Guide wire control device cassette and method for using the same

Abstract

To provide a system and method for intravascular procedure.SOLUTION: A guide wire control device cassette includes: a first drive unit having a first drive assembly which has a first rotation actuator and is configured to mechanically connect to a first intravascular insertion device advancing assembly of a first cassette; a second drive unit having a second drive assembly, the second drive assembly having a second rotation actuator and being configured to mechanically connect to a second intravascular insertion device advancing assembly of a second cassette; and a third drive assembly having a third rotation actuator and configured to mechanically connect to a third intravascular insertion device advancing assembly of a third cassette.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present specification relates to medical devices and control methods used in minimally invasive interventional procedures, and more particularly to the field of robotic control systems for intravascular interventions that use guidewires and catheters to apply their distal tips to their target sites within human body cavities. [Background technology]

[0002] A guidewire is used to guide a secondary sheath (e.g., a catheter) over and along the guidewire to a desired location within the body, e.g., a mammalian body such as a human. In one application of minimally invasive interventional procedures, a guidewire is introduced into a body cavity, i.e., a blood vessel, through an incision made through the patient's skin and the wall of the body cavity, and the introducing or distal end of the guidewire is then guided to a desired location within the body cavity or within a body cavity branching off from or into which the guidewire is being introduced.

[0003] One problem with guidewire introduction systems is their limited ability to adapt the distal end of a guidewire to follow the geometry of a tortuous body lumen and to navigate the distal end into a crossing or branching body lumen that is connected to the body lumen in which the distal end of the guidewire is located. To navigate the distal end of a guidewire into a branching body lumen, the distal end of the guidewire must be moved in a controlled manner from alignment with the body lumen at the point where the guidewire reaches the branching body lumen to a position where the guidewire will enter and follow the branching body lumen as the guidewire is moved further inside the body. In some cases, the branching body lumen intersects the body lumen in which the distal end of the guidewire is located, at a large angle, e.g., greater than 45 degrees, or even greater than 90 degrees, that is the target destination of the distal end of the guidewire. Additionally, in some cases, it can be difficult to guide the distal end of the guidewire through the tortuous and sharp turns of the blood vessel without trauma to the body lumen, because fluid flow adjacent to the turns and side walls tends to push the guidewire against the side walls of the vessel.

[0004] To overcome these problems, one method for facilitating control of the orientation of the distal end of the guidewire is to develop a robotic system for stably controlling the movement of the catheter and the surrounding guidewire. For example, U.S. Patent No. 10,342,953 B2 discloses a robotic catheter system. The catheter system includes a housing and a drive mechanism supported by the housing. The drive mechanism includes an engagement structure configured to engage with and impart movement to the catheter device. A cassette for use with the robotic catheter system is also provided. The cassette includes a housing, a first axial drive mechanism supported by the housing that releasably engages with the guidewire and drives the guidewire along its longitudinal axis, a second axial drive mechanism supported by the housing that releasably engages with the working catheter and drives the working catheter along its longitudinal axis, and a rotational drive mechanism supported by the housing that rotates the guidewire about its longitudinal axis. Summary of the Invention

[0005] To overcome the above-mentioned challenges, there remains a strong need for novel robotic control systems that are easy to navigate, have excellent stability, and have the potential to produce more uniform operator-independent results while reducing radiation exposure to the patient and surgeon.

[0006] In one aspect, the present specification provides a system for intravascular procedures, including a first drive unit including a first drive assembly having a first rotary actuator and configured to be mechanically coupled to a first intravascular insertion device advancing assembly of a first cassette; a second drive unit having a second drive assembly, the second drive assembly having a second rotary actuator and configured to be mechanically coupled to a second intravascular insertion device advancing assembly of a second cassette; a third drive unit including a third drive assembly having a third rotary actuator and configured to be mechanically coupled to a third intravascular insertion device advancing assembly of a third cassette; and a track, wherein the first drive unit is fixedly coupled to the track and the second and third drive units are mechanically coupled to the track, the second drive unit is disposed between the first and third drive units along the track, and the second and third drive units are movable along the track.

[0007] For a particular understanding of the above-listed features, reference is now made to the following detailed description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of a simplified multi-axial catheter system, according to some examples. [Figure 2] FIG. 1 is a perspective view of a multi-axial catheter system, according to some examples. [Figure 3A] FIG. 10 is a perspective view of a proximal drive unit, according to some examples. [Figure 3B] FIG. 10 is a side view of a proximal drive unit, according to some examples. [Figure 3C] FIG. 10 is a top view of a proximal drive unit, according to some examples. [Figure 3D] FIG. 10 is a bottom view of a proximal drive unit, according to some examples. [Figure 4A] FIG. 1 is a perspective view of an intermediate drive unit, according to some examples. [Figure 4B] FIG. 10 is a side view of an intermediate drive unit, according to some examples. [Figure 4C] FIG. 10 is a top view of a mid-drive unit, according to some examples. [Figure 4D] FIG. 10 is a bottom view of a mid-drive unit, according to some examples. [Figure 5A] FIG. 10 is a perspective view of a distal drive unit, according to some examples. [Figure 5B] FIG. 10 is a side view of a distal drive unit, according to some examples. [Figure 5C] FIG. 10 is a top view of a distal drive unit, according to some examples. [Figure 5D] FIG. 10 is a bottom view of a distal drive unit, according to some examples. [Figure 6] FIG. 1 is an exploded perspective view of a drive assembly, according to some examples. [Figure 7A] FIG. 10 is a perspective view of a proximal cassette, according to some examples. [Figure 7B] 7B is a perspective view of each of the proximal cassettes of FIG. 7A partially disassembled, according to some examples. [Figure 7C] 7B is a perspective view of each of the proximal cassettes of FIG. 7A partially disassembled, according to some examples. [Figure 7D] FIG. 7D is a rear view of the partially disassembled proximal cassette of FIG. 7C, according to some examples. [Figure 7E] FIG. 7D is a front view of the partially disassembled proximal cassette of FIG. 7C, according to some examples. [Figure 7F] FIG. 7D is a top view of the partially disassembled proximal cassette of FIG. 7C, according to some examples. [Figure 7G] FIG. 7D is a bottom view of the partially disassembled proximal cassette of FIG. 7C, according to some examples. [Figure 8A] 1 is a schematic diagram illustrating rotation of a guidewire, according to some examples. [Figure 8B] 1 is a schematic diagram illustrating the advancement of a guidewire, according to some examples. [Figure 9A]9A, 9B, and 9C are exploded perspective views of a translation assembly mechanically coupled to a track, according to some examples, and schematic diagrams of a proximal cassette with the translation assembly positioned therein, according to some examples. [Figure 9B] 9A, 9B, and 9C are exploded perspective views of a translation assembly mechanically coupled to a track, according to some examples, and schematic diagrams of a proximal cassette with the translation assembly positioned therein, according to some examples. [Figure 9C] 9A, 9B, and 9C are exploded perspective views of a translation assembly mechanically coupled to a track, according to some examples, and schematic diagrams of a proximal cassette with the translation assembly positioned therein, according to some examples. [Figure 10] FIG. 10 is an exploded perspective view of a fastener assembly, according to some examples. [Figure 11A] FIG. 10 is an exploded perspective view of portions of a clamping assembly, according to some examples. [Figure 11B] FIG. 10 is an exploded perspective view of a portion of an advancement assembly, according to some examples. [Figure 12] FIG. 10 is an exploded perspective view of a follower assembly, according to some examples. [Figure 13] FIG. 1 is an exploded perspective view of a catheter rotation assembly, according to some examples. [Figure 14] FIG. 1 is an exploded perspective view of a guidewire rotation assembly, according to some examples. [Figure 15] FIG. 1 is a diagram illustrating a configuration including a catheter and a Y-connector, according to some examples. [Figure 16] FIG. 1 is a diagram illustrating a configuration including a catheter and a Y-connector, according to some examples. [Figure 17] FIG. 1 is a diagram illustrating a configuration including a catheter and a Y-connector, according to some examples. [Figure 18] 1 is a schematic diagram illustrating rotation of a catheter, according to some examples. [Figure 19] 1A-1C are schematic diagrams depicting catheter advancement, according to some examples. [Figure 20] 1 is a flowchart of a method for operating a system for an intravascular procedure, according to some examples. [Figure 21] 1 is a flowchart of a method for operating a system for an intravascular procedure, according to some examples. DETAILED DESCRIPTION OF THE INVENTION

[0009] Examples described herein generally relate to systems and methods for intravascular procedures. More specifically, some examples described herein enable robotic systems for intravascular procedures and methods for operating such robotic systems. In some examples, a multi-axis catheter system can include multiple drive units, each with a corresponding cassette. The drive units can collectively advance and rotate several catheters and guidewires. In such systems, the advancement and rotation of a catheter or guidewire can occur independently from the advancement or rotation of any other catheter or guidewire. Some examples include a cassette that can perform the advancement and / or rotation of a catheter or guidewire.

[0010] The examples described herein may achieve various benefits. The robotic system allows a surgeon performing an intravascular procedure to precisely control the navigation of an intravascular device (e.g., a catheter and / or guidewire). Rotation of the intravascular device during an intravascular procedure allows the intravascular device to be guided through the tortuous vasculature of the body undergoing the intravascular procedure. Furthermore, a rotation assembly configured to rotate the intravascular device can maintain a mechanical connection to the intravascular device (e.g., including while advancing the intravascular device), thereby maintaining the rotational orientation of the intravascular device.

[0011] Various features are described below with reference to the figures. An illustrated example does not necessarily have all aspects or advantages shown. Aspects or advantages described in connection with a particular example are not necessarily limited to that example and may be implemented in any other example, even if not so illustrated or explicitly described. Furthermore, while methods described herein may be described with a particular order of operations, other methods according to other examples may be implemented in various other orders with more or fewer operations (e.g., including different serial or parallel execution of various operations). While various figures are illustrated with three-dimensional coordinate axes for determining the orientation of the figures relative to one another, such axes may not be explicitly described below. The three-dimensional coordinate axes indicate the direction of positive movement along each axis. More specifically, the three-dimensional coordinate axes indicate the positive X (+X) direction, the positive Y (+Y) direction, and the positive Z (+Z) direction.

[0012] FIG. 1 shows a perspective view of a simplified multi-axial catheter system 10 according to some examples. The multi-axial catheter system 10 includes a frame 12, a track 14, cassette platforms 22, 24, 26, and 28, and drive units 32, 34, 36, and 38. In operation, the multi-axial catheter system 10 utilizes a distal cassette 42, a first intermediate cassette 44, a second intermediate cassette 46, and a proximal cassette 48. Cassettes 42-48 may be single-use cassettes (e.g., usable for a single intravascular procedure). The illustrated multi-axial catheter system 10 utilizes cassette platforms and drive units for two intermediate cassettes. Other examples may utilize cassette platforms and drive units for fewer or more intermediate cassettes (e.g., one, three, four, etc.).

[0013] Frame 12 is a support structure to which various other components of multi-axial catheter system 10 are mechanically coupled and supported. Although not shown, a casing or shroud may also be included around frame 12. Track 14 underlies and is mechanically coupled to frame 12. Track 14 extends along the longitudinal axis of frame 12, which is the X direction in FIG. 1. Track 14 allows translation in a direction parallel to the longitudinal axis (e.g., the X direction) of components mechanically coupled to and movable along track 14.

[0014] While the distal cassette platform 22 is illustrated as being integral with the frame 12, in other examples, the distal cassette platform 22 may be mechanically coupled to the frame 12 in other ways, such as by a bracket and / or other framework. The distal drive unit 32 is below the distal cassette platform 22 and is mechanically coupled to the distal cassette platform 22 and / or the frame 12. The distal cassette platform 22 and the distal drive unit 32 are in a fixed position relative to the frame 12 (e.g., by mechanical coupling to the frame 12). During operation, a distal cassette 42 may be disposed on the distal cassette platform 22 and mechanically attached to the distal cassette platform 22 and / or the distal drive unit 32.

[0015] The first intermediate cassette platform 24 and / or the first intermediate drive unit 34 are mechanically coupled to and movable along the track 14. The first intermediate drive unit 34 is located below and mechanically coupled to the first intermediate cassette platform 24. The first intermediate cassette platform 24 and the first intermediate drive unit 34 are configured and capable of translating along a direction parallel to the longitudinal direction of the track 14 (e.g., the X direction). During operation, a first intermediate cassette 44 may be disposed on the first intermediate cassette platform 24 and mechanically attached to the first intermediate cassette platform 24 and / or the first intermediate drive unit 34.

[0016] The second intermediate cassette platform 26 and / or the second intermediate drive unit 36 ​​are mechanically coupled to and movable along the track 14. The second intermediate drive unit 36 ​​is located below and mechanically coupled to the second intermediate cassette platform 26. The second intermediate cassette platform 26 and the second intermediate drive unit 36 ​​are configured and capable of translating along a direction parallel to the longitudinal direction of the track 14 (e.g., the X direction). During operation, the second intermediate cassette 46 may be disposed on the second intermediate cassette platform 26 and mechanically attached to the second intermediate cassette platform 26 and / or the second intermediate drive unit 36.

[0017] The proximal cassette platform 28 and / or the proximal drive unit 38 are mechanically coupled to and movable along the track 14. The proximal drive unit 38 is located below and mechanically coupled to the proximal cassette platform 28. The proximal cassette platform 28 and the proximal drive unit 38 are configured and capable of translation along a direction parallel to the longitudinal direction of the track 14 (e.g., the X direction). During operation, a proximal cassette 48 may be disposed on the proximal cassette platform 28 and mechanically attached to the proximal cassette platform 28 and / or the proximal drive unit 38. The proximal cassette platform 28 and its components are described in detail below.

[0018] As shown, the first intermediate cassette platform 24 (with the corresponding first intermediate drive unit 34) is disposed between the distal cassette platform 22 (with the corresponding distal drive unit 32) and the second intermediate cassette platform 26 (with the corresponding second intermediate drive unit 36) and is movable therebetween along the track 14. Similarly, the second intermediate cassette platform 26 (with the corresponding second intermediate drive unit 36) is disposed between the first intermediate cassette platform 24 (with the corresponding first intermediate drive unit 34) and the proximal cassette platform 28 (with the corresponding proximal drive unit 38) and is movable therebetween along the track 14. Furthermore, the proximal cassette platform 28 (with the corresponding proximal drive unit 38) is disposed in a proximal position relative to the second intermediate cassette platform 26 (with the corresponding second intermediate drive unit 36) and is movable along the track 14 within such relative proximal position.

