RU2844250C2 - Robotic medical system for performing neurosurgical operations on spine - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical equipment, specifically to a robotic medical system for performing neurosurgical operations on the spine, a rotary locking unit, a locking manipulator with a manual movement principle, a set of surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system and a method for navigating the working member of a robotic medical system. Robotic medical system consists of a rotational fixing assembly, a fixing manipulator with a manual principle of movement and a set of surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system. Rotary fixing unit is configured to fix its output link with the movable rail base of the fixing manipulator with a manual displacement principle and has an automatically controlled brake and a manual locking eccentric clamp made with possibility of actuation by means of mechanical detachable handle. Fixing manipulator with manual principle of movement consists of four in-series connected to each other by means of links rotational fixing units seven basing holes in form of cone, four threaded holes and split elastic clamp. Kit consists of a surgical wireless device, mounts with integrated spherical markers of a stereophotogrammetric measuring system. Method involves preoperative planning of transpedicular screw trajectories and tying 3D vertebral models to the actual spatial position of the vertebrae. Method comprises initialising axis of working element with a needle probe and performing installation of wireless surgical device with working element by means of split elastic clamp. Method comprises a process of obtaining information on progress of surgical manipulations and performing intraoperative navigation of surgical instruments by means of a volumetric target, which visualizes the position coordinates of the end point of the surgical instruments with fasteners, having spherical markers of the stereophotogrammetric measuring system.

EFFECT: possibility to perform navigation of surgical instruments by means of working element installed on fixing manipulator with manual principle of movement, and stereophotogrammetric system in accordance with proposed method.

5 cl, 38 dwg

Description

Field of technology

The group of inventions relates to the field of medical engineering, namely medical equipment for performing neurosurgical operations on the spine, namely to robotic medical systems for operations on transpedicular fixation of vertebrae. The system is applicable for operations with an open surgical field and has the ability to perform the following surgical manipulations: initialize holes in the vertebrae with an awl, cut threaded channels in the pedicles of the vertebrae using transpedicular taps and screw transpedicular screws into these channels. These surgical manipulations are performed with intraoperative navigation of surgical instruments and are carried out under the control of a stereophotogrammetric system with fixation of the input direction using a working element mounted on a fixing manipulator with a manual movement principle. The robotic medical system has the ability to analyze the course of surgical manipulations with their graphic visualization. Before operating the robotic medical system, information software is used for preoperative planning. The operation of all parts of the system occurs in accordance with the proposed method.

State of the art

Transpedicular fixation of the spine is a surgical operation aimed at fixing the vertebrae relative to each other in a certain position using metal structures in the form of rods and transpedicular screws. Spinal surgeries that include the installation of screws require the preparation of holes in the vertebrae before installing the screws and ensuring a given trajectory when screwing them in. In some embodiments of such operations, preoperative planning is used with the help of computed tomography (DICOM file), based on which the surgeon determines the trajectory of insertion of the surgical instrument. Navigation methods such as fluoroscopy, 3D fluoroscopy or methods based on natural landmarks can also be used. The success of transpedicular fixation largely depends on the experience of the surgeon. Errors in the location of screws when installing them in the vertebrae are a known problem in such surgeries.

It is known to use robotic medical systems in surgery to improve the accuracy of surgical manipulations, reduce the duration of the operation and reduce the traumatic impact on tissues located inside the surgical field. Robotic medical systems can include: manipulators that provide navigation and positioning of surgical instruments; specialized working bodies used to fix surgical instruments; software for intraoperative navigation and control systems for the components of the robotic medical system. Therefore, a robotic medical system is a group of inventions that includes several components. Robotic medical systems are known in which the surgeon is required to direct the robot to the desired trajectory in the surgical field using images displayed on a two-dimensional screen, with subsequent manipulations with surgical instruments. Such systems are controlled in a certain way, since the surgeon must simultaneously compare the trajectory of the surgical instrument on the surgical field and on the screen during the operation to confirm their compliance.

Among the components of robotic medical systems, patents for rotary electromechanical units of manipulators are known:

A patent for an electromechanical unit containing a wave reducer, a motor and a rotation angle sensor is known, described in CN 210361380 U. The design feature of the unit is the presence of a hollow through shaft, through which hidden installation of the manipulator wires can be carried out. The disadvantage of this solution is the lack of an automatically controlled brake, which, by applying voltage, brakes the output link of the manipulator unit during its manual movement. Another disadvantage is the lack of the ability to move the output link of the manipulator unit manually.

A patent for an electromechanical unit with a wave reducer, which can be used in the design of multi-link robotic devices, is known, described in RU 94776 U1, with the ability to install an output flange on the end of the housing of the moving part of the module, and an input flange on the end of the housing of the fixed part of the module. The disadvantage of this solution is the absence of such design elements as an automatically controlled brake and a manual locking eccentric clamp. Another disadvantage is the lack of the ability to two-stage adjustable stop, carried out by sequentially using 2 sequentially switched on systems - an automatically controlled brake and a manual locking eccentric clamp, which can cause emergency situations due to untimely stopping of the output flange. The presence of a motor makes the module automatically movable, which creates additional risks associated with the likelihood of a failure in the module control system.

A patent for an electromechanical unit for a robot is known, described in EP 3045273 B1, with the ability to attach links to the output flange without using auxiliary parts and a safe normally closed braking device. The disadvantage of this solution is the use of a safety friction spring brake, which stops the link when the power is turned off, but does not participate in the positioning of the link due to braking using a ratchet mechanism, which has a high positioning error due to its design. Another disadvantage is the lack of an eccentric clamp capable of fixing the output flange using a manual stopper with a load value for the braking moment of up to 150 N * m.

Among the components of robotic medical systems, patents for manipulators for use in surgery are known:

A portal-type manipulator for navigating surgical instruments during spinal surgeries is known, described in CN 110251234 A. The design feature is a closed kinematic structure of the manipulator, which moves along the surgical table. The disadvantage of the existing solution is the lack of rotary locking units, allowing the fixation of the manipulator links in a given position.

A manipulator is known, which is part of a robotic medical system with intraoperative navigation of surgical instruments based on data on the position and movement of the working element, described in CN 101160104 A. The scope of this medical robotic system is knee joint surgery, not spinal surgery. The disadvantage of the existing solution is the use of a counterweight system on the manipulator, due to which the system can obscure part of the surgeon's field of vision and block areas around the operating table. Another disadvantage is the presence of motors in the manipulator design, rather than its manual movement by the surgeon, the automatic movement of the manipulator increases the likelihood of error during surgical operations.

A manipulator is known, which is part of a universal surgical robot, described in RU 2760468 C1. A distinctive feature of this surgical robot is its use for interventional angiographic surgery and interventional therapeutic surgery. The disadvantage of the existing solution is the lack of the ability to adjust the height of the manipulator stand above the base for a convenient location of the working element, due to which it is possible to position patients with different torso thicknesses. Another disadvantage of the system is the lack of rotary locking units, sequentially connected to each other by means of links.

Among the components of robotic medical systems, patents for manipulator control systems are known:

A surgical robot control system is known, described in WO 2021198661 A2. A feature of this solution is the presence in the control system of the ability to control the position of the manipulator based on data from force and torque sensors installed in the rotary fixing units, which allows compensating for force and torque loads applied to the manipulator from the outside. The disadvantage of such a solution is the lack of the ability to move the manipulator with switching power between electromechanical units using a power redistribution element. The presence of such an element in the control system allows switching power between automatically controlled brakes of the rotary fixing units and minimizes the amount of energy consumed.

Among the components of robotic medical systems, patents are known for surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system:

A mount with spherical markers for a surgical awl, tap, screwdriver is known, described in US 6021343. The product is an adapter with a mount equipped with spherical markers. On both ends of the adapter there are projections or holes of a square shape for positioning the mount and the surgical instrument. It is possible to quickly change the surgical instrument directly during the operation. The disadvantage of such a solution is the lack of the ability to attach a surgical wireless device that allows collecting intraoperative data on the forces and moments that arise during the interaction of surgical instruments with the operated tissues of the spine, as well as the lack of fasteners with integrated spherical markers for surgical instruments, such as a needle probe and an elastic clamp, allowing the binding of a 3D model of a vertebra to its actual position, as well as the lack of fasteners with integrated spherical markers for a set of instruments to a surgical wireless device, such as a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw.

A patent for a spring mount with spherical markers to a cylindrical surface of a surgical instrument is known, described in US 11644053 B2. The solution features the use of a mount with various surgical instruments. The disadvantage of the solution is the presence of a large number of moving parts, which negatively affects the reliability of the structure. Another disadvantage is the lack of additional mounts in the form of a parallelepiped with holes for a neurosurgical drill and a trapezoidal prism for a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw for calibrating the orientation parameters of surgical instruments in the 3D space of a robotic medical system.

Among the components of robotic medical systems, patents are known for working elements for use in surgery with attachment to a manipulator:

A medical working element for use together with a robotic medical system is known, described in EP 3344179 B1. A feature of this design is the described possibility of embedding a surgical instrument position sensor directly into the working element. A disadvantage of the existing solution is the need to replace the working element directly during the operation, which negatively affects the accuracy of positioning of surgical instruments.

A medical working element for robotic surgical systems is known, which can be used as a guide for various surgical instruments, described in EP 3351202 A1. A feature of this guide for surgical instruments is the possibility of its direct attachment to the output flange of the manipulator of the robotic surgical system or connection to it through an intermediate handle. A disadvantage of the existing solution is the need to use non-standard elongated versions of surgical instruments and cannulas, as well as the lack of locating holes in the form of a cone, allowing the binding of the mathematical axis for guiding the movement of surgical instruments of the working element to its actual location in the space of the working area of the manipulator.

A patent for a working element in the form of an autonomous mobile module of a robotic surgical instrument is known, described in RU 2715684 C1. A special feature of this working element is the use of a parallel kinematics mechanism in its design. This system is intended for use in areas of surgery, such as endoscopic and open surgery, as well as microsurgery and neurosurgery. The disadvantage of the existing solution is the large mass of the system, which leads to the need to use more load-bearing and massive models of manipulators for its installation. Another disadvantage of this system is the lack of a bicomponent sensor that determines the forces and moments applied to the working element during surgical manipulations.

A patent is known for a working element with a limitation of vertical movement of a surgical instrument and the ability to extract a surgical instrument from a holder with a small force, described in US 20140066944 A1. The disadvantage of the existing solution is the impossibility of its use in conjunction with a mount with spherical markers and a stereophotogrammetric system, which increases the positioning error and makes it impossible to navigate a number of surgical instruments necessary for transpedicular fixation of the spine. Another disadvantage is the lack of threaded holes for installing the handle in a position convenient for the surgeon to move the links of the manipulator in which the working element is installed.

A working element for a robotic medical system is known, described in US 20230013550 A1, which can work with various surgical instruments. This system is capable of independently determining the surgical instrument installed in it. The disadvantage of this solution is the lack of a split elastic clamp used as a guide with the ability to clamp the bushings installed on the surgical instruments used, which leads to the occurrence of a gap between the surface of the surgical instrument and the inner surface of the cannula, thereby complicating the positioning of the surgical instrument along the required trajectory.

