Integration of force isolation elements into steerable elongate members
By integrating force isolation elements in the elongated member, the problem of longitudinal compression or extension of the elongated member during joint movement is solved, efficient and accurate anatomical structure steering and motion control is achieved, and the operating performance of the robot surgical system is improved.
Patent Information
- Application Number
- CN202380089655.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-12-12
- Filing Date
- 2023-12-28
- Publication Date
- 2025-08-08
AI Technical Summary
In existing robot surgical systems, elongated members are prone to longitudinal compression or extension due to material properties when performing joint movements, affecting motion accuracy and efficiency, and joint motion control elements may invade working channels or affect component efficiency.
The force isolation element is used to integrate into the steerable elongated member, and the body is formed using a uniform material and combined with a compressibility and ductility design prevents longitudinal compression or extension while avoiding the joint motion control element affecting member efficiency.
The flexible steering and precise movement of elongated members in complex anatomical structures are achieved, the accuracy and efficiency of movement are improved, and undesirable longitudinal deformation and channel occupation are avoided.
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Figure CN120456878A_ABST
Abstract
Description
[0001] priority
[0002] This application claims the benefit of U.S. patent application No. 18 / 536,621, filed on December 12, 2023, entitled “Integration of Force Isolation Elements into Steerable Elongate Member,” which claims priority to U.S. patent application No. 63 / 436,194, filed on December 30, 2022, entitled “Integration of Force Isolation Elements into Steerable Elongate Member,” the disclosures of which are incorporated herein by reference. Background Art
[0003] Various surgical instruments include end effectors that are used in medical treatments and procedures performed by medical professionals, including applications in robotic-assisted surgery. In robotic-assisted surgery, a surgeon can operate a master controller to remotely control the movement of such surgical instruments at the surgical site. The controller can be located a significant distance from the patient (e.g., across the operating room, in a different room, or in a completely different building from the patient), or very close to the patient in the operating room. The controller can include one or more hand input devices (such as a joystick, an exoskeleton glove, or a master manipulator) coupled to the surgical instrument by a servo mechanism. In one example, a servo motor moves the manipulator supporting the surgical instrument based on the surgeon's manipulation of the hand input device. During surgery, the surgeon can use a variety of surgical instruments via the robotic surgical system, including ultrasonic scalpels, surgical staplers, tissue graspers, needle drivers, electrosurgical cauterization probes, and the like. Each of these structures performs a function for the surgeon, such as cutting tissue, coagulating tissue, manipulating a needle, grasping a blood vessel, dissecting tissue, or cauterizing tissue. The robotically controlled instrument may be introduced into the patient through an incision, through a naturally existing orifice, or in other ways.
[0004] While several robotic surgical systems and associated components have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] While this specification results in claims that particularly point out and distinctly claim this technology, it is believed that this technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate like elements, and wherein:
[0006] Figure 1 A top plan view of an example of a robotic surgical system for use in urological surgery is shown.
[0007] Figure 2 Shown Figure 1 Schematic diagram of the different components of a robotic surgical system.
[0008] Figure 3 Shown Figure 1 A magnified view of other components of the robotic surgical system, including the distal portion of the ureteroscope.
[0009] Figure 4 Shows that Figure 1 Schematic diagram of an example of an articulated elongated member for use with a robotic surgical system.
[0010] Figure 5 Shown along Figure 4 The line 5-5 is intercepted Figure 4 A cross-sectional side view of an elongated member.
[0011] Figure 6 Shown along Figure 5 The line 6-6 intercepts Figure 5 A cross-sectional end view of an elongated member.
[0012] Figure 7 Shown along Figure 5 The line 7-7 is intercepted Figure 5 A cross-sectional end view of an elongated member.
[0013] Figure 8 Shown along Figure 5 The line 8-8 intercepts Figure 5 A cross-sectional end view of an elongated member.
[0014] Figure 9 Shown along Figure 5 The line 9-9 intercepts Figure 5 A cross-sectional end view of an elongated member.
[0015] Figure 10 A perspective view of components of an apparatus that can be used to manufacture an elongated member having a braided structure is shown.
[0016] Figure 11 Shows that it can be Figure 10 A variant of the device is used to make Figure 5 Example of a mandrel group for a slender member.
[0017] Figure 12 Shown along Figure 11 The line 12-12 is intercepted Figure 11 Cross-sectional end view of the mandrel assembly.
[0018] Figure 13A Shows when the mandrel group is used to make Figure 5 The first part of the process of the slender member is along Figure 11 The line 12-12 is intercepted Figure 11 Cross-sectional end view of the mandrel assembly.
[0019] Figure 13B Shows when the mandrel group is used to make Figure 5 The second part of the process of the slender member is along Figure 11 The line 12-12 is intercepted Figure 11 Cross-sectional end view of the mandrel assembly.
[0020] Figure 13C Out of the mandrel group used to manufacture Figure 5 The third part of the process of the slender member is along Figure 11 The line 12-12 is intercepted Figure 11 Cross-sectional end view of the mandrel assembly.
[0021] Figure 13D Shown in the manufacturing Figure 5 The elongated member has been removed during the process Figure 11 After the remaining spindles of the spindle group Figure 5 A cross-sectional end view of a portion of an elongated member.
[0022] Figure 14 shows the methods that can be used to perform manufacturing Figure 5 Schematic diagram of an example of the components and steps of the elongated member process.
[0023] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology; it should be understood, however, that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0024] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments and advantages of the present technology will become apparent to those skilled in the art from the following description, which is provided by way of example, which is one of the best modes contemplated for implementing the present technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and description should be regarded as illustrative in nature and not restrictive.
[0025] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the following teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Based on the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0026] For clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to a position of an element that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of the surgical instrument. The term "distal" refers to a position of an element that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of the surgical instrument. It should also be understood that for convenience and clarity, spatial terms such as "side," "upward," and "downward" are also used herein with reference to relative positions and directions. For clarity, such terms are used below with reference to the drawings and are not intended to limit the invention described herein.
[0027] Various aspects of the present examples described herein can be integrated into a robotically enabled medical system, including as a robotic surgical system capable of performing a variety of medical procedures, including both minimally invasive procedures such as laparoscopy and non-invasive procedures such as endoscopy. Among endoscopy procedures, the robotically enabled medical system can perform bronchoscopy, ureteroscopy, gastroscopy, etc.
[0028] In addition to performing a wide range of procedures, robotically enabled medical systems can provide additional benefits, such as enhanced imaging and guidance to assist medical professionals. Additionally, robotically enabled medical systems can provide medical professionals with the ability to perform procedures from an ergonomic position without the need for awkward arm motions and positions. Additionally, robotically enabled medical systems can provide medical professionals with the ability to perform procedures with improved ease of use, such that one or more of the instruments of the robotically enabled medical system can be controlled by a single operator.
[0029] I. Examples of Robot-Enabled Medical Systems
[0030] Figure 1 An example medical system (100) for performing various medical procedures according to aspects of the present disclosure is shown. The medical system (100) may be used, for example, for endoscopic (e.g., ureteroscopic) procedures. Some ureteroscopic procedures involve the treatment / removal of kidney stones. Although Figure 1The system (100) is presented in the context of a ureteroscopic procedure, but it should be understood that the principles disclosed herein may be implemented in any type of endoscopic (e.g., bronchoscope, gastroenteroscope, etc.) and / or percutaneous procedure.
[0031] The disclosed medical system (100) includes a robotic system (10) (e.g., a mobile robotic cart) configured to engage and / or control one or more medical instruments (e.g., a ureteroscope (40), a basketing system (30), etc.) via one or more robotic arms (12) to perform a direct access procedure on a patient (7). In some versions, the robotic system (10) and / or the control system (50) are configured to receive from the scope (40) a signal representing the internal anatomy of the patient (7) (i.e., information about the internal anatomy of the patient (7)). Figure 1 images and / or image data of the urinary system (specifically depicting the urinary system) and / or display images based thereon.
