Scalable AI-designed articulated catheter device based on biometric measurements.

Abstract

A computerized system and method for manufacturing articulated surgical devices. Using surgical device pathway data (often acquired from medical scans), target and entry point position data, and design parameters stored in computer memory, customized devices are automatically designed and subsequently manufactured. The devices typically comprise multiple units, which may have different lengths and widths and are connected to one another by at least one movable joint. The devices are configured to accommodate multiple pull cables, often extending from the distal end to the proximal end. These cables allow the operator to precisely control the orientation of the distal end as the device traverses the patient's internal pathway, often using a proximal control device. The distal end of the device may have an effector unit configured to perform medical operations. Design and manufacturing are facilitated by the use of AI-powered computerized design techniques and computer-controlled (CNC, laser cutting, 3D printing) methods.

Description

Technical Field

[0001] Background of the Invention Field of the Invention The present invention belongs to the fields of medical catheters, medical robotics, and medical robotic catheters.

Background Art

[0002] Description of Related Art Catheters are widely used in various aspects of surgery and medicine. This includes cardiac catheters configured to be inserted through an opening in one of the patient's veins and then guided to a target area within the heart. At the tip of such catheters, various types of effector devices configured to administer therapeutic agents or radiopaque agents, apply stents, balloon devices, etc. are often attached.

[0003] In recent years, laparoscopic surgery has also become popular. These methods, often called keyhole surgery, aim to minimize patient trauma by using small, thin surgical devices that enter the body through small incisions and then perform useful surgical operations. For this purpose, many sophisticated devices have been devised, including various types of laparoscopes and other surgical devices. Robotic surgery, as demonstrated by Intuitive Surgical's Da Vinci robotic-assisted surgery platform, also employs advanced robotic control methods for performing laparoscopic surgery and other types of keyhole surgery.

[0004] Catheters often consist of a single, snake- or hose-like structure with little to no internal articulation, and are therefore not "articulated." Many conventional laparoscopic devices have a linear intermediate section and are therefore not articulated, at least in this intermediate section. Between these two extremes lies a third type of elongated device, which consists of numerous small articulated units, all strung together like a necklace. When properly controlled, such articulated devices are expected to address medical challenges that are difficult to tackle with conventional catheter designs and laparoscopy.

[0005] One example of an articulated surgical device is U.S. Patent No. 10,029,073 by Kalbe et al. Kalbe teaches a type of maneuverable assembly for surgical catheters. This is an articulated device composed of multiple units, which Kalbe refers to as segments. Each unit is an independent link connected to another unit by an articulation, which allows for pivotal movement around a single axis between different units (links).

[0006] As another example, Schmitz (who is also the inventor of this application) discloses an articulated device called a universal joint for surgical robots in U.S. Patent No. 11,033,342. This articulated device also consists of multiple units, where each unit further includes links and yokes, and they are configured such that each unit is connected to another unit by multiple joints, and these joints enable pivotal movement around two axes between the units.

[0007] Figure 1A shows an example of an articulated surgical device (100). In this embodiment, the device consists of repeatedly arranged articulated units (102), each unit including a yoke (104) and a link (106), and each unit can rotate around two independent axes (108) and (110). These may be referred to in this disclosure as “hypermobile” units.

[0008] Figure 1B shows another example of an articulated surgical device (120), in this alternative embodiment as well, the device consists of repeatedly arranged articulated units (122), each unit containing only a link (126), and each link being able to rotate around only one axis (124). Thus, in Figure 1B, the units (122) and links (126) are identical. [Overview of the project] [Means for solving the problem]

[0009] Summary of the Invention This invention is partly inspired by the insight that articulated medical devices, such as the aforementioned Kalbe and Schmitz devices, can be superior to accessing parts of the body that are currently difficult to access using conventional catheter and laparoscope designs.

[0010] The present invention is also inspired, in part, by the insight that there is considerable variability in patient morphology, particularly with respect to branched internal lumens such as blood vessels, lung structures, and certain intestinal regions. While articulated medical devices that can be precisely manipulated and guided as needed using internal pull wires offer some advantages here, the large variability in patient morphology makes it difficult for a standardized design to fit all situations.

[0011] The present invention is also inspired in part by the insight that modern medical scanning methods, when combined with modern computer-aided design techniques (often artificial intelligence-aided techniques) and advances in automated manufacturing methods, can now rapidly generate customized designs. Specifically, the present invention is inspired by the concept of a system and method that can rapidly progress from a medical scan to a customized articulated catheter or articulated laparoscopic device precisely tailored to address medical situations that cannot be adequately addressed by conventional devices.

[0012] Therefore, in some embodiments, the present invention can be a computerized system and method for manufacturing articulated surgical devices. In terms of the method, the method can manufacture a customized device from surgical device pathway data (often obtained from a medical scan) that describes the structural dimensions of at least a portion of a patient's internal lumen or other internal passage. Other data, such as target location data describing at least one target location within the patient's body relative to this pathway, and surgical device design parameters are also required. Here, the articulated surgical device comprises a plurality of connected units, each having at least one movable joint which may have a variable diameter or length.

[0013] Computerized systems typically comprise at least one computer processor and often a dedicated AI coprocessor, enabling them to acquire this data and automatically design patient-customized articulated surgical devices that can be tailored to the specific patient's physical morphology and medical needs. The output from this design can then be combined with suitable automated manufacturing processes, such as laser cutting and / or CNC methods, to rapidly produce the customized devices. In practice, a variety of customized devices, often configured to address situations where standard catheters, endoscopes, bronchoscopes, or laparoscopes are insufficient, can be pre-manufactured and kept on hand or in stock for emergency use. [Brief explanation of the drawing]