Among the components of robotic medical systems, patents are known for methods of navigation of surgical instruments and software for robotic medical systems. Basically, such methods are described together with descriptions of systems for surgical navigation:

A surgical navigation system described in RU 2019143439 A is known, including a device for spatial orientation of a surgical instrument for surgical navigation. This system provides increased accuracy of surgical navigation and micromanipulations, as well as a reduction in the operation time. The disadvantage of this solution is the impossibility of using the navigation system within the robotic medical system due to the lack of binding of 3D models of vertebrae to the actual position of the vertebrae in space, which is carried out by measuring the coordinates of spherical markers with a stereophotogrammetric measuring system. Another disadvantage is the lack of preoperative planning of pedicle screw insertion trajectories with volumetric visualization of the patient's vertebrae, with the possibility of their free orientation in 3D space and the ability to visually adjust the location of sections on 3D models of the vertebrae.

A system for surgical navigation is known, described in EP 1743591 A2, which includes a non-invasive device and/or an invasive marker, which is taken as a reference point on the patient's body. Navigation is carried out using surgical instruments with sensor tips. The disadvantage of this solution is the lack of a method for intraoperative navigation of surgical instruments using a volumetric target visualizing the coordinates of the position of the end point of surgical instruments with fasteners having spherical markers of a stereophotogrammetric measuring system.

Surgical navigation software is known, described in the framework of patent US 20190021795 A1 for a robotic surgical system. This system consists of a computer for planning a surgical operation, connected to a fluoroscopic device and a stereophotogrammetric system for tracking markers. The disadvantage of this solution is the lack of a surgical wireless device with a working element with the ability to obtain information on the progress of the surgical manipulation being performed for subsequent presentation of this information to the surgeon for intraoperative analysis. Another disadvantage is the impossibility of implementing a two-stage adjustable stop of the manual fixing manipulator in a given direction.

A system and method for controlling and navigating a surgical robot are known, described in WO 2023038906 A1. A feature of this system is the correction of the position of the surgical robot in response to the detection of patient movement using tracking methods based on a stereophotogrammetric system and data obtained from sensors. The disadvantage of this solution is the lack of a needle probe for initializing the axis of the working element, which determines the course of surgical manipulations and the trajectory of insertion of surgical instruments in a robotic medical system. The ability to use a needle probe allows for more accurate binding of the patient's vertebrae to their three-dimensional models.

Among the components of robotic medical systems, patents are known for robotic medical systems for performing neurosurgical operations on the spine:

A robotic medical system for minimally invasive transpedicular fixation is known, described in work EP 3258872 B1. The disadvantage of this type of robotic medical system is the principle of interaction with the patient. The working element of the manipulator is in direct contact with soft tissues during the operation. The disadvantage of this configuration is the inability to resist in the event of an emergency situation associated with jamming of the hinges of the manipulator. In this case, it becomes impossible to pull the working element of the manipulator out of the operating area. This is due to the fact that the working element is an expander-guide, which is placed inside the patient's body and is rigidly connected to the structure of the output flange of the manipulator. As a result, the safety of the robotic medical system is reduced. Another disadvantage is the lack of an information software module for analyzing the progress of the surgical manipulation of screwing in transpedicular screws, graphically visualizing information about the progress of this process to the doctor on the screen.

A robotic system for positioning a surgical instrument using feedback is known, described in EP 3824839 A1, a feature of this system is the automatic alignment of the trajectory of the surgical instrument. A distinctive feature of this system is the presence of two linear degrees of mobility. The disadvantage of this solution is the lack of a surgical wireless device that provides the surgeon with information on the forces and moments that arise during transpedicular fixation for intraoperative analysis.

A robotic medical system for minimally invasive surgery is known, described in RU 2412799 C2. This system is intended for use in areas of surgery, such as laparoscopy in urology, gynecology and cardiology. This system is not suitable for transpedicular fixation of the spine. The disadvantage of this solution is the automatic movement of the manipulator links, which, as opposed to manual, increases the likelihood of error and reduces the safety of the system during surgical operations, as well as the lack of fasteners with spherical markers on surgical instruments, which does not allow binding the 3D model of the operated part to its actual position.

The patent US 20190021795 A1 was chosen as the closest analogue (prototype). This robotic medical system consists of a computer for planning a surgical operation connected to an fluoroscopic device, a stereophotogrammetric system for tracking markers and a robot. The disadvantage of the prototype when performing neurosurgical operations on the spine is the use of a set of surgical instruments made specifically for work with a specific robotic medical system, the installation of a Shantz screw for attaching one of the optical markers, the use of a cannula as a guide, which leads to a gap that complicates the positioning of the surgical instrument along the required trajectory. Also, the disadvantage of the prototype is the lack of a manual fixing manipulator based on rotary fixing units with a control system that performs a two-stage adjustable stop of the working element with its fixation within the selected direction in accordance with the navigation method and the lack of intraoperative navigation of surgical instruments, including a software module for collecting coordinates of vertebral surface points.

Disclosure of the essence of the invention

The group of inventions under consideration constitutes a robotic medical system for neurosurgical operations on the spine. The system includes a fixing manipulator with a manual movement principle based on rotary fixing units with a two-stage adjustable stop function. The presence of a fixing manipulator with a manual movement principle allows for increasing the accuracy of positioning surgical instruments and reducing the time of performing a surgical operation compared to operations without using a robotic medical system. On the output flange of the fixing manipulator with a manual movement principle, a working element with a split elastic clamp is installed, used as a guide with the ability to clamp bushings installed on surgical instruments used in the robotic medical system. The fixing manipulator with a manual movement principle interacts with a stereophotogrammetric system that performs intraoperative navigation of surgical instruments, as well as with information software for preoperative planning and performing surgical operations on the spine. The use of information software for preoperative planning and intraoperative navigation of surgical instruments, including information software modules for operating room equipment control, for collecting coordinates of vertebral surface points and for planning and navigation in spinal neurosurgery, helps the surgeon obtain more complete information about the progress of the surgical operation, which allows for faster decision-making and more accurate prediction of the response to the surgical manipulations being performed.

The technical result consists in the possibility of navigating surgical instruments using a working element mounted on a fixing manipulator with a manual movement principle and a stereophotogrammetric system in accordance with the proposed method. The proposed robotic medical system is aimed at performing surgical operations on transpedicular fixation of vertebrae with an open surgical field. Surgical operations include the following set of surgical manipulations: initialization of the opening in the vertebrae with an awl, cutting threaded channels in the pedicles of the vertebrae using transpedicular taps and screwing transpedicular screws into these channels.

The claimed technical solution, unlike the closest prototype, allows using a set of surgical instruments similar to those used in standard surgical operations on the spine without using a robotic medical system. Due to this, the surgeon has the opportunity to perform an operation both using a robotic medical system and simply using a set of surgical instruments. Also, the claimed robotic medical system allows not to use a Schantz screw for attaching an optical marker, which reduces trauma during surgical manipulations. The design of the fixing manipulator with a manual movement principle does not contain engines, but is moved manually by the surgeon, which increases the safety of work during surgical operations on the spine, eliminating all possible errors associated with the automatic movement of the robot. The fixing manipulator with a manual movement principle is equipped with rotary locking units that ensure holding and fixing its links in a given position. Also, the information software module for analyzing the progress of a surgical operation graphically visualizes information to the surgeon about the force and torque loads that arise during various surgical manipulations.

Brief description of the drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the foregoing general description of the invention and the following detailed description of embodiments, serve to explain the features of the present invention. In the drawings, like reference numerals are used to designate like parts or structural elements.

Fig. 1 shows a general view of the operating room, which houses a robotic medical system for performing neurosurgical operations on the spine.

Fig. 2 shows the design and main components of a fixing manipulator with a manual movement principle based on rotary fixing units with a two-stage adjustable stop function.

Fig. 3A shows a general view of a rotary locking unit with a two-stage adjustable stop function for the first axis.

Fig. 3B shows a general view of the rotary locking unit with the function of a two-stage adjustable stop of the second axis.

Fig. 3B shows a general view of a rotary locking unit with a two-stage adjustable stop function for the third axis.

Fig. 3G shows a general view of the rotary locking unit with the function of a two-stage adjustable stop of the fourth axis.

Fig. 4 shows a general view of the design of the lifting mechanism and the axis of the first link.

Fig. 5 shows a general view of the design of the second axle link.

Fig. 6 shows a general view of the design of the third axle link.

Fig. 7 shows a general view of the design of the fourth axle link.

Fig. 8 shows a general view of the design of the working element of a robotic medical system with a split elastic clamp.

Fig. 9 shows a general view of the design of the working element of a robotic medical system with a built-in multi-component force-torque sensor.

Fig. 10 shows the external appearance of the control system rack of the robotic medical system based on the power redistribution element between automatically controlled brakes.

Fig. 11 shows a diagram of the electronic units of the control system.

Fig. 12 shows a diagram of the control system of the electronic power redistribution unit.

Fig. 13 shows a set of surgical instruments with integrated spherical markers.

Fig. 14 shows the design of a needle probe with integrated spherical markers.

Fig. 15 shows the design of an elastic clamp with integrated spherical markers.

Fig. 16 shows the components for calibrating the orientation of surgical instruments and the method of using them.

Fig. 17 shows the patient data editing tab of the robotic medical system information software.

Fig. 18 shows images of the patient model using different lighting patterns for the vertebrae (left - only color, right - Phong lighting).

Fig. 19 shows the screw insertion trajectory planning tab in the robotic medical system information software.

Fig. 20 shows the screw insertion trajectory planning tab with additional control elements in the information software of the robotic medical system.

Fig. 21 shows the tab for preparing the surfaces of the 3D model of the vertebra for binding in the information software of the robotic medical system.

Fig. 22 shows the tab for performing calibration and checking the position of the tip of the surgical instrument in the information software of the robotic medical system.

Fig. 23 shows the tab for performing calibration and checking the orientation of the surgical instrument axis in the information software of the robotic medical system.

Fig. 24 shows the virtual scene tab in the information software of the robotic medical system.

Fig. 25 shows a method for using a needle probe for attachment to a patient's vertebra.

Fig. 26 shows the algorithm for using a needle probe for attachment to the patient's vertebra.

Fig. 27 shows the algorithm for bringing together the measured points of the vertebra with the surfaces of its three-dimensional model.

Fig. 28 shows a method for attaching the working element of a robotic medical system.

Fig. 29 shows an algorithm for using a needle probe to attach the working element of a robotic medical system.

Fig. 30 shows a method for guiding the axis of the working element of a robotic medical system to the planned trajectory of insertion of surgical instruments into the patient's vertebra.

Fig. 31 shows a graph of the movement of a link of a fixing manipulator with a manual principle of movement at a given angle.

Fig. 32 shows a method for using a surgical wireless device with a surgical instrument, installing it in the working element of the surgical wireless device using a split clamp.

Fig. 33 shows the process of obtaining information about the progress of the surgical manipulation being performed for subsequent presentation of this information to the doctor for intraoperative analysis.

Fig. 34 shows the intraoperative navigation tab in the information software of the robotic medical system.

Fig. 35 shows an analysis of the progress of the surgical manipulation of screwing in transpedicular screws, graphically visualizing information about the progress of this process to the doctor on the screen.