[0019] In operation, each cassette 42, 44, 46 is configured to cooperate with a respective drive unit 32, 34, 36 to advance a respective catheter (e.g., deliver the respective catheter into or remove the respective catheter from the body). A given catheter advanced by a given cassette 42, 44, 46 has a proximal end that is mechanically coupled to a Y connector secured by the next more proximally disposed cassette 44, 46, 48. For example, a catheter advanced by the distal cassette 42 has a proximal end that is mechanically coupled to a Y connector secured by the first intermediate cassette 44, a catheter advanced by the first intermediate cassette 44 has a proximal end that is mechanically coupled to a Y connector secured by the second intermediate cassette 46, and a catheter advanced by the second intermediate cassette 46 has a proximal end that is mechanically coupled to a Y connector secured by the proximal cassette 48. Thus, advancement of the catheter through the cassette can result in translation of the next more proximally located cassette and the corresponding cassette platform and drive unit. The multi-axial catheter system 10 can further include one or more translation assemblies that can cooperatively translate the cassette (and corresponding cassette platform and drive unit) upon advancement of a catheter having a proximal end secured by the cassette, thereby reducing or preventing catheter tension and catheter buckling. Additionally, the proximal cassette 48 is configured to advance a guidewire.

[0020] Additionally, each cassette 44, 46, 48 is configured to rotate a respective catheter having a proximal end mechanically coupled to a Y-connector secured by that cassette 44, 46, 48. Additionally, proximal cassette 48 is configured to rotate a guidewire.

[0021] In the multi-axial catheter system 10 of Figure 1, each catheter and guidewire can be advanced independently of each other catheter and guidewire. Additionally, each catheter and guidewire can be rotated independently of each other catheter and guidewire. Details of such operations and components for implementing such operations are described below in connection with various examples.

[0022] Additionally, each cassette 44, 46, 48 is configured to rotate a respective catheter having a proximal end mechanically coupled to a Y-connector secured by that cassette 44, 46, 48. Additionally, proximal cassette 48 is configured to rotate a guidewire.

[0023] In the multi-axial catheter system 10 of Figure 1, each catheter and guidewire can be advanced independently of each other catheter and guidewire. Additionally, each catheter and guidewire can be rotated independently of each other catheter and guidewire. Details of such operations and components for implementing such operations are described below in connection with various examples.

[0024] Figure 2 shows a perspective view of a multi-axial catheter system 100, according to some examples. The multi-axial catheter system 100 of Figure 2 illustrates additional details of the simplified multi-axial catheter system 10 of Figure 1. The multi-axial catheter system 100 similarly includes a frame 112, a (hidden) track, cassette platforms 122, 124, 126, and 128, and drive units 132, 134, 136, and 138 (e.g., housed within respective housings attached to the respective cassette platforms 122-128). Here, distal drive unit 132 corresponds to distal drive unit 32 of Figure 1, first intermediate drive unit 134 corresponds to first intermediate drive unit 34 of Figure 1, second intermediate drive unit 136 corresponds to second intermediate drive unit 36 ​​of Figure 1, and proximal drive unit 48 corresponds to proximal drive unit 48 of Figure 1. Figure 2 also shows cassettes 142, 144, 146, 148 mechanically attached to corresponding cassette platforms 122, 124, 126, 128 and / or drive units 132, 134, 136, 138. Cassettes 142-148 may be single-use cassettes (e.g., usable for a single intravascular procedure). Those skilled in the art will readily appreciate the correspondence between these components in Figure 2 and the components shown in Figure 1 and described above. Figure 2 shows cassettes 144-148 translated along the track to a distal position.

[0025] 2 also shows catheters 152, 154, 156, guidewire 158, and Y-connectors 162, 164, 166. A second catheter 154, supported on and driven by second drive unit 134, is advanced through a lumen of first catheter 152, supported on and driven by first drive unit 132. A third catheter 156, supported on and driven by third drive unit 136, is advanced through a lumen of second catheter 154, supported on and driven by second drive unit 135. A guidewire 158, supported on and driven by fourth drive unit 138, is advanced through a lumen of third catheter 156, supported on and driven by third drive unit 136. Here, the inner diameter (e.g., diameter of the hole) of the first catheter 152 is larger than the outer diameter of the second catheter 154, the inner diameter (e.g., diameter of the hole) of the second catheter 154 is larger than the outer diameter of the third catheter 156, and the inner diameter (e.g., diameter of the hole) of the third catheter 156 is larger than the outer diameter of the guidewire 158. In some cases, the first catheter 152 may be referred to as a guide catheter, the second catheter 154 may be referred to as an intermediate catheter, and the third catheter 156 may be referred to as a microcatheter.

[0026] The first catheter 152 has a female luer lock connector at its proximal end, which is mechanically coupled to the male luer lock connector of the Y connector 162. The Y connector 162 is secured by the first intermediate cassette 144. The second catheter 154 has a female luer lock connector at its proximal end, which is mechanically coupled to the male luer lock connector of the Y connector 164. The Y connector 164 is secured by the second intermediate cassette 146. The third catheter 156 has a female luer lock connector at its proximal end, which is mechanically coupled to the male luer lock connector of the Y connector 166. The Y connector 166 is secured by the proximal cassette 148. The female luer lock connector of the catheter can be mechanically coupled to the male luer lock connector of the Y connector by a direct connection or by an intervening component. Some examples are described below.

[0027] Distal cassette 142 (associated with distal drive unit 132) is configured to advance a first catheter 152, and first intermediate cassette 144 (associated with first intermediate drive unit 134) is configured to rotate first catheter 152. First intermediate cassette 144 (associated with first intermediate drive unit 134) is configured to advance a second catheter 154, and second intermediate cassette 146 (associated with second intermediate drive unit 136) is configured to rotate second catheter 154. Second intermediate cassette 146 (associated with second intermediate drive unit 136) is configured to advance a third catheter 156, and proximal cassette 148 (associated with proximal drive unit 138) is configured to rotate third catheter 156. Proximal cassette 148 (in communication with proximal drive unit 138 ) is configured to advance and rotate guidewire 158 .

[0028] Figures 3A, 3B, 3C, and 3D are perspective, side, top, and bottom views of proximal drive unit 138, according to some examples. Figures 4A, 4B, 4C, and 4D are perspective, side, top, and bottom views of intermediate drive units (e.g., first intermediate drive unit 134 and second intermediate drive unit 136), according to some examples. Figures 5A, 5B, 5C, and 5D are perspective, side, top, and bottom views of distal drive unit 132, according to some examples. The drive units shown in Figures 3A-3D through 5A-5D include several common components. To avoid redundant description, components in the figures are labeled with a "-8," "-4," or "-2" to indicate whether a given component is included in proximal drive unit 138, intermediate drive unit 134, 136, or distal drive unit 132, respectively. However, a description of such a component may be made without reference to the "-8," "-4," or "-2" labeled component. It will be apparent to one skilled in the art that various modifications, including different orientations, for such components may be made between different drive units to accommodate different components, to accommodate different sized catheters or guidewires, etc.

[0029] Each drive unit, proximal drive unit 138, intermediate drive units 134, 136, and distal drive unit 132, includes a support plate 202. Support plate 202 mechanically supports and is mechanically coupled to the components of the respective drive unit. Support plate 202 can vary in size, layout, or both between different drive units to accommodate different components and / or different sized components.

[0030] Each drive unit includes a pair of hooks 204 and a fastening rib 206 mounted on a side of the support plate 202 that will be adjacent to the respective cassette platform during operation. The hooks 204 each have an inner surface that is a partial cylinder, the cylinder being defined by a radius extending from the longitudinal center of the cylinder. The hooks 204 are mounted such that the longitudinal centers of the partial cylinders that define the inner surfaces of the hooks 204 are aligned, for example, along the y-direction (as shown in the "B" side view). The fastening ribs 206 are mounted on the support plate 202 such that the ribs 208 of the fastening ribs 206 face and oppose the openings of the hooks 204. The ribs 208 have an inclined upper flat surface and a lower flat surface. As will become more apparent below, the hooks 204 and fastening ribs 206 are configured to secure the cassette. When the cassette is installed, each tab on the cassette engages the hook 204, which in turn engages the spring-loaded catches on the cassette with catch ribs 206. The spring-loaded catches have an inverted, flat surface that first contacts the sloped, upper, flat surface of ribs 208, causing the catches on the cassette to displace. Once the catches clear the ribs 208, the springs return the catches against the ribs 208, securing them and securing the cassette.

[0031] Each drive unit includes multiple drive assemblies. Figure 6 shows an exploded perspective view of a drive assembly 220, according to some examples. Although the drive assembly 220 in Figure 6 is used as the drive assembly in the drive unit, different drive assemblies may be implemented in the drive unit and / or modifications to the illustrated drive assembly 220 may be made. Although various types of shafts and gears are described below for the drive assembly 220, other types of shafts and gears may be implemented to achieve different configurations or orientations of the drive assembly.

[0032] Drive assembly 220 includes a rotary actuator 222. Rotary actuator 222 includes a drive shaft 224 (e.g., a shaft having a D-shaped cross-section perpendicular to the axis of rotation of the shaft). Rotary actuator 222 is configured to rotate drive shaft 224. In some examples, rotary actuator 222 is a motor, such as an electric motor. In some cases, rotary actuator 222 can be a servo motor. Rotary actuator 222 is mechanically mounted and attached to bracket 226, which is mechanically mounted and attached to support plate 202 (as shown in other figures). A screw gear 228 is mechanically attached to drive shaft 224.

[0033] Drive assembly 220 further includes a lateral shaft 230 (e.g., a shaft having a D-shaped cross-section perpendicular to the shaft's axis of rotation). A gear 232 (e.g., a spur gear having a concave outwardly facing surface) is mechanically attached to and surrounds lateral shaft 230. A ball bearing 234 mechanically couples lateral shaft 230 to bracket 226. A ball bearing 236 mechanically couples lateral shaft 230 to support plate 202 through an opening in support plate 202. Ball bearings 234, 236 are disposed on lateral shaft 230 on either side of gear 232.

[0034] Helical gear 228 engages gear 232. Rotary actuator 222 is configured to rotate drive shaft 224, which causes helical gear 228 to rotate about the drive axis. Rotation of helical gear 228 causes rotation of gear 232 about a lateral axis transverse to the drive axis. Rotation of gear 232 causes rotation of lateral shaft 230 about its lateral axis.

[0035] Drive assembly 220 also includes a linkage assembly 240. Linkage assembly 240 includes an open-ended hollow cylinder 242, a male connector 244, a spring 246, and a pin 248. Cylinder 242 (e.g., the closed end of cylinder 242) is disposed on the end of lateral shaft 230 opposite where lateral shaft 230 is mechanically coupled to bracket 226 (by ball bearing 234). The longitudinal center axis of cylinder 242 is collinear with the lateral axis. Male connector 244 includes a solid cylinder having a piston 250 extending from a (bottom) circular surface and a linkage projection 252 extending from another opposite (top) circular surface. One or more of projections 252 extend in a direction parallel to the lateral axis at a location offset or displaced from the lateral axis. As a result, rotation of the piston 250 causes the piston 250 to move on the protrusion in a circular path generally centered on the longitudinal axis of the piston 250. The spring 246 and piston 250 are disposed within a hollow region of the cylinder 242. The piston 250 has an elongated opening 254 extending therethrough in a direction perpendicular to the lateral axis, the elongated opening 254 being elongated in a direction along the lateral axis. The cylinder 242 has an opening 256 extending through its sidewall. With the spring 246 and piston 250 positioned within the cylinder 242, a pin 248 is inserted through the opening 256 in the cylinder 242 and the elongated opening 254 in the piston 250 in a direction perpendicular to the lateral axis. The pin 248 thereby secures the spring 246 and piston 250 within the cylinder 242.

[0036] The elongated opening 254 is elongated along the lateral axis, thereby allowing the piston 250, and therefore the male connector 244, to translate along, or move in the direction of, the lateral axis. A pin 248 is inserted through the elongated opening 254, limiting such translation to the range allowed by the length of the elongated opening 254. In the absence of other forces, the spring 246 exerts a force on the piston 250 away from the lateral shaft 230, causing the male connector 244 to reach as far as is allowed by the lateral shaft 230. The allowed translation of the male connector 244 allows for tolerances to be accommodated when mating the male connector 244 with the female connector of the cassette.

[0037] As the lateral shaft 230 rotates about the lateral axis, the cylinder 242 rotates as well due to the mechanical connection between the lateral shaft 230 and the cylinder 242. The pin 248 is inserted perpendicular to the lateral axis, thereby transferring the rotation of the cylinder 242 to the piston 250 and thus to the male connector 244. The off-axis position of the protrusion 252 transfers the rotation of the male connector 244 to the female connector of the cassette when mechanically coupled together.

[0038] Referring again to Figures 3A-3D through 5A-5D, each of proximal drive unit 138, intermediate drive units 134, 136, and distal drive unit 132 includes an advancement drive assembly 220a and a clamp drive assembly 220b. With reference to Figures 3A-3D and 4A-4D, proximal drive unit 138 and intermediate drive units 134, 136 each include a catheter rotational drive assembly 220c. With reference to Figures 3A-3D, proximal drive unit 138 includes a guidewire rotational drive assembly 220d. While drive assemblies 220a, 220b, 220c, and 220d are not explicitly identified in Figures 3A-3D through 5A-5D, several components of drive assemblies 220a, 220b, 220c, and 220d are identified, and corresponding reference numbers in Figure 6 are prefixed with "a," "b," "c," or "d." The appended "a," "b," "c," or "d" corresponds to drive assembly 220a, 220b, 220c, 220d, respectively. As shown, for each of drive assemblies 220a, 220b, 220c, 220d, a corresponding bracket 226 to which a rotary actuator 222 is mechanically attached is mechanically attached and mounted to the bottom surface of a corresponding support plate 202. Each lateral shaft 230 extends through an opening through support plate 202, with a male connector 244 extending away from the top surface of support plate 202.

[0039] Each drive unit, including the proximal drive unit 138, the intermediate drive units 134, 136, and the distal drive unit 132, includes an encoder 262 and an encoder coupler 264. The encoder 262 is mounted through an opening extending through the support plate 202 and includes a shaft. The encoder coupler 264 is mechanically attached to the shaft of the encoder 262. The encoder coupler 264 extends away from the top surface of the support plate 202. The encoder 262 is configured to detect the rotational position of the shaft of the encoder 262, which is rotated through the encoder coupler 264. As described in more detail below, the encoder 262 detects the rotational position of the shaft so that a controller can determine the length and direction an intravascular insertion device (e.g., a catheter or guidewire) has been advanced by the corresponding cassette. The encoder 262 can be used as feedback to control the advancement of the intravascular insertion device.

[0040] Each drive unit may also include other components not shown. For example, each drive unit may include electrical components (e.g., a controller, circuit board, wires, and connectors) to enable operation of the rotary actuators 222. Each drive unit may include a sensor to detect when a cassette is secured to the drive unit, so that, for example, the controller can prevent operation of any rotary actuators 222 while the sensor detects that no cassette is secured to the drive unit. A spring-loaded release may be included to apply a force to any secured cassette, which can assist in decoupling the cassette during removal from the drive unit.