[0014] Brief explanation of the drawing [Figure 1A] An example of an articulated surgical device is shown. In this embodiment, the device consists of repeatedly arranged articulated units, each unit including a yoke and a link, and each unit can rotate around two independent axes. These may be referred to as highly articulated units. [Figure 1B] Another example of an articulated surgical device is shown, in this alternative embodiment as well, the device consists of repeatedly arranged articulated units, each unit containing only one type of link, and each link can also rotate around only one axis. [Figure 2] A longer section of an articulated surgical device comprising multiple yoke and link units is shown. Here, the device also has an effector unit, here a grasping tool, attached to the most distal unit of the device. In some embodiments, the movement of at least the most distal unit is controlled by various pull wires (often four independently operated pull wires) passing through small pull wire holes in the various units. [Figure 3A]Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3B] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3C] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3D] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3E] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3F]Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3G] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3H] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3I] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 3J] Figure 1A shows a detailed enlarged view of the link, yoke, and link (1.5 units). As can be seen from the figure, the link on the left is connected to the yoke by one yoke pivot boss, and the link on the right is connected to the yoke by a different yoke pivot boss, which allows for a highly movable array of units that can pivot simultaneously up and down and left and right, as shown in the figure. [Figure 4A]An enlarged view of the yoke portion of the super-mobile unit from the first angle is shown, and the dotted arrow indicates how an optional pull wire can pass through the hole in the yoke. [Figure 4B] An enlarged view of the yoke portion of the super-mobile unit from the second angle is shown, and the dotted circle indicates an optional pull wire (cable feed) passing through the hole in the yoke. [Figure 4C] A perspective view of the link portion of the super-mobile unit is shown. [Figure 5] An example of a path of a surgical device is shown. Here, these paths include at least a portion of the lumens of the patient's bronchi and bronchioles of the patient's lungs. Here, the small black circle on the left is a target lesion located in the difficult-to-access outer third portion of the lung, and it is assumed that the patient's physician desires to access it using a custom-made articulated surgical device. [Figure 6] An example of a method of tapering a multi-unit articulated surgical device from an initial wide proximal diameter to a narrow distal diameter is shown. [Figure 7] An example of a tapered multi-unit articulated surgical device is shown, which is similar to FIG. 6 and further includes a camera and a working channel at the distal end, both of which include either a light source and an optical fiber or a camera. [Figure 8] An example of a part of a device that can be used to automatically manufacture at least a part of a surgical device, such as an entire unit or at least a part of a unit, is shown. [Figure 9] A flowchart showing some aspects of the computerized design and manufacturing method of the present invention is shown. [Figure 10] An example of some elements considered by the automatic design system of the present invention is shown. Here, when the device passes through the body path, the diameters of various units (bracket 310) should generally become thinner as the width of the path narrows. The joints or radii of rotation between various units are also shown. [Figure 11]This demonstrates that automated design software can also be given additional design guidelines. Here, a sharp angle of attack (a steep bend) is required to effectively treat a given target located on the side of an internal lumen. [Figure 12] In some embodiments, we demonstrate how automated design software can match the diameter of a unit to the size of an internal lumen according to design guidelines. [Figure 13] This demonstrates that, in several constricted path situations, automated design software can generate a "neck" that has a wide area before and after the constricted section, but is narrowed at the constricted section, in accordance with design guidelines. [Figure 14] This shows a partial abstraction of the design guidelines for automated design software. Here, parentheses indicate a given set of unit diameter parameters, and intersecting asterisks indicate a given set of pivot point parameters (which can be controlled by the unit length and / or yoke position). [Figure 15] This describes a later stage of the automated design software process. Here, after a preferred set of unit diameters and pivot points has been selected, the automated design software can use these parameters to calculate other aspects of the design, such as the design of individual yokes and links. [Figure 16] A short assembled section of an articulated surgical device is shown, with its approximate length, diameter, and pivot point roughly scaled as shown in Figures 14 and 15. [Modes for carrying out the invention]

[0015] Detailed description of the invention As mentioned above, the present invention is in part based on the insight that the usefulness of various types of articulated surgical devices can be improved if those devices are further customized for a given patient and a given set of surgical problems.

[0016] Figure 2 shows a longer section of an articulated surgical device including multiple yoke and link units according to Figure 1A. The device also has an effector unit (130), here a gripper, attached to the most distal unit of the device. In some embodiments, the movement of at least the most distal unit or yoke is controlled by various cables or pull wires (often four independently operated pull wires, see Figures 4A–4C) passing through holes in the various units, links, and yokes. These often terminate at or near the most distal unit, link, or yoke. In embodiments where the surgical device is intended for use in the body, the outside of the device is covered with a flexible coating or layer (132), often made of a biocompatible polymer, to facilitate the device's passage through various internal pathways. In some embodiments, the most distal link may be attached to the most distal yoke without any movable link joint, thereby allowing the cables or wires terminating at the most distal yoke to more precisely control the orientation of the most distal link by manipulating the angle of the yoke.

[0017] The proximal portion (134) of the device is often connected to a larger control mechanism, which is an electrically controlled device that allows the surgeon to guide the surgical device through various internal pathways by using a combination of forces applied to the proximal unit and by manipulating various pull wires or cables that penetrate the device from distal to proximal, thereby allowing the distal portion of the surgical device to be manipulated through one or more axes as the device advances. This control mechanism (134) is often located outside the patient's body.

[0018] Since the distance from the link mechanism to the control unit (134) is often very long, in some embodiments, an intermediate section of other material, such as a less flexible catheter material, can constitute the extra length between (132) and (134).

[0019] In a preferred embodiment, the articulated surgical device includes a highly articulated unit comprising a link and yoke unit, as previously shown in Figure 1A. However, while many of the examples herein show highly articulated units, other types of units, such as the unit shown in Figure 1B, may also be used.

[0020] Figures 3A to 3J show detailed enlarged views of the link (106), yoke (104), and link (1.5 units) from Figure 1A. As can be seen from the figures, the left link (106) is connected to the yoke (104) by one yoke pivot boss, forming the first axis of rotation (108). The right link is connected to the yoke (104) by a different yoke pivot boss, forming the second axis of rotation (110). This allows the super-movable unit array to rotate simultaneously up and down and left and right, as shown in the figures. In Figures 3A to 3J, all configurations are possible by suitably manipulating various wires or cables (112 in Figure 4A, 112 in Figure 4B) by a control unit (134).

[0021] Figure 4A shows a magnified view of the yoke portion (104) of the super-movable unit from a first angle, and the dotted arrow (112) indicates how an optional pull wire or cable can pass through the hole in the yoke. Note that there are four pull wires, and the pressure on these different pull wires allows the distal unit (or yoke) to rotate in either direction on two different axes (108, 110).

[0022] Figure 4B shows an enlarged view of the yoke portion (104) of the super-movable unit from a second angle, where the solid circle (114) indicates a hole, and the dotted circle (112) shows how an optional pull wire (cable feeder) can pass through the hole (114) in the yoke. The central part (116) of the yoke is open, forming an internal working channel through which various components can move.

[0023] Figure 4C shows an enlarged perspective view of the link portion (106) of the super-movable unit. Here, an optional pull wire or cable (shown above as 112) can pass through the center of the link (118). This is because the center of the link (118) is also open and, together with the corresponding yoke, forms an internal "working channel" (as they are both open in this region).

[0024] Figure 5 shows an example of a pathway for a surgical device discussed in this disclosure. In this example, these pathways may include at least a portion of the lumen of the patient's bronchial tubes and bronchioles of the patient's lungs (140). Here, the small black circle on the left represents a target intracellular lesion (142) that the patient's physician wishes to access using a custom-made articulated surgical device, such as the device in Figure 2. The dotted line (144) represents a pathway that the articulated surgical device may need to traverse to reach the target (142) from the entry point (146). As discussed, this disclosure teaches an automated method for designing and manufacturing a surgical device suitable for achieving this objective.

[0025] Please note that Figure 5 is the copyrighted work of medical illustrator Patrick J. Lynch and medical doctor and cardiologist C. Carl Jaffe, and is used under the Creative Commons Attribution 2.5 License 2006.

[0026] As described above, in some embodiments, the present invention may be a computerized system or method for manufacturing articulated surgical devices (see 100 in Figure 1A, 120 in Figure 1A). In terms of method, the method may include receiving surgical device pathway data (see 144 in Figure 5) into computer memory that describes the structural dimensions of at least a portion of a patient's internal lumen or other internal passage. Furthermore, target location data (142) describing at least one target location within the patient's body and its relative position to the surgical device pathway data is also received into computer memory.