Designations

1 Fixing manipulator with manual movement principle

2 Working body

3 Stereophotogrammetric system

4 Control system

5 Set of surgical instruments

6 Patient

7 Operating table

8 Surgeon

9 Movable rail base of the fixing manipulator with manual movement principle

10 First flange

11 Automatically controlled brake

12 Shaft of the rotary braking locking unit

13 Automatically controlled brake plate

14 Automatically controlled brake

15 Rotary locking unit housing with two-stage adjustable stop function

16 Adjusting nut

17 Eccentric eye

18 Eccentric

19 Eccentric handle

20 Adapter for rotary eccentric handle

21 Sterile cover for fixing manipulator with manual movement principle

22 Handle locking element

23 Coupling

24 Compression spring

25 Metal ball

26 Tapered thrust bearing

27 Transition flange

28 Cylindrical part with window

29 Thrust ball bearing

30 Bearing cover of the first axis rotary locking unit

31 Lifting mechanism housing

32 Output flange of the first axis locking rotary unit

33 Lifting mechanism housing cover

34 Lead screw

35 Cylindrical guide

36 Chassis platform

37 Guide support

38 Support with bearings

39 Trapezoidal nut

40 Ball bushing with flange

41 Flywheel

42 Handwheel handle

43 Lower element of the running cylinder

44 Upper element of the running cylinder

45 Locking screw

46 Housing element of the second axle locking link

47 Corner stiffener

48 Cover of the element of the fixing link of the second axle

49 Bearing cover of the second axis rotary locking unit

50 Third axle link plate

51 Output flange of the second axis rotary locking unit

52 Third axle link housing

53 Mounting plate for installing the rotary locking unit

54 Mounting plate for installation of automatically controlled brake

55 Bearing cover of the third axis rotating locking unit

56 Auxiliary shaft

57 Fourth Axis Link Plate

58 Output flange of the third axis rotary locking unit

59 Faceplate Mounting Plate

60 End Mounting Plate

61 Bearing cover of the fourth axis rotary locking unit

62 Output flange of the fourth axis rotary locking unit

63 Force-torque sensor

64 Working element flange

65 Ball joint

66 Flag clamping mechanism

67 Transition platform

68 Split elastic clamp

69 Bushing of working surgical instrument

70 Gap adjustment screw

71 Mount with spherical markers

72 Fastening clamp

73 Manipulation handle

74 Adapter plate for sensor to fixing manipulator with manual movement principle

75 Adapter plate of the sensor to the working element

76 Needle probe

77 Control computer

78 Electronic power redistribution unit

79 Socket block

80 Rack

81 External power supply network

82 Ethernet Local Area Network

83 Interface devices

84 External power supply network

85 Electronic block input voltage converter

86 Electronic power supply for a single-board computer

87 External control device

88 Single board computer

89 Speaker

90 Interfacing electronic indicator unit

91 Electronic indicator units

92 Electronic unit for supplying analog signals

93 Power Line Matrix Switch

94 Electronic unit low voltage converter

95 Tap for performing surgical manipulations for transpedicular fixation of the spine.

96 Awl for performing surgical manipulations for transpedicular fixation of the spine.

97 Transpedicular screwdriver with transpedicular screw for performing surgical manipulations on transpedicular fixation of the spine.

98 Base for clamping a tap and awl mount, for fixing the mount with spherical markers.

99 Tap and awl mounting clamp, for fixing the mounting with spherical markers.

100 Base for clamping mount of transpedicular screwdriver, for fixing mount with spherical markers.

101 Pedicle screwdriver mounting clamp, for fixing the mount with spherical markers.

102 Fixed mount with spherical markers.

103 Screws for installing the mounting clamp with spherical markers.

104 Nuts for installing the fastening clamp with spherical markers.

105 Screw for fixing the mount with spherical markers.

106 Needle probe handle.

107 Fastening the needle probe.

108 Needle probe clamping screw.

109 Screw for fixing the mount with spherical markers on the needle probe.

110 Disposable medical needle.

111 Elastic clamp.

112 Elastic clamp handles.

113 Special mount with spherical markers for elastic clamping.

114 Screws for special fastening to elastic clamp.

115 Nuts for special fastening to elastic clamp.

116 Trapezoidal prism for calibration of orientation of hand surgical instrument.

117 Parallelepiped with standardized holes for calibrating the orientation of a surgical drill.

118 Reference (fixed) mount with spherical markers.

119 Surgical drill, for use with a surgical drill.

120 Screws for fixing the calibration part to the reference mount.

121 Nuts for fixing the calibration part to the reference mount.

122 Fastening with spherical markers on the working element.

123 Special attachment with spherical markers on the patient's vertebra.

124 Input point of the axis of the working element of the robotic medical system

125 Output point of the axis of the working element of the robotic medical system

126 Point of entry of the surgical instrument into the vertebra

127 Target point for insertion of pedicle screw in the vertebral body

128 Clicking the button to start the vertebra binding process in the control interface

129 Sound signal about the beginning of the process of collecting coordinates of the vertebral points

130 Moving the tip of a medical needle, mounted on a needle probe, to a pre-planned area of the vertebral surface

131 Checking the distance to the previously recorded point

132 Checking the immobility of the needle tip for two seconds

133 Sound signal about successful recording of coordinates of the current point of the vertebral surface

134 Point and Surface Counter

135 Sound signal about successful recording of coordinates of all points on the current surface

136 Checking whether the number of recorded points corresponds to the planned one

137 Sound signal about successful completion of the process of collecting coordinates of the vertebral surface points

138 Reconciliation of the position and orientation of a real vertebra and its 3D model

139 Checking the binding results

140 Clicking on the button to start the binding process of the working element in the control interface

141 Sound signal about the beginning of the process of binding the working element

142 Moving the tip of a medical needle mounted on a needle probe into a calibration well on the surface of the working element

143 Sound signal about successful recording of coordinates of the current point on the surface of the working element

144 Sound signal about successful completion of the process of collecting coordinates of the working element surface points

145 Calculation of the orientation of the axis of the working element of a medical manipulation robot in information software with data output to the control interface

146 Surgical Wireless Device

147 Log file with data

148 Information software interface

149 Patient's full name input field

150 Button for loading session data (if the patient is in the patient database (PD)) or creating a new patient

151 Button for saving active session data in the patient database (PD);

152 Button to center the right view camera on the center of the loaded DICOM file

153 Path to the directory containing the DICOM file with the spine image

154 Edit button for the transfer function for the spine DICOM file

155 Spine DICOM file display size controls

156 Name of the first vertebra

157 Path to the STL file of the first vertebra model

158 Path to the directory containing the DICOM file with the image of the first vertebra

159 Edit button for the transfer function for the first vertebra DICOM file

160 Visualization of all DICOM files related to a patient

161 Go to the previous tab

162 Go to the next tab

163 Tab with logs of the information software of the robotic medical system

164 Robotic Medical System Information Software Connections Tab

165 Patient data tab of robotic medical system information software

166 Robotic Medical System Information Software Operation Planning Tab

167 Tab preparation of surfaces of 3D model of vertebra for binding of information software of robotic medical system

168 Virtual scene tab of robotic medical system information software

169 Intraoperative navigation tab of the information software of the robotic medical system

170 Combo list used to select the active vertebra

171 "Focus view" button - allows you to reset the position of the cameras, placing the vertebrae in the center of the views

172 DicomTF - transfer function editor for a 3D voxel model of a vertebra.

173 SliceTF - transfer function editor for 2D projection of a vertebra onto a slice plane

174 SlicePosition - editor of the center point of the spatial position of the slice plane.

175 SliceNormal - editor of the normal vector of the slice plane.

176 Control points visible - allows you to hide/show controls for path points

177 Middle point visible - allows you to hide/show the control for the entire middle point of the path

178 Show screw - allows you to hide / show the 3D model of the screw

179 Point in - coordinates of the starting point of the screw insertion trajectory

180 Point target - coordinates of the end point of the screw insertion trajectory

181 Screw position - screw offset relative to the target point of the first screw

182 Screw position - screw offset relative to the target point of the second screw

183 Save Plan - allows you to save the plan

184 Visualization window with a section in the frontal plane

185 Visualization window in the horizontal projection area

186 Slider for controlling the depth of the visualization window in the horizontal projection area

187 3D model of a screw

188 Vertebra selection menu in the 3D vertebra model surface preparation tab for binding the information software

189 The "Add/Rem" button switches the mode of adding or deleting a surface in the surface preparation tab of the 3D model of the vertebra for binding the information software

190 Action panel for setting up color indication of surfaces in the surface preparation tab of the 3D model of the vertebra for binding the information software

191 The "Clear surface" button, which is used to delete all marked surfaces in the 3D vertebra model surface preparation tab for binding the information software

192 The "Save" button, used to save the data of the marked areas

193 3D cursor for marking surfaces on a 3D model of a vertebra in the surface preparation tab of a 3D model of a vertebra for binding information software

194 3D model of the vertebra in the tab of preparation of surfaces 3D model of the vertebra for binding of information software

195 Edit button for the transfer function for the spine DICOM file

196 Edit button for the transfer function for the first vertebra DICOM file

197 First vertebra display on/off button

198 Virtual scene display window

199 Active vertebra selection field

200 Active surgical instrument selection field

201 Field for outputting information about the calibration error of the surgical instrument and the distance from the target point and the orientation deviation during the operation

202 Button to start the process of registering the active vertebra

203 Marking the scale of insertion of a surgical instrument along a given trajectory, associated with the entry point

204 Marking the scale of insertion of a surgical instrument along a given trajectory, associated with the current position of the active surgical instrument

205 Marking the scale of insertion of a surgical instrument along a given trajectory, associated with the target point

206 Graphical tool for assessing the orientation of the needle probe relative to the trajectory of the screw location in the active vertebra

207 Graphical tool for assessing the distance of the needle probe from the screw path in the active vertebra

208 Manipulation Parameter Selection Menu

209 Information software module control menu

210 Data on the progress of the surgical procedure in numerical form

211 Data on the progress of surgical manipulation in graphical form

Implementation of the invention

Figure 1 shows a robotic medical system for performing neurosurgical operations on the spine. The system includes a manual fixing manipulator with a manual movement principle 1 based on rotary fixing units with a control system 4, implementing a two-stage adjustable stop of the working element 2 with its fixation within the selected direction in accordance with the navigation method and the installed information software for preoperative planning and intraoperative navigation of surgical instruments, including information software modules for controlling the operating room equipment, for collecting coordinates of vertebral surface points using a stereophotogrammetric system 3 and for planning and navigation in neurosurgery of the spine with indicative visual information. The example shown in Figure 1 displays the interrelations of the components of the robotic medical system for performing transpedicular fixation. Patient 6, covered with a sterile sheet, lies on the operating table 7, along which the fixing manipulator with the manual movement principle 1 moves. The surgeon 8 works with the fixing manipulator 1. The fixing manipulator with the manual movement principle 1 is used for positioning and orienting the working element 2, which holds the surgical instrument 5. During the operation, the surgeon 8 manually moves each link of the fixing manipulator with the manual movement principle 1 using the control system 4. The information software module for analyzing the progress of the surgical manipulation of screwing in transpedicular screws graphically visualizes information about the progress of the surgical operation on the monitor screen for the surgeon 8. To implement the navigation process, the required orientation of the working element 2 is determined using the stereophotogrammetric system 3.