[0041] In the context of the multi-axial catheter system 100 shown in FIG. 2 , the top surface of the drive unit support plate 202 is mechanically attached to the bottom surface of the respective cassette platform 122, 124, 126, 128. The top surface of the support plate 202-2 of the distal drive unit 132 is mechanically attached to the bottom surface of the distal cassette platform 122. The top surface of the support plate 202 (e.g., support plate 202-4) of the first intermediate drive unit 134 is mechanically attached to the bottom surface of the first intermediate cassette platform 124. The top surface of the support plate 202 (e.g., support plate 202-4) of the second intermediate drive unit 136 is mechanically attached to the bottom surface of the second intermediate cassette platform 126. The top surface of the support plate 202-8 of the proximal drive unit 138 is mechanically attached to the bottom surface of the proximal cassette platform 128. For each drive unit and respective cassette platform, the hooks 204, fastening ribs 206, male connector 244 of the drive assembly 220, and encoder coupler 264 of the drive unit extend through the cassette platform to couple with the cassette.

[0042] FIG. 7A is a perspective view of a proximal cassette 148 according to some examples. FIGS. 7B and 7C are perspective views of the partially disassembled proximal cassette 148 of FIG. 7A , respectively, according to some examples. FIGS. 7D, 7E, 7F, and 7G are rear, front, top, and bottom views, respectively, of the partially disassembled proximal cassette 148 of FIG. 7C . The cassettes shown in FIGS. 7A-7G include several common components. To avoid redundant descriptions, components in the figures are labeled with a "-8," "-4," or "-2" to indicate whether a given component is included in the proximal cassette 148, the intermediate cassette, or the distal cassette 142, respectively. However, descriptions of such components may be made without reference to the "-8," "-4," or "-2" labels. It will be apparent to one skilled in the art to make various modifications, including different orientations of such components, between different cassettes to accommodate different components, to accommodate different size catheters or guidewires, etc.

[0043] Each of the proximal cassette 148, the intermediate cassettes 144, 146, and the distal cassette 142 includes a base 302, a housing 304, and a lid 306. The base 302, the housing 304, and the lid 306 can be made of any suitable material, such as molded plastic, that provides mechanical support for the various components and has the structural integrity to mechanically support these components. The housing 304 is fixedly mechanically attached to the base 302, and the lid 306 is hingedly attached to the housing 304. A channel 308 extends through the housing 304. The channel 308 extends in the direction in which the respective intravascular insertion device advances (e.g., in the X direction when referring to FIG. 2 ). The channel 308 is configured to receive an intravascular insertion device, i.e., a guidewire or a catheter, therethrough. For example, in the case of distal cassette 142, up to three catheters may be nested together with a central guideware extending through channel 308, with only the outer surface of the outermost catheter exposed to the walls of channel 308. Lid 306 includes proximal and distal restraints 310, 312 configured to protrude into channel 308 when lid 306 is closed on housing 304 to limit vertical movement of the intravascular insertion device during operation therein.

[0044] Each cassette includes a tab 314 and a fastener assembly. The tab 314 protrudes from the base 302 and is configured to engage with the hook 204 when the corresponding cassette is secured to an appropriate drive unit. FIG. 10 shows an exploded perspective view of the fastener assembly, according to some examples. The fastener assembly includes a fastener 322, a spring 324, and buttons 326 on either side. The fastener 322 is generally a block having a rib 328 and a flange 330. The rib 328 has a sloped lower flat surface (e.g., oppositely sloped to the sloped flat surface of each rib 208) and an upper flat surface. When secured to the drive unit, the rib 328 is oriented to face the fastener rib 206 of the appropriate drive unit. Each flange 330 has an elongated opening 332 extending therethrough. The fastener 322 is at least partially disposed within an opening 334 extending through the base 302. Each screw 336 passes through an elongated opening 332 in flange 330 of fastener 322 to secure fastener 322, which is at least partially disposed within opening 334. Elongated opening 332 allows fastener 322 to translate laterally. Spring 324 is disposed between wall 340 of base 302 and fastener 322, opposite rib 328. Spring 324 is positioned and configured to exert an opposing force on wall 340 and fastener 322.

[0045] Each of the buttons 326 has a beveled tab 342 protruding from the respective button 326. A limiter 344 protrudes from the beveled tab 342. When assembled, the base 302 and the housing 304 have walls with openings through which the corresponding beveled tabs 342 extend toward the catch 322. The limiter 344 cooperates with the walls of the base 302 and the housing 304 to limit the movement of the buttons 326.

[0046] When assembled and in the absence of other forces, spring 324 exerts a force on fastener 322, positioning it distally from wall 340 at opening 334. When the cassette is secured to the drive unit, tab 314 first engages hook 204, and the fastener assembly is lowered onto fastener rib 206. The angled surfaces of ribs 208, 328 come into contact, and as the cassette is lowered, fastener 322 is displaced more proximally toward wall 340, allowing rib 328 to pass rib 208. Once rib 328 has passed, spring 324 displaces fastener 322 more distally, causing ribs 208, 328 to engage each other. This secures the cassette to the drive unit. To remove the cassette from the drive unit, button 326 is depressed toward the inside of the cassette, which displaces catch 322 more proximally toward wall 340 by beveled tab 342. This allows rib 328 to pass rib 208, thereby allowing the cassette to be removed.

[0047] Each cassette includes a clamping and advancing assembly. Figures 11A and 11B show exploded perspective views of portions of the clamping and advancing assembly, according to some examples. The clamping and advancing assembly includes advancing rollers 352, 354, advancing spur gears 356, 358, and advancing shafts 360, 362. The roller surfaces of the advancing rollers 352, 354 face each other. During operation, an intravascular insertion device is disposed between the roller surfaces of the advancing rollers 352, 354. The channels 308 of the housing 304 each have an opening in the wall that defines the channel 308, allowing the roller surfaces of the advancing rollers 352, 354 to contact and advance the intravascular insertion device within the channel 308.

[0048] In the illustrated example, forward shaft 360 is integral with forward spur gear 356, and forward shaft 362 is integral with forward spur gear 358. In other examples, one or both of forward shafts 360, 362 can be separate components from the respective forward spur gears 356, 358. Forward spur gear 356 is disposed on and surrounds forward shaft 360, and forward spur gear 358 is disposed on and surrounds forward shaft 362. Forward roller 352 is disposed on and surrounds forward shaft 360, and forward roller 354 is disposed on and surrounds forward shaft 362. Each of forward shafts 360, 362 can have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of forward shafts 360, 362) on which each forward roller 352, 354 is disposed on forward shaft 360, 362. Similarly, each of the advance rollers 352, 354 may have an opening with a cross-section corresponding to the cross-section of the corresponding advance shaft 360, 362 to help ensure that the advance rollers 352, 354 rotate with the rotation of the corresponding advance shaft 360, 362.

[0049] A female connector 364 is disposed on and mechanically attached to advancement shaft 360. Advancement shaft 360 may have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of advancement shaft 360) at which female connector 364 is disposed on advancement shaft 360. Similarly, female connector 364 may have an opening with a cross-section corresponding to the cross-section of advancement shaft 360 to help ensure that advancement shaft 360 rotates with rotation of female connector 364. Female connector 364 is exposed and / or extends through base 302 of the cassette.

[0050] A ball bearing 366 mechanically couples the advancement shaft 360 to the cassette base 302, and a ball bearing 368 mechanically couples the advancement shaft 360 to the cassette housing 304. The ball bearings 366, 368 allow the advancement shaft 360 to rotate freely while secured within the cassette.

[0051] The clamping and advancing assembly includes a clamping support frame, which in the illustrated example includes a lower support frame 370, a middle support frame 372, and an upper support frame 374. Lower support frame 370 is mechanically attached to the underside of middle support frame 372, and upper support frame 374 is mechanically attached to the upper side of middle support frame 372. A ball bearing 376 mechanically couples advancement shaft 362 to lower support frame 370, and a ball bearing 378 mechanically couples advancement shaft 362 to upper support frame 374. Ball bearings 376, 378 allow advancement shaft 362 to rotate freely while secured between lower support frame 370 and upper support frame 374 of the clamping support frame.

[0052] A rack 380 is mechanically attached to the clamping support frame (e.g., to the intermediate support frame 372). The rack 380 extends laterally away from the clamping support frame in a direction perpendicular to the rotational axis of the advancement shaft 362. A pinion 382 is engaged with the rack 380. The pinion 382 is disposed on and surrounds the clamping shaft 384. In the illustrated example, the clamping shaft 384 is integral with the pinion 382. In other examples, the clamping shaft 384 may be a separate component from the pinion 382. A female connector 386 is disposed on the clamping shaft 384 and mechanically attached thereto. The clamping shaft 384 may have one or more flat surfaces (e.g., have a D-shaped cross section perpendicular to the rotational axis of the clamping shaft 384), where the female connector 386 is disposed on the clamping shaft 384. Similarly, the female connector 386 may have an opening with a cross-section corresponding to the cross-section of the clamping shaft 384 to help ensure that the clamping shaft 384 rotates with rotation of the female connector 386. The female connector 386 is exposed and / or extends through the base 302 of the cassette.

[0053] A ball bearing 388 mechanically couples the clamping shaft 384 to the cassette base 302, and a ball bearing 390 mechanically couples the clamping shaft 384 to the cassette housing 304. The ball bearings 388, 390 allow the clamping shaft 384 to rotate freely while secured within the cassette.

[0054] When the cassettes are secured to their respective drive units, female connector 364 engages male connector 244a of forward drive assembly 220a of the drive unit, and female connector 386 engages male connector 244b of pincher drive assembly 220b of the drive unit. In this exemplary configuration, the longitudinal axis of advancement shaft 360 (e.g., about which advancement shaft 360 rotates) is aligned with the lateral axis of forward drive assembly 220a, and the longitudinal axis of pincher shaft 384 (e.g., about which pincher shaft 384 rotates) is aligned with the lateral axis of pincher drive assembly 220b.

[0055] Rotation of lateral shaft 230b of jaw drive assembly 220b (e.g., via male connector 244b and female connector 386) causes rotation of jaw shaft 384. Rotation of jaw shaft 384 causes rotation of pinion 382, ​​which causes lateral translation of rack 380 along the direction of extension of rack 380. Lateral translation of rack 380 causes lateral translation of the jaw support frame, thereby causing lateral translation of advance shaft 362 and advance roller 354. Walls and / or surfaces of housing 304 and / or base 302, and / or other components within the cassette may limit significant lateral and vertical movement of the jaw support frame in any direction perpendicular to the direction in which rack 380 extends from the jaw support frame. Additionally, walls, slots, tracks, and / or surfaces of the housing 304 and / or base 302, and / or other components within the cassette may limit the amount of lateral movement of the clamp support frame in the direction in which the rack 380 extends from the clamp support frame, helping to prevent excessive movement of the clamp support frame.

[0056] Notably, the configuration of the clamping support frame, rack 380, and pinion 382 allows the advancement roller 354 and advancement shaft 362 to assume at least two positions. In the release position of the advancement roller 354 and advancement shaft 362, the advancement roller 354 is distal from the advancement roller 352. In the release position, the intravascular insertion device is released from between the advancement rollers 352, 354. When the advancement roller 354 is in the release position, no force is applied to the intravascular insertion device by the advancement rollers 352, 354. Furthermore, in the release position, the advancement spur gear 358 may be disengaged from the advancement spur gear 356. In the clamping position of the advancement roller 354 and advancement shaft 362, the advancement roller 354 is proximal to the advancement roller 352. In the clamping position, the intravascular insertion device is clamped by the advancement rollers 352, 354, thereby mechanically coupling and securing them. The forward rollers 352, 354 can exert opposing forces on the intravascular insertion device to clamp the intravascular insertion device. In the clamping position, the forward spur gear 358 engages the forward spur gear 356.

[0057] In the clamping position, the clamping and advancing assembly can advance the intravascular insertion device. Rotation of the lateral shaft 230a of the advancement drive assembly 220a (e.g., via the male connector 244a and the female connector 364) causes rotation of the advancement shaft 360. Rotation of the advancement shaft 360 causes rotation of the advancement spur gear 356, which in turn causes rotation of the advancement spur gear 358 and advancement shaft 362 in the opposite direction. The reverse rotation of the advancement shafts 360, 362 causes reverse rotation of the advancement rollers 352, 354. Because the advancement rollers 352, 354 clamp the intravascular insertion device in this clamping position, rotation of the advancement rollers 352, 354 advances the intravascular insertion device (e.g., to deliver a corresponding catheter into or remove a catheter from the body).

[0058] Each cassette includes a follower assembly. Figure 12 shows an exploded perspective view of a follower assembly according to some examples. The follower assembly includes follower rollers 402, 404, follower spur gears 406, 408, follower shafts 410, 412, bevel gears 414, 416, a shaft 418, and an encoder coupler 420. The roller surfaces of the follower rollers 402, 404 face each other. During operation, an intravascular insertion device is disposed between the roller surfaces of the follower rollers 402, 404. The channel 308 of the housing 304 has an opening in the wall that forms the channel 308, allowing the roller surfaces of the follower rollers 402, 404 to contact the intravascular insertion device.

[0059] In the illustrated example, follower shaft 410 is integral with follower spur gear 406, and follower shaft 412 is integral with follower spur gear 408. In other examples, one or both of follower shafts 410, 412 can be separate components from their respective follower spur gears 406, 408. Follower spur gear 406 is disposed on and surrounds follower shaft 410, and follower spur gear 408 is disposed on and surrounds follower shaft 412. Follower roller 402 is disposed on and surrounds follower shaft 410, and follower roller 404 is disposed on and surrounds follower shaft 412. Each of the follower shafts 410, 412 can have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of the follower shaft 410, 412) on which the respective follower rollers 402, 404 are disposed on the follower shaft 410, 412. Similarly, each of the follower rollers 402, 404 can have an opening with a cross-section corresponding to the cross-section of the corresponding follower shaft 410, 412 to help ensure that the follower rollers 402, 404 rotate with the rotation of the corresponding follower shaft 410, 412. The bevel gear 414 is mechanically attached to the follower spur gear 406 and / or the follower shaft 410. As shown, the bevel gear 414 is integral with the follower spur gear 406, although in other examples, the bevel gear 414 can be a separate component from the follower spur gear 406. Brackets 422, 424 mechanically couple the assembled follower shaft 410, follower roller 402, follower spur gear 406, and bevel gear 414 to the cassette base 302 and / or housing 304. A ball bearing 426 mechanically couples the follower shaft 410 to bracket 422, and a ball bearing 428 mechanically couples the bevel gear 414 to bracket 424. The ball bearings 426, 428 allow the assembled follower shaft 410, follower roller 402, follower spur gear 406, and bevel gear 414 to rotate freely while secured within the cassette.