[0027] Furthermore, other information, such as design parameters for the articulated surgical device, must also reside in computer memory. In some embodiments, this articulated surgical device (sometimes referred to as an articulated device, device, catheter, robotic catheter, or robotic device) comprises a plurality of connected units (102, 122). At least some of these units typically have any of a variable diameter and length.

[0028] More specifically, as shown in Figures 1A and 1B, these units further comprise at least one movable joint (108, 110) and are configured to move about at least one axis (108, 110). As shown in Figures 8 and 9, this method typically uses at least one computer processor (208), surgical device path data (144), at least one target location data (142), and articulated surgical device design parameters to automatically design a patient-customized articulated surgical device (e.g., Figure 2 or Figure 7). This device is configured to travel along a path (144) from an entry point (146) in the patient's internal lumen or other internal passage to at least one target location (142) along the patient's internal lumen or other internal passage (144). This design can then be used to automatically manufacture at least a portion of this articulated device.

[0029] Figure 6 shows an example of how a multi-unit articulated surgical device can be tapered from an initial, wider proximal diameter (150) to a narrower distal diameter (152). Here, the units have the same overall design, but the initial proximal unit is wider and longer than the final distal unit. As previously mentioned, the dashed line (132) indicates the approximate location of a polymer sheath or cover that often surrounds the device to minimize interaction between the lateral side of the device and patient tissue during insertion and removal.

[0030] Figure 7 shows an example of a tapered, multi-unit articulated surgical device similar to that in Figure 6, which includes one or more light sources (such as an LED light source 156) and a camera (158) at the distal end (154), which may include either an optical fiber or a camera. Here, the working channel (which forms the large cavities 116 and 118 shown in Figures 4B and 4C) is generally concealed but penetrates the center of the device.

[0031] Figure 8 shows an example of some equipment that can be used to automatically manufacture at least a part of a surgical device, for example, the entire unit or a part of the unit.

[0032] This method can be implemented according to various options.

[0033] In some embodiments, surgical devices may be customized for specific patients. In other embodiments, a broader range of more standardized surgical devices may be fabricated, each optimized for different patient classes or surgical target classes. If a given patient and surgical target can be adequately covered by an available standardized surgical device, that standardized surgical device may be used. Otherwise, a customized surgical device may be fabricated. Here, we assume that the patient requires a customized surgical device.

[0034] For customized surgical devices, it is often useful to obtain certain data related to the structural dimensions of the patient's internal lumens or other internal passages intended for the surgical route. Location information of the surgical target is also required. In this example, this data is assumed to be obtained by a suitable medical imaging scan, such as a CAT scan, CT scan, MRI scan, ultrasound scan, X-ray, or other modality (202).

[0035] As shown in Figure 8, to do this, a medical scanner (202) can scan the patient (200). (The obtained medical scan data may be annotated to indicate the desired surgical route and target.) The obtained medical scan data is transferred to computer memory (204). Additional data, such as design parameters for the desired surgical device, may also be transferred to computer memory (206) (if not already present). This information is then processed by at least one computer processor (208). This at least one computer processor can be selected from ARM, x86, MIPS, or other processor families and may further include additional AI (artificial intelligence) hardware such as a dedicated neural network or AI processor (NPU), graphics processor (GPU), FPGA (field-programmable gate array), and coprocessor in some embodiments. Examples of suitable NPU and GPU processors include the Intel NCS2 chip, Telum processor, Nvidia DGX A100, Google Cloud TPU, Edge TPU, and Cerebras WSE-2.

[0036] The AI / processor system (208) acquires patent scan and medical target data, design parameters related to the desired type of arthroscopic surgical device, and (often supplemented or trained by a historical database of other arthroscopic surgical devices / pathways-target situations) to determine the arthroscopic surgical device that best satisfies various constraints. See Figure 9 for details.

[0037] Once the overall design is determined, an AI / processor (208) or a different AI or processor unit can determine the manufacturing instructions (212) necessary to produce the various components of the articulated surgical device. These components may include the diameters and lengths of at least some of the various units or parts of units (102, 104, 106, 122, 126), and other components as needed. (As mentioned above, in some embodiments, unit 122 may consist of link 126.)

[0038] These manufacturing instructions (212) can also be stored in computer memory (212). In some embodiments, at least the memories (204, 206, optionally the history database 210), the AI / processor 208, and / or some parts of the manufacturing instruction memory (212) can be packaged as a single unit (228), which is often referred to herein as the AI ​​system, but such packaging is optional.

[0039] Some parts of articulated standardized devices, particularly the control unit (134) and, in some cases, the effector unit (130) (i.e., the "payload" at the distal end of the catheter, often configured to perform medically useful tasks), can often be standardized, pre-fabricated units. However, in many cases, the intermediate parts of the device (e.g., at least some of the various units) can be customized to suit its particular patient / pathway / target situation.

[0040] In some embodiments, manufacturing instructions (212) can be used to operate various types of automated manufacturing equipment, such as CNC (computer numerical control) machining equipment and computerized laser cutting equipment. In Figure 8, these instructions (212) are shown operating a laser cutter (214), which is cutting (216) various subunits of various dimensions, such as precursors (218) of units or subunits (106, 122, 126), from stock material such as a hollow hypodermic tube (218). This tube can be made from stainless steel or other medical-grade material.

[0041] After optional further processing, these precursors (218) become surgical device units or subunits (e.g., 106, 122, 126), which can then be further assembled to form longer portions of articulated surgical devices (100, 120). After assembly, these form completed articulated surgical devices (Figures 2, 6, and 7) customized to specific surgical routes and target situations.

[0042] Figure 9 shows a flowchart illustrating several embodiments of the design and manufacturing method for a computerized articulated surgical device according to the present invention.

[0043] As mentioned above, this process often begins with receiving (230) pathway data and target data into computer memory (204). This typically includes surgical device pathway data describing the structural dimensions of at least some of the patient's internal lumens or other internal passages. Furthermore, this process often requires inputting additional information into computer memory, such as target location data describing at least one target location (142) within the patient's body and its relative position to the surgical device pathway data (144).

[0044] This method also requires computer memory configured to include articulated surgical device design parameters (232), as previously mentioned. For example, this articulated surgical device typically includes several connected units (102, 122). In many cases, at least some of these units will have any of the variable diameters and lengths (see Figures 6 and 7).

[0045] As mentioned above, these multiple units (102, 122) further include at least one movable joint (108, 110, 124) which is typically configured to move around at least one axis (108, 110, 124).

[0046] The method then uses at least one computer processor (e.g., AI / processor 208), surgical device path data (144), at least one target location data (142), and the articulated surgical device design parameters to automatically design a patient-customized articulated surgical device configured to traverse a path from an entry point (146) in the patient's internal lumen or other internal passage to this at least one target location (142) along the patient's internal lumen (144) or other internal passage.

[0047] Some elements of an automated system (228) or method that may be considered include evaluating multiple alternative articulated surgical device design candidates (either iteratively or through AI techniques).

