroke), and the robotic technology of the system may apply additional constraints, steps, or challenges. Each of these factors increases the time of the exchange robotic procedure compared to a manual procedure. The methods, devices, and processes described below can be used to make the exchange faster, safer, and more consistent.
[0243] Full drive of the EMD is defined as initially driving the EMD from the starting position, where the distal end of the EMD is slightly inserted into the more distal EMD such that the EMD does not project distally from the more distal EMD, and advancing the EMD as needed to potentially reach its full working length. The length required for a robotic drive device configured to hub drive the EMD and be capable of full driving of a rapid exchange EMD, the actuation length will be the length of all EMDs that can be added end-to-end for use. The actuation length may also take into account the length of the hub of the device, the length of the hemostatic valve Y-connector and gear adapter, and the distance between device modules. For example, for a robotic drive configured for endovascular treatment of acute ischemic stroke, which includes a guiding catheter (e.g., 95 cm in length), a suction catheter (e.g., 135 cm in length), a microcatheter (e.g., 165 cm in length), and a microfilament (e.g., 180 - 200 cm in length), the robotic drive actuation distance will need to be almost 7 meters long. To reduce the length, a manual loading procedure can be used that allows the bedside operator to load and unload the EMD with at least minimal experience without risk of vascular injury to the patient.
[0244] Figure 117FIG. 0 is a block diagram illustrating loading or unloading an EMD in a robotic driver at a safe loading distance according to an embodiment. To load the EMD, an operator removes a second EMD 1126 (or more than one EMD in other embodiments) and inserts the second EMD 1126 into the hub of a more distal first EMD 1124. For example, the first EMD 1124 may be a guide catheter and the second EMD 1126 may be a distal access catheter. The robotic driver (e.g., a control computing system) may be configured to automatically position a second device module 1122 (coupled to a rail or linear member 1132) at a distance from a first device module 1120 (coupled to a rail 1132), herein referred to as a loading offset 1130. The loading offset is selected such that when the operator places the second (proximal) EMD 1126 into the second device module 1122, the second EMD 1126 will not exit the distal end 1134 of the more distal first EMD 1124. Thus, the second EMD 1126 will not be exposed to the vasculature. To correctly position the second (proximal) device module 1122, the relative distance to the first (more distal) device module 1120 must be known. The loading offset 1130 may be based on a desired gap 1128 (e.g., 5 centimeters) between the distal end 1134 of the first EMD 1124 and the distal end 1136 of the second EMD 1126 when the second EMD 1126 is loaded, the length of the first (distal) EMD 1124, and the length of the second (proximal) EMD 1126. In another embodiment, various parameters of the robotic driver may also affect the loading offset 1130, such as, for example, hub length and gear adapter length. In various embodiments, the loading offset 1130 may be defined by differences in EMD lengths (minimum distal device module EMD length, maximum loaded EMD length), different usage scenarios, an operator input based on the EMD lengths used, or may be determined by a catheter-based surgical system by scanning the EMDs opened during the procedure. The catheter-based surgical system (e.g., a control computing system) may automatically drive the second device module 1122 (e.g., along the rail 1132 of the robotic driver) to the correct position along the rail 1132 at the correct loading offset 1130, e.g., in response to a user input provided by the operator. In another embodiment, the second device module 1122 may be inched by the operator along the rail 1132 at the correct loading offset 1130 to the correct position. In yet another embodiment, the second device module 1122 may be manually driven by the operator at the correct loading offset 1130 back to the correct position along the rail 1132. When the EMD is inside the patient, to unload the EMD, the robotic driver or the doctor may drive the second device module 1122 along the rail 1132 to a position that is the loading offset 1130 away from the first device module 1120.This ensures that the bedside operator does not manipulate the EMD that is directly surrounded by the patient's vasculature. Although reference. Figure 117 A loading offset 1130 is described, but in other embodiments, more than one loading offset may be used, where each loading offset provides an area for safe loading or unloading of the EMD.