[0060] In the illustrated example, the shaft 418 is integral with the bevel gear 416. In other examples, the shaft 418 may be a separate component from the bevel gear 416. The bevel gear 416 is disposed on the end of the shaft 418. The bevel gear 416 is engaged with the bevel gear 414. The encoder coupler 420 is disposed on the shaft 418 and mechanically attached thereto. The shaft 418 may have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of the shaft 418) at which the encoder coupler 420 is disposed on the shaft 418. Similarly, the encoder coupler 420 may have an opening with a cross-section corresponding to the cross-section of the shaft 418 to help ensure that the shaft 418 rotates with the encoder coupler 420. The encoder coupler 420 is exposed and / or extends through the cassette base 302. Ball bearings 430 mechanically couple the shaft 418 to the cassette base 302. Ball bearings 430 allow the shaft 418 to rotate freely while secured within the cassette.

[0061] The frame 436 mechanically couples the assembled follower shaft 412, follower roller 404, and follower spur gear 408. Ball bearings 438, 440 mechanically couple the follower shaft 412 to the frame 436. The ball bearings 438, 440 allow the assembled follower shaft 412, follower roller 404, and follower spur gear 408 to rotate freely while secured within the cassette. The frame 436 is mechanically coupled to a bracket 442, which is mechanically attached to the bottom surface of the cassette lid 306. The frame 436 is vertically movable within the bracket 442. The frame 436 includes opposing tabs 444 (one of which is hidden in FIG. 12 ) that protrude laterally from the frame 436 in opposite directions, and the bracket 442 has an elongated opening 446 extending through each side. Each tab 444 of the frame 436 is inserted into a corresponding elongated opening 446 in the bracket 442, thereby mechanically coupling the frame 436 to the bracket 442. The elongated openings 446 allow vertical movement of the tabs 444 within the elongated openings 446, thereby allowing vertical movement of the frame 436 relative to the bracket 442. A spring 448 is vertically disposed between the top surface of the frame 436 and the underside of the bracket 442. In the absence of another force, the spring 448 urges the frame 436 into a distal position relative to the bracket 442.

[0062] When the cassette is secured to a corresponding drive unit, the encoder coupler 420 engages the encoder coupler 264 of the drive unit. An intravascular insertion device can be placed between the follower rollers 402, 404 by lifting or removing the cassette lid 306 and placing the intravascular insertion device in the cassette channel 308. Lifting or removing the lid 306 displaces the follower roller 404, follower shaft 412, follower spur gear 408, frame 436, and bracket 442, eliminating contact between the surface of follower roller 404 and follower roller 402 through channel 308 and allowing the intravascular insertion device to be placed in channel 308 between follower rollers 402, 404. The lid 306 is then replaced or closed, moving the follower roller 404, follower shaft 412, follower spur gear 408, frame 436, and bracket 442, and moving the surface of the follower roller 404 inward from the channel 308. At this time, the intravascular insertion device is disposed between the follower rollers 402, 404. The spring 448 exerts opposing forces on the follower rollers 402, 404 to limit vertical movement of the intravascular insertion device. The opposing forces exerted by the follower rollers 402, 404 on the intravascular insertion device are large enough to limit vertical movement of the intravascular insertion device and rotate the follower rollers 402, 404 as the intravascular insertion device advances, but small enough to allow rotation of the intravascular insertion device between the follower rollers 402, 404. Normally, when the lid 306 is replaced or closed, the follower spur gear 408 engages the follower spur gear 406 .

[0063] In operation, as the intravascular insertion device is advanced by the cassette clamping and advancing assembly, the advancement of the intravascular insertion device causes the follower rollers 402, 404 to rotate in opposite directions. The rotation of the follower rollers 402, 404 causes rotation of the follower shafts 410, 412 and, correspondingly, the follower spur gears 406, 408. The rotation of the follower rollers 402, 404 and the follower shafts 410, 412 may operate cooperatively as a result of the engagement of the follower spur gear 408 with the follower spur gear 406. The rotation of the follower shaft 410 and / or the follower spur gear 406 causes rotation of the bevel gear 414 about the axis of rotation about which the follower shaft 410 rotates. The rotation of the bevel gear 414 causes rotation of the bevel gear 416 and the shaft 418. The rotation of the bevel gear 416 and shaft 418 is about an axis of rotation transverse to the axes of rotation of the bevel gear 414, follower shaft 410, follower spur gear 406, and follower roller 402. The shaft of the encoder 262 is rotated by the rotation of the shaft 418 (e.g., via encoder couplers 264, 420). The rotation of the shaft of the encoder 262 is detected by the encoder 262 and can be used by a control device (e.g., a processor) to estimate the length, direction, and / or advancement speed of the intravascular insertion device. In this case, the follower assembly and encoder 262 can be implemented for feedback control to advance the intravascular insertion device.

[0064] Each of the intermediate cassettes 144, 146 and the distal cassette 142 includes a catheter rotation assembly. Figure 13 shows an exploded perspective view of a catheter rotation assembly according to some examples. The catheter rotation assembly includes a Y-connector housing, a bevel gear 452, and a rotation shaft 454. The Y-connector housing includes a base 456 and a lid 458. The base 456 is mechanically attached to the cassette housing 304. The lid 458 is attached to the base 456 by a hinge. The base 456 and the lid 458 are configured to secure the Y-connector between the base 456 and the lid 458 when the lid 458 is closed onto the base 456.

[0065] In the illustrated example, the rotating shaft 454 is integral with the bevel gear 452. In other examples, the rotating shaft 454 may be a separate component from the bevel gear 452. The bevel gear 452 is disposed on the end of the rotating shaft 454. A female connector 460 is disposed on the rotating shaft 454 and mechanically attached thereto. The rotating shaft 454 may have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of the rotating shaft 454) at which the female connector 460 is disposed on the rotating shaft 454. Similarly, the female connector 460 may have an opening with a cross-section corresponding to the cross-section of the rotating shaft 454 to help ensure that the rotating shaft 454 rotates as the female connector 460 rotates. The female connector 460 is exposed and / or extends through the base 302 of the cassette. A ball bearing 462 mechanically couples the rotating shaft 454 to the base 302 of the cassette. Ball bearings 462 allow free rotation of rotating shaft 454 while secured within the cassette.

[0066] When the cassette is secured to a corresponding drive unit, the female connector 460 engages the male connector 244c of the catheter rotary drive assembly 220c of the drive unit. In this exemplary configuration, the longitudinal axis of the rotary shaft 454 (e.g., about which the rotary shaft 454 rotates) is aligned with the lateral axis of the catheter rotary drive assembly 220c.

[0067] Rotation of transverse shaft 230c of catheter rotary drive assembly 220c (e.g., via male connector 244c and female connector 460) causes rotation of rotary shaft 454. Rotation of rotary shaft 454 causes rotation of bevel gear 452. In operation, bevel gear 452 (through opening 464 through base 456) is engaged with another bevel gear mechanically coupled to a catheter attached to a Y-connector secured by a Y-connector housing. Rotation of bevel gear 452 causes rotation of the bevel gear mechanically coupled to the catheter, which in turn causes rotation of the catheter, as described in more detail below. Rotation of the bevel gear mechanically coupled to the catheter occurs about an axis transverse to the axis about which rotary shaft 454 rotates.

[0068] The proximal cassette 148 includes a guidewire rotation assembly. FIG. 14 shows an exploded perspective view of a guidewire rotation assembly according to some examples. The guidewire rotation assembly includes a drive bevel gear 482 and a rotating shaft 484. In the illustrated example, the rotating shaft 484 is integral with the drive bevel gear 482. In other examples, the rotating shaft 484 may be a separate component from the drive bevel gear 482. A female connector 486 is disposed on the rotating shaft 484 and is mechanically attached thereto. The rotating shaft 484 may have one or more flat surfaces (e.g., having a D-shaped cross-section perpendicular to the axis of rotation of the rotating shaft 484) at which the female connector 486 is disposed on the rotating shaft 484. Similarly, the female connector 486 may have an opening with a cross-section corresponding to the cross-section of the rotating shaft 484 to help ensure that the rotating shaft 484 rotates with the rotation of the female connector 486. Female connector 486 is exposed and / or extends through cassette base 302. Ball bearings 488 mechanically couple rotating shaft 484 to cassette base 302, and ball bearings 490 mechanically couple rotating shaft 484 to cassette housing 304. Ball bearings 488, 490 allow rotating shaft 484 to rotate freely while secured within the cassette.

[0069] The guidewire rotation assembly further includes a driven bevel gear 492 that meshes with the drive bevel gear 482, a first spur gear 494 and a second spur gear 496, and a bracket 498. The bracket 498 is mechanically attached to the base 302 of the proximal cassette 148. The bracket 498 has protrusions 500, 502. The first spur gear 494 is mechanically coupled to and rotatable about the protrusion 500, and the second spur gear 496 is mechanically coupled to and rotatable about the protrusion 502. The first spur gear 494 is engaged with (meshes with) the second spur gear 496. The first bevel gear 492 is mechanically attached to the first spur gear 494. The rotation axes of the first bevel gear 492 and the first spur gear 494 are collinear.

[0070] The guidewire rotation assembly includes a cap 512, a cap spur gear 514, a collet 516, a guidewire connector 518, and a clamp bracket 520. The cap spur gear 514 is mechanically attached to the end of the cap 512. In the illustrated example, the cap spur gear 514 is integral with the cap 512; however, in other examples, the cap spur gear 514 and the cap 512 may be separate components. The cap 512 includes a threaded female connector (hidden in FIG. 14 ). The guidewire connector 518 includes a threaded male connector 522. When assembled, the threaded female connector of the cap 512 mates with the threaded male connector 522 of the guidewire connector 518. The guidewire connector 518 includes a tapered-walled recess inside the threaded male connector 522. The tapered wall of the guidewire connector 518 generally matches the angled surface of the collet 516. When assembled, collet 516 is inserted into a recess in guidewire connector 518, with the threaded female connector of cap 512 mating with the threaded male connector 522 of guidewire connector 518. The threaded engagement causes cap 512 to rotate onto guidewire connector 518, compressing collet 516. A guidewire can be passed through the opening through collet 516 and cap 512, whereupon collet 516 compresses, clamping and securing the guidewire.

[0071] The clamp bracket 520 is mechanically attached to the housing 304 of the proximal cassette 148. The clamp bracket 520 is configured to hold the guidewire connector 518 while allowing it to rotate. The guidewire connector 518 has ribs 524 along the outer periphery of the guidewire connector 518. The clamp bracket 520 has limiting portions 526. When the clamp bracket 520 holds the guidewire connector 518, the limiting portions 526 are disposed laterally between the ribs 524 of the guidewire connector 518, thereby limiting significant lateral movement of the guidewire connector 518. The clamp bracket 520 allows rotation of the guidewire connector 518 about its longitudinal axis. When the clamp bracket 520 holds the guidewire connector 518 with the cap 512 disposed on the guidewire connector 518, the spur gear 514 engages the spur gear 496.

[0072] When proximal cassette 148 is secured to proximal drive unit 138, female connector 486 engages male connector 244d of guidewire rotary drive assembly 220d of proximal drive unit 138. In this exemplary configuration, the longitudinal axis of rotatable shaft 484 (e.g., about which rotatable shaft 484 rotates) is aligned with the transverse axis of guidewire rotary drive assembly 220d.

[0073] Rotation of lateral shaft 230d of guidewire rotary drive assembly 220d (e.g., via male connector 244d and female connector 486) causes rotation of rotatable shaft 484. Rotation of rotatable shaft 484 causes rotation of drive bevel gear 482, which causes rotation of driven bevel gear 492 about an axis that is transverse to the lateral axis of guidewire rotary drive assembly 220d. Rotation of driven bevel gear 492 causes rotation of first spur gear 494 in the same direction. Rotation of first spur gear 494 causes rotation of second spur gear 496 in the opposite direction. Rotation of second spur gear 496 causes rotation of cap spur gear 514 in the opposite direction, which causes rotation of the guidewire when collet 516 is clamped onto the guidewire extending therethrough.

[0074] Figures 15, 16, and 17 show diagrams including a catheter and a Y-connector. In Figure 15, Y-connector 602 includes a female luer lock connector. The female luer lock connector has a connector bevel gear 604 integral with the outer sheath of the female connector. Catheter 606 has a tab and a male luer lock connector at the proximal end of catheter 606. The male connector of catheter 606 is engaged with the female connector of Y-connector 602 during operation. Rotation of connector bevel gear 604 on the sheath of the female connector causes rotation of catheter 606.

[0075] In Figure 16, Y connector 608 includes a female luer lock connector. Catheter 606 has a tab and a male luer lock connector at the proximal end of catheter 606. Intermediate connector 610 has a female luer lock connector and a male luer lock connector. Intermediate connector 610 has a mid-connector bevel gear 612 integral with the outer sheath of intermediate connector 610. In operation, the male connector of catheter 606 engages with the female connector of intermediate connector 610, and the male connector of intermediate connector 610 engages with the female connector of Y connector 608. Rotation of intermediate connector bevel gear 612 on intermediate connector 610 causes rotation of catheter 606.

[0076] 17, Y-connector 608 includes a female Luer lock connector. Catheter 614 has a tab and a male Luer lock connector at the proximal end of catheter 614. The male connector of catheter 614 has a Luer bevel gear 616 integral with the outer sheath of the male connector. During operation, the male connector of catheter 614 is engaged with the female connector of Y-connector 608. Rotation of Luer bevel gear 616 on the sheath of the male connector causes rotation of catheter 614.

[0077] 13 , Y-connector housing (including base 456 and lid 458) can be configured to receive and secure Y-connectors, including Y-connectors 602, 608 of FIGS. 15-17. The Y-connector housing is configured such that when the Y-connector housing secures Y-connectors 602, 608, bevel gears 604, 612, 616, which are mechanically coupled to Y-connectors 602, 608 and / or catheters 606, 614, engage Y-connector bevel gear 452 of the catheter rotation assembly through opening 464. As a result, rotation of Y-connector bevel gear 452 (due to rotation of rotatable shaft 454) causes rotation of bevel gears 604, 612, 616 about axes transverse to the axis of rotation of rotatable shaft 454, which in turn causes rotation of catheters 606, 614.

[0078] 18 and 19 are schematic diagrams illustrating catheter rotation and advancement, respectively, according to some examples. Figures 18 and 19 show a first cassette 702 and a second cassette 704. The first cassette 702 is positioned more proximally, and the second cassette 704 is positioned more distally. The first cassette 702 and the second cassette 704 may be the distal cassette 142 and the first intermediate cassette 144, respectively. The first cassette 702 and the second cassette 704 may be the first intermediate cassette 144 and the second intermediate cassette 146, respectively. The first cassette 702 and the second cassette 704 may be the second intermediate cassette 146 and the proximal cassette 148, respectively.