[0032] It should be understood that the direct access instruments operated by the systems (10, 50) may include any type of medical instrument or combination of instruments, including endoscopes (such as ureteroscopes (40)), catheters (such as steerable or non-steerable catheters), nephroscopes, laparoscopes, basket systems (30), and / or other types of medical instruments. The various endoscopic instruments disclosed herein (such as the scope (40) of the system (100)) may be configured to navigate within human anatomy, such as within a natural orifice or lumen of the human anatomy. The terms "scope" and "endoscope" are used herein according to their broad and ordinary meanings; and may refer to any type of elongated medical instrument having image generating, viewing, and / or capturing functionality and configured to be introduced into any type of organ, cavity, lumen, chamber, or space in the body. The scope may include, for example, a ureteroscope (e.g., for accessing the urinary tract), a laparoscope, a nephroscope (e.g., for accessing the kidney), a bronchoscope (e.g., for accessing airways such as the bronchi), a colonoscope (e.g., for accessing the colon), an arthroscope (e.g., for accessing a joint), a cystoscope (e.g., for accessing the bladder), a colonoscope (e.g., for accessing the colon and / or rectum), a borescope, etc. In some cases, the scope / endoscope may include a rigid or flexible tube and may be sized to pass within an outer sheath, catheter, introducer, or other lumen-type device, or may be used without such a device.
[0033] The medical system (100) of this example further includes a control system (50), a table (15), and an electromagnetic (EM) field generator (18). The table (15) is configured to hold the patient (7). The EM field generator (18) may be held by one or more of the robotic arms (12) of the robotic system (10), or may be a stand-alone device. Figures 1 to 2As shown, the control system (50) of this example includes various input / output (I / O) components (258) that are configured to assist a physician (5) or other person in performing a medical procedure. For example, the I / O components (258) may be configured to allow user input to control / navigate the scope (40) and / or basket system (30) within the patient (7). The I / O components (258) of this example include a controller (55) configured to receive user input from an operator; and a display (56) configured to present certain information to assist the operator. The controller (55) may take any suitable form, including but not limited to one or more buttons, keys, joysticks, handheld controllers (e.g., video game-type controllers), computer mice, touchpads, trackballs, control pads, and / or sensors that capture hand gestures and finger gestures (e.g., motion sensors or cameras), touch screens, and the like.
[0034] Also like Figure 2 As shown, the control system (50) of this example includes a communication interface (254) that is operable to provide a communication interface between the control system (50) and the robotic system (10), the basket system (30), the endoscope (40), and / or other components. Communication via the communication interface (254) may include data, commands, power, and / or other forms of communication. The communication interface (254) may also be configured to provide communication via wired, wireless, and / or other modalities. The control system (50) also includes a power interface (259) that can receive power via wires, batteries, and / or any other suitable type of power source to drive the control system (50). The control circuit (251) of the control system (50) can provide signal processing and execute control algorithms to implement the functions of the medical system (100) as described herein.
[0035] The control system (50) may also communicate with the robotic system (10) to receive therefrom position data relating to the position of the distal end of the scope (40), the access sheath (90), or the basket device (30). Such position data relating to the position of the scope (40), the access sheath (90), or the basket device (30) may be derived using one or more electromagnetic sensors associated with the respective components. Furthermore, in some versions, the control system (50) may communicate with the table (15) to position the table (15) in a particular orientation or otherwise control the table (15). The control system (50) may also communicate with the EM field generator (18) to control the generation of an EM field in the area surrounding the patient (7).
[0036] As mentioned above and as Figures 1 to 2As shown, the robotic system (10) includes a robotic arm (12) configured to engage and / or control a scope (40) and / or a basket system (30) to perform one or more aspects of a procedure. It should be understood that the robotic arm (12) may be coupled to a Figure 1 The instruments shown are different instruments; and in some cases, one or more of the robotic arms (12) may not be utilized or coupled to a medical instrument. Each robotic arm (12) includes a plurality of arm segments (23) coupled to joints (24) that can provide multiple degrees of movement / freedom. Figure 1 In an example, a robotic system (10) is positioned proximate to a patient's leg, and a robotic arm (12) is actuated to engage and position a scope (40) for entry into an access opening, such as the urethra (65) of the patient (7). When the robotic system (10) is properly positioned, the scope (40) can be inserted into the patient (7) robotically using the robotic arm (12), manually by the physician (5), or a combination thereof. A scope driver instrument coupling (11) (e.g., an instrument device manipulator (IDM)) can be attached to a distal portion of one of the arms (12b) to facilitate robotic control / advancement of the scope (40). The other of the arms (12c) can include an instrument coupling / manipulator (19) configured to facilitate advancement and operation of a basketing device (30). The scope (40) can include one or more working channels through which additional tools, such as a lithotripter, basketing device, forceps, etc., can be introduced into the treatment site.
[0037] The robotic system (10) can be coupled to any component of the medical system (100), such as the control system (50), the table (15), the EM field generator (18), the scope (40), the basket system (30), and / or various types of percutaneous access instruments (e.g., needles, catheters, nephroscopes, etc.). As described above, the robotic system (10) can be communicatively coupled to the control system (50) via the communication interface (214, 254). The robotic system (10) also includes a power interface (219) that can receive power via a wire, a battery, and / or any other suitable type of power source to drive the robotic system (10). In addition, the robotic system (10) of this example includes various input / output (I / O) components (218) that are configured to assist the physician (5) or other person in performing a medical procedure. Such I / O components (218) can include any of the various I / O components (258) described herein in the context of the control system (50). Additionally or alternatively, the I / O component (218) of the robotic system (10) may take any suitable form (or may be omitted altogether).
[0038] The robotic system (10) of this example generally includes a column (14), a base (25), and a console (13) located on top of the column (14). The column (14) may include a base (25) for supporting one or more robotic arms (12) ( Figure 2 The robotic arm (12) of the present example may generally include a robotic arm base (21) and an end effector (22) separated by a series of linked arm segments (23) connected by a series of joints (24), each joint including one or more independent actuators (217). Each actuator (217) may include an independently controllable motor. An I / O component (218) may be positioned at the upper end of the column (14). The console (13) may also include a handle (27) to assist in manipulating and stabilizing the robotic system (10).
[0039] The end effector (213) of each of the robotic arms (12) may include an instrument device manipulator (IDM) that can be attached using a mechanism converter interface (MCI). In some versions, the IDM (213) can be removed and replaced with a different type of IDM (213), for example, a first type (11) of IDM (213) can manipulate the endoscope (40) while a second type (19) of IDM (213) can manipulate the basket system (30). Another type of IDM (213) can be configured to hold an electromagnetic field generator (18). The MCI can provide a power and control interface (e.g., a connector for transmitting pneumatic pressure, electrical power, electrical signals, and / or optical signals from the robotic arm (12) to the IDM (213)). The IDM (213) can be configured to manipulate a medical device (e.g., a surgical tool / instrument) such as a endoscope (40) using technologies including, for example, direct drive, harmonic drive, gear drive, belt and pulley, magnetic drive, etc.
[0040] The system (100) may include specific control circuitry configured to perform specific functions described herein, including the control circuitry (211) of the robotic system (10) and / or the control circuitry (251) of the control system (50). That is, the control circuitry of the system (100) may be the robotic system (10), the control system (50), or some combination thereof. The term "control circuitry" is used herein in its broad and ordinary sense and may refer to any collection of the following: a processor, processing circuitry, processing module / unit, chip, die (e.g., a semiconductor die including one or more active and / or passive devices and / or connectivity circuitry), microprocessor, microcontroller, digital signal processor, microcomputer, central processing unit, field programmable gate array, programmable logic device, state machine (e.g., hardware state machine), logic circuitry, analog circuitry, digital circuitry, and / or any device that manipulates signals based on hard coding of circuitry and / or operating instructions. The control circuitry referred to herein may also include one or more circuit substrates (e.g., printed circuit boards), conductive traces and through-holes and / or mounting pads, connectors, and / or components. The control circuitry referred to herein may also include one or more storage devices, which may be embodied in a single memory device, a plurality of memory devices, and / or embedded circuitry of the device. Such data storage devices may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in embodiments where the control circuitry includes a hardware and / or software state machine, analog circuitry, digital circuitry, and / or logic circuitry, the data storage device / register storing any associated operating instructions may be embedded within the circuitry including the state machine, analog circuitry, digital circuitry, and / or logic circuitry, or external to the circuitry.
[0041] The control circuitry (211, 251) may include a computer-readable medium that stores and / or is configured to store hard-coded instructions and / or operational instructions corresponding to at least some of the steps and / or functions illustrated in one or more of the figures and / or described herein. In some cases, such a computer-readable medium may be included in an article of manufacture. The control circuitry (211, 251) may be entirely maintained / located locally, or may be at least partially remotely located (e.g., indirectly communicatively coupled via a local area network and / or a wide area network).
