WO2026024691A1

WO2026024691A1 - Fixed mechanical catheter steering system

Info

Publication number: WO2026024691A1
Application number: PCT/US2025/038608
Authority: WO
Inventors: Benjamin T. ZINSER; Matthew C. BLANCO; Shivansh Kumar; Nathan J. Knutson; Evan M. Gustafson; Badr Elmaanaoui; Scott Robert Tiesma; Dany JUNIO; Paul M. Loschak; Jonathan Scott THOMSON
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2024-07-22
Filing date: 2025-07-22
Publication date: 2026-01-29
Anticipated expiration: 2027-01-22

Abstract

A catheter drive system including a catheter, a catheter insertion mechanism configured to advance and retract the catheter, a catheter steering interface configured to receive one or more mechanical inputs from a user, a steering transmission configured to receive inputs from the catheter steering interface and generate steering outputs, and a catheter steering mechanism secured to the catheter and configured to receive the steering outputs from the steering transmission and apply the steering outputs for articulation of the catheter.

Description

FIXED MECHANICAL CATHETER STEERING SYSTEM

BACKGROUND

1. Technical Field

[0001] The disclosure relates to catheter drive systems including mechanisms for navigation, manipulation, and articulation of catheters and other tools. Aspects of the disclosure are directed to systems for driving and articulating endoluminal catheters within natural lumens of a patient.

2. Discussion of Related Art

[0002] A common interventional procedure in the field of pulmonary medicine is bronchoscopy, in which a catheter is inserted into the airways through the patient’s nose or mouth. The structure of a catheter generally includes a long, thin, flexible tube that may include one or more of three elements: an illumination assembly for illuminating the region distal to the catheter’s tip (e.g., via an optical fiber connected to an external light source); an imaging assembly for delivering a video image from the catheter’s distal tip; and a lumen or working channel through which instruments may be inserted for aspects of a procedure. The tools may facilitate placement (e.g., guide wires), diagnosis (e.g., biopsy tools) and therapy (e.g., treatment catheters including laser, cryogenic, radio-frequency, chemical, or microwave ablation tissue treatment probes) and others.

[0003] With a similar construction, catheters may also be employed to navigate major blood vessels of a patient in order to place a prosthetic device such as a stent or a replacement heart valve. The prosthetic device may be carried as a payload to be deployed within the vasculature of the patient at a desired location. The vascular catheters may be a dual catheter design, where a first catheter enables effective articulation for navigation of the vasculature and once at a desired location an inner catheter carrying the payload may be advanced from the first catheter and the payload deployed.

[0004] Historically, whether navigation of the airways, the vasculature, or other bodily lumens, the catheters have been manually navigated to a desired location. In the example of the airways, a bronchoscope has been employed for initial navigation and the catheter is advanced from the bronchoscope for further navigation of airways that are too small to receive the bronchoscope. Navigation of the vasculature often employs the use of a guide wire which is initially placed within the patient, and the catheter is advanced over the guide wire. Both systems provide immediate feedback to the clinician during the navigation but do have drawbacks in that they require the bronchoscope, catheter, guidewire, and other tools to be held by the clinician during the procedure, resulting in fatigue for the clinician and at times requiring additional hands from a second clinician or nursing staff members to accommodate the many implements being simultaneously employed in the procedure.

[0005] As will be appreciated, robotic systems have also been developed for navigation of robotic catheters. While robotic systems have their benefits, they can be quite complex to set up and require a large capital investment on the part of the hospital or clinic in which they are placed. Further, fully robotic systems, while often receiving user input (e.g., via a game controller), provide only limited and often indirect feedback to the clinician. Accordingly, there is a need for catheter drive systems providing ease of use, appropriate feedback, and at a reasonable cost.

SUMMARY

[0006] One aspect of the disclosure is directed to a catheter drive system including a catheter, a catheter insertion mechanism configured to advance and retract the catheter; a catheter steering interface configured to receive one or more mechanical inputs from a user, a steering transmission configured to receive inputs from the catheter steering interface and generate steering outputs, and a catheter steering mechanism secured to the catheter and configured to receive the steering outputs from the steering transmission and apply the steering outputs for articulation of the catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0007] Implementations may include one or more of the following features. The catheter drive system may include a catheter driver configured to drive the catheter. The catheter driver system includes a drive wheel and an idler wheel, and where the catheter is configured to be received between the drive wheel and the idle wheel. The catheter insertion mechanism includes a belt operably connected to the catheter driver. The belt is operably connected to a driven wheel of the catheter driver and a pulley of the catheter insertion mechanism. The catheter insertion mechanism includes a knob operably connected to the pulley, and where rotation of the knob rotates the driven wheel to advance or retract the catheter. The catheter slack manager secures the catheter between the catheter steering mechanism and the catheter driver. The catheter slack manager includes an inner radius configured to prevent kinking of the catheter. The catheter drive includes a motor operably connected to the first shaft or the third shaft. The catheter drive includes a computer, wherein the computer receives inputs from a sensor operatively connected to the motor and transmits signals to the motor for driving the motor and providing input to the steering transmission. The motor is lockable, and when locked, mechanical inputs to the catheter steering interface are directly transmitted to the steering transmission. The catheter drive system may include a remote transmission operably connecting the steering interface, the catheter insertion mechanism, and the steering transmission. The plurality encoders are configured to detect inputs to the steering interface or the catheter insertion mechanism and transmit them to the remote transmission. The plurality of decoders receive inputs from the remote transmission and signal motors associated with the catheter insertion mechanism and the steering interface to advance, retract, or articulate the catheter. The input section is isolated from the output section via the encoders, the remote transmission and the decoders. The catheter drive system wherein the catheter steering interface may include a handle configured rotate a first shaft and a second shaft. The first shaft connects directly to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a first plane. The second shaft connects to a gear box, and a third shaft extending from the gear box connects to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a second plane. The handle is in sliding engagement with the first shaft. The steering transmission include a gearing arrangement configured to transform the rotation of the first shaft or the second shaft into inputs to the catheter steering mechanism. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0009] FIG. 1 is a top view of a manual mechanical catheter drive system in accordance with the disclosure;

