WO2016185302A1

WO2016185302A1 - Image-based surgical navigation system in a computer

Info

Publication number: WO2016185302A1
Application number: PCT/IB2016/052330
Authority: WO
Inventors: Alher Mauricio HERNÁNDEZ; Juan Diego LEMOS; Andres Felipe VALLEJO; Daniel ESTRADA; John Fredy OCHOA; Jhon Jairo VELÁSQUEZ
Original assignee: Universidad De Antioquia
Priority date: 2015-05-21
Filing date: 2016-04-25
Publication date: 2016-11-24
Also published as: CO7280147A1

Abstract

An image-based surgical navigation system, connected to a computer having the suitable software, permits surgeries to be carried out that are guided by previously recorded diagnostic images. The device makes it easier for the surgeon to position the surgical instrument over the diagnostic images and over the three-dimensional reconstruction achieved on the basis of said diagnostic images. In addition, the device facilitates the marking of events with the aid of a pedal connected to the computer, so that the doctor can record the coordinates of points of interest during the surgery. The system comprises a dual AC fields sensor (300) connected to each surgical instrument used, a source (200) of signals, and a pedal (400) for marking events, the activation of which pedal causes the system to store the variables of the moment or time interval of activation. The system has the capacity to store and process the information obtained by the sensors and a previous diagnostic image for the display thereof. The position of the dual sensors (300) is superimposed on the diagnostic image in order to orient the surgeon.

Description

SURGICAL NAVIGATION SYSTEM IN COMPUTER BASED ON

IMAGES

TECHNICAL FIELD OF THE INVENTION

[0001] The present invention is related to the field of diagnostic images, more specifically with the use of said images as support or aid during surgeries, and more specifically with a three-dimensional monitoring system of surgical instruments in terms of orientation and position based on electromagnetic fields.

BACKGROUND OF THE INVENTION

[0002] There are several devices in the state of the art that use diagnostic images as an aid during surgical operations. Among them are the following:

[0003] US 571 1299 A discloses a surgical guidance method and system for approaching a target within the body, the system includes a magnetic field generator on a support frame, a guide system controller, at minus a magnetic field sensor located in a surgical instrument, and a visual feedback device. The guidance system indicates the position of the surgical instrument with respect to a trajectory as the instrument approaches the surgical target within the body. The magnetic field generator establishes a magnetic field with geometric characteristics that indicate the path from an initial point to the target. The sensors detect the appreciable orientation of the magnetic field along the path, and the display device indicates whether the surgical instrument is aligned or misaligned with the path. The magnetic field generator is adjustable on the support frame so that the approach angle and path position can be selected. However, this document does not describe the detail of the sensors and provides a system that allows recording the events and variables of interest during the procedure. [0004] EP 1267741 B1 discloses a trajectory storage apparatus for an image-guided surgical navigation system, which allows storing and performing measurements on trajectories followed by surgical instruments, an icon representing the trajectory in Real time of the tracked instrument is superimposed on the pre-acquired images of the patient. Under the surgeon's command, the navigation system can store multiple instrument paths and create a static icon that represents each saved path. The surgeon can measure the flat angle between two paths, which is calculated in the image plane and therefore calculated separately for each image displayed; In addition, the surgeon has the option of calculating and showing the three-dimensional distance between two points belonging to any pair of trajectories. This device also does not allow recording or recording variables of interest related to the operation or the patient at relevant points during surgery.

[0005] EP 1421900 A1 discloses a positioning device with dynamic immunity to metals, includes a set of radiators that are arranged in the vicinity of the patient's body generating electromagnetic fields, a position sensor that generates agreement signals to the magnetic field, one or more reference elements designed to be placed in positions close to the sensor and generate reference signals in response to the magnetic fields, a control unit that determines for each reference element undistorted parameters according to its known position. The control unit receives the sensor and reference signals, calculates the error for each reference element in response to the interaction of a metallic element with the fields, and then calculates the position of the sensor from the sensor signal and the error calculated in the reference elements. This device is relatively complex, as it has sensors in fixed relative distances, accelerometer and gyro.

BRIEF DESCRIPTION OF THE INVENTION

[0006] The present invention relates to an electronic device that, connected to a computer with the appropriate software, allows surgery guided by previously registered diagnostic images. This device makes it easier for the surgeon to locate the surgical instruments on the diagnostic images and on the three-dimensional reconstruction achieved from them. Additionally, this device facilitates the marking of events with the support of a pedal connected to the computer so that the doctor can record the coordinates of points of interest during surgery. The device consists of four components, namely: transmitting antenna, information processing unit registered by the sensors, dual low interference sensors and a pedal for recording events. The sensors are connected to the processing unit and said unit, as well as the source and the pedal are connected to the computer that hosts the specific system software.