Fig. 2 shows a general view of the proposed manual fixing manipulator with a manual movement principle based on rotary fixing braking units. The fixing manipulator with a manual movement principle 1 is intended for moving and positioning the working element 2 within the boundaries of its working area. The fixing manipulator with a manual movement principle 1 is used for positioning and orienting the working element 2 guiding the surgical instruments 5. The fixing manipulator with a manual movement principle 1 is fixed vertically on the movable rail base 9 of the fixing manipulator with a manual movement principle using the first flange 10. The first flange 10 has openings through which it can be fixed with screws relative to the movable rail base 9 of the fixing manipulator with a manual movement principle. The fixing manipulator with a manual movement principle 1 includes 4 rotary fixing units, sequentially connected to each other using links. The design of the fixing manipulator with the manual movement principle 1 does not contain engines, but is moved by the surgeon 8 manually, which increases the safety of work during surgical operations on the spine, eliminating all possible errors associated with the automatic movement of the fixing manipulator with the manual movement principle 1. The design of the fixing manipulator with the manual movement principle 1 has in its composition rotary fixing units that allow fixing the links in a given position. The design of the fixing manipulator with the manual movement principle 1 has the ability to set the height in the range from 243 mm to 338 mm above the movable rail base 9 of the fixing manipulator with the manual movement principle for convenient placement of the working element 2. Due to this, it becomes possible to position the patient 6 with a torso thickness in the range from 140 mm to 240 mm.

The claimed fixing manipulator with a manual movement principle 1 comprises the following connected in series: a first axis unit (Fig. 3A), a lifting mechanism (Fig. 4), a second axis link (Fig. 5), a second axis unit (Fig. 3B), a third axis link (Fig. 6), a third axis unit (Fig. 3C), a fourth axis link (Fig. 7), a fourth axis unit (Fig. 3G). The claimed fixing manipulator with a manual movement principle 1 additionally comprises an automatically controlled brake 11, which is attached to the shaft 12 of the rotary fixing braking unit of the third axis. The automatically controlled brake 11 is attached to the plate 13 and serves to increase the holding moment of the axis.

All the rotary locking units (Fig. 3A-G) of the claimed locking manipulator with the manual movement principle 1, with the exception of the third one (Fig. 3B), have 2 structural elements in their composition: an automatically controlled brake 14 and a manual locking eccentric clamp. These elements ensure the fixation of the rotary locking units from: rotation of the lifting mechanism (Fig. 4), rotation of the second axis link (Fig. 5), rotation of the third axis link (Fig. 6), rotation of the fourth axis link (Fig. 7) of the locking manipulator with the manual movement principle 1. A distinctive feature of the rotary locking units (Fig. 3A-G) is the ability to implement an adjustable stop, carried out by sequentially using 2 sequentially switched on systems - the automatically controlled brake 14 and the manual locking eccentric clamp. The rotary fixing units of the robotic medical system do not include engines, the output link of the rotary fixing unit of the robotic medical system is moved manually. The braking torque of the automatically controlled brakes 14 and 11 is determined by the required moments and changes during the navigation of the working element 2 of the fixing manipulator with the manual movement principle 1. The automatically controlled brakes 14 and 11, by changing the voltage supplied to them, brake the output link of the rotary fixing unit of the robotic medical system from manual movement with a braking torque load value of up to 5 N m in total. After fixing the rotary fixing unit in a certain position using the automatically controlled brake 14, an eccentric clamp is used, which fixes the output rotary fixing unit of the robotic medical system using a manual stopper with a braking torque load value of up to 150 N m. The manual stopper has a removable mechanical handle, which allows the overall size of the rotary locking unit to be reduced when it is disconnected.

The first axis unit (Fig. 3A) is structurally located inside the structure, and the remaining rotational locking units (Fig. 3B-G) are installed directly into the mating plates.

Fig. 3 (A-G) shows general views of all the proposed rotary locking units. The rotary locking units have a design consisting of a housing element 15, to which an automatically controlled brake 14 with a single shaft 12 passing through the entire housing 15 is attached along a radial surface. The part of the housing through which the single shaft 12 passes is a terminal connection with the possibility of clamping it using an eccentric clamp, which consists of: an adjusting nut 16, an eccentric eye 17, an eccentric 18. The eccentric eye 17 is installed in an opening on the housing, and the eccentric 18 is in turn attached to it; the use of the adjusting nut 16 allows for fine adjustment of the clamping force of the terminal connection, which depends on the magnitude of the forces acting on a specific unit during operation. A rotary eccentric handle 19 is attached to the eccentric 18, the rotation of which clamps the terminal connection. The rotary handle of the eccentric 19 is fastened using the adapter 20, which simultaneously acts as a retainer for the sterile cover of the fixing manipulator with a manual movement principle 21. Additionally, the adapter 20 is equipped with a ball locking mechanism on a spring-loaded clutch, consisting of a direct locking element 22, a clutch 23, a spring 24 and a set of metal balls 25, which provide the possibility of quickly detachable fastening of the rotary handle of the eccentric 19. The rotary handle of the eccentric 19 and the locking mechanism on the spring-loaded clutch are made of stainless steel, to ensure the possibility of its autoclaving, and serve to clamp the eccentric clamps of all rotary fixing units in sterile conditions. Conical thrust bearings 26 are also installed in the unit, providing rigidity of the rotary fixing unit, and providing unloading of the rotary fixing unit from all forces, except for the torque. Bearings 26 are fixed using a cover of the rotary fixing unit, which also acts as a mounting flange. An output flange is installed on the output surface of the common shaft 12, which is used to fasten subsequent links or the working element 2.

Fig. 4 shows a general view of the design of the lifting mechanism and the axis of the first link. The first flange 10, connected to the rotary locking unit of the first axis through the adapter flange 27 and the cylindrical part with a window 28, has a cylindrical shape with mounting holes for securing it on the movable rail base 9 of the locking manipulator with a manual movement principle. In the claimed locking manipulator with a manual movement principle 1, the first axis unit is the most loaded and is provided with an additional thrust ball bearing 29 between the bearing cover of the rotary locking unit of the first axis 30 and the housing of the lifting mechanism 31. The cylindrical part with a window 28 is a short cylinder with a selected sector in the upper part, on which the cover 30 rests, wherein the axis of the cover 30 coincides with the axis of the cylindrical part with a window 28. All the parts described above are made of metal, primarily of an aluminum alloy.

The lifting mechanism serves to adapt the height of the fixing manipulator with the manual movement principle 1 to the overall parameters of the patient 6 and is fixed on the output flange of the rotary fixing unit of the first axis 32. The housing of the lifting mechanism 31 is a hollow cylinder with holes, closed by a cover 33. Inside the housing of the lifting mechanism 31, a lead screw with a trapezoidal thread 34 and at least two cylindrical guides 35 are installed, along which the running platform 36 moves. The fastening of the guides 35 to the housing 31 is implemented using fixed supports 37, the lead screw 34 in turn is fixed using supports with bearings 38 to ensure the possibility of free rotation around its axis. The running platform 36 is a plate on which a trapezoidal nut 39 and two ball bushings with a flange 40 are rigidly fixed, which are necessary for the free movement of the running platform 36 in the vertical plane and provide rigidity of the lifting mechanism structure in other planes. The movement of the running platform 36 occurs due to the rotation of the flywheel 41, to which a handle 42 is added for ease of use. The running platform 36 has a seat for fastening the lower element of the running cylinder 43, to which, in turn, the upper element of the running cylinder 44 is attached, these elements serve for the subsequent fastening of the link of the second axis (Fig. 5), as well as for ensuring the fixation of the locking manipulator with a manual movement principle at the height necessary for performing surgical manipulations using a locking screw 45.

Fig. 5 shows a general view of the design of the second axle link. The second axle link structurally includes a housing element 46, which is secured to the upper element of the running cylinder 44 using screws and corner ribs 47 to increase the rigidity of the structure, and its cover 48. Cover 48 is installed on the housing element from above and allows for greater rigidity of the second axle link design (Fig. 5), as well as for closing the cavity used for mounting the wires of the rotary locking units. Housing element 46 and cover 48 have a mounting socket for fastening the rotary locking unit of the second axle (Fig. 3B) using cover 49. All parts of the second axle link are made of metal, primarily of an aluminum alloy, stiffening ribs 47 can be made of materials with higher rigidity parameters.

Fig. 6 shows a general view of the design of the third axle link. The third axle link structurally includes a plate 50, which is secured to the output flange of the rotary locking unit of the second axle 51 using screws, and a housing 52, which serves the task of increasing the rigidity of the structure and provides a cavity for internal installation of wires of the rotary locking units for braking. A fastening plate 53 for installing the rotary locking unit and a fastening plate 54 for installing the automatically controlled brake 11 are fixed to the plate 50 perpendicular to its surface. The third axle unit (Fig. 3B) is installed in the mounting socket of the fastening plate 53 with fixation along the cover 55 and is connected to the automatically controlled brake 11 using the auxiliary shaft 56. The common shaft 12 and the auxiliary shaft 56 are fastened using screws along the radial surface. In turn, the automatically controlled brake 11 is rigidly fixed to the mounting plate 54. All parts of the second axle link are made of metal, mainly of aluminum alloy.

Fig. 7 shows a general view of the design of the fourth axis link. The fourth axis link structurally includes a plate 57, which is secured to the output flange of the rotary locking unit of the third axis 58 using screws, a front fastening plate 59 and an end fastening plate 60, secured perpendicularly to the plane of the plate 57. The fourth axis unit (Fig. 3G) is secured between plates 59 and 60 by cover 61 to increase the ability to withstand bending loads that occur when working with the locking manipulator 1 with a manual movement principle. The output flange of the rotary locking unit 62 for braking has mounting holes for securing the working element (Fig. 8) directly or through a force-torque sensor 63.

Figure 8 shows a general view of the design of the working element 2 of the robotic medical system with a split elastic clamp 68. The working element 2 is intended for navigation and positioning of the surgical instrument 5. The working element 2 is connected to the fixing manipulator with a manual movement principle using a flange 64, which is fixedly attached to the ball joint 65. The ball joint 65 is used to ensure free rotation in two planes simultaneously, preventing movement in any direction, thus it is possible to ensure high-precision adjustment of the insertion angle of the surgical instrument 5. The fixation of the ball joint 65 occurs due to the clamping of the clamp on the body using the flag mechanism 66. A transition platform 67 made of stainless steel, which undergoes preoperative autoclaving, is attached to the output platform of the ball joint through a cover 21. A split elastic clamp 68 is attached to the transition platform 67 by means of screws, which is used as a guide with the possibility of clamping the bushings 69 installed on the surgical instruments 5 used in the robotic medical system. The play of the bushing 69 of the working surgical instrument 5 relative to the split elastic clamp 68 is reduced by selecting a radial clearance by means of two adjusting screws 70. Additionally, the split elastic clamp 68 is provided with holes for installing a fastener with spherical markers 71 by means of a clamp 72. The clamp 72 consists of a pin vice with a through hole and a set screw. Up to 3 fasteners 71 can be placed on the split elastic clamp at the same time in 5 places. Also on the surface of the split elastic clamp 68 there are 7 basing holes in the form of a cone, allowing to bind the mathematical axis for guiding the movement of the surgical instruments 5 of the working element 2 to its actual location in the space of the working zone of the fixing manipulator with the manual movement principle 1 using the needle probe 76. Additionally, the surface of the split elastic clamp 68 is provided with 4 threaded holes for installing the manipulation handle 73 in a position convenient for the surgeon 8 for moving the links of the manual fixing manipulator with the manual movement principle 1.