[0245] When calculating the loading offset 1130, various additional factors can be used. The factors used in the calculation can be based on the desired workflow of the catheter-based surgical system. Additional factors can include the current position along the track of the device module with the EMD being exchanged, the current stack of devices in the robotic driver, and the stack of devices to be loaded into the robotic driver. Another factor is that if the device module is close enough proximally and additional cartridges are added distally (e.g., from a biaxial configuration to a triaxial configuration), the device module may need to move distally to allow the additional cartridges to be added to the robotic driver.
[0246] An example of why the EMD length is important is when a doctor is trying to reach a distal clot. A typical stack for distal aspiration EMD would be a guiding catheter (95 cm), a suction catheter (135 cm), a microcatheter (165 cm), and a guidewire (300 cm). If the 165-cm microcatheter cannot reach the clot because it is "pushed out" behind the suction catheter and the guiding catheter (the device is in the maximum forward position), the doctor can remove the suction catheter and insert the microcatheter directly into the guiding catheter. By doing so, the doctor can increase the number of microcatheters inserted into the body because they have eliminated the length of the hub of the suction catheter and the hemostatic valve on the back of the suction catheter. The impact of this change is realized when loading the microcatheter behind the catheter. In the past, the 135-cm suction catheter was loaded behind the 95-cm guiding catheter, and now the 165-cm microcatheter is loaded behind the 95-cm guiding catheter. If the same loading position is used, the tip of the microcatheter will be 30 cm further forward, deeper into the patient's vasculature. By knowing the length of the EMD being loaded and the length of the EMD into which it is being loaded, and using the methods described herein for determining and implementing a safe loading offset, the catheter-based surgical system / robotic driver can ensure a safe loading distance for all use cases.
[0247] A catheter-based surgical system / robot driver can use various methods to determine the length of the EMD in a device module. For example, the catheter-based surgical system / robot driver can determine the EMD length of each device module through electrical or optical identification (RFID, barcode, QR, etc.), the operator manually inputs the EMD length data or has a specified EMD length range, and selects a length combination, which will cause the device module to be driven as far as possible (worst or worst, i.e., the safest condition). To enable the use of a safe loading offset, the robot driver can be configured to detect when a device module is not filled (no EMD is loaded in the cassette), and move the unfilled device module without blocking the path of the device module that needs to reach the loading offset. During use, a device module may interfere with the planned path of other device modules, so the ability to avoid a collision state is important. In another embodiment, if the user slowly feeds a device module backward to bring it to the loading position, and it moves into another device module instead of entering a "collision" state where both device modules are deactivated, the command for the device module being slowly fed will also be sent to the device module that obstructs its path so that both device modules move in the same direction.
[0248] There are various methods to insert the EMD while restricting its forward travel. In one example, the EMD hub can be placed into the device module into which it is being loaded, and the operator ensures that the EMD hub is fixed (i.e., the EMD cannot move forward while the device is being inserted). Then the EMD or a set of EMDs is inserted into the more distal EMD. When the inserted EMD approaches the loading offset distance, it will become taut and no longer be able to be further inserted into the patient. In another example, the EMD to be loaded can be axially inserted through the cassette into which it is being loaded. The cassette acts as a hard stop and does not allow the EMD hub to be further inserted into the patient. In another example, a mechanical clip can be attached to the EMD shaft to act as a hard stop when inserted into the more distal EMD hub.
[0249] In an embodiment, a robotic driver (e.g., a control computing system of the robotic driver) can be configured to correctly position a device on adapter on a wire-based device to allow for a specified throw amount. In another embodiment, the robotic driver (e.g., a control computing system of the robotic driver) can be configured to generate and provide an alert (e.g., a visual or audible alert) to indicate whether the current position of a device module along a track in the robotic driver does not allow for loading all EMDs based on, for example, the length of an EMD. In another embodiment, the robotic driver (e.g., a control computing system of the robotic driver) can be configured to provide a notification (e.g., on a display) of where (i.e., at what position along the track) to drive one or more device modules. For example, the user can then command the robotic driver (e.g., using a control station) to drive one or more device modules based on the position information provided by the robotic driver. In this embodiment, the robotic driver can also be configured to provide a notification (e.g., on a display) when the device module is in a safe position.