[0007] The position and displacement information of the dual sensor constructed to be coupled to the surgical instruments, is transmitted to a processing unit that in turn transmits it to the computer in charge of providing the visual feedback. Once the position information of the sensor is available in the space, said position is superimposed on the images of computed tomography and / or magnetic resonance in a visualization means, or screen, allowing the surgeon to know the position of his instruments in every moment within the surgical field.

[0008] The processing unit also has a port through which it can capture information from vital or electrophysiological signs monitors, so that such information is part of the navigation history. This component is of particular importance because the subsequent review of the procedure or even during the procedure allows to have information superimposed on the diagnostic images, which allows the doctor not to perform redundant navigation because he could easily verify on the computer the patient's condition when he navigated certain structures

[0009] The transmitting antenna of electromagnetic fields generates an alternating electromagnetic field of low frequency (20 KHz) in the X plane and with differences of 400 Hz in the Y and Z planes (19.6 KHz and 20.4 KHz respectively). Said three-dimensional electromagnetic field can be measured with sufficient accuracy in a 2 m radius wait. The dual sensor that includes the system allows to measure the field in the three axes in two positions of the space, the precision of said measurements in the presence of interferences caused Ferromagnetic materials are adjusted because the distance between the two sensor receiving antennas is known. Additionally, the dual sensor has an accelerometer that allows correcting the orientation of the sensor in three-dimensional space. The information captured by the sensor is conditioned and transmitted to the processing unit which in turn conditions and digitizes the information of up to two dual sensors to be sent to the computer.

[0010] On the other hand, the device has a digital pedal whose shape refers to the brain activation maps that allow the surgeon to mark events during the planning of the surgery or during the performance of the surgery. Said pedal generates events recorded by the processing unit so that the coordinates of the instruments can be captured and recorded in a synchronized manner. The event information as well as the entire navigation is stored in a removable memory located in the processing unit and in turn transmitted to the computer.

BRIEF DESCRIPTION OF THE FIGURES

[001 1] Figure 1: System components.

[0012] Figure 2: Modules that make up the processing unit.

[0013] Figure 3: Modules that make up the signal source.

[0014] Figure 4: Dual sensor components.

[0015] Figure 5: Components of the event marking pedal.

RELATIONSHIP OF ALL THE ELEMENTS ILLUSTRATED IN THE FIGURES

[0016] (100) Processing unit

[0017] (101) Upper cover of the processing unit housing

[0018] (102) Aluminum bottom sheet for electromagnetic insulation

[0019] (103) Electronic processing unit card

[0020] (104) Upper aluminum foil for electromagnetic insulation [0021] (105) Processing unit switch

[0022] (106) Lower cover of the processing unit housing

[0023] (107) Housing screw 1

[0024] (108) Housing screw 2

[0025] (109) Screw 3 of the housing

[0026] (1 10) Screw 4 of the housing [0027 (1 1 1 Screw 5 of the housing

[002 & (1 12 Electronic Card Screw 1

[0029; (1 13 Electronic card screw 2

[oo3o; (1 14 Electronic card screw 3

[0031 (1 15 Electronic card screw 4

[0032 (1 16 Sensor slot 1

[0033; (1 17 Sensor Slot 2

[0034 (1 18 External memory slot

[0035 (1 19 Physiological or Vital Signs Monitor Slot

[0036 (120 Slot for connection of Pe

[0037 (121 Slot for pedal connection for event marking

[0038 (200 signal source

[0039 (201 signal source housing

[0040 (202 transmitter antenna

[0041 (203 electronic signal source card

[0042 (204 base of the signal source housing

[0043 (205 coil cable in plane X

[0044 (206 coil cable in Y-plane

[0045 (207 coil cable in Z plane

[0046 (208 Precision capacitor coupled to X-plane coil

[0047 (209 Precision capacitor coupled to Y-plane coil

[0048 (210 Precision capacitor coupled to Z-plane coil

[0049 (300 dual sensor

[0050 (301 lower dual sensor housing

[0051 (302 dual sensor upper housing

[0052 (303 receiving antenna 1

[0053 (304 receiving antenna 2

[0054 (305 tuning and conditioning circuit of the receiving antenna: ora 2

[0055; (306 receiver antenna tuning and conditioning circuit: ora 1

[0056 I (307 copper winding in perpendicular configuration for the plane

X of antenna 1 [0057] (308) copper winding in perpendicular configuration for the plane

And from antenna 1

[0058] (309) copper winding in perpendicular configuration for the Z plane of antenna 1