Figure 9 shows a general view of the design of the working element 2 of the robotic medical system with a built-in bicomponent force-torque sensor 63. This modification of the design of the working element 2 allows measuring forces and moments arising from the interaction of surgical instruments 5 with the patient's tissues during neurosurgical intervention, with the possibility of subsequently providing this information to the surgeon for intraoperative analysis. In the case of using this modification, fastening to the output flange of the fourth axis is carried out using plate 74 to which one of the ends of the sensor is attached, the second end of the sensor is attached to plate 75, which is then attached to ball joint 65.

Fig. 10 shows the external appearance of the rack of the control system of the robotic medical system based on the element of redistribution of power between automatically controlled brakes. The rack 80 is a structure with fasteners of the 19-inch size, for installation in it of the electronic units of the control system. It contains the control computer 77 with information software, the electronic unit of redistribution of power between automatically controlled brakes 78 and the socket unit 79 for connection of all electronic units to the external power network. The movement of the manual fixing manipulator with the manual principle of movement 1 is carried out manually using the electronic unit of redistribution of power 78, allowing switching of power between the automatically controlled brakes 14 of the rotary fixing units.

The structural diagram of the control system is shown in Fig. 11. The control system includes a main control computer 77, an electronic power redistribution unit 78 and a socket block 79. The control computer 77 is connected by a power cable to the socket block 79 and the electronic power redistribution unit 78 via a data bus. Interface devices 83, allowing the operator to interact with the information software, can also be connected to the main control computer 77, and additional peripheral information devices such as the stereo camera 3 can be connected to it via access via the local Ethernet network. The task of the main control computer 77 is to ensure the operation of specialized information software responsible for collecting data from all devices connected to it, processing incoming data from the devices, and transmitting control commands to the electronic power distribution unit 78. The electronic power distribution unit 78 is connected to the socket unit 79 via a power cable, the main control computer 77 via a data bus, and the fixing manipulator with a manual movement principle 1 via connection wires. The task of the electronic power distribution unit 78 is to supply analog control signals to the automatically controlled brakes 14 of the fixing manipulator with the manual movement principle 1, control of the electronic indication units 91 of the fixing manipulator with the manual movement principle 1 and sound indication. These tasks are processed in accordance with the control commands coming via the data bus from the main control computer 77.

The structural diagram of the electronic power redistribution unit is shown in Fig. 12. The electronic power redistribution unit 78 includes an electronic input voltage converter unit 85, an electronic low voltage converter unit 94, an electronic power supply unit of a single-board computer 86, a single-board computer 88, a speaker 89, a matrix switch of power lines 93, an electronic unit for feeding analog signals 92, a coupling electronic indicator unit 90. The electronic input voltage converter unit 85 is coupled by means of wires with: an external power supply network 84 using a block of sockets 79 of the control system; an electronic power supply unit of a single-board computer 86; an electronic low voltage converter unit 94; an electronic unit for feeding analog signals 92. The task of the input voltage converter 85 is to convert the input alternating voltage from the external power supply network 81 into a fixed direct voltage to provide power to all devices connected to the electronic unit 85. The low voltage converter electronic unit 94 is interfaced with the input voltage converter electronic unit 85 and the power line matrix switch 93. The task of the low voltage converter electronic unit 94 is to reduce the direct voltage from the input voltage converter electronic unit 85 in order to provide uninterruptible power supply for the matrix switch 93. The single-board computer electronic power supply unit 86 is interfaced with the input voltage converter electronic unit 85 and the single-board computer 88. The task of the single-board computer electronic power supply unit 86 is to convert the direct voltage from the input voltage converter electronic unit 85 in order to provide uninterruptible power supply and protection against voltage pulsations and surges for the single-board computer 88. The single-board computer 88 is interfaced with the external control device 87 in the form of: the main control computer 77; the power line matrix switch 93; the electronic analog signal supply unit 92; the coupling electronic indicator unit 90 and the speaker 89. The task of the single-board computer 88 is to receive control commands from the external control device 87 and, in accordance with the received commands, to generate response messages, to generate control signals for the automatically controlled brakes 14 and to carry out indication by means of sound signals or color signals on the electronic indicator units 91 of the fixing manipulator with a manual movement principle. The control signals for the automatically controlled brake 14 of the fixing manipulator with the manual movement principle 1 are generated by simultaneously controlling the matrix switch 93 and the electronic unit for supplying analog signals 92. Indication by sound signals is carried out by using the speaker 89. Visual indication is carried out by sending control commands to the interface electronic indication unit 90. The interface electronic indication unit 90 is interfaced with the single-board computer 88 and seven electronic indication units 91. Its task is to supply control signals to the electronic indication units 91 in accordance with the control commands coming from the single-board computer 88. The matrix switch of power lines 93 is interfaced with the single-board computer 88, the electronic unit of low voltage converter 94, the electronic unit for supplying analog signals 92 and five automatically controlled brakes 14 (four are designated by the number 14, one is designated by the number 11). Its task is, in accordance with commands from the single-board computer 88, to switch the windings of the selected automatically controlled brake 14 and the electronic unit for supplying analog signals 92. The switch itself is galvanically isolated from the power lines, thereby ensuring protection of the control elements of the electronic power redistribution unit 78. The electronic unit for supplying analog signals 92 is interfaced with the single-board computer 88, the electronic unit of the input voltage converter 85 and the matrix switch of the power lines 93. The task of this electronic unit 92 is to supply control analog signals to the automatically controlled brake 14 connected via the matrix switch 93. The formation of these voltages is carried out by converting the direct voltage received from the electronic unit of the input voltage converter 85 by means of the built-in H-bridge and the pulse-width regulator of the electronic unit. The range of the generated voltages can vary from 30 to -30 V. The setting of the required voltage is carried out in accordance with the control commands coming from the single-board computer 88.

Thus, by means of the electronic power redistribution unit 78, it becomes possible to supply control signals in the form of supply voltages to one automatically controlled brake 14 at a time. Within the framework of the control system, it becomes possible to control the elements of the fixing manipulator with the manual movement principle 1 in accordance with the commands coming from the surgeon 8 and the data received from additional peripheral information devices, such as the stereo camera 3 with the additional possibility of sound or light indication. The possibility of supplying supply voltages only to one automatically controlled brake 14 creates a limitation on changing the generalized coordinates of only one degree of mobility of the fixing manipulator with the manual movement principle 1 at a time.

A set of surgical instruments 5 with integrated spherical markers is shown in Figure 13. The set of surgical instruments 5 consists of a surgical tap 95, a surgical awl 96 and a transpedicular screwdriver 97. For fixed fastenings with spherical markers 102, two sets of retainers are used for the listed surgical instruments, based on the clamping function and differing in the diameter of the clamped surgical instrument. The retainer consists of a base part 98 (for the tap 95 and the awl 96) and 100 (for the transpedicular screwdriver 97), and a clamp part 99 (for the tap 95 and the awl 96) and 101 (for the transpedicular screwdriver 97). The assembly of the parts of the retainer is carried out by means of screws 103 and nuts 105. The fastening with spherical markers 102 is held by means of screw 105. The base and clamp of the retainer, as well as the fastenings for the spherical markers, are produced by an additive method from bioinert and autoclavable plastic. The fastening elements are made of stainless steel. Surgical instruments 5 are installed in surgical wireless device 146, allowing the collection of intraoperative data on the forces and moments arising during the interaction of surgical instruments 5 with the operated tissues of the spine.

The design of the needle probe with integrated spherical markers is shown in Figure 14. This device is intended for measuring the coordinates of the points of the patient's vertebra surfaces or determining the axis of the working element 2 of the robotic medical system and allows for binding the 3D model of the vertebra 194 to its actual position. The basis of the device is a hollow ergonomic handle 106, on one side having a special groove suitable for installing a fastener with spherical markers 102, by means of a screw 109, and on the other side a groove for inserting a fastener 107 for holding a disposable medical needle 110. The fastener and the medical needle 110 are fixed in the handle by a screw with a knurled head 108. The handle 106 and the fastener 107 of the needle probe are produced by an additive method from bioinert and autoclavable plastic. The fastener elements are made of stainless steel.

The design of the elastic clamp with integrated spherical markers is shown in Figure 15. This product is necessary for fastening to the spinous process of the patient's vertebra, to improve the quality of navigation of surgical instruments 5, due to compensation of relative movements of the vertebra during surgical manipulations and allows to bind the 3D model of the vertebra 194 to its actual position. The basis of the product is the elastic clamp 111 made of sheet stainless steel, for rigid fastening to the spinous process, on it are cut successive sharp teeth, the principle itself is based on the elastic properties of the metal from which the clamp is made. To open the jaws of the clamp, the device provides handles 112 made of stainless steel. A special fastening with spherical markers 113 is fixed to the clamp by means of screws 114 and nuts 115.

The parts for calibrating the orientation of surgical instruments and the method of using them are shown in Figure 16. The peculiarity of the parts consists in the presence of a parallelepiped with standardized holes 117 for a neurosurgical drill 119 and a trapezoidal prism 116 for a neurosurgical awl 96, a transpedicular tap 95 and a transpedicular screwdriver 97 with a screw for calibrating the orientation parameters of surgical instruments 5 in the 3D space of the robotic medical system. The process of calibrating the orientation of surgical instruments consists in applying a flat cylindrical surface of the surgical instruments to the surface of the calibration part 116 and translational movement along the channel axis with recording several reference points (at least two). The parallelepiped 117 and the prism 116 are fixed on a fixed reference mount 118, by means of screws 120 and nuts 121.

The method of navigation of the working element of a robotic medical system with the implementation of a two-stage controlled stop includes a set of the following methods from a list of successive ones:

1) A method for preoperative planning of trajectories for insertion of transpedicular screws with volumetric visualization of the patient’s vertebrae, with the possibility of their free orientation in 3D space and the possibility of visual adjustment of the location of sections on 3D models of the vertebrae;

2) A method for linking 3D models of vertebrae 194 to the actual position of the vertebrae in space, which is carried out by measuring the coordinates of spherical markers 71 with a stereophotogrammetric measuring system 3 on a needle probe 76 and determining, using the tip of the needle 110 of the needle probe, a set of vertebral surfaces in accordance with the linking algorithm;

3) A method for using a needle probe 76 to initialize the axis of the working element, determining the course of surgical manipulations and the trajectory of insertion of surgical instruments 5 in a robotic medical system;

4) A method for implementing a two-stage adjustable stop of a manual fixing manipulator with a manual principle of movement 1 in a given direction;

5) A method for using a surgical wireless device 146 with a working element, installation in the working element of the surgical wireless device using a cutting clamp 68, the process of obtaining information about the progress of the surgical manipulation being performed for subsequent presentation of this information to the doctor for intraoperative analysis;

6) A method for intraoperative navigation of surgical instruments 5 using a volumetric target that visualizes the coordinates of the position of the end point of surgical instruments 5 with fasteners having spherical markers of the stereophotogrammetric measuring system 71;

The method of navigation of the working element is a single whole consisting of the 6 above-mentioned methods, and its description begins with the method of preoperative planning of trajectories of the introduction of transpedicular screws with volumetric visualization of the patient's vertebrae, with the possibility of their free orientation in 3D space and the possibility of visual adjustment of the location of sections on 3D models of the vertebrae 194. The method of preoperative planning of trajectories of the introduction includes the use of information software for preoperative planning, consisting of a set of interconnected modules. The user interface module (hereinafter referred to as the application) of the information software is intended for preoperative planning for managing the operation session. Using the application, the surgeon 8 can prepare the patient's 6 data, perform preoperative planning and manage the system modules during the operation.