[0010] FIG. 2 is a side view of the manual mechanical catheter drive system of FIG. 1 in accordance with the disclosure; [0011] FIG. 3 is a side view of the manual mechanical catheter drive system of FIGS. 1 and 2 in use navigating within a patient in accordance with the disclosure;

[0012] FIG. 4 is a top view of an electro-mechanical catheter drive system in accordance with the disclosure;

[0013] FIG. 5 is a side view of the electromechanical catheter drive system of FIG. 4 in use navigating within a patient in accordance with the disclosure;

[0014] FIG. 6 schematic diagram of a computing device storing one or more applications for use with a catheter drive system in accordance with the disclosure.

[0015] FIG. 7 is a top view of a remote catheter drive system in accordance with the disclosure;

[0016] FIG. 8 is a side view of the remote catheter drive system of FIG. 6 in use navigating within a patient in accordance with the disclosure;

[0017] FIG. 9A is a perspective view of a sanitary cover for a catheter drive system in accordance with the disclosure; and

[0018] FIG. 9B is perspective view of a further sanitary cover for a catheter drive system in accordance with the disclosure.

[0019] FIGS. 10A and 10B are right and left perspective views of a catheter drive system in accordance with the disclosure;

[0020] FIG. 11 is a side view of the catheter drive system of FIGS. 10A and 10B in accordance with the disclosure;

[0021] FIG. 12 is a bottom semi-transparent view of the catheter drive system of FIGS. 10A and 10B in accordance with the disclosure;

[0022] FIG. 13 is a top view of the catheter drive system of FIGS. 10A and 10B in accordance with the disclosure; and

[0023] FIGS. 14A-14C are top views of a three-position clutching mechanism for the catheter drive system of FIGS. 10A and 10B in accordance with the disclosure.

DETAILED DESCRIPTION

[0024] This disclosure is directed to catheter drive systems configured to advance a catheter into a patient, articulate to achieve a desired location and orientation within the patient, and enable placement of one or more tools or prosthetic devices within the patient. In some aspects of the disclosure the catheters being driven by the catheter drive system are endoluminal catheters configured for insertion into one of a patient’s natural lumens including without limitation the airways, the vasculature, the alimentary canal, bile or gall ducts, and others without departing from the scope of the disclosure. Alternatively, the catheters may be cardiac catheters configured for insertion into the femoral artery or femoral vein or the jugular vein via an incision and navigated within the artery or vein to the heart for application of therapy or deployment of a prosthetic.

[0025] FIG. 1 depicts a top view of a mechanical catheter drive system 100 in accordance with the disclosure. FIG. 2 depicts a side view of the mechanical catheter drive system 100. The mechanical drive system 100 includes a platform 102 to which other components of the mechanical drive system 100 are connected. As shown in FIG. 1 the platform is formed in part of a longitudinal rail 104, and a pair of horizontal rails 106 connected to and extending substantially perpendicularly from the longitudinal rail 104.

[0026] At a proximal end 108 of the mechanical drive system 100 and mounted to a first of the horizontal rails 106 is a catheter steering interface 110. The catheter steering interface 110 includes a handle 112 supported by two struts 114 and fixed to a first shaft 116. Movement of the handle 112 between and in parallel with the two struts 114 in a first direction (e.g., substantially parallel to the horizontal rail 106) causes the first shaft 116 connected to the handle 112 to rotate. As will be described in greater detail below, the rotation of the shaft 116 is transferred to the catheter via a steering transmission 118 to articulate the catheter in a first plane. [0027] The two struts 114 are connected to a second shaft 120. Movement of the handle 112 and the struts 114 in a second direction (substantially parallel to the longitudinal rail 104 and substantially perpendicular to the second shaft 120), causes the second shaft 120 to rotate about its axis. In at least one aspect of the disclosure, to enable the rotation of the second shaft 120 the handle 112 sliding engages the first shaft 116 (move along its length) in a direction parallel with the longitudinal rail 104. The sliding arrangement allows the handle 112 and struts 114 to rotate about the second shaft 120. [0028] A gear box 122 into which the second shaft extends transfers the rotation of the second shaft 120 to a third shaft 124 which is received in the steering transmission 118 causing the catheter to articulate in a second plane (substantially perpendicular to the first plane). As will be appreciated, articulating the catheter in both the first and second planes enables articulation in substantially all planes between the first and second planes.

[0029] A knob 126 on a catheter insertion mechanism 127 connects to a fourth shaft 128 and a pully 130 is mounted on the fourth shaft 128. The fourth shaft 128 and pulley 130 may be in a housing 134 may be connected to the gear box 122. The housing 134 and/or the gear box 122 are connected to and supported by the longitudinal rail 104. A belt 136 extends from the pulley 130 to a catheter driver 138. A second pulley (not shown) is driven by the belt 136. The second pulley is connected (e.g., via a shaft not shown) to one or more drive wheels (not shown) within the catheter driver 138. The catheter driver 138 also includes one or more idler wheels (not shown). The catheter is located between the one or more drive wheels and the one or more idler wheels maintaining its column shape and friction between the one or more drive wheels and the catheter advance or retract the catheter depending on the direction of rotation of the knob 126 and the force applied to the drive wheel via the belt 136.

[0030] As described above the first shaft 116 and the third shaft 124 extend to the steering transmission 118. Mounted on the steering transmission 118 is a catheter steering mechanism 140. The steering transmission 118 receives the input from the first shaft 116 and third shaft 124 and converts the inputs using a gearing arrangement (e.g., a bull gear connected to the shafts 116 and 124 mating with pinion gears) to an appropriate output. Steering transmission 118 (and specifically the gearing arrangement) enables the inputs received via the handle 112 to be transferred and converted to inputs to the catheter steering mechanism 140.

