Highly maneuverable surgical catheter and drive system

Abstract

A catheter device and drive system configured to navigate a catheter through complex, narrow tissue openings, such as lung bronchial tract openings of 3 mm or less. The device includes a proximal catheter portion housing a hollow torque shaft, and a tip catheter portion connected to the proximal portion connected to this torque shaft. The tip position of the catheter is controlled by at least one control cable / tension cable arrangement. The system uses a processor-controlled actuator that acts as a control cable while simultaneously rotating the torque shaft and at least one control cable / tension cable in a 1:1 relationship. The catheter tip is formed by a tool plate, which is equipped with various sensors and other devices and can be connected to the outside via other conduits.

Description

Technical Field

[0001] Background of the Invention Field of the Invention The present invention relates to the field of robotic surgery and robotic systems and methods for operating surgical catheters and bronchoscopes.

Background Art

[0002] Description of Related Art Medical and surgical catheters, and such more specialized versions of catheters as bronchoscopes, are medical devices commonly used for medical diagnosis and treatment. Such "snake-like" devices are designed to traverse various body lumens, such as those of arteries, veins, the urinary system, the gastrointestinal system and parts of the genital system, as well as various parts of the respiratory system and lungs. These devices are also frequently used for other surgical applications.

[0003] Some medical devices are formed from long continuous tubes, often from medical-grade polymers. Other such devices may include, in many cases, articulating sections formed from a plurality of smaller components interconnected by flexible joints. Such articulating devices themselves may often be covered with an optional flexible medical-grade plastic polymer.

[0004] Some of these medical devices are designed for direct operation by a surgeon or other medical professional. Other such devices may also have various motorized, processor-controlled, and even robot-driven accessories. These are often used for higher precision and control.

[0005] Examples of such devices include various U.S. patents and patent applications, such as Wallace, U.S. Patent Application Publication No. 20210137620; Romo, U.S. Patent Application Publication Nos. 20220087755 and 20220304550; Zhang, U.S. Patent Application Publication No. 20220313375; Souper, U.S. Patent Application Publication No. 20210100627; and Schmitz, U.S. Patent No. 11033342.

[0006] Other prior art includes electroporation, an energy therapy of pulsed electric fields in the microsecond and nanosecond range that, when delivered through a microbronchoscope, can be used for gene delivery related to immune responses, initiation of necrosis, or initiation of immunogenic responses.

[0007] Despite these advancements, further progress in this technology is desirable. [Overview of the project] [Means for solving the problem]

[0008] Brief Overview of the Invention While the systems and methods disclosed herein can be used for many different medical purposes, the present invention was conceived in part in consideration of difficult-to-treat lung diseases and the shortcomings of prior art manual and robotic bronchoscopy.

[0009] Therefore, this disclosure describes in some detail both the structure of the lung and the usefulness of these improved methods for lung diseases. However, this extensive discussion of the structure of the lung and improved bronchoscopes is not intended to be limiting. The improved medical devices disclosed herein may be given different names and may be used for a wide variety of medical and veterinary diagnostic and surgical purposes.

[0010] On the structure of the lungs and the limitations of prior art bronchoscopy: The bronchi of the lungs can be considered to follow a typical tree-like natural Fibonacci pattern, where the branches branch out and become smaller in size as they move outward relative to the main trunk, i.e., in this case, relative to the trachea. Figure 1, showing the pulmonary bronchial system, shows that the size of the bronchial tree decreases as air moves from the larynx (10) to the trachea (12) and branches into primary bronchi (14), secondary bronchi (16), tertiary bronchi (18), and finally many bronchioles (20).

[0011] The diameter of the bronchial pathway decreases as the branches move outward and downward away from the trachea. For example, as you progress from the subsegments (tertiary) to the terminal bronchi (anterior to the bronchioles), the diameter typically decreases from about 5 mm to about 1 mm. This means that approximately 1,000 terminal bronchi are located in the outer third of the lung (22). Many lung diseases, such as lung tumors, can develop in this region.

[0012] Unfortunately, this outer third of the lung (22) is largely inaccessible with prior art bronchoscopes. This is because the minimum diameter of prior art bronchoscopes, including robot-driven bronchoscopes, is typically 3.5–4.2 mm. Such devices also have limited flexibility (e.g., limited or large joint radius), making them difficult to maneuver through the many winding bronchial trees.

[0013] Prior art bronchoscopes and robotic bronchoscopes have a diameter of approximately 4 mm and an articular radius of 18–20 mm. These prior art bronchoscopes are typically single-stage catheters, often with a continuous diameter, that are introduced into the lung with the help of an introducer sheath. Sometimes, medical professionals attach a 19–22 gauge (approximately 1 mm) flexible nitinol needle to the tip of the bronchoscope and use this wire tip to reach deeper parts of the lung for lesion biopsy. However, such wire tips are often insufficient for this purpose because their flexibility and maneuverability are limited (articular movement is limited). With a bronchial diameter of 4 mm, approximately 50 bronchi can be accessed using a prior art robotic bronchoscope. When the bronchial diameter decreases to 3 mm, if a 3 mm robotic bronchoscope exists, approximately 100 bronchi can be accessed using this robotic bronchoscope.

[0014] While not limited to small diameter situations, the present invention is partly based on the insight that improved bronchoscopes with diameters of less than 3 mm can offer a 6 to 20 times greater opportunity to detect and treat cancerous lesions in the outer third of the lung that are currently inaccessible. Therefore, at 3 mm, there is effectively a "biometric transition point" beyond which prior art bronchoscopes cannot advance further along lung bronchi of even smaller diameters. A 3mm diameter bronchoscope can access approximately 100 bronchi that are currently inaccessible. A 2.5mm diameter bronchoscope can access approximately 300 bronchi that are currently inaccessible. A bronchoscope with a diameter of 1 mm can access approximately 1,000 bronchi that are currently inaccessible.

[0015] This invention is based on the further insight that, because prior art flexible needles are not actively maneuverable, it is inappropriate to use such needles to extend the range. Such needles, when exiting a prior art bronchoscope, are at high risk of tearing through delicate vascular structures because their trajectory is almost a straight path.

[0016] The present invention is also partly based on the insight that there is a need for an improved bronchoscope with a very narrow tip diameter and the ability to drive precisely. In some embodiments, this improved device may also utilize an introducer sheath.

[0017] Figure 2 shows magnified views of various pulmonary bronchi and bronchial pathways, indicating a pathway transition point (104) where the second, narrower stage of a two-stage bronchoscope (100) can extend from the wider first stage (see Figure 3). The wider first stage (106) guides the device through a larger diameter bronchial pathway, and then the narrower second stage (108) can be positioned to proceed further through increasingly narrower segmental bronchi and enter the appropriate bronchiole closest to the target (often a potential lesion or tumor).

[0018] The challenges of such improved devices should be recognized. As shown in Figure 2, the bronchial branches bend sharply at many angles. For best performance, improved bronchoscopy devices need to clearly indicate and navigate these increasingly smaller diameter pathways. Therefore, even in this case, the tertiary or subsegmental bronchi (3-6 mm in diameter, 18 in total) have approximately 38 branches. However, when traversing the device beyond the 3 mm tertiary branches, the terminal bronchi (the outer third of the lungs) potentially have more than 1,000 branches. Ideally, this design should allow the operator to clearly indicate and manipulate the tip of the bronchoscope through each branch without penetrating or otherwise damaging the delicate vascular structure and / or bronchial wall.

[0019] The present invention also draws partly from the insight that such an improved device should be able to perform useful work once it reaches its destination. This includes the ability to robotically position useful sensors, such as cameras and lighting systems, to obtain tissue biopsies and to administer effective therapy to tissue targets located in such hard-to-reach areas.

[0020] As described below, in some embodiments, the present invention uses a tension actuator to create and relieve tension on various catheter steering cables while rotating these steering cables at a 1:1 ratio with actuator-controlled rotation of different parts of a hollow catheter, to bend and relieve the bending of various parts of the hollow catheter, teaching a processor-controlled robotic system and method. This makes it possible to advance the catheter into difficult-to-reach parts of the body, while ensuring that the various steering cables and rotational movements do not interfere with each other.

Brief Description of the Drawings

[0021] Brief Description of the Drawings [Figure 1] Shows the pulmonary bronchial system. [Figure 2] Shows various bronchial structures and paths. [Figure 3] Shows the virtual path of the bronchoscope of the present invention reaching the outer third of the lung. [Figure 4A] Shows the distal end of the catheter device of the present invention, indicating that the distal end may include a highly flexible articulable distal section, an optional insulating transition coupler, and a proximal portion including a torque shaft or tube. [Figure 4B] Shows the distal end of an alternative embodiment of the catheter device of the present invention. Here, the catheter includes a highly flexible articulable distal segment joined (often by adhesion or welding) to a proximal segment including a torque shaft or tube. There is no insulating transition coupler, but the two segments are different. [Figure 4C]Shows the tip of another embodiment of the catheter device of the present invention. Here, the catheter includes a highly flexible articulable tip portion that is continuous with a proximal portion configured to function as a torque shaft or tube. There is no insulation transition coupler. Since the two parts are made of the same material, no joints or junctions are necessary, but here, a tip portion with a plurality of slits is shown for higher operability. The slits can have any pattern that allows bending. Instead of slits, this can be a multi-durometer polymer material having a rigid back side and a soft (low durometer value) inner side (inside the highly flexible region) where a cable pulls to compress this soft material. [Figure 5A] Shows a cross-sectional view of an embodiment of the catheter. In this embodiment, the proximal portion of the cable is disposed inside the proximal portion of the catheter, and the distal portion of the tension cable is disposed along the outside of the distal portion of the catheter. [Figure 5B] Shows the exterior of the catheter device previously shown in FIG. 5A. [Figure 5C] Shows a cross-sectional view of an alternative embodiment of a system using this optional polymer jacket with a spring / elastic return mechanism configured to oppose the force exerted by the tension cable. [Figure 6A] Shows an enlarged view of the first side of the optional insulation transition coupler previously shown in FIGS. 5A and 5B. [Figure 6B] Shows an enlarged view of the opposite side of the optional insulation transition coupler previously shown in FIGS. 5A and 5B. [Figure 7A] Shows a cross-sectional view of a different embodiment of the catheter where the proximal portion of the tension cable is disposed outside the proximal portion of the catheter and the distal portion of the tension cable is also disposed along the outside of the distal portion of the catheter. [Figure 7B] Shows the exterior of the catheter device previously shown in FIG. 7A. [Figure 8] Shows an enlarged view of the optional insulation transition coupler previously shown in FIGS. 7A and 7B. [Figure 9] Shows the details of the extreme tip of the catheter where the tension cable is disposed outside the tip catheter. [Figure 10A] The cross-sectional view shows a different embodiment of the catheter in which the proximal end of the tension cable is positioned along the inside of the proximal end of the catheter, and the tip of the tension cable is also positioned along the inside of the tip of the catheter. [Figure 10B] An enlarged view of the optional insulating transfer coupler shown in Figure 10A is shown above. [Figure 10C] This shows a cross-sectional view of an alternative embodiment of a two-stage catheter, in which the tip stage is fixed to the end of the proximal stage by a joint. In this embodiment, the tension cable does not have an insulating coil and does not have an insulating transfer coupler. [Figure 10D] A cross-sectional view of a single-stage catheter is shown. Here, the tip and proximal portions are part of the same catheter, and there is no joint or insulating transfer coupler. In this embodiment, the tension cable also does not have an insulating coil. [Figure 11] This demonstrates how the flexible section can be adjusted to fit specific bronchi in patients where the lesion site may be in a more difficult-to-reach area due to slight mismatches. [Figure 12A] This demonstrates the use of arbitrarily selected electrodes. [Figure 12B] This demonstrates the use of arbitrarily selected electrodes. [Figure 13] A cross-sectional view of the system is shown, which uses a unidirectionally steerable introducer sheath, a unidirectional base stage, and a unidirectional tip stage with torque operation. [Figure 14] The different pull wire orientations for each type of flexible system are shown, namely, 1-plane / 1-direction (1 direction), 1-plane / 2-direction (2 directions), 3-plane 3D (3 directions), and 4-plane 3D (4 directions). [Figure 15] An example of a system with a controllable introducer sheath control head is shown. [Figure 16] Here is another example of a jointed, rotating robotic bronchoscope control head. [Figure 17] This shows a device implemented in a robotic system, equipped with both a controllable sheath and a controllable bronchoscope control head, which move independently. [Figure 18]This illustrates an embodiment in which a robotic system applies a catheter to a patient. [Figure 19] This shows a tool head equipped with a camera, lighting, and forceps. [Figure 20A] This shows a tool head equipped with a biopsy needle. [Figure 20B] Shows a tool head with a closed tip. [Figure 20C] Figure 20B shows a cross-sectional view of a tool head with a closed tip. [Figure 21] This shows some of the components that can be incorporated into the tool plate of a tool head. [Figure 22A] Here is another example of how a catheter device can be driven. [Figure 22B] Further details illustrating how the robot drive system in Figure 22A can operate are shown. [Figure 23] The cross-sectional view of the apparatus shown in Figures 22A and 22B is shown above. [Figure 24] Enlarged cross-sectional views of the drive rack, transmission gear, rotary drive gear, and sliding drive pin portion of the device shown in Figures 22A, 22B, and 23 are shown below. [Figure 25] This diagram shows an enlarged view of the drive rack, transmission gears, and rotary gear system, along with examples of how various sensors can be used to control and monitor the position of the drive unit. [Figure 26] This shows one extreme position of the linear circular gear rack of the device. [Figure 27] This shows different extreme positions of the linear circular gear rack of the device. [Figure 28A] A cross-sectional view of the rotary and linear drive system is shown. [Figure 28B] A more detailed view of the drive rack shown earlier in Figure 29A is shown below. [Figure 29A] A cross-sectional view of the rotary and linear drive system is shown. [Figure 29B] A more detailed view of Figure 30A is shown. [Figure 30] A schematic diagram of the complete system, including both the drive system and the catheter, is shown. [Figure 31A] This shows how a disposable housing or cartridge can accommodate the proximal drive side (or gear train) of a multi-stage catheter drive assembly. [Figure 31B] A detailed diagram shows how the motor coupler from the gear train in the disposable housing / cartridge can interact with the actuator's drive pin. [Figure 31C] Another diagram shows how the coupler from the gear train in the disposable housing / cartridge may interact with the actuator's drive pin. [Figure 32] Another diagram of a rotating linear robotic catheter is shown. [Modes for carrying out the invention]

