RU2736162C2 - Multifunctional device with replaceable surgical instruments for measuring forces and moments acting on them during neurosurgical operations - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device with replaceable surgical instruments for measurement of forces and moments acting on interaction with tissues of patients during neurosurgical operations includes a handle for manual manipulations, having fastening with retainer in form of button, adapter flange for attachment of force and moment measurement sensor, and replaceable surgical tools conjugated with structural connections. These compounds include a lap joint for the installation of neurosurgical spatulas and raspatory, a rectangular joint for the installation of chisels and bits, retractors, probes and conductors; threaded connection for installation of scalpels and knives; and cylindrical connection for installation of instruments for screwing of transpedicular screws and nuts, sleeves for punching of cortical layer of bone, drill for cutting holes in vertebrae, and neurosurgical tapping for threaded holes for transpedicular screws. Force and torque measuring sensor is connected to the data processing system. Data processing system includes a controller and a processing module supplied from the power module. Processing module is configured to exchange data with the controller. Controller has the ability to control the conversion and data processing. Data processing system through interfaces is connected to personal computer with possibility of displaying measurement data in graphical form, warning about approaching measured forces and moments to working range boundary and on possible breakage and breakdown of tissues.

EFFECT: technical result consists in providing surgical manipulations for a minimum time and high accuracy, thereby facilitating the work of surgeons.

1 cl, 10 dwg

Description

The invention relates to the field of medical technology, namely to devices and surgical instruments used in neurosurgery for work associated with the installation or removal of internal fixation devices, as well as for the dilution of soft tissues and their retention to create an operating field, which provides the convenience of the surgeon's operation. For example, the following basic tools are used to perform operations of transpedicular fixation of the vertebrae: awl, drill, devices for screwing transpedicular screws and nuts. And to provide access to soft tissues, various retractors, chisels and other instruments are used. It is possible to manipulate and navigate these instruments using specialized robotic or mechatronic devices. When designing such robotic and mechatronic devices in neurosurgery, questions arise related to the need to obtain optimal, convenient multifunctional structures that would allow for, simplify and improve surgical procedures, as well as, thereby, minimize the time of surgical intervention, facilitating the work of surgeons. A multifunctional device with interchangeable surgical instruments allows you to measure forces and moments from interaction with various tissues of patients (bones, meat, skin, etc.), to receive and process values of forces and moments in real time. These values are used to design optimal designs for robotic and mechatronic systems used in neurosurgery. This approach eliminates the need to develop preliminary non-optimized design options for robotic systems, which increases the speed of development and further positively affects the economic efficiency of the proposed robotic-medical systems.

Known patents for devices and tools for osteosynthesis in neurosurgery:

RU 64046 U1 (26.02.2006) - a device for the introduction of transpedicular screws, consisting of a T-shaped rod and a guide sleeve. This device facilitates the process of introducing transpedicular screws, ensures the reliability of fixation of the vertebrae, reduces the duration of the operation and increases the efficiency of the spine stabilization.

RU 114833 U1 (19.08.2011) - a device for screwing nuts and bolts in the depth of the surgical wound, consisting of a flat rectangular body, the proximal end of which is beveled at an angle of 45 °. This device provides a tighter fixation between a rectangular gear wheel made with a through channel in the form of an equilateral hexagon, with a bolt head, and also increases the compression effect when fixing the plates to the spinous processes.

RU 2615863 C2 (12.05.2015) - endoprosthesis of a vertebral body for minimally invasive (thoracoscopic) spinal fusion, a tool for implantation of an endoprosthesis with a fixing device. This device and instrument are used in the operations of anterolateral fusion in the surgical treatment of fractures and pathological processes of the thoracic and lumbar vertebrae.

Despite the fact that the above-described devices and instruments are used in neurosurgery for osteosynthesis, they have various functions that are not structurally combined on a single base, and none of them has sensors or sensitive elements that allow measuring forces and moments.

Known patents for devices and tools with the ability to measure force:

US 6730021 B2 (05/04/2004), US 9049989 B2 (06/09/2015) - tissue separators with the ability to measure force in one direction, its indication, including the limit value. These devices are retractors that allow the surgeon to measure and control the value of retraction force during surgery. However, the presented devices are highly specialized only for one function - retraction.

