Support device fixed point follow-up adjustment system and surgical robot system

Abstract

The application provides a support device fixed point follow-up adjustment system and a surgical robot system, the support device fixed point follow-up adjustment system comprising: a positioning unit and a control unit; the control unit is in communication connection with the positioning unit, the control unit is used for acquiring first pose information of a support device relative to a patient end control device through the positioning unit; the control unit monitors the pose change of the support device relative to the patient end control device based on the first pose information; wherein the mechanical arm of the patient end control device is used for driving the connected instrument to move through a fixed point; the control unit is configured to control the patient end control device to make corresponding movement when it is identified that the pose change exceeds a predetermined value, so that the pose of the fixed point relative to the support device remains unchanged. In this way, intraoperative body position adjustment can be carried out without interrupting the operation.

Description

Technical Field

[0001] This invention relates to the field of robot-assisted surgery technology, and in particular to a support device fixed point follow-up adjustment system and a surgical robot system. Background Technology

[0002] The emergence of surgical robots aligns with the development trend of precision surgery. Surgical robots have become powerful tools to assist doctors in performing surgeries, and various surgical robots suitable for different indications have already been developed in multiple departments and fields.

[0003] Surgical robots are designed to perform complex surgical procedures with precision and dexterity using minimally invasive techniques, offering high accuracy and safety. Addressing the limitations of traditional surgery, surgical robots have been developed to replace it. They overcome the limitations of the human eye, employing 3D imaging technology to present internal organs more clearly to the operator. In areas previously inaccessible by hand, robotic arms can perform 360-degree rotation, movement, swinging, or gripping, while avoiding tremors. Patients experience smaller incisions, less bleeding, and faster recovery, significantly shortening postoperative hospital stays and improving postoperative survival and recovery rates. These advancements have made them popular with both doctors and patients, and they are now widely used in various clinical surgeries as a high-end medical device.

[0004] Unlike traditional laparoscopic surgery, surgical robot systems feature a fixed-point mechanism. This mechanism ensures that the robotic arm moves around a fixed point during surgery, which coincides with the surgical opening in the patient's abdominal cavity. This prevents the robotic arm from harming the patient during movement. However, the presence of this fixed point also limits the operating space of the surgical robot's instruments. The mechanical volume of the surgical robot is several to tens of times larger than that of ordinary laparoscopic instruments. Interference between the robotic arms further reduces the operable range of the instruments. Once the fixed point of the surgical robot system is matched with the patient's surgical opening, the position of the surgical robot and the patient's position cannot be adjusted; otherwise, the fixed point will be compromised. The characteristics of robotic surgery, such as the risk of patient injury due to positional changes, place extremely high demands on the preoperative drilling positions. Failure to properly position the drilling points will restrict the robotic arm's movement space, affecting surgical procedures and potentially preventing the surgery from being completed. This necessitates removing instruments and endoscopes from the robotic arm, detaching the robotic arm's fixed points from the patient's surgical port, readjusting the patient's position and the robotic arm's position, and re-matching the robotic arm's fixed points with the patient's surgical port. This entire process leads to surgical interruptions, prolonged operation, and an inability to monitor the adjustment process or ensure that the adjusted position meets operational space requirements. Therefore, it results in prolonged surgery time and reduced safety.

[0005] Current robotic surgical procedures require lengthy preoperative preparation times, rely heavily on experience for incision selection, and are prone to inappropriate placement due to patient differences. This can lead to surgical difficulties, interruptions, or even the need for re-selection of incision positions, causing unnecessary harm to the patient. Therefore, there is an urgent need for a method that allows for intraoperative positioning adjustments without interruption of the procedure, addressing the limitations of current robotic surgical systems and improving both efficiency and safety. Summary of the Invention

[0006] The purpose of this invention is to provide a fixed-point follow-up adjustment system for a support device and a surgical robot system, so as to solve the problem that existing surgical robot systems cannot efficiently adjust the position of the surgical robot and the patient's position during surgery.

[0007] To solve the above-mentioned technical problems, according to a first aspect of the present invention, a fixed point follow-up adjustment system for a support device is provided, comprising: a positioning unit and a control unit;

[0008] The control unit is communicatively connected to the positioning unit, and the control unit is used to obtain the first position information of the support device relative to the patient-end control device through the positioning unit.

[0009] The control unit monitors the positional changes of the support device relative to the patient-end control device based on the first positional information; wherein the robotic arm of the patient-end control device is used to drive the connected instrument to move through a fixed point.

[0010] The control unit is configured to control the patient-end control device to make corresponding movements when it is detected that the pose change exceeds a predetermined value, so that the pose of the fixed point relative to the support device remains unchanged.

[0011] Optionally, the first pose information includes the distance of the support device relative to the patient-end control device, and the angle of the support device relative to the patient-end control device.

[0012] Optionally, the fixed point follow-up adjustment system of the support device further includes: a first pose acquisition unit communicatively connected to the control unit; the first pose acquisition unit is used to acquire the second pose information of the robotic arm of the patient end control device; the control unit obtains the coordinate information of the fixed point in the coordinate system of the patient end control device based on the second pose information.

[0013] Optionally, the fixed-point follow-up adjustment system of the support device further includes: a second pose acquisition unit communicatively connected to the control unit; the second pose acquisition unit is used to acquire the third pose information of the bed board of the support device; the control unit obtains the coordinate information of the bed board in the coordinate system of the support device based on the third pose information.

[0014] Optionally, the third pose information includes the lifting height information of the bed board and the rotation angle of the bed board; the second pose acquisition unit includes an encoder disposed on the lifting column and a gyroscope disposed on the rotary joint, the encoder being used to feed back the lifting height information of the bed board and the gyroscope being used to feed back the rotation angle of the bed board.

[0015] Optionally, the positioning unit includes a first end and a second end that are adapted to each other. The first end is used to sense the position of the second end through a predetermined sensing medium. The first end and the second end are disposed on the patient end control device and / or the support device according to the type of the sensing medium, so as to obtain the first pose information of the support device relative to the patient end control device.