[0022] Detailed description of the invention Surgical procedures need to be improved by using the least invasive techniques to reach more diverse areas of the body. In all cases, the internal pathways of the body follow a series of narrowing branches. The further one goes into a branch or blood vessel, the narrower the internal pathway becomes. This presents many challenges for technicians, thereby expanding the limits of creativity and technology.

[0023] Catheter development relies on the efficient implementation of metals, polymers, and semiconductors. Metals provide higher stress limits and therefore smaller components, enabling the manufacture of smaller tools. Stainless steel and nitinol metals are used for the skeletons of catheters and micromechanical tools. Polymers are used for the catheter sheath and insulation, enabling smooth interaction between the tool and the biological pathway. Silicone provides sensing and feedback for manufacturing smart implantable devices at the tip of the catheter. Other electronic implantable elements can include video cameras such as CMOS cameras and LED illumination. CMOS cameras and pico-LEDs offer significant advantages by achieving higher flexibility in the tip conductor and along the length of the catheter. This is due to braided electrical wires for power conductors, return conductors, and communication conductors. On the other hand, fiber optic scopes and fiber optic illumination limit the bending radius or joint movement angle of the catheter due to the high bending resistance of the glass fibers.

[0024] Advances in robotics and visualization systems are creating new opportunities in medicine. These new opportunities offer advantages over manually driven instruments. One advantage is stability, and safety is readily apparent when conventional manual surgical tools are mounted on robots. When catheters are robotically driven, several advantages can be leveraged, namely semi-autonomous or fully autonomous pathfinding, locked positions, driving methods for traverses, and tracking of position relative to the target using real-time C-arm surgical imaging devices (CT or MRI).

[0025] Applying robotics to catheters presents many challenges. A good balance between cost and performance must be struck within the disposable cost model. Novel approaches addressing manufacturing process considerations (DFM) and the initial cost challenges will advance both creative and technological possibilities.

[0026] This invention addresses these challenges by utilizing advanced technologies in microtool development combined with robotics and visualization techniques.

[0027] Regarding terminology: In this disclosure, the present invention will instead be described as the invention, apparatus, catheter, bronchoscope, and even robot-driven articulated bronchoscope. These terms are interchangeable, and the use of any given term in a particular context is not intended to be limiting.

[0028] Description of use (treatment of lung diseases) Advances in robotic procedures and real-time computer-aided visualization of living organisms are opening up entirely new methods for targeting and treating many diseases. One such area is the diagnosis and treatment of lung cancer. Most lung lesions are located in the periphery of the lungs; 70% of lung lesions are in the outer third of the lung. This presents a great opportunity to apply minimally invasive techniques through narrowing of the peripheral bronchi.

[0029] Current detection and treatment methods, even with the application of robotics, are limited by several drawbacks. In the case of robotic bronchoscopy, catheter technology is limited by the cost constraints of disposable materials, which directly affect the size and mobility of the catheter. Miniaturizing the device presents many challenges and, if not approached carefully, can result in disadvantages in terms of cost and performance.

[0030] These constraints present a unique opportunity for technological innovation. Reaching and treating lesions in the outer third of the lung, which are currently inaccessible, is achievable by applying creative manufacturing methods. It is desirable to develop a highly mobile sub-3mm robotic bronchoscope that can safely target the outer third of the lung. This is the area of ​​the lung where thoracic surgeons must apply a biopsy needle under fluoroscopy by advancing transthoracically to obtain a tissue sample. This is the standard treatment for hard-to-reach areas of the lung, but comes at the cost of a 20% pneumothorax rate. Additionally, if the lesion is cancerous, this procedure does not offer targeted therapy or a cure; it is merely a diagnostic method. The cost of dealing with a 20% pneumothorax rate is a significant problem and presents a great opportunity to develop better treatment methods.

[0031] 70% of lung lesions are located in the outer third of the lung (22). By advancing transluminally from the bronchi to the outer third, an opportunity is gained to perform a biopsy (detection) and treat the lesion (if it turns out to be cancerous) during the same procedure. In addition to cancer detection and treatment, other diseases such as chronic bronchitis can be treated by electroporation to induce an immunogenic response. Another application is targeted microlung lavage in the alveoli.

[0032] Figure 2 shows the trajectory from the primary bronchus (14) to the secondary bronchus (16) and then to the terminal tertiary bronchus (18), where the trajectory narrows to less than 3 mm in the subsegmental bronchus. This is the transition to the terminal bronchus. Thick discontinuous or dashed lines represent the bronchoscope (100) trajectory. Transition points are labeled along the bronchoscope trajectory. These points are labeled “introducer trajectory end” (104), “proximal trajectory end” (24), “biometric transition point” (50), and “tip trajectory” (26). These labels represent a portion of important regions along the length of the intraluminal catheter disclosed in this application.

[0033] As mentioned above, prior art robotic bronchoscopes have a diameter of approximately 4 mm and an articular radius (radius of rotation) of approximately 18-20 mm. In some prior art situations, a flexible nitinol needle of 19-22 gauge (approximately 1 mm in diameter) can be attached to the tip of the bronchoscope for lesion biopsy, but such needles tend to be difficult to maneuver and unsuitable for many purposes.

[0034] Based on the trajectory paths in Figures 2 and 3, the "biometric measurement transition point" (50) can be considered to be the region of the lung where the prior art bronchoscope stops and where the bronchial diameter is 3 mm or less.

[0035] As described above, in some embodiments, the present invention may be a bronchoscope comprising at least one stage and an optional introducer sheath (102), wherein one or more stages (106) and (108) are robotically driven along the same axis. Figure 3 is a magnified view of a pathway transition point where a two-stage bronchoscope may be divided (based on biometric data).

[0036] This is particularly difficult when the bronchial branches bend at sharp angles. Narrowing the pathways (50) to less than 3 mm in diameter creates a great opportunity for improved bronchoscopes that can clearly indicate and navigate these smaller diameter pathways. There are 38 branches in the tertiary or subsegmental bronchi (3-6 mm). If the bronchoscope is traversed beyond the 3 mm tertiary branches (50), the opportunity increases to 1000 branches in the terminal bronchi (the outer third of the lung 22). Beyond the tertiary branches, this can be considered a biomechanical transition in a two-stage bronchoscope design. The improved devices and methods disclosed herein can, in some embodiments, be designed to pass through this region (less than 3 mm in diameter) of the lung (22) with miniaturization and improved operability. This allows the devices to reach areas that are generally inaccessible to prior art manual or robotic bronchoscopes.

[0037] Figure 3 shows four main components of a two-stage embodiment of the improved catheter system. These are the introducer sheath (102), the proximal stage (106), the tip stage (108), and the probe or tool (110). The proximal stage (106) has an optional insulated transition coupler or joint (107) to which it is coupled or bonded, welded, or snapped together with the tip stage (108). As can be seen in Figure 3, the tip stage (108) may have a much smaller outer diameter (OD) than the proximal stage (106). The device can be configured so that a surgeon or robot can manipulate the primary stage (106) and the transition region (107) near the coupler, joint, or biometric transition point (50), and then use the tip stage (108) to advance further to the outer third of the lung (22) or other hard-to-access areas.

[0038] In a preferred embodiment, the surgeon, with or without robot assistance, often operates (106), (107), and (108) synchronously to reach a desired position near the target. A tool or probe, such as (110), can then slide outward to extend towards the target.

[0039] Accordingly, in some embodiments, the present invention may be a one-stage or multi-stage catheter device for traversing a passage in the body, and this at least one-stage catheter device includes a tip hollow catheter portion and a similar or different proximal hollow catheter portion. If the present invention is a one-stage catheter device and the tip and proximal ends of the catheter are made of the same material, these ends are referred to as the tip portion and the proximal portion. If the present invention is a multi-stage catheter device having at least two stages, the tip side is referred to as the tip stage, and the proximal side (which may have different materials or dimensions) is often referred to as the different proximal stage. The term "stage / part" may be used when it is not an issue whether we are referring to a catheter portion or a stage.

[0040] Considering the two-stage embodiment first, in this embodiment, the different proximal stage hollow catheters (106) include a hollow torque shaft (200). Here, one end of the tip stage hollow catheter (108) is fixed to one end of the hollow torque shaft (200) by a joint such as a region (107j) where both sides are bonded, welded, or snapped together, or by an insulating transition coupler (107, 107a, 107a1, 107a2). The joint (107j) generally has the same diameter as the larger of the two sections. In the case of an insulating transition coupler, the insulating transition coupler may be configured to traverse a bodily passage (i.e., the bodily passage targeted for that particular medical procedure) (e.g., having an appropriate outer diameter).

[0041] The insulated transfer couplers (107, 107a, 107a1, 107a2) generally include a hollow cylindrical housing with at least one tip coil stopper (107b). As previously described, the insulated transfer couplers (107, 107a, 107a1, 107a2) are configured to function as a joint between one end (e.g., the proximal end) of the tip stage hollow catheter (108) and the tip of the hollow torque shaft (200, 106). This joint functions to connect the two stages so that the torque applied to the (proximal) hollow torque shaft (200) is transmitted to the tip stage hollow catheter (108).