[0250] In manual neurosurgery, a technician will typically prepare a large number of EMDs on a separate sterile table behind the catheterization system table. These EMDs are typically loaded within each other and then loaded into an EMD that has been inserted into a patient. For example, a distal access catheter, a microcatheter, and a 0.014 guidewire can be assembled together and then, once access to the carotid artery is obtained, the entire prepared set of EMDs can be loaded into a guiding catheter. A robotic driver (e.g., Figure 3 the robotic driver 24 shown) can be configured such that a prepared (or pre-assembled) EMD "sub-assembly" (or group) can be side-loaded into two or more device modules of the robotic driver. In an embodiment, a prepared set of EMDs is loaded into two or more device modules substantially simultaneously. In another embodiment, each EMD in a pre-assembled set of EMDs can be loaded into a device module sequentially. Figure 1181 is a top view of the device modules of the robotic drive in a loading position according to an embodiment. First device module 1140 is in the distal-most device module position and has a first device support 1148 that extends and encapsulates a first EMD 1156 supported by first device module 1140. Second device module 1142, third device module 1144, and fourth device module 1146 are positioned proximal to first device module 1140. Second device module 1142, third device module 1144, and fourth device module 1146 have a second device support 1150, a third device support 1152, and a fourth device support 1154, respectively. Each of second device support 1150, third device support 1152, and fourth device support 1154 is pulled to its proximal-most position, and the lid of a cassette (not shown) loaded onto each device module 1142, 1144, and 146 is opened to facilitate loading of the EMD into the corresponding device module. In one embodiment, the robotic drive may include a spring-loaded member to aid usability when opening the lid and retracting the device support to enable loading. In another embodiment, the robotic drive may include an actuated member to aid usability when opening the lid and retracting the device support to enable loading. In this embodiment, the robotic drive may be configured to automatically control the actuating member.
[0251] Figure 119 is in a loading position according to an embodiment Figure 118 1162. A subassembly or group of EMDs 1164 is prepared (or preassembled) and includes a second EMD 1158, a third EMD 1160, and a fourth EMD 1162. The end of the second EMD 1158 is inserted into a y-shaped connector mounted on the first device module 1140. When the lid is opened and the device supports 1150, 1152, 1154 are retracted to their most proximal positions, as indicated by arrows 1166, the group of EMDs 1164 can all be loaded into their corresponding device modules at once. That is, the second EMD 1158, the third EMD 1160, and the fourth EMD 1162 can be loaded into the second device module 1142, the third device module 1144, and the fourth device module 1146, respectively, at the same time. Figure 120 Each of the EMDs 1158, 1160, 1162 is shown in a subassembly of a prepared EMD 1164 loaded into their respective device modules.
[0252] In an embodiment, the device adapter (referenced above) Figures 23-25One or more EMDs that can be added to an EMD subassembly (or device stack) on a preparation table (discussed) are allowed to be swapped into the system without adding or removing a dedicated cassette. Additionally, referring to Figures 118-120 The described design enables loading multiple coaxial devices into a robotic actuator. This design also contributes to safety as the operator can convert the robotic program to a manual program by removing all EMDs and continuing with no large cassettes or device support mechanisms still attached to the EMDs. Only smaller devices (such as on-device adapters (e.g., gear adapters or chucks)) will remain attached to the EMD. The ability to remove an entire device stack (e.g., a prepared EMD subassembly) from the cassette of a device module and the side-loading / unloading design facilitate the conversion from a robotic program to a manual program.