[0042] In some versions, for example, a physician (5) may provide input to a control system (50) and / or a robotic system (10); and in response to this input, control signals may be sent to the robotic system (10) to manipulate the endoscope (40) and / or the catheter basketing system (30). The control system (50) may include one or more display devices (56) to provide various information about the procedure. For example, the display (56) may provide information about the endoscope (40) and / or the basketing system (30). The control system (50) may receive real-time images captured by the endoscope (40) and display these real-time images via the display (56).
[0043] like Figure 2 As shown, the basketing device (30) of the present example includes a basket (35) formed by one or more wire tines (36) disposed within a basketing sheath (37) over the length of the basketing sheath, wherein the tines protrude from the distal end of the sheath (37) to form the basket (35). The tines (36) further extend from the proximal end of the sheath (37) and are slidable within the basketing sheath (37). The tines (36) and the sheath (37) can be coupled to respective actuators (75) of the basket bin component (32). The basket bin (32) can be physically and / or communicatively coupled to a handle portion / component (31) of the basketing system (30). The handle component (31) can be configured to assist in basketing control, either manually or through robotic control. The basketing system (30) may be powered and / or controlled via a control interface (38) through a power interface (39), each or both of which may interface with a robotic arm / component of the robotic system (10). The basketing system (30) may also include one or more sensors (72), such as pressure sensors and / or other force-reading sensors, which may be configured to generate signals indicative of forces experienced at / by one or more actuators (75) and / or other couplings of the basketing system (30).
[0044] In an exemplary use case, if a patient (7) has a kidney stone (80) located in a kidney (70), a physician may perform a procedure to remove the stone (80) through the urinary tract (65, 60, 63). Specifically, and as Figure 1As shown, a physician can operate the medical system (100) to enable the endoscope (40) to enter the urinary tract (65, 60, 63) of the patient (7) directly through the urethra (65). The physician (5) can interact with the control system (50) and / or the robotic system (10) to enable / control the robotic system (10) to advance and navigate the endoscope (40) from the urethra (65) through the bladder (60), along the ureter (63) and into the renal pelvis (71) and / or the calyx network of the kidney (70) where the stone (80) is located. The physician (5) can also interact with the control system (50) and / or the robotic system (10) to control the advancement of the basket device (30) through the working channel of the endoscope (40), wherein the basket device (30) is configured to facilitate the capture and removal of kidney stones. The control system (50) may provide information associated with the medical instrument (40) and / or other instruments of the system (100) via the display (56), such as real-time endoscopic images captured by the medical instrument, to assist the physician (5) in navigating / controlling such instrumentation.
[0045] In this example, a ureteral access sheath (90) is positioned within the urinary tract (65, 60, 63) to an area near the kidney (70). A scope (40) can be passed through the ureteral access sheath (90) to access the internal anatomy of the kidney (70), as shown. Once at the site of the kidney stone (80), for example, within a target calyx (73) of the kidney (70), through which the stone (80) can be accessed, the scope (40) can be used to deliver / guide the basketing device (30) to the target location. Once the stone (80) has been captured in the distal basket portion (35) of the basketing device (30), the kidney stone (80) can be extracted from the patient (7) using the utilized ureteral access route.
[0046] Figure 3 An example of a scope (440) is shown that can be used as the scope (40) described above. The scope (440) of this example includes a working channel (444) that is used to deploy medical instruments (e.g., a lithotripter, a basketing system (30), forceps, etc.) to a surgical area at the distal end of the scope (440) to flush and / or aspirate the area. The scope (440) can be articulated, such as relative to at least the distal portion of the scope (440), so that the scope (440) can be steered within the human anatomy. In some versions, the scope (440) is configured to articulate with, for example, five degrees of freedom, including XYZ coordinate movement, as well as pitch and yaw. In some versions, the scope (440) provides six degrees of freedom, including X, Y, and Z coordinate positions, as well as pitch, roll, and yaw. The position sensor of the scope (440) may also have similar degrees of freedom relative to the position information generated / provided by the position sensor. As Figure 3As shown, the distal end (442) of the scope (440) may be oriented with zero deflection relative to its longitudinal axis (406) (also referred to as the "roll axis").
[0047] In this example, the scope (440) can accommodate electrical wires and / or optical fibers to transmit signals to / from the optical assembly and the distal end (442) of the scope (440), which can include an imaging device (448), such as an optical camera. The imaging device (448) can be used to capture images of an internal anatomical space, such as a target calyx / nipple of a kidney (70). The scope (440) can also be configured to accommodate an optical fiber to carry light from a proximally located light source (such as a light emitting diode) to the distal end (442) of the scope (440). The distal end (442) of the scope (440) can include a port for the light source to illuminate the anatomical space when the imaging device (448) is used. The imaging device (448) can include an optical fiber, an optical fiber array, and / or a lens; or a light emitting diode located at the distal end (442). The optical components of the imaging device (448) move with the distal end (442) of the scope (440) such that movement of the distal end (442) of the scope (440) causes the image captured by the imaging device (448) to change.
[0048] To capture images along different orientations of the end (442), the robotic system (10) can be configured to deflect the end (442) along a positive yaw axis (402), a negative yaw axis (403), a positive pitch axis (404), a negative pitch axis (405), or a roll axis (406). The end (442) or body (445) of the endoscope (442) can be extended or translated along a longitudinal axis (406), an x-axis (408), or a y-axis (409). The endoscope (440) can include a reference structure (not shown) to calibrate the position of the endoscope (440). For example, the robotic system (10) and / or the control system (50) can measure the deflection of the endoscope (440) relative to the reference structure. The reference structure can be located, for example, on the proximal end of the endoscope (440) and can include a key, a slot, or a flange.
[0049] The robotic arm (12) of the robotic system (10) may be configured / capable of manipulating the scope (440) as described above. Such manipulation may be performed by actuating one or more elongated members, such as one or more pull wires (e.g., pull wires or push wires), cables, fibers, and / or flexible shafts. For example, the robotic arm (12) may be configured to actuate a plurality of pull wires (not shown) coupled to the scope (440) to deflect the distal end (442) of the scope (440). The pull wires may comprise any suitable or desired material, such as metallic and non-metallic materials, such as stainless steel, aramid fiber, tungsten, carbon fiber, etc. In some embodiments, the scope (440) is configured to exhibit nonlinear behavior in response to a force applied by the elongated moving member. The nonlinear behavior may be based on the stiffness and compressibility of the scope (440), and the variability in slack or stiffness between different elongated moving members.
[0050] In some versions, the scope (440) includes at least one sensor configured to generate sensor position data and / or transmit the sensor position data to another device. The sensor position data may indicate the position and / or orientation of the scope (440) (e.g., its distal end (442)) and / or may be used to determine / infer the position / or orientation of the scope (440). For example, the sensor (sometimes referred to as a "position sensor") may include an electromagnetic (EM) sensor having a coil of conductive material or other form of antenna. In some versions, the position sensor is positioned on the distal end (442) of the scope (440), while in other embodiments, the sensor is positioned at another location on the scope (440).
[0051] like Figure 3 As shown, the EM field generator (18) is configured to broadcast an alternating EM field 90 that is detected by the EM position sensor of the scope (440). The alternating magnetic field (MF) induces a small current in the coil of the EM position sensor, which can be analyzed to determine the distance and / or angle / or orientation between the EM position sensor and the EM field generator (18). It should be understood that the scope (440) can include other types of sensors, such as shape sensing fibers, accelerometers, gyroscopes, satellite-based positioning sensors (e.g., global positioning system (GPS) sensors), radio frequency transceivers, etc. In this example, the EM position sensor of the scope (440) provides sensor data to the control system (50), which then uses the sensor data to determine the position and / or orientation of the scope (440).
[0052] In some variations, any of the features and aspects described above may be constructed and operated in accordance with at least some of the teachings of: U.S. Patent No. 11,737,663, entitled “Target Anatomical Feature Localization,” published on August 29, 2023, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2021 / 0369384, entitled “Stuck Instrument Management,” published on December 2, 2021, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2021 / 0401527, entitled “Robotic Medical Systems Including User Interfaces with Graphical Representations of User Input Devices,” published on December 30, 2021, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,737,663, entitled “Target Anatomical Feature Localization,” published on August 29, 2023, the disclosure of which is incorporated herein by reference in its entirety; Arms” U.S. Publication No. 2022 / 0096183, the disclosure of which is incorporated herein by reference in its entirety.