The application stores the patient database (hereinafter referred to as PD) in the file system as a hierarchy of directories. A patient record includes data from the electronic medical record and medical imaging data in the DICOM file format of the entire spine and individual vertebrae. All data from an operating session is linked to a patient. Patient data is stored in text files in the patient directory. The patient directory and all necessary files can be added when creating a patient or at the preoperative planning stage. Before performing any operations, patient data must be loaded into the application; only one patient can be loaded at a time. This can be done on the patient data tab.

The implementation variant of the application interface is shown in Figures 17-24, as well as Figures 34-35, and is an application with a common menu, but divided into several tabs, according to the stages of preparation and execution of the operation.

The patient data tab, shown in Figure 17, is horizontally divided into two areas: the left side allows the user to edit the active patient's data, while the right side displays a 3D merged model of the patient's DICOM files with the patient's images. It is important to note that the position and orientation of the vertebra model STL file must match the position and orientation of the vertebra in the DICOM image file. As DICOM image files are added, they will be displayed in the window on the right. The main controls on the Patient Data tab are as follows: patient name input field 149, session data loading button (if the patient is in the BP) or new patient creation button 150, active session data saving button in the BP 151, right view camera centering button on loaded DICOM file center 152, path to directory containing spine image DICOM file 153, spine DICOM file editing button 154, spine DICOM file size controls 155, first vertebra name 156, first vertebra model STL file path 157, first vertebra image DICOM file path 158, first vertebra DICOM file editing button 159. All patient DICOM files are displayed on the 3D scene 160.

The work with the application is done sequentially from preparation to the operation. The stages of preparation or operation are displayed in tabs. The transitions between tabs are provided by the buttons "Previous step" 161 and "Next step" 162. It is also possible to select any tab necessary at the moment: tab with logs 163, tab connections 164, tab with patient data 165, tab planning operation 166, tab preparation of surfaces for registration 167, tab virtual scene of the operating room 168, tab intraoperative navigation 169.

To visualize medical images of a patient, the application contains a function for 3D reconstruction of images in DICOM file format with the ability to combine with models in STL file format. To obtain an image of the vertebrae, the volume rendering technique is used. The input data for volume rendering is a three-dimensional data array. The result of volume rendering is a two-dimensional image of a three-dimensional voxel model. The voxel model divides the entire volume of the three-dimensional image into cells - voxels, creating a three-dimensional raster. To form an image, rays are launched from the observation point, which, passing through the voxel model, allow you to calculate the pixel values of the final image. To select points along the launched ray, the equation of a straight line is used. To calculate the density at the selected point, trilinear interpolation is used, since the points on the ray will not coincide with the grid nodes of the three-dimensional data array. After selecting a point and determining its density, it is necessary to convert this value into pixel parameters: color and transparency. This conversion is performed using transfer functions. The user has the ability to flexibly configure the transfer function for each DICOM file, as well as select the lighting calculation model for the scene, as shown in Figure 18.

The user can change the parameters of the transfer functions in the Transfer Function Editor window, which is available in the application for each displayed DICOM file. The parameters of the transfer functions determine the visibility and color of the displayed structures of the volumetric image. To set the transfer function, a set of points is used, each of which corresponds to a threshold value for density and the corresponding value of density and color. The number of points is not limited, the parameters in the areas between the points are calculated using linear interpolation. Additionally, a histogram is displayed in the transfer function setting window. The histogram allows you to estimate the range of values of the three-dimensional data array, as well as the degree of presence of certain structures. This method of setting the transfer function allows you to flexibly set the structures displayed on the screen and their visual representation.

One of the main steps in the preoperative planning stage is planning the placement of the pedicle screw in the vertebra. The physician must select two points on the screw axis that clearly define its position. The target point defines the final placement of the screw within the vertebra, and the entry point defines the orientation of the screw axis and the position of the entry point of the surgical instrument.

The selection of the trajectory of the screw insertion into the vertebra is performed on a separate tab of the application. The editing window is divided into several areas, as shown in Figure 19. In the left part there is a panel with information and tools. The central part of the window is occupied by the visualization window with a free camera. In the upper right part there is a visualization window with a cut in the frontal plane, the vertebra is always cut along the screw axis, the orientation of the cut is always perpendicular to the direction of the camera view. In the lower right part there is a visualization window in the horizontal projection area, the direction of the camera view corresponds to the screw axis, the location of the cut plane can be changed using the "SlicePos" slider, located in the lower left corner of the window.

The following controls are available on the toolbar: a combo box for selecting the active vertebra 170, the "Focus view" button - resets the camera positions, placing the vertebrae in the center of the views 171, DicomTF - editor of the transfer function for the three-dimensional voxel model of the vertebra 172, SliceTF - editor of the transfer function for the two-dimensional projection of the vertebra onto the slice plane 173, SlicePosition - editor of the center point of the spatial position of the slice plane 174, SliceNormal - editor of the normal vector of the slice plane 175, Control points visible - allows you to hide / show the controls for the trajectory points 176, Middle point visible - allows you to hide / show the control for the entire middle point of the trajectory 177, Show screw - allows you to hide / show the screw model 178, Point in - coordinates of the starting point of the screw insertion trajectory 179, Point target - coordinates of the end point of the screw insertion trajectory 180, Screw position - screw offset relative to the target point of the first screw 181, Screw position - screw offset relative to the target point of the second screw 182, Save Plan - allows you to save the plan 183, visualization window with a cut in the frontal plane 184, visualization window in the horizontal projection area 185, slider to control the depth of the cut of the visualization window in the horizontal projection area 186, 3D model of the screw 187.

Before creating a plan, the user must select the vertebra for which this plan will be intended. After selecting a vertebra, it will be displayed in the central visualization window and the last saved plan for this vertebra will be loaded. The user can move the camera in the central window in the same way as in other windows of the application with a free camera. In addition to the vertebra, the central view has a movable plane that cuts off a part of the vertebra to display the internal structure. The user can move the plane using the mouse. It should be noted that each vertebra corresponds to one screw trajectory, and specifying points simply changes its position. After the screw insertion trajectory is specified inside the vertebra, the user can display the screw and evaluate its location in the views on the right.

The position of the trajectory is refined using the controls displayed at the points of the trajectory segment shown in Figure 20. The controls at the ends of the segment allow the target point and the insertion point to be moved along one or more axes in the world coordinate system. The control at the center of the segment allows both points to be moved simultaneously depending on the orientation of the segment. When the position of the trajectory segment is changed, the projections in the right view will be recalculated, allowing the clinician to evaluate the quality of the screw insertion plan in real time. The control located at the center of the trajectory segment allows convenient control of the screw insertion depth and its displacement without changing the orientation.

The views on the right side of the window allow you to estimate the distance to the bone edge in different projections. The user can move the camera in the upper right view 184 around the screw, estimating the distance in different projections. In the lower right view 185, the camera position always corresponds to the insertion trajectory - the camera "looks" at the screw from the target point to the insertion point.

After selecting the appropriate screw placement points, click the save plan button 183. The plan data is saved to the patient directory. Saving the plan data updates the plan in the intraoperative navigation tab if an editable vertebra is selected.

The marking of the vertebral surfaces is performed in a separate tab of the application, as shown in Figure 21. The tab is divided into two windows: on the left is the action panel, on the right is the visualization of the selected vertebra model. The doctor needs to mark, on the 3D model of vertebra 194, those surfaces on which the measurements of the coordinates of the patient's vertebra points will be performed during the operation, using a needle probe. The vertebra can be selected in the drop-down list of the action panel 188. The selected vertebra model is displayed in the window on the right. For the selected vertebra, the previously saved data on the marking of the surfaces is automatically loaded.

Each of the seven zones has a unique color indication in the action panel 190 and when placed on the model. The user can select an active zone by clicking on the button of the corresponding color in the action panel. The surface is marked using the 3D cursor 193. When placed on the model surface, the 3D cursor marks the adjacent surface within a certain radius, or deletes the marking of the corresponding zone, depending on the mode set on the action panel. Changing the mode (adding / deleting) is done by pressing the "Add / Rem" button 189. To quickly clear all selected surfaces, the user can use the "Clear surfaces" button 191. During editing, the user can move the camera using the mouse; the camera can be returned to its original position by pressing the "Focus view" button 171.

The marked zones on the model surface may overlap each other. The zone with the lower number has the priority of display. If necessary, the user can hide the display of the zone by deselecting the zone flag on the action panel. To complete the marking of the stl-model zones, the user must click the "Save" button 192 to save the data of the marked areas. The data is saved in the catalog of the selected patient.

Figure 22 shows the calibration tab and checking the position of the tip of the surgical instrument. It contains two windows, the left one for calibration, the right one for checking. Calibration and checking is the implementation of the necessary manipulations with the surgical instrument before each operation, as well as in cases where the mount with spherical markers installed on the surgical instrument has been shifted relative to its original calibrated position. The process of performing calibration and checking is carried out according to the established regulations and in accordance with visual and sound signals in the information software of the robotic medical system.

Figure 23 shows the tab for calibration and checking the orientation of the surgical instrument axis. It contains two windows, the left one for calibration, the right one for checking. The process of performing calibration of the orientation of the surgical instrument axis occurs according to the established regulations in accordance with the visual and audio instructions in the information software of the robotic medical system.

The virtual scene tab, shown in Figure 24, displays a general view of the arrangement of all models in a single coordinate system and serves to visualize the surgical field during the operation. The tab is divided into 2 parts: on the left is a scene graph, where you can select a scene element and determine its coordinates, and on the right is a large window with an image of all unhidden scene elements and a free camera. Using the graph, the user can change the position of the vertebrae, performing corrections to the position of the rods in the virtual environment. The main purpose of this tab is to visually assess the arrangement of the vertebrae, rods, and surgical instruments during and after registration.

The method of using the needle probe for vertebrae binding is shown in Figure 25. The process of vertebrae binding consists of sequentially recording the coordinates of the points of the vertebra surfaces to which the tip of the medical needle 110 installed in the needle probe 76 is applied. The process of vertebra binding is necessary to determine the position and orientation of the vertebra relative to the attachment with spherical markers 102 installed on a special tripod of the elastic clamp, which is fixed on the vertebra, to ensure navigation during surgical manipulations to insert a transpedicular screw into the body of this vertebra. The surfaces of the vertebra and the number of points on the surfaces are specified at the preoperative stage in the information software of the robotic medical system. The collection of points occurs sequentially from surface to surface, for recording a point, it occurs with a motionless holding of the tip of the needle 110 in a certain area for some time automatically. Such operations as the beginning of recording, the end of recording, recording a new point and a complete recording of a new surface are indicated by a sound signal from the speaker.