[0253] As discussed above, various embodiments utilize on-device adapters positioned on the shaft of an EMD (e.g., a wire-based EMD). The position of the on-device adapter on one or more EMDs is important for loading / unloading or swapping the EMD using the safety offset as described above with reference to Figure 117 and for loading a pre-assembled set of EMDs as described above with reference to Figures 118-120 For example, if the on-device adapter is positioned too proximally on the EMD, the distal tip will extend beyond the catheter tip when loading / unloading or attempting to swap using the safe loading offset, which can cause vascular damage. If the on-device adapter is placed too distally on the EMD, the EMD may not have sufficient forward throw to extend past the distal tip of, for example, the catheter in which the EMD is positioned. Setting the on-device adapter at a known position along the EMD helps achieve a safe and efficient workflow.
[0254] In various embodiments, a gap tool can be used to achieve setting the on-device adapter at a specific position on the EMD. The gap tool is configured with the correct offset that specifies the throw the on-device adapter should have when loaded into the robotic actuator. The gap tool can be used on a separate sterile table behind the catheterization system table when preparing the EMD or loading the EMD into the robotic system. In one embodiment, the gap tool can be configured to position the on-device adapter based on the alignment of the distal tip of the EMD and the distal tip of the catheter in which the EMD is positioned. Figure 121 is a schematic diagram of an elongate medical device, a gap tool, and an on-device adapter according to an embodiment. In Figure 121In this case, the clearance tool 1170 is positioned adjacent to and along the EMD 1174 (e.g., wire-based EMD) between the Y-shaped connector (or hub) 1182 of the catheter 1176 and the on-device adapter 1172. The clearance tool 1170 is configured to define a distance 1184 that is based on the desired offset between the Y-connector 1182 and the on-device adapter 1182, and this offset provides the throw that the on-device adapter should have when loaded into the robotic actuator. First, as Figure 121 shown, the distal end 1178 of the EMD 1173 is substantially aligned with the distal end 1180 of the catheter 1176. When the distal end 1178 of the EMD 1174 and the distal end 1180 of the catheter 1176 are aligned, the clearance tool can be positioned adjacent to the EMD 1174 to indicate the correct position or offset of the on-device adapter on the EMD 1174 relative to the Y-shaped connector 1182 of the catheter 1176 (i.e., the device into which the EMD 1174 is actuated). In an embodiment, the clearance tool 1170 can be adjustable such that the distance 1184 (or clearance) can be adjusted based on parameters of the catheter-based surgical system, such as parameters of the robotic actuator.
[0255] In another embodiment, the clearance tool can be configured to position or align the on-device adapter based on the lengths of the EMD and other devices (such as the length of the Y-shaped connector). Figure 122 is a schematic view of an elongate medical device, a clearance tool, and an on-device adapter according to an embodiment. In this embodiment, the position of the on-device adapter at either end (proximal or distal) of the EMD 1192 (e.g., wire-based EMD) can be calculated based on the length of the catheter (not shown) in which the EMD is positioned, the length of the EMD 1192, and other parameters (such as, for example, the length of the Y-shaped connector of the catheter). In Figure 122 this case, the clearance tool 1190 is shown positioned adjacent to and along the EMD 1192 and is used to position the on-device adapter 1194 from the proximal end 1196 of the EMD 1192. The clearance tool 1190 is configured to be adjustable to change the desired offset of the device, for example, based on parameters of the catheter-based surgical system (such as parameters of the robotic actuator). For example, the clearance tool 1190 can include a scale 1198 and a slider 1197 that can be moved to adjust the distance (or clearance) 1195 defined by the clearance tool 1180. Since the clearance tool 1190 is configured to position or align the on-device adapter based on the known length of the EMD, the clearance tool 1190 can be used to position the on-device adapter 1194 on the EMD 1192 before the EMD is positioned in the catheter in the vasculature. In another embodiment, the clearance tool can be configured to be similar to a custom measuring tape.Figure 123 It is a schematic diagram of an exemplary gap tool according to an embodiment. The gap tool 1200 includes a scale 1202. The scale 1202 can be moved to account for desired throw amounts, lengths of hubs and Y-connectors, etc. In an embodiment, the scale 1202 can be read in centimeters of catheter length. In Figure 123 , the gap tool 1200 is shown positioned next to the EMD 1204 via the device-on adapter 1206. In another embodiment, as Figure 124 shown, the tape measure form of the gap tool can be configured in a spiral shape. The spiral shape of the gap tool 1210 with the scale 1212 can improve the usability of the gap tool 1210. The gap tool 1210 can be unwound when it is needed to be positioned along the EMD to position the device-on adapter on the EMD.