[0053] II. Examples of Integrating Force Isolation Elements into Steerable Elongated Members
[0054] As described above, it may be desirable to provide an elongated member (e.g., a shaft of a scope (440) having one or more articulating segments) that may allow the elongated member to be actively steered along tortuous anatomical structures to provide a movable field of view from a camera at the distal end of the elongated member, thereby facilitating access to a target anatomical structure with another instrument slidably disposed in the elongated member, and / or for other purposes. To the extent that pull wires and / or other tensioning elements are used to achieve such articulation, it may be further desirable to prevent longitudinal compression from occurring in one or more regions of the elongated member when the elongated member is formed from a material that is not longitudinally compressible. Similarly, it may be desirable to prevent longitudinal extension from occurring in one or more regions of the elongated member when the elongated member is formed from a material that is not longitudinally extendable. Otherwise, undesirable longitudinal extension or compression within the elongated member may result in undesirable articulation of the elongated member. In situations where a joint motion driving element (e.g., a tendon) may tend to cause undesirable longitudinal extension or compression within an elongated member in a first longitudinal region while intentionally driving joint motion in a second longitudinal region, it may be beneficial to include a force isolation element that prevents such undesirable longitudinal extension or compression within the elongated member in the first longitudinal region.
[0055] In some cases, a particular segment of the elongated member body (e.g., the proximal segment) may be formed from an incompressible / inextensible material (e.g., a steel tube, etc.), while another segment of the elongated member body (e.g., the distal segment) is formed from a compressible / extensible material (e.g., a polymer, a braid, etc.). However, the use of such different materials may complicate the process of manufacturing the elongated member, may increase costs, and / or may have other undesirable consequences. Therefore, it may be desirable to provide an elongated member having a body formed from a material that is substantially uniform along the length of the body, while also providing a degree of compressibility / extensibility that varies along the length of the body. It may also be desirable to provide an elongated member having an articulation control element (e.g., a tendon) that does not intrude upon the working channel of the elongated member or otherwise adversely affect the cross-sectional efficiency of the elongated member.
[0056] Figure 4-5 An example of an articulated elongated member (500) is shown that can provide one or more of the beneficial features and functions mentioned above. An articulated elongated member (500) can be used with a robotic surgical system (10). By way of example only, the elongated member (500) can represent a variation of a scope (40), an access sheath (90), or a scope (440). Alternatively, the elongated member (500) can take the form of a catheter and / or any other suitable type of elongated instrument. The elongated member (500) of this example includes a body (502) having a proximal portion (510), an intermediate portion (512), and a distal portion (514). In this example, the intermediate portion (512) and the distal portion (514) are each operable to articulate such that the distal end (504) of the elongated member (500) can be deflected laterally away from and toward a central longitudinal axis (LA) (e.g., defined by the proximal portion (510)). In some versions, elongate member (500) is operable to articulate at only one, or at more than two, distinct regions along the length of elongate member (500). For example, distal portion (514) may include one or more articulation segments, intermediate portion (512) may include one or more articulation segments, and / or proximal portion (510) may include one or more articulation segments.
[0057] The proximal portion (510) is coupled to an instrument coupling (11) of the robotic surgical system (10) such that the robotic surgical system (10) is operable to drive the elongated member (500) via the instrument coupling (11). By way of example only, the robotic surgical system (10) is operable to drive translation along a central longitudinal axis (LA), rotation (e.g., rotation about the central longitudinal axis (LA)), articulation, and / or other forms of movement of the elongated member (500).
[0058] The distal end (504) of this example may include one or more openings through which one or more additional instruments can access the surgical space or other anatomical region within the patient's body. The distal end (504) may also include one or more imaging devices, such as imaging device (448), which may take the form of one or more cameras, one or more optical fibers with corresponding lenses, etc. The distal end (504) may also include one or more lighting elements, such as one or more integrated light-emitting diodes, one or more lenses optically coupled to corresponding optical fibers, etc. In some versions, the distal end (504) includes an end effector that is operable to perform one or more operations on tissue, such as grasping, cutting, suturing, sealing (e.g., via RF energy or ultrasonic energy), anastomosis, etc. In this example, the distal end (504) includes a control ring (504) that is securely secured to the body (502). The control ring (504) is configured to provide a distal anchor point for the tendon (524, 534), as will be described in more detail below. To the extent that other components are positioned at distal end ( 504 ) (eg, imaging devices, lighting elements, end effectors, etc.), such additional components may be positioned distally of control ring ( 504 ).
[0059] like Figure 5-8 As shown, the body (502) of this example defines an inner cavity (542) and an array of angularly spaced tendon assembly lumens (508). The inner cavity (542) is configured to receive other components. In this example, the inner cavity receives a working channel (546), which may include a braided shaft and / or any other suitable component. The working channel (546) defines a lumen (548). The working channel (546) is located at Figure 6-8 shown in the figure, but for clarity Figure 5. In some versions, the lumen (548) can slidably receive other instruments. By way of example only, the basket (35) and the basket sheath (37) of the basket device (30) can be advanced distally through the lumen (548) of the working channel (546). By way of another example, a laser fiber or other instrument can be disposed in the lumen (548) of the working channel (546). Alternatively, a fluid (e.g., a liquid, an aspirate, etc.) can be delivered through the lumen (548) of the working channel (546). The lumen (542) and the working channel (546) can extend all the way to the distal end (504), wherein the lumen (542) can terminate at a distal opening, thereby allowing instruments disposed in the working channel (546) to exit distally from the elongated member (500). In this example, lumen (542) includes a liner (540) configured to reduce friction and thereby promote slidability through lumen (542). By way of example only, liner (540) may include polytetrafluoroethylene (PTFE), polyimide, and / or any other suitable type of material. Although not shown, other features such as electrical wires, optical fibers, flexible circuits, etc. may extend along at least a portion of the length of lumen (542) outside of working channel (546).
[0060] In this example, the tendon assembly lumens (508) are positioned approximately 90 degrees apart from one another about the central longitudinal axis (LA). Figure 6-8 In the illustrated view, tendon lumen (508a) is at the 12 o'clock position, tendon lumen (508b) is at the 6 o'clock position, tendon lumen (508c) is at the 3 o'clock position, and tendon lumen (508d) is at the 9 o'clock position. In this example, tendon lumen (508) extends along the entire length of body (502). Each tendon assembly lumen (508) contains a corresponding tendon assembly (520, 530). Specifically, tendon assembly (520a) is disposed at the 12 o'clock position in tendon lumen (508a), tendon assembly (520b) is disposed at the 6 o'clock position in tendon lumen (508b), tendon assembly (530a) is disposed at the 3 o'clock position in tendon lumen (508c), and tendon assembly (530b) is disposed at the 9 o'clock position in tendon lumen (508d). It should be understood that the number of tendon assembly lumens (508) and the angular positions of the tendon assembly lumens (508) described above are merely illustrative examples. Other variations may have any other suitable number of tendon assembly lumens (508) at any other suitable angular positions.
[0061] Each tendon assembly (520, 530) includes a housing (522, 532) and a tendon (524, 534) slidably disposed in the housing (522, 532). The housing (522, 532) is configured to bend laterally away from a central longitudinal axis (LA); but without longitudinal compression. By way of example only, the housing (522, 532) may be configured as a coil formed from round or square steel wire. As another example, the housing (522, 532) may include several wires wound into a plurality of adjacent spirals. As yet another example, the housing (522, 532) may include a tubular structure formed from steel, high-strength plastic, and / or any other suitable material (including combinations thereof). In some variations, the housing (522, 532) includes a stainless steel hypotube. Alternatively, the housing (522, 532) may take any other suitable form. In some variations, the housing (522, 532) includes a low-friction (e.g., polytetrafluoroethylene (PTFE), polyimide, etc.) liner within the lumen in which the tendon (524, 534) is disposed. The housing (522, 532) may also include a lubricated interface on the exterior of the housing (522, 532) to facilitate sliding of the housing (522, 532) within the tendon assembly lumen (508).
[0062] Similarly, instead of using laser-cut hypotubes to form the housings (522, 532), the housings (522, 532) may comprise coils. Such coils may be longitudinally stretched along a distal region of the coils to plastically deform the coils, thereby effectively opening the coils along the distal region of the coils. Such plastically deformed distal regions may be positioned along the articulated distal region of the elongated member (500), similar to the laser-cut region of the hypotubes described above. Such plastically deformed distal regions may provide a desired amount of compression along the distal portion (514) of the elongated member (500).