[0031] The catheter steering mechanism 140 includes a catheter 142, and in accordance with this aspect of the disclosure includes two pairs of articulation wires or pull wires (not shown) extending to the distal end of the catheter 142. The catheter steering mechanism 140 is a replaceable component, which can be removed from the remainder of the catheter drive system 100. The catheter steering mechanism 140 receives the rotational input from the steering transmission 118 and converts the rotational input into linear movement. That linear movement acts on the articulation wires causing them to lengthen or shorten respectively to enable articulation of the catheter 142. Movement of the handle 112 causes either or both of the shafts 116 and 124 to rotate, this rotation is converted by the steering transmission 118 to an input to the catheter steering mechanism 140, as described above, acting on the pairs of articulation wires. Referring to just one pair of the articulation wires, by shortening one wire and lengthening the second of the pair articulation of the catheter 142 in a first plane is achieved. Referring to the second pair, shortening one wire and lengthening the second wire of the second articulates the catheter 142 in a second plane. As will be appreciated, the use of both pairs of articulation wires enables articulation of the catheter to substantially any angle or orientation necessary for navigation within a patient and is limited only by the mechanical limits of the materials making up the catheter 142. Adjusting the articulation of the catheter 142, an orientation of the distal portion of the catheter can be adjusted. This adjustment can be used to orient the catheter for advancement into an airway at a bifurcation, to prevent impact of the catheter on certain tissues, or navigate a change in direction of a natural lumen of the patient. [0032] A catheter slack manager 144 is secured to the longitudinal rail 104. The catheter slack manager 144 wedges a proximal portion of the catheter 142 between two fins 146 to prevent movement of the proximal portion of the catheter 142 along the longitudinal axis of the catheter 142. The distal portion of the catheter 142 is placed in the catheter driver 138. Slack in the catheter 142 (See FIG. 3) causes the catheter 142 to bow upwards between the catheter driver 138 and the location in the slack manager 144 where the catheter is wedged. As the knob 126 is rotated causing belt 136 to rotate the drive wheel of the catheter driver 138, the catheter 142 is advanced through the catheter driver 138 and into the patient. By this advancement of the catheter 142 the slack in the catheter 142 is reduced. By trapping the catheter 142 between the catheter slack manager 144 and the catheter driver 138 the excess length of the catheter 142 not yet inserted into the patient is held in place and no additional hands of the clinical staff are needed to limit the catheter’s movement or otherwise control the catheter 142. Further, though the catheter 142 is held in place by the slack manager 144, the articulation of the distal portion of the catheter 142 (as described above) is not limited or affected by the slack manager 144. [0033] The catheter slack manager 144 includes an inner radius, not shown. In inner radius prevents the catheter 142 from being forced into a sharp angle when inserted into the patient. As will be appreciated, by maintaining a radiused shape, the catheter 142 is prevented from kinking. Kinking of the catheter 142 can prevent tools such as biopsy or therapy tools, or tools carrying a prosthetic device for implant from being passed through the catheter 142. In addition, kinking of the catheter 142 could prevent the articulation wires from being effectively manipulated (as described above) and therewith prevent the articulation of the catheter 142. Still further, the catheter 142 may include one or more sensor wires (not shown) connected to a sensor at a distal end of the catheter 142, which when kinked may be damaged limiting their effectiveness.

[0034] FIG. 3 depicts a clinician “C” using the mechanical catheter drive system 100 to advance a catheter 142 into a patient “P ” As shown, the catheter slack manager 144 in combination with the catheter driver 138 manages the slack in the catheter 142. In addition, the combination ensures that the catheter 142, as it is initially advanced into the patient “P” is in a substantially vertical orientation allowing easy access through the mouth or the nose to enter the trachea and navigation of the airways via articulation. As described above, the inner radius of the slack manager 144 prevents kinking of the catheter 142 as the catheter 142 reaches the end of its insertion length and all of the slack in the catheter is removed.

[0035] A further aspect of the mechanical catheter drive system 100 is the ability to change the speed of the inputs from the clinician “C.” As an example, the knob 126 may have a configuration similar to that found on a microscope, where and outer ring of the knob 126 allows for movement at a first speed (e.g., high-speed), whereas an inner ring of the knob 126 may be geared such that it produces movement at a second (e.g., low speed). This enables rapid advancement of the catheter 142 when navigating the central airways and further enables more fine advancements when catheter is located in the periphery where smaller movements may be desired. Similarly, the first shaft 116 and the third shaft 124 may be configured to receive input not just from the handle 112, but also from knobs (not shown) connected thereto. These knobs may be geared and allow for smaller more controlled articulation of the catheter 142 as might be required for final placement and orientation of the catheter 142 prior to acquisition of a biopsy, application of therapy, or deployment of a prosthetic.

[0036] In addition to the fine adjustment mechanisms described above, the knob 126 and the handle 112 may include a locking mechanism. The locking mechanism may prevent rotation of the knob 16 and prevent further insertion of the catheter 142 into the patient. Similarly, one or more locks may prevent the rotation of the first shaft 116 or the second shaft 124. By preventing the rotation of either of these shafts (116, 124) the handle 112 can be prevented from moving in at least one direction to prevent articulation of the catheter 142 using the pull wires. Further, these locks may be configured in a “toggle lock off’ arrangement where to enable any movement of the knob 126 or the shafts 116, 124 the lock must be first turned off before advancement or articulatio of the catheter 142 is possible. Alternatively, the locks may be configured in a “toggle lock on” arrangement where after navigating the catheter to a desired location and orientation the locks can be engaged to prevent further advancement or articulation of the catheter 142.

[0037] Those of ordinary skill in the art will recognize that due to the mechanical nature of the inputs of the mechanical catheter drive system 100, resistances to advancement and articulation can be felt by the clinician and thus inform the clinician of the nature of the patient’s airway. This direct feedback (resistance to movement) is most similar to that experienced by clinicians when using prior manual catheter navigation systems.

