Guide catheter controls flexible track

Abstract

The robotic catheter system includes a base and a robotic mechanism having a longitudinal axis and movable relative to the base along the longitudinal axis. A flexible track is releasably secured to the base and includes an outer surface having a longitudinal open slot extending therethrough to an interior passage. A rigid guide has a non-linear portion that is fixed relative to the robotic mechanism, and when the robotic mechanism moves relative to the base, a portion of the flexible track moves away from the longitudinal axis along the non-linear portion of the rigid guide.

Description

[0001] This application is a divisional application of the Chinese patent application entitled “Guide catheter controlled flexible track” and application number 201910887877.X filed on September 19, 2019.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 61 / 891,389, filed on October 15, 2013, entitled “GUIDE CATHETER CONTROLLED BENDABLE SUPPORT,” and U.S. Provisional Application No. 61 / 952,872, filed on March 14, 2014, entitled “GUIDE CATHETER CONTROLLED BENDABLE SUPPORT,” both of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present application generally relates to the field of catheter systems for performing diagnostic and / or percutaneous coronary interventional procedures. The present application particularly relates to guide catheter control for use in robotic catheter systems. Background Art

[0005] Vascular disease, especially cardiovascular disease, can be treated in a variety of ways. Surgery, such as heart bypass surgery, is one method used to treat cardiovascular disease. However, in some cases, vascular disease can be treated with catheter-based interventions, such as angioplasty. Catheter-based interventions are generally considered less invasive than surgery.

[0006] In one type of interventional means, a guide catheter is inserted into the femoral artery of the patient by an introducer and positioned near the coronary artery ostium of the patient's heart. A guide wire is typically inserted into the guide catheter by a hemostatic valve and manipulated by the patient's arterial system until the guide wire arrives at the lesion site. Then, a working catheter moves along the guide wire until the working catheter (such as a balloon and a stent) is positioned near the lesion, so as to open the blocked part, so as to allow the blood flow near the lesion to increase. Except for cardiovascular disease, other diseases can also be treated with catheter insertion means. Summary of the invention

[0007] In one embodiment, a robotic catheter system includes a base and a robotic mechanism having a longitudinal axis and movable relative to the base along the longitudinal axis. A flexible track is releasably fixed to the base and includes an outer surface having a longitudinal open slot extending therethrough to an internal passage. A rigid guide has a non-linear portion fixed relative to the robotic mechanism. When the robotic mechanism moves along the longitudinal axis, a portion of the flexible track moves away from the longitudinal axis along the non-linear portion of the rigid guide.

[0008] In one embodiment, a method of supporting an elongated medical device includes translating a robotic mechanism relative to a base along a longitudinal axis. The robotic mechanism includes a rigid guide having a distal portion along the longitudinal axis and an offset portion that deviates from the longitudinal axis. The method further includes providing a flexible track having a slot extending into an interior region; placing the flexible track within the rigid guide; operably securing a portion of the flexible track to the base; and moving a portion of the flexible track between the offset portion and the distal portion as the robotic mechanism extends and retracts along the longitudinal axis.

[0009] In one embodiment, an apparatus includes a base and a robotic mechanism movable relative to the base along a longitudinal axis by a linear drive. The robotic mechanism includes a rigid guide having a distal portion along the longitudinal axis and a deviated portion deviating from the longitudinal axis. The flexible track has an interior region and includes a portion operably fixed to the base. The flexible track includes a portion within the rigid guide. An elongated medical device extends from the robotic mechanism and extends along the longitudinal axis. A portion of the flexible track moves between the deviated portion and the distal portion of the rigid guide when the robotic mechanism is extended and retracted along the longitudinal axis, and a portion of the flexible track extends relative to the elongated medical device near the junction between the deviated portion and the distal portion of the rigid guide when the robotic mechanism is extended along the longitudinal axis.

[0010] In a further aspect of one embodiment, the proximal and distal ends of the flexible track remain in fixed positions as the robotic mechanism moves along the longitudinal axis.

[0011] In one embodiment, a support system for a portion of a guide catheter extending between a patient in which a guide catheter has been inserted and a robotic mechanism for incremental movement of the guide catheter includes a flexible track having an internal channel. The flexible track includes a slot extending longitudinally along the track, the slot removably receiving a portion of the guide catheter therethrough. A rigid guide fixed relative to the robotic mechanism provides an arcuate path for the flexible track, the path advancing from the portion of the robotic mechanism to a longitudinal axis of the guide catheter extending from the robotic mechanism connected to a position offset from the longitudinal axis.

[0012] In one embodiment, a support system for a guide catheter includes a flexible track having a longitudinal slit that receives the guide catheter into a lumen of the track when the guide catheter is in a linear orientation. A rigid guide guides the flexible track toward and away from a longitudinal axis of the guide catheter. The flexible track is coaxial with the guide catheter between an entry point where the guide catheter enters the lumen of the flexible track, and at least a portion of the flexible track between the entry point and a proximal end of the flexible support is not coaxial with the guide catheter.

[0013] In one embodiment, a system for manipulating a guide catheter that has been inserted into a patient for performing a percutaneous procedure is also provided. It includes a robotic mechanism for advancing a guidewire and / or a working catheter to the proximal end of the guide catheter, a guide catheter attached to the distal end of the robotic mechanism, and a support system for supporting the portion of the guide catheter that extends between the patient and the robotic mechanism. The support system includes a flexible track and a rigid guide, the flexible track carrying a channel through which a portion of the guide catheter is releasably inserted, and a rigid guide attached to the robotic mechanism and providing a path for the flexible track toward and away from the longitudinal axis of the guide catheter when the distal end of the guide catheter moves toward and away from the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The present invention will be more fully understood from the following detailed description taken in conjunction with the following drawings, in which like reference numerals refer to like elements, and in which:

[0015] Figure 1 is an isometric view of a robotic catheter system.

[0016] Figure 2 yes Figure 1 Isometric top view of the front portion of the robotic catheter system, with exploded views of the guide catheter and Y-connector.

[0017] Figure 3 yes Figure 2 A side elevation view of a front portion of a robotic catheter system with a guide catheter positioned within a Y-connector support in a raised position.

[0018] Figure 4 yes Figure 2 Isometric view of a portion of a system with the Y-connector and support in a lower position and the Y-connector support cover in a raised position.

[0019] Figure 5 yes Figure 2 A top view of the front portion of the robotic catheter system with the guide catheter in the engaged position.

[0020] Fig. 6A is an isometric view of a robotic catheter system with the sheath clip in an installed position.

[0021] Figure 6B is an isometric view of a robotic catheter system with the sheath clamp in the engaged position.

[0022] Figure 7 is an exploded view of the arcuate portion of the rigid guide and the front portion of the robotic catheter system.

[0023] Figure 8 yes Figure 7 Close-up of the sheath clamp, flexible track, and rigid support.

[0024] Fig. 9 is an exploded view of the distal end of the sheath clamp and rigid guide.

[0025] Fig.10 is an isometric view of the front portion of the robotic catheter system with the flexible track in the extended position.