[0063] like Figure 5 and Figure 6 As shown, the housings (522, 532) extend along the entire length of the proximal portion (510). Figure 5 and Figure 7As shown, the housing (522) continues to extend through the middle portion (512), while the housing (532) terminates distally in the middle portion (512). An adhesive portion is provided within the tendon component lumen (508) to securely fix the distal portion of the housing (532) relative to the body (502) within the middle portion (512). By way of example only, the adhesive portion may be provided via a separate adhesive applied within the tendon component lumen (508). By way of further example only, the adhesive portion may be provided by reflowing the material forming the body (502), reflowing the material forming the housing (532), and / or providing some other form of thermal bonding process. Alternatively, an adhesive portion may be formed between the distal portion of the housing (532) and the body (502) in any other suitable manner. It should also be understood that the adhesive portion may be isolated only from the distal end of the housing (532); or may extend proximally from the distal end along the housing (532) to any suitable extent.
[0064] like Figure 5 and Figure 8 As shown, the housing (522) terminates distally in the distal portion (514). An adhesive portion (526) is provided within the tendon assembly lumen (508) to securely secure the distal portion of the housing (522) within the distal portion (514) relative to the body (502). By way of example only, the adhesive portion (526) may be provided via a separate adhesive applied within the tendon assembly lumen (508). By way of further example only, the adhesive portion (526) may be provided by reflowing the material forming the body (502), reflowing the material forming the housing (522), and / or providing some other form of thermal bonding process. Alternatively, the adhesive portion (526) may be formed between the distal portion of the housing (522) and the body (502) in any other suitable manner. It should also be understood that adhesive portion (526) may be isolated only from the distal end of housing (522); or may extend proximally from the distal end along housing (522) to any suitable extent.
[0065] In some variations, in addition to housing (522) terminating distally in distal portion (514), housing (532) terminates distally in distal portion (514). In some such embodiments where housing (522, 532) comprises a stainless steel hypotube, the distal region of housing (522, 532) may be laser cut to form a compression spring (i.e., the spring portion of housing (522, 532)). Housing (532) may be securely secured to body (502) and / or braid assembly (550) only proximal to distal portion (514) (e.g., via thermal bonding, etc.). The spring portion of housing (522, 532) extending along distal portion (514) may allow for desired compression for articulation of distal portion (514). The pitch of the spring portion of the housing (522, 532) can be adjusted as needed to provide a variable stiffness / allowable amount of compression (before the spring portion becomes fully stacked). This allows for better adjustment of the joint motion as needed. In addition, this arrangement allows the braid assembly (550) to have a fixed lumen size over its entire length without worrying about excessive gaps / deformability in the joint motion segment (between the inner cavity 542 and the tendon assembly (520, 530)).
[0066] Returning to this example, Figure 5-9 As shown, each tendon (524, 534) extends along the entire length of the body (502), wherein the distal end of the tendon (524, 534) is securely fixed to the control ring (506), and wherein the control ring (506) is securely fixed to the distal end of the body (502). By way of example only, each tendon (524, 534) may include a pull wire, a drive belt, a single-strand cable, a multi-strand cable, one or more metals, one or more fibers, and / or any other suitable component operable to transmit tension along the length of the elongated member (500) to provide articulation of the elongated member (500) without substantially stretching. Such tendons (524, 534) may also be coupled to the instrument coupling (11) of the robotic surgical system (10), such that the robotic surgical system (10) is operable to drive the tendons (524, 534) via the instrument coupling (11).
[0067] As described above, the housing (532) terminates distally in the intermediate region (512); while the housing (522) terminates distally in the distal region (514). Also as described above, the housing (532) is configured to be longitudinally non-compressible. Thus, when tension is applied to either of the tendons (524), the region of the distal portion (514) distal to the distal end of the corresponding housing (522) will articulate; while the housing (522) will provide isolation against compressive forces along the entire length of the body (502) proximal to the distal end of the housing (522). In other words, the region of the body (502) proximal to the distal end of the housing (522) will not deform in response to tension applied to the corresponding tendon (524). Similarly, when tension is applied to either of the tendons (534), the distal portion (514) and the region of the intermediate portion (512) distal to the distal end of the corresponding housing (532) will articulate; while the housing (532) will provide isolation against compressive forces along the entire length of the body (502) proximal to the distal end of the housing (532). In other words, the region of the body (502) proximal to the distal end of the housing (532) will not deform in response to tension applied to the corresponding tendon (534). From the foregoing, it should be understood that the tendon assemblies (520, 530) can be configured and operable like a Bowden cable assembly.
[0068] In some variations, the housing (522, 532) does not terminate distally at the above and Figure 5 The position shown. Some such variations may include the use of additional housing structures that are used solely for adhesive closure, such as plugs made of similar materials as described above (e.g., metal or polymer, composite materials, etc.). For example, a short segment made of housing (522, 532) can be placed in the tendon component lumen (508) and bonded thereto. Thus, this can form a subassembly. The remaining length of housing (522, 532) can abut the subassembly and would not need to be bonded to the tendon component lumen (508).
[0069] In this example, tendon assemblies (520, 530) extend along the entire length of elongated member (500) along respective linear paths parallel to the central longitudinal axis (LA). In some other versions, tendon assemblies (520, 530) may extend along a helical path along at least a portion of the length of elongated member (500). Figure 6-8 As shown, the tendon (524) extends along a first plane (ie, Figure 6-8 The tendon (534) is positioned along the first plane (ie, the vertical plane in the view of FIG), the first plane extending along the central longitudinal axis (LA); Figure 6-82 and 3. The tendon (524) is positioned in a horizontal plane (in the horizontal plane of the view of the body) extending along the central longitudinal axis (LA). Thus, the tendon (524) is operable to drive joint motion along a plane that is orthogonal to the plane along which the tendon (534) is operable to drive joint motion. In this example, the tendons (532, 534) can be driven independently. Thus, the distal portion (514) can be articulated in a first direction, while the middle portion (512) can be articulated in a second direction. It will be understood that any other suitable number of tendon assemblies can be provided at any other suitable angular position about the central longitudinal axis (LA); and any alternative tendon assembly can have a housing that terminates distally at any suitable position along the length of the body (502) by an adhesion portion. Such angular position changes and changes in the position of the adhesion portion at the distal end of the housing can be selected and combined to provide a desired joint motion feature.
[0070] In some versions, the proximal ends of the housings (522, 532) are fixedly secured relative to the instrument coupling (11) (or relative to the handle or other structure); but are not fixedly secured relative to the proximal end of the body (502). In some such versions, the entire length of each housing (522, 532) proximal to the adhesion portion (526, 536) is longitudinally slidable relative to the body (502). In other words, the proximal end of each housing (522, 532) can be configured to translate longitudinally relative to the region of the body (502) proximal to the adhesion portion (526, 536). In some such embodiments, such slidability of the proximal ends of the housings (522, 532) relative to the body (502) can allow the proximal portion (510) of the elongated member (500) to flex laterally (e.g., to traverse tortuous anatomical structures) without causing undesirable articulation of the intermediate portion (512) or distal portion (514) of the elongated member (500). To facilitate such slidability, the exterior regions of the housings (522, 532) and / or the interior regions of the tendon assembly lumen (508) can include a lubricating material (e.g., polytetrafluoroethylene, etc.).
[0071] Likewise Figure 6-8As shown, the elongated member (500) of this example includes a braid assembly (550). The braid assembly (550) is wrapped around the liner (540) and embedded within the body (502). The braid assembly (550) includes a plurality of strands (552) that are wrapped to form an elongated braided structure extending along the length of the liner (540) and the body (502). The tendon components (520, 530) are effectively interwoven within the braid assembly (550) such that each tendon component (520, 530) is disposed in a space (554) defined by the strands (552). As described in more detail below, in some versions, the tendon components (520, 530) may be effectively captured between the braid component (550) and the pad (540); while in other versions, the tendon components (520, 530) may be effectively integrated into the braid component (550) by being interwoven with the strands (552).