[0079] First cassette 702 is shown including a Y-connector housing (including base 456 and lid 458) that secures Y-connector 602 having bevel gear 604. Catheter 606 is engaged with Y-connector 602. The Y-connector housing can secure any Y-connector and bevel gear configuration, and in other examples, can accommodate any catheter. Bevel gear 604 is engaged with bevel gear 452 of the catheter rotation assembly of first cassette 702. Catheter 606 extends through channel 308 of second cassette 704 (e.g., between advancement rollers 352, 354).

[0080] During operation, the clamping and advancing assembly of the second cassette 704 can secure the catheter 606 within the channel 308 of the second cassette 704, preventing it from moving or allowing it to advance laterally. When the catheter 606 is to be rotated, the clamping and advancing assembly of the second cassette 704 releases the catheter 606 for rotation. Regardless of the movement of the catheter 606 (e.g., rotation, advancement, and no movement), the catheter rotation assembly of the first cassette 702, which is configured to rotate the catheter 606, can maintain a mechanical connection with the catheter 606 (e.g., by the bevel gear 452 engaging the bevel gear 604, which is mechanically coupled to the catheter 606).

[0081] First, assume that the first cassette 702 and the second cassette 704 are in their respective positions such that the catheter 606 is not moving and the clamping and advancing assembly of the second cassette 704 secures the catheter 606 between the advancement rollers 352, 354 of the second cassette 704. To rotate the catheter 606, the clamping and advancing assembly of the second cassette 704 releases the catheter 606. The advancement roller 354 of the second cassette 704 is translated laterally so that the opposing advancement rollers 352, 354 do not exert opposing forces on (e.g., clamp) the catheter 606. 11A and 11B, pinion 382 is rotated by pinch drive assembly 220b (e.g., via male connector 244b and female connector 386), and the rotation of pinion 382 causes translation of rack 380, which in turn translates the pinch support frame (including lower support frame 370, middle support frame 372, and upper support frame 374) and advance roller 354 away from advance roller 352 (e.g., in the −Y direction). Referring to FIG. 18, advance roller 354 is translated in direction 712 away from advance roller 352 to a released position.

[0082] With the clamping and advancing assembly releasing the catheter 606, the catheter rotation assembly of the first cassette 702 can rotate the catheter 606. To rotate the catheter 606, the bevel gear 452 of the first cassette 702 is rotated 714 about an axis 716. The rotation 714 of the bevel gear 452 of the first cassette 702 causes the bevel gear 604 to rotate about the lateral axis, which in turn causes the catheter 606 to rotate 718. Referring to FIG. 13 , the bevel gear 452 is rotated by the catheter rotation drive assembly 220c (e.g., via the male connector 244c and the female connector 460). The axis 716 corresponds to the longitudinal axis of the rotation shaft 454, about which the rotation shaft 454 and the bevel gear 452 rotate.

[0083] To advance catheter 606, referring to FIG. 19 , the clamping and advancing assembly of second cassette 704 clamps catheter 606. Advancing roller 354 of second cassette 704 is translated laterally, whereupon opposing advancing rollers 352, 354 exert opposing forces on (e.g., clamp) catheter 606. Referring to FIGS. 11A and 11B , pinion 382 is rotated by clamp drive assembly 220b (e.g., via male connector 244b and female connector 386), and the rotation of pinion 382 causes translation of rack 380, which in turn translates the clamp support frame (including lower support frame 370, middle support frame 372, and upper support frame 374) and advancing roller 354 in a direction toward advancing roller 352 (e.g., in the +Y direction). Referring to FIG. 19, advancing roller 354 is translated in direction 720 toward advancing roller 352 to a clamping position.

[0084] With the catheter 606 clamped by the clamping and advancing assembly, the clamping and advancing assembly of the second cassette 704 can advance (e.g., deliver into or withdraw from the body) the catheter 606. To advance the catheter 606, the advancement shaft 360 of the second cassette 704 is rotated by the advancement drive assembly 220a (e.g., via the male connector 244a and the female connector 364), causing the advancement roller 352 to rotate 722. Furthermore, the rotation of the advancement shaft 360 of the second cassette 704 similarly causes the forward spur gear 356 to rotate. In the clamping position, the forward spur gear 356 engages the forward spur gear 358. As a result, the rotation of the forward spur gear 356 causes the forward spur gear 358 to rotate in the reverse direction, which in turn causes the advancement roller 354 to rotate in the reverse direction 724. 19, the catheter 606 can be advanced into the body by rotating the advancing rollers 352, 354 in the opposite direction to the respective rotations 722, 724 shown, and the catheter can be withdrawn from the body by rotating the advancing rollers 352, 354 in the opposite direction to the respective rotations 722, 724 shown.

[0085] As the clamping and advancing assembly of the second cassette 704 advances the catheter 606, the first cassette 702 tracks the advancement of the catheter 606. As shown in FIG. 19 , the first cassette 702 follows a lateral translation direction 726 (e.g., as the catheter 606 is advanced into the body). The first cassette 702 can follow a lateral translation direction opposite to direction 726 (e.g., as the catheter 606 is withdrawn from the body). The tracking of the first cassette 702 can be achieved by an independent translation assembly, such as one described below. The tracking of the first cassette 702 allows little or no tension to be generated on the catheter 606 between the advancement rollers 352, 354 of the second cassette 704, which clamp the catheter 606, and the Y-connector 602, which is secured by the Y-connector housing of the first cassette 702. The absence of such tension is illustrated in FIG. 19 by the presence of slack 728 in catheter 606.

[0086] As shown in FIGS. 18 and 19 , the catheter rotation assembly of the first cassette 702 can maintain engagement or mechanical coupling with the connector bevel gear 604 (e.g., by the bevel gear 452 engaging the connector bevel gear 604) regardless of movement of the catheter 606. In this case, the catheter rotation assembly can maintain mechanical coupling to the catheter 606 regardless of movement of the catheter 606 during operation. In FIG. 19 , the catheter rotation assembly is not operated to rotate the catheter 606, and the bevel gear 452 remains engaged with the bevel gear 604 while the catheter 606 is advanced. Also shown in FIGS. 18 and 19 , the clamping and advancing assembly of the second cassette 704 is disengaged or mechanically disconnected from the catheter 606 to allow rotation of the catheter 606 through the channel 308 of the second cassette 704.

[0087] 8A and 8B are schematic diagrams depicting the rotation and advancement, respectively, of a guidewire 732, according to some examples. FIGS. 8A and 8B show a proximal cassette 148. The proximal cassette 148 is shown including a guidewire connector 518 and a cap 512. The guidewire 732 is secured by the guidewire connector 518, the cap 512, and a collet 516 (not shown), as previously described. The cap spur gear 514 on the cap 512 is engaged with the spur gear 496. The guidewire 732 extends from the guidewire connector 518 and the cap 512 through the channel 308 of the proximal cassette 148 (e.g., between the advancement rollers 352, 354). The length of the guidewire 732 extending from the cap 512 to the housing 304 (e.g., through the housing 304 to the channel 308) may be referred to as the loopback of the guidewire 732.

[0088] During operation, the clamping and advancing assembly of the proximal cassette 148 can secure the guidewire 732 within the channel 308 of the proximal cassette 148 so that it does not move or advances laterally. When the guidewire 732 is rotated, the clamping and advancing assembly of the proximal cassette 148 releases the guidewire 732 for rotation. Regardless of the movement of the guidewire 732 (e.g., rotation, advancement, or no movement), the guidewire rotation assembly of the proximal cassette 148 can maintain a mechanical coupling to the guidewire 732 (e.g., by the collet 516, the guidewire connector 518, and the cap 512).

[0089] First, assume that the proximal cassette 148 is in a position where the guidewire 732 is not moving and where the clamping and advancing assembly of the proximal cassette 148 will cause the guidewire 732 to be secured between the advancement rollers 352, 354 of the proximal cassette 148. To rotate the guidewire 732, the clamping and advancing assembly releases the guidewire 732. The advancement rollers 354 of the proximal cassette 148 are translated laterally in direction 734 to a released position where the opposing advancement rollers 352, 354 do not exert opposing forces on (e.g., clamp) the guidewire 732, as described above with respect to FIG.

[0090] With the clamping and advancing assembly of the proximal cassette 148 releasing the guidewire 732, the catheter rotation assembly of the proximal cassette 148 can rotate the guidewire 732. To rotate the guidewire 732, the spur gear 496 of the proximal cassette 148 is rotated 736 about an axis 738. The rotation 736 of the spur gear 496 causes the cap spur gear 514, and thus the cap 512, the guidewire connector 518, and the collet 516, to rotate in the opposite direction to the rotation 736, which in turn causes the guidewire 732 to rotate 740. Referring to FIG. 14 , the spur gear 496 is rotated by the guidewire rotation drive assembly 220d (e.g., via the male connector 244d and the female connector 486).

[0091] To advance guidewire 732, with reference to FIG. 21 , the clamping and advancing assembly of proximal cassette 148 clamps guidewire 732. Advancing roller 354 is translated laterally, whereupon opposing advancing rollers 352, 354 apply opposing forces to (e.g., clamp) guidewire 732, as described with reference to FIG. 19 . Advancing roller 354 is translated in direction 742 toward advancing roller 352 to a clamping position.

[0092] With the guidewire 732 clamped by the clamping and advancing assembly, the clamping and advancing assembly can advance (e.g., deliver into or withdraw from the body) the guidewire 732. To advance the guidewire 732, the advancement shaft 360 of the proximal cassette 148 is rotated by the advancement drive assembly 220a (e.g., via the male connector 244a and the female connector 364), causing the advancement roller 352 to rotate 744. Furthermore, the rotation of the advancement shaft 360 similarly causes the advancement spur gear 356 to rotate. In the clamping position, the advancement spur gear 356 engages with the advancement spur gear 358. As a result, the rotation of the forward spur gear 356 causes the forward spur gear 358 to rotate in the opposite direction, which in turn causes the advancement roller 354 to rotate in the opposite direction 746. The rotations 744, 746 of the advancement rollers 352, 354 shown in FIG. 21 allow the guidewire 732 to be advanced into the body. Rotation of the advancement rollers 352, 354 in the opposite direction to the illustrated rotation 744, 746, respectively, allows the catheter to be withdrawn from the body.

[0093] As the clamping and advancing assembly of the proximal cassette 148 advances the guidewire 732, the loopback of the guidewire 732 may change. As shown in FIG. 21 , the length of the loopback may decrease as the guidewire 732 is advanced in a lateral translation direction 748 (e.g., as the guidewire 732 is advanced into the body). Similarly, the length of the loopback may increase as the guidewire 732 is advanced in a lateral translation direction opposite direction 748 (e.g., as the guidewire 732 is withdrawn from the body).

[0094] 8A and 8B, the guidewire rotation assembly of the proximal cassette 148 can maintain an engagement or mechanical coupling with the guidewire 732 (e.g., by the guidewire connector 518, collet 516, and cap 512 securing the guidewire 732) regardless of movement of the guidewire 732. In this case, the guidewire rotation assembly can maintain a mechanical coupling to the guidewire 732 regardless of movement of the guidewire 732 during operation. In FIG. 21, the catheter rotation assembly is not actuated to rotate the guidewire 732; the guidewire connector 518, collet 516, and cap 512 remain secured to the guidewire 732, and the spur gears 514, 496 remain engaged while the guidewire 732 is advanced. Also, as shown in Figures 20 and 21, the clamping and advancing assembly of the proximal cassette 148 is released or mechanically decoupled from the guidewire 732 to allow rotation of the guidewire 732 through the channel 308 of the proximal cassette 148.

[0095] 9A-9C show exploded perspective views of translation assemblies mechanically coupled to tracks, according to some examples. First intermediate drive unit 134, second intermediate drive unit 136, and proximal drive unit 138 each include a respective translation assembly mechanically coupled thereto. The translation assemblies enable each drive unit 134-138 to translate along the track (e.g., in the X direction). Different translation assemblies may be implemented for the drive units and / or modifications to the illustrated translation assemblies may be made. Although various types of shafts and gears are described below for the translation assemblies, other types of shafts and gears may be implemented to achieve different configurations of the translation assemblies.

[0096] The translation assembly includes a rotary actuator 802. The rotary actuator 802 includes a drive shaft 804 (e.g., a shaft having a D-shaped cross section perpendicular to the axis of rotation of the shaft). The rotary actuator 802 is configured to rotate the drive shaft 804. In some examples, the rotary actuator 802 is a motor, such as an electric motor. The rotary actuator 802 is mechanically mounted and attached on a bracket 806. A screw gear 808 is mechanically attached to the drive shaft 804.

[0097] The translation assembly further includes a lateral shaft 810 (e.g., a shaft having a D-shaped cross-section perpendicular to the shaft's axis of rotation). A gear 812 (e.g., a spur gear having a concave outer surface) and a pinion 814 are each mechanically attached to and surround the lateral shaft 810. A screw gear 808 engages the gear 812. The rotary actuator 802 is configured to rotate the drive shaft 804, which causes the screw gear 808 to rotate about the drive shaft. Rotation of the screw gear 808 causes rotation of the gear 812 about a lateral axis transverse to the drive shaft. Rotation of the gear 812 causes rotation of the lateral shaft 810 about a lateral axis, which in turn causes rotation of the pinion 814 about the lateral axis. The translation assembly may also include a slider 816. The slider 816 generally has a C-shaped cross-section, as shown in FIG. 22B . The slider 816 is mechanically attached to the bracket 806 .

[0098] The track includes a guide 818 and a rack 820. Although not shown in Figures 9A and 9B, the guide 818 and rack 820 are mechanically coupled to and supported by the frame 112. The guide 818 has a groove on its top surface and a groove on its bottom surface. The slider 816 engages with the grooves in the guide 818 to mechanically support the translation assembly and to allow translation of the translation assembly along the guide 818. The pinion 814 engages with the rack 820. Rotation of the pinion 814 by engaging with the rack 820 causes translation of the translation assembly.

[0099] The translation assemblies are mechanically coupled to their respective drive units. In Figures 9A and 9B, bracket 806 has a mounting plate 822 mechanically attached to it. Mounting plate 822 is mechanically attached to spacer 824, which is mechanically attached to the support plate 202 of the corresponding drive unit.

[0100] The translating assembly may also include an articulating conduit 826. In the illustrated example, an end of the articulating conduit 826 is mechanically attached to a bracket 828, which is mechanically attached to bracket 806. The other end of the articulating conduit 826 is mechanically coupled to frame 112 (not shown). The articulating conduit 826 may carry wires and cables that transmit power and / or control signals to various electrical components within the translating assembly and drive unit. The end of the articulating conduit 826 that is mechanically coupled to frame 112 may remain in a stationary position, while the end of the articulating conduit 826 that is mechanically attached to bracket 828 may be movable as the translating assembly translates. The articulating conduit 826 may reduce kinking or tangling of the wires or cables carried by the articulating conduit 826.

[0101] 9A and 9B is incorporated into its housing, according to some examples. Here, proximal cassette 830 includes housing 832. A clamping and advancing assembly 834, as shown in FIG. 11A, a guidewire rotation assembly 834, as shown in FIG. 14, and a guidewire 838 are received entirely within housing 832.