[0048] In some embodiments, for at least some of these designs, the system / method can calculate several different paths that a given articulated surgical device candidate may take along the path (144) between the entry point (146) and the target (142). Note that different surgical devices fabricated with units of different sizes often take somewhat different paths.

[0049] For at least some of the various articulated surgical device candidates, at least one computer processor (208) can evaluate the diameter of a given articulated surgical device candidate along a path (144). The processor can also evaluate the ability of some of the units of a given articulated surgical device candidate to bend along a given path. The processor can also evaluate the ability of at least some proximal units (150) of the given articulated surgical device candidate to drive and / or guide a given distal unit (152) of the articulated surgical device candidate as the distal unit approaches the target (142).

[0050] These considerations will be examined in more detail in Figures 10 to 15.

[0051] According to this method, at least one computer processor (208) can preferentially select a design that satisfies predefined criteria. These predefined criteria may include a variety of elements, such as minimizing the calculated trauma to any side of the path (144) between the entry point (146) and the target (142).

[0052] These criteria do not need to be complex. For example, a simple Hooke's Law or other mechanical stress and strain type calculation can be used, which can utilize the force exerted by the spring action of a surgical device on body tissue. Here, the greater the force, the greater the calculated damage, and the damage factor can be generated experimentally. Other types of polynomials or functions may also be used. In any case, the pressure exerted by the device on non-target tissue should generally be minimized.

[0053] Figure 10 shows some examples of elements that the automated design system (228) of the present invention can consider. As the device passes through a bodily pathway (144), the diameters of the various units (310) can generally be configured to become thinner as the width of the pathway narrows (see Figure 5). The positions of the joints between the various units are also shown. The software can provide general guidelines, such as that a larger diameter is preferable for large openings, a smaller diameter is necessary to enter narrow pathways, and the device must be configured to reach a given target.

[0054] In this figure, the wall of a blood vessel or lumen in the body is shown as (300). The distance between units is shown as (302). The centerline of the proposed route of the surgical device is shown as (304). Here, the target (142a) is a concentric lesion with concentric morphology that completely occludes the blood vessel.

[0055] As a simplified example, the AI ​​system can generate trajectory paths, create a unit diameter fiducial, and calculate the optimal distance between units. Here, the AI ​​system generates an initial "stick" map, which can be converted to the unit lengths and the type of yoke (if any) used for these parts of the device.

[0056] In some designs where the unit includes both a yoke and links, after the unit's diameter is calculated, the software can optimize the position (e.g., the length of the links, or at least the length of the link arms) to determine where the yokes and their corresponding yoke pivot points should be placed.

[0057] In some embodiments, after the orbital path including the diameter reference is mapped, the system can identify the ideal yoke pivot position (312).

[0058] Figure 11 shows that additional design guidelines can also be provided to the automated design software. Here, the target (142b) is an eccentric lesion located on the blood vessel wall. As a result, a sharp angle of attack (steep bend 306) is required to effectively treat this target located on the side of the internal lumen. Here, the software can refer to historical data of past successful designs for further design constraints, for example.

[0059] Specifically, for sharp angles of attack, the AI ​​system can be trained using historical data (210) of successful designs that have performed well in this type of situation in the past. This historical data may also include additional elements such as the load on any robotic motor (134) used to drive the unit, and the location of the target (lesion). Note that in Figure 11, the distal section transitions from a small diameter that can accommodate a tight bending radius to a larger proximal diameter, with the proximal diameter being used to stabilize the device and support the distal load while force and work are being transmitted to the target lesion (142b).

[0060] Figure 12 shows that in several embodiments, automated design software can be configured to match the size of a body lumen according to design guidelines. Here, the AI ​​system can also generate the type of distal tip (effector unit) required to examine or treat a specific target, along with a diameter standard (unit diameter) that precisely fits the changes in blood vessel / lumen diameter. In this example, the distal portion of the surgical device is smaller depending on the type of work required. The diameter gradually increases as it moves proximal. In this case, the entire device is fabricated to follow the natural tapering of this body blood vessel / lumen.

[0061] Figure 13 shows that in several constricted path conditions, the automated design software can form a "neck" that has a wide area before and after the constricted section (308), but a narrowed area within the constricted section, according to the design guidelines. Here, the computer system can examine the design and calculate whether the device will use the force transmitted by the wide unit on the proximal side of the neck to help the device pass through the constricted section more easily.

[0062] Specifically, for a stenotic pathway, the AI ​​system can generate a diameter-reducing section to reach the target lesion location (142c) beyond the stenotic portion (308). To provide stability to the device, the proximal section rapidly transitions to a larger diameter. The AI ​​system can also be configured to use historical data from the robot motor load (134) to provide appropriate gradual expansion when transitioning from distal to proximal in the hyperflexible maneuverable portion of the device.

[0063] Figure 14 shows a partial abstraction of the design guidelines for automated design software. Here, parentheses indicate a given set of unit diameter parameters (310), and intersecting stars (312) indicate a given set of pivot point parameters (these can be controlled by the unit length and / or yoke position). In some embodiments, automated design software can iterate over a wide range of these parameters and / or use AI methods such as neural network techniques to effectively examine a wide range of alternative designs and select the design with the best merit according to a merit algorithm.

[0064] Figure 15 shows a later stage of the automated software design process. Here, after a preferred set of unit diameters (310) and pivot points (312) is selected, the automated design software can use these parameters to calculate other aspects of the design, such as the lengths of individual links. This information can then be transmitted to suitable manufacturing equipment (214), such as a CNC laser cutter, CNC machine tool, or 3D printer. Here, the lengths of links (106) and (126) are shown as lines (314).

[0065] As will be discussed in more detail below, in some embodiments, a computerized system can evaluate the ability of at least some proximal units (150) of a given articulated surgical device candidate to drive and / or guide a distal unit (152) of the articulated surgical device candidate as the distal unit approaches a target (142), using the following criteria. a) The distance from the target (142) to any proximal end of the electric drive control head (134). b) Output of any motor (134) used to drive the proximal end of the candidate articulated surgical device. c) The estimated centerline trajectory (304) of the articulated surgical device candidate as it passes the distance from the entry point (146) to the target (142) along the path. d) The estimated steepest bend (308) of the candidate articulated surgical device as it passes the distance from the entry point (146) to the target (142) along the path. e) The smallest lumen or blood vessel diameter along the trajectory along the path between the inlet point (146) and the target position (142). f) The dimensions and characteristics of the internal lesion or abnormality (e.g., 142a, 142b, 142c) located at the target position. g) A constriction (308) along the path between the entry point and the target that could obstruct the passage of the candidate articulated surgical device. h) The estimated flexibility of any side (300) of the path between the entry point (146) and the target (142). i) The type of therapy intended to be applied to the target. This is often determined by the selection of the effector unit located at the distal end of the device.

[0066] As shown in Figure 8, this method (and system 228) can then automatically manufacture at least a portion (100, 120) of the articulated device (214, 216, 218, 220, 106) using this design (and manufacturing instructions, often stored in memory 212).

[0067] As described above, according to this method, the surgical pathway data (144) includes (or is derived from) at least one 3D image obtained from an imaging scan (202) of the patient (200). Furthermore, the target location data includes the location (142) within the patient's body, which can be accessed by passing through the patient's internal lumen (144) or other internal passages.