[0072] The body (502) of this example is formed around the exterior of the braid component (550). By way of example only, the body (502) can be formed around the exterior of the braid component (550) by a reflow process and / or by any other suitable process. The body (502) can include a reflow material, such as polyether block amide (PEBA) and / or any other suitable type of material. At least some of the material used to form the area of the body (502) outside the braid component (550) can also reach the area between the braid component (550) and the liner (540), such as Figure 6-8 As shown. In the event that any of the tendon assemblies (520, 530) would otherwise tend to exert an outward / outwardly directed force on the body (520) (e.g., during bending of the elongated member (500), particularly during actuated joint motion), the braid assembly (550) can effectively absorb such forces, thereby protecting the body (502) from any damage that the tendon assemblies (520, 530) might cause to the body (502). Thus, the braid assembly (550) provides structural reinforcement for the body (502). However, the braid assembly (550) still allows the body (502) to flexibly deflect laterally, such as during traversing tortuous anatomical structures and / or during actively actuated joint motion.
[0073] III. Examples of Apparatus and Methods for Making Steerable Elongated Members with Integrated Force Isolation Elements
[0074] Figure 10 An example of an apparatus (600) that can be used in a process of manufacturing at least a portion of an elongated member including a braided structure is shown. Specifically, Figure 10A head (610) is shown at the distal end of a shaft (612) with a central shaft (620) disposed in a central opening (614) defined by the head (610). In this example, the head (610) has a rounded, generally conical shape. The proximal end of the shaft (612) can be coupled to a motor (not shown) that can be operable to rotate the shaft (612) and the head (610) about a central longitudinal axis shared by the shaft (612) and the spindle (620). An actuator (not shown) can be coupled to the spindle (620) to drive the spindle (620) longitudinally relative to the shaft (612). Alternatively, an actuator can be coupled to the shaft (612) to drive the shaft (612) and the head (610) longitudinally relative to the spindle (620).
[0075] Regardless of whether the head (610) is rotated relative to the mandrel (620) during longitudinal translation of the mandrel (620) relative to the head (610) (or during longitudinal translation of the head (610) relative to the mandrel (620)), the plurality of braided strands (602) may be wound around the mandrel (620) (or onto a structure pre-positioned on the mandrel (620)), thereby forming a braid around the mandrel (620) (and around any structure pre-positioned on the mandrel (620)). Such braid winding of the strands (602) may be performed using known components and techniques by coordinated movement of various spools, etc., from which the strands (602) are fed. The rounded, generally conical shape of the head (610) supports the strands (602), thereby helping to guide the strands (602) into position along the mandrel (620) (or onto a structure pre-set on the mandrel (620)) as the strands (602) are wrapped to form the braid (604).
[0076] As described above, it may be desirable to form an elongated member (500) wherein tendon components (520, 530) are effectively interwoven within a braid component (550) such that each tendon component (520, 530) is disposed within a space (554) defined by strands (552). Figure 11-12 An example of a mandrel assembly (700) that can be employed in a variation of the apparatus (600) during the process of manufacturing the elongated member (500) is shown. The mandrel assembly (700) of this example includes a central mandrel (702) and an array of outer mandrels (704) spaced angularly around the central mandrel (702). The central mandrel (702) can effectively serve as the mandrel (620) described above, such that the central mandrel (702) can be longitudinally translated through the central opening (614) of the head (610). The diameter of the central mandrel (702) corresponds to the diameter of the lumen (542).
[0077] In some versions, the outer mandrel (704) is fixedly pre-set such as Figure 12In some embodiments, the outer mandrel (704) is engaged with the central mandrel (702) through the central opening of the head (610). This allows the outer mandrel (704) to be effectively captured within the braid assembly (550) against the pad (540) without having to be interwoven between the strands (552). In some other embodiments, the outer mandrel (704) is laterally flexible and is fed along the mandrel (702) with the strands (552) under the guidance of the head (610). This promotes the interweaving of the mandrel (704) between the strands (552), so that the mandrel (704) and the strands (552) cooperate to be effectively integrated into the braid assembly (550).
[0078] The position and diameter of outer mandrel (704a) ultimately correspond to the position and diameter of tendon assembly lumen (508a). The position and diameter of outer mandrel (704b) ultimately correspond to the position and diameter of tendon assembly lumen (508b). The position and diameter of outer mandrel (704c) ultimately correspond to the position and diameter of tendon assembly lumen (508c). The position and diameter of outer mandrel (704d) ultimately correspond to the position and diameter of tendon assembly lumen (508d).
[0079] Figures 13A-13D and Figure 14 Examples of materials and steps that may be used to manufacture an elongated member (500) using a version of an apparatus (600) including a mandrel assembly (700) are shown. Specifically, Figure 14 A set of components (800) is shown, including a low friction material (802) (e.g., polytetrafluoroethylene, polyimide, etc.) for forming a liner (540); a material (804) (e.g., stainless steel, aramid fiber, etc.) for forming the strands (552) that will ultimately form the braid assembly (550); one or more materials (806) (e.g., steel and / or polymer) for forming the mandrel (702, 704); a material (810) (e.g., polyether block amide (PEBA), etc.) for forming the body (502); a material (816) (e.g., steel wire coil, steel hypotube, an incompressible but laterally flexible polymer structure, etc.) for forming the shell (522, 532); a material (820) (e.g., stainless steel, aramid fiber, tungsten, carbon fiber, etc.) for forming the tendons (524, 534); and a material (824) (e.g., stainless steel, a rigid polymer, etc.) for forming the control ring (506).
[0080] At the beginning of the manufacturing process, a lubricant may be applied to at least the outer mandrel (704); and in some cases, to the center mandrel (702). The liner (540) is then positioned around the center mandrel (702), as shown. Figure 13AThen, when the liner (540) is placed on the central mandrel, the strands (552) are wound together with (or around) the outer mandrel (704) and the central mandrel (702) so that the braid assembly (550) is formed around the liner (540), as shown. Figure 13B This braid formation process is also Figure 14 As described above, in some versions of the braid forming process, the outer mandrel (704) is guided by the head (610) and fed / wound around the pad (540) and the center mandrel (702) along with the strands (552). In this version, the outer mandrel (704) is interwoven with the strands (552) to be effectively integrated into the braid assembly (550).
[0081] Whether the outer mandrel (704) is effectively captured between the braid component (550) and the liner (540) or cooperates with the strands (552) to be effectively integrated into the braid component (550), the material (810) used to form the body (502) can then be applied around the braid component (550) and the mandrel assembly (700), as Figure 14 As described above, the process may include a reflow process, a molding process, an extrusion process, and / or any other suitable process to form the body (502). In any case, the resulting formation may be as shown in FIG. Figure 13C It should be appreciated that, in this example, braid component (550) is coextensive with body (502), such that braid component (550) extends along the entire length of body (502), and vice versa.
[0082] When the body (502) is formed, the mandrel assembly (700) is removed, as Figure 14 As described above, a lubricant may be applied to at least the outer mandrel (704) such that the lubricant may facilitate removal of the mandrel (704) from the body (502) and braid assembly (550). In either case, the resulting formation may be as shown in FIG. Figure 13D shown.
[0083] like Figure 13D As shown, the tendon component lumen (508) is formed at this stage and is ready to receive the corresponding tendon component (520, 530). The material (816) forming the shell (522, 532) is then inserted into the corresponding tendon component lumen (508) and fixed at the appropriate longitudinal position via the adhesive portion (526, 536), as shown. Figure 14The inner diameter of the tendon assembly lumen (508) may be significantly larger than the outer diameter of the housing (522, 532), such that lubricant may not be required to facilitate insertion of the housing (522, 532) into the corresponding tendon assembly lumen (508). By way of example only, the inner diameter of the tendon assembly lumen (508) may be at least about 0.002 inches larger than the outer diameter of the housing (522, 532).
[0084] In versions in which the adhesions (526, 536) are formed by thermal bonding, the heat may be concentrated on a longitudinal region of the body (502) corresponding to the distal portion of the housing (522, 532) and / or anywhere else along the length of the body (502) where it is desirable to form adhesions (526, 536). To the extent that some heat reaches regions of the lumen (508) that do not contain the housing (522, 532), the heat may tend to slightly reduce the inner diameter of such lumen (508) without necessarily causing such lumen to effectively collapse over the tendon (524, 534). In some variations, the housing (522, 532) includes an outer polymer layer (not shown) along the distal region where the adhesions (526, 536) will be formed. Such an outer polymer layer may tend to enhance the strength of the adhesion at the adhesions (526, 536).