[0038] In accordance with the disclosure, the catheter steering mechanism 140 and the catheter 142 connected thereto may be single use component that is removed and disposed of following a procedure. Alternatively, the catheter steering mechanism 140 and the catheter may be reprocessed. A sterilization procedure as well as a quality check procedure (e.g., inspection and confirmation of pull wires and sensors operating properly) can be undertaken during reprocessing. Optionally during reprocessing, the catheter 142 may be disconnected from the catheter steering mechanism 140 and a new catheter 142, the only portion of the mechanical catheter drive system to contact the patient, can be attached. As will be appreciated, in accordance with an aspect of the disclosure replacement of the catheter 142 may require connection the articulation wires and sensor wires within the catheter steering mechanism 140 to enable effective operation of the catheter 142 in a luminal navigation procedure.

[0039] The catheter steering mechanism 140 includes a port (not shown) connected to an inner lumen of the catheter 142. The port provides access to the inner lumen and allows for insertion of tools (e.g., biopsy tools, therapy tools, prosthetic deployment tools, etc.). In this manner, following or during navigation of the catheter 142 to a desired location and orientation, the tool can be inserted through the lumen of the catheter 142 to the desired location for biopsy, therapy, or prosthetic placement. Though not shown, a tool driving mechanism, similar to the catheter driver 138 may be optionally employed to advance the tool through the catheter 142.

[0040] As will be appreciated, the platform 102 can also provide a location for placement of additional clinical tools. The additional tools may include suction, lavage, and others that can utilize the lumen of the catheter to gain access to the patient. As will be described in greater detail below, the platform 102 may also include a cover incorporating palm or wrist rests for ergonomics so that the clinician does not become fatigued during a procedure, and to provide additional support and leverage for the clinician’s hands during the procedure.

[0041] The steering transmission 118 may include a clutching mechanism where a user could engage or disengage the catheter steering mechanism 140 from the catheter steering interface 110. This clutch mechanism allows a homing step in the setup workflow to ensure the center of motion of the catheter 142 and the handle 112 are aligned. This can be adjusted after the catheter steering mechanism 140 is installed onto steering transmission 118. In accordance with the disclosure, the clutching mechanism allows the user to adjust the range of motion of their catheter 144 and change the position of the distal end of the catheter relative to the handle 112 after the catheter drive system 100 is set up.

[0042] FIG. 4 depicts a further aspect of the disclosure, and electromechanical catheter drive system 200. The electromechanical catheter drive system 200 substantially mirrors the mechanical catheter drive system 100, except that it includes inline motors 202 between the catheter steering interface 110 and the steering transmission 118, as well as between the gear box 122 and the steering transmission 118. Rather than relying solely on the mechanical inputs from the handle 112 to drive the first shaft 116 and the third shaft 124 and provide input to the steering transmission 118, in accordance with embodiments of the disclosure, sensor(s) associated with the inline motors 202 detect the mechanical movements of the handle 112. The mechanical movement of the handle 112 is then converted to a signal that is transmitted to a computer 204 (FIG. 5) including a memory, one or more processors, and one or more application stored in the memory and executable by the processors. The applications detect the signal from the sensor of the motor 202 and output a signal to the motor 202 to drive the motor202 and therewith shafts 116 and 124 to provide inputs to the steering transmission 118. Using these inputs the articulation of the catheter 142 is achieved. Though not shown, another sensor/motor 202 may be located on the fourth shaft 128 connected to the knob 126 to control movement of the belt 136 and the advancement of the catheter 142 into the patient.

[0043] Though reducing direct feedback to the clinician by placing the motor 202 between the inputs from the clinician and the actions of the catheter 142, the use of sensor/motors may provide some additional advantages. For example, the motor 202 can enable clutching where magnitude output of motor 202 is based on the magnitude of the input received from the handle 112. In this manner the fine adjustments can be performed by the motor 202 without the need for a separate fine adjustment knob. Further once the pressure on the handle 112 is released the output from the motor 202 to the first shaft 116 or third shaft 124 is stopped, and the motor 202 acts as an electro-mechanical brake preventing back-driving of the motor 202 and the articulation of the catheter 142. Further, through the use of inputs, the motor 202 can be used as a lock preventing activation of articulation in one of the planes (e.g., that caused by shaft 116 or shaft 124). Still further, the motor 202 can provide further data for position and orientation tracking of the distal portion of the catheter 142. The rotations of the motor 202 can be tracked and a change in position or orientation can be calculated from the number of rotations, which relate though the gear ratios of the steering transmission 118 and the catheter insertion mechanism 127 to a magnitude of articulation or a magnitude of insertion travel into the patient. This data may be used to augment or confirm data from one or more sensors located at the distal end of the catheter 142.

[0044] Still further, feedback to the clinician may be provided. For example, by monitoring the current necessary to drive motors 202 a determination can be made of the resistance to movement caused by the patient’s lumen (e.g., the airways). This resistance can be used to determine an acceptable magnitude of force to be applied by the motor 202 in attempting to meet the input from the handle 112 and knob 126, this resistance can be manifest in an induced resistance to operating the handle 112 or knob 126 by the motor portion of the motor 202. Further an alert can be signaled to the clinician of the resistance (e.g., sound, or visually) or the provision of outputs from the motor 202 to the steering transmission 118 can be ceased to prevent damage to the tissues of the patient.

[0045] The one or more sensors on the distal portion of the catheter can provide an indication of movement of the distal end of the catheter. The motors 202 can receive an input regarding the movement and where the movements are caused by patient activities such as heartbeat or respiration, the motors 202 can output signals seeking maintain the position of the distal portion of the catheter 142 despite these forces causing the movement of the catheter 142.