[0068] As described above, in a preferred embodiment, at least one processor (208) implements these various automated considerations by any of the following: artificial intelligence-type machine learning or predetermined computer algorithms.

[0069] Figure 9 also shows how, in some embodiments, the processor may, alternatively, implement these considerations (240) as an iterative process. Here, the processor may consider one design based on a first set of design parameters (first permutation). The processor may then assign and store merits to this first design by weighting various elements (242). For example, a design may be assigned a high merit if it follows all design rules and a low merit if it does not follow all design rules, and the results may be evaluated according to a weighting function which can assign different weight values ​​to each rule as needed. The system then iterates through a series of design permutations (244) and finally (248) selects the highest merit (246). In an AI-type method, alternatively, the same result may be achieved using a neural network (210) trained on a historical database. The system can then compute manufacturing instructions (212, 250) for the highest merit design.

[0070] Figure 9 also shows an example of a method by which automated manufacturing equipment can be operated using automated manufacturing instructions to manufacture at least a part of a surgical device, such as the entire unit or a portion of the unit.

[0071] As described above, in some embodiments, the automated manufacturing method includes generating instructions to operate any of the following: a CNC machining apparatus, a CNC laser cutting apparatus, or a 3D printing apparatus (214).

[0072] More specifically, in some embodiments, the automated manufacturing further includes using the instructions to operate any of the following: a CNC machining apparatus, a CNC laser cutting apparatus, or a 3D printing apparatus, thereby manufacturing unit portions including at least a portion of the units (218, 106, etc.). These unit portions can then be assembled into at least a portion of the articulated surgical devices (100, 120).

[0073] In some embodiments, the CNC machining apparatus, CNC laser cutting apparatus, or 3D printing apparatus further uses at least one subcutaneous injection tube (220) as a starting material for manufacturing these unit parts. In the case of CNC machining, a solid metal rod raw material may be used.

[0074] As previously shown in Figures 6 and 7, and Figures 10 to 15, in some embodiments the design further includes units of different lengths and diameters, such that the diameter of the proximal (150) unit of the articulated surgical device is greater than the diameter of the distal (152) unit of the articulated surgical device, and the length of the proximal (150) unit of the articulated surgical device is greater than the length of the distal (152) unit of the articulated surgical device.

[0075] As described above, in some embodiments, according to this method, at least a portion of the articulated device may be further covered with a flexible cover (132). In preferred embodiments, this cover often comprises a biocompatible polymer selected to have minimal thrombogenic properties, flexibility, and the ability to withstand sterilization processes. Examples of preferred polymers include polyurethane, polycarbonate, polyamide, fluoropolymer, polyolefin, and polyimide.

[0076] This flexible cover is typically selected to reduce interaction between the articulated device and the patient's bodily fluids and / or the non-target side of internal lumens or other internal passages. Furthermore, the interior of the articulated device is configured to have a working channel (Figure 4B, 115), the dimensions of which are often selected to allow at least some instruments to pass through the working channel. In some embodiments, this may extend from the entry point (156) to the most distal unit (152) of the articulated device.

[0077] As described above, in some embodiments, at least some of the units are hypermovable units, which further include at least two movable joints and are configured to move about at least two axes (108, 110).

[0078] As shown in Figures 4A and 4C, these hypermovable units may further include hypermovable links and hypermovable joints, at least some of the hypermovable joints further comprising a yoke (104) including a polygonal or circumferential base (109) having a central opening (116) and four vertically oriented pull wire holes (114) spaced 90 degrees apart from each other. The yoke further comprises four cylindrical pivot bosses (117) extending laterally from the base at 90-degree intervals. The yoke is configured to connect to a first link (106a) of its unit (102) and a second link (106b) of an adjacent unit. The first links (106, 106a) are movably connected to a first set of two of the four cylindrical pivot bosses and extend in a first direction from the yoke so that the first links pivot relative to the yoke in a first plane (108). The second link (106b) is movably connected to a second set of two of the four cylindrical pivot bosses, and thus extends in a second direction from the yoke, so that the second link (106b) pivots in a second plane perpendicular to the first plane.

[0079] As shown in Figure 4C, in some embodiments, the first link (106a) comprises a first ring (106r), from which a first arm set (106d) extends perpendicularly in a first direction, and from which a second arm set (106e) extends perpendicularly in a second direction opposite to the first ring. Referring to Figures 3A and 4C, in some embodiments, the second link (106b, otherwise identical to the first link) comprises a second ring and a third arm set (106d) extending perpendicularly in a first direction from the second ring (unnumbered). A fourth arm set (106e) also extends perpendicularly in a second direction opposite to the second ring. Again, each arm in the arm set includes a circular hole (106h) sized to fit into one of the four cylindrical pivot bosses (117) of the yoke (104).

[0080] As shown in Figures 4A and 4C, in some embodiments, at least some of the bases (109) of the yoke further comprise four vertically oriented pull wire holes (114) arranged at 90-degree intervals from one another. Here, the multiple yoke bases of the multiple articulated surgical device further comprise four pull wires (112) individually positioned in each of the four pull wire holes (114).

[0081] As previously mentioned (see Figures 6, 7, and 10-15), in some embodiments, the design of the articulated surgical device further includes links and yokes of different lengths and diameters. Typically, the diameter of the proximal (150) links and yokes of the articulated surgical device is greater than the diameter of the distal (152) links and yokes of the articulated surgical device. Furthermore, in many cases, the length of any of the proximal arm sets (106d or 106e) of the articulated surgical device is greater than the length of the distal arm set of the articulated surgical device.

[0082] Furthermore, as mentioned above, at least one effector unit (130, 154) including any of the following is often attached to the distal unit of the articulated surgical device: a camera, a gripping device, a cutting device, a unipolar or bipolar electrode, a tissue sampling device, a radioactive seed, or a radiation or drug delivery device.

[0083] Further consideration When combined with state-of-the-art imaging technologies, namely preoperative CT / MRI, it is possible to generate a 3D model of the access route to the patient's target location. This 3D model provides crucial information that is currently not fully utilized in surgical devices. Target-centered approaches may make the design of fully custom robotic catheters a reality.

[0084] In robotic or articulated catheter systems, customizable link-yoke catheters can fully implement stability, control, and precision even in hard-to-reach areas. A motor (134) that applies tension to a control cable (112) through an articulated surgical device can leverage these attributes to actuate and drive a patient-adjusted, four-way maneuverable catheter.

[0085] A key feature of this articulated surgical device is its ability to be miniaturized to an extremely small size where needed (for example, down to a diameter of 1 mm and a link wall thickness of 25 microns). This allows surgeons to perform critical tasks by precisely fixing the distal portion of the catheter in a determined position based on preoperative CT / MRI images / modeling and real-time CT / MRI imaging during surgery. The latter method eliminates CT-to-body divergence by aligning real-time imaging with predetermined path and target information.