[0085] In this example, the material (820) forming the tendons (524, 534) is pre-disposed in the housings (522, 532), such that the process does not necessarily require the additional step of feeding the tendons (524, 534) into the respective housings (522, 532). However, some variations of the process may include such a feeding step. Another optional step may include stripping the coating from the distal end of the tendons (524, 534), such as Figure 14 822 to facilitate coupling of the tendons (524, 534) to the control ring (506), as described below. However, this step may be omitted in some versions (e.g., based on existing configurations of the tendons (524, 534), such as those lacking a coating). Regardless of whether the stripping step (822) is employed, the distal ends of the tendons (524, 534) may be securely secured to the control ring (506), as described below. Figure 14 By way of example only, this step (826) may include laser welding, brazing, adhesive bonding, or any other suitable technique (and / or fastening components).
[0086] With the tendon assemblies (520, 530) secured in their respective tendon assembly lumens (508) and the distal ends of the tendons (524, 534) securely secured to the control ring (506), the control ring (506) is then securely secured to the distal end of the body (502). Figure 14At this stage, the manufacturing process of the elongated member (500) can be considered complete, as shown in the box (828). Figure 14 , as shown in box (830) of . This is particularly true when the slender member (500) is used as a guide sheath or guide catheter. In some other versions, such as when the slender member (500) is used as a variation of the endoscope (400), one or more imaging devices (e.g., imaging device (448)), one or more lighting elements (e.g., one or more integrated light emitting diodes, one or more lenses optically coupled to corresponding optical fibers, etc.), and / or other features may be secured at or near the control ring (506). Alternatively, an end effector (e.g., a basket (35) or other features operable to perform one or more operations on tissue such as grasping, cutting, suturing, sealing, stapling, etc.) may be secured at or near the control ring (506). With reference to the teachings herein, in completing the control ring (506), the end effector (e.g., a basket (35) or other features operable to perform one or more operations on tissue such as grasping, cutting, suturing, sealing, stapling, etc.) may be secured at or near the control ring (506). Figures 13A-13D and Figure 14 Other suitable steps to follow the illustrated process may be apparent to those skilled in the art.
[0087] IV. Combined Examples
[0088] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided for illustrative purposes only. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise expressly indicated as such by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.
[0089] Example 1
[0090] A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a sidewall comprising a flexible material, (ii) a proximal portion, and (iii) a distal portion terminating at a distal end; and (b) a first tendon assembly operable to drive a portion of the elongated body to deflect away from the central longitudinal axis, the first tendon assembly comprising: (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end fixed at a first longitudinal position along the elongated body, and (ii) a first tendon slidably disposed in the first tendon housing, the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being securely fixed relative to the elongated body.
[0091] Example 2
[0092] Embodiment 1 The device of embodiment 1, wherein the flexible material is one or both longitudinally extendable and longitudinally compressible.
[0093] Example 3
[0094] Embodiment 2 : The device of any one of embodiments 1-2, wherein the flexible material comprises polyether block amide.
[0095] Example 4
[0096]
[00146] According to the apparatus of any one of embodiments 1 to 3, the first tendon shell is longitudinally incompressible.
[0097] Example 5
[0098] Embodiment 4: The apparatus of any one of embodiments 1 to 4 wherein the first tendon housing comprises a coil.
[0099] Example 6
[0100] Embodiment 1: The apparatus of any one of embodiments 1 to 5 wherein the first tendon comprises a pull wire.
[0101] Example 7
[0102] Embodiment 6: The apparatus of any one of embodiments 1 to 6, wherein the first tendon assembly forms a Bowden cable assembly.
[0103] Example 8
[0104] Embodiment 1: The device of any one of embodiments 1 to 7, wherein the first longitudinal position is proximal to a distal end of the distal portion of the elongated body.
[0105] Example 9
[0106]
[00106] The apparatus of any one of Examples 1 to 8 further comprising an anchoring element at a distal end of the distal portion of the elongated body.
[0107] Example 10
[0108] According to the device of Example 9, the distal portion of the first tendon is fixedly secured to the anchoring element.
[0109] Example 11
[0110] According to the device of any of Examples 9-10, the anchoring element comprises a control ring.
[0111] Example 12
[0112] Embodiment 1: The apparatus of any one of embodiments 1 to 11, wherein the first tendon component is operable to drive deflection of a distal portion of the elongated body away from the central longitudinal axis.
[0113] Example 13
[0114] Embodiment 1: The device of any one of embodiments 1 to 12, wherein the elongated body further defines a lumen.
[0115] Example 14
[0116]
[00116] Embodiment 13: The apparatus of embodiment 13, wherein the lumen is coaxial with the central longitudinal axis.
[0117] Example 15
[0118] The apparatus of any one of Examples 13-14 further comprising a liner in the lumen such that the liner is radially interposed between the sidewall and the lumen.
[0119] Example 16
[0120] Embodiment 15: The apparatus of embodiment 15, wherein the gasket comprises polytetrafluoroethylene or polyimide.
[0121] Example 17
[0122] The apparatus of any one of embodiments 1 to 16 further comprising a braid component.
[0123] Example 18
[0124]
[00116] In the apparatus of embodiment 17, the braid component is positioned within the side wall.
[0125] Example 19
[0126] Embodiment 17: The apparatus of any one of Embodiments 17-18, wherein the braid component includes strands, the first tendon component being interwoven with the strands such that the first tendon component is integrated into the braid component.
[0127] Example 20
[0128] The device according to any one of Examples 1 to 19 further includes a second tendon assembly, which is operable to drive a portion of the slender body to deflect away from the central longitudinal axis, the second tendon assembly comprising: (i) a second tendon shell, which extends through the side wall at a second angular position around the central longitudinal axis, the second tendon shell having a distal end fixed to the slender body, and (ii) a second tendon, which is slidably disposed in the second tendon shell, the second tendon having a distal portion extending distally from the distal end of the second tendon shell, and the distal portion of the second tendon is firmly fixed relative to the slender body.
[0129] Example 21
[0130] According to the apparatus of embodiment 20, the second angular position is angularly offset from the first angular position by approximately 90 degrees.
[0131] Example 22
[0132] According to the apparatus of embodiment 20, the second angular position is angularly offset from the first angular position by approximately 180 degrees.
[0133] Example 23
[0134]
[00106] In the apparatus of any one of Examples 20 to 22, the distal end of the second tendon shell is secured to the elongated body at a second longitudinal position along the elongated body.
[0135] Example 24
[0136]
[00126] In the apparatus of embodiment 23, the second longitudinal position is proximal to the first longitudinal position.
[0137] Example 25
[0138] According to the device of Example 24, the slender body also includes a middle portion located between the proximal portion and the distal portion, the first tendon assembly is operable to drive the deflection of the distal portion of the slender body away from the central longitudinal axis, and the second tendon assembly is operable to drive the deflection of the middle portion of the slender body away from the central longitudinal axis.
[0139] Example 26
[0140] In accordance with the device described in any one of Examples 20 to 25, the first tendon assembly is operable to drive the deflection of the distal portion of the slender body along a first joint motion plane away from the central longitudinal axis, and the second tendon assembly is operable to drive the deflection of the distal portion of the slender body along a second joint motion plane away from the central longitudinal axis.
[0141] Example 27
[0142]
[00146] In the apparatus of Example 26, the second plane of articulation is orthogonal to the first plane of articulation.
[0143] Example 28
[0144] A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a sidewall comprising a flexible material, (ii) a proximal portion, and (iii) a distal portion terminating at a distal end; (b) a tendon assembly extending through the sidewall, the tendon assembly being operable to drive deflection of a portion of the elongated body away from the central longitudinal axis; and (c) a braid assembly positioned within the sidewall, the braid assembly comprising strands, the tendon assembly being interwoven with the strands such that the tendon assembly is integrated into the braid assembly.
[0145] Example 29
[0146] According to the device described in Example 28, the tendon assembly includes: (i) a tendon housing extending through the side wall, the tendon housing having a distal end fixed at a longitudinal position along the slender body, and (ii) a tendon slidably disposed in the tendon housing, the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being firmly fixed relative to the slender body.
[0147] Example 30
[0148] A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a sidewall comprising a flexible material, (ii) a proximal portion, (iii) a distal portion terminating at a distal end, and (iv) an intermediate portion located between the proximal portion and the distal portion; (b) a first Bowden cable assembly extending through the sidewall, the first Bowden cable assembly being operable to drive deflection of the distal portion of the elongated body away from the central longitudinal axis; and (c) a second Bowden cable assembly extending through the sidewall, the second Bowden cable assembly being operable to drive deflection of the intermediate portion of the elongated body away from the central longitudinal axis.