[0046] Still further, in one aspect of the disclosure as the catheter 142 extends into the patient (e.g., from the central airways to the peripheral airways) as detected via the sensors on the distal portion of the catheter 142 and applications running on computer 204, the magnitude of the outputs from the sensor/motors 202 can be reduced, thus reducing the magnitude of changes in articulation or insertion of the catheter 142 for any given input to the handle 112 or the knob 126. [0047] Navigation of the catheter 142 can be undertaken in connection with one or more software applications. In accordance with aspects of the disclosure the software applications present images and three-dimensional (3D) models of portions of the patient. Sensors located on a distal portion of the catheter can be detected and the patient can be registered to the images or 3D models. In accordance with one aspect of the disclosure, the mapping of the inputs (e g., via the handle 112 and the first shaft 116 and third shaft 124) to the output and articulation of the catheter 142 may be adjusted. In one example, the planes of articulation from manipulating handle 112 and rotating the first shaft 116 and the third shaft 124 may be swapped, thus rotation of the third shaft results in articulation in the first plane while articulation of the first shaft results in articulation of the second plane (the opposite of the description above). This ability to re-map the steering input can compensate for catheter variation (e.g., from different manufacturers), or just for user preferences (e g., to accommodate the hand dominance of the clinician).

[0048] Still further, in some instances motor 202 may be locked to the first shaft 116 and third shaft 124. This can allow the motor 202 to rotate with the shafts and enable manual or nonmotorized articulation and drive of the catheter 142. Motorized drive of the catheter 142 may then be selectively enabled by the clinician and implemented as described above.

[0049] FIG. 5 depicts the clinician “C” using the electro-mechanical catheter drive system 200 to advance a catheter 142 into a patient “P.” As shown, motors 202 are connected to the computer 204. The motors 202 are located between the handle 112 and the steering transmission 118, and as described above can be employed to isolate the manual mechanical movements of the handle 112 or knob 126 from the steering transmission 118. The inputs to the steering transmission 118 are instead provided via the computer 204 to drive the motor 202. Other aspects of the electromechanical catheter drive system 200 are substantially the same as mechanical catheter drive system 100. For example, the catheter slack manager 144 in combination with the catheter driver 138 manages the slack in the catheter 142. In addition, the combination ensures that the catheter 142, as it is initially advanced into the patient “P” is in a substantially vertical orientation allowing easy access through the mouth or the nose to the trachea and subsequent articulation and navigation of the airways. And, as described above, the inner radius of the slack manager 144 prevents kinking of the catheter 142 as the catheter 142 reaches the end of its insertion length and all of the slack in the catheter is removed. [0050] Reference is now made to FIG. 6, which is a schematic diagram of the computer 204 of the and electromechanical catheter drive system 200. Computer 204 may optionally be connected to an imaging device 206 (e.g., CBCT, CT, PET, MRI, fluoroscopic imaging system, or other suitable radiographic imaging system) either directly or indirectly, e.g., by wireless communication. Computer 204 includes a memory 250, a processor 252, a display 254 and an input device 256. The processor 252 may include one or more hardware processors. Computer 204 may optionally include an output module 258 and a network interface 260. Memory 250 may store an application 262 and image data 264. Application 262 may include instructions executable by processor 252 for executing the methods of the disclosure.

[0051] Application 262 may further include a user interface 266. Image data 264 may include the CT scans, fluoroscopic images, 3D reconstructions, 3D models, or any other image data. Processor 252 may be coupled with memory 250, display 254, input device 256, output module 258, network interface 260 and imaging device 206. Computer 204 may be a stationary computing device, such as a personal computer, or a portable computing device such as a tablet computer or may be embodied on a plurality of computer devices.

[0052] Memory 250 may include any non-transitory computer-readable storage media for storing data and/or software including instructions that are executable by processor 252 and which control the operation of the computer 204 and, in some embodiments, may also control the operation of imaging device 206. In an embodiment, memory 250 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, memory 250 may include one or more mass storage devices connected to the processor 252 through a mass storage controller (not shown) and a communications bus (not shown).

[0053] Although the description of computer-readable media contained herein refers to solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 252. That is, computer readable storage media may include non-transitory, volatile, and non-volatile, removable, and nonremovable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by computer 204.

[0054] Application 262 may, when executed by processor 252, cause display 254 to present user interface 266. User interface 266 may be configured to present to the user a single screen including a three-dimensional (3D) view of a 3D model of the patient’s and include the area of interest for navigation to within the patient. The user interface 266 may also display a live image, for example to confirm the position of the catheter 142, as described above. The user interface 266 may be presented on the display 254 and the display 254 may be a touch screen to receive inputs from a user. User interface 266 may be further configured to display the area of interest and targets within the images or 3D models derived from the images.

[0055] Network interface 260 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and/or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and/or the Internet. Network interface 260 may be used to connect between computer 24 and imaging device 206. Network interface 260 may also be used to receive image data 264 from other sources. Input device 256 may be any device by which a user may interact with computer 204, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface. Output module 258 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art. From the foregoing and with reference to the various figures, those skilled in the art will appreciate that certain modifications can be made to the disclosure without departing from the scope of the disclosure.

[0056] Yet a further aspect of the disclosure is depicted in FIG. 7. In FIG. 7 the electromechanical catheter drive system 200, is bifurcated connected via a remote transmission 300 into an input section 200a and an output section 200b to enable remote navigation and articulation of the catheter 142. The mechanical inputs (e.g., knob 126 and handle 112) of the input section 200a are the same as both the mechanical catheter drive system 100 and the electro-mechanical catheter drive system 200, however, the first shaft 116, third shaft 124, and belt 136 are each bifurcated with a first portion connected to encoders 302. The encoders 302 detect the rotation of the shafts 116 and 124 as well as the advancement or retraction of the belt 136. The encoders 302 translate detected mechanical inputs and generate signals. The generated signals are transmitted to a remote transmission 300. The remote transmission 300 may optionally condition the signal and transmit a signal to decoders 304 located on the output section 200b in proximity to the catheter insertion mechanism 127 and steering transmission 118. The decoders 304 receive the signals and drive motors in accordance with the received signal. The motors are operably connected to a second portion of the first shaft 116, third shaft 124, and belt 136 to achieve advancement and articulation of the catheter 142 substantially as described herein above. [0057] By bifurcating the electro-mechanical catheter drive system 200 into an input section 200a and output section 200b connected by the remote transmission 300, the clinician can control the navigation and articulation for different locations. This may be as simple as a different orientation of the clinician relative to the patient up to and including remote navigation and articulation of the catheter 142 form different rooms in a hospital or at remote locations (e.g., different US states or different countries).