[0016] Optionally, the first end includes at least two optical imaging devices, and the second end includes an optical target group, the optical target group including at least three non-collinear optical targets. The first end is used to be mounted on the patient-end control device, and the second end is used to be mounted on the support device.

[0017] Optionally, the second end includes a plurality of optical target groups, each of which is disposed on one side of the support device.

[0018] Optionally, the first end includes at least two ultrasound transmitters, and the second end includes at least two ultrasound receivers. The first end is configured to be disposed in one of the support device and the patient-end control device, and the second end is configured to be disposed in the other of the support device and the patient-end control device.

[0019] Optionally, each of the ultrasound receivers is used to receive ultrasound waves emitted by at least two of the ultrasound transmitters; the control unit is also used to exclude redundant position information of the ultrasound transmitters obtained based on the ultrasound receivers, according to the position information of the robotic arm of the patient-end control device relative to the support device.

[0020] Optionally, the first end includes a magnetic field generator, and the second end includes a magnetic positioning sensor with at least 3 degrees of freedom. The first end is used to be mounted on the patient-side control device, and the second end is used to be mounted on the support device.

[0021] Optionally, the second end includes a 6-DOF magnetic positioning sensor.

[0022] Optionally, the first end includes a magnetic field generator, and the second end includes at least three magnetic positioning sensors that are not on the same straight line. The first end is used to be mounted on the patient-side control device, and the second end is used to be mounted on the support device.

[0023] Optionally, the first end includes a laser, and the second end includes an imaging device. Both the first end and the second end are configured to be mounted on the patient-side control device, or both the first end and the second end are configured to be mounted on the support device.

[0024] Optionally, the positioning unit further includes a reflector plate, which is disposed on one of the patient-end control device and the support device that does not have the laser and the imaging device, for reflecting the laser emitted by the laser.

[0025] To address the aforementioned technical problems, according to a second aspect of the present invention, a surgical robot system is also provided, comprising: a support device, a patient-end control device, and a support device fixed-point follow-up adjustment system as described above; the support device fixed-point follow-up adjustment system is used to control the movement of the patient-end control device so that the position of the fixed point relative to the support device remains unchanged.

[0026] In summary, in the support device fixed point follow-up adjustment system and surgical robot system provided by the present invention, the support device fixed point follow-up adjustment system includes: a positioning unit and a control unit; the control unit is communicatively connected to the positioning unit, and the control unit is used to obtain the first pose information of the support device relative to the patient-end control device through the positioning unit; the control unit monitors the pose change of the support device relative to the patient-end control device based on the first pose information; wherein the robotic arm of the patient-end control device is used to drive the connected instrument to move through the fixed point; the control unit is configured to control the patient-end control device to perform corresponding movements when the pose change is detected to exceed a predetermined value, so that the pose of the fixed point relative to the support device remains unchanged.

[0027] With this configuration, the control unit can detect the relative pose between the support device and the patient-end control device in real time through the positioning unit, and control the patient-end control device to make corresponding movements. This ensures that the pose of the fixed point relative to the support device remains unchanged. Without interrupting the surgery, intraoperative positioning adjustments can be made to address situations where the movement space of the robotic arm is limited or the position of the surgical port is not ideal due to the relationship between the current position of the surgical robot and the patient's position. Moreover, the instruments do not need to be removed during the adjustment, which can effectively meet various intraoperative positioning adjustments, improve the efficiency and safety of surgical robot surgery, reduce preoperative preparation time, effectively make up for the risks and defects of existing surgical perforation operations, improve the precision of surgical operations, reduce patient pain, and improve recovery efficiency. Attached Figure Description

[0028] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0029] Figure 1 This is a schematic diagram of a surgical scenario involving the surgical robot system of the present invention;

[0030] Figure 2 This invention relates to a flowchart of the overall steps of surgical planning;

[0031] Figure 3 This is a schematic diagram illustrating the establishment of the environmental coordinate system for a surgical scene, as per the present invention.

[0032] Figure 4a and Figure 4b This is a schematic diagram illustrating the establishment of the surgical scene involved in this invention;

[0033] Figure 5 This is a schematic diagram of the surgical port creation involved in the present invention;

[0034] Figure 6 This is a schematic diagram of the patient-side surgical platform involved in the present invention;

[0035] Figure 7a This is a schematic diagram of establishing a safe zone using a position sensor, which is an invention of the present invention;

[0036] Figure 7b This is a schematic diagram of the invention relating to establishing a security area using an optical fiber shape sensor;

[0037] Figure 8 This is a schematic diagram of the robot before adaptation, as per the present invention;

[0038] Figure 9 This is a schematic diagram of the robot after adaptation, as per the present invention.

[0039] Figure 10This is a schematic diagram of a surgical robot system according to an embodiment of the present invention;

[0040] Figure 11 This is a schematic diagram of the positioning unit including an optical imaging positioning component in an embodiment of the present invention;

[0041] Figure 12a and Figure 12b This is a schematic diagram of the binocular vision positioning principle according to an embodiment of the present invention;

[0042] Figure 13 This is a schematic diagram of a distributed optical target group according to an embodiment of the present invention;

[0043] Figure 14 This is a schematic diagram of an integrated optical target assembly according to an embodiment of the present invention;

[0044] Figure 15a and Figure 15b This is a schematic diagram of a positioning unit including an ultrasonic positioning component according to an embodiment of the present invention;

[0045] Figure 16 This is a schematic diagram of the positioning principle of the ultrasonic positioning component according to an embodiment of the present invention;

[0046] Figure 17 This is a schematic diagram of a positioning unit including a magnetic field positioning component according to an embodiment of the present invention;

[0047] Figure 18a and Figure 18b This is a schematic diagram of a positioning unit in an embodiment of the present invention including another magnetic field positioning component;

[0048] Figure 19a and Figure 19b This is a schematic diagram of a positioning unit including a laser positioning component according to an embodiment of the present invention;

[0049] Figure 20 This is a schematic diagram of the laser positioning component according to an embodiment of the present invention;

[0050] Figure 21 This is a schematic diagram illustrating the laser light reflection measurement principle of an embodiment of the present invention;

[0051] Figure 22 This is a schematic diagram of the first pose acquisition unit in an embodiment of the present invention;

[0052] Figure 23 This is a schematic diagram of the second pose acquisition unit according to an embodiment of the present invention;

[0053] Figure 24 This is a schematic diagram of the patient-side control device and support device arranged on the same horizontal plane according to an embodiment of the present invention.