US 2006/0025656 A1 (02.02.2006) - retraction device with force measurement. This device includes several sequentially mounted retractors, each of which has the ability to measure force, however, this device also has limited functionality aimed only at retraction.

The above retractors have the ability to measure forces and moments, however, their stationary bases do not imply the possibility of introducing other surgical instruments.

Known patent RU 2322212 C1 (24.11.2004), which describes a set of instruments for implantation of an intervertebral joint prosthesis. This invention is used in neurosurgery and includes a set of instruments for implanting an intervertebral joint prosthesis in the space between the bodies of two vertebrae, which includes several different instruments, however, they also do not have a common base, and the ability to measure force.

Known patent EP 3473202 A1 (04.24.2019), which describes a method of using a robotic system for minimally invasive surgery in various areas of medical practice. The product proposed by the authors of the patent is capable of measuring forces and moments acting on various replaceable surgical instruments. However, instead of a handle that can be used by a surgeon to perform manual manipulation, this device already assumes the presence of a manipulator that replaces a human hand. In this case, the goal to design a robotic system with optimal design parameters is fulfilled only after the implementation of its non-optimized version. This leads to significant economic costs for the development of a design that will deliberately have false indicators. In addition, the authors do not specify the types of transitional connections between the tools used and the manipulator, as well as the way to change them. It should be noted that the authors of this patent do not imply a separate manual use by the surgeon of the proposed device outside the manipulator. And in the case of installing a sensor holder with tools in the form of a button, similar to the button given in patent RU 2080454 C1 (05/27/1997), the robotic system proposed by the authors of EP 3473202 A1 (04/24/2019) will not have the required accuracy.

Patent RU 2261648 C1 (11.02.2004) was chosen as the closest analogue (prototype). This is a device for illumination of the wound channel during the surgical treatment of intracerebral hemorrhage. This device has one single base - a handle, on which various neurosurgical spatulas are installed. However, this handle does not imply the installation of other surgical instruments and there are also no sensors or sensing elements that allow measuring forces and moments from interactions with various tissues.

Disclosure of invention

The proposed invention is aimed at solving the problem of measuring the forces and moments arising from the interaction of replaceable (replaceable) surgical instruments with human tissues (bones, meat, skin, nerves, brain tissue, gums, eyes, etc.).

EFFECT: obtaining quantitative data on forces and moments arising from manipulations with surgical instruments during neurosurgical operations. The limits of measurement of forces and moments depend on the installed sensor for measuring forces and moments, on the size and weight of each instrument used for a specific surgical operation, as well as on the type of manual surgical procedures.

The problem is solved, and the claimed technical result is achieved by the fact that in a multifunctional device for measuring forces and moments, structurally based on a single handle, there is a built-in sensor that measures forces and moments, and there is a set of replaceable surgical instruments mainly used for performing operations in neurosurgery , including tools for installing or removing internal fixing devices, and the following tools: chisel, retractor, chisel, spatula, guide, probe, raspator, scalpel, awl, drill (drill), etc., which are installed on the force and moment sensor using several adapters (flanges).

The claimed technical solution allows, in contrast to the nearest prototype, to measure the forces and moments arising from the interaction of removable surgical instruments with human tissues, taking into account the weight and size of the removable instrument, as well as to install a significantly larger number of removable surgical instruments. The use of this device will allow in the future to develop the design of a robotic system manipulator with optimal rigidity and weight, eliminating the need to assemble a preliminary non-optimized design option. The use of installations with greater than necessary rigidity and weight will lead to an increase in the size of the manipulator, its cost, and complicate its use in neurosurgery.

Brief Description of Drawings

The invention is illustrated by images, where:

Figure 1 shows the design of a multifunctional device with replaceable surgical instruments for measuring the forces and moments acting on them

Figure 2 shows a set of typical connections that ensure the pluralism of installed surgical instruments and allow them to be changed

Figure 3 shows the first part of a set of interchangeable surgical instruments installed in a multifunctional force and moment measuring device

Figure 4 shows the second part of a set of interchangeable surgical instruments installed in a multifunctional device for measuring forces and moments

Figure 5 shows the data processing system of a multifunctional device with replaceable surgical instruments for measuring the forces and moments acting on them

Figure 6 (a) and (b) show photographs of experimental studies on the measurement of forces and moments using a multifunctional device on back phantoms

Figure 7 shows graphs of the measured values of the forces and moments arising when the pedicle screw is screwed in.