[0058] In one aspect of the disclosure the remote transmission 300 may be selectively connectable to multiple output sections 200b. In this manner, multiple patients may be prepared for a procedure (e.g., airway navigation). The clinician can then perform one navigation procedure while connected to a first output section 200b and select a second output section 200b and perform a second navigation procedure.

[0059] FIG. 8 depicts a clinician “C” operating an electro-mechanical catheter drive system 200 employing the remote transmission 300. As shown, the clinician “C” is simply spaced from the patient by a desired distance, which may provide a better vantage point for viewing the navigation of the catheter 142 into the patient “P.” Though the remote transmission 300 is described herein above as an electrical or electronic, the disclosure is not so limited, and the remote transmission may employ one or more of a hydraulic linkage, a pneumatic linkage, simple cable and sheath, or electronic wireless systems without departing from the scope of the disclosure.

[0060] In accordance with aspects of the disclosure the catheter 142 may include or be operable with a variety of catheter tools. The catheter tools include sensing tools (e.g., position and orientation sensors) visualization tools (e.g., cameras, ultrasound transducers) biopsy tools (e.g., needles and brushes), therapy tools including ablation tools (e.g., microwave ablation catheters, radio-frequency ablation catheters, cryogenic ablation catheters, chemical ablation catheters and others), suction, and lavage, and other surgical or navigational tools. The catheter drive systems described herein allow the clinician to perform any portion of the navigation procedure and also step away from the catheter drive system and any tools being employed without inducing any unintended catheter or tool motion.

[0061] FIGS. 9 and 10 depict two user input covers for the catheter drive systems described herein above. In FIG. 9A, in its simplest form, the cover 400 has a generally C-shape and is configured to mate with the handle 112 and the knob 126. The C-shape allows the cover 400 to releasably connect and cover the catheter steering interface 110, the gear box 122, the housing 134, and the knob 126. Pass through membranes 402 allow for the handle 112 to pass through the cover 400 and be manipulated by the clinician. A similar passthrough membrane 402 may be made to receive the knob 126 (as shown the knob 126 may be replaced with in-out buttons 404 to perform substantially the same functions of the knob 126 to advance and retract the catheter 142). In FIG. 9B0 the cover 400 includes wrist rests 406 to improve the ergonomics of catheter drive system and reduce fatigue that might be experienced by the clinician during a procedure. A vent strap 408 helps secure a ventilator tube to the catheter drive system. A tool rack 410 allows various tools (e.g., suction, lavage, biopsy tools, etc.) to be held in a convenient place for use during a navigation procedure. Through the use of the covers 400 depicted in the catheter drive systems described can be isolated from the clinician’s hands and thus limiting the opportunity for any contaminants from the clinician or from the procedure itself from impacting the catheter drive systems. This isolation promotes cleanliness and sterility and eases post procedural cleaning. Prior to the start of a procedure the catheter drive system may be wiped down with a cleaning solution to remove any contaminants and the cover 400 applied. Following a procedure the cover 400 can be removed and disposed of. The catheter drive systems described may again be simply wiped down with an appropriate cleaning agent and are essentially ready for the next procedure.

[0062] FIGS. 10A-14B depict a further catheter drive system 500 in accordance with the disclosure. The catheter drive system 500 includes a base 502 configured to support the catheter drive system and for securing the catheter drive system 500 to a support (e.g., a table or stand) to place the catheter drive system 500 at a convenient height for manipulation by a user. A catheter insertion mechanism 504 includes a knob 506 operably connected to catheter drive 508 via a gear train, described in greater detail below. [0063] A catheter steering interface 510 connects via a steering transmission 512 pull wires or tendons formed within catheter 514 to enable articulation of the catheter 514. A proximal end of the catheter 514 is supported by a catheter steering mechanism 516. The catheter steering mechanism 516 may be a disposable component in which the catheter 514 is secured and the pull wires or tendons are configured to connect to one or more outputs (e.g., shafts) from the steering transmission 512, which as noted above, is mechanically coupled to the catheter steering interface 510. In this manner, movements of the steering interface 510 are translated to the catheter 514 and the pull wires or tendons of the catheter 514 to articulate the catheter 514.

[0064] The steering interface 510 is similar to the steering interface 110. The handle 518 is configured to rotate a first shaft 520 about its axis. Rotation of the first shaft 520 results in rotation of first pulley 522. Rotation of the pully 522 translates belt 524. The belt 524 connects to a second pulley 526 (FIG. 12). The second pulley 526 rotates a shaft 528, the shaft 528 connects to two opposite-direction driven gears 530, each of the oppositely driven gears 530 connects to a shaft 532, each shaft 532 includes a driver (not shown) configured to connect to spools in the catheter steering mechanism 516 that connect to a proximal end of a pull wires within the catheter 514. By driving each spool in an opposite direction, one spool (within the catheter steering mechanism 516) takes up a length of pull wire, while the second spool (also within the catheter steering mechanism 516) lets out a length of pull wire. In this manner, articulation in a first plane is achieved and controlled.