[0026] Fig.11 It is roughly along Figure 5 A cross-sectional view of a front portion of the robotic catheter system taken along line 11-11 showing the extension member protruding into the flexible track slot.

[0027] Fig.12 It is roughly along Fig. 6A A cross-sectional view of a front portion of the robotic catheter system taken along line 12 - 12 with the sheath clip in a loaded position.

[0028] Fig.13 It is roughly along Figure 6B A cross-sectional view of a front portion of the robotic catheter system taken along line 13-13 with the sheath clamped in an operating position.

[0029] Fig.14 is a top view of the robotic catheter system with the flexible track in the fully retracted position.

[0030] Fig.15 is a top view of the robotic catheter system with the flexible track in the extended position.

[0031] Fig.16 is a top view of the robotic catheter system with the robotic drive in a first position.

[0032] Fig.17 is a top view of the robotic catheter system with the robotic drive in a second extended position.

[0033] Fig.18 is an isometric rear view of a robotic catheter system with a linear actuator.

[0034] Fig.19 is an exploded isometric rear view of the robotic catheter system with the cartridge in a pre-assembled position relative to the robotic drive base.

[0035] Fig. 20 is an isometric rear view of the robotic catheter system with the cassette secured to the robotic drive base and the locking rail clamp in the disengaged position.

[0036] Fig.21 It is roughly along Fig. 20 A close-up isometric view of the locking track clamp taken along line 21-21 in FIG.

[0037] Fig. 22 is a close up isometric view of the locking track clamp in the engaged position.

[0038] Fig.23 is a cross-sectional view of the locking track clamp in the engaged position and unlocked.

[0039] Fig.24 An exploded view of a portion of the locking track clamp.

[0040] Fig.25A is a cross-sectional view of the locking track clamp in the unlocked position.

[0041] Fig.26A is a cross-sectional view of the locking track clamp in the unlocked position.

[0042] Fig.25B is a cross-sectional view of the locking track clamp in the locked position.

[0043] Fig.26B is a cross-sectional view of the locking track clamp in the locked position.

[0044] Fig. 27 is a schematic diagram of a robotic catheter system with a remote control station.

[0045] Fig.28 is an illustration of a robotic catheter system with a guide catheter engaged with a patient.

[0046] Fig.29 is a view of the hemostasis valve control mechanism.

[0047] Fig.30 is a cross-sectional view of the hemostatic valve illustrating opening and closing of the rear portion of the hemostatic valve.

[0048] Fig.31 is an isometric view of the sheath clamp.

[0049] Fig.32 yes Fig.31Isometric view of the sheath clamp and introducer.

[0050] Fig.33 yes Fig.31 Isometric view of a sheath clamp and an introducer connected to the sheath clamp. DETAILED DESCRIPTION

[0051] refer to Figure 1 , the robotic catheter system 210 includes a robotic mechanism 212 that automatically moves an elongated medical device. The robotic mechanism 212 is movable relative to a base 214. A flexible track 216 is movable along a rigid guide rail 218 having a non-linear portion. Fig.16 , the flexible track 216 includes a proximal end 253 and a distal end 254 .

[0052] As described in greater detail herein, the flexible track 216 supports an elongated medical device, such as a guide catheter, so that the guide catheter can be advanced into a patient without buckling.

[0053] As used herein, the direction "far" is the direction toward the patient, and the direction "near" is the direction away from the patient. The terms "upper" and "upper" refer to the general direction away from the direction of gravity, and the terms "bottom", "lower" and "down" refer to the general direction of gravity. The term "front" refers to the side of the robotic mechanism facing the user and away from the articulated arm. The term "rear" refers to the side of the robotic mechanism closest to the articulated arm. The term "inwardly" refers to the inner part of a feature. The term "outwardly" refers to the outer part of a feature.

[0054] The robotic mechanism 212 includes a robotic actuator base 220 movable relative to the base 214 and a box 222 operably secured to the robotic actuator base 220. In one embodiment, the box 222 includes a structure that defines a support rigid guide 218. In one embodiment, the base 214 alone or in combination with the box 222 defines the rigid guide 218.

[0055] In one embodiment, the base 214 is secured to an articulated arm 224 that allows a user to position the robotic mechanism 212 close to a patient. In one embodiment, the base 214 is a distal portion of the articulated arm 224. The articulated arm 224 is secured to a patient bed by a rail clamp or bed clamp 226. In this manner, the base 214 is secured to the patient bed. Through manipulation of the articulated arm 224, the base 214 is placed in a fixed position relative to a patient lying on the patient bed. Once the desired position of the robotic mechanism 212 is set relative to the patient, the arm of the articulated arm 224 can be secured.

[0056] refer to Figure 2, an elongated medical device such as a guide catheter 228 is operably secured to the robotic mechanism 212 via the cartridge 222. The guide catheter 228 includes a proximal end 230, an opposite distal end 232, and an intermediate portion 234 extending between the proximal end 230 and the distal end 232. In one embodiment, the proximal end 230 of the guide catheter 228 is operably secured to a Y-shaped connector 233 and a Y-shaped connector engagement mechanism 236. In one embodiment, the Y-shaped connector 233 is a hemostatic valve secured to the cartridge 222 via the Y-shaped connector engagement mechanism 236 and a housing member 244, the Y-shaped connector engagement mechanism 236 including a Y-shaped connector base 238 that is part of the cartridge 222, the housing member 244 including a cover 243 and a support member 245. The Y-shaped connector base 238 includes a guide catheter drive mechanism 240 located in the cartridge 222, which in turn is operably connected to the robotic base 220. Guide catheter drive mechanism 240 includes a drive mechanism that operably engages guide catheter 228 and rotates guide catheter 228 in a direction of its longitudinal axis about its longitudinal axis based on commands provided by a remote control center.

[0057] refer to Figure 3 , the Y-shaped connector housing 244 is pivoted to a raised mounting position to provide easy installation of the guide catheter 228 and the Y-shaped connector 233. Figure 4 , the Y-shaped connector housing 244 pivots along a vector 242 from a raised position to an operational lower position in use. In one embodiment, the guide catheter drive mechanism 240 interacts with a gear 241 on a rotary Luer lock connector fixed to the proximal end 230 of the guide catheter 228 to automatically rotate the guide catheter 228 around its longitudinal axis. The operation of the Y-shaped connector holder and the drive mechanism 236 to automatically rotate the guide catheter 228 around its longitudinal axis is described in the disclosed US application No. US2014 / 0171863A1 entitled "Hemostatic Valve for Guide Catheter Control", which is incorporated herein by reference in its entirety. The automatic control of the Y-shaped connector hemostatic valve 233 will be discussed in further detail below.

[0058] refer to Figure 4 6, the Y-shaped connector holder 238 includes a cover 244 that pivots from an open position to a closed position. The Y-shaped connector holder 238 is releasably coupled to a portion of the cassette 222 by a release button 246. Movement of the release button 246 allows the Y-shaped connector holder 238 to pivot from an operational lower position to a raised position for loading the guide catheter 228 and the Y-shaped connector 233.