[0054] In the attached image:

[0055] 100-Doctor's terminal control device; 101-Main operator; 102-Imaging equipment; 103-Foot-operated surgical control device;

[0056] 200 - Patient-end control device; 201 - Base; 210 - Robotic arm; 211 - Adjusting arm; 212 - Tool arm; 220 - Instrument; 221 - Surgical instrument; 222 - Endoscope;

[0057] 300-Image trolley; 302-Display device; 400-Support device; 410-Patient; 411-Operating port; 500-Safe area; 510-Operating space; 520-Lesion area; 610-Position sensor; 620-Target; 630-Fiber optic shape sensor;

[0058] 700-Positioning unit; 711-Optical imaging device; 712-Ultrasonic transmitter; 7120-Redundancy solution; 713-Magnetic field generator; 714-Laser; 721-Optical target group; 7210-Optical target; 722-Ultrasonic receiver; 723-Magnetic positioning sensor; 724-Imaging device; 730-Reflector; 800-Control unit; 810-First pose acquisition unit; 820-Second pose acquisition unit; 821-Lifting column; 822-Rotation joint. Detailed Implementation

[0059] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0060] As used in this specification, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature. The term “proximal” generally refers to the end closer to the operator, and the term “distal” generally refers to the end closer to the patient, i.e., closer to the lesion. “One end” and “the other end,” as well as “proximal” and “distal,” generally refer to two corresponding parts, including not only endpoints. The terms “installed,” “connected,” and “joined” should be interpreted broadly; for example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Furthermore, as used herein, the phrase "one element is disposed on another element" generally only indicates a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial relationship between the two elements, meaning one element can be located arbitrarily inside, outside, above, below, or to the side of another element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this specification based on the specific circumstances.

[0061] The purpose of this invention is to provide a method for adjusting the fixed point during surgery, a system for adjusting the fixed point of a support device, a method for adjusting a surgical robot, a readable storage medium, and a surgical robot system, so as to solve the problem that existing surgical robot systems cannot adjust the position of the surgical robot and the patient's position during surgery.

[0062] The following description refers to the accompanying drawings.

[0063] Please refer to Figures 1 to 9 ,in, Figure 1 This is a schematic diagram of a surgical scenario involving the surgical robot system of the present invention; Figure 2 This invention relates to a flowchart of the overall steps of surgical planning; Figure 3 This is a schematic diagram illustrating the establishment of the environmental coordinate system for a surgical scene, as per the present invention. Figure 4a and Figure 4b This is a schematic diagram illustrating the establishment of the surgical scene involved in this invention; Figure 5 This is a schematic diagram of the surgical port creation involved in the present invention; Figure 6 This is a schematic diagram of the patient-side surgical platform involved in the present invention; Figure 7a This is a schematic diagram of establishing a safe zone using a position sensor, which is an invention of the present invention; Figure 7b This is a schematic diagram of the invention relating to establishing a security area using an optical fiber shape sensor; Figure 8 This is a schematic diagram of the robot before adaptation, as per the present invention; Figure 9 This is a schematic diagram of the robot after adaptation, as per the present invention.

[0064] Figure 1 An application scenario of a surgical robot system is illustrated. The surgical robot system includes a master-slave teleoperated surgical robot, comprising a doctor-side control device 100, a patient-side control device 200, a main controller 10, and a support device 400 (e.g., an operating table) for supporting the surgical object during surgery. It should be noted that in some embodiments, the support device 400 may be replaced with other surgical operating platforms; this invention is not limited thereto.

[0065] The doctor-end control device 100 is the operating end of the remote-controlled surgical robot and includes a main manipulator 101 mounted thereon. The main manipulator 101 receives hand movement information from the operator as motion control signal input for the entire system. Optionally, the main controller is also located on the doctor-end control device 100. Preferably, the doctor-end control device 100 further includes an imaging device 102, which provides the operator with stereoscopic images and surgical operation information. This surgical operation information includes the type and quantity of surgical instruments, their position in the abdomen, and the morphology and arrangement of the patient's organs, tissues, and surrounding organs and blood vessels. Optionally, the doctor-end control device 100 also includes a foot-operated surgical control device 103, through which the operator can input commands for electrocautery, electrocoagulation, and other related operations.

[0066] The patient-side control device 200 serves as the execution platform for the teleoperated surgical robot and includes a base 201 and surgical execution components mounted thereon. The surgical execution components include a robotic arm 210 and instruments 220. Instruments 220 include surgical instruments 221 for performing the surgery (such as a high-frequency electrosurgical unit) and endoscopes 222 for auxiliary observation. In one embodiment, the robotic arm includes an adjusting arm 211 and a working arm 212. The working arm 212 is a mechanical fixed-point mechanism used to drive the instrument 220 to move around a mechanical fixed point, thereby enabling minimally invasive surgical treatment of the patient 410 on the support device 400. The adjusting arm 211 is used to adjust the position of the mechanical fixed point in the workspace. In another embodiment, the robotic arm 210 is a spatial configuration mechanism with at least six degrees of freedom, used to drive the instrument 220 to move around an active fixed point under program control. The instrument 220 is used to perform specific surgical operations, such as clamping, cutting, and scissing, or to assist in surgery, such as imaging. It should be noted that, since the actual device 220 has a certain volume, the aforementioned "fixed point" should be understood as a stationary region. Of course, those skilled in the art can interpret the "fixed point" based on existing technology.

[0067] The main controller is communicatively connected to both the doctor-side control device 100 and the patient-side control device 200, and is used to control the movement of the surgical execution component based on the movement of the master manipulator 101. Specifically, the main controller includes a master-slave mapping module, which is used to acquire the end effector pose of the master manipulator 101 and a predetermined master-slave mapping relationship, obtain the desired end effector pose of the surgical execution component, and then control the robotic arm 210 to drive the instrument 220 to move to the desired end effector pose. Furthermore, the master-slave mapping module is also used to receive instrument function operation commands (such as electrocautery, electrocoagulation, and other related operation commands), and control the energy driver of the instrument 220 to release energy to perform surgical operations such as electrocautery and electrocoagulation.