[0042] The device, at least one stage, further includes at least one maneuvering cable-type conduit (e.g., 220) extending along the catheter from the proximal stage (often from the proximal end of the proximal stage) to the distal stage (often at the distal end of the distal stage). In some embodiments, at least one of these maneuvering cables includes both a (maneuvering) cable (220) and a surrounding insulating coil (380). In any case, the maneuvering cable is often referred to as a “tension cable,” with or without a surrounding insulating coil. Thus, some “tension cables” may have an insulating coil and some may not. Further explanation (i.e., drawings or text indicating whether a particular maneuvering cable / tension cable has an insulating coil) would help in distinguishing between them. In the absence of further explanation, both options may be used.

[0043] In the case of a tension cable including a control cable (220) and a surrounding insulating coil (380), such tension cables are connected to their respective end coil stoppers (107b), and as a result, these particular end coil stoppers function as insulating coil stoppers to prevent further forward movement and advancement of the insulating coil (380). At the same time, the end coil stoppers (107b) are configured to allow the internal control cable (220) itself to pass through the end coil stopper (107b) (often having a suitable central hole 107c). In other words, at the end coil stopper, further forward movement of the surrounding insulating coil (380) is prevented, but further forward movement and advancement of the internal control cable (220) is permitted.

[0044] The catheter device may also be configured such that a hollow torque shaft, a tip-stage hollow catheter, and an insulated transfer coupler further include a working channel (228). This working channel is configured to transport at least one other type of conduit (230, a different type of conduit other than the maneuvering cable 220) through the proximal / partially hollow catheter and the tip-stage / partially hollow catheter to at least a tip tool plate (109) often attached to the tip of the tip-stage / partially hollow catheter (108). Alternatively, one or more maneuvering cables (220) may be bonded or welded to the end of the catheter (108).

[0045] It should be noted that at least one of the tension cables includes, in many cases, at least one tip stage maneuvering cable (220) (fixed 220t) connected to the tip tool plate (109). This at least one tip stage maneuvering cable is configured to transmit tip stage maneuvering force to the tip tool plate (109) and to move or bend the tip tool plate and tip stage catheter in accordance with the tip stage maneuvering force.

[0046] Figure 4A shows the tip of the highly maneuverable and simplified catheter device of the present invention, which includes a highly flexible and articulate tip section (108), an optional insulated transfer coupler (107), and a proximal portion (106) including a torque tube (200).

[0047] Figure 4B shows the tip of an alternative embodiment of the catheter device of the present invention. Here, the catheter includes a highly flexible, articulated tip section (108) joined at a junction (107j) to a proximal section including a torque shaft or tube (106 / 200). There is no insulating transfer coupler, but the two sections are distinct.

[0048] Figure 4C shows the tip of another embodiment of the catheter device of the present invention. Here, the catheter includes a highly flexible, articulated tip (108p) joined to a proximal portion (106p), which is configured to function here as a torque shaft or tube (100). There is no insulating transfer coupler or joint. The two parts are made of the same material, but here the tip has multiple slits for greater maneuverability than (108a). The slits can have any pattern that allows bending. Instead of slits, this may be a multi-durometer polymer material having a rigid back and a flexible (lower durometer value) inside (inside the highly flexible region) through which a cable pulls to compress this flexible material.

[0049] Figure 5A shows a cross-sectional view of one embodiment of a catheter in which the proximal ends of the tension cables (220, 380) are positioned inside the proximal portion of the catheter (106 / 200), while the tip portion of the tension cable (i.e., the control cable 220) is positioned along the outside of the tip portion of the catheter (108).

[0050] Figure 5B shows the external view of the catheter device shown earlier in Figure 5A.

[0051] In this embodiment, the proximal (108) torque shaft (200) is fixed to the tip section (106) via an insulating transfer coupler (107). This insulating transfer coupler (107) typically includes a housing (107a) and at least one insulating coil stopper (107b). The catheter further includes at least one control cable (220).

[0052] As described above, in some embodiments, the maneuvering cable (220) is covered by a surrounding insulating coil (380) until the insulating coil (380) encounters an insulating coil stopper (107b) as the cable advances upward through the proximal portion of the catheter. The insulating coil stopper prevents further tip-direction movement of the insulating coil, but the maneuvering portion of the tension cable (220) itself can advance upward through the tip portion of the catheter (108) (often through the hole 107 of the insulating coil stopper) until it typically hits a fixing point (220t) of the tip tool plate (109). See Figures 9, 12A, and 21(220). In some embodiments, the catheter may be further covered by an optional flexible polymer jacket (103).

[0053] This flexible polymer jacket (103) is often different from an optional sheath (102). The polymer jacket may contain a biocompatible polymer selected to absorb shock and facilitate the passage of the catheter through a narrow bio-opening. Examples of suitable polymers include hydrogels such as Pluronic(F127) / acrylic acid(AA) hydrogel.

[0054] More specifically, in some embodiments, any of the tip-stage hollow catheter (108), the proximal-stage hollow catheter (106 / 200), and the insulating transfer couplers (107, 107a, 107a1, 107a2) may be surrounded by a flexible polymer jacket (103) whose outer surface may be continuous or discontinuous between sections.

[0055] In some embodiments, as shown in Figure 5C, the device may further include at least one elastic (219i or 219o) “or spring” element configured to counteract the force applied by at least one of the at least one tensile cable (220) (wherein 220o is a tensile cable positioned outside the catheter and optionally within or beneath the polymer jacket, while 220i is a tensile cable positioned inside the catheter). This elastic element is often positioned on the catheter side, 180 degrees opposite to the tensile cable (220) against which the elastic element is intended to counteract. (Other angles are possible and may be desirable if a slight catheter curve is desired). In some embodiments, one or more elastic elements may form part of a flexible polymer jacket. These elastic elements may be springs or spring materials, e.g., nitinol, elastic polymer ligaments, or other elastic materials.

[0056] In these embodiments, the polymer jacket (103) may have the property (elastic element 219i or 219o) of returning the flexible portion of the catheter to a straight state or other desired curvature when the tension is released. These elastic elements may be a thicker elastic section or a spring wire embedded in or under (219o) the elastic jacket. Alternatively, an internal elastic bias may be generated, such as a spring wire (219i) positioned inside the catheter 108 (or 106) that returns the catheter to a straight state or other desired curvature when the tension is released.

[0057] Figure 5C shows a cross-sectional view of an alternative embodiment of the system using this optional polymer jacket, which includes a spring / elastic return mechanism configured to counteract the forces exerted by the tensile cable.

[0058] As described above, in the embodiments shown in Figures 5A and 5B, it should be noted that the control cable (220) and the surrounding insulating coil (380) first advance along the inside of the torque shaft (200). However, further advancement of the insulating coil (380) is blocked by the insulating coil stopper (107b), and then the tension cable / control cable (220) advances through the hole of the insulating transfer coupler (see 107c in Figure 5B) and then along the outside of the tip portion of the catheter (108). Here, the control cable (220) may optionally be held in place by various external clips (108ec). It should be noted that these clips are loose enough to allow the control cable (220) to move along the axis of the catheter, but tight enough to hold the control cable relatively close to the outside of the tip portion of the catheter (108). Clip 108ec is attached by adhesive, welding, clip fastening, snap fastening, and is formed or extruded from tube 108.

[0059] Note the distinction between the leading edge insulated coil (386d) and the insulated coil stopper (107b). The leading edge insulated coil end (386d) is where the insulated coil (380) terminates at the tip. In contrast, the insulated coil stopper (107b) is a physical mechanism on the insulated transfer coupler (107b) that prevents the insulated coil (380) from moving further toward the tip.

[0060] Figure 6A shows an enlarged view of one side of one embodiment of the insulating transfer coupler (107a), showing details of the hollow interior (107b) and the front end of the tip coil stopper (107b). Here, the larger inner diameter is indicated as (107l). The thickness of the insulating transfer coupler sheath is indicated as (107t). Therefore, the outer diameter of this portion is (107l) + 2 * (107t).

[0061] Figure 6B shows an enlarged view of the opposite side of this embodiment of the insulated transfer coupler (107a), showing the exit hole (107c) through which the tension cable (220) can exit the end coil stopper. The smaller inner diameter is shown as (107s). Assuming that the thickness of the insulated transfer coupler sheath in this region is also (107t), the outer diameter of this portion is (107s) + 2 * (107t). Typically, the thickness of the insulated transfer coupler sheath (107t) is less than 10-20% of (107l) or (107s).

[0062] The thickness of the insulating transfer coupler wall (107t) is typically similar to the thickness of the proximal (106 / 200) and distal (106) portions of the catheter, and this thickness is typically less than 20% of the inner diameter (107s and / or 107l).

[0063] It should be noted that the tip-stage hollow catheter typically tapers from a large diameter (10⁷l) at the proximal end of the insulating transfer coupler to a smaller diameter (10⁷s) at the tip of the tip-stage hollow catheter. Generally, the device is configured to allow at least the tip portion of the tip-stage hollow catheter to be manipulated through a biological lumen with an internal opening diameter of 3 millimeters or less. Therefore, the sum of the dimensions (10⁷l) + 2*(10⁷t) can often be 3 millimeters or less.

[0064] Figure 7A shows a cross-sectional view of a different embodiment of the catheter in which the proximal end of the tension cable (220) is positioned outside the proximal end of the catheter, and the tip of the tension cable (220) is also positioned along the outside of the tip of the catheter. This version of the insulated transition coupler (107a1) does not have the exit hole (107c) shown earlier in Figure 6B. In this version, the tip coil stopper (107b) is located outside the insulated transition coupler. For this reason, this version of the insulated transition coupler is shown here as (107a1), but in other cases it is still referred to as the “insulated transition coupler,” and the reference numerals (107 and 107a) are generally intended to refer to this version as well.

[0065] Figure 7B shows the external view of the catheter device shown earlier in Figure 7A.

[0066] To elaborate further on the insulated coil, as mentioned above, in some embodiments, at least one portion of the tip-stage control cable (220) is further arranged within the insulated coil (380). This insulated coil (380) includes an insulated coil far end (Figure 5A, 386d) and an insulated coil near end (Figure 28B, 382n). In this embodiment, each insulated coil far end is mounted close to the tip end of the corresponding control cable (220) in such a manner that it allows the corresponding control cable (220) to protrude movably beyond the insulated coil far end (386d) while preventing axial movement of the insulated coil far end.

[0067] Furthermore, each insulated coil near end (382n) is mounted in close proximity to its respective bending actuator in such a manner that the corresponding control cable (220) can protrude beyond the insulated coil near end (382n) while preventing axial movement of the insulated coil near end.

[0068] Figures 7 and 11 also show that at least the tip-stage hollow catheter (108), and often the proximal-stage hollow catheter (106 / 200), often include multiple slits (106a, 108a) along at least a portion of their outer circumference. The slitted shaft for 106 / 200 is functional for both bending and torque transmission. These slits are configured to have positions and dimensions that facilitate traversal of the catheter device through a series of branching internal lumens with gradually decreasing inner diameters, as shown in Figure 3.

[0069] In fact, it should be noted that in some embodiments, either the tip step / section or the proximal step / section includes one of a woven, nonwoven, or continuous material having multiple slits or openings along at least one portion of their outer circumference. Generally, this material is selected to have positions and dimensions configured to allow the device to move within a series of branching internal lumens whose inner diameter gradually decreases.

[0070] Figure 8 shows an enlarged view of the optional insulating transfer coupler (107a1) shown earlier in Figures 7A and 7B.