[0059] refer to Figure 5The relationship between the guide catheter 228, the rigid guide 218, and the flexible track 216 will be described. The guide catheter 228 maintains a linear position along its longitudinal axis 248 within the box 222 and maintains at least a certain distance from the distal end of the box 222. In one embodiment, the longitudinal axis 248 corresponds to the longitudinal axis of the box 222.

[0060] During medical procedures such as percutaneous coronary intervention (PCI), the guide catheter 228 is used to guide other elongated medical devices such as guidewires and balloon stent catheters into the patient to perform exploratory diagnosis or to treat stenosis in the patient's vascular system. In one such procedure, the distal end 232 of the guide catheter 228 is located in the hole of the patient's heart. The robot mechanism 212 drives the guidewire and / or a working catheter such as a balloon stent catheter into or out of the patient's body. The guidewire and the working catheter are driven into the guide catheter 228 between the distal end of the robot mechanism 212 and the patient. In one embodiment, the longitudinal axis 248 is an axis around which the rotation of the guidewire is caused by the axis box 222, and the axis box 222 drives the guidewire along its longitudinal axis and drives a working catheter such as a balloon stent catheter along its longitudinal axis. In one embodiment, the robot drive system is a type described in U.S. Pat. No. 7,887,549 entitled "Catheter System", and the patent is incorporated herein by reference in its entirety.

[0061] refer to Figure 5 , 7 9, a loop 250 is formed at the distal end of the rigid guide 218. The loop 250 includes a vertically extending opening 278 through which the guide catheter 228 is loaded into the flexible track 216.

[0062] The distal end 254 of the flexible track 216 is secured to a sheath clip 256 which is releasably connected to the cassette 222. The flexible track 246 includes a loop 250 secured to the distal end 252. Fig. 9 In one embodiment, the sheath clip 256 includes a proximal end 258 that includes an attachment portion 260. The distal end 254 of the flexible track 216 is fixed to the attachment portion 260. The sheath clip 256 includes a gripping portion 262 that allows a user to manipulate the sheath clip 256 and the flexible track 216. Intermediate the gripping portion 262 and the flexible track attachment portion 260 is a loop engagement portion 264. The loop engagement portion 264 includes a guide positioning member 266 that is configured to position the sheath clip 256 within the loop 250.

[0063] refer to Figure 7, the rigid guide 218 includes a top member 268 and a bottom channel member 270. When secured together using a plurality of fasteners or other fastening mechanisms, the top member 268 and the bottom channel member 270 form an internal channel 272 through which the flexible track 216 moves relative to the rigid guide 218.

[0064] refer to Figure 8 , the flexible track 216 includes an opening 274, which is adjacent to the end 254 of the flexible track 216 at a predetermined distance and toward the proximal end of the flexible track 216. When the distal end 254 of the flexible track 216 is positioned adjacent to the ring 250, the opening 274 extends from the ring 250 toward the Y-shaped connector holder a sufficient distance so that the opening 274 extends from the ring 250 to the area where the rigid guide 218 begins to leave the arcuate path of the longitudinal axis 248. In one embodiment, the arcuate path forms an s-curve having at least one inflection point along the arcuate path. As discussed below, the opening 274 provides a path for the guide catheter 228 to be placed directly into the cavity of the flexible track from a position on the longitudinal axis. In this way, the guide catheter 228 can be placed in the flexible track 216 near the opening 274, and the guide catheter 228 is linear. In other words, in one embodiment, when the guide catheter 228 is inserted through the opening 274, the guide catheter 228 is in a straight line. In one embodiment, the opening 274 extends 90 degrees around the opening of the end 254 of the flexible track 216. The opening 274 tapers to a slot 286 that extends substantially the entire length of the flexible track 216. In one embodiment, the slot 286 extends a sufficient distance from the opening 274 to allow the entire intended operation of the robotic catheter system through which the guide catheter 228 is passed to enter and exit the interior portion of the flexible track 216. The opening 274 is defined by a pair of substantially parallel section lines 288, 290 in the outer surface of the flexible track 216. The opening 274 is further defined by a tapered portion 294 having an arcuate line 296 extending from the section line 288 toward the slot 286. In one embodiment, the flexible track 216 has sufficient rigidity to maintain the slot 286 in an open position, i.e., the two portions of the outer surface of the flexible track 216 defining the slot 286 remain separated during the movement of the flexible track 216 as described herein, and do not collapse on each other to eliminate the opening. In one embodiment, the slot 286 collapses during movement of a particular portion of the flexible track 216 as it passes through a particular portion of the rigid guide 218. In one embodiment, the slot 286 collapses, i.e., the two edges defining the slot are in contact with each other except in the region where the guide catheter 228 enters and exits the flexible track 218. The edges defining the slot are forced apart by the stretching member 298 in the region where the longitudinal axis 248 coincides with the portion of the rigid guide where the non-linear arcuate portion begins.

[0065] refer to Figure 1 , the distal end of the flexible track 216 is fed into the channel of the rigid guide 218 through its adjacent opening 276. The rigid guide 218 includes a linear portion starting at the adjacent opening 276 and a non-linear portion defined by the cover 268 and the base 270. In one embodiment, the non-linear portion is an arcuate portion having at least one inflection point. The flexible track 216 is initially positioned within the rigid guide 218 by feeding the distal end 254 of the flexible track 218 into the adjacent opening 276 of the rigid guide 218 until the distal end 254 of the flexible track 216 extends beyond the ring 250 of the rigid guide 218. The distal end 254 of the flexible track 216 is operably connected to the member 258 of the sheath clamp 256. The sheath clamp 258 is positioned within the ring 250 so that the member 266 is positioned in a corresponding matching groove in the ring 250. The sheath clip 256 is positioned in a first loading position wherein the passage opening 276 of the sheath clip 258 is aligned with the opening 278 of the collar 250 .

[0066] The flexible track 216 is rotated by a technician or operator within the rigid guide 218 so that the opening 274 faces in an upward direction. In other words, the opening 274 of the flexible track 216 is secured to the sheath clip 256 in such a manner that when the sheath clip 256 is engaged with the ring 250, the opening 276 of the sheath clip 256 is aligned with the opening 278 of the ring 250, and the opening 278 of the ring 250 is also aligned with the opening 274 of the flexible track 216.

[0067] refer to Fig.10 , the flexible track 216 is fixed to the sheath clamp 256, wherein a portion of the flexible track 216 extends beyond the ring 250 in the distal position. The extension of the distal end 254 of the flexible track 216 allows for easy insertion of the flexible track 216 into the sheath clamp 256. Since the flexible track 216 is formed of a flexible material having an elastic modulus less than the elastic modulus of the rigid guide material, the flexible track 216 moves along the curved non-linear portion of the channel defined by the rigid guide 218. Note that the elastic modulus of the flexible track 216 is below a value that would cause the flexible track 216 to break or rupture by moving along the non-linear portion of the rigid guide 218. In one embodiment, the flexible track 216 is formed of a polytetrafluoroethylene (PTFE) material. The sheath clamp 256 moves adjacent to the ring 250 with the distal end 254 of the flexible track 216. The sheath clamp 256 rotates with the flexible track 216 so that the opening 276 of the sheath clamp 256 is aligned with the opening 278 of the ring 250, defining the installation position of the guide catheter. As discussed below, in one embodiment, the sheath clip 420 is configured to be received within the cartridge 222 in a suitable installation orientation.