[0068] Furthermore, the medical robot system also includes an image carriage 300. The image carriage 300 includes an endoscope processor (not shown) communicatively connected to the endoscope 222. The endoscope 222 is used to acquire surgical operation information within the cavity (referring to the patient's body cavity). The endoscope processor is used to perform image processing on the surgical operation information acquired by the endoscope 222 and transmit it to the imaging device 102 so that the operator can observe the surgical operation information. Optionally, the image carriage 300 also includes a display device 302. The display device 302 is communicatively connected to the endoscope processor and is used to provide real-time display of surgical operation information to the operator (e.g., a nurse).

[0069] During the surgery, the operator (e.g., the primary surgeon) sits in front of the surgeon's end control device 100 located outside the sterile area, observes the surgical operation information transmitted back through the imaging device 102, and controls the surgical execution components and laparoscopic movement by operating the primary operating hand 101 to complete various surgical operations.

[0070] Please refer to the following. Figure 2 The following describes an illustrative application scenario of the surgical robot system involved in this invention. Before adjusting the fixed point or the patient-side control device using the surgical robot system, the following steps may be included:

[0071] Step SO1: Establish the surgical scene and transform the coordinate system of the support device 400 and the surgical robot coordinate system where the robotic arm 210 is located into an environment coordinate system; the poses of the support device 400 and the robotic arm 210 are both expressed based on the environment coordinate system. Please refer to... Figure 3 In one example, an environmental coordinate system (X0, Y0, Z0) can be established for the surgical scene using certain methods. The coordinates of the surgical robot (X1, Y1, Z1) and the support device (X2, Y2, Z2) can then be unified into the environmental coordinate system (X0, Y0, Z0), achieving coordinate unification of the surgical scene and establishing the positional relationship between the support device coordinates and the surgical robot coordinates. This provides a coordinate change relationship for subsequent adjustments to the support device 400 that cause changes in the patient's surgical port position and the position changes of the fixed points of the patient-side control device 200. Establishing the surgical scene is the first step in intraoperative fixed-point adjustment. In one example, the relative positional relationship between the patient-side control device 200 and the support device 400 can be established using a position sensor 610 (e.g., a binocular vision device) and a target 620. The steps for establishing the surgical scene are as follows: Figure 4a As shown, it mainly includes:

[0072] Step SP1: Establishing environmental coordinates. The coordinates (X0, Y0, Z0) of the environment where the patient-end control device 200 and support device 400 are located are established through the position sensor 610, and the coordinates of each system are unified.

[0073] Step SP2: Establishment of patient-end control device coordinates: For surgical robots in which the robotic arm 210 is fixed to the patient-end control device 200, the position sensor 610 identifies the coordinates of the patient-end control device 200 in the environmental coordinate system (X0, Y0, Z0) to determine the position of the patient-end control device 200 in the environmental coordinate system (X0, Y0, Z0), which is then used to further determine the position of the fixed point of the surgical robot system in the environmental coordinate system;

[0074] Step SP3: Establishment of support device coordinates: The position sensor 610 identifies the coordinates of the support device 400 in the environmental coordinate system to determine the position of the support device 400 in the environmental coordinate system. This will be further used to determine the coordinates and path of the positional change of the patient's surgical port when the support device 400 is adjusted.

[0075] Step SP4: Establishing the coordinates of the fixed point: as follows Figure 5 As shown, after the patient 410 is placed on the support device 400 and the surgical hole 411 is established, the position sensor 610 identifies the coordinates of the surgical hole 411 on the patient 410's body surface in the environmental coordinate system to determine the position of the surgical hole 411 in the environmental coordinate system.

[0076] Step SP5: Coordinate unification. After completing the establishment of environmental coordinates in Step SP1, the establishment of patient-end control device coordinates in Step SP2, the establishment of support device coordinates in Step SP3, and the establishment of fixed point coordinates in Step SP4, the coordinate system unification is completed. The coordinates of the patient-end control device 200, support device 400, and the surgical port 411 of the patient 410 are unified, so that intraoperative adjustments can be made under a unified coordinate system.

[0077] Depending on the type of surgical robot, there are different embodiments for establishing environmental coordinates. For example, in another embodiment, the support device 400 is connected to the patient-side control device 200. Figure 6 As shown, a unified patient-side surgical platform is formed. Understandably, at this point, it is not necessary to separately identify the coordinates of the patient-side control device 200 and the support device 400; they are integrated into step SP6: establishing the coordinates of the patient-side surgical platform. The flowchart for establishing the surgical scene is as follows... Figure 4b As shown. Of course, the present invention is not limited to the coordinate identification and establishment methods described above, and those skilled in the art can select other coordinate identification and establishment methods according to actual needs.

[0078] Continue to refer to Figure 2 Step SO2: Drilling. The operator selects the location of the surgical hole according to the location of the lesion and performs the drilling operation.

[0079] Step SO3: Fixed-point identification. After drilling, the surgical incision on the patient is identified using certain technical means to obtain its coordinates in the environmental coordinate system. For example, the position sensor 610 and target 620 can be used to identify the surgical incision coordinates. These surgical incision coordinates are updated as the support device 400 is adjusted. The surgical incision coordinates are matched with the fixed-point coordinates of the patient-side control device 200, and the matching degree is monitored to ensure the matching of the fixed points during the operation, thereby ensuring the safety of the operation.

[0080] Furthermore, to ensure the validity of fixed-point identification, this embodiment provides two different specific identification schemes:

[0081] Fixed point identification scheme one: The fixed point is identified in the environmental coordinate system by the position sensor 610: After the surgical hole 411 is established, the target 620 is used to identify the coordinates of the surgical hole 411. Specifically, the target 620 is connected to the support device 400 system. When the relative position of the patient 410 and the support device 400 remains fixed, the change in the coordinates of the fixed point is only caused by the movement of the support device 400.