The algorithm for using the needle probe for binding to the patient's vertebra is shown in Figure 26. The binding process to the patient's vertebra begins by pressing the button in the control interface 128 and is reported to the surgeon by a special sound signal 129 from the speaker of the control stand. Then the surgeon moves the tip of the needle probe to any point convenient for him on the planned surface of the vertebra 130, the information software for collecting points checks the condition by the distance to the previous point 131 in order to exclude erroneous recording of the coordinates of closely located points, which will worsen the quality of subsequent reduction, if the point is the first, a comparison with the zero coordinate is made. Then the condition of immobility of the tip of the angular probe on the surface of the vertebra 132 is checked, for recording the coordinates it is necessary to hold the tip in a fixed position for at least two seconds, if this condition is met, the coordinates of the point on the surface of the vertebra are recorded and a special sound signal 133 follows it, to notify the surgeon of the need to move to the next point. The information software has a built-in counter of points and surfaces 134, the quantities of which are planned in advance in the preoperative mode, this counter allows notifying the surgeon with a special sound signal 135 that all points on the current surface have been recorded, and it is possible to move on to the next one. When recording the coordinates of all planned points on all planned surfaces of the patient's vertebra 136, the surgeon is notified by means of a special sound signal 137. The measured coordinates of the vertebral surface points are formed into a data package and sent to the information software for intraoperative navigation of surgical instruments for subsequent reduction of the measured coordinates of the vertebral surface points with its 3D model 138. As a result of the reduction, the position and orientation of the real vertebra and its 3D model are compared, thus the data on the position and orientation of the planned trajectory of insertion of surgical instruments on the 3D model of the vertebra are converted into the position and orientation of the trajectory of insertion of surgical instruments on the real vertebra in the stereophotogrammetric navigation system. During the mathematical calculation, an assessment of the standard deviation of the results of the reduction is also made, according to the value of which the results of the binding 139 are checked; if a certain threshold of the standard deviation is exceeded, the results are considered unsatisfactory and the process of binding to the patient's vertebra should be repeated until the required value of the standard deviation is achieved.

The algorithm for bringing together the measured points of the vertebra with the surfaces of its three-dimensional model to determine the position of the vertebra relative to the reference mount is shown in Figure 27. The algorithm receives two sets of data as input: sets of points divided into groups and sets of surfaces presented as triangles, also divided into groups. The output data are six parameters describing the position of the vertebra model and a comparative parameter for estimating the error.

Point sets are represented by a list of point groups. Each group is also a list, which contains structures describing three-dimensional vectors - entities with x, y, and z fields represented by IEEE 754 floating-point numbers. The x, y, and z fields describe the corresponding projections of the vector onto the X, Y, and Z axes.

Sets of surfaces are represented by a list of surfaces. Each surface is described by a list of triangles. Each triangle, in turn, is represented by a triple of vectors.

The position of the vertebra model is represented as six numbers: x, y, z, a, b and c. The values of x, y and z describe the displacement of the model relative to the reference position along the X, Y and Z axes in millimetres. The values of a, b and c specify successive rotations of the vertebra model relative to the reference position around the Z, Y, X axes passing through the zero point of the displaced model. The goal of the algorithm is to find x, y, z, a, b and c such that when the vertebra model in the virtual space is displaced relative to the reference position, the position of the vertebra model relative to the zero of the virtual space coincides with the position of the real vertebra relative to the reference mount. This is achieved by finding x, y, z, a, b and c that result in placing the measured points on the marked surfaces.

The algorithm's operation can be divided into several stages. At the first stage, preliminary data preparation occurs. The center of the point sets is found

:

Where:

• n - the total number of points in all groups of points;

• - position of the i-th point.

In addition, the center parallel to the axes of the bounding surface of the parallelepiped is found. :

Where:

• A is the index of the vector component, takes the value X, Y or Z;

• - the greatest value of the A component of the surface vectors;

• - the smallest value of the A component of the surface vectors.

At the second stage, the value of the parameter set s is searched for, which ensures a position of the sets of points relative to the corresponding surfaces that is close to the optimal position. The following evaluation method is used to estimate the position of the sets of points relative to the corresponding surfaces:

Where:

• n - the total number of points in all groups of points;

• D _i (s) is the deviation estimate, which is given as:

where min(T _ij (s)) is the minimum square of the distance from the i-th point to the corresponding

surface. The minimum of the square of the distance from the i-th point to the corresponding surface is determined as the minimum of the squares of the distance from the i-th point to the triangles of the corresponding surface. The square of the distance from the i-th point to the j-th triangle of the surface is determined as:

Where - delta vector between the i-th point and the closest point to it on the surface of the j-th triangle.

Position of the i-th point is defined as follows:

Where - point transformation function:

Where - point rotation function:

where F _ang (s) is the modulus of the vector containing the rotation angles of the axis-angle representation for the point rotation function , a F _ax (s) is the normalized modulus of the vector containing the coordinates of the axis-angle representation for the point rotation function :

The search for the optimal value of s is performed using the Nelder-Mead numerical search algorithm. The initial parameters for the search are automatically generated values of s:

The optimal values of s obtained after running the Nelder-Mead algorithm are used to subsequently calculate the output parameters. The values of x, y, and z are determined as:

where F _inv is defined as

The values of a, b and c are determined as follows:

Where:

The obtained values of x, y, z, a, b and c can be used to determine the position of the vertebra relative to the supporting reference mount 118.

The method of using a needle probe for binding the working element of a robotic medical system is shown in Figure 28. The binding process of the working element 2 of the robotic medical system occurs by placing the tip of the medical needle 110 of the needle probe 76 into certain recesses on the surface of the working element 2. The binding process of the working element 2 of the robotic medical system is necessary for determining the position and orientation of the axis of the working element of the robotic medical system relative to the mount with spherical markers 102 installed on it. The binding process begins by pressing a button in the control interface. Such operations as the start of recording, the end of recording and recording a new point are indicated by a sound signal from the speaker.

The algorithm for using the needle probe for binding the working element of the robotic medical system is shown in Figure 29. The process of binding the working element of the robotic medical system begins by pressing the button in the control interface 140 and is reported to the surgeon by a special sound signal 141 from the speaker of the control stand. Then the surgeon moves the tip of the needle probe to any calibration well on the surface of the working element 142. The point is recorded under the condition of immobility of the tip of the angular probe in the well of the working element 132, to record the coordinates it is necessary to hold the tip in a fixed position for at least two seconds, if this condition is met, the coordinates of the point on the surface of the working element will be recorded and a special sound signal 143 will follow it to notify the surgeon of the need to move to the next point. After recording the coordinates of the required number of points on the surface of the working element 136, a warning sound signal about the completion of the process 144 occurs. Then, the orientation of the axis of the working element of the fixing manipulator with the manual movement principle is calculated in the information software with the output of data to the control interface 145 from the set of coordinates of the obtained points. During the mathematical calculation, the standard deviation of the results of the binding of the working element is also estimated, according to the value of which the results of the binding 139 are checked; if a certain threshold of the standard deviation is exceeded, the results are considered unsatisfactory and the process of binding the working element should be repeated until the required value of the standard deviation is achieved.

The method of guiding the axis of the working element of the robotic medical system to the planned trajectory, to ensure the navigation function when introducing surgical instruments into the patient's vertebra is shown in Figure 30. The process of guiding the axis of the working element to the planned trajectory occurs after planning the trajectory, calibrating all surgical instruments, binding the vertebra and the working element 2 in the stereophotogrammetric system. The method of binding 3D models of vertebrae to the actual position of the vertebrae in space is carried out by measuring the coordinates of the spherical markers with the stereophotogrammetric measuring system on the needle probe 76 and determining with the tip of the needle 110 of the needle probe 76 a set of vertebral surfaces in accordance with the binding algorithm. The needle probe 76 is also used to initialize the axis of the working element 2, determining the course of surgical manipulations and the trajectory of insertion of surgical instruments 5 in the robotic medical system. When aiming, the field of view of the stereo camera 3 must include mounts with spherical markers installed on the working element of the robotic medical system 2, a mount with spherical markers on an elastic clamp 124 installed on the spinous process of the patient's vertebra, on which surgical manipulations are currently being performed to introduce surgical instruments 5, as well as a fixed reference mount with spherical markers 125, which can be installed on the operating table or another fixed plane. The aiming process consists of aligning the axis of the working element of the robotic medical system, which is described by the coordinates of the input 126 and output 127 points of the axis of the working element, determined when binding the working element in the stereophotogrammetric system, and the trajectory of insertion of the surgical instruments into the vertebral body, described by the entry point 128 and the target point 129, which were planned in the information software at the preoperative stage and determined in the stereophotogrammetric system when binding to the patient's vertebra. First of all, the axis of the working element of the robotic medical system and the beam of the trajectory of the introduction of surgical instruments are aligned, then the working element 2 is moved to ensure the necessary distance between the surface of the vertebra and the lower surface of the working element, which will limit the depth of entry of the surgical instrument to the planned target point 129.

The movement of the working element 2 is ensured by successive movement of the axes of the fixing manipulator with the manual movement principle to the required configuration. To move the first axis, it is necessary to install the rotary handle of the eccentric 19 in the first axis unit and to unlock the axis, then voltage is applied to the automatically controlled brake 14, and the surgeon 8 moves the fixing manipulator with the manual movement principle 1 around the first axis to the calculated position, after which the voltage supply is stopped and the eccentric of the rotary fixing unit of the first axis is fixed. To move the second, third and fourth axes, it is also necessary to apply a similar procedure with a two-stage unlocking. For the second axis, the rotary handle of the eccentric 19 must be installed in the second axis unit with subsequent unlocking of the eccentric. Then voltage is applied to the automatically controlled brake 14, and the surgeon 8 moves the links of the fixing manipulator with the manual movement principle 1 to set the second axis to the calculated position. After reaching the calculated position, the voltage supply is stopped, and the eccentric of the rotary fixing unit of the second axis is fixed. For the third axis, by analogy, the rotary handle of the eccentric 19 must be installed in the unit of the third axis, and the axis must be unlocked. The voltage supply is carried out simultaneously to the automatically controlled brake 14 and to the additional automatically controlled brake 11, which allows the surgeon 8 to move the links of the fixing manipulator with the manual movement principle 1 around the third axis until reaching the calculated position. After this, the voltage supply is stopped, and the eccentric of the rotary fixing unit of the third axis is fixed. To move the fourth axis, the rotary handle of the eccentric 19 is installed in the unit of the fourth axis and the axis is unlocked. Voltage is applied to the automatically controlled brake 11, and the surgeon 8 rotates the output link of the fixing manipulator with the manual movement principle 1 around the fourth axis until reaching the desired rotation angle. After which the voltage supply is stopped, and the eccentric of the rotary fixing unit of the fourth axis is fixed.