[0256] According to the above method, computer-executable instructions for robotic intervention surgery can be stored in the form of a computer-readable medium. The computer-readable medium includes volatile and non-volatile, removable and non-removable media implemented by any method or technology for storing information such as computer-readable instructions, data structures, program modules, or other data. The computer-readable medium includes but is not limited to random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other storage technologies, compact disc read-only memory (CD-ROM), digital versatile disc (DVD) or other optical memory, cartridges, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the required instructions and can be accessed by the system 10 (as Figure 1 shown), including access via the Internet or other forms of computer networks.
[0257] The control computing system described herein may include a processor having processing circuitry. The processor may include a central processor, an application specific integrated circuit (ASIC), circuitry including one or more processing components, a group of distributed processing components, a group of distributed computers configured for processing, etc., which are configured to provide the functions of the modules or subsystem components discussed herein. A storage unit (e.g., a memory device, a storage device, etc.) is a device for storing data and / or computer code to complete and / or facilitate the various processes described in this disclosure. The memory unit may include volatile memory and / or non-volatile memory. The memory unit may include database components, object code components, script components, and / or any other type of information structure for supporting the various activities described in this disclosure. According to an exemplary embodiment, any distributed and / or local memory device, past, present, or future, may be used with the systems and methods of this disclosure. According to an exemplary embodiment, the memory unit is communicatively connected to one or more associated processing circuits. The connection may be via circuitry or any other wired, wireless, or network connection, and includes computer code for performing one or more of the processes described herein. A single memory unit may include various individual memory devices, chips, disks, and / or other storage structures or systems. A module or subsystem component may be computer code (e.g., object code, program code, compiled code, script code, executable code, or any combination thereof) for performing the corresponding function of each module.
[0258] This written description uses examples to disclose the invention, including the best mode, and also enables any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. If these other examples have structural elements that are not different from the literal language of the claims, or if these other examples include equivalent structural elements that are not substantially different from the literal language of the claims, then these other examples are intended to be within the scope of the claims. According to an alternative embodiment, the order and sequence of any process or method steps may be changed or reordered.
[0259] Many other changes and modifications may be made to the invention without departing from the spirit thereof. From the appended claims, the scope of these and other variations will become apparent.
Claims
1. A system, comprising: A robotic driver; A linear member; A first device module connected to the linear member, the first device module being configured to receive a first elongate medical device (EMD); A second device module connected to the linear member, the second device module being configured to receive a second EMD; A global stop fixture configured to be attached to the robotic driver, the global stop fixture being configured to hold a third EMD when attached to the robotic driver, wherein the first device module is configured to receive the second EMD and the third EMD, wherein when the global stop fixture is attached to the robotic driver, the global stop fixture is configured to allow the first and second device modules to move linearly while holding the third EMD fixed relative to the patient.
2. The system of claim 1, wherein the second and third EMDs enter the first EMD 664 parallel to each other.
3. The system of claim 1, wherein the robotic driver includes a frame, and the global stop fixture is configured to be attached to the frame.
4. The system of claim 1, wherein the first device module is connected to the linear member using a first platform, and the second device module is connected to the linear member using a second platform.
5. The system of claim 1, wherein when the global stop fixture is attached to the robotic driver, the third EMD is angled relative to the first and second EMDs.
6. A system for driving at least one elongate medical device (EMD), the system comprising: A linear member; A first device module connected to the linear member via a first platform, the first device module being configured to receive a first elongate medical device (EMD); A second device module connected to the linear member via a second platform, the second device module being configured to receive a second EMD; A global stop fixture connected to the linear member via a frame; wherein the global stop fixture is configured to hold a third EMD, wherein the first device module is configured to receive the second EMD and the third EMD, wherein when the global stop fixture is attached to the frame, the global stop fixture is configured to allow the first and second device modules to move linearly while holding the third EMD fixed relative to the patient.