[0086] One feature that helps provide catheter stability is the way the outer diameter (outer diameter) transitions from a smaller diameter (152) at the distal end (152) to a larger outer diameter (150) towards the proximal end. Ideally, the catheter has a larger outer diameter and reduced mobility proximally. The mobile portion is concentrated near the target at the distal end. This can improve catheter stability when the catheter is controlled from outside the patient's body. The patient's anatomical structure determines the design of the catheter along its entire length, both at the normal entry point of the blood vessel through which the catheter passes and at the abnormal or narrowed target portion. Any anatomical abnormalities in the patient also determine the design from the target side. In a preferred embodiment, the scalability of the link-yoke catheter configuration allows for progressive miniaturization of the four-way maneuvering portion, thereby improving the required stability upstream. This feature may be useful in achieving high-precision motion control at the target (142).

[0087] While the present invention can operate with simpler designs (see Figure 1B), more complex designs such as those shown in Figure 1A are often preferred. This Link-Yoke catheter has the largest internal diameter (or working channel) with the smallest diameter, allowing for the highest level of four-directional control. As a result, the catheter has the ability to provide visual information, instruments, and the necessary treatment, and can be advanced through a winding path (144) to the target site (142). As shown in Figure 5, this winding path may contain narrowed sections and sharp bends. This is also a crucial element for achieving final precision at the target, as it allows for appropriate articulated control of treatment delivery at, near, or beyond the target, depending on the type of biopsy or treatment.

[0088] The precision of link-yoke catheters in custom biometric design is made possible by two key technological advancements: 1) the ability to custom design catheters to match the patient's anatomical structure through preoperative 3D images generated by CT or MRI, along with historical learning data obtained from AI-based systems; and 2) the ability to create four-way maneuverable catheters with stepped diameter and variable-length link sections that can be fully designed and manufactured at the highest cost-effectiveness using only computer automation with the most efficient processes.

[0089] Once the anterior distal section of the catheter is advanced to the target, surgical precision, such as finely controlled movement in any direction, often becomes the ultimate performance criterion. Designing catheters using AI based on the patient's unique anatomical structure and learned information from past patients can provide significantly greater benefits to new patients.

[0090] To reiterate the key points so far: Links and yokes are customizable or scalable in both diameter and length. This allows for individual variation of link length or diameter (tapered devices). The ability to produce progressively smaller distal sections allows for the design of catheters to conform to given anatomical structures. This tapered shape can be important when moving from one vessel to another and branching into smaller vessels. The reduction in link diameter provides full load conditions for the maneuvering cable, and the distal end bends with a smaller radius of curvature than the proximal end, because there is more alternating arrangement or space for the preceding link to penetrate deeper into the following link. Also, with fixed or variable diameters, longer links are located proximal, and the links shorten as the catheter length progresses distally. This progressive increase in length and diameter proximal provides greater stability, control, and precision in robotic catheters.

[0091] Scalability between the yoke and its corresponding link is also important. The yoke acts as a transition link (like a railway coupler), enabling a universally expandable and maneuverable catheter. The yoke enables scalability.

[0092] In summary: The link length and diameter are scalable. Furthermore, the link length can be varied, and having more links distally can result in a tighter bending radius towards the distal tip. This can also be used to fabricate tapered articulated surgical devices.

[0093] A yoke can act as a transition coupler between links of different diameters, enabling diameter scalability.

[0094] By transitioning from a small distal diameter with short links to a larger diameter and length of proximal links, greater stability, control, and precision are achieved in this articulated surgical device.

[0095] From a manufacturing perspective, scalability incurs virtually no cost because the catheter length is entirely derived from laser-cut or 3D-printed links. The links determine the entire length of the catheter. Since the links can be cut from the hypotube by an automated laser, there is virtually no tool cost for adjusting the length. Similarly, the diameter of the hypotube can be easily changed by replacing the collet and the hypotube itself. Because there is no tool change, any change in length or diameter only requires updating the planar pattern in the CAD software, and these steps are fully automated.

[0096] As mentioned above, Figure 6 shows a link-yoke catheter section with links of different lengths and diameters, and both non-transition yokes and transition yokes.

[0097] Similarly, as previously mentioned, Figure 7 shows a tapered link-yoke system for use in endoscopic applications, comprising a camera, LED illumination, and a work channel, articulated to a specific bending radius. In this case, the device has at least one camera (158), a work channel for delivering instruments (116, 118 in Figure 4), and two LED lights (156). Four pull wires (see 112 in Figures 4A and 4B) extend from a tool plate (not shown) for four-way control of the link-yoke. The camera can be a CMOS, CCD, or fiberscope. The LEDs can be replaced with fiber illumination.

[0098] Unique scalability, efficient manufacturing, and snap-fit ​​assembly make the preferred link-yoke configuration suitable for AI-powered biometric applications.

[0099] The link and yoke chain can be adjusted to conform to the patient's anatomical structure at the most important target site (142) where the work is performed.

[0100] The length and diameter can be adjusted to cross or pass through narrowed areas (308) in the patient's internal lumen or blood vessels. The distal link diameter of articulated surgical devices is reduced, while the proximal diameter is increased. A larger proximal diameter is important, particularly in robotic systems, for handling force transmission and resistance to buckling and torsion (stability) while applying work to specific sites.

[0101] As described above, a 3D model of the pathway for catheterization can be generated from past biometric data and preoperative patient CT or MRI scans (Figure 8, 200, 202). After importing this 3D model into AI software (228) specifically designed for the biometric development of catheters, the AI ​​determines the length and amount of taper required to adapt to the patient's blood vessels in a particular procedure. The AI ​​system disclosed herein can also consider robot tracking, robot motor loading, and the design of stepwise transitions along the flexible link from the distal tip to the proximal tip of the hyperflexible portion of the catheter.

[0102] In a preferred embodiment, the AI ​​system (228) disclosed herein also generates the final design of a custom-fitted articulated surgical device (catheter). The link length is completely unique and is cut from a standard or custom diameter hypotube (220), as shown in Figure 8. The yoke can be selected from a group of non-transitional (no gradual diameter reduction) yokes and transitional (with gradual diameter reduction) yokes.

[0103] In some embodiments, the AI ​​system can start the design process from a 3D model target (142) and design the catheter from distal to proximal.

[0104] Past data and other variables related to AI learning include the following: 1. Distance from the lesion to the robot drive control head (tool connection part to the robot) 2. Motor load output 3. Centerline trajectory 4. The steepest bend 5. Minimum vessel diameter along the orbit 6. Eccentric or concentric lesions 7. Stenosis 8. Vascular tissue flexibility / Patient's age / Body part 9. Therapy Type 10. Type, density, and hardness of the lesion

[0105] As previously mentioned, Figures 10, 11, 12, and 13 show four pathway models. These models represent the inside of internal lumens, blood vessels, arteries, or veins. There is a trajectory path (304) that shows the theoretical path that the biomedical catheter should follow. Lines (310) perpendicular to the trajectory path represent diameter references for the ideal clearance and fit of articulated surgical devices (catheters).