[0065] The handle 518 of the steering interface 510 is configured to rotate a second shaft 534 about its axis. The second shaft 534 connects to a set of bevel gears 536 causing rotation of a third pulley 538. Rotation of the third pulley 538 causes translation of a second belt 540 and therewith rotation of a fourth pulley 542. The fourth pulley 542 rotates a shaft 544, the shaft 544 connects to two opposite-direction driven gears 546, each of the opposite-direction driven gears 546 connects a shaft 548, each shaft 548 includes a driver (not shown) configured to connect to spools in the catheter steering mechanism 516 that connect to a proximal end of a pull wires within the catheter 514. By driving each spool in an opposite direction, one spool (within the catheter steering mechanism 516) takes up a length of pull wire, while the second spool (also within the catheter steering mechanism 516) lets out a length of pull wire. In this manner, articulation in a second plane is achieved and controlled. As will be appreciated, by adjusting the articulation of the catheter 514 in two orthogonal planes the catheter 514 can be articulated to a near infinite number of planes a points defined by those two planes (e.g., a hemisphere of articulation).

[0066] As noted above, and as depicted in FIG. 12 the knob 506 connects via a shaft 550 to a set of bevel gears 552. The bevel gears 552 connect to a catheter drive shaft 554 within a housing 556. The housing is rigidly affixed to the base 502. The catheter drive 508 is composed of two parts, a driving part 558 which is affixed to the housing 556 and includes at least a pair of driving gears 560 mechanically coupled to the drive shaft 554. The driving gears 560 are configured to mate with a pair of wheels (not shown) within a driven part 562 of the catheter drive 508. Rotation of the drive shaft 554 causes rotation of the driving gears 560 and therewith the wheels within the driven part 562. Rotation of the wheel in a first direction advances the catheter 514 into the patient and rotation of the wheel in a second direction retracts the catheter 514.

[0067] Like the catheter drive 508, the catheter steering mechanism 516 is composed of two portions, a first portion is a mount 564 is affixed to the base 502 and includes the drivers connected to shafts 532 and 548. A second portion, the disposable 566 contains the spools that take up and pay out the pull wires or tendons, as described above. The combination of the disposable 566, the catheter 514 which is secured on its proximal end in the disposable 566, and the driven part 562 form a disposable catheter system. In practice, for each procedure, a new disposable catheter system is mounted to the catheter drive system 500 for advancement into a patient and performance of a procedure.

[0068] In FIGS 10A, 10B and 11 is a slack manager 568, a proximal portion of the catheter 514 between two fins to prevent movement of the proximal portion of the catheter 514 along its longitudinal axis. The distal portion of the catheter 514 is placed in the driven part 562. Slack in the catheter 514 causes the catheter 514 to bow upwards between the driven part 562 and the location in the slack manager 567 where the catheter 514 is wedged.

[0069] A further aspect of the disclosure is a clutching mechanism 600 depicted in FIGS. 14A, 14B, and 14C. The three-position clutching mechanism 600 connects and disconnects the catheter steering interface 510 from the catheter steering mechanism 516. In this manner, once a desired articulation of the catheter 514 is achieved any inputs to the handle 518 can be isolated from the pull wires in the catheter 514 to avoid unintended movements of the catheter 514. In addition, the entire catheter 514 can be locked by the three-position clutching mechanism 600 preventing any movements of the catheter 514. This may be particularly useful as the catheter 514 is a desired location within the patient (e.g., at a target for biopsy or therapy).

[0070] As depicted in FIG. 14A, a handle 602 pivots about an axis 604. The handle 602 acts on a cams 606. Only the cam 606 connected to shaft 548 is shown in FIG. 14A, however a similar cam 606 is also connected to shaft 532. On a proximal end of the cam 606 is a clutch pad 608. A corresponding clutch pad 608 is also found on collar 610 which is connected to shaft 544. In FIG. 14Athe handle 602 is in a clutched position, with a gap formed between the clutch pad 608 on the cam 606 and the clutch pad 608 on the collar 610. A magnetic switch 612 is in an off position, allowing the handle 602 to be moved away from the magnetic surface 614. In this configuration any inputs from the steering interface 510 via belts 524 and 540 are not transferred to the catheter 514. In this manner, the surgeon and ensure that no unintended articulation is input to the catheter.

[0071] In FIG. 14B the magnetic switch 612 is in the on position, generating a magnetic field that attracts the handle 602. The handle 602 acts on the cam 606 and brings the clutch pad 608 on the cam 606 into firm contact with the clutch pad 608 on the collar 610 creating high friction between the lever 602 and the cam 606. This high friction of the clutch pads 608 causes the entire assembly to be locked and preventing movement of the catheter 514 (both articulation and advancement or retraction). This might be utilized, for example upon navigating a catheter 514 to a desired position and orientation relative to a target (e.g., a tumor or lesion) in an effort to maintain position and prevent unintended movements of the catheter 514 while biopsy or therapy tools are inserted for their intended purposes.

[0072] FIG. 14C depicts the normal operating position of the handle 602. The magnetic switch 512 is in the off position as in FIG. 14A. Though not shown an internal spring within the cam 606 applies pressure to the cam 606 to bring the clutch pad 608 on the cam 606 into contact with the clutch pad 608 on the collar 610. The spring provides sufficient force that the friction between the clutch pads 608 enables translation of movements from the steering interface 510 through the belts 540, 524 to be translated to the pull wires or tendons within the catheter 514 to articulate the catheter 514 as desired. Advancement and retraction of the catheter via the catheter insertion mechanism 504 can also proceed unimpeded. In this manner the three-position clutching mechanism 600 enables normal operations, de-coupling of the articulation inputs from the steering interface 510, and a locking of the entire catheter 514 so that no inputs can be input to the catheter 514.

[0073] Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.

EXAMPLES

[0074] In accordance with aspects of the disclosure, the following examples are presented.