[0071] Figure 9 shows details of the tip of the catheter. In this embodiment, the maneuvering cable (220) end of the tension cable terminates at the tip plate (109). The maneuvering cable (220) end is terminated by being connected (e.g., bonded, gippled, welded, or adhesive) at the termination region (220t). As a result, the force or tension on this maneuvering cable (220) end of the tension cable causes the tip of the catheter to bend in the direction of the applied force. As mentioned above, in some embodiments, there may be multiple maneuvering or tension cables (see 220, 222, 224, and 226 in Figure 14) configured to bend the tip of the catheter in multiple directions depending on the applied force. Each direction of bending may also be referred to as a "direction," such as one direction, two directions, etc.

[0072] Figure 10A shows a cross-sectional view of yet another embodiment of the catheter, in which the proximal end of the tension cable is positioned along the interior of the proximal end of the catheter, and the distal end of the tension cable is also positioned along the interior of the distal end of the catheter. This version of the insulated transition coupler also lacks the exit hole (107c) shown earlier in Figure 6B, and the distal coil stopper (107b) is located inside the insulated transition coupler. For this reason, this version of the insulated transition coupler is shown here as (107a2), but in other cases it is still referred to as an "insulated transition coupler," and the designation (107a) is generally intended to refer to this version as well.

[0073] Figure 10B shows an enlarged view of the optional insulating transfer coupler (107a2) shown earlier in Figure 10A.

[0074] Figure 10C shows a cross-sectional view of an alternative embodiment of a two-stage catheter in which the tip stage is fixed to the end of the proximal stage by a joint (107j). There is no insulating transfer coupler. In this embodiment, the control cable / tension cable (220) does not have an insulating coil.

[0075] Figure 10D shows a cross-sectional view of a single-stage catheter. Here, the tip and proximal portions are part of the same catheter, and there is no joint or insulating transfer coupler. In this embodiment, the control cable / tension cable (220) also has no insulating coil.

[0076] Figure 11 shows how the flexible sections (106 and 108) can be modified (e.g., custom-made) to better fit specific bronchi in patients where the lesion site (e.g., target) may be in a more difficult-to-reach area due to some pathway mismatch.

[0077] As previously mentioned, Figure 11 also shows that either the tip section hollow catheter (108) or the proximal section hollow catheter (106) may further include a number of slits (108a, 106a, etc.) along at least a portion of their outer circumference. These slits may have positions and dimensions configured to facilitate the traverse of the catheter through a series of branching internal lumens whose inner diameters gradually decrease. Note that in some embodiments, the proximal section hollow catheter (106) itself is used to impart torque to the tip section hollow catheter (108). In this embodiment, the proximal section hollow catheter (106) is also referred to as the torque axis (200).

[0078] In some embodiments, the structure of a patient's specific pathway can be obtained by scanning (e.g., by scanning the patient using a C-arm medical imaging scanner or other type of scanner to create a computed 3D model of the patient). This computed 3D model can be generated before surgery. Pathway data from this model can be used to determine the ideal trajectory of the apical stage (108). This apical stage design can be automatically generated by a standard computer processor or AI method, etc., using the patient's current scan (e.g., 3D model and historical data / 3D scan generated by CT / MRS). This data can be used to determine the distribution and flexibility of optional flexion joints (108a, 106a) along the apical and proximal stages (106, 108), and how to construct the lengths of the apical and proximal stages.

[0079] Figures 12A and 12B illustrate the use of optional electrodes, such as (110a and 110b), shown here extending outside the tip plate (109). In some embodiments, bipolar (e.g., two) electrodes may be used for targeted procedures and can be used to deliver high-frequency electrical energy from a suitable source. These microelectrodes (110a, 110b) can be insulated from each other by insulating tubular lumens. In some embodiments, electrodes may be made from DFT® wire (Drawn Filled Tube). Such DFT wires include a gold core electrode (120) surrounded by nitinol (122) and often an insulator (124). This makes it possible to optimize elasticity and conductivity in small diameter wires of less than 1 mm. Conventional wires, such as insulated copper wire, may also be used (126). In some embodiments, these wires also have radiopaqueness for visualizing the electrode position during real-time C-arm CT scans or other imaging processes.

[0080] Therefore, some of the conduits may often include conduits that are tension cables or maneuvering cables, such as (220), but at least some of the conduits may also include electrical conduits (110a, 110b, etc.). These electrical conduits may be used to transmit any power or electrical signals to various probes, sensors, or other electrically operated devices that are located on or pass through the tip tool plate (109).

[0081] Furthermore, in many embodiments, at least some of the conduits may include optical fibers or hollow tubes (230) configured to transport optical signals, electromagnetic signals, or radio frequency (RF) signals or chemical substances to or from a device positioned on an end tool plate (109).

[0082] Figure 13 shows a cross-sectional view of the catheter system. This embodiment uses a unidirectionally maneuverable introducer sheath (102) equipped with its own sheath maneuvering cable (e.g., 102b).

[0083] This embodiment also includes a base stage (106) or base portion. In some embodiments, this base stage may also be operable (e.g., operable in one direction) using an optional base stage control cable such as 210 or optionally 220 inside 200 / 106. In some embodiments, as described above, the base stage (106) is also a torque shaft (200).

[0084] The drawing also shows a tip stage / section (108) configured to be steerable in one direction using its own control cable (220, etc.). The interior of the tip stage (108), and also the interior of the base stage (106), includes a hollow working channel (228) through which various other types of conduits, such as electrical conduits or tubes (230) and / or others, can pass.

[0085] In other words, in some embodiments, at least the proximal portion of a proximal hollow catheter is housed within at least one hollow sheath (102). This hollow sheath (102) is configured to allow at least a portion of the catheter device (e.g., 106 / 200, 108) to protrude or retract inward and outward from at least one hollow sheath (102). The degree of this extension or retraction depends on the force (manual or robotic) applied to this at least one hollow sheath (102) and at least this proximal hollow catheter (106). This is illustrated in more detail in Figures 15, 16, and 17.

[0086] Most examples in this disclosure use only a single steering cable / pull wire, such as 220 (shown here with an external coil and sometimes configured as a tension cable), but in some embodiments, multiple steering cables may be used.

[0087] Figure 14 shows different orientations of pull wires or control cables relative to the tip stage / section (108) cable. Various embodiments are possible, including 1-plane / 1-direction (1 direction), 1-plane / 2-direction (2 directions), 3-plane 3D (3 directions), and 4-plane 3D (4 directions).

[0088] Four-way control (four control cables) offers the highest degree of freedom of movement, but comes with some trade-offs in terms of higher complexity and the larger amount of internal / external space required to accommodate more control cables. Fewer control cables, such as one-way control (one control cable), have certain advantages because they reduce the space required for such cables. This results in a smaller outer diameter, greater accessibility, and the ability to design catheters with larger working channels. This allows for more conduits for cameras, lighting, sensors, probes, etc.

[0089] In Figure 14, the upper section shows the internal control cable configuration as shown in Figure 10A. The (alternative) configurations in the lower section relate to the external control cable configuration as shown in Figures 5A, 5B, 7A, and 7B.

[0090] System Integration Examples As described above, in some embodiments, at least the proximal portion of the proximal hollow catheter (106, 200) is placed within at least one hollow sheath (102). This at least one hollow sheath is configured to allow at least a portion of the catheter device to protrude or retract inward and outward from the sheath in response to forces applied to the sheath (102) and / or the proximal hollow catheter (106, 200). Thus, the sheath is a good method for introducing the catheter into the patient's body.

[0091] Figure 15 shows an example of a system of a maneuverable introducer sheath (102) mounted on a drive cartridge for a robotic system. A first cartridge or control head (300) can actuate the introducer sheath (102) to bend / flex or rotate. This hollow sheath can be used to deliver a catheter (device). In a preferred embodiment, the arrangement of this sheath and control head may have at least one plane of articulation in at least one direction (at least one-directional maneuverability). In other embodiments, the hollow sheath and control head may have up to fully articulated articulation (e.g., four-directional maneuverability). In Figure 15, the upper figure shows the outside of the control head / sheath system, while the lower figure shows some of the internal mechanisms of the control head / sheath system, such as the sheath articulation cable 102b, and various drive wheels (306) and motors (M), often referred to as actuators (306) that can be used to operate one or more sheath articulation cables.

[0092] In other embodiments, the “sheath” may include a mechanism that crushes but does not buckle.

[0093] Figure 15 also shows that the joint motion introducer sheath (102) can have at least one plane and one direction of joint motion having a rotation axis located in the control head housing (300, 302) (here using the sheath joint motion cable 102b).

[0094] In other words, in some embodiments, the multistage catheter device may further include at least one control head (300). This at least one control head may include a hollow introducer sheath (102) and an insertion funnel (304) configured to insert at least a portion of the multistage catheter device (e.g., 106, 107, 108, 109) into a body lumen through an insertion funnel and a hollow introducer sheath.

[0095] Figure 16 shows an alternative embodiment of the catheter device control head, designated here as (310), and also shows other parts of the device, such as the proximal portion (105) connected to the proximal portion (106), the tip portion (108), and other parts (here, (105) can be considered the proximal portion of the device which may have different flexibility from the proximal region (106), and which is configured to be flexible but does not necessarily have to be configured to be maneuverable). A conduit (111) connected to the tool tip (110) after passing through the insertion funnel (304) is also shown. This control head may also have additional drive wheels (306) and motors (M), often called actuators, which are often processor-controlled electric actuators used to control other joint movement / maneuvering cables. Other devices shown (309) are connectors and interfaces for operating and controlling other conduits, such as a camera controlling a camera, lights, sensors, position indicators, electrodes, and the tool tip. Please note that, for the sake of simplification, the introducer's chapter is not shown.

[0096] Therefore, in some embodiments, at least one control head (300, 310) may further comprise at least one computerized drive wheel (306) and a motor (M), which is often referred to as a motor actuator or sometimes simply an actuator. This at least one computerized motor actuator is • Applying variable torque to a hollow torque shaft (200) - Applying variable tension to either at least one base stage / partial control cable (210) and / or at least one tip stage control cable (220), • In accordance with the discussion of the introducer sheath in Figure 15, variable tension is also applied to at least one control cable (102b) located inside the hollow introducer sheath (102). It may be configured to perform one of the following:

[0097] As shown in Figures 15 and 16, in some embodiments, the device further includes at least one sheath steering cable (102b) connected to the tip of the sheath. Here, the at least one sheath steering cable is located inside the sheath. As previously stated, this at least one sheath steering cable (102b) may be configured to transmit a sheath off-axis steering force to the tip of the sheath, and to move the tip sheath and the enclosed multistage catheter device off-axis in accordance with this sheath off-axis steering force.

[0098] To operate the device, the device may further include a sheathed off-axis manual force application fixture and / or an actuator for the sheathed steering cable. These can be configured to further control the sheathed off-axis steering force by generating and releasing tension on the at least one sheathed steering cable (102b).

[0099] Various actuators, such as the arrangement of the aforementioned drive wheel (306) and motor (M), may be part of the control head (300 or 310). In some embodiments, the actuator system may have several actuator components, such as the drive wheel (306) mounted on the control head (300, 310), as well as other components, such as the motor (M), mounted on a robot system, such as a robot arm.

[0100] In some embodiments, a control head (310) or an optional manual grip structure (311) attached to the sheath (102) may be used to apply manual force to the sheath as needed.

[0101] In some embodiments, the systems shown in Figures 16 and 15 may be configured to be disposable or reusable (reusable for a limited number of times) and should be noted that they are pre-sterilized and delivered in sterile packaging. The drive wheel (306) may be part of a disposable or reusable system, and the motor (M) interfaced with the drive wheel may be configured as part of a durable medical device (such as part of a robotic system). After installation, the motor (M) is detachable from the drive wheel (306).