[0082] In the second embodiment of fixed point recognition, the position sensor 610 performs real-time recognition of the fixed point in the environmental coordinate system: the recognition target 620 is fixed to the position of the surgical hole 411 of the patient 410 in a certain way (such as by bonding), and the coordinate position of the target 620 in the environmental coordinate system is recognized in real time. The change of the target 620 is caused by the real-time state of the support device 400 and the patient 410, which can more accurately determine the coordinates of the position of the surgical hole 411 of the patient 410.

[0083] Optionally, in some embodiments, step SO4 is further included: establishing a safety area 500. After the patient is fixed to the support device 400, the coordinates of the patient area are established to avoid collisions between the robotic arm 210 and the patient during the operation and intraoperative adjustments, thereby ensuring the patient's safety. Specifically, the establishment of the safety area 500 may include the following steps: Step SO41: obtaining the surface information of a predetermined object (such as the patient 410) placed on the support device 400; Step SO42: establishing the safety area 500 based on the surface information and associating the position information of the safety area 500 with the position information of the support device 400; the pose adjustment of the robotic arm 210 avoids the safety area 500. In practice, the safety area 500 is the area around the patient and a certain range outside the patient's body surface. The robotic arm 210 should avoid the safety area 500 to avoid causing harm to the patient during adjustments.

[0084] Please refer to Figure 7a In an alternative embodiment, the safety zone can be established using a position sensor 610 and a target 620. The method for establishing the safety zone includes: acquiring point cloud data obtained by the position sensor 610 through the contact of the target 620 with the surface of a predetermined object; and fitting the safety zone based on the point cloud data. Please refer to [reference needed]. Figure 7bIn another alternative embodiment, the establishment of the safety area can also be achieved using the fiber optic shape sensor 630. Specifically, the method for establishing the safety area includes: acquiring shape data obtained from the surface covering of a predetermined object using the fiber optic shape sensor 630; and fitting the safety area based on the shape data.

[0085] Step SO5: Fixed point adjustment. During the operation, the fixed points are adjusted to ensure that the operating space of the surgical robot meets the operational requirements.

[0086] Optionally, in some embodiments, step SO6 is also included: robot adaptation. After completing the fixed-point adjustment in step SO5, the robotic arm 210 is adjusted to a suitable pose based on its adjusted pose. Specifically, the robotic arm 210 adjusts its posture to a suitable ideal pose based on the lesion location, fixed-point pose, safe area, and relative position of the robotic arm 210, to facilitate operation. In practice, after the fixed-point adjustment in step SO5 is completed, the current operating posture of the robotic arm 210 may not be in a state that facilitates operation. In this case, such as... Figure 8 and Figure 9 As shown, the robot can undergo adaptation steps, adjusting the robotic arm 210 to a suitable operating position for the instrument 220. Furthermore, after the robotic arm 210 is adjusted to a suitable pose, its current pose can be matched with the control arm (i.e., the main operator 101) of the doctor's control terminal (i.e., the doctor's control device 100), so that the control arm of the doctor's control terminal updates its pose to match the current pose of the robotic arm 210.

[0087] As can be seen from the background description, in a typical surgical robot system, once the fixed point of the surgical robot system is matched with the patient's surgical port, the position of the surgical robot and the patient's position cannot be adjusted further; otherwise, the fixed point's position will shift, causing harm to the patient. Therefore, this invention provides several embodiments to solve the problem of difficulty in adjusting the patient's position during surgery.

[0088] Please refer to Figures 10 to 24 ,in, Figure 10 This is a schematic diagram of a surgical robot system according to an embodiment of the present invention; Figure 11 This is a schematic diagram of the positioning unit including an optical imaging positioning component in an embodiment of the present invention; Figure 12a and Figure 12b This is a schematic diagram of the binocular vision positioning principle according to an embodiment of the present invention; Figure 13 This is a schematic diagram of a distributed optical target group according to an embodiment of the present invention; Figure 14 This is a schematic diagram of an integrated optical target assembly according to an embodiment of the present invention; Figure 15a and Figure 15bThis is a schematic diagram of a positioning unit including an ultrasonic positioning component according to an embodiment of the present invention; Figure 16 This is a schematic diagram of the positioning principle of the ultrasonic positioning component according to an embodiment of the present invention; Figure 17 This is a schematic diagram of a positioning unit including a magnetic field positioning component according to an embodiment of the present invention; Figure 18a and Figure 18b This is a schematic diagram of a positioning unit in an embodiment of the present invention including another magnetic field positioning component; Figure 19a and Figure 19b This is a schematic diagram of a positioning unit including a laser positioning component according to an embodiment of the present invention; Figure 20 This is a schematic diagram of the laser positioning component according to an embodiment of the present invention; Figure 21 This is a schematic diagram illustrating the laser light reflection measurement principle of an embodiment of the present invention; Figure 22 This is a schematic diagram of the first pose acquisition unit in an embodiment of the present invention; Figure 23 This is a schematic diagram of the second pose acquisition unit according to an embodiment of the present invention; Figure 24 This is a schematic diagram of the patient-side control device and support device arranged on the same horizontal plane according to an embodiment of the present invention.

[0089] Please refer to Figure 10 This embodiment provides a fixed-point follow-up adjustment system for a support device, comprising: a positioning unit 700 and a control unit 800; the control unit 800 is communicatively connected to the positioning unit 700, and is used to acquire first pose information of the support device 400 relative to the patient-end control device 200 through the positioning unit 700; the control unit 800 monitors the pose change of the support device 400 relative to the patient-end control device 200 based on the first pose information; wherein the robotic arm 210 of the patient-end control device 200 is used to drive the connected instrument 220 to move through the fixed point; the control unit 800 is configured to control the patient-end control device 200 to perform corresponding movements when it is detected that the pose change of the support device 400 relative to the patient-end control device 200 exceeds a predetermined value, so as to keep the pose of the fixed point relative to the support device 400 unchanged.