[0059] (310) copper winding in perpendicular configuration for plane X of antenna 2

[0060] (31 1) copper winding in perpendicular configuration for the plane

And from antenna 2

[0061] (312) copper winding in perpendicular configuration for the Z plane of antenna 2

[0062] (313) Cable coupling connecting the dual sensor with the processing unit (100)

[0063] (400) pedal for event marking

[0064] (401) upper event marking pedal housing

[0065] (402) lower event marking pedal housing

[0066] (403) switch cover

[0067] (404) Electronic card for conditioning and USB transmission

[0068] (405) upper action plate

[0069] (406) electronic switch

[0070] (407) Pin that holds the pedal mechanism

[0071] (408) button spring

[0072] (409) Bottom plate of the pedal mechanism

DETAILED DESCRIPTION OF THE INVENTION

[0073] This invention seeks to solve four existing problems in image-guided navigation, interference caused by metals in devices based on alternating electromagnetic fields, easy surgical planning, post-verification of the procedures performed and the availability of physiological information of the patient during the procedure superimposed on the navigation environment. The proposed solution for each of the problems described above is presented below:

[0074] Metal interference is resolved through the use of dual sensors (see figure 4) that can be placed in the instruments attached to the patient's skull. Each dual sensor is composed of two units that measure three-dimensional electromagnetic fields, a three-dimensional accelerometer and a gyroscope. The components that measure the electromagnetic fields are at a known fixed distance, so that the coordinates measured by each sensor are verified and corrected according to the known distance between the two units, in addition said position information is corrected by the information of the accelerometer and gyroscope in cases where there are rapid movements or very high interference.

[0075] The problem of ease in surgical planning is solved by incorporating a pedal for marking events that are superimposed on the images by means of visualization such as a screen. With this tool the surgeon can mark the points of interest during the planning and also during the procedure. The software used in the computer will allow to trace trajectories and calculate distances between points of interest.

[0076] The subsequent verification of the procedures performed is facilitated by the storage system that saves the paths followed along with the marked events and the information from vital signs monitors or physiological activity.

[0077] Thanks to the ability to provide visualization of vital signs or physiological data on the computer screen as navigation is performed, the surgeon can make quick decisions that ensure patient safety. In addition, this information is part of the stored browsing history.

MEANS TO SOLVE PROBLEMS

[0078] The present invention addresses three problems clearly identified in commercially available systems and those reported in the literature and patent databases. First, a single AC field sensor coupled to the instrument is highly affected by the ferromagnetic elements of the environment thus producing errors in these positions and as a result an erroneous navigation. Second, the available and described systems do not have an event marking system and procedure record for later analysis. And third, no device has the possibility of synchronize the physiological information of the patient during the procedure superimposed on the navigation environment.

[0079] The present invention includes a processing unit with high computational performance and dedicated software for the processing of all generated information, a dual sensor that includes a three-dimensional accelerometer and a gyro, an event marking pedal, a port in the processing unit to capture the vital and / or physiological information of the patient during navigation.

[0080] According to the invention described above, a dual sensor that also includes a three-dimensional accelerometer and a gyro allows processing redundant position information with respect to the source of electromagnetic fields and correcting the problem of interference of ferromagnetic elements in the environment. Since the relative position of one sensor relative to the other is known, the possible locations of the two sensors in the presence of disturbances are reduced. Additionally, the accelerometer and gyroscope provide information about the movements performed in such a way that it can be identified if a change of position registered in the electromagnetic sensors actually corresponds to a movement performed or to interference.

[0081] A pedal that allows the marking of anatomical areas of interest in the planning and the marking of events in the procedure allow to improve the surgical planning avoiding using the keyboard or mouse as it would force the use of the hands which are occupied with surgical instruments; With a processing unit with excellent features and dedicated software, the system can include information on vital and electrophysiological signs of the patient and superimpose it with the information of the position of the surgical instruments and in addition to this, keep the navigation and procedure data at all times. for subsequent viewing. This aspect is of great relevance in functional surgeries, during which any change in vital signs provides information to the neurosurgeon about the areas of the brain that is intervening.

EFFECT OF THE INVENTION [0082] The present invention solves the problems of using low frequency alternating electromagnetic fields in image-based navigation, notably improving the accuracy in the location of the instruments in the surgical field and the use of metallic instruments. Additionally, it allows surgery planning by marking the areas of interest with the help of a pedal and displaying them immediately on the diagnostic images, which is more practical than marking areas of interest with a computer mouse or keyboard. Regarding patient safety, the present invention makes it easier for the doctor to make decisions because he can have functional information about the patient superimposed on the navigation images. Finally, the present invention allows storing the entire navigation, marking the events of interest along with the physiological information of the moments in which the events occur.