[0102] Figure 17 shows a device implemented in a robot system with two control heads (300, 310), each containing a block of motor "M" that is mounted (in this case on a robot arm 330) and can interface with a drive wheel (306) on the control head. In this configuration, both control heads are configured to move independently of each other along the same axis.

[0103] In Figure 17, the computerized motor actuator system includes two control heads (300, 310). These control heads are mounted on a processor-controlled robotic arm (330). This processor-controlled robotic arm is further configured to move the catheter / bronchoscopy device and control the computerized motor actuator system (such as the aforementioned drive wheel 306 and motor "M") to guide at least the tip tool plate (109) of the tip stage hollow catheter (108) to a target position. Here, (308) shows a connector and / or position encoder for controlling motor "M" and / or any other motor to control the linear stage of the robotic arm. As previously stated, (309) shows connectors and interfaces for operating and controlling other conduits, such as a camera for controlling the camera, lights, sensors, position indicators, electrodes, and tool tips.

[0104] Figure 18 shows an embodiment in which the robotic system applies the catheter to the patient.

[0105] In some embodiments, at least one control head is mounted on a processor-controlled robotic arm. The processor-controlled robotic arm is configured to move the device and control at least one computerized motor actuator. These are used to guide at least the tip tool plate of the tip of the tip-stage hollow catheter to a target position (inside the patient).

[0106] Tool head (tip plate) Figure 19 shows an end-tip tool plate (also known as tool head 109) equipped with a camera (250), illumination (252) (such as the two LED lights shown), and forceps. Here, the outer wall of the end portion (108) is not shown (or is instead made transparent) so that the various components and conduits (210-240) can be seen.

[0107] For example, a camera (250) may be made available by a first electrical conduit (232), and an LED (252) may be provided by a second or third electrical conduit (234). The conduit may also include a hollow tube (236) from which various devices such as forceps (254) can be fed and controlled.

[0108] In Figure 19, the tip tool plate has an opening that is not as large as the inner diameter of the tip stage hollow catheter, but this is not limited to this. In some embodiments, the tip tool plate (109) may be configured to have an opening with a tip tool plate opening diameter that is the same as the inner diameter of the tip stage hollow catheter.

[0109] In other words, the tip section (tip portion 108) often has a tool head (109), also called a tip tool plate, at its tip. While the examples so far have only shown the electrode (110) as a type of tool, many alternative tools and configurations are possible. As shown in Figure 19, other devices such as a camera, light source, and a tube or opening for delivering a tool (e.g., forceps, brush, biopsy needle, electrode, drug delivery needle, etc.) may be attached to this tool head (109) either alternatively or additionally.

[0110] As mentioned above, the tip tool plate typically covers at least a portion of the tip opening of the hollow tip catheter (108), but alternative embodiments are possible. In some embodiments, the tip tool plate (109) may be configured to have a tip tool plate opening diameter the same size as the inner diameter of the hollow tip catheter (108). Note that this larger-opening tip tool plate is also configured to be attached to the control cable (220...226). See Figure 9 for an example. Alternatively, the cable may be attached to the inside or outside of 108, just below the base of the plate, by adhesive, snap-fit, soldering, or welding.

[0111] In some embodiments, at least some of the conduits may include electrical conduits (234) configured to transmit power or electrical signals to probes, sensors, or other electrically operated devices positioned on or passing through an end tool plate.

[0112] Alternatively or additionally, in some embodiments, at least some of the conduits (234) may include optical fibers or hollow tubes configured to transport optical signals, electromagnetic signals, or radio frequency (RF) signals or chemical substances to or from a device positioned on an end tool plate.

[0113] Figure 20A shows a tool head (109) equipped with a biopsy needle (256).

[0114] As shown in Figure 20A, in some embodiments, at least some of the conduits (such as 236) and the tip tool plate (109) may be configured to obtain a tissue biopsy from the target tissue or to treat the target tissue.

[0115] Figure 20B shows a tool head with a closed tip (260).

[0116] Figure 20C shows a cross-sectional view of the tool head (109) with the closed tip (260) shown earlier in Figure 20B. Various shapes of the closed tip are possible, including rounded tips, pointed tips, and tips with softened edges (as shown). Such tips can be made of conductive or non-conductive materials and can be used for a variety of purposes, such as electrophysiological monitoring and electrical defibrillation therapy. In some cases, there may be very small holes in or near the tip for delivering fluids such as saline or drug therapy.

[0117] Therefore, in some embodiments, the leading edge of the catheter's tip section / part does not need to be hollow. In fact, depending on the configuration, it may be filled with the same material as the catheter wall itself or other materials as desired, all the way to the entire tip section / part.

[0118] Figure 21 shows another diagram of components and some of the conduits that may be incorporated into the tool plate (109) of the tool head. Here, the tool plate (109) includes a camera (250), a working channel which can also be considered a hollow tube conduit (236) for delivering the tool, and two LED lights (252). Extending from the tool plate (109) are the four aforementioned pull wires, conduits, or cables (220, 222, 224, and 226) for four-directional tip articulated movement (e.g., X, Y, Z axis movement, or 3D articulated movement). Conduit wires (232), (234) for the camera and LEDs are also shown. The camera (250) can be any type of miniature video camera, including CMOS, CCD, or fiberscope. The LEDs (252) can be replaced with optical fiber illumination if desired, in which case some of the conduits (e.g., 234) may be optical fibers.

[0119] In many cases, it is useful to use various types of position tracking or imaging devices to determine the position of the apparatus, particularly the tool plate (109) and / or associated tools. Therefore, in some embodiments, either the tip tool plate (109) or a portion of the conduit may include either a photodetector or emitter, or a high-frequency detector or emitter, or a radiopaque material, configured to enable the determination of the position of the tip tool plate or the portion of the conduit.

[0120] As mentioned above, the photodetector (250) may often be a video camera, and the emitter (252, etc.) may be configured to emit light for this video camera.

[0121] Further consideration of the tip tool plate: As previously mentioned, the tip plate, also called the tip tool plate (109), is a major structural element, often disc-shaped, positioned at the tip of the tip segment or tip portion (108). The tip tool plate holds various conduits for transmitting electrical or chemical signals between the tip of the device and the operator or computer at the base of the device. The tip tool plate can also provide access for the tool to reach the treatment area.

[0122] As mentioned above, Figure 21 shows an embodiment of a tool plate (109) for positioning and mounting a video camera (250), two LEDs (252) that provide light, and a hollow tube conduit (236) that can be used as a tool port.

[0123] An alternative embodiment of the tool board (109) may have two hollow tube conduits (236) providing two tool ports, a camera (250), and two LEDs (252).

[0124] In some embodiments, the tool plate (109) may have a tool port (238) that provides another type of conduit, in addition to the camera (250) and LED (252), which can provide a guide mechanism for introducing bipolar electrodes (such as (110a and 110b)) or other tools.

[0125] Method of biopsy, and method of delivering treatment using a toolhead. In some embodiments, a needle may be used to collect a biopsy from the lesion site using a catheter device.

[0126] In some embodiments, the system may be used for monopolar therapy (defined here as therapy using only one probe), such as injecting drugs into cancerous tumors using the device. Alternatively, other monopolar therapy methods may be used, such as treating cancerous tumors with radiofrequency (RF) monopolar energy from a single electrode to directly treat the tumor or to activate drugs that subsequently attack the tumor.

[0127] Alternatively, bipolar therapy, defined here as administering treatment using two probes, may be used. In this approach, a drug can be injected into the cancerous tumor using a first probe or needle. A return needle is also injected into the tumor and may be used to deliver a second drug, to deliver more of the first drug, or to return any excess drug from the tumor.

[0128] Another example of bipolar therapy is that cancerous tumors can be treated with RF (radio frequency) energy between two electrodes to directly treat the tumor or to activate drugs to subsequently attack the tumor. Alternatively, bipolar RF energy can be used to treat tumors by activating a payload containing therapeutic agents. In this case, two (or more) electrode needles are spread within the tumor.

[0129] As yet another example, a tumor can be injected with a single needle, and this same needle can function as a first electrode for delivering RF energy. Here, the head plate (109) or the body of the catheter (108) can function as a second electrode. Thus, in this arrangement, the electrode can be exposed on the front of the catheter, and the bipolar RF energy can return through the body of the catheter.

[0130] Driving method, crawling movement In some embodiments, the catheter can be constructed to crawl through tissue with a undulating wave that can be set between the tip section (108) and the proximal section (106). This motion, along with the rotation of the tip section (induced by the hollow shaft 200), can produce a crawling or meandering movement. The bending and rotating tip section allows it to penetrate further into a biological lumen (such as a blood vessel or bronchi) toward a desired target.

[0131] In some embodiments, the movement of the device may be controlled by one or more processors that drive actuators / motors (often located in a control head) to generate a kind of wave between the tip stage (108) and the base stage (106).

[0132] Further consideration Any of the following devices, namely cameras and illumination, needle biopsy devices, brush biopsy devices, forceps biopsy devices, debridement biopsy devices, RF coagulation / cutting devices (unipolar, bipolar), probes, sealing devices, etc., can pass through the device and reach the tip end effector at the tip of the device. Similarly, the joints and devices described herein, but not limited to, can be used or adapted for use in any appropriate medical or surgical procedure, including, but not limited to, debleeder-assisted tumor resection, shear-assisted tumor resection, delivery of biologics and drugs, neurological tumor resection, polyp resection or biopsy, breast biopsy, lung biopsy, cardiac bypass with minimal portal vein access, endoscopic submucosal dissection, transurethral procedures (TURP, bladder tumors), prostatectomy, hysterectomy, stem cell delivery, delivery of arthroscopic tools, knee and hip, and transnasal procedures (frontal sinus tissue resection, functional endoscopic sinus surgery, etc.). However, these are merely examples, and other end effectors and procedures may be used in various alternative embodiments.

[0133] Further consideration of various systems and methods for driving catheters As will be described later, in some embodiments, the present invention may be an apparatus, system, or method for driving a catheter apparatus for traversing a passage in the body by actuator assistance or robot. As previously stated, this catheter apparatus typically has at least one stage and may include, for example, a tip stage hollow catheter (108) and a different proximal stage hollow catheter (106).

[0134] In this configuration, one end of the tip stage hollow catheter can be fixed to the end of a different proximal stage hollow catheter by an optional insulating transfer coupler (107a, 107a1, 107a2, or joint (107j)).

[0135] This optional insulated transition coupler, if present, is typically configured to traverse a bodily passage. The insulated transition coupler typically includes a transition housing (107a) which may optionally include at least one tip coil stopper (107b) for an optional insulated coil. The coupler may be configured to allow one end of a tip stage hollow catheter to be attached to the end of a different proximal stage hollow catheter.

[0136] The catheter device further includes a hollow torque shaft (200), which in some embodiments forms a proximal / partially hollow catheter (106). The hollow torque shaft can be attached to an optional insulated transfer coupler (107a) or joint (107j). The hollow torque shaft is configured to transmit torque between the coupler or joint and the proximal / partially hollow catheter (108).

[0137] The catheter device further includes at least one tip stage / partial control cable (220). This cable is connected by and through an optional insulated transfer coupler (107a). This at least one tip stage control cable can be located either inside or outside the proximal stage hollow catheter (106) or the hollow torque shaft (200). The at least one tip stage control cable (220) is configured to transmit tip stage control force to the tool plate (109) and to move (e.g., bend) the tool plate and the tip stage hollow catheter (108) according to the tip stage control force.