[0106] In some embodiments, the "design AI" (Figure 8-228, Figure 9) can analyze 3D models from preoperative CT / MRI scans and create 3D trajectories of key pathways, including diameter criteria. This method allows for the generation of the most efficient pathways by analyzing in-context data from thousands of potentially recorded procedures related to a particular therapy. The in-context data can initially be created in recording mode from a manually driven surgical robot. As the history database becomes richer (AI training matures), ideally this history database (training set) will come to contain a vast amount of information about patients, their disease status, procedures, and outcomes. Fitting the optimal trajectory is important because it can be linked to the delivery of a specific treatment.

[0107] In a preferred embodiment, the design AI method (Figures 8-228, 9) takes into account the stability required to deliver a specific treatment from an articulated surgical device. The ability to construct the link-yoke catheter with increasing diameter from the target at the distal end to the proximal end helps to provide stability, control, and precision.

[0108] In some embodiments, the design AI system (228 in Figure 9) can be configured to use a lookup table to select known (e.g., commercially available) hypotube diameters (220). This allows the system to select critical diameters to be used in appropriate sections using a reference, thereby generating designs that are easier to manufacture (see Figures 14 and 15).

[0109] As described in Figures 10-15, the AI ​​design system can generate diameter references (e.g., reference points, fixation points, or lines) for a catheter that closely matches the changes in vascular diameter and the type of distal tip required to treat a specific lesion (target). In this case, the distal section becomes smaller to match the type of work. As it moves proximal, the diameter increases gradually. In this case, it follows the natural taper of the vascular vessel.

[0110] The AI ​​software system (228) generates orbital paths and creates diameter references and distances between them. This initial stick map can be converted to link length and yoke type (transitional and non-transitional).

[0111] For sharp angles of attack, the AI ​​system references historical data regarding the load on the robot motor and the location of the lesion. The distal section transitions from a smaller diameter, which allows for a tighter bending radius, to a larger proximal diameter, stabilizing and supporting the distal load while the work is being transmitted to the lesion.

[0112] As shown in Figures 10–13, the AI ​​software can generate catheter diameter references that closely match the changes in vessel diameter and the type of distal tip required to treat a specific lesion. In this case, the distal section becomes smaller to match the type of work. As you move proximal, the diameter increases gradually. In this case, it follows the natural tapered shape of the vessel.

[0113] As shown in Figure 13, for a stenotic pathway, AI can generate a diameter-reducing section to reach the lesion site (142c) beyond the stenosis (308). To provide stability to the catheter, the proximal section rapidly transitions to a larger diameter. AI also uses historical data from the robot motor load to ensure appropriate gradual increases in the distal-to-proximal transition in the hyperflexible maneuvering section of the catheter.

[0114] Figures 10 and 14 also show an AI-designed implementation of the ideal yoke pivot position. Here, in some embodiments, after the trajectory path including the diameter reference is mapped, the design AI identifies the ideal yoke pivot position (312).

[0115] In some embodiments, the design AI system / method takes in the trajectory path and constructs a linear stick frame (Figures 14 and 15) to determine the precise yoke pivot point (312) and assembly length (314) for manufacturing. This provides the specifications for manufacturing. From this layout, an overall model of the assembly is constructed.

[0116] Figure 14 shows that the design AI system and method create a linear stick frame layout that indicates yoke pivot points and diameter references obtained from a nonlinear model of the patient's critical treatment zones. This simple layout gives the precise length and diameter of the links and indicates where the pivots will be placed.

[0117] Figure 15 shows how a design AI system and method can generate an envelope stick frame. This shows an envelope that follows the diameter and length of the links. From this, an assembly can be automatically generated, and subsequently, drawings and planar patterns for laser cutting of the links can be generated.

[0118] Figure 16 shows a short section of an articulated surgical device, with its approximate length, diameter, and pivot point roughly scaled as shown in Figures 14 and 15.

[0119] In some embodiments, as shown in Figure 8, the design AI constructs the actual device assembly, which is created from a selectable yoke and various hypotube diameters. The link diameter can be selected from standard or custom hypotube using a lookup table or other method. The link length can be variable, and each link can be laser-serialized before falling from the tube at final cutting. This allows each link to be directed to a specific assembly and patient. Thus, final inspection can be performed by a visual robotic scanner as needed.

[0120] The catheter is constructed with an appropriate distal effector (based on the treatment), a control cable (112) is passed through a yoke, and a much more proximal link is attached to another tubular section of a suitable type of mobility or flexibility. The entire catheter is then covered with a biocompatible polymer sheath (132), which provides elasticity and flexibility as well as a smooth transition surface. This entire tubular assembly is then connected to a drive cartridge (134), where the control cable (112) from the link / yoke, and optionally other independently controllable sections more proximal, are fixed to an actuator spool or linear drive. This cartridge can be snapped into an articulated surgical device, forming a type of robotic catheter in which the cable (112) is actuated based on input from a physician or an autonomous AI controller.

Claims

1. A computerized method for manufacturing articulated surgical devices, The computer memory receives surgical device pathway data describing the structural dimensions of one or more internal lumens or other internal passages in the patient, The computer memory receives target location data describing at least one target location within the patient's body and its relative position to the surgical device path data, Receiving design parameters for an articulated surgical device into computer memory, wherein the articulated surgical device comprises a plurality of connected units, and one or more of the units have any of a variable diameter and length, The plurality of units further include at least one movable joint and are configured to move about at least one axis, To automatically design a patient-customized articulated surgical device, configured to traverse a path from an entry point in the patient's internal lumen or other internal passage, along the patient's internal lumen or other internal passage, to the at least one target location, using at least one computer processor, the surgical device path data, at least one target location data, and the articulated surgical device design parameters, Using the aforementioned design, to automatically manufacture at least a portion of the articulated device, A method that includes this.

2. The surgical pathway data includes at least one 3D image obtained from the patient's imaging scan, The method according to claim 1, wherein the target location data includes a location within the patient's body that can be accessed by passing through the internal lumen or other internal passage.

3. The at least one computer processor automatically examines a plurality of alternative articulated surgical device design candidates, and for one or more of the designs, A given candidate articulated surgical device calculates multiple different paths that it may take to pass between the entry point and the target along the aforementioned path. With respect to one or more of the articulated surgical device candidates, the at least one computer processor further examines the diameter of the given articulated surgical device candidate along the path, the ability of one or more of the units of the given articulated surgical device candidate to bend along the path, and the ability of one or more proximal units of the given articulated surgical device candidate to drive and / or guide the distal unit of the given articulated surgical device candidate as the distal unit approaches the target. The method according to claim 1, wherein the at least one computer processor preferentially selects a design that satisfies a preset criterion, the preset criterion comprising minimizing calculated trauma to any side of the path between the entry point and the target.

4. The ability of one or more proximal units of the given articulated surgical device candidate to drive and / or guide the distal unit of the given articulated surgical device candidate as the distal unit approaches the target, a) The distance from the target to the motorized drive control head at any proximal end, b) The output of any motor used to drive the proximal end of the candidate articulated surgical device, c) The estimated centerline trajectory of the articulated surgical device candidate as it passes through the distance from the entry point to the target along the path, d) The estimated steepest bend of the candidate articulated surgical device as it passes the distance from the entry point to the target along the path, e) The minimum blood vessel diameter along the trajectory along the path between the entry point and the target position, f) The dimensions and characteristics of the internal lesion or abnormality located at the target position, g) A constriction along the path between the entry point and the target that may obstruct the passage of the candidate articulated surgical device, h) The estimated flexibility of any side of the path between the entry point and the target, i) The type of therapy to be applied to the target, The method according to claim 3, comprising at least one of the following.