In this case, the initial data are the boundary conditions, i.e. the generalized coordinates, velocities and accelerations at the initial and final moments of time. The entire trajectory is a single segment, since there are no requirements for intermediate configurations of the fixing manipulator with the manual principle of movement 1. The law of motion of each link is described by a polynomial with coefficients, with the help of which the interpolation of the generalized coordinates, velocities and accelerations is carried out when moving the fixing manipulator with the manual principle of movement 1 from one point to another. Figure 31 shows a graph of the movement of the link of the fixing manipulator with the manual principle of movement by a given angle. Surgeon 8 manually moves the link from the initial position q1 to the final position q2. When approaching the target position at time t1, the braking torque smoothly increases from Mmin to Mmax by changing the voltage supplied to the automatically controlled brake 14 until the specified position is reached at time t2. In this case, the speed of movement of the link V at a constant force exerted by the surgeon 8 on the link gradually decreases, since the acceleration of the link becomes negative. After fixing the link in the specified position with the help of the automatically controlled brake 14, the fixation of the eccentric clamp is applied to implement the possibility of a force action on the rotary fixing units of the fixing manipulator with the manual movement principle. Thus, a two-stage adjustable stop of the manual fixing manipulator with the manual movement principle 1 in a specified direction is carried out. After fixing all links of the fixing manipulator with the manual movement principle in a given configuration, a surgical wireless device 146 is installed in the working element 2 of the fixing manipulator with the manual movement principle for performing surgical manipulations using the surgical instrument 5 and obtaining information about the progress of the surgical manipulation being performed for subsequent presentation of this information to the surgeon 8 for intraoperative analysis. Intraoperative navigation of the surgical instruments 5 is carried out using a volumetric target visualizing the coordinates of the position of the end point of the surgical instruments with fasteners having spherical markers of the stereophotogrammetric measuring system.

The method of using a surgical wireless device with a working element and the method of installing the surgical wireless device in the working element using a split clamp are shown in Figure 32. The surgical wireless device 146, within the framework of a robotic medical system, is used to analyze the progress of surgical manipulations.

The process of obtaining information on the progress of the surgical manipulation being performed for subsequent presentation of this information to the doctor for intraoperative analysis is shown in Figure 33. To analyze the progress of the surgical manipulation, the surgical instrument 5 is fixed in the final link of the surgical wireless device 146. Data from the surgical wireless device 146 transmits data on torques, linear forces and orientation of the surgical instrument 5 in space on the control stand 4 via the wireless Wi-Fi interface. Then, the obtained data are output in parallel mode to the user interface of the information software 148 of the robotic medical system and are recorded in the log file with data 147 for further processing.

The intraoperative navigation tab, shown in Figure 34, is used to evaluate the position of surgical instruments in relation to the plan for the selected vertebra and to control the system during surgery. This tab schematically shows the process of positioning the transpedicular screw, a two-dimensional projection and the depth of insertion. The tab is divided into several areas. Main controls: spine DICOM file transfer function editing button 195, first vertebra DICOM file transfer function editing button 196, first vertebra display on/off button 197, virtual scene display window 198, active vertebra selection field 199, active surgical instrument selection field 210, error information output field, surgical instrument calibration accuracy and distance from the target point and orientation deviation during surgery 201, active vertebra registration process start button 202, surgical instrument insertion scale mark along the specified trajectory associated with the entry point 203, surgical instrument insertion scale mark along the specified trajectory associated with the current position of the active surgical instrument 204, surgical instrument insertion scale mark along the specified trajectory associated with the target point 205, graphical tool for estimating probe orientation relative to the screw location trajectory in the active vertebra 206, graphical tool for estimating probe distance from trajectories of screw placement in active vertebra 207.

The central part of the window contains a tool for assessing the position and orientation of the probe relative to the trajectory of the screw in the selected vertebra. After selecting the vertebra and the tool used, this window will visually display the distance of the surgical instrument from the trajectory point (along the normal), the deviation in orientation from the trajectory, and the distance from the target point. The position of the white cross shows the deviation of the surgical instrument from the trajectory in position, the position of the white cross relative to the center of the window (marked with a white circle) corresponds to the displacement of the surgical instrument relative to the trajectory. The red circles show the deviation of the surgical instrument in orientation and change orientation depending on the magnitude of the deviation. The scale on the right indicates the position of the surgical instrument relative to the start and end points of the trajectory. The upper circle corresponds to the point of insertion of the surgical instrument, the lower one - to the target point. If necessary, the user can enable the display of force and torque data in order to inform the surgeon during the operation.

After selecting a surgical instrument, the user has access to the surgical instrument calibration function. To perform calibration, the user must place the end point of the surgical instrument in a special groove on the surface of the reference mount, then rotate around the end point of the stroke measurement unit so that the markers on the reference mount and the stroke measurement unit are in the field of view of the stereophotogrammetric system cameras. The position of the navigation system cameras can be changed during calibration, since it determines the position of the marker groups relative to the mount, and not relative to the cameras themselves. After registration is complete, the information about the result and the error value will be displayed in the information output field.

The user interface of the information software module for analyzing the progress of the surgical manipulation of screwing in transpedicular screws, graphically visualizing information on the progress of this process to the doctor on the screen, is shown in Figure 35. The interface includes a menu with a choice of parameters of the surgical manipulation being performed 208 set automatically or manually, a control menu for connecting and performing additional functions for recording and processing data on the progress of the surgical manipulation 209. The main parts of the interface are a window for outputting data in numerical form 210, which presents to the surgeon the numerical values of the current readings of the torque and the depth of entry of the surgical instrument into the vertebral body, and a window for outputting graphic information on the progress of the surgical manipulation 211, which represents the dependence of the torque on the depth of entry of the medical instrument and the calculated average trend line of the change in this dependence.

Claims (5)

1. A robotic medical system for performing neurosurgical operations on the spine, consisting of a rotary locking unit according to claim 2, configured to lock its output link with a movable rail base of a locking manipulator with a manual movement principle, having a first automatically controlled brake configured to be controlled by connecting a direct electric current and with the ability to adjust the value of the direct electric current for braking the output link from manual rotation with a braking torque value of up to 2.5 N m, and a manual locking eccentric clamp configured to be activated by a mechanical removable handle to fix the output link with a load value for the braking torque of up to 150 N m, a locking manipulator with a manual movement principle according to claim 3, consisting of four rotary locking units connected in series with each other by means of links, configured to fix their output link with a movable rail base of the locking manipulator with a manual principle movement, having a rotary eccentric handle, configured to change the height for positioning the working element in the range from 243 mm to 338 mm relative to the rail base of the fixing manipulator with a manual movement principle above a patient with a torso thickness in the range from 140 mm to 240 mm, wherein the third rotary fixing unit from the movable rail base of the fixing manipulator with a manual movement principle has a second automatically controlled brake, configured to increase the braking torque of the output link of the third rotary fixing unit from manual rotation to 5 N * m; a control system for the fixing manipulator with a manual movement principle; a working element consisting of a six-component sensor configured to determine the forces and moments arising during the interaction of surgical instruments with the operated tissues of the spine; seven locating holes in the shape of a cone; a split elastic clamp, a set of surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system according to claim 4, consisting of a surgical wireless device; fasteners with integrated spherical markers of a stereophotogrammetric measuring system for surgical instruments in the form of a needle probe and a split elastic clamp, designed with the possibility of binding a 3D model of a vertebra to the actual position of the vertebra; fasteners with integrated spherical markers of a stereophotogrammetric measuring system for a set of instruments for a surgical wireless device in the form of a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw; a parallelepiped with holes for a neurosurgical drill and a trapezoidal prism for a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw for calibrating the orientation parameters of surgical instruments in the 3D space of a robotic medical system. 2. A rotary locking unit, designed with the possibility of locking its output link with a movable rail base of a locking manipulator with a manual movement principle, having a first automatically controlled brake, designed with the possibility of control by connecting a direct electric current and with the possibility of adjusting the value of the direct electric current for braking the output link from manual rotation with a braking torque value of up to 2.5 N*m, and a manual locking eccentric clamp, designed with the possibility of being activated by a mechanical removable handle to fix the output link with a load value for the braking torque of up to 150 N*m. 3. A fixing manipulator with a manual movement principle, consisting of four rotary fixing units connected in series to each other by means of links, configured to fix their output link with a movable rail base of the fixing manipulator with a manual movement principle, having a rotary eccentric handle configured to change the height for positioning the working element in the range from 243 mm to 338 mm relative to the rail base of the fixing manipulator with a manual movement principle over a patient with a torso thickness in the range from 140 mm to 240 mm, wherein the third rotary fixing unit from the movable rail base of the fixing manipulator with a manual movement principle has a second automatically controlled brake configured to increase the braking torque of the output link of the third rotary fixing unit from manual rotation to 5 Nm; a control system for a fixing manipulator with a manual movement principle, configured to switch power between four rotary fixing units and to select a rotary fixing unit for releasing fixation using a power redistribution element and performing manual movement; a working element consisting of a six-component sensor configured to determine forces and moments arising during the interaction of surgical instruments with the operated tissues of the spine; seven cone-shaped locating holes configured to bind a mathematical axis for guiding the movement of surgical instruments of the working element to its actual location of the mathematical axis for guiding the movement of surgical instruments of the working element in the space of the working area of the fixing manipulator with a manual movement principle using a needle probe, four threaded holes configured to set the position of the manipulation for moving the links of the fixing manipulator with a manual movement principle; a split elastic clamp configured to be used as a guide and to clamp bushings installed on the surgical instruments of the working element. 4. A set of surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system, consisting of a surgical wireless device designed with the ability to collect intraoperative data on the forces and moments arising during the interaction of surgical instruments with the operated tissues of the spine; fasteners with integrated spherical markers of a stereophotogrammetric measuring system for surgical instruments in the form of a needle probe and a split elastic clamp, made with the possibility of binding a 3D model of a vertebra to the actual position of the vertebra, fasteners with integrated spherical markers of a stereophotogrammetric measuring system for a set of instruments for a surgical wireless device in the form of a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw: a parallelepiped with holes for a neurosurgical drill and a trapezoidal prism for a neurosurgical awl, a transpedicular tap and a transpedicular screwdriver with a screw for calibrating the orientation parameters of surgical instruments in the 3D space of a robotic medical system. 5. A method for navigating the working element of a robotic medical system for performing neurosurgical operations on the spine according to claim 1, consisting of rotary fixing units according to claim 2, a fixing manipulator with a manual movement principle according to claim 3 and a set of surgical instruments with integrated spherical markers of a stereophotogrammetric measuring system according to claim 4, in which preoperative planning of trajectories for inserting transpedicular screws is performed with volumetric visualization of the patient's vertebrae, with the possibility of their free orientation in 3D space and the possibility of visually adjusting the location of sections on 3D models of the vertebrae; binding of 3D models of the vertebrae to the actual position of the vertebrae in space is performed, carried out by measuring the coordinates of the spherical markers with a stereophotogrammetric measuring system on a needle probe and determining, using the tip of the needle of the needle probe, a set of vertebral surfaces in accordance with the binding algorithm; initializing the axis of the working element with a needle probe to determine the progress of surgical manipulations and the trajectory of insertion of surgical instruments in the robotic medical system according to paragraph 1; installing a wireless surgical device with a working element using a split elastic clamp; performing a process of obtaining information about the progress of the surgical manipulation being performed for subsequent presentation of the progress of the surgical manipulation being performed to the doctor for intraoperative analysis, and performing intraoperative navigation of surgical instruments using a volumetric target visualizing the coordinates of the position of the end point of the surgical instruments with fasteners having spherical markers of the stereophotogrammetric measuring system.