[0138] A hollow torque shaft (200), a tip stage / partially hollow catheter (108), and an optional insulated transfer coupler (107a) typically further include a working channel (see 228 in Figure 13) configured to transport multiple conduits through a proximal stage hollow catheter and a tip stage hollow catheter to at least a tip tool plate (109) attached to the tip of the tip stage hollow catheter (108).

[0139] In a preferred embodiment, at least some of the conduits include at least one tip-stage maneuvering cable (220) connected to a tip tool plate (109) at the tip of the tip-stage / partially hollow catheter. This at least one tip-stage maneuvering cable (220) is configured to transmit tip-stage maneuvering force to the tip tool plate (109). This causes the tip tool plate and tip-stage catheter to move further in accordance with the tip-stage maneuvering force (e.g., bend or straighten out the bend).

[0140] With respect to the apparatus, system, or method for driving the above-described catheter, the present invention can be expressed in method form as typically comprising bending and unbending the end of a tip stage / partially hollow catheter. This can be done by using at least one tip stage tension actuator (e.g., either 350f1 or 350af1) to generate and release tension on at least one of the tip stage steering cables (220). This is typically done by rotating this at least one tip stage steering cable in a 1:1 ratio with any rotation of a torque shaft (200) which is directly coupled to a tip stage hollow catheter (108) (in the case of a single-stage catheter) coupled or connected by an optional insulated transfer coupler (107a) or joint (107j).

[0141] Drive mechanism: In some embodiments, the catheter device may further include at least one tip stage / partial tension actuator (350f) configured to bend and unbend the end of a tip stage hollow catheter by generating and releasing tension on at least one of the tip stage steering cables (220).

[0142] An important aspect of this embodiment is that the at least one tip stage / partial tension actuator is further configured to rotate the at least one tip stage control cable (220) in a 1:1 ratio with any rotation of the tip stage / partial hollow catheter (108). In a preferred embodiment, the tip stage / partial catheter (108) is rotated by the proximal stage / partial catheter (106) and the torque shaft (200), so this means that the tip stage control cable (220) is rotated in a 1:1 ratio with any rotation of the torque shaft (200). Therefore, a suitable mechanism must provide this synchronized operation of the control cable (220) and rotation of the catheter.

[0143] Figure 22A shows an example of how a catheter device can be driven synchronously. In this embodiment, the robotic system uses both a rotational torque mechanism and a linear actuation mechanism. These two types of mechanisms (342) are coupled together to produce both rotational and linear motion simultaneously. In some embodiments, multiple rotational torque mechanisms and linear actuation mechanisms (e.g., multiple iterations of 342) may be coupled together to operate multiple tension cables and / or produce multiple rotational degrees of freedom simultaneously.

[0144] In some embodiments, the present invention may move an optional insulated transition coupler (107a) or joint (107j) by using different proximal stage tension actuators to generate and release tension on at least one of at least one optional pair of proximal stage steering cables (210). In this case as well, this is done while rotating the proximal stage steering cables (210) of this optional pair at a 1:1 ratio with any rotation of the proximal stage / partially hollow catheter and the tip stage / partially hollow catheter, often by using another coupling of a rotary drive unit and a linear actuator similar to 342.

[0145] Figure 22B shows a further detailed diagram illustrating how this robot drive system (342) can operate. Each drive section may further include a bearing (346), an end- and / or base-end drive shaft (349, 347), an optional motor drive coupler (348), and a motor / actuator. In some embodiments, these motors / actuators are electromagnetic motors / actuators, often controlled by appropriate processors and sensors.

[0146] In the single interlocking option shown, the rotation of the proximal portion of the catheter torque axis (108 / 200) can be controlled by a rotation axis actuator (350r1), while the movement of the tip stage steering cable (220) (or tension cable) can be controlled by a tip stage bending actuator (350f1). In this embodiment, since the tip stage (108) is firmly coupled to the proximal stage / rotation axis (106 / 200) by an optional insulated transfer coupler (107a) or joint (107j), the rotation of both the tip stage / part and the proximal stage / part is controlled by the same rotation axis actuator (350r1).

[0147] Therefore, the motor / actuator includes a "tension motor / actuator" (350f1) and a "rotation motor / actuator" (350r1). Other components may include a torque shaft (200), potentially outside the proximal portion of the catheter (106), a miter gear (354), and other types of gear arrangements (356). Additional components may include an insertion funnel or Luer lock device (358), optional electrical wire coils for a camera or treatment device (360), and other electronic components such as sensors and device circuits (362).

[0148] As will be stated shortly, “tension motors / actuators” (350f1) are generally configured to “bend,” “curve,” or “maneuver” at least the tip section / part of the catheter (often using a suitable gear assembly) by controlling tension on a suitable steering cable, usually such as (220). In contrast, “rotation motors / actuators” (350r1) are generally configured to rotate their particular steering cable (again using a suitable gear assembly) in relation to other rotations of the catheter device (e.g., rotation of the torque shaft 200) to prevent the various cables from becoming entangled with each other as parts of the catheter device rotate (to traverse various biological passages as necessary).

[0149] Definition: These mechanisms convert forces between various processor-controlled electromagnetic actuators into desired mechanical movement and are generally defined as “contact mechanisms.” Here, a “gear assembly” can be a specific type of contact mechanism, but other contact mechanisms that do not use gears may also be used.

[0150] In some embodiments, the present invention may also include the use of at least one end stage tension actuator (350f1) and at least one contact mechanism. These actuators often include at least one electromagnetic actuator controlled by a processor (410). To assist in precise movement, often at least one motion sensor or position sensor (e.g., 412, 376a, 376b) may be analyzed by this at least one processor during this process to control one or more actuators. In some embodiments, the actuators may have built-in motion or position sensing capabilities, in which case the sensors may further include such built-in sensors.

[0151] As shown in more detail in Figures 22A and 22B, the rotation axis (352d) of all catheter stages is defined as the motor drive axis from which the mechanical drive system rotates at least one or more catheter stages.

[0152] In other words, in some embodiments, the device may include at least one front-end tension actuator. This front-end tension actuator may include at least one contact mechanism (such as a gear assembly), at least one electromagnetic actuator (350f1, 350f2), and at least one processor (410) configured to control the at least one electromagnetic actuator. Additionally, in preferred embodiments, the device may include at least one motion or position sensor, such as (412, 376a, 376b). Here, the at least one processor (410) is further configured to control this at least one electromagnetic actuator using input from the at least one motion or position sensor.

[0153] In some embodiments, as described above, the contact mechanism includes at least one gear assembly (for example, one of 354, 364, 366, 368, 370, or 375 as shown in Figure 22B). Furthermore, at least a portion of this gear assembly may be configured in a disposable or reusable cartridge that can be reversibly coupled to and detached from at least one electromagnetic actuator, such as 350f1 or 350f2.

[0154] Disposable and reusable forms are described in more detail in Figure 31A.

[0155] Figure 22B shows a detailed diagram of how the mechanical drive system can operate to rotate various sections of the catheter device.

[0156] As mentioned above, in a typical embodiment, at least some, and often all, of the various actuators (350f1, 350r1, etc.) are electromechanical actuators. Typically, these actuators are driven under processor control by one or more processors (usually one or more microprocessors (410)). The microprocessors then typically receive input from one or more sensors (412), such as various sensors (376a, 376b), which will be described shortly.

[0157] In many cases, electromagnetic actuators are given as specific examples, but other actuators such as electroactivated nitinol and polymers, air-driven actuators (pneumatic actuators), or fluid-driven actuators may also be used.

[0158] Figures 23 and 24 show how the tip linear circular gear rack (364) slides along the drive shaft. These figures also show how the tip circular gear rack is driven by a rotary drive gear, which is firmly connected to the drive shaft, and the drive shaft is bonded to the proximal torque shaft of the catheter. In this embodiment, the linear circular gear rack slides along the drive shaft and, at the same time, is coupled to a drive pin that slides through the rotary drive gear. This coupling prevents the control cable (220) from twisting while being actuated by the linear circular gear rack, rotating 1:1 with the drive shaft (e.g., torque shaft 200). Many other methods exist for slidably fitting the linear circular gear rack to the drive shaft to transmit torque. These include flat (single, double...hexagonal, etc.), pin, spline, or other mechanisms as keyway devices. A sliding fitting (e.g., pin 370 or another mechanism) restricts radial movement from the rotating member or catheter axis, while allowing transverse movement along the rotating member or catheter axis.

[0159] Figure 23 shows a cross-sectional view of the apparatus previously shown in Figures 22A and 22B. This figure shows a linear circular drive rack (364), a transmission gear (366), a rotary drive gear (368), an optional sliding drive pin (370), and a suitable control cable (372), such as the aforementioned tip stage control cable (220). Note that in some embodiments, there are multiple versions of this apparatus, namely those configured to operate the tip portion of a catheter (342) and others configured to operate additional control cables or sheaths.

[0160] The large arrows indicate the various directions of motion of each component in operation. As can be seen, the device can be commanded to rotate (along 372) around its axis (376a) and also to produce axial inward and outward motion (376b). The power transmission path from the actuator (350r1) to the rotary drive gear (368) through various optional intermediate gears such as (354) and (366) is shown as (376a).

[0161] In this case as well, the "in-and-out" motion (376b) is used to bend or unbend at least the tip of the catheter or to apply or release tension to a given control cable (such as 220) used to maneuver the tip. The rotational motion is designed to rotate different parts of the catheter to traverse various biological lumens, for example by using the aforementioned hollow torque shaft (200), while preventing the control cable from becoming entangled.

[0162] In other words, in some embodiments, the rotary drive gear (368) rotates the drive shaft (347), which is connected to the outer base tube body and torque shaft (e.g., 347-106 / 200).

[0163] In some embodiments, the tip linear circular gear rack (364) (tip 342) rotates while its rotation is coupled to a sliding drive pin (370). These gear racks are driven to rotate in a 1:1 ratio by their respective rotary drive gears (368). Any given linear circular gear rack (364) (tip 342) can be actuated by a linear circular pinion gear (see 374 in Figure 25) for an axial "in-and-out motion" or "tension motion" (376b) along the axial direction (372), and the linear circular pinion gear is permitted to slide within a cut groove (364) while (364) is rotating and driven by a sliding drive pin (370) on a suitable drive shaft.

[0164] In this embodiment, rotational motion is directed from the motor / actuator (350r1) to the miter gear (354), then to the transmission gear (366), and finally to the rotary drive gear (368), via a contact mechanism including a motor coupler (348). In some embodiments, one or more contact gears such as these gears may be referred to as a “gear assembly”.

[0165] It should be noted that in some embodiments, the proximal outer tube body (106) may be attached, mounted, or otherwise bonded to its respective drive shaft (347). In this embodiment, the proximal drive shaft (347) may be used to directly rotate the proximal outer tube body (106) and the torque shaft (200). This controls the rotation of the insulating transfer coupler (107a) and transmits it directly to the tip catheter portion (108).

[0166] The control cable (220) can bend or curve the tip of the catheter (108) at any rotational position.

[0167] Figure 24 shows an enlarged cross-sectional view of the drive rack (364), transmission gear (366), rotary drive gear (368), and sliding drive pin (370) portions of the device previously shown in Figures 22A and 22B. This figure provides further details on how the device achieves both rotational and sliding operation of the in / out control cables. Here, the linear circular gear rack (or drive rack) (364) is shown in its fully extended state. In this configuration, the drive rack (364) pulls the control cables (220, 210) to their fully bent state.

[0168] Figure 25 shows an alternative diagram illustrating a non-cross-sectional view of this part of the system. Optional sensors (376a) and sensor electronics (376b) are also shown.

[0169] Figure 25 shows an enlarged view of the drive rack, transmission gear, and rotary gear system, and an example of how various sensors (376a, 376b) may be used to control and monitor the position of the drive unit.