[0102] 20 and 21 are flowcharts of methods 900A, 900B for operating a system for an intravascular procedure, according to some examples. The various operations of methods 900A, 900B of FIGS. 20 and 21 are described in conjunction with the various components described with respect to multi-axis catheter system 100 of FIG. 2 and other figures. Different systems may be used in other embodiments. The various operations of methods 900A, 900B may be performed in any order. Furthermore, in some examples, fewer (or more) operations are performed than those illustrated in and described with respect to methods 900A, 900B of FIGS. 20 and 21. In some examples, any logical permutation or subset of the operations of methods 900A, 900B may be performed.

[0103] During operation, the distal cassette 142 is disposed on the distal cassette platform 122 and mechanically secured to the distal drive unit 132. The tabs 314-2 of the distal cassette 142 engage with the hooks 204-2 of the distal drive unit 132, and the fasteners 322-2 of the distal cassette 142 engage with the fastener ribs 206-2 of the distal drive unit 132. The male connector 244a-2 of the distal drive unit 132 engages with the female connector 364-2 of the distal cassette 142, and the male connector 244b-2 of the distal drive unit 132 engages with the female connector 386-2 of the distal cassette 142. The encoder coupler 264-2 of the distal drive unit 132 engages with the encoder coupler 420-2 of the distal cassette 142.

[0104] The first intermediate cassette 144 is disposed on the first intermediate cassette platform 124 and mechanically fixed to the first intermediate drive unit 134. The tabs 314 (e.g., tab 314-4) of the first intermediate cassette 144 engage with the hooks 204 (e.g., hook 204-4) of the first intermediate drive unit 134, and the fasteners 322 (e.g., fastener 322-4) of the first intermediate cassette 144 engage with the fastener ribs 206 (e.g., fastener rib 206-4) of the first intermediate drive unit 134. The male connector 244a (e.g., male connector 244a-4) of the first intermediate drive unit 134 engages with the female connector 364 (e.g., female connector 364-4) of the first intermediate cassette 144. The male connector 244b (e.g., male connector 244b-4) of the first intermediate drive unit 134 engages with the female connector 386 (e.g., female connector 386-4) of the first intermediate cassette 144. The male connector 244c (e.g., male connector 244c-4) of the first intermediate drive unit 134 engages with the female connector 460 (e.g., female connector 460-4) of the first intermediate cassette 144. The encoder coupler 264 (e.g., encoder coupler 264-4) of the first intermediate drive unit 134 engages with the encoder coupler 420 (e.g., encoder coupler 420-4) of the first intermediate cassette 144.

[0105] The second intermediate cassette 146 is disposed on the second intermediate cassette platform 126 and mechanically fixed to the second intermediate drive unit 136. The tabs 314 (e.g., tab 314-4) of the second intermediate cassette 146 engage with the hooks 204 (e.g., hook 204-4) of the second intermediate drive unit 136, and the fasteners 322 (e.g., fastener 322-4) of the second intermediate cassette 146 engage with the fastener ribs 206 (e.g., fastener rib 206-4) of the second intermediate drive unit 136. The male connector 244a (e.g., male connector 244a-4) of the second intermediate drive unit 136 engages with the female connector 364 (e.g., female connector 364-4) of the second intermediate cassette 146. The male connector 244b (e.g., male connector 244b-4) of the second intermediate drive unit 136 engages with the female connector 386 (e.g., female connector 386-4) of the second intermediate cassette 146. The male connector 244c (e.g., male connector 244c-4) of the second intermediate drive unit 136 engages with the female connector 460 (e.g., female connector 460-4) of the second intermediate cassette 146. The encoder coupler 264 (e.g., encoder coupler 264-4) of the second intermediate drive unit 136 engages with the encoder coupler 420 (e.g., encoder coupler 420-4) of the second intermediate cassette 146.

[0106] The proximal cassette 148 is disposed on the proximal cassette platform 128 and mechanically secured to the proximal drive unit 138. The tabs 314-8 of the proximal cassette 148 engage with the hooks 204-8 of the proximal drive unit 138, and the fasteners 322-8 of the proximal cassette 148 engage with the fastener ribs 206-8 of the proximal drive unit 138. The male connector 244a-8 of the proximal drive unit 138 engages with the female connector 364-8 of the proximal cassette 148. The male connector 244b-8 of the proximal drive unit 138 engages with the female connector 386-8 of the proximal cassette 148. The male connector 244c-8 of the proximal drive unit 138 engages with the female connector 460-8 of the proximal cassette 148. Male connector 244d-8 of proximal drive unit 138 engages female connector 486-8 of proximal cassette 148. Encoder coupler 264-8 of proximal drive unit 138 engages encoder coupler 420-8 of proximal cassette 148.

[0107] The first catheter 152 is disposed through the channel 308-2 of the distal cassette 142, including between the advancement rollers 352-2 and 354-2 and between the follower rollers 402-2 and 404-2. The proximal end of the first catheter 152 is mechanically coupled to the Y connector 162, which is mechanically secured by the Y connector housing (including the base 456 and the lid 458 (e.g., the base 456-4 and the lid 458-4)) of the first intermediate cassette 144. A gear is mechanically coupled to the first catheter 152, and the gear surrounds the axis of rotation of the first catheter 152 as described with reference to FIGS. 15-17 . The gear is engaged with a bevel gear 452 (e.g., the bevel gear 452-4) of the catheter rotation assembly of the first intermediate cassette 144.

[0108] The second catheter 154 is disposed through a channel 308 (e.g., channel 308-4) of the first intermediate cassette 144, including between the advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) and between the follower rollers 402, 404 (e.g., follower rollers 402-4, 404-4). The proximal end of the second catheter 154 is mechanically coupled to a Y-connector 164, which is mechanically secured by a Y-connector housing (including a base 456 and a lid 458 (e.g., a base 456-4 and a lid 458-4)) of the second intermediate cassette 146. A gear is mechanically coupled to the second catheter 154, and the gear surrounds the axis of rotation of the second catheter 154 as described with respect to FIGS. 15-17. This gear is engaged with a bevel gear 452 (e.g., bevel gear 452-4) of the catheter rotation assembly of the second intermediate cassette 146. A second catheter 154 is inserted through the first catheter 152 and is movable within the first catheter 152.

[0109] The third catheter 156 is disposed through a channel 308 (e.g., channel 308-4) of the second intermediate cassette 146, including between the advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) and between the follower rollers 402, 404 (e.g., follower rollers 402-4, 404-4). The proximal end of the third catheter 156 is mechanically coupled to a Y-connector 166, which is mechanically secured by a Y-connector housing (including a base 456-8 and a lid 458-8) of the proximal cassette 148. A gear is mechanically coupled to the third catheter 156, and the gear surrounds the axis of rotation of the third catheter 156, as described with reference to FIGS. 15-17 . The gear is engaged with a bevel gear 452-8 of the catheter rotation assembly of the proximal cassette 148. A third catheter 156 is inserted through the second catheter 154 and is movable within the second catheter 154 .

[0110] The guidewire 158 is disposed through the channel 308-8 of the proximal cassette 148, including between the advancement rollers 352-8, 354-8 and between the follower rollers 402-8, 404-8. The proximal end of the guidewire 158 is mechanically coupled to the guidewire connector 518-8, collet 516-8, and cap 512-8 of the proximal cassette 148. The spur gear 514-8 is mechanically attached to the cap 512-8 and engages with the spur gear 496-8 of the guidewire rotation assembly of the proximal cassette 148. The guidewire 158 is inserted through the second catheter 154 and is movable within the second catheter 154.

[0111] In block 902, the first catheter 152 is mechanically coupled to the clamping and advancing assembly of the distal cassette 142. The first catheter 152 is mechanically coupled to the clamping and advancing assembly of the distal cassette 142 by translating the advancing roller 354-2 of the distal cassette 142 to the clamping position, whereby the first catheter 152 is clamped and mechanically coupled between the advancing rollers 352-2, 354-2 of the distal cassette 142. The advancing roller 354-2 can be translated by actuating the rotational actuator 222b-2 of the clamping drive assembly 220b-2 of the distal drive unit 132, as described above.

[0112] In block 904, the first catheter 152 is advanced by the clamping and advancing assembly of the distal cassette 142. Advancing the first catheter 152 may include one or both of feeding the first catheter 152 into the body in block 906 and retrieving the first catheter 152 from the body in block 908. Advancing the first catheter 152 includes rotating the advancement rollers 352-2, 354-2 of the clamping and advancing assembly of the distal cassette 142. The advancement rollers 352-2, 354-2 may be rotated by actuating the rotational actuator 222a-2 of the advancement drive assembly 220a-2 of the distal drive unit 132, as described above.

[0113] During advancement of the first catheter 152 in block 904, the first catheter 152 is mechanically coupled to the clamping and advancing assembly of the distal cassette 142 and to the catheter rotation assembly of the first intermediate cassette 144. During advancement, the first catheter 152 remains clamped between the advancement rollers 352-2, 352-4 of the distal cassette 142. The first catheter 152 also remains mechanically coupled to gears surrounding the Y connector 162 and the rotation axis of the first catheter 152, and a bevel gear 452 (e.g., bevel gear 452-4) of the catheter rotation assembly of the first intermediate cassette 144 remains engaged with the surrounding gear during advancement of the first catheter 152 by the clamping and advancing assembly of the distal cassette 142.

[0114] Further, while advancing the first catheter 152 in block 904, the first intermediate cassette 144 is translated correspondingly along the track. The rotational actuator 802 of the translation assembly for the first intermediate drive unit 134 can be actuated to cause translation of the first intermediate drive unit 134 along the track (e.g., guide 818 and rack 820). As the first catheter 152 is advanced into the body in block 906, the distance between the distal cassette 142 and the first intermediate cassette 144 decreases due to corresponding translation of the first intermediate cassette 144 and the first intermediate drive unit 134 by the corresponding translation assembly. As the first catheter 152 is withdrawn from the body in block 908, the distance between the distal cassette 142 and the first intermediate cassette 144 increases due to corresponding translation of the first intermediate cassette 144 and the first intermediate drive unit 134 by the corresponding translation assembly. Translation of the first intermediate cassette 144 can reduce or eliminate tension on the first catheter 152 between the distal cassette 142 and the first intermediate cassette 144. The second intermediate cassette 146 and the proximal cassette 148 can also be translated accordingly or can remain stationary while the first catheter 152 is advanced.

[0115] In block 910, the first catheter 152 is mechanically decoupled from the clamp and advancement assembly of the distal cassette 142. The first catheter 152 is mechanically decoupled from the clamp and advancement assembly of the distal cassette 142 by translating the advancement roller 354-2 of the distal cassette 142 to a release position, thereby releasing and mechanically decoupling the first catheter 152 from the advancement rollers 352-2, 354-2 of the distal cassette 142. The advancement roller 354-2 may be translated by actuating the rotational actuator 222b-2 of the clamp drive assembly 220b-2 of the distal drive unit 132, as described above.

[0116] In block 912, the catheter rotation assembly of the first intermediate cassette 144 rotates the first catheter 152 while the first catheter 152 is mechanically decoupled from the clamping and advancing assembly of the distal cassette 142. The first catheter 152 can be rotated by actuating the rotational actuator 222c (e.g., rotational actuator 222c-4) of the catheter rotational drive assembly 220c (e.g., catheter rotational drive assembly 220c-4) of the first intermediate drive unit 134, as described above. Mechanically decoupling the first catheter 152 from the clamping and advancing assembly of the distal cassette 142 allows the first catheter 152 to rotate through the distal cassette 142.

[0117] In block 914, the second catheter 154 is mechanically coupled to the clamping and advancing assembly of the first intermediate cassette 144. The second catheter 154 is mechanically coupled to the clamping and advancing assembly of the first intermediate cassette 144 by translating the advancing rollers 354 (e.g., advancing roller 354-4) of the first intermediate cassette 144 to the clamping position, whereby the second catheter 154 is clamped and mechanically coupled between the advancing rollers 352, 354 (e.g., advancing rollers 352-4, 354-4) of the first intermediate cassette 144. The advancing rollers 354 can be translated by actuating the rotational actuator 222b (e.g., rotational actuator 222b-4) of the clamping drive assembly 220b (e.g., clamping drive assembly 220b-4) of the first intermediate drive unit 134, as described above.

[0118] In block 916, the second catheter 154 is advanced by the clamping and advancing assembly of the first intermediate cassette 144. Advancing the second catheter 154 may include one or both of feeding the second catheter 154 into the body in block 918 and retrieving the second catheter 154 from the body in block 920. Advancing the second catheter 154 includes rotating advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) of the clamping and advancing assembly of the first intermediate cassette 144. The advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) may be rotated by actuating the rotational actuator 222a (e.g., rotational actuator 222a-4) of the advancement drive assembly 220a (e.g., advancement drive assembly 220a-4) of the first intermediate drive unit 134, as described above.

[0119] During advancement of the second catheter 154 in block 916, the second catheter 154 is mechanically coupled to the clamping and advancing assembly of the first intermediate cassette 144 and to the catheter rotation assembly of the second intermediate cassette 146. The second catheter 154 remains clamped between the advancement rollers 352, 354 of the first intermediate cassette 144 during advancement. The second catheter 154 also remains mechanically coupled to a gear surrounding the Y connector 164 and the rotation axis of the second catheter 154, and a bevel gear 452 (e.g., bevel gear 452-4) of the catheter rotation assembly of the second intermediate cassette 146 remains engaged with the surrounding gear during advancement of the second catheter 154 by the clamping and advancing assembly of the first intermediate cassette 144.

[0120] Further, during advancement of the second catheter 154 in block 916, the second intermediate cassette 146 is translated correspondingly along the track. The rotational actuator 802 of the translation assembly for the second intermediate drive unit 136 can be actuated to cause translation of the second intermediate drive unit 136 along the track (e.g., guide 818 and rack 820). As the second catheter 154 is advanced into the body in block 918, the distance between the first intermediate cassette 144 and the second intermediate cassette 146 decreases due to corresponding translation of the second intermediate cassette 146 and the second intermediate drive unit 136 by the corresponding translation assembly. As the second catheter 154 is withdrawn from the body in block 920, the distance between the first intermediate cassette 144 and the second intermediate cassette 146 increases due to corresponding translation of the second intermediate cassette 146 and the second intermediate drive unit 136 by the corresponding translation assembly. Translation of the second intermediate cassette 146 can reduce or eliminate tension on the second catheter 154 between the first intermediate cassette 144 and the second intermediate cassette 146. The proximal cassette 148 can also be translated accordingly or can remain stationary while the second catheter 154 is advanced.