[0068] refer to Figure 5, the guide catheter 228 is positioned within the opening 274 of the flexible track 216 through the opening 278 of the ring 250 and the opening 276 of the sheath clip 256. Figure 5 and Fig. 9 , the distal end 280 of the sheath clip 256 includes a collar 282 having an opening 284. In the installed position, the guide catheter 228 extends through the opening 274, through the opening 278 of the collar 250, and through the openings 276, 284 of the sheath clip 256 into the flexible track 216. In this installed position, the guide catheter 228 maintains a straight and linear orientation along its longitudinal axis 248 from the Y-shaped connector holder 236 through the distal end of the sheath clip 256.

[0069] refer to Fig.11 , the rigid guide 218 includes a stretch member 298 extending into a channel defined by the outer wall of the rigid guide 218. The stretch member 298 is received into the channel of the flexible track 218 through the slot 286. The stretch member 298 is positioned proximate to the distal end 300 of the arcuate portion of the rigid guide 218. The stretch member 298 has a thickness equal to or greater than the opening defined by the slot 286 to ensure that the edges of the flexible track 216 defining the slot remain separated so that the guide catheter 228 can extend through the slot into the channel portion of the flexible track 216. In one embodiment, the thickness of the stretch member 298 is greater than the opening defined by the slot and the diameter of the guide catheter 228. In this way, the opening defined by the slot 286 is increased at the stretch member and is immediately adjacent to the stretch member to allow insertion and removal of a portion of the guide catheter 228. In one embodiment, the opening defined by the slot is smaller than the diameter of the guide catheter 228, which helps maintain the distal portion of the guide catheter in the channel of the flexible track 216 during operation of the robotic catheter system.

[0070] refer to Fig. 6A and Fig.12 , the sheath clip 256 is placed in the installed position with the opening 276 in the upward direction. In other words, the opening 276 is formed by a channel in the sheath clip 256 that defines an opening that is entered from the upward direction. This orientation allows the guide catheter 228 to be positioned within the channel of the sheath clip 256 and the opening 274 of the flexible track 216 in the same orientation as the guide catheter is secured to the cassette 222. In this orientation, the guide catheter 228 can be placed into the channel of the flexible track 216 through the openings 276 and 284 of the sheath clip 256 and through the opening 274 of the flexible track 216.

[0071] refer to Figure 6B and Fig.13 In one embodiment, the sheath clamp 256 is rotated about the longitudinal axis 248 until the opening 276 is Fig.12286. In this manner, the guide catheter 228 is helped to remain within the channel of the flexible track 216. When the sheath clamp 256 is rotated 90 degrees, the extension member 298 acts immediately adjacent the longitudinal axis 248 to widen the opening defined by the slit 286. In this manner, the guide catheter 228 can enter and exit the flexible track 216 without interfering with the edges of the flexible track defining the slit 286. In one embodiment described below, the sheath clamp 420 need not be rotated, but simply pulled distally away from the box 222.

[0072] In one embodiment, the sheath clip 256 is Figure 6B In one embodiment, the sheath clip 256 is rotated 90 degrees in the first direction illustrated in FIG, and in another embodiment, the sheath clip 256 is rotated 90 degrees in the direction opposite to the direction. It is also contemplated that the sheath clip 256 can be rotated less than or greater than 90 degrees. In one embodiment described below, the sheath clip 420 does not need to be rotated.

[0073] refer to Fig.14 and Fig.15 In one embodiment, once the sheath clip 256 has been rotated to Fig.13 , the user pulls the sheath clip away from the box 222 in the direction along the longitudinal axis 248 until the distal end 280 of the sheath clip 256 is close to the patient. In one embodiment, the introducer is fixed to the distal end 280 of the sheath clip 256. The introducer is a device fixed to the patient to clearly position the introducer to the patient to allow the insertion and removal of an elongated medical device such as a guide catheter, a guide wire, and or a working catheter into the patient with minimal tissue damage to the patient. Once the operator pulls the sheath clip and the accompanying flexible track toward the patient to bring the introducer close to the patient, the flexible track is locked in place by the locking clamp 310.

[0074] The locking clamp 310 secures the flexible track 216 to the base 214 so that a portion of the flexible track 216 is in a fixed position relative to the bed and the patient to the extent that the patient can still lie in the bed. Fig.18 The linear drive mechanism 312 includes a linear slide that is automatically controlled by the user through a remote control station. The catheter drive mechanism 312 drives the robotic mechanism 212 along the longitudinal axis 248. Since the rigid guide 218 is fixed relative to the robotic mechanism 212, the flexible track 216 moves relative to the rigid guide 218 as the robotic mechanism 212 moves along the longitudinal axis 248.

[0075] refer to Fig.14 , 15 , 16 and 17, the operation and movement of the flexible track 216 relative to the rigid guide 218 will be described. Fig.14, the flexible track 216 is shown in an installed first position, wherein the guide catheter 228 is positioned within the sheath clip 256 and the flexible track opening 274 as described above. Fig.15 As described above, once the sheath clip 256 has been released from the cartridge 222, the sheath clip 256 and the distal end of the flexible track are pulled away from the cartridge 222 by the user so that the distal end of the sheath clip 256 is proximate to the patient's entry point where a percutaneous intervention will occur. As described in further detail below, the locking clamp 310 is operable to clamp a portion of the flexible track 216 that secures the flexible track 216 relative to the base 214.

[0076] refer to Fig.14 and 15 , the portion of the flexible track 216 positioned in the arcuate portion of the rigid guide 218 is pulled out from the distal end of the rigid guide 218 in a direction generally along the longitudinal axis 248. Similarly, the portion 322 of the flexible track 216 outside the arcuate portion of the rigid guide 218 and not located within the arcuate portion is pulled into the arcuate portion of the rigid guide 218, and depending on how far the end of the flexible track is pulled toward the patient, the portion 322 of the flexible track 216 will enter the arcuate portion of the rigid guide 218 and may extend therefrom. In other words, the flexible track 216 includes three general regions that change with the operation of the guide catheter system. A first proximal region, which includes the portion of the flexible track from the proximal end 253 of the arcuate portion of the rigid guide 218 to the opening 324. The flexible track 216 includes a second portion located between the proximal end 324 of the arcuate portion of the rigid guide 218 and the distal end 325 of the proximal ring 250 of the arcuate portion of the rigid guide. The flexible track includes a third region extending from the loop 250 of the rigid guide 218 in a direction defined by a vector generally along the longitudinal axis 248 , the vector having an origin at the Y-connector and extending in a direction toward the loop 250 .