[0170] Figures 26 and 27 illustrate how the rotational position of a rotary drive gear can be tracked using sensors such as photoemitter / photodetector pairs and edge markings on the gear surface. The closed-loop linear position of a linear circular gear rack can be sensed by a Hall effect sensor or other photoemitter / photodetector pairs in combination with a magnetic or reflective surface. Different types of sensors may also be used.

[0171] Figures 26 and 27 show the extreme positions of a linear circular gear rack (364) for a single stage (e.g., 342). Understanding this rotational linear drive is important in a simplified single-stage / single-catheter configuration where the linear actuation rotates directly or in a 1:1 ratio with the rotating stage. This rotation can exceed 360 degrees in any direction without limitation and without a linear actuation mechanism that would cause twisting of the tension cable. This is important because a primary objective of the present invention is to prevent cable twisting that could interfere with the function of the catheter device.

[0172] Figure 26 shows the relaxed position with no cable tension. Figure 27 shows the fully bent state where sufficient tension is applied to the cable by a linear pinion gear (374) that drives the linear circular gear rack (364) with an output that engages with the linear circular gear rack (364) and bends the catheter.

[0173] Figure 26 shows one extreme position of the linear circular gear rack (374) (for a single stage, such as one of the 342s) of the device. Here, the linear circular pinion gear (374) rotates clockwise and, by engaging with one or more protrusions formed on the drive rack (364), pushes the drive rack (364) and pin 370 as far away from the rotary drive gear (368), thereby relieving tension on one of the tip or base stage control cables.

[0174] Figure 27 shows different extreme positions of the linear circular gear rack of the device (for the same stages as above). Here, the linear circular pinion gear (374) rotates counterclockwise, and in this case as well, by engaging with one or more protrusions formed on the drive rack (364), it pulls the drive rack (364) and pin 370 closest together, thereby creating tension on one of the end or base stage control cables. Here, one or more sensors (376a, 376b) and processor (410) of the system can be used, in this case as well, to adjust this tension to a desired degree.

[0175] Figure 28A shows a cross-sectional view of the rotary and linear drive system. Figure 28B is a magnified portion of Figure 28A, showing the position of the drive rack (364) and how the steering cable (220) is positioned as a result of the movement of the linear circular pinion gear (374). This figure also shows an optional tightly wound insulating coil (380) which in some embodiments may surround (and shield) a large portion of each of its steering cables (220, etc.). This optional insulating coil (380) is often configured to have some extra length between two optional insulating coil stoppers, such as (382n) and (386d). This means that the insulating coil has an incompressible length that is slightly greater than the neutral axis located inside the catheter. This optional insulating coil helps to insulate the tension of the steering cable (220) so that the steering cable (flex cable) does not generate tension along the entire length of the catheter. Instead, due to the insulating or force-insulating properties of the insulating coil (380), the tension in the control cable (220) is directed only to the flexible tip section of the catheter, which is designed to allow the control cable to bend or curve.

[0176] Please note that if an insulating coil is not used, the stopper for the insulating coil may also be omitted.

[0177] The basic idea of ​​the optional insulated coil is similar to the principle used in cable-operated handbrakes on bicycles and motorcycles. Mechanically, each insulated coil functions by applying an equal but opposite force to its internal control cable (220). As a result, the cable force is insulated until the control cable force reaches its destination at the leading edge insulated stopper (386d) where the control cable (220) protrudes beyond the insulated stopper. The control cable force is ultimately directed towards the section catheter after the insulated coil has terminated (after 386d). This causes the catheter to bend from the point where the cable is attached (e.g., near the leading edge of the tool plate 220t, transition housing, or catheter tube) to the end of the insulated coil (386d).

[0178] Note that in Figures 28A and 28B, the linear circular gear rack is not operating, and the end of the catheter system controlled by its specific control cable is in a relaxed state (large gray arrow is straight).

[0179] Figure 28A shows a cross-sectional view of the rotational and linear drive systems. Here, the drive system is in a first "relaxed" state, similar to the state shown in Figure 26. In this configuration, the tension on the tip (or proximal) control cable, such as (220), is low, and as a result, the relevant tip portion (108) of the catheter tends to be straight (not bent).

[0180] In other words, in some embodiments, each optional insulated coil (380) results in insulated coil compression. At least the near end (382n) of the insulated coil is mounted in close proximity to its respective bending actuator in a manner that further allows for adjustment of this insulated coil compression. The device is further configured to adjust this insulated coil compression by a manual insulated coil compression regulator and / or compression actuator.

[0181] Figure 28B shows a further detailed view of the drive rack (364) shown earlier in Figure 28A. Note that, depending on which drive section (tip 342) is involved, the proximal end of the tip control cable (220) is often fixed to the end of the drive rack. As previously mentioned, some or all of the control cables (220, etc.) may optionally pass through or traverse their own insulating coil (380) to help prevent mechanical crosstalk between the control cables and other parts of the device. This insulating coil is hollow, and the inside of the coil has a diameter sufficient to allow the control cables (220) to pass freely through this hollow interior. At the same time, the insulating coil helps to block or "insulate" the movement of the control cables (220) from the rest of the catheter device, at least while the control cables (220) are inside the insulating coil.

[0182] As previously shown, this insulating coil (if present) generally extends along the entire length of the catheter to the tip coil stopper (107b). This tip coil stopper (107b) is typically positioned at the insulating transfer coupler (107a). From there, the control cable (220) typically extends over a shorter distance to the tip catheter portion (108) to its destination (usually at or near the tip tool plate 109, such as 220t, depending on the type of control cable).

[0183] An optional insulated coil has a near end (382n) and a far end (see 386d in Figures 5A, 7A, and 10A). The near (e.g., base) portion of the control cable is attached (e.g., clamped) to the bending actuator (here, the end of 364). The near end of the insulated cable (382n) is also attached in such a manner that it allows the control cable to protrude movably beyond the near end (382n) of the insulated coil, while preventing axial movement of the insulated coil at this end. This attachment of the insulated coil can be done in various ways, such as by an adjustable insulated coil set screw (384), which can also be used to set the compression of the insulated coil. This compression setting can be very finely adjusted because the insulated coil is tightly wound.

[0184] In other words, in some embodiments, at least one end-stage control cable (220) may be further positioned inside the insulating coil (380), which includes an insulating coil far end (386d) and an insulating coil near end (382n). Here, each insulating coil far end is mounted close to the end of its corresponding control cable in such a manner (e.g., by an end coil stopper 107b) that prevents axial movement of the insulating coil far end while allowing its corresponding control cable (220) to protrude movably beyond the insulating coil far end (386d).

[0185] Furthermore, the near end (382n) of each insulated coil may be mounted in close proximity to its respective bending actuator in such a manner that the corresponding steering cable (220) can protrude movably beyond the near end of the insulated coil, while preventing axial movement of the near end of the insulated coil. In a preferred embodiment, the device is further configured to rotate at least one insulated coil in a 1:1 ratio with any rotation of the respective steering cable and the respective end stage. This scheme helps or enables the variable tension applied by each bending actuator to be insulated from its respective steering cable while the cable is inside its respective insulated coil.

[0186] Furthermore, as mentioned above, it should be noted that each insulating coil (380) results in insulating coil compression. Additionally, the near end (382n) of the insulating coil is mounted in close proximity to its respective bending actuator in a manner that further allows for adjustment of this insulating coil compression. The device may also be configured to adjust this insulating coil compression by either a manual insulating coil compression regulator and / or a compression actuator.

[0187] Figure 28B shows details of the tip drive section (342), and also shows a portion of the hollow torque shaft (200). In some embodiments of the present invention, at least one torque shaft actuator (e.g., 350r1) may be used to apply torque to the hollow torque shaft (200).

[0188] In contrast, Figures 29A and 29B show the linear circular gear rack in operation, with the catheter system in a bent position (indicated by a large gray arrow pointing upwards).

[0189] Figure 29A shows a cross-sectional view of the rotational and linear drive system. Here, the drive unit is in the second “actualized or flexed” state. Here, the relative movement of the flexion actuator (364) moves the tip or proximal control cable (220) toward full tension. As a result, this control cable pulls on the other end of each of the catheters, fully flexing or curving the outer tip (108) catheter tube.

[0190] Figure 29B shows a more detailed view of Figure 29A. In the relaxed state shown in Figure 28A / 28B or the bent state shown in Figure 29A / 29B, the tip drive section (342) can rotate together with the respective tip or proximal catheter at any rotational position.

[0191] Figure 30 shows an overview of the system.

[0192] Figure 30 (right side) shows a schematic diagram of how the rotational and linear drive systems can drive the catheter. As previously mentioned, here the tip stage (108) is bent and rotates clockwise or counterclockwise depending on its actuator. The tip bend may be due to tension transmitted to the tip tool plate (109) by the tip stage control cable (220). The rotation of the tip stage is transmitted by the torque shaft (200). At the same time, the proximal stage (106) is also bent and rotates clockwise or counterclockwise, like the tip stage, as the two stages are connected by an insulating transfer coupler (107a).

[0193] The left side of Figure 30 shows a magnified view of a portion of the rotational and linear drive system (here, 342) during the drive process of the multi-stage catheter shown on the right side of Figure 30.

[0194] In this diagram, a circular linear gear rack (drive rack 364) is extended by the driving force of a linear circular pinion gear (374). This controls the tension in the tip control cable (220) and curves the outer tip (108) portion of the catheter.

[0195] Disposable or reusable housing embodiment Figures 31A, 31B, and 31C illustrate how the proximal drive end of the catheter can be housed in a disposable or reusable housing. The disposable housing can be coupled to an array of drive motors mounted on a fixed platform, such as the robotic arm shown in Figure 32. The motor has a drive hub with a protruding pin attached to the output shaft. The motor hub drive pin engages with a coupler that is directly connected to the drive train gear of the cartridge.

[0196] Figure 31A shows how a disposable / reusable housing (388) may house the drive side (or gear train) of a catheter drive assembly. This can then interact with various actuators (e.g., electric motors) located on a robotic arm or other platform.

[0197] Figure 31B shows a detailed diagram of how the motor coupler (348) from the gear train of the disposable housing (388) may interact with the drive pin (351) of the actuator (350f1, or 350r1, etc.).

[0198] Figure 31C shows another diagram illustrating how a coupler (348) from a gear train out of a disposable housing (388) may interact with a drive pin (351) of an actuator (such as 350f1 or 350r1).

[0199] In some embodiments, at least one contact mechanism may include at least one gear assembly (e.g., any of 354, 364, 366, 368, 370, 374 or other gears that transmit force from one or more actuators to various parts of a catheter). Here, at least a portion of this gear assembly may be configured within a disposable or reusable cartridge (388) that can be reversibly coupled to and detached from one of various processor-controlled electromagnetic actuators (such as any of 350f1, 350f2, 350r1, 350r2). Thus, while the electromagnetic actuator can be mounted more permanently to a robotic arm, the disposable, preferably sterilized gears within the cartridge (388) can be mounted, discarded, or repaired and adjusted for subsequent use.

[0200] It should be noted that in some embodiments, the contact mechanism may alternatively include a lever / finger or fork having a pivot point connected to an actuator located inside the groove or on a protruding ring of a rotatable and sliding element. This lever / finger or fork can be pushed or pulled against either edge of the groove or on a ring having two edges.

[0201] Further methods for operating a rotary robotic catheter To generalize the above concept, other operating methods that do not use gears may also be used.

[0202] Rotary or linear motion can be driven by electromagnetic actuators, shape memory alloy actuators, pneumatic actuators, vacuum actuators, fluid actuators, and the like.