[0121] In block 922, the second catheter 154 is mechanically decoupled from the clamping and advancing assembly of the first intermediate cassette 144. The second catheter 154 is mechanically decoupled from the clamping and advancing assembly of the first intermediate cassette 144 by translating the advancement rollers 354 (e.g., advancement roller 354-4) of the first intermediate cassette 144 to a release position, thereby releasing and mechanically decoupling the second catheter 154 from the advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) of the first intermediate cassette 144. The advancement rollers 354 can be translated by actuating the rotational actuator 222b (e.g., rotational actuator 222b-4) of the clamp drive assembly 220b (e.g., clamp drive assembly 220b-4) of the first intermediate drive unit 134, as described above.

[0122] In block 924, the catheter rotation assembly of the second intermediate cassette 146 rotates the second catheter 154 while the second catheter 154 is mechanically decoupled from the clamping and advancing assembly of the first intermediate cassette 144. The second catheter 154 can be rotated by actuating the rotational actuator 222c (e.g., rotational actuator 222c-4) of the catheter rotational drive assembly 220c (e.g., catheter rotational drive assembly 220c-4) of the second intermediate drive unit 136, as described above. Mechanically decoupling the second catheter 154 from the clamping and advancing assembly of the first intermediate cassette 144 allows the second catheter 154 to rotate through the first intermediate cassette 144.

[0123] The first catheter 152, in some examples, maintains mechanical coupling with the clamping and advancing assembly of the distal cassette 142 while the second catheter 154 is advanced at block 916 and / or rotated at block 924. In some examples, the first catheter 152 may be mechanically decoupled from the clamping and advancing assembly of the distal cassette 142 while the second catheter 154 is advanced at block 916 and / or rotated at block 924.

[0124] In block 926, the third catheter 156 is mechanically coupled to the clamping and advancing assembly of the second intermediate cassette 146. The third catheter 156 is mechanically coupled to the clamping and advancing assembly of the second intermediate cassette 146 by translating the advancing rollers 354 (e.g., advancing roller 354-4) of the second intermediate cassette 146 to the clamping position, whereby the third catheter 156 is clamped between and mechanically coupled to the advancing rollers 352, 354 (e.g., advancing rollers 352-4, 354-4) of the second intermediate cassette 146. The advancing rollers 354 can be translated by actuating the rotational actuator 222b (e.g., rotational actuator 222b-4) of the clamping drive assembly 220b (e.g., clamping drive assembly 220b-4) of the second intermediate drive unit 136, as described above.

[0125] In block 928, the third catheter 156 is advanced by the clamping and advancing assembly of the second intermediate cassette 146. Advancing the third catheter 156 may include one or both of feeding the third catheter 156 into the body in block 930 and retrieving the third catheter 156 from the body in block 932. Advancing the third catheter 156 includes rotating advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) of the clamping and advancing assembly of the second intermediate cassette 146. The advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) may be rotated by actuating the rotational actuator 222a (e.g., rotational actuator 222a-4) of the advancement drive assembly 220a (e.g., advancement drive assembly 220a-4) of the second intermediate drive unit 136, as described above.

[0126] During advancement of the third catheter 156 in block 928, the third catheter 156 is mechanically coupled to the clamping and advancing assembly of the second intermediate cassette 146 and to the catheter rotation assembly of the proximal cassette 148. The third catheter 156 remains clamped between the advancement rollers 352, 354 of the second intermediate cassette 146 during advancement. The third catheter 156 also remains mechanically coupled to a gear surrounding the Y connector 166 and the rotation axis of the third catheter 156, and the bevel gear 452-8 of the catheter rotation assembly of the proximal cassette 148 remains engaged with the surrounding gear during advancement of the third catheter 156 by the clamping and advancing assembly of the second intermediate cassette 146.

[0127] Further, during advancement of the third catheter 156 at block 928, the proximal cassette 148 is translated correspondingly along the track. The rotational actuator 802 of the translation assembly for the proximal drive unit 138 may be actuated to cause translation of the proximal drive unit 138 along the track (e.g., guide 818 and rack 820). As the third catheter 156 is advanced into the body at block 930, the distance between the second intermediate cassette 146 and the proximal cassette 148 decreases due to corresponding translation of the proximal cassette 148 and the proximal drive unit 138 by the corresponding translation assembly. As the third catheter 156 is withdrawn from the body at block 932, the distance between the second intermediate cassette 146 and the proximal cassette 148 increases due to corresponding translation of the proximal cassette 148 and the proximal drive unit 138 by the corresponding translation assembly. The translation of the proximal cassette 148 can reduce or eliminate tension on the third catheter 156 between the second intermediate cassette 146 and the proximal cassette 148 .

[0128] In block 934, the third catheter 156 is mechanically decoupled from the clamp and advancement assembly of the second intermediate cassette 146. The third catheter 156 is mechanically decoupled from the clamp and advancement assembly of the second intermediate cassette 146 by translating the advancement rollers 354 (e.g., advancement roller 354-4) of the second intermediate cassette 146 to a release position, thereby releasing and mechanically decoupling the third catheter 156 from the advancement rollers 352, 354 (e.g., advancement rollers 352-4, 354-4) of the second intermediate cassette 146. The advancement rollers 354 may be translated by actuating the rotational actuator 222b (e.g., rotational actuator 222b-4) of the clamp drive assembly 220b (e.g., clamp drive assembly 220b-4) of the second intermediate drive unit 136, as described above.

[0129] In block 936, the catheter rotation assembly of the proximal cassette 148 rotates the third catheter 156 while the third catheter 156 is mechanically decoupled from the clamping and advancing assembly of the second intermediate cassette 146. The third catheter 156 may be rotated by actuating the rotational actuator 222c-8 of the catheter rotation drive assembly 220c-8 of the proximal drive unit 138, as described above. Mechanically decoupling the third catheter 156 from the clamping and advancing assembly of the second intermediate cassette 146 allows the third catheter 156 to rotate through the second intermediate cassette 146.

[0130] The catheters 152, 154, in some examples, maintain mechanical coupling to the clamping and advancing assemblies of the distal cassette 142 and the first intermediate cassette 144, respectively, while the third catheter 156 is advanced at block 928 and / or rotated at block 936. In some examples, the catheters 152, 154 may be mechanically decoupled from the clamping and advancing assemblies of the distal cassette 142 and the first intermediate cassette 144, respectively, while the third catheter 156 is advanced at block 928 and / or rotated at block 936.

[0131] At block 938, the guidewire 158 is mechanically coupled to the clamping and advancing assembly of the proximal cassette 148. The guidewire 158 is mechanically coupled to the clamping and advancing assembly of the proximal cassette 148 by translating the advancing roller 354-8 of the proximal cassette 148 to the clamping position, whereby the guidewire 158 is clamped and mechanically coupled between the advancing rollers 352-8, 354-8 of the proximal cassette 148. The advancing roller 354-8 can be translated by actuating the rotational actuator 222b-8 of the clamping drive assembly 220b-8 of the proximal drive unit 138, as described above.

[0132] At block 940, the guidewire 158 is advanced by the clamping and advancing assembly of the proximal cassette 148. Advancing the guidewire 158 may include one or both of feeding the guidewire 158 into the body at block 942 and retrieving the guidewire 158 from the body at block 944. Advancing the guidewire 158 includes rotating the advancement rollers 352-8, 354-8 of the clamping and advancing assembly of the proximal cassette 148. The advancement rollers 352-8, 354-8 may be rotated by actuating the rotational actuators 222a-8 of the advancement drive assembly 220a-8 of the proximal drive unit 138, as described above.

[0133] During the advancement of the guidewire 158 in block 940, the guidewire 158 is mechanically coupled to the clamping and advancing assembly and the guidewire rotation assembly of the proximal cassette 148. The guidewire 158 remains clamped between the advancement rollers 352-8, 354-8 of the proximal cassette 148 during advancement. The guidewire 158 also remains mechanically coupled to the guidewire connector 518-8, the collet 516-8, the cap 512-8, and the spur gear 514-8 that surrounds the axis of rotation of the guidewire 158, and the spur gear 496-8 of the guidewire rotation assembly of the proximal cassette 148 remains engaged with the spur gear 514-8 during the advancement of the guidewire 158 through the clamping and advancing assembly of the proximal cassette 148.

[0134] As the guidewire 158 is advanced into the body at block 942, the length of the loopback of the guidewire 158 decreases. As the guidewire 158 is withdrawn from the body at block 944, the length of the loopback of the guidewire 158 increases.

[0135] At block 946, the guidewire 158 is mechanically decoupled from the clamp and advance assembly of the proximal cassette 148. The guidewire 158 is mechanically decoupled from the clamp and advance assembly of the proximal cassette 148 by translating the advance roller 354-8 of the proximal cassette 148 to a release position, which releases and mechanically decouples the guidewire 158 from the advance rollers 352-8, 354-8 of the proximal cassette 148. The advance roller 354-8 may be translated by actuating the rotational actuator 222b-8 of the clamp drive assembly 220b-8 of the proximal drive unit 138, as described above.

[0136] At block 948, the guidewire rotation assembly of the proximal cassette 148 rotates the guidewire 158 while the guidewire 158 is mechanically decoupled from the clamping and advancing assembly of the proximal cassette 148. The guidewire 158 may be rotated by actuating the rotational actuator 222d-8 of the guidewire rotation drive assembly 220d-8 of the proximal drive unit 138, as described above. Mechanically decoupling the guidewire 158 from the clamping and advancing assembly of the proximal cassette 148 allows the guidewire 158 to rotate through the proximal cassette 148.

[0137] The catheters 152, 154, 156, in some examples, maintain mechanical coupling to the clamping and advancing assemblies of the distal cassette 142, the first intermediate cassette 144, and the second intermediate cassette 146, respectively, while the guidewire 158 is advanced at block 940 and / or rotated at block 948. In some examples, the catheters 152, 154, 156 may be mechanically decoupled from the clamping and advancing assemblies of the distal cassette 142, the first intermediate cassette 144, and the second intermediate cassette 146, respectively, while the guidewire 158 is advanced at block 940 and / or rotated at block 948.

[0138] appendix Claim 1 a first drive unit comprising a first drive assembly, the first drive assembly comprising a first rotary actuator, the first drive assembly configured to be mechanically coupled to a first intravascular insertion device advancing assembly of a first cassette; a second drive unit comprising a second drive assembly, the second drive assembly comprising a second rotary actuator, the second drive assembly configured to be mechanically coupled to a second intravascular insertion device advancing assembly of a second cassette; and a third drive unit comprising a third drive assembly, the third drive assembly comprising a third rotary actuator, the third drive assembly configured to be mechanically coupled to a third intravascular insertion device advancing assembly of a third cassette; and a track, wherein the first drive unit, the second drive unit, and the third drive unit are each mechanically coupled to the track, the first drive unit is mechanically coupled to the track in a fixed position, the second drive unit is disposed along the track between the first drive unit and the third drive unit, and the second drive unit and the third drive unit are mechanically coupled to the track and are movable along the track. A system for endovascular procedures.

[0139] Claim 2 the second drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotational actuator, the fourth drive assembly configured to be mechanically coupled to a first intravascular insertion device rotation assembly of the second cassette; the third drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator, the fifth drive assembly configured to be mechanically coupled to a second intravascular insertion device rotation assembly of the third cassette. The system of claim 1.

[0140] Claim 3 3. The system of claim 2, wherein the third drive unit comprises a sixth drive assembly, the sixth drive assembly comprising a sixth rotational actuator, the sixth drive assembly configured to be mechanically coupled to a third intravascular insertion device rotation assembly of the third cassette.

[0141] Claim 4 the first drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotary actuator, the fourth drive assembly configured to be mechanically coupled to a first intravascular insertion device clamping assembly of the first cassette; the second drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotary actuator, the fifth drive assembly configured to be mechanically coupled to a second intravascular insertion device clamping assembly of the second cassette; the third drive unit comprises a sixth drive assembly, the sixth drive assembly comprising a sixth rotary actuator, the sixth drive assembly configured to be mechanically coupled to a third intravascular insertion device clamping assembly of the third cassette. The system of claim 1.

[0142] Claim 5 10. The system of claim 1, further comprising a fourth drive unit comprising a fourth drive assembly, the fourth drive assembly comprising a fourth rotary actuator, the fourth drive assembly configured to be mechanically coupled to a fourth intravascular insertion device advancing assembly of a fourth cassette, the fourth drive unit mechanically coupled to the track, the fourth drive unit disposed along the track between the second drive unit and the third drive unit, the fourth drive unit mechanically coupled to the track and movable along the track.

[0143] Claim 6 6. The system of claim 5, wherein the fourth drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator, the fifth drive assembly configured to be mechanically coupled to an intravascular insertion device rotation assembly of the fourth cassette.

[0144] Claim 7 6. The system of claim 5, wherein the fourth drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotary actuator, the fifth drive assembly configured to be mechanically coupled to an intravascular insertion device clamping assembly of the fourth cassette.

[0145] Claim 8 the second drive unit is mechanically coupled to the track by a first translation assembly; the third drive unit is mechanically coupled to the track by a second translation assembly; The track includes a guide and a rack. Each of the first translation assembly and the second translation assembly comprises: a slider engaged with the guide and movable along the guide; a fourth rotary actuator configured to rotate a pinion engaged with the rack; The system of claim 1.

[0146] Claim 9 a housing having a channel configured to pass a first intravascular insertion device therethrough; a clamping and advancing assembly comprising a first roller and a second roller; the clamping and advancing assembly configured to translate the second roller between a clamping position and a release position upon operation of the clamping and advancing assembly, wherein in the clamping position, the first roller and the second roller are configured to secure the first intravascular insertion device and in the release position, the first roller and the second roller are configured to release the first intravascular insertion device; and the clamping and advancing assembly is further configured to advance the first intravascular insertion device when the second roller is in the clamping position.

[0147] Claim 10 The clamping and advancing assembly includes: a first shaft, the first roller being disposed on and surrounding the first shaft; a first spur gear disposed on and surrounding the first shaft; a second shaft, the second roller being disposed on and surrounding the second shaft; 10. The cassette of claim 9, further comprising: a second spur gear disposed on and surrounding the second shaft, wherein in the clamping position the second spur gear engages the first spur gear and the first shaft is configured to be rotated by a drive assembly.

[0148] Claim 11 The clamping and advancing assembly includes: a shaft on which the second roller is disposed and surrounds the shaft; a support frame, the shaft being mechanically coupled to and supported by the support frame; 10. The cassette of claim 9, comprising a rack and pinion, the rack mechanically coupled to the support frame, the pinion engaging the rack, and rotation of the pinion causing translation of the second roller.

[0149] Claim 12 10. The cassette of claim 9, further comprising a base, wherein the clamping and advancing assembly comprises a first external connector and a second external connector external to the base, the first external connector configured to mechanically couple with a first drive assembly for advancing the first intravascular insertion device, and the second external connector configured to mechanically couple with a second drive assembly for translating the second roller.