[0077] As described above, the first and second regions of the flexible track 216 are offset from and not co-linear with the longitudinal axis 248. As the flexible track 216 exits the loop 250 of the rigid guide 218, the third portion of the flexible track 216 is substantially co-axial with the longitudinal axis 248.

[0078] During one type of intervention, a guide catheter 228 is inserted into a patient's femoral artery via an introducer and positioned proximate to the coronary ostium of the patient's heart. The operator may wish to automatically reposition the distal end of the guide catheter. Fig.16 and Fig.17 , the control of the distal end of the guide catheter 228 will be described. Fig.16, the guide catheter 228 has a distal portion that extends beyond the distal end of the sheath clip 256 to extend beyond the end of the guide catheter 228 in a direction away from the end of the sheath clip. As described above, the distal end of the guide catheter 228 can be placed near the patient's orifice. Automatic control of the distal end of the guide catheter 228 is achieved by the robotic drive mechanism 212 moving relative to the base 214 through the linear drive 312. The guide catheter is located in the channel of the flexible track from the box 222 to the sheath clip 256. Since the flexible track 216 is fixed relative to the base 214, as described above, the second portion of the flexible track 216 will move from within the arcuate portion of the rigid guide 218 to a position offset from the longitudinal axis 248. Similarly, the third portion of the flexible track 216 that extends distally beyond the ring 250 will retract and move into the arcuate portion of the rigid guide 218, and in doing so move away from and offset from the longitudinal axis 248.

[0079] If the guide catheter begins to slip out of the hole during the PCI procedure, it is possible to extend the distal end of the guide catheter 228 back into the patient's hole by automatically moving the robotic drive 212 toward the patient. In doing so, as an example, the distal end of the guide catheter 228 is moved toward the patient, causing the distal end of the guide catheter to be reinserted or positioned into the patient's hole. When the robotic drive mechanism 212 moves along the longitudinal axis 248, the flexible track 216 moves relative to the rigid guide 218. In actual operation, a portion of the flexible track 216 is fixed in the gap relative to the base 214 at the locking clamp 310. However, depending on the direction in which the robotic drive mechanism 212 moves, the portion of the flexible track 216 located within the arcuate section of the rigid guide 216 moves toward the longitudinal axis 248 or moves away from the longitudinal axis 248. The guide catheter 228 moves into or out of the section of the flexible track 216 that moves in and out of the arcuate portion of the rigid guide 218. In this manner, the portion of the guide catheter 228 between the cartridge 222 and the sheath clip remains within the channel of the flexible track 216. In this manner, the guide catheter 228 may be manipulated within the flexible track 216 during percutaneous interventions without buckling or causing other undesirable movement.

[0080] refer to Fig.16 and Fig.17, since the movement of the flexible track 216 about the rigid guide 218 is related to a single segment A on the flexible track 216, the movement of the flexible track 216 about the rigid guide 218 will be described. In one embodiment, the segment A on the flexible track 216 is located away from the loop 250 of the rigid guide 218. When the operator determines to insert the guide catheter 228 further into or toward the patient in a direction away from the loop 250, the input device is manipulated by the user at the remote control station, which drives the robotic drive 212 distally along the longitudinal axis 248 by activating the linear drive 312. The proximal end of the guide catheter 228 is longitudinally fixed in the box 222 by the clamp 310, so that when the robotic drive 312 including the box 222 is moved relative to the base 214 by the linear drive 312, the guide catheter 228 is moved distally along the longitudinal axis 248 in a direction toward the patient. As a result, the distal end of the guide catheter 228 moves toward and / or into the patient.

[0081] As the robotic drive mechanism moves along the longitudinal axis 248, segment A of the flexible track 216 moves through the loop 250 into the rigid guide 218 and along the arcuate portion of the rigid guide 218 until segment A of the flexible track 216 is adjacent the proximal opening of the rigid guide 218. In this manner, the distal end of the flexible track remains in a constant position, but segment A of the flexible track 216 moves out of or away from the longitudinal axis 248. As segment A moves from a point proximate the loop 250 into the arcuate channel defined by the rigid guide 218, the guide catheter 228 enters the channel or hollow lumen of the flexible track 216 through the slot in the engagement region proximate the loop 250. In this manner, the flexible track 216 provides continuous support and guidance of the guide catheter 228 between the loop 250 and the patient as the distal end of the guide catheter 228 moves toward and away from the patient.

[0082] Similarly, if the operator desires to retract the distal end of the guide catheter 228 from within the patient, the user provides commands to the linear actuator via the remote control station to move the robotic drive mechanism 212 in a direction away from the patient. In this way, segment A of the flexible track 216 will enter the proximal end of the arcuate portion of the rigid guide and be guided within the channel of the rigid guide 218 until segment A exits the distal end of the rigid guide 218. The guide catheter 228 will enter the slot at segment A, or in other words, a portion of the guide catheter 228 will enter the flexible track 216 via a portion of the slot that is within the concentric circle made at segment A of the flexible track. It is noted that although the segments of the flexible track are positioned in different areas of the rigid guide as the robotic mechanism moves toward and away from the patient, the proximal and distal ends of the flexible track remain in fixed locations as the robotic mechanism moves along the longitudinal axis.

[0083] refer to Figure 19-2 6, the locking clamp 310 includes a base portion 320 operably connected to the base 214 and a clamp portion 322 coupled to the base portion 320 via an engagement mechanism 324. The engagement mechanism 324 includes a pair of hooks 370, 371 on the base portion 320, which engage the portion 357 via two notches or grooves 360 and 362 on the clamp portion 322. The clamp portion 322 includes a body 326 having a rigid guide connector 328 pivotally received in an opening in the rigid guide. The connector 328 includes a cylindrical member 356 received in an opening in the rigid guide 218. Reference Fig.21 , the clamp portion 322 is in a raised position that can be used to transport the box separately from the robot drive base 220 without the clamp portion 322 extending outwardly or rearwardly from the box. The clamp portion 322 is pivoted about the longitudinal axis of the rigid guide 218 near the opening in the rigid guide 218 to be oriented outwardly to couple to the base portion 320.

[0084] refer to Fig.24 , the cylindrical member 356 defines a channel extending therethrough, through which the flexible track 216 extends. A flat plate support 332 extends inwardly from the cylindrical member 356 into the channel. An inner cylindrical guide member 330 extends from the flat plate support 332 so that the cylindrical guide member is coaxial with the cylindrical member 356. The flexible track 216 is spiraled through an adjacent opening in the rigid guide 218 and over the inner cylindrical guide member 330 so that the slot in the flexible track 216 passes over the flat plate support 332. In this way, the flexible track 216 is positioned between the inner cylindrical guide member 330 and the cylindrical member 356. Reference Fig.26A , cylindrical member 356 includes a longitudinal opening through which cam member 338 extends from body 326 toward an area defined between inner cylindrical guide member 330 and cylindrical member 356. Cam member 338 acts to lock flexible track 216 against inner cylindrical guide member 330, as described below.