[0075] Example 1 - A catheter drive system including a catheter, a catheter insertion mechanism configured to advance and retract the catheter, a catheter steering interface configured to receive one or more mechanical inputs from a user, a steering transmission configured to receive inputs from the catheter steering interface and generate steering outputs, and a catheter steering mechanism secured to the catheter and configured to receive the steering outputs from the steering transmission and apply the steering outputs for articulation of the catheter.

[0076] Example 2 - The catheter drive system of example 1, further comprising a catheter driver configured to drive the catheter.

[0077] Example 3 - The catheter drive system of example 2, wherein the catheter driver includes a drive wheel and an idler wheel, and wherein the catheter is configured to be received between the drive wheel and the idle wheel.

[0078] Example 4 - The catheter drive system of any of examples 2-3, wherein the catheter insertion mechanism includes a belt operably connected to the catheter driver.

[0079] Example 5 - The catheter drive system of example 4, wherein the belt is operably connected to a driven wheel of the catheter driver and a pulley of the catheter insertion mechanism.

[0080] Example 6 - The catheter drive system of example 5, wherein the catheter insertion mechanism includes a knob operably connected to the pulley, and wherein rotation of the knob rotates the driven wheel to advance or retract the catheter.

[0081] Example 7 - The catheter drive system of example 1, the catheter steering interface further comprising a handle configured rotate a first shaft and a second shaft. [0082] Example 8 - The catheter drive system of example 7, wherein the first shaft connects directly to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a first plane.

[0083] Example 9 - The catheter drive system of examples 7 or 8, wherein the second shaft connects to a gear box, and a third shaft extending from the gear box connect to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a second plane.

[0084] Example 10 - The catheter drive system of any of examples 7-9 wherein the handle is in sliding engagement with the first shaft.

[0085] Example 11 - The catheter drive system of any of examples 7-10, wherein the steering transmission includes a gearing arrangement configured to transform the rotation of the first shaft or the second shaft into inputs to the catheter steering mechanism.

[0086] Example 12 - The catheter drive system of any of examples 1-11, further comprising a catheter slack manager, wherein the catheter slack manager secures the catheter between the catheter steering mechanism and the catheter driver.

[0087] Example 13 - The catheter drive system of example 12, wherein the catheter slack manager includes an inner radius configured to prevent kinking of the catheter.

[0088] Example 14 - The catheter drive system of any of examples 1-13 further comprising a motor operably connected to the first shaft or the third shaft.

[0089] Example 15 - The catheter drive system of example 14, further comprising a computer, wherein the computer receives inputs from a sensor operatively connected to the motor and transmits signals to the motor for driving the motor and providing input to the steering transmission.

[0090] Example 16 - The catheter drive system of one of examples 14 or 15 wherein the motor is lockable, and wherein when locked, mechanical inputs to the catheter steering interface are directly transmitted to the steering transmission.

[0091] Example 17 - The catheter drive system of one of examples 1-13, further comprising a remote transmission operably connecting the steering interface, the catheter insertion mechanism, and the steering transmission. [0092] Example 18 - The catheter drive system of example 17, further comprising a plurality of encoders, wherein the plurality encoders are configured to detect inputs to the steering interface or the catheter insertion mechanism and transmit them to the remote transmission.

[0093] Example 19 - The catheter drive system of example 18, further comprising a plurality of decoders, wherein the plurality of decoders receive inputs from the remote transmission and signal motors associated with the catheter insertion mechanism and the steering interface to advance, retract, or articulate the catheter.

[0094] Example 20 - The catheter drive system of example 19, further comprising an input section and an output section, wherein input section is isolated from the output section via the encoders, the remote transmission and the decoders.

Claims

CLAIMS:

1. A catheter drive system comprising: a catheter; a catheter insertion mechanism configured to advance and retract the catheter; a catheter steering interface configured to receive one or more mechanical inputs from a user; a steering transmission configured to receive inputs from the catheter steering interface and generate steering outputs; and a catheter steering mechanism secured to the catheter and configured to receive the steering outputs from the steering transmission and apply the steering outputs for articulation of the catheter.

2. The catheter drive system of claim 1, further comprising a catheter driver configured to drive the catheter.

3. The catheter drive system of claim 2, wherein the catheter driver includes a drive wheel and an idler wheel, and wherein the catheter is configured to be received between the drive wheel and the idler wheel.

4. The catheter drive system of claim 2, wherein the catheter insertion mechanism includes a belt operably connected to the catheter driver.

5. The catheter drive system of claim 4, wherein the belt is operably connected to a driven wheel of the catheter driver and a pulley of the catheter insertion mechanism.

6. The catheter drive system of claim 5, wherein the catheter insertion mechanism includes a knob operably connected to the pulley, and wherein rotation of the knob rotates the driven wheel to advance or retract the catheter.

7. The catheter drive system of claim 1, the catheter steering interface further comprising a handle configured rotate a first shaft and a second shaft.

8. The catheter drive system of claim 7, wherein the first shaft connects directly to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a first plane.

9. The catheter drive system of claim 7, wherein the second shaft connects to a gear box, and a third shaft extending from the gear box connect to the steering transmission and is configured to generate inputs to the steering transmission for articulating of the catheter in a second plane.

10. The catheter drive system of claim 7 wherein the handle is in sliding engagement with the first shaft.

11. The catheter drive system of claim 7, wherein the steering transmission includes a gearing arrangement configured to transform the rotation of the first shaft or the second shaft into inputs to the catheter steering mechanism.

12. The catheter drive system of claim 1, further comprising a catheter slack manager, wherein the catheter slack manager secures the catheter between the catheter steering mechanism and the catheter driver.

13. The catheter drive system of claim 12, wherein the catheter slack manager includes an inner radius configured to prevent kinking of the catheter.

14. The catheter drive system of claim 1, further comprising a motor operably connected to the first shaft or the third shaft.

15. The catheter drive system of claim 14, further comprising a computer, wherein the computer receives inputs from a sensor operatively connected to the motor and transmits signals to the motor for driving the motor and providing input to the steering transmission.