[0149] Example 31
[0150] According to the device described in Example 30, the first Bowden cable assembly includes a first shell, the first shell having a distal end fixed at a first longitudinal position along the slender body, and the second Bowden cable assembly includes a second shell, the second shell having a distal end fixed at a second longitudinal position along the slender body, and the second longitudinal position is proximal to the first longitudinal position.
[0151] Example 32
[0152] A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a sidewall comprising a flexible material, (ii) a proximal portion, (iii) a distal portion terminating at a distal end, and (iv) an intermediate portion located between the proximal portion and the distal portion; (b) a first Bowden cable assembly extending through the sidewall, the first Bowden cable assembly being operable to drive deflection of the distal portion of the elongated body away from the central longitudinal axis, the first Bowden cable assembly being positioned at a first angular position about the central longitudinal axis; and (c) a second Bowden cable assembly extending through the sidewall, the second Bowden cable assembly being operable to drive deflection of the distal portion of the elongated body away from the central longitudinal axis, the second Bowden cable assembly being positioned at a second angular position about the central longitudinal axis.
[0153] Example 33
[0154] In the device of embodiment 32, the first Bowden cable assembly is operable to drive the deflection of the distal portion of the slender body along a first direction away from the central longitudinal axis, and the second Bowden cable assembly is operable to drive the deflection of the distal portion of the slender body along a second direction away from the central longitudinal axis.
[0155] Example 34
[0156] A method comprising: (a) translating a central mandrel relative to a head; (b) positioning a plurality of outer mandrels around the central mandrel; and (c) winding a plurality of strands around the central mandrel and the outer mandrels to form a braid assembly while the central mandrel is translated relative to the head.
[0157] Example 35
[0158] The method of embodiment 34 further includes positioning a pad around the central mandrel such that the braid assembly is formed around the pad.
[0159] Example 36
[0160] The method of embodiment 35, wherein the liner comprises polytetrafluoroethylene or polyimide.
[0161] Example 37
[0162] According to the method described in any one of Examples 34 to 36, positioning the plurality of outer core shafts around the central lumen includes guiding the outer core shafts along the head as the central core shaft translates relative to the head, and the plurality of outer core shafts also translate relative to the head as the central core shaft translates relative to the head.
[0163] Example 38
[0164] According to the method of any one of embodiments 34 to 37, winding the plurality of strands around the central mandrel and the outer mandrel to form a braided fabric component further comprises interweaving the plurality of mandrels with the plurality of strands, thereby incorporating the plurality of strands into the braided fabric component.
[0165] Example 39
[0166] The method of any one of embodiments 34 to 38 further includes forming an elongated body around the braid component, wherein the central mandrel and the plurality of outer mandrels are retained within the braid component when the elongated body is formed around the braid component.
[0167] Example 40
[0168] The method of embodiment 39, wherein forming the elongated body comprises one or more of a reflow process, an overmolding process, or an extrusion process.
[0169] Example 41
[0170] The method according to any one of Examples 39 to 40 further includes removing the central core shaft and the multiple outer core shafts from the combination of the slender body and the braid component, wherein the removal of the central core shaft forms an inner cavity along the combination of the slender body and the braid component, and the removal of the multiple outer core shafts forms multiple tendon component cavities.
[0171] Example 42
[0172] The method according to Example 41 further includes inserting a tendon component into the tendon component lumen, each tendon component including a tendon shell and a tendon.
[0173] Example 43
[0174] The method according to Example 42 also includes securely securing the distal portion of each tendon shell to the slender body.
[0175] Example 44
[0176] The method of any one of Examples 42-43 further comprises securely securing a distal end of each tendon relative to the elongated body.
[0177] Example 45
[0178] The method of Example 44 further includes: (a) securely securing the distal end of each tendon to an anchoring member; and (b) securely securing the anchoring member to the distal end of the elongated body.
[0179] V. Miscellaneous
[0180] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.
[0181] The patterns described above can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case or both cases, these patterns can be repaired for reuse after at least one use. Repair can include any combination of the following steps: disassembling the system, apparatus and / or its parts, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some patterns of systems, apparatus and / or its parts can be disassembled, and any number of specific parts or components of the system, apparatus and / or its parts can be optionally replaced or removed in any combination. When cleaning and / or replacing specific components, some patterns of systems, apparatus and / or its parts can be reassembled at a repair facility or reassembled by the operator before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of systems, apparatus and / or its parts can utilize a variety of techniques to disassemble, clean / replace and reassemble. The use of such techniques and the repaired systems, apparatus and / or its parts obtained are all within the scope of the present application.
[0182] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the system, instrument, and / or its parts are placed in a closed and sealed container (such as a plastic or TYVEK bag). The container and the system, instrument, and / or its parts can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation can kill bacteria on the system, instrument, and / or its parts and in the container. The sterilized system, instrument, and / or its parts can then be stored in a sterile container for later use. The system, instrument, and / or its parts can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0183] Various embodiments of the present invention have been shown and described, and further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.
Claims
1. A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a side wall comprising a flexible material, (ii) the proximal portion, and (iii) a distal portion terminating at a distal end; and (b) a first tendon assembly operable to drive a portion of the elongated body to deflect away from the central longitudinal axis, the first tendon assembly comprising: (i) a first tendon housing extending through the side wall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end secured at a first longitudinal position along the elongated body, and (ii) a first tendon slidably disposed in the first tendon housing, the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being securely fixed relative to the elongated body.
2. The apparatus of claim 1, the flexible material being one or both longitudinally extendable or longitudinally compressible.
3. The device of claim 1, wherein the flexible material comprises polyether block amide.
4. The apparatus of claim 1 , wherein the first tendon housing is longitudinally incompressible.
5. The apparatus of claim 1 , wherein the first tendon housing comprises a coil.
6. The apparatus of claim 1, the first tendon comprising a pull wire.
7. The apparatus of claim 1, wherein the first tendon assembly forms a Bowden cable assembly.
8. The apparatus of claim 1, the first longitudinal position being proximal to the distal end of the distal portion of the elongated body.
9. The apparatus of claim 1, further comprising an anchoring element at the distal end of the distal portion of the elongated body.
10. The apparatus of claim 1, the first tendon component being operable to drive deflection of the distal portion of the elongated body away from the central longitudinal axis.
11. The apparatus of claim 1 , the elongated body further defining an inner lumen.
12. The apparatus of claim 1 further comprising a braid component.
13. The apparatus of claim 1 , further comprising a second tendon assembly operable to drive a portion of the elongated body to deflect away from the central longitudinal axis, the second tendon assembly comprising: (i) a second tendon housing extending through the side wall at a second angular position about the central longitudinal axis, the second tendon housing having a distal end secured to the elongated body, and (ii) a second tendon slidably disposed in the second tendon housing, the second tendon having a distal portion extending distally from the distal end of the second tendon housing, the distal portion of the second tendon being securely fixed relative to the elongated body.
14. The apparatus of claim 13, the second angular position being angularly offset from the first angular position by approximately 90 degrees.
15. The apparatus of claim 13, the second angular position being angularly offset from the first angular position by approximately 180 degrees.
16. A device comprising: (a) an elongated body defining a central longitudinal axis, the elongated body comprising: (i) a side wall comprising a flexible material, (ii) the proximal portion, and (iii) a distal portion terminating at a distal end; (b) a tendon assembly extending through the side wall, the tendon assembly being operable to drive deflection of a portion of the elongated body away from the central longitudinal axis; and (c) a braid component positioned within the sidewall, the braid component including strands, the tendon component being interwoven with the strands such that the tendon component is integrated into the braid component.
17. The apparatus of claim 16, wherein the tendon assembly comprises: (i) a tendon housing extending through the side wall, the tendon housing having a distal end fixed at a longitudinal position along the elongated body, and (ii) a tendon slidably disposed in the tendon housing, the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being securely fixed relative to the elongated body.
18. A method comprising: (a) Translation of the central axis relative to the head; (b) positioning a plurality of outer mandrels around the central mandrel; as well as (c) wrapping a plurality of strands around the central mandrel and the outer mandrel to form a braid assembly as the central mandrel translates relative to the head.
19. The method of claim 18, further comprising positioning a pad about the central mandrel such that the braid assembly is formed around the pad.
20. The method of claim 18, wherein positioning the plurality of outer mandrels about the central lumen comprises guiding the outer mandrels along the head as the central mandrel translates relative to the head, the plurality of outer mandrels translating relative to the head as the central mandrel translates relative to the head.
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