[0085] The cam lock portion 322 includes a handle member 334 having a handle portion 354 and a bearing surface 358, and a cam portion 355. The handle member 334 includes a keyed rod 352 connected to the bottom key socket 344 through a keyed opening 350. Fasteners secure the handle 334 to the bottom key socket 344. The body 326 includes an opening 336 through which the bearing 358 and the cam 355 extend. The cam plate 338 includes a hole 342 having an interior surface. The cam plate 338 includes a locking surface 340. In operation, the cam plate 342 is positioned in a slot in the body 326 so that the opening 342 is aligned with the opening 336.

[0086] refer to Fig.25A , 26A, in the unlocked position, the locking surface 340 does not abut the flexible track 216. Fig.25B and 26B , the bearing member 358 cooperates with the wall of the opening 336 to centrally position the handle 334 within the opening 336. The cam member 355 is positioned within the opening 342 of the cam plate 338 so that when the handle 334 is rotated, the locking surface 340 moves toward and away from the rigid guide 218 to operably lock and unlock the flexible track 216 relative to the lock 310 and thereby relative to the base 214.

[0087] refer to Fig.29 and 30 , the Y-shaped connector 233 is a hemostatic valve 402 including a valve body and a first leg having a proximal port, a distal port, and a cavity extending between the proximal port and the distal port. At least one valve is located in the cavity adjacent to the proximal port to allow an interventional device to pass therethrough. The valve body includes a second leg extending at an angle relative to the first leg and in fluid communication with the first leg. A swivel male Luer lock connector is rotatably connected to the valve body near the distal end to secure the proximal end of the guide catheter 228 to the proximal end of the guide catheter 228.

[0088] To it.

[0089] In one embodiment, the hemostasis valve 402 includes a blood flashback valve for reducing blood that may be lost during an interventional procedure. The blood flashback valve acts to allow an elongated device such as a guidewire to extend therethrough but minimizes blood loss across the valve. In one embodiment, the hemostasis valve 402 includes a Tuohy-Borst adapter that allows adjustment of the size of the opening in the proximal end. Rotation of the engagement member about the longitudinal axis of the valve acts to increase or decrease the diameter of the opening.

[0090] In one embodiment, the blood flashback valve is opened from a closed position to a fully open position by movement or translation of the engagement member alone. In one embodiment, the engagement member is pushed or pulled along the longitudinal axis of the elongated medical device to fully open or fully close the valve. Some hemostatic valve devices include two types of controls: a push-pull control that opens and closes the Tuohy-Borst valve by rotating the engagement member about the longitudinal axis of the engagement member and moving the engagement member along the longitudinal axis to open and close the blood flashback valve. Other types of control mechanisms are known, such as using a lever or ratchet to open or close the valve.

[0091] refer to Fig.29 and Fig.30, the hemostasis valve 402 includes an engagement member 416 that provides operation of a Tuohy-Borst valve by rotation of the engagement member 416 and provides push-pull adjustment of the blood return valve between fully open and closed positions by movement of the engagement member 416 along the longitudinal axis of the hemostasis valve.

[0092] Control of the Tuohy-Borst and flashback valves is accomplished automatically from the remote control station 14 via a first drive member 406 operably connected to a first drive member 404 to rotate the engagement member about the longitudinal axis. In one embodiment, the first drive member is a drive gear and the drive member 404 is a bevel gear fixed to the engagement member 416 and operably connected to the drive gear. A second drive member 412 is operably connected to the engagement member to translate the engagement member 416 along the longitudinal axis of the hemostasis valve. In one embodiment, the second drive member is a rod that is automatically controlled via a motor controlled by the remote control station 14. The rod 412 operably engages a circular groove 414 in the outer periphery of the engagement member 16 so that movement of the rod 412 results in translation of the engagement member 416, which opens the flashback valve between the closed and open positions as described above.

[0093] In one embodiment, the user can operate the first drive member 412 and the second drive member 412 by providing instructions through user input to rotate the engagement member 416 about the longitudinal axis and / or rotate and translate the engagement member 416 along the longitudinal axis to open and close the blood return valve and the Tuohy-Borst valve. In one embodiment, the first drive member 412 and the second drive member 412 are automatically operated by the remote automatic control station 14 in response to sensors that sense blood flow and / or friction required to move the elongated medical device through the hemostatic valve and / or the patient's vascular system. When the system detects that the force required to automatically rotate and / or translate the elongated medical device reaches a certain predetermined value, the processor will provide instructions to incrementally open and or close the opening in one or both valves. Monitoring of the patient's blood pressure and or whether blood is lost through the valve will be used as a factor in the algorithm to determine the appropriate adjustment of the opening in the valve.

[0094] Reference Fig. 27, the robotic catheter system 210 operates the bedside system 12 adjacent to the patient's bed 22 in close proximity. The remote workstation 14 includes a control controller 16, a user interface 18, and a display 20. The imaging system 24 can be any medical imaging system (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.) that can be used in conjunction with a catheter-based medical approach. In one embodiment, the imaging system 24 is a digital x-ray imaging device that communicates with the workstation 14. The imaging system 24 is configured to take an x-ray image of an appropriate part of the patient during a particular approach. For example, the imaging system 24 can be configured to take one or more x-ray images of the heart to diagnose a cardiac condition. The imaging system 24 can also be configured to take one or more x-ray images (e.g., real-time images) during a catheter-based medical approach to assist the user of the workstation 14 in correctly positioning the guidewire, guide catheter, and working catheter (such as a stent) during the approach. One or more images can be displayed on the display 20 to allow the user to accurately position the distal tip of the guidewire or working catheter into the appropriate position of the patient's vascular system.

[0095] refer to Fig.28 , the flexible track 216 extends toward the patient along the longitudinal axis 248. However, the patient may move during the procedure, causing the sheath clip to be pulled away from or toward the patient. In one embodiment, the flexible track 216 presents an arc between the distal end of the box 222 and the patient. The guide catheter 228 positioned within the lumen defined by the flexible track 216 presents the same arc as the flexible track 216. If the patient moves away from the box 222 during the procedure, the arc 390 will flatten. Similarly, if the patient moves toward the box 222 during the procedure, the arc 390 will be more pronounced. In both cases, the flexible track 216 prevents the guide catheter 228 from buckling during the PCI procedure.

[0096] refer to Fig.30 In one embodiment, the sheath clip 420 is explicitly received within the distal end of the cassette 222. The distal end of the flexible track 216 is secured to the sheath clip 410 adjacent the radially extending handle portion 428, and the sheath clip 420 includes a groove 430 having an opening 432. The distal end of the flexible track 216 is located within the bottom of the groove 430. Fig.31 In the illustrated installed position, the longitudinal axis of the sheath clip 420 is coaxial with the longitudinal axis 248 of the robotic mechanism 212. To position the sheath clip 420 and the flexible track 216 in the operating position, the user pulls on the handle portion 428 and extends the sheath clip 420 and the attached flexible track 216 in a direction away from the robotic mechanism 212 and toward the patient. In one embodiment, the introducer sheath 420 does not need to be rotated relative to the cartridge 222. The user simply pulls the sheath clip 420 distally in a direction away from the robotic mechanism 212.