5. The method according to claim 3, wherein the at least one processor implements the automated considerations by any of the following: artificial intelligence-type machine learning or a predetermined computer algorithm.

6. The method according to claim 1, wherein the automated manufacturing includes generating instructions to operate any of the following: a CNC machining apparatus, a CNC laser cutting apparatus, or a 3D printing apparatus.

7. The automated manufacturing process involves using the instructions to operate any of the following: a CNC machining apparatus, a CNC laser cutting apparatus, or a 3D printing apparatus, thereby manufacturing a unit portion that includes at least a part of the unit. The unit portion is assembled to at least a part of the articulated surgical device, The method according to claim 6, further comprising:

8. The method according to claim 7, wherein the CNC processing apparatus, CNC laser cutting apparatus, or 3D printing apparatus further uses at least one subcutaneous injection tube as a starting material for manufacturing the unit portion.

9. The design further includes units of different lengths and diameters, wherein the diameter of the proximal unit of the articulated surgical device is greater than the diameter of the distal unit of the articulated surgical device. The method according to claim 1, wherein the length of the proximal unit of the articulated surgical device is longer than the length of the distal unit of the articulated surgical device.

10. The further comprising covering at least a portion of the articulated device with a flexible cover, wherein the cover comprises a biocompatible polymer selected to reduce interaction between the articulated device and the patient's bodily fluids and / or the non-target side of the internal lumen or other internal passage, and / or The method according to claim 1, wherein the interior of the articulated device is configured to have a work channel, the work channel having dimensions selected to allow one or more instruments to pass through the work channel from an entry point to the most distal unit of the articulated device.

11. One or more of the aforementioned units are super-articulated units that further include at least two movable joints and are configured to move around at least two axes, The super-articulated unit further includes a super-articulated link and a super-articulated joint, and one or more of the super-articulated joints are A yoke comprising a polygonal or circumferential base, forming a central opening, and having four vertically oriented pull wire holes spaced 90 degrees apart from each other, Four cylindrical pivot bosses extending laterally from the base at 90-degree intervals, It further includes, The yoke is configured to connect to the first link of its unit and the second link of an adjacent unit. The first link is movably connected to a first set of two of the four cylindrical pivot bosses, extending in a first direction from the yoke, so that the first link pivots relative to the yoke in a first plane. The method according to claim 1, wherein the second link is movably connected to a second set of two of the four cylindrical pivot bosses and extends in a second direction from the yoke so that the second link pivots in a second plane perpendicular to the first plane.

12. The first link mentioned above is The first ring, A first arm set extending perpendicularly from the first ring in a first direction, A second arm set extending perpendicularly from the first ring in the opposite second direction, Includes, The second link mentioned above is The second ring, A third arm set extending perpendicularly from the second ring in the first direction, A fourth arm set extending perpendicularly from the second ring in the opposite second direction, The method according to claim 11, wherein each arm of the arm set includes a circular hole sized to fit into one of the four cylindrical pivot bosses of the yoke.

13. The method according to claim 11, wherein one or more of the bases of the yoke further comprises four vertically oriented pull wire holes arranged at 90-degree intervals from one another, and further comprises four pull wires individually positioned in each of the four pull wire holes of the articulated surgical device.

14. The design further includes links and yokes of different lengths and diameters, wherein the diameter of the proximal links and yokes of the articulated surgical device is greater than the diameter of the distal links and yokes of the articulated surgical device. The length of any of the proximal arm sets of the articulated surgical device is greater than the length of the distal arm set of the articulated surgical device. The method according to claim 11.

15. The method according to claim 1, further comprising attaching at least one effector unit to the distal unit of the articulated surgical device, which includes any of the following: a camera, a gripping device, a cutting device, a unipolar or bipolar electrode, a tissue sampling device, a radioactive seed, or a radiation or drug delivery device.

16. A computerized system configured to manufacture articulated surgical devices, At least one computer processor and computer memory, wherein the computer memory includes surgical device pathway data describing the structural dimensions of one or more internal lumens or other internal passages of a patient. Equipped with, The computer memory also includes target location data describing at least one target location within the patient's body and its relative position to the surgical device routing data, The computer memory also includes articulated surgical device design parameters, and the articulated surgical device includes a plurality of connected units, one or more of the units having any of a variable diameter and length. The plurality of units are configured to include at least one movable joint and to move about at least one axis, The at least one computer processor is configured to automatically design a patient-customized articulated surgical device, which is configured to travel along a path from an entry point in the patient's internal lumen or other internal passage to the at least one target location, using the surgical device path data, at least one target location data, and articulated surgical device design parameters. The system further comprises an automated manufacturing machine configured to automatically manufacture at least a portion of the articulated device using the design.

17. The at least one computer processor is configured to automatically evaluate a plurality of alternative articular surgical device design candidates, and for one or more of the designs, The at least one computer processor is configured to calculate a number of different paths along which a given candidate articulated surgical device may pass between the entry point and the target. With respect to one or more of the articulated surgical device candidates, the at least one computer processor further evaluates the diameter of the given articulated surgical device candidate along the path, the ability of one or more of the units of the given articulated surgical device candidate to bend along the path, and the ability of one or more proximal units of the given articulated surgical device candidate to drive and / or guide the distal unit of the given articulated surgical device candidate as the distal unit approaches the target. The at least one computer processor is configured to preferentially select a design that satisfies a set of predefined criteria, the predefined criteria including minimizing calculated trauma to any side of the path between the entry point and the target, The system according to claim 16.

18. The system according to claim 17, wherein the at least one processor is configured to implement the automatic evaluation by any of the following: artificial intelligence type machine learning or a predetermined computer algorithm.

19. The aforementioned automated manufacturing equipment is configured to receive instructions to operate any of the following: a CNC machining device, a CNC laser cutting device, or a 3D printing device. The system according to claim 16, further comprising any CNC machining apparatus, CNC laser cutting apparatus, or 3D printing apparatus configured to manufacture a unit portion including at least a part of the unit.

20. One or more of the aforementioned units are super-articulated units that further include at least two movable joints and are configured to move around at least two axes, The super-articulated unit further includes a super-articulated link and a super-articulated joint, and one or more of the super-articulated joints are A yoke comprising a polygonal or circumferential base, forming a central opening, and having four vertically oriented pull wire holes spaced 90 degrees apart from each other, Four cylindrical pivot bosses extending laterally from the base at 90-degree intervals, It further includes, The yoke is configured to connect to the first link of its unit and the second link of an adjacent unit. The first link is movably connected to a first set of two of the four cylindrical pivot bosses, extending in a first direction from the yoke, so that the first link pivots relative to the yoke in a first plane. The system according to claim 16, wherein the second link is movably connected to a second set of two of the four cylindrical pivot bosses, extending in a second direction from the yoke, so that the second link pivots in a second plane perpendicular to the first plane.

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