[0090] With this configuration, the control unit 800 can detect the relative pose between the support device 400 and the patient-end control device 200 in real time through the positioning unit 700, and control the patient-end control device 200 to make corresponding movements. This ensures that the pose of the fixed point relative to the support device 400 remains unchanged. Without interrupting the surgery, intraoperative positioning adjustments can be made to address situations where the robotic arm's movement space is limited or the surgical port position is not ideal due to the relationship between the current position of the surgical robot and the patient's position. Moreover, the instruments do not need to be removed during adjustments, which can effectively meet various intraoperative positioning needs, improve the efficiency and safety of surgical robot surgery, reduce preoperative preparation time, effectively compensate for the risks and defects of existing surgical perforation operations, improve the precision of surgical operations, reduce patient pain, and improve recovery efficiency.

[0091] Optionally, the first pose information includes the distance between the support device 400 and the patient-end control device 200, and the angle between the support device 400 and the patient-end control device 200. It can be understood that after obtaining the distance and angle between the support device 400 and the patient-end control device 200, the relative pose relationship between the two can be determined, that is, the first pose information is determined.

[0092] Preferably, the positioning unit 700 includes a first end and a second end that are adapted to each other. The first end is used to sense the position of the second end through a predetermined sensing medium. The first end and the second end are disposed on the patient end control device 200 and / or the support device 400 according to the type of the sensing medium.

[0093] Please refer to Figure 11 In an alternative embodiment, the sensing medium is light. The first end includes at least two optical imaging devices 711, and the second end includes an optical target group 721, which includes at least three non-collinear optical targets 7210. The first end is used to be mounted on the patient-side control device 200, and the second end is used to be mounted on the support device 400. The optical imaging device 711 may be an NDI optical measuring instrument, which may be mounted on the base 201 of the patient-side control device 200. The optical target group 721 may be mounted at a specific location on the support device 400. The control unit 800 can obtain the position and orientation between the base 201 of the patient-side control device 200 and the support device 400 through the NDI optical measuring instrument, and thus obtain the coordinates of the support device centered on the coordinates of the patient-side control device 200.

[0094] The optical imaging device 711 utilizes the principle of binocular vision for detection. Please refer to [reference needed]. Figure 12a and Figure 12b ,in Figure 12aThis is a top view of the positioning unit 700. Figure 12b This is a front view of the positioning unit 700, illustrating the principle of binocular vision positioning. Since the two optical imaging devices 711 are fixedly mounted on the patient-side control device 200, the side length a can be considered known. The optical imaging devices 711 can measure the sizes of angles C and B, and the lengths of b and c, thus determining the distance from the optical target 7210 to the optical imaging device 711. Since the optical target 7210 is fixedly mounted on the support device 400, its own coordinates are known. A surface can be determined by three points not on a straight line; therefore, at least three optical targets 7210 can be used to obtain the coordinates of a surface in the coordinate system of the optical imaging device 711.

[0095] Furthermore, the second end includes a plurality of optical target groups 721, each of which is disposed on one side of the support device 400. Please refer to Figure 13 An optical target group 721 is installed on each side of the bed board of the support device 400. Each optical target group 721 comprises N (N≥3) dispersed optical targets 7210, and the N optical targets 7210 in each optical target group 721 are not collinear. The figure shows a case where the optical target group 721 includes four optical targets 7210. The control unit 800 can obtain the distance and orientation of the support device 400 relative to the optical targets 7210 by measuring the distance from the patient-end control device 200 to each optical target 7210.

[0096] Please refer to Figure 14 In the first example, an optical target group 721 is installed on each side of the bed board of the support device 400. The optical target group 721 is an integrated target group, which includes N (N≥3) optical targets 7210 that are not in a straight line. Its application principle is the same as that of the distributed optical targets 7210 mentioned above.

[0097] In the second example, the sensing medium is ultrasound, and the positioning unit 700 includes an ultrasonic positioning component. Please refer to [reference needed]. Figure 15a and Figure 15b ,in Figure 15a This is a top view of the ultrasonic positioning component. Figure 15b This is a front view of the ultrasound positioning assembly. The first end includes at least two ultrasound transmitters 712, and the second end includes at least two ultrasound receivers 722. The first end is configured to be disposed in one of the support device 400 and the patient-end control device 200, and the second end is configured to be disposed in the other of the support device 400 and the patient-end control device 200.

[0098] The following example uses a device where the first end is mounted on the support device 400 and the second end is mounted on the patient-side control device 200. The first end includes two ultrasound transmitters 712, and the second end includes two ultrasound receivers 722. Please refer to the following examples for further details. Figure 16 Explanation:

[0099] Two ultrasonic transmitters 712 are mounted on the support device 400. Each ultrasonic transmitter 712 is communicatively connected to the control unit 800 (e.g., via cable or wireless connection). Under the control of the control unit 800, the ultrasonic transmitters 712 emit ultrasonic waves. Two ultrasonic receivers 722 are mounted on the base 201 of the patient-side control device 200. The ultrasonic receivers 722 are also communicatively connected to the control unit 800. The ultrasonic receivers 722 can receive the ultrasonic waves emitted by the ultrasonic transmitters 712. Therefore, the control unit 800 can determine the transmission time of the ultrasonic waves between the ultrasonic transmitters 712 and the ultrasonic receivers 722, and thus calculate the distance between them. For example, if the time it takes for the ultrasonic transmitter 712 to emit the sound wave is t1, and the time it takes for the ultrasonic receiver 722 to receive the sound wave is t2, then the distance between the ultrasonic transmitter 712 and the ultrasonic receiver 722 is s = 340 * (t2 - t1). Furthermore, by measuring the distance from one ultrasonic transmitter 12 to two ultrasonic receivers 722, a specific distance and shape can be obtained.

[0100] Furthermore, each of the ultrasound receivers 722 is used to receive ultrasound waves emitted by at least two of the ultrasound transmitters 712; the control unit 800 is also used to exclude redundant ultrasound transmitter position information obtained based on the ultrasound receivers 722, according to the position information of the robotic arm 210 of the patient-end control device 200 relative to the support device 400. Please continue to refer to Figure X Based on the ultrasonic waves received by the two ultrasonic receivers 722, two solutions for the actual position of the ultrasonic transmitter 712 can be obtained. These two solutions are axially symmetric about the line connecting the ultrasonic receivers 722. One solution is in front of the patient-end control device 200 (in the same direction as the robotic arm 210), and the other is behind the patient-end control device 200 (in the opposite direction to the robotic arm 210). One of these solutions is redundant, solution 7120. Based on the position information of the robotic arm 210 relative to the support device 400, redundant solution 7120 can be eliminated, and the true position of the ultrasonic transmitter 712 can be obtained. Therefore, the relative pose relationship between the support device 400 and the patient-end control device 200 can be determined.