[0097] refer to Fig.32 and Fig.33 , the sheath clamp 420 includes a catheter sheath connector 424 that releasably engages the catheter sheath 422. The catheter sheath connector includes at least a portion of the sheath clamp 420 that is rotatably coupled to the handle portion 428. The catheter sheath connector 424 includes an arm 436 that releasably engages an outer surface of the introducer 422 to operably couple the catheter sheath to the sheath clamp 420. Fig.33 The arms 436 in the engaged position shown in FIG. 4 prevent the catheter sheath 422 from moving along the longitudinal axis toward or away from the sheath clamp 420 toward the patient. The tube extending from the catheter sheath 422 is captured between the sheath clamp 420 and the arms 436.

[0098] Although the above written description of the present invention enables ordinary technicians to make and use what is currently considered to be the best mode thereof, those ordinary technicians will understand and appreciate that variations, combinations and equivalents of the specific embodiments, methods and embodiments herein exist. Therefore, the present invention should not be limited by the above embodiments, methods and embodiments, but by all embodiments and methods within the scope and spirit required by the present invention.

[0099] 1. A robotic catheter system comprising:

[0100] Pedestal;

[0101] a robotic mechanism having a longitudinal axis and movable along the longitudinal axis relative to the base;

[0102] a flexible track releasably secured to the base and including an outer surface having a longitudinal open slot extending therethrough to an interior passage;

[0103] a rigid guide having a non-linear portion fixed relative to the robotic mechanism,

[0104] As the robotic mechanism moves relative to the base, a portion of the flexible track moves along a non-linear path portion of the rigid guide.

[0105] 2. The robotic catheter system of clause 1, further comprising an elongated medical device operably connected to the robotic mechanism, the elongated medical device positioned in the interior channel of the flexible track.

[0106] 3. A robotic catheter system according to claim 2, wherein the elongated medical device is a guide catheter having a linear longitudinal axis, and when the robotic mechanism moves relative to the base, a portion of the flexible track moves from a position that is not coaxial with the longitudinal axis of the guide catheter to a position that is coaxial with the longitudinal axis.

[0107] 4. The robotic catheter system of clause 3, wherein the guide catheter and a portion of the flexible track are coaxial distal to the robotic mechanism.

[0108] 5. The robotic catheter system of clause 4, wherein the guide catheter and a portion of the flexible track are non-coaxial near the distal end of the robotic mechanism.

[0109] 6. The robotic catheter system of clause 1, wherein a portion of the flexible track moves away from the longitudinal axis of the elongated medical device when the robotic mechanism moves relative to the base along the longitudinal axis.

[0110] 7. The robotic catheter system of clause 6, wherein the robotic mechanism comprises at least one drive mechanism to drive a guidewire along the longitudinal axis.

[0111] 8. A robotic catheter system according to claim 2, wherein the elongated medical device is a guidewire and the robotic mechanism includes a first drive to transmit linear motion to the guidewire along the longitudinal axis and a second drive to transmit rotational motion to the guidewire about the longitudinal axis.

[0112] 9. The robotic catheter system of clause 1, wherein the rigid guide is fixed relative to the robotic mechanism.

[0113] 10. The robotic catheter system of clause 9, wherein the robotic mechanism comprises a base drive portion and a separate box operably secured to the base drive portion, the rigid guide being attached to the box.

[0114] 11. The robotic catheter system of clause 10, wherein the flexible track and the guide catheter are coaxial distal to the cartridge and non-coaxial along the longitudinal axis of the cartridge and the guide catheter.

[0115] 12. The robotic catheter system of clause 1, further comprising a clamp that releasably secures a portion of the flexible track to the base.

[0116] 13. The robotic catheter system of clause 12, wherein the clamp comprises an outer cylindrical member extending through an opening into a channel of the rigid guide.

[0117] 14. The robotic catheter system of clause 13, wherein the outer cylindrical member comprises an inner cylindrical member operably connected to an inner wall of the outer cylindrical member with a connecting member.

[0118] 15. The robotic system of clause 14, wherein a portion of the flexible track is positioned between an inner wall of the outer cylindrical member and the inner cylindrical member, and the connecting member extends through the seam of the flexible track.

[0119] 16. The robotic system of clause 15, wherein the cylindrical clamp comprises an engagement member that releasably presses a portion of the flexible track against the inner cylindrical member.

[0120] 17. The robotic system of clause 1, wherein the flexible track comprises an opening in the outer surface of the flexible track, the opening extending from the seam proximate a distal end of the flexible track.

[0121] 18. The robotic system of clause 17, wherein the opening extends 45 degrees or more around the flexible track.

[0122] 19. The robotic system of clause 18, wherein the opening tapers into the slot at a predetermined distance from the distal end of the flexible track toward the proximal end of the flexible track, the distance being sufficient to place a guide catheter into the opening when the guide catheter is straight.

[0123] 20. The robotic system of clause 1, further comprising a sheath clamp operably connected to the distal end of the flexible track, the sheath clamp comprising an opening extending from an outer surface, the opening of the sheath clamp allowing the guide catheter to be inserted into the sheath clamp when the guide catheter is straight.

[0124] 21. The robotic system of clause 20, wherein the sheath clamp comprises a connector proximate a distal end of the sheath clamp for coupling a catheter sheath to the sheath clamp.

[0125] 22. The robotic system of clause 1, wherein the robotic mechanism comprises a hemostatic valve actuator comprising a first automatically controlled drive member to open and close a first valve in the hemostatic valve.

[0126] 23. The robotic system according to clause 22, wherein the first valve is one of a tough-borst valve and a blood return valve.

[0127] 24. The robotic system of clause 23, wherein the first drive member transmits rotational movement to an engagement member on the hemostatic valve.

[0128] 25. The robotic system of clause 23, wherein the first drive member transfers linear movement to an engagement member on the hemostatic valve.

[0129] 26. The robotic system of clause 1, wherein the proximal and distal ends of the flexible track remain in fixed positions as the robotic mechanism moves along the longitudinal axis.

[0130] 27. A method of supporting an elongated medical device, comprising:

[0131] translating a robotic mechanism relative to a base along a longitudinal axis, the robotic mechanism comprising a rigid guide having a distal portion along the longitudinal axis and an offset portion offset from the longitudinal axis;

[0132] providing a flexible track having a slot extending into the interior region;

[0133] placing the flexible track within the rigid guide;

[0134] operably securing a portion of the flexible track to the base;

[0135] A portion of the flexible track is moved between the offset portion and the distal portion as the robotic mechanism is extended and retracted along the longitudinal axis.

[0136] 28. The method according to clause 27, further comprising:

[0137] providing an elongated medical device from said robotic mechanism along said longitudinal axis; and

[0138] The flexible track is positioned relative to the elongated medical device proximate a junction between the offset portion and the distal portion of the rigid guide as the robotic mechanism extends along the longitudinal axis.