[0203] In some alternative embodiments, an electromagnetic linear actuator (motor) that rotates around the axis of a rotary drive motor may be used. This embodiment does not require the use of a drive pin to keep the linear actuator synchronized with the rotary actuator. Instead, a rigid mount can be used to fix the linear actuator to the rotary actuator. These motors can be open-loop or closed-loop DC or AC type motors. The electrical wires for the spin motor are managed by giving them extra length so that the motor can rotate more than 360 degrees in either direction, depending on the loop size of the wire coil.

[0204] In another alternative embodiment, the front and rear stages are coupled stages driven by an alternative electromagnetic actuator system. Here, rotational operation is powered by a through-shaft motor, and linear operation is powered by a linear electromagnetic motor pulling a flexible cable. In this embodiment, both the rotary and linear motors can have a through-hole design, eliminating the need for managing electric motor wires.

[0205] Rotating linear robotic catheter system with independently rotatable, bendable, and sliding catheters In some embodiments, the system may use one or more linear actuator motors that use pulleys rotating around through-hole motors.

[0206] Figure 32 shows another diagram of a rotary linear robotic catheter system with an independently rotatable, bendable, and slidable catheter. Note that during surgery on a patient, in many cases at least the tip portion of the sheath (102) and the remaining tip components (e.g., 106, 107a, 108, 110, etc.) (e.g., the catheter components to the right of the dividing line 396) are inserted into the patient. In contrast, the various actuators, gears, robotic arms, and other parts of the system to the left of the dividing line 396 remain outside the patient. These latter systems can be mounted on a robotic arm, such as the one described above (330).

[0207] It should be noted that in some embodiments, similar types of 1:1 synchronized linear and rotary drive systems, and optional sheath steering cables may also be used to control the movement of the sheath (102) while it is inside a living organism. This optional sheath system is shown as (398). In addition, other actuator systems, such as a therapeutic payload conduit administration system (400), may also be used, where the therapeutic delivery or generation unit itself is shown as (401).

[0208] Figure 32 also shows that in some embodiments, the device may further include at least one payload dosing actuator (402t) configured to move at least one payload along the working channel (228) by advancing or retracting the payload dosing conduit along the working channel.

[0209] Figure 32 also shows that in some embodiments of the present invention, at least the proximal portion of a proximal stage hollow catheter (106) may be placed within at least one hollow sheath (102). This at least one hollow sheath may be configured to allow at least a portion of the multistage catheter device to protrude or retract (axially) in and out of this at least one hollow sheath in response to forces applied to the at least one hollow sheath (102) and at least the proximal stage hollow catheter (106). Here, the axial movement of this hollow sheath may be controlled according to a sheath translational stage actuator (402s) and optionally by a processor (410) or another controller.

[0210] In other words, Figure 32 also shows that in some embodiments, the device may further be configured to have at least a proximal portion of a proximal stage hollow catheter (106) disposed within at least one hollow sheath (102). Here, the at least one hollow sheath may be configured to allow at least a portion of the multistage catheter device to protrude or retract inward and outward from the sheath in response to forces applied to the sheath and / or the proximal stage hollow catheter. Furthermore, the device may be configured to have a sheath translational stage actuator (402s) configured to control the axial movement of the sheath.

[0211] Catheter system tracking In the case of a rotary linear robotic catheter system with an independently rotatable, bendable, and sliding catheter, providing a method for tracking the catheter position in real time while the catheter is in the patient is often useful.

[0212] In some embodiments, each catheter segment may include radiopaque components, such as platinum rings. These radiopaque components, when used in conjunction with an imaging system such as real-time CT, allow tracking of the position of each catheter tip. Thus, the axis of each leading catheter is always defined by two points. This makes it possible to determine the positions of the leading ring and the next proximal ring of the catheter section.

Claims

1. A catheter device for traversing a passage in the body, wherein the catheter device is A hollow catheter comprising at least one section, the hollow catheter comprising a tip portion and a proximal portion, The aforementioned base portion includes a hollow torque shaft. The hollow catheter is configured such that the torque applied to the hollow torque shaft is transmitted to the tip portion. The apparatus further includes a conduit comprising at least one tension cable extending along the catheter from the proximal portion to the tip portion, each of which tension cables comprises a control cable. The hollow torque shaft and the tip portion further include a working channel configured to transport at least one other conduit through the base portion and the tip portion to at least a tip tool plate attached to the tip of the tip portion, The at least one tension cable includes at least one tip portion control cable connected to the tip tool plate, The at least one tip portion control cable is configured to transmit tip portion control force to the tip portion tool plate and to move the tip portion tool plate and the tip portion in accordance with the tip portion control force. The device further includes at least one tip portion tension actuator configured to generate and release tension on at least one of the at least one tip portion control cables, thereby bending the end of the tip portion and unbending the end. A catheter device wherein the at least one tip portion tension actuator is further configured to rotate the at least one tip portion control cable in a 1:1 ratio with at least any rotation of the tip portion.

2. The apparatus according to claim 1, wherein either the tip portion or the base portion is surrounded by a flexible polymer jacket whose outer surface may be continuous or discontinuous between sections.

3. The apparatus according to claim 1, further comprising at least one elastic element configured to resist a force applied by at least one of the at least one tension cable.

4. The apparatus according to claim 1, wherein the tip tool plate has an opening having a tip tool plate opening diameter that is less than or equal to the inner diameter of the tip portion.

5. The apparatus according to claim 1, wherein at least some of the conduits include electrical conduits configured to transmit either power or an electrical signal to any probe, sensor, or other electrically operated device located on or passing through the tip tool plate.

6. The apparatus according to claim 1, wherein at least some of the conduits include either optical fibers or hollow tubes configured to transport optical signals, electromagnetic signals, or radio frequency (RF) signals or chemical substances to or from a device positioned on the tip tool plate.

7. The aforementioned hollow catheter is a multi-stage catheter in which the tip portion is a tip-stage hollow catheter and the proximal portion is a different proximal-stage hollow catheter. The apparatus according to claim 1, wherein one end of the tip stage hollow catheter is fixed to one end of the hollow torque shaft by a joint between the one end of the tip stage hollow catheter and the hollow torque shaft, so that the torque applied to the hollow torque shaft is transmitted to the tip stage hollow catheter.

8. Either the tip portion or the base portion includes a woven fabric, nonwoven fabric, continuous material, or other material having a plurality of slits or openings along at least a portion of their outer circumference, The apparatus according to claim 1, wherein the material is positioned and sized to facilitate traversal of the apparatus through a series of branching internal lumens whose inner diameter gradually decreases.

9. The apparatus according to claim 1, wherein at least the proximal portion of the proximal end is disposed within at least one hollow sheath, and is configured to allow at least a portion of the catheter device to protrude or retract inward and outward from the at least one hollow sheath in response to a force applied to the at least one hollow sheath and at least the proximal end portion.

10. At least a portion of the aforementioned at least one tip portion control cable is further disposed inside an insulating coil, which includes the far end and near end of the insulating coil. Each of the far ends of the insulating coils is attached in close proximity to the tip of the corresponding control cable, in such a manner that it allows the corresponding control cable to protrude movably beyond the far end of the insulating coil, while preventing axial movement of the far end of the insulating coil. The apparatus according to claim 1, wherein the near end of each insulating coil is mounted in close proximity to its respective bending actuator in such a manner that the corresponding control cable can protrude beyond the near end of the insulating coil while preventing axial movement of the near end of the insulating coil.

11. The at least one tip portion tension actuator includes at least one contact mechanism, at least one electromagnetic actuator, and at least one processor configured to control the at least one electromagnetic actuator. The device further includes at least one motion sensor or position sensor, The apparatus according to claim 1, wherein the at least one processor is further configured to control the at least one electromagnetic actuator using input from the at least one motion sensor or position sensor.

12. A multi-stage catheter device for traversing a passage in the body, wherein the multi-stage catheter device is It includes a hollow catheter with a tip section and a hollow catheter with a different proximal section. The aforementioned different proximal stage hollow catheters include a hollow torque shaft, One end of the aforementioned hollow tip catheter is fixed to one end of the hollow torque shaft by a joint between the end of the hollow tip catheter and the hollow torque shaft, so that the torque applied to the hollow torque shaft is transmitted to the hollow tip catheter. The apparatus further includes a conduit comprising at least one tension cable extending along the catheter from the proximal stage to the tip stage, each of which tension cables comprises a control cable. The hollow torque shaft and the tip hollow catheter further include a working channel configured to transport at least one other conduit through the proximal hollow catheter and the tip hollow catheter to at least a tip tool plate attached to the tip of the tip hollow catheter, The at least one tension cable includes at least one tip stage control cable connected to the tip tool plate, The at least one tip stage control cable is configured to transmit tip stage control force to the tip tool plate and to move the tip tool plate and the tip stage catheter according to the tip stage control force. The device further includes at least one tip stage tension actuator configured to bend and unbend the end of the tip stage hollow catheter by generating and releasing tension on at least one of the at least one tip stage control cables, A multi-stage catheter device wherein the at least one tip stage tension actuator is further configured to rotate the at least one tip stage steering cable in a 1:1 ratio with any rotation of at least the tip stage hollow catheter.

13. The at least one front stage tension actuator includes at least one contact mechanism, at least one electromagnetic actuator, and at least one processor configured to control the at least one electromagnetic actuator. The device further includes at least one motion sensor or position sensor, The apparatus according to claim 12, wherein the at least one processor is further configured to control the at least one electromagnetic actuator using input from the at least one motion sensor or position sensor.

14. The at least one contact mechanism includes at least one gear assembly, The apparatus according to claim 13, wherein at least a portion of the gear assembly is contained within a disposable or reusable cartridge that can be reversibly coupled to and detached from the at least one electromagnetic actuator.

15. The apparatus of claim 12, further comprising at least one payload administration actuator configured to move at least one payload along the work channel by advancing or retracting the payload administration conduit along the work channel.

16. Any of the at least one of the tip stage control cables is further positioned inside the insulating coil, which includes the far end and near end of the insulating coil. Each of the far ends of the insulating coils is attached in close proximity to the tip of the corresponding control cable, in such a manner that it allows the corresponding control cable to protrude movably beyond the far end of the insulating coil, while preventing axial movement of the far end of the insulating coil. Each insulated coil near end is mounted in close proximity to its respective bending actuator in such a manner that the corresponding control cable can protrude beyond the insulated coil near end while preventing axial movement of the insulated coil near end. The device is further configured to rotate each of the insulating coils in a 1:1 ratio along with any rotation of each control cable and each of the end stages. The apparatus according to claim 12, which thereby enables the variable tension applied by each of the respective bending actuators to be insulated from each of the respective control cables while the cables are inside their respective insulating coils.

17. Each of the aforementioned insulating coils causes insulating coil compression, At least the near end of the insulating coil is mounted in close proximity to its respective bending actuator in a manner that further allows for adjustment of the compression of the insulating coil. The apparatus according to claim 16, further configured to adjust the compression of the insulating coil by either a manual insulating coil compression regulator or a compression actuator.

18. The apparatus according to claim 12, further comprising a torque shaft actuator configured to apply torque to the hollow torque shaft.

19. The apparatus according to claim 12, wherein either the front end stage or the base end stage is surrounded by a flexible polymer jacket whose outer surface may be continuous or discontinuous between sections.

20. The apparatus according to claim 12, further comprising at least one elastic element configured to resist a force applied by at least one of the at least one tension cable.

21. The apparatus is further configured to have at least a proximal portion of the proximal stage hollow catheter disposed within at least one hollow sheath, At least one of the at least one hollow sheaths is configured to allow at least a portion of the multistage catheter device to protrude or retract inward and outward from the at least one hollow sheath in response to a force applied to the at least one hollow sheath and at least the proximal hollow catheter. The apparatus according to claim 12, further comprising a sheath translational step actuator configured to further control the axial movement of the hollow sheath.

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