[0101] Please refer to Figure 17In the third example, the sensing medium is a magnetic field. The first end includes a magnetic field generator 713, and the second end includes a magnetic positioning sensor 723 with at least three degrees of freedom (the magnetic positioning sensor may be a magnetic positioning coil, etc.). The first end is used to be mounted on the patient-side control device 200, and the second end is used to be mounted on the support device 400. The magnetic field generator 713 may be mounted on the surface of the base 201 of the patient-side control device 200. The control unit 800 can obtain the coordinates of the support device 400 in the coordinate system of the patient-side control device by acquiring the attitude information and distance information of the magnetic positioning sensor 723.

[0102] In some embodiments, the magnetic positioning sensor 723 is a 3-DOF coil. The control unit 800 can acquire the X, Y, and Z coordinates of the magnetic positioning sensor 723 to obtain its position information, but it cannot directly obtain the α, β, and γ coordinates of the magnetic positioning sensor 723 and therefore cannot obtain its attitude information. Optionally, the support device 400 also includes a gyroscope, which can acquire the angle information α, β, and γ coordinates of the support device 400. Thus, the control unit 800 can obtain the pose of the support device 400 relative to the patient-end control device 200.

[0103] Preferably, the second end includes a 6-DOF magnetic positioning sensor 723. The control unit 800 can directly obtain the X, Y, Z, α, β, and γ coordinates of the magnetic positioning sensor 723 through the 6-DOF magnetic positioning sensor 723, thereby directly obtaining the pose of the support device 400. Of course, in some embodiments, the α, β, and γ coordinates obtained by the magnetic field generator 713 through the 6-DOF magnetic positioning sensor 723 can also be cross-checked with the α, β, and γ coordinates collected by the gyroscope.

[0104] In the fourth example, the sensing medium is also a magnetic field; please refer to [reference needed]. Figure 18a and Figure 18b ,in Figure 18a A front view of another magnetic field positioning component. Figure 18b This is a perspective view of a magnetic positioning sensor 723 mounted on a support device 400. The first end includes a magnetic field generator 713, and the second end includes at least three magnetic positioning sensors 723 that are not collinear. The first end is used to mount the patient-side control device 200, and the second end is used to mount the support device 400. In one example, the second end includes four magnetic positioning sensors 723, which are respectively positioned at the four corners of the base of the support device 400. Thus, the control unit 800 can obtain the distance between the magnetic field generator 713 and each magnetic positioning sensor 723, thereby obtaining the distance and angle of the support device 400 relative to the patient-side control device 200.

[0105] In the fifth example, the sensing medium is laser, and the positioning unit 700 includes a laser positioning component. Please refer to [reference needed]. Figure 19a , Figure 19b and Figure 20 ,in Figure 19a This is a top view of the laser positioning assembly. Figure 19b This is a front view of the laser positioning assembly. The first end includes a laser 714, and the second end includes an imaging device 724. Both the first and second ends are mounted on the patient-side control device 200, or both are mounted on the support device 400. Both the laser 714 and the imaging device 724 can rotate within a certain angular range. In one example, a laser 714 and an imaging device 724 are mounted on the base 201 of the patient-side control device 200, and the support device 400 reflects the laser emitted by the laser 714. The laser 714 emits pulsed laser light and scans the entire area of ​​the base of the support device 400 by rotation. The imaging device 724 receives the laser light, thereby allowing the control unit 800 to calculate the distance between the two ends of the base of the support device 400, and thus determine the distance and orientation of the support device 400 relative to the patient-side control device 200.

[0106] The following is combined with Figure 21 This section explains the principle of laser reflection measurement. Let the three sides of a triangle be a, b, and c, and its opposite angles be A, B, and C. If the angle B of the laser 714 and the angle A of the imaging device 724 are known, then the angle C is also determined. Since the laser 714 and the imaging device 724 are fixed to the base 201 of the patient-end control device 200, the distance c between them can be considered known. According to the sine theorem: a / sinA = b / sinB = c / sinC, the lengths of a and b can be calculated. Therefore, the distance and angle from the support device 400 to the patient-end control device 200 can be obtained.

[0107] Preferably, the positioning unit 700 further includes a reflector 730, which is disposed on either the patient-side control device 200 or the support device 400 where neither the laser 714 nor the imaging device 724 is disposed, for reflecting the laser emitted by the laser 714. For example, in an exemplary embodiment, both the laser 714 and the imaging device 724 are disposed on the patient-side control device 200, in which case the reflector 730 may be disposed on the support device 400 accordingly.

[0108] Please refer to Figure 22Optionally, the fixed-point follow-up adjustment system of the support device further includes: a first pose acquisition unit 810 communicatively connected to the control unit 800; the first pose acquisition unit 810 is used to acquire the second pose information of the robotic arm 210 of the patient-end control device 200; the control unit 800 obtains the coordinate information of the fixed point in the coordinate system of the patient-end control device based on the second pose information. The first pose acquisition unit 810 may include encoders installed on each joint of the lifting column, suspension plate, adjusting arm, or tool arm of the patient-end control device 200. The encoders can feed back the translation distance information or rotation angle information of each joint motor. Through the information fed back by each encoder, the control unit 800 can obtain the coordinate information of the fixed point in the coordinate system of the patient-end control device. Specifically, the coordinates of the patient-end control device 200 itself are... The coordinates of the fixed point are reached after passing through N joints. Each joint is equipped with an encoder to calculate the translational distance and rotational angle. Based on the DH parameters, the coordinates of the end effector can be obtained.