[0139] 29. The method according to clause 28, further comprising:

[0140] The flexible track is removed relative to the guide catheter from the junction between the offset portion and the distal portion proximate the rigid guide when the robotic mechanism is retracted along the longitudinal axis.

[0141] 30. The method of clause 29, wherein the guide catheter is supported in a region of the flexible track in a direction away from the robotic mechanism and the flexible track includes a portion that deviates from the longitudinal axis and does not support the guide catheter.

[0142] 31. A method according to clause 30, wherein the flexible track is an elongated tubular member having an interior region accessible through the slot; and wherein positioning the flexible track relative to the guide catheter comprises placing the guide catheter within the interior region of the flexible track.

[0143] 32. A method according to clause 31, wherein the rigid guide includes an arcuate portion between the distal end and the proximal end of the rigid guide.

[0144] 33. A method according to clause 27, wherein the robotic mechanism includes a box and a robotic drive base, and wherein the rigid track is part of the box.

[0145] 34. A method according to clause 33, wherein the proximal and distal ends of the flexible track remain in fixed positions as the robotic mechanism moves along the longitudinal axis.

[0146] 35. An apparatus comprising:

[0147] Pedestal;

[0148] a robotic mechanism movable along a longitudinal axis relative to a base by a linear drive, the robotic mechanism comprising a rigid guide having a distal portion along the longitudinal axis and an offset portion offset from the longitudinal axis;

[0149] a flexible track having an interior region, the flexible track including a portion operably secured to the base, the flexible track including a portion within the rigid guide;

[0150] an elongated medical device extending from the robotic mechanism and extending along the longitudinal axis;

[0151] wherein a portion of the flexible track moves between the deviated portion and the distal portion of the rigid guide as the robotic mechanism extends and retracts along the longitudinal axis, and wherein a portion of the flexible track extends relative to the elongated medical device near the junction between the deviated portion and the distal portion of the rigid guide as the robotic mechanism extends along the longitudinal axis.

[0152] 36. A method according to clause 33, wherein the proximal and distal ends of the flexible track remain in fixed positions as the robotic mechanism moves along the longitudinal axis.

Claims

1. A system for controlling a hemostatic valve, comprising: Hemostatic valve, including: a body portion having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end; at least one valve positioned at the proximal end of the body portion; and an engagement member operably coupled to the at least one valve; a sensor configured to sense blood flow; a controller coupled to the sensor and the engagement member; a first drive member coupled to the engagement member and to the controller; as well as a second drive member coupled to the engagement member and to the controller, Wherein, the controller is configured to control the first drive member and the second drive member based on the blood flow sensed by the sensor to respectively impart rotational motion and linear motion to the engagement member to operate the at least one valve.

2. The system according to claim 1, wherein: The controller is configured to incrementally adjust an amount by which the at least one valve is opened or closed.

3. The system according to claim 1, wherein: The at least one valve is a Tuohy-Borst valve.

4. The system according to claim 3, wherein: The controller rotates the engagement member about a longitudinal axis of the hemostatic valve to increase or decrease a size of an opening of the at least one valve.

5. The system according to claim 1, wherein: The at least one valve is a blood return valve.

6. The system according to claim 5, wherein: The controller translates the engagement member along a longitudinal axis of the hemostatic valve to open and close the at least one valve.

7. The system according to claim 1, wherein: The at least one valve includes a blood return valve and a Tuohy-Borst valve.

8. The system according to claim 1, wherein: The hemostasis valve is pivotable from a raised position to an in-use position.

9. The system according to claim 1, wherein: The hemostasis valve is pivotable between a raised position for disengaging the engagement member from the first and second drive members and an in-use position for coupling the engagement member to the first and second drive members.

10. The system according to claim 8, wherein: The first drive member is removably coupled to the engagement member when the hemostasis valve is pivoted to the in-use position and is disengaged from the engagement member when the hemostasis valve is pivoted to the raised position.

11. The system according to claim 10, wherein: The controller is configured to control the second drive member to impart movement to the engagement member to open and close the at least one valve.

12. The system according to claim 11, wherein: The first drive member imparts rotational movement to the engagement member.

13. The system according to claim 11, wherein: The second drive member imparts linear motion to the engagement member.

14. A system for controlling a hemostatic valve, comprising: Hemostatic valve, including: a body portion having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end; at least one valve positioned at the proximal end of the body portion; and an engagement member operably coupled to the at least one valve; a sensor configured to sense frictional forces required to move an elongated medical device through the hemostatic valve and / or a patient's vasculature; a controller coupled to the sensor and the engagement member; a first drive member coupled to the engagement member and to the controller; as well as a second drive member coupled to the engagement member and to the controller, Wherein, the controller is configured to control the first drive member and the second drive member based on the sensed friction force to respectively impart rotational motion and linear motion to the engagement member to operate the at least one valve.

15. The system of claim 14, wherein: The controller is configured to incrementally adjust an amount by which the at least one valve is opened or closed.

16. The system of claim 14, wherein: The at least one valve is a Tuohy-Borst valve.

17. The system of claim 16, wherein: The controller rotates the engagement member about a longitudinal axis of the hemostatic valve to increase or decrease a size of an opening of the at least one valve.

18. The system of claim 14, wherein: The at least one valve is a blood return valve.

19. The system of claim 18, wherein: The controller translates the engagement member along a longitudinal axis of the hemostatic valve to open and close the at least one valve.

20. The system of claim 14, wherein: The at least one valve includes a blood return valve and a Tuohy-Borst valve.

21. The system of claim 14, wherein: The hemostasis valve is pivotable from a raised position to an in-use position.

22. The system of claim 14, wherein: The hemostasis valve is pivotable between a raised position for disengaging the engagement member from the first and second drive members and an in-use position for coupling the engagement member to the first and second drive members.

23. The system of claim 21, wherein: The first drive member is removably coupled to the engagement member when the hemostasis valve is pivoted to the in-use position and is disengaged from the engagement member when the hemostasis valve is pivoted to the raised position.

24. The system of claim 23, wherein: The controller is configured to control the second drive member to impart movement to the engagement member to open and close the at least one valve.

25. The system of claim 24, wherein: The first drive member imparts rotational movement to the engagement member.

26. The system of claim 24, wherein: The second drive member imparts linear motion to the engagement member.

27. A system for controlling a hemostatic valve, comprising: Hemostatic valve, including: a body portion having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end; at least one valve positioned at the proximal end of the body portion; and an engagement member operably coupled to the at least one valve, wherein the hemostatic valve is capable of pivoting from a raised position to an in-use position; a first drive member and a second drive member removably coupled to the engagement member when the hemostasis valve is pivoted to the in-use position and uncoupled from the engagement member when the hemostasis valve is pivoted to the raised position; and A controller is coupled to the first drive member and the second drive member, the controller being configured to control the first drive member and the second drive member to impart rotational movement and linear movement to the engagement member, respectively, to operate the at least one valve.

Images