[0150] Claim 13 10. The cassette of claim 9, further comprising a first rotation assembly configured to rotate a second intravascular insertion device, the first rotation assembly comprising a connector housing configured to be mechanically coupled to the second intravascular insertion device.

[0151] Claim 14 the connector housing is a Y-connector housing having a first gear mechanically coupled thereto and configured to secure a Y-connector mechanically coupled to the second intravascular insertion device; the first rotating assembly includes a second gear configured to engage the first gear in the Y-connector housing, the second gear configured to be rotated by a drive assembly. 14. The cassette of claim 13.

[0152] Claim 15 14. The cassette of claim 13, further comprising a second rotation assembly configured to rotate the first intravascular insertion device.

[0153] Claim 16 The second rotating assembly includes: a guidewire connector; a cap configured for threaded engagement with the guidewire connector; a collet disposed between the guidewire connector and the cap, the collet configured to cooperate with the guidewire connector and the cap to secure the first intravascular insertion device; and a first gear mechanically attached to the cap; 16. The cassette of claim 15, comprising: a second gear engaged with the first gear and configured to be rotated by a drive assembly.

[0154] Claim 17 a base having a tab and an opening; a fastener assembly including a fastener disposed at least partially within the opening, the tab and the fastener assembly configured to secure the base to a drive unit. 10. The cassette of claim 9.

[0155] Claim 18 delivering a first intravascular insertion device into a body with a first cassette, wherein a distance between the first cassette and a second cassette decreases during delivery of the first intravascular insertion device into the body, and an end of the first intravascular insertion device is mechanically coupled to the second cassette; removing the first intravascular insertion device from the body with the first cassette, wherein the distance between the first cassette and the second cassette increases during the removal of the first intravascular insertion device from the body; and 11. A method of operating a system for an endovascular procedure, comprising:

[0156] Claim 19 20. The method of claim 18, further comprising rotating the first intravascular insertion device with the second cassette.

[0157] Claim 20 delivering a second intravascular insertion device into the body with the second cassette, the second intravascular insertion device penetrating and movable through the first intravascular insertion device, wherein a distance between the second cassette and a third cassette decreases during delivery of the second intravascular insertion device, and an end of the second intravascular insertion device is mechanically coupled to the third cassette; removing the second intravascular insertion device from the body with the second cassette, wherein the distance between the second cassette and the third cassette increases during the removal of the second intravascular insertion device from the body; and 20. The method of claim 18, further comprising:

[0158] Claim 21 mechanically coupling the intravascular insertion device to an advancement assembly; advancing the intravascular insertion device with the advancing assembly while the intravascular insertion device is mechanically coupled to the advancing assembly, wherein a rotating assembly is mechanically coupled to the intravascular insertion device while advancing the intravascular insertion device; mechanically decoupling the intravascular insertion device from the advancement assembly; rotating the intravascular insertion device with the rotation assembly while the intravascular insertion device is mechanically decoupled from the advancement assembly; 11. A method of operating a system for an endovascular procedure, comprising:

[0159] Claim 22 mechanically coupling the intravascular insertion device to the advancing assembly includes clamping the intravascular insertion device between rollers of the advancing assembly; mechanically decoupling the intravascular insertion device from the advancing assembly includes translating at least one of the rollers of the advancing assembly to release the intravascular insertion device from between the rollers of the advancing assembly. 22. The method of claim 21.

[0160] Claim 23 the intravascular insertion device is mechanically coupled to a first gear configured to rotate the intravascular insertion device, the first gear surrounding an axis of rotation of the intravascular insertion device; the rotating assembly includes a second gear; the rotating assembly is mechanically coupled to the intravascular insertion device by the second gear engaging the first gear; 22. The method of claim 21.

[0161] Claim 24 a first cassette comprising said advancement assembly; a second cassette comprising the rotating assembly, the second cassette being spaced apart from the first cassette; 22. The method of claim 21.

[0162] Claim 25 25. The method of claim 24, wherein advancing the intravascular insertion device changes the distance between the first cassette and the second cassette.

[0163] Claim 26 25. The method of claim 24, wherein both the first cassette and the second cassette are mechanically coupled to a track and are movable along the track.

[0164] Claim 27 The method of claim 21 , wherein one cassette comprises both the advancement assembly and the rotation assembly.

[0165] Claim 28 translating a first roller to a clamping position, wherein the first roller and the second roller secure the intravascular insertion device between the first roller and the second roller; advancing the intravascular insertion device with the first roller and the second roller while the first roller is in the clamping position, wherein a rotation assembly is mechanically coupled to the intravascular insertion device during advancement of the intravascular insertion device; translating the first roller to a release position, wherein the intravascular insertion device is released from between the first roller and the second roller; rotating the intravascular insertion device with the rotation assembly while the first roller is in the release position; 11. A method of operating a system for an endovascular procedure, comprising:

[0166] Claim 29 the intravascular insertion device is mechanically coupled to a first gear configured to rotate the intravascular insertion device, the first gear surrounding an axis of rotation of the intravascular insertion device; the rotating assembly includes a second gear; the rotating assembly is mechanically coupled to the intravascular insertion device by the second gear engaging the first gear; 29. The method of claim 28.

[0167] Claim 30 the intravascular insertion device is a catheter, the catheter is mechanically connected to a Y-connector; the first gear is integral with the Y connector; 30. The method of claim 29.

[0168] Claim 31 the intravascular insertion device is a guidewire; the guidewire is mechanically secured by a collet disposed between the guidewire connector and the cap; the first gear is mechanically attached to the cap; 30. The method of claim 29.

[0169] Claim 32 a first cassette including an advancing assembly, the advancing assembly including the first roller and the second roller; a second cassette comprising the rotating assembly, the second cassette being spaced apart from the first cassette; 29. The method of claim 28.

[0170] Claim 33 33. The method of claim 32, wherein advancing the intravascular insertion device changes the distance between the first cassette and the second cassette.

[0171] Claim 34 34. The method of claim 33, wherein both the first cassette and the second cassette are mechanically coupled to a track and are movable along the track.

[0172] Claim 35 30. The method of claim 28, wherein one cassette comprises both an advancing assembly and the rotating assembly, the advancing assembly comprising the first roller and the second roller.

[0173] Claim 36 clamping the catheter between first rollers of a first cassette; advancing the catheter by rotating the first rollers, wherein the catheter is clamped between the first rollers during advancement of the catheter, and a first rotating assembly of a second cassette is mechanically coupled to the catheter during advancement of the catheter, the second cassette being spaced from the first cassette; Releasing the catheter from between the first rollers; rotating the catheter by the first rotating assembly of the second cassette, the catheter being released from between the first rollers during rotation of the catheter; 11. A method of operating a system for an endovascular procedure, comprising:

[0174] Claim 37 the catheter is mechanically coupled to a Y-connector; the Y-connector is mechanically coupled to a first gear configured to rotate the catheter; the first rotating assembly includes a second gear; the first rotating assembly is mechanically coupled to the catheter by the second gear engaging the first gear; 37. The method of claim 36.

[0175] Claim 38 clamping a guidewire between second rollers of the second cassette, the guidewire extending through and movable within the catheter; advancing the guidewire by rotating the second roller, wherein the guidewire is clamped between the second rollers during advancement of the guidewire and a second rotating assembly of the second cassette is mechanically coupled to the guidewire during advancement of the guidewire; and Releasing the guidewire from between the second rollers; rotating the guidewire with the second rotating assembly of the second cassette, wherein the guidewire is released from between the second rollers during rotation of the guidewire; 37. The method of claim 36, further comprising:

[0176] Claim 39 the guidewire is mechanically secured by a collet disposed between the guidewire connector and the cap; a first gear mechanically attached to the cap, the first gear configured to rotate the guidewire; the second rotating assembly includes a second gear; the second rotating assembly is mechanically coupled to the guidewire by the second gear engaging the first gear; 39. The method of claim 38.

[0177] Claim 40 37. The method of claim 36, wherein advancing the catheter changes the distance between the first cassette and the second cassette.

Claims

1. 1. A system for an endovascular procedure, comprising: a first drive unit comprising a first drive assembly, the first drive assembly comprising a first rotary actuator, the first drive assembly configured to be mechanically coupled to a first intravascular insertion device advancing assembly of a first cassette; a second drive unit comprising a second drive assembly, the second drive assembly comprising a second rotary actuator, the second drive assembly configured to be mechanically coupled to a second intravascular insertion device advancing assembly of a second cassette; and a third drive unit comprising a third drive assembly, the third drive assembly comprising a third rotary actuator, the third drive assembly configured to be mechanically coupled to a third intravascular insertion device advancing assembly of a third cassette; and a track, wherein the first drive unit, the second drive unit, and the third drive unit are each mechanically coupled to the track, the first drive unit is mechanically coupled to the track in a fixed position, the second drive unit is disposed along the track between the first drive unit and the third drive unit, and the second drive unit and the third drive unit are mechanically coupled to the track and are movable along the track. system.

2. the second drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotational actuator, the fourth drive assembly configured to be mechanically coupled to a first intravascular insertion device rotation assembly of the second cassette; the third drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator, the fifth drive assembly configured to be mechanically coupled to a second intravascular insertion device rotation assembly of the third cassette. The system of claim 1 .

3. 3. The system of claim 2, wherein the third drive unit comprises a sixth drive assembly, the sixth drive assembly comprising a sixth rotational actuator, the sixth drive assembly configured to be mechanically coupled to a third intravascular insertion device rotation assembly of the third cassette.

4. the first drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotary actuator, the fourth drive assembly configured to be mechanically coupled to a first intravascular insertion device clamping assembly of the first cassette; the second drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotary actuator, the fifth drive assembly configured to be mechanically coupled to a second intravascular insertion device clamping assembly of the second cassette; the third drive unit includes a sixth drive assembly, the sixth drive assembly including a sixth rotary actuator, the sixth drive assembly configured to be mechanically coupled to a third intravascular insertion device clamping assembly of the third cassette; The system of claim 1 .

5. 2. The system of claim 1, further comprising a fourth drive unit comprising a fourth drive assembly, the fourth drive assembly comprising a fourth rotary actuator, the fourth drive assembly configured to be mechanically coupled to a fourth intravascular insertion device advancing assembly of a fourth cassette, the fourth drive unit mechanically coupled to the track, the fourth drive unit disposed along the track between the second drive unit and the third drive unit, and the fourth drive unit mechanically coupled to the track and movable along the track.

6. 6. The system of claim 5, wherein the fourth drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator, the fifth drive assembly configured to be mechanically coupled to an intravascular insertion device rotation assembly of the fourth cassette.

7. 6. The system of claim 5, wherein the fourth drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotary actuator, the fifth drive assembly configured to be mechanically coupled to an intravascular insertion device clamping assembly of the fourth cassette.

8. the second drive unit is mechanically coupled to the track by a first translation assembly; the third drive unit is mechanically coupled to the track by a second translation assembly; The track includes a guide and a rack. Each of the first translation assembly and the second translation assembly comprises: a slider engaged with the guide and movable along the guide; a fourth rotary actuator configured to rotate a pinion engaged with the rack; The system of claim 1 .

9. 1. A cassette for an endovascular procedure, comprising: a housing having a channel configured to pass a first intravascular insertion device therethrough; a nip and advance assembly comprising a first roller and a second roller; the clamping and advancing assembly configured to translate the second roller between a clamping position and a release position upon operation of the clamping and advancing assembly, wherein in the clamping position, the first roller and the second roller are configured to secure the first intravascular insertion device and in the release position, the first roller and the second roller are configured to release the first intravascular insertion device, and the clamping and advancing assembly is further configured to advance the first intravascular insertion device when the second roller is in the clamping position.

10. The clamping and advancing assembly includes: a first shaft, the first roller being disposed on and surrounding the first shaft; a first spur gear disposed on and surrounding the first shaft; a second shaft, the second roller being disposed on and surrounding the second shaft; a second spur gear disposed on and surrounding said second shaft, wherein in said clamping position said second spur gear engages said first spur gear, and said first shaft is configured to be rotated by a drive assembly.

11. The clamping and advancing assembly includes: a shaft on which the second roller is disposed and surrounds the shaft; a support frame, the shaft being mechanically coupled to and supported by the support frame; 10. The cassette of claim 9, comprising a rack and pinion, the rack mechanically coupled to the support frame, the pinion engaging the rack, and rotation of the pinion causing translation of the second roller.

12. 10. The cassette of claim 9, further comprising a base, wherein the clamping and advancing assembly comprises a first external connector and a second external connector external to the base, the first external connector configured to mechanically couple with a first drive assembly for advancing the first intravascular insertion device, and the second external connector configured to mechanically couple with a second drive assembly for translating the second roller.

13. 10. The cassette of claim 9, further comprising a first rotation assembly configured to rotate a second intravascular insertion device, the first rotation assembly comprising a connector housing configured to be mechanically coupled to the second intravascular insertion device.

14. the connector housing is a Y-connector housing having a first gear mechanically coupled thereto and configured to secure a Y-connector mechanically coupled to the second intravascular insertion device; the first rotating assembly includes a second gear configured to engage the first gear in the Y-connector housing, the second gear configured to be rotated by a drive assembly.

14. The cassette of claim 13.

15. The cassette of claim 13 , further comprising a second rotation assembly configured to rotate the first intravascular insertion device.

16. The second rotating assembly includes: a guidewire connector; a cap configured for threaded engagement with the guidewire connector; a collet disposed between the guidewire connector and the cap, the collet configured to cooperate with the guidewire connector and the cap to secure the first intravascular insertion device; and a first gear mechanically attached to the cap; 16. The cassette of claim 15, comprising: a second gear engaged with the first gear and configured to be rotated by a drive assembly.

17. a base having a tab and an opening; a fastener assembly including a fastener disposed at least partially within the opening, the tab and the fastener assembly configured to secure the base to a drive unit.

10. The cassette of claim 9.

18. 1. A method of operating a system for an endovascular procedure, comprising: delivering a first intravascular insertion device into a body with a first cassette, wherein a distance between the first cassette and a second cassette decreases during delivery of the first intravascular insertion device into the body, and an end of the first intravascular insertion device is mechanically coupled to the second cassette; removing the first intravascular insertion device from the body with the first cassette, wherein the distance between the first cassette and the second cassette increases during the removal of the first intravascular insertion device from the body; and A method comprising:

19. 20. The method of claim 18, further comprising rotating the first intravascular insertion device with the second cassette.

20. delivering a second intravascular insertion device into the body with the second cassette, the second intravascular insertion device penetrating and movable through the first intravascular insertion device, wherein a distance between the second cassette and a third cassette decreases during delivery of the second intravascular insertion device, and an end of the second intravascular insertion device is mechanically coupled to the third cassette; removing the second intravascular insertion device from the body with the second cassette, wherein the distance between the second cassette and the third cassette increases during the removal of the second intravascular insertion device from the body; and 20. The method of claim 18, further comprising:

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