Figure 8 shows graphs of the measured values of forces and moments arising from the expansion of soft tissues

Figure 9 shows the algorithm of the HMI software

Figure 10 shows the program algorithm executed by the controller of the sensor data processing system

The positions shown in the pictures correspond to the following:

1. A handle designed for manual manipulations performed by a surgeon, which is a single base for a multifunctional device.

2. A snap-on mount that allows some removable surgical instruments to be installed, and an adapter flange for attaching a force and moment transducer.

3. Transitional flange for the sensor for measuring forces and moments.

4. Sensor for measuring forces and moments.

5. Flange for the installation of removable surgical instruments.

6. An example of a tool from a set of interchangeable surgical instruments is a small-sized chisel or chisel with a rectangular attachment.

7. Wire that provides data transmission to the data processing module.

8. Flange to accommodate replacement surgical instruments for overlapping applications.

9. Flange to accommodate replaceable surgical instruments for rectangular connections.

10. Flange to accommodate replaceable surgical instruments for threaded connections.

11. Flange for fitting removable surgical instruments for cylindrical connections.

12. Attachment of replacement surgical instrument for overlapping joints.

13. Attachment of removable surgical instruments for rectangular connections.

14. Attachment of removable surgical instruments for threaded connections.

15. Attachment of removable surgical instrument for cylindrical connection.

16. Replaceable surgical instrument for tightening pedicle nuts with cylindrical attachment.

17. Replacement surgical instrument for tightening pedicle screws with cylindrical attachment

18. Replaceable surgical instrument - an awl with a cylindrical mount.

19. Replaceable Surgical Instrument - Cylindrical Taps.

20. Replaceable Surgical Instrument - Cylindrical Hole Cutting Drill.

21. Replaceable surgical instrument - threaded scalpel.

22. Replaceable surgical instrument - rectangular retractor.

23. Replaceable surgical instrument - small-sized rectangular retractor.

24. Replaceable surgical instrument - chisel or chisel with rectangular attachment.

25. Replaceable surgical instrument - a small-sized chisel or chisel with a rectangular attachment.

26. Replaceable surgical instrument - small-sized spatula with rectangular attachment.

27. Replaceable surgical instrument - rectangular spatula.

Implementation of the invention

A multifunctional device for measuring the forces acting on instruments during neurosurgical operations is an invention that has several versions that allow measuring forces and moments during operations in neurosurgery.

A multifunctional device for measuring the forces acting on the instruments during neurosurgical operations is shown in Figure 1, it consists of a handle 1, which has a fastener 2 with a lock in the form of a button, an adapter flange 3 for attaching a force and moment measurement sensor 4 and a flange 5 for installation replaceable surgical instruments, for example 6. Wire 7 is used to transfer data from the force and moment measurement sensor to the data processing system from the force and moment measurement sensor, which is shown in Figure 5. It consists of a processing module that communicates with a controller that controls the process transformations and data processing. The processing module and controller are powered by a power module, which is supplied with voltage from a power supply. Data on forces and moments from the data processing system via interfaces 2 and 3 are transmitted to the user into a human-machine interface - a personal computer that has a software interface that displays in graphical form and allows you to record or additionally process the obtained measurements.

The human-machine interface in a multifunctional device includes the ability to warn about the approach to the working range of the measured values of the forces and moments of the sensor, as well as warn about the approach of a critical situation in which rupture and breakdown of tissues with which removable surgical instruments interact during operations. The limit of the measured force is set by the neurosurgeon in the software, based on his experience and data obtained through multiple experimental studies. The multifunctional device software installed in the HMI is also capable of displaying force and torque data on the screen and signaling the approach of critical situations visually and with audible signals.

The algorithm of the software for the human-machine interface is shown in Figure 9. At the first stage of the program, the graphical interface of the application is initialized. Next, an attempt is made to connect to the server of the data processing system from the sensor. If the connection is successful, the polling cycle of the data processing system starts, during which the data packet is received, the data is checked for exceeding the limit threshold values, the data is displayed in a graphical environment and written to a text file. In the event that the device cannot connect to the host server, an error check is performed. A negative result of the error check returns the system to the stage of trying to connect to the server, and a positive result starts the error handling mode.

The program algorithm executed by the controller of the data processing system from the sensor is shown in Figure 10. After power is applied, the controller initializes the server to connect clients via data exchange protocols with the subsequent possibility of receiving control commands and transferring data received from the ADC unit. If there are no errors, the server goes into client standby mode. At the moment the client connects, an endless cycle of data reading from the ADC unit is launched with the subsequent transfer of data to the client. After each transfer, an error check is performed, the positive result of which, as in the case of an error detected at the server initialization stage, switches to the error processing mode.

The patented multifunctional device is capable of measuring forces and moments in accordance with the functions of the replaceable surgical instruments. Each surgical instrument connected to the multifunctional device has its own purpose or function, the force pattern of which becomes known through the measurement of forces and moments. Based on the flexibility requirements, the device is implemented on the basis of a multicomponent force and moment sensor, which includes the measurement of various forces and moments, for example, the measurement of three sensor forces along each axis of the Cartesian coordinate system and three moments around these axes. However, the sensor can have fewer measuring directions. The number of measured directions is determined by the specifics of the selected replaceable surgical instrument.

The replaceable surgical instruments used in the multifunction device are connected to a force and moment transducer. Figure 2 shows four connections that accommodate a variety of removable surgical instruments. The lapped joint, which has a corresponding flange 8 and a counterpart on the surgical instrument 12, is used to install flat instruments that are thin and create small forces of interaction with soft tissues perpendicular to the surface of the instruments. The rectangular connection, which has a corresponding flange 9 and a counterpart on the surgical instrument 13, is used to accommodate instruments that have a rigid rectangular shape and create large forces of interaction with soft tissues directed in all directions, including torsion. A threaded connection, which has a corresponding flange 10 and a counterpart on a surgical instrument 14, is used to install instruments that have a cylindrical or rectangular shape, and also create small forces of interaction with soft tissues directed along and across the axis of the instrument, excluding rotational forces around the axis tool. The cylindrical connection, which has a corresponding flange 11 and a counterpart on the surgical instrument 15, is used to accommodate instruments that are cylindrical in shape and create forces of interaction with soft tissues directed along the axis of the instrument, including torsion.

Examples of replaceable surgical instruments are shown in Figure 3 and Figure 4. An example of replaceable surgical instruments with an overlap joint are neurosurgical spatulas differing in size 26 and 27. To use a rectangular connection, it is advisable to use neurosurgical chisels or neurosurgical chisels (24, 25), as well as retractors (22, 23). When installing or removing fixation devices, it is convenient to use a cylindrical connection, which allows the use of interchangeable surgical instruments for screwing in pedicle screws 17 and nuts 16, piercing the cortical bone 18 (such an instrument as a neurosurgical awl), cutting holes in the vertebrae 20 (such an instrument as a neurosurgical drill ) and for cutting threaded holes for pedicle screws 19 (such as a neurosurgical tap). To cut soft tissues, a threaded connection is used, the tools in which are a set of scalpels and knives 21.

The proposed multifunctional device differs significantly from the prototype in that it has the ability to install a much larger number of surgical instruments, including the ability to measure the forces and moments arising from their interaction with human tissues during operations in neurosurgery. The multifunctional device has a handle designed for manual manipulation, which has a fastening with a lock in the form of a button, which allows you to switch between the possibilities of using replaceable surgical instruments with and without a sensor for measuring forces and moments.

To confirm the possibility of using a multifunctional device to measure forces and moments from the interaction of removable surgical instruments with human tissues, tests were carried out on back phantoms. Photos of the tests performed are shown in Figure 6.

Example 1:

Surgical manipulation of the pedicle screw screwing into the pedicle of the vertebral phantom made of composite foam using a multifunctional device is shown in Figure 6 (a). When performing this manipulation, the maximum force appeared along the Z axis of the multifunctional device - an axis parallel to the axis of rotation of the pedicle screw, and amounted to 64 N. The maximum moment was recorded around the X axis and amounted to 1.6 N * m.

Graphs of the measured values of the forces and moments arising when the pedicle screw is screwed in are shown in Figure 7.

Example 2:

Surgical manipulation to expand soft tissues is implemented on a back phantom made of hard transparent silicone and is shown in Figure 6 (b). When performing this manipulation, the maximum force appeared along the Y-axis of the multifunctional device and amounted to 34 N. The maximum moment was fixed around the X-axis, and amounted to 4.3 N * m.

Graphs of the measured values of forces and moments arising during the expansion of soft tissues are shown in Figure 8.

The ability to obtain quantitative data on the force and moments arising from the interaction of removable surgical instruments with soft tissues allows for optimal design of modern robotic and mechatronic systems. Optimal design presupposes various criteria by which the best solutions are sought. In this case, the main optimization criterion is understood as the rigidity of the structure, which is directly related to the force acting on the device being developed. Such a design process makes it possible to obtain convenient multifunctional designs that make it possible to carry out, simplify, improve and increase the accuracy of surgical procedures, as well as, thereby, minimize the time of surgical intervention, facilitating the work of surgeons.

Taking into account the foregoing, it can be concluded that the set task - measuring the forces and moments arising from the interaction of different surgical instruments with various tissues - was solved using a multifunctional device, and the claimed technical result is to obtain quantitative data on the forces and moments arising from manipulations surgical instruments during neurosurgical operations - achieved, eliminating the need to assemble a preliminary non-optimized version of the design of the robotic system.

The analysis of the claimed technical solution for compliance with the conditions of patentability showed that the features indicated in the independent claim are essential and interconnected with the formation of a stable set of necessary features unknown at the priority date from the prior art, sufficient to obtain the required synergistic (over-sum) technical result. Thus, the above information indicates the fulfillment of the following set of conditions when using the claimed technical solution:

объект, воплощающий заявленное техническое решение, при его осуществлении относится области медицинской техники, а именно к устройствам и хирургическим инструментам, применяемым в нейрохирургии для работы, связанной с установкой или удалением внутренних фиксирующих устройств;

an object embodying the claimed technical solution, in its implementation, relates to the field of medical technology, namely, devices and surgical instruments used in neurosurgery for work related to the installation or removal of internal fixing devices;

для заявленного объекта в том виде, как он охарактеризован в независимом пункте нижеизложенной формулы, подтверждена возможность его осуществления с помощью вышеописанных в заявке и/или известных из уровня техники на дату приоритета средств и методов;

for the claimed object in the form as it is characterized in the independent clause of the following formula, the possibility of its implementation is confirmed using the means and methods described above in the application and / or known from the prior art at the priority date;

объект, воплощающий заявленное техническое решение, при его осуществлении способен обеспечить достижение усматриваемого заявителем технического результата.

an object that embodies the claimed technical solution, when implemented, is capable of achieving the technical result perceived by the applicant.

Therefore, the claimed subject matter meets the criteria of patentability "novelty", "inventive step" and "industrial applicability" under the current legislation.

Claims (1)

A device with replaceable surgical instruments for measuring the forces and moments acting on them from interaction with the tissues of patients during neurosurgical operations, including a handle for manual manipulations with a fixation in the form of a button, an adapter flange for attaching a sensor for measuring forces and moments, and replaceable surgical instruments mated with structural joints, including an overlap joint for installing neurosurgical spatulas and raspators, a rectangular joint for installing chisels and chisels, retractors, probes and wires; threaded connection for installing scalpels and knives; and a cylindrical connection for installing tools for screwing pedicle screws and nuts, an awl for piercing the cortical layer of the bone, drills for cutting holes in the vertebrae, and neurosurgical taps for cutting threaded holes for pedicular screws, while the sensor for measuring forces and moments is connected to the data processing system , the data processing system includes a controller and a processing module powered by a power supply module, the processing module is configured to exchange data with the controller, the controller has the ability to control the process of converting and processing data, and the data processing system is connected via interfaces to a personal computer with the ability to display measurement data in graphic form, warning about the approach of the measured forces and moments to the border of the working range and about possible rupture and breakdown of tissues.

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