DESCRIPTION OF THE PREFERRED MODE OF THE INVENTION

[0083] Figure 1 corresponds to a view of the three modules that make up the present invention. The processing unit (100), the signal source (200), the dual sensor (300) and the pedal for event marking (400).

[0084] Figure 2 shows the different components of the processing unit module (100). This module consists of a housing composed of the covers (101 and 106) fastened with the screws (107 - 1 10). The sheets (102 and 104) are 0.5 mm aluminum pieces that allow shielding the electronic card against electromagnetic interference. The electronic card (103) processes the information transmitted by the two dual sensors (300) that the system has and a USB type communication port (120) that transmits the information to the computer. The dual sensors are connected through the ports (1 16 and 1 17). The processing unit also has a power switch (105) in the unit housing, an external memory slot (1 18), a port for receiving data from an external physiological monitor (1 19), a pedal connector event marking (121), source and processing unit and information management (computer). The electronic card is attached to the housing with the screws (1 12-1 15).

[0085] Figure 3 shows the different parts that make up the signal source (200). This system is made up of a material housing ABS composed of the elements (201 and 204). The signal source also comprises a transmitting antenna (202, 205, 206, and 207), an electronic control card (203) and capacitors coupled to the coils in the three planes (208, 209 and 210). The transmitting antennas have an ABS core (202) and are copper windings in perpendicular configuration covering the X (205), Y (206) and Z (207) planes. This source is powered by the electronic card (203) which also has three precision capacitors (208, 209 and 210) tuned to the coils (205, 206 and 207).

[0086] Figure 4 shows the dual sensor (300) that is composed of two receiving antennas (303 and 304) have a core in ABS and their windings in X, Y and Z (307, 308 and 309) are connected to two independent tuning circuits (305 and 306). This system is connected by cable to the processing unit that conditions the position signals, accelerations and turns and transmits them together with the events generated by the pedal (400) to the computer. The independent signal tuning and conditioning circuit located on the electronic cards (305 and 306) also includes a 3D accelerometer and a gyroscope that facilitate position correction in the presence of high interference. The dual sensor system has a housing that fits under pressure and is constructed of ABS material composed of the elements (301 and 302).

[0087] Figure 5 shows the pedal for event marking (400). This pedal with the shape of the skulls used in brain mapping consists of a housing in ABS (401 and 402), a switch cover also in plastic (403). This system also includes electronic card for conditioning and USB transmission (404), and the pedal mechanism (405, 406,

407, 408, 409). The pedal mechanism consists of a lower plate (409), a spring (408) and an upper action plate (405). The pedal closing mechanism is pressurized using notches in the bottom plate of the housing (402). The element (406) corresponds to an electronic switch coupled to an electronic card that conditions the signal and transmits the events via cable to the processing unit.

Claims

1. An image-based surgical navigation system comprising:

to. a dual AC field sensor (300) connected to each surgical instrument used;

b. a signal source (200);

C. an event marking pedal (400) whose activation causes the system to store the variables of the instant or time interval of activation;

d. a processing unit (100) that receives the information from the dual sensors (300), is connected to the pedal (400), stores information and processes the information for display; Y

and. display means showing the positions of the dual sensors (300) superimposed on a diagnostic image.

wherein each dual sensor (300) is formed by two receiving antennas (303, 304) separated from each other, each antenna (303, 304) comprising three copper windings (307, 308, 309) perpendicular to each other.

2. The system according to claim 1, wherein each dual sensor (300) further comprises an accelerometer.

3. The system according to any of claims 1 or 2, wherein each dual sensor (300) further comprises a gyroscope.

4. The system according to any of the preceding claims, wherein each dual sensor (300) further comprises electronic cards (305, 306) for signal tuning and conditioning.

5. The system according to any of the preceding claims, further comprising a dual sensor (300) attached to the patient's skull.

6. The system according to any of the preceding claims, wherein the signal source (200) is formed by three copper windings (205, 206, 207) perpendicular to each other.

7. The system according to claim 6, wherein the signal source (200) comprises three precision capacitors (208, 209, 210) tuned to the coils (205, 206, 207).

8. The system according to any of the preceding claims, wherein the signal source (200) is a low frequency antenna.

9. The system according to any of the preceding claims, wherein the processing unit (100) further comprises a port for receiving an external memory (1 18).

10. The system according to any of the preceding claims, wherein the processing unit (100) further comprises a connection to a computer (120).

11. The system according to any of the preceding claims, wherein the processing unit (100) further comprises a connection to a vital signs monitor (1 19).