[0109]

[0110] Please refer to Figure 23 Optionally, the fixed-point follow-up adjustment system of the support device further includes: a second pose acquisition unit 820 communicatively connected to the control unit 800; the second pose acquisition unit 820 is used to acquire the third pose information of the bed board of the support device 400; the control unit obtains the coordinate information of the bed board in the coordinate system of the support device based on the third pose information. Generally, the support device 400 has a lifting column 821 and a rotary joint 822, which are used to control the lifting and rotating of the bed board, respectively. The third pose information includes the lifting height information of the bed board and the rotation angle of the bed board. The bed board can rotate omnidirectionally around the rotary joint 822, such as... Figure 23 As shown. Preferably, the second pose acquisition unit 820 includes an encoder mounted on the lifting column and a gyroscope mounted on the rotary joint. The encoder in the lifting column can provide feedback on the lifting height information of the bed board, and the gyroscope can provide feedback on the rotation angle of the bed board. Then, based on the DH parameters, the coordinates of the bed board in the coordinate system of the support device can be obtained.

[0111] Please refer to Figure 24 Optionally, the patient-end control device 200 and the support device 400 are both set on the same horizontal plane, and their Z-axis coordinates are consistent. Furthermore, as long as the distance information (X-axis coordinate) of the support device 400 relative to the patient-end control device 200 and the angle information (Y-axis coordinate) of the support device 400 relative to the patient-end control device 200 are obtained, the coordinates of the support device coordinate system under the patient-end control device coordinate system can be obtained.

[0112] Based on the aforementioned fixed-point follow-up adjustment system for the support device, this embodiment also provides a surgical robot system, which includes: a support device 400, a patient-end control device 200, and the fixed-point follow-up adjustment system for the support device as described above; the fixed-point follow-up adjustment system for the support device is used to control the movement of the patient-end control device 200 so that the pose of the fixed point relative to the support device 400 remains unchanged.

[0113] It should be noted that the above-described embodiments are not limited to individual use, but can be combined with each other, and the present invention is not limited in this respect. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the claims.

Claims

1. A system for adjusting the fixed point of a support device, characterized in that, include: Positioning unit and control unit; The positioning unit includes a first end and a second end that are adapted to each other. The first end is used to sense the position of the second end through a predetermined sensing medium. The first end and the second end are disposed on the patient end control device and / or the support device according to the type of the sensing medium, so as to obtain the first pose information of the support device relative to the patient end control device. The control unit is communicatively connected to the positioning unit, and the control unit is used to obtain the first position information of the support device relative to the patient-end control device through the positioning unit. The control unit monitors the positional changes of the support device relative to the patient-end control device based on the first positional information; wherein the robotic arm of the patient-end control device is used to drive the connected instrument to move through a fixed point. The control unit is configured to control the patient-end control device to make corresponding movements when it is detected that the pose change exceeds a predetermined value, so that the pose of the fixed point relative to the support device remains unchanged.

2. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first pose information includes the distance of the support device relative to the patient-end control device, and the angle of the support device relative to the patient-end control device.

3. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The fixed point follow-up adjustment system of the support device further includes: a first pose acquisition unit that is communicatively connected to the control unit; the first pose acquisition unit is used to acquire the second pose information of the robotic arm of the patient end control device; the control unit obtains the coordinate information of the fixed point in the coordinate system of the patient end control device based on the second pose information.

4. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The fixed point follow-up adjustment system of the support device further includes: a second pose acquisition unit that is communicatively connected to the control unit; the second pose acquisition unit is used to acquire the third pose information of the bed board of the support device; the control unit obtains the coordinate information of the bed board in the coordinate system of the support device based on the third pose information.

5. The fixed-point follow-up adjustment system for the support device according to claim 4, characterized in that, The third pose information includes the lifting height information of the bed board and the rotation angle of the bed board; the second pose acquisition unit includes an encoder installed on the lifting column and a gyroscope installed on the rotating joint. The encoder is used to feed back the lifting height information of the bed board, and the gyroscope is used to feed back the rotation angle of the bed board.

6. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first end includes at least two optical imaging devices, and the second end includes an optical target group, which includes at least three non-collinear optical targets. The first end is used to be mounted on the patient-end control device, and the second end is used to be mounted on the support device.

7. The fixed-point follow-up adjustment system for the support device according to claim 6, characterized in that, The second end includes multiple optical target groups, each of which is disposed on one side of the support device.

8. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first end includes at least two ultrasound transmitters, and the second end includes at least two ultrasound receivers. The first end is configured to be disposed in one of the support device and the patient-end control device, and the second end is configured to be disposed in the other of the support device and the patient-end control device.

9. The fixed-point follow-up adjustment system for the support device according to claim 8, characterized in that, Each of the ultrasound receivers is used to receive ultrasound waves emitted by at least two of the ultrasound transmitters; the control unit is also used to exclude redundant position information of the ultrasound transmitters obtained based on the ultrasound receivers, according to the position information of the robotic arm of the patient-end control device relative to the support device.

10. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first end includes a magnetic field generator, and the second end includes a magnetic positioning sensor with at least 3 degrees of freedom. The first end is used to be mounted on the patient-side control device, and the second end is used to be mounted on the support device.

11. The fixed-point follow-up adjustment system for the support device according to claim 10, characterized in that, The second end includes a 6-DOF magnetic positioning sensor.

12. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first end includes a magnetic field generator, and the second end includes at least three magnetic positioning sensors that are not on the same straight line. The first end is used to be mounted on the patient end control device, and the second end is used to be mounted on the support device.

13. The fixed-point follow-up adjustment system for the support device according to claim 1, characterized in that, The first end includes a laser, and the second end includes an imaging device. Both the first end and the second end are used to be mounted on the patient-side control device, or both the first end and the second end are used to be mounted on the support device.

14. The fixed-point follow-up adjustment system for the support device according to claim 13, characterized in that, The positioning unit further includes a reflector plate, which is disposed on one of the patient-end control device and the support device that does not have the laser and the imaging device, and is used to reflect the laser emitted by the laser.

15. A surgical robot system, characterized in that, include: Support device, patient end control device, and support device fixed point follow-up adjustment system according to any one of claims 1 to 14; The fixed point follow-up adjustment system of the support device is used to control the movement of the patient end control device so that the position of the fixed point relative to the support device remains unchanged.

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