7. The system of claim 6, further comprising a robotic driver coupled to the linear member and configured to manipulate the first, second, and third EMDs and linearly move the first and second device modules.
8. A system for driving at least one elongate medical device (EMD), the system comprising: A linear member; A first drive module connected to the linear member via a first platform, the first drive module including a coupler and being configured to receive a first cartridge, the first drive module being configured to manipulate a first elongate medical device (EMD) via the first cartridge; A second drive module connected to the linear member via a second platform, the second drive module including a coupler and configured to receive a second cartridge, the first drive module being configured to manipulate a second elongate medical device (EMD) via the second cartridge; A global stop fixture connected to the linear member via a frame; wherein the global stop fixture is configured to hold a third EMD; wherein when the first cartridge is coupled to the first drive module and the second cartridge is coupled to the second drive module, the first cartridge is configured to receive the second EMD and the third EMD; wherein when the global stop fixture is attached to the frame, the global stop fixture is configured to allow linear movement of the first and second device modules while holding the third EMD fixed relative to the patient.
9. The system of claim 8, further comprising a robotic driver coupled to the linear member and configured to manipulate the first, second, and third EMDs and linearly move the first and second drive modules.
10. A system for driving at least one elongate medical device (EMD), the system comprising: A first linear member; A second linear member; A first device module connected to the first linear member, the first device module being configured to manipulate a first elongate medical device (EMD); A global stop fixture attached to the second linear member, the global stop fixture being configured to hold a second EMD; wherein the global stop fixture is configured to linearly move along the second linear member.
11. The system of claim 10, further comprising a robotic driver, wherein the global stop fixture is configured to linearly move along the second linear member by the robotic driver.
12. The system of claim 10, wherein the first device module is connected to the first linear member using a first platform.
13. The system of claim 10, wherein the global stop fixture is coupled to the second rail 682 using a mounting bracket connected to a second platform, the second platform being mounted to the second linear member.
14. The system of claim 10, wherein the global stop fixture is configured to linearly move by translating the second platform along the second rail using a platform translation motor (not shown).
15. The system of claim 10, wherein the first EMD and the second EMD are in a parallel configuration.
16. A system for driving at least one elongate medical device (EMD), the system comprising: A first linear member; A second linear member; A first drive module connected to the first linear member 670, the first drive module being configured to receive a first cartridge and manipulate a first elongate medical device (EMD) via the first cartridge; A global stop fixture attached to the second linear member, the global stop fixture being configured to hold a second EMD; wherein the global stop fixture is configured to linearly move along the second linear member.
17. An apparatus module for attachment to a robotic driver configured to drive at least one elongate medical device (EMD), the apparatus module comprising: A cartridge having a proximal end and a distal end, the cartridge being configured to manipulate a first EMD having a hub; A module docking fixture 698 mounted to the proximal end 696 of the cartridge 692; The docking fixture being configured to hold a second EMD.
18. The apparatus module of claim 17, wherein the docking fixture is positioned such that the second EMD will enter the hub of the first EMD.
19. A system comprising: A robotic driver; An apparatus module connected to the robotic driver, the apparatus module comprising a cartridge having a proximal end and a distal end, the cartridge being configured to manipulate a first EMD having a hub; A module docking fixture mounted to the proximal end of the cartridge, the docking fixture being configured to hold a second EMD, Wherein the robotic driver is configured to linearly move the apparatus module along the length of the robotic driver, Wherein the linear movement of the apparatus module moves the second EMD to adjust the position of the second EMD.
20. The system of claim 19, wherein the docking fixture is positioned such that the second EMD will enter the hub of the first EMD.
21. The system of claim 19, wherein the second EMD is a self-expanding stent and the fixture 698 is configured to hold the deployment wire of the stent.
22. The system of claim 19, wherein the second wire is a balloon stent and the fixture is configured for docking the balloon for